Inflammopharmacology. 2023 Aug 21. doi: 10.1007/s10787-023-01264-3. Online ahead of print.

ABSTRACT

This study aimed at determining whether there is a difference in the safety profile between fast release (FR) aspirin tablets and regular galenic formulations of aspirin. This study was based on a clinical study database pool (Bayer HealthCare) including 84 clinical studies and 16,095 human subjects. The meta-analysis included 72 studies applying a single dose of aspirin of at most 1000 mg and was, therefore, based on individual data from 9288 subjects. Of these, 6029 subjects took aspirin and 3259 subjects took placebo. Endpoints were adverse events (AEs) of any kind and, especially of gastrointestinal (GI) nature. Event incidence and odds ratios (OR) based on Mantel-Haenszel risk estimates were calcuated. Subjects on aspirin FR had a significantly decreased OR of 0.65 [0.48, 0.90] [95% confidence interval] for all AEs and of 0.39 [0.20, 0.79] for drug-related all AEs versus placebo. The risk of all GI AEs tended to be reduced for subjects on aspirin FR (0.65 [0.41; 1.03]), but not for drug-related GI AEs. Subject on aspirin mono and aspirin mono (plain only, w/o FR) showed an increased risk of drug-related all AEs compared to placebo (1.34 [1.11; 1.62] and 1.43 [1.13; 1.80]). However, subjects on aspirin FR and those on regular aspirin had almost the same risk of all determined AEs. In conclusion, aspirin FR tablets showed a comparable GI tolerability to regular galenic formulations of aspirin after short-term treatment. Major GI complication did not occur after intake of any galenic formulation of aspirin.

PMID:37603157 | DOI:10.1007/s10787-023-01264-3

J Hypertens. 2023 Aug 15. doi: 10.1097/HJH.0000000000003536. Online ahead of print.

ABSTRACT

OBJECTIVE: Cough caused by angiotensin-converting enzyme inhibitors (ACEIs) limits their clinical application and cardiovascular benefits. This randomized trial investigated whether genotype-guided perindopril use could reduce drug-related cough in 20 to 79-year-old individuals with hypertension.

METHODS: After screening 120 patients and randomization, 68 were assigned to genotyping (n = 41) and control (n = 27) groups. NELL1 p.Arg382Trp (rs8176786) and intron (rs10766756) genotype information was used to subdivide the genotyping group into high-risk and low-risk subgroups with at least one or no risk alleles for ACEI-related cough, respectively. The high-risk subgroup received candesartan (8 mg/day) for 6 weeks, whereas the low-risk subgroup received perindopril (4 mg/day). The control group, which was not genotyped, received perindopril (4 mg/day). The primary outcome variables were cough and moderate/severe cough; the secondary outcome variable was any adverse event.

RESULTS: During the 6-week period, the risk of cough was lower in the genotyping group than in the control group [five (12.2%) and nine (33.3%) participants, respectively; hazard ratio: 0.25; log-rank P = 0.017]. The moderate/severe cough risk was also lower in the genotyping group [one (2.4%) and five (18.5%) participants, respectively; hazard ratio: 0.12; log-rank P = 0.025]. Differences in cough (hazard ratio: 0.56; log-rank P = 0.32) and moderate/severe cough risk (hazard ratio: 0.26; log-rank P = 0.19) between the low-risk and control groups were not significant. The risk of total adverse events was similar between any two groups.

CONCLUSION: Cough risk was lower during genotype-guided treatment than during conventional treatment. These results support the utility of NELL1 variant data in clinical decision making to personalize renin-angiotensin system blocker therapy use.

TRIAL REGISTRATION: ClinicalTrials.gov number: NCT05535595 (retrospectively registered at September 7, 2022).Video Abstract style, http://links.lww.com/HJH/C257.

PMID:37602458 | DOI:10.1097/HJH.0000000000003536

Explor Res Clin Soc Pharm. 2023 Jul 24;11:100313. doi: 10.1016/j.rcsop.2023.100313. eCollection 2023 Sep.

ABSTRACT

Arterial hypertension is a lifelong disease, which management is recognized as the most effective way to reduce cardiovascular mortality. Even though there is extensive evidence on the benefits of lifestyle modification and antihypertensive treatment, many patients with hypertension do not reach blood pressure targets. This paper aims to review the history of antihypertensive treatment of one patient and identify the drug related problems that occurred over the study period. In this case report, the patient's health record was studied, guidelines checked and a semi-structured interview conducted. Drug related problems were identified and possible pharmacist interventions were introduced. Drug related problems that could have contributed to the lack of hypertension control were adherence, side effects and disease-drug interaction. Identified pharmacists' interventions ranged from managing self-medication, to collaboration with general practitioner to change prescribing, and counselling the patient on medication use, including adherence. Even though the drug related problems were not that serious in the studied case, the patient could have valued from pharmacist intervention.

PMID:37601158 | PMC:PMC10433230 | DOI:10.1016/j.rcsop.2023.100313

Res Pract Thromb Haemost. 2023 Jun 22;7(5):100283. doi: 10.1016/j.rpth.2023.100283. eCollection 2023 Jul.

ABSTRACT

Heparin-induced thrombocytopenia (HIT) is an immune-mediated adverse drug effect from unfractionated or low-molecular-weight heparin that results in thrombocytopenia and potentially catastrophic thrombosis. HIT occurs due to the development of platelet-activating antibodies against multimolecular complexes of platelet factor 4 and heparin. Given the frequency of thrombocytopenia and heparin use among hospitalized patients, calculation of the 4Ts Score is recommended to identify patients at increased likelihood of HIT and direct further evaluation. In patients with an intermediate or high probability 4Ts Score, an immunoassay and functional assay are recommended to confirm or refute the diagnosis of HIT. Heparin avoidance and initiation of nonheparin anticoagulation are the mainstays of acute HIT management. In this illustrated review, we provide visual summaries of the diagnosis and management of HIT, highlighting connections between pathophysiology and clinical care as well as summarizing efforts in quality improvement in the field. We further emphasize common pitfalls and pearls in diagnosis and management to encourage evidence-based care. We include graphical representation of the unique challenges of HIT with cardiopulmonary bypass and also delineate autoimmune HIT and its subtypes.

PMID:37601013 | PMC:PMC10439402 | DOI:10.1016/j.rpth.2023.100283

Front Immunol. 2023 Aug 4;14:1223062. doi: 10.3389/fimmu.2023.1223062. eCollection 2023.

ABSTRACT

Hemophagocytic lymphohistiocytosis (HLH) is a severe and life-threatening hyperinflammatory condition characterized by excessive activation of macrophages and T cells and resulted in multi-organ dysfunction. HLH can be a primary disease or secondary to infections, malignancy, and some autoimmune diseases, including adult-onset Still's disease (AOSD) and systemic lupus erythematosus (SLE). However, it is rare for HLH to occur as a secondary condition to drug-induced lupus erythematosus (DILE). In this report, we present a case of HLH as an unusual complication during SLE treatment in a 31-year-old male patient. The patient initially suffered from active chronic hepatitis B (CHB) and was treated with pegylated INFα-2b (Peg-INFα-2b), tenofovir disoproxil and lamivudine. After 19 months, CHB obtained biochemical and virological response with HBsAg positive to HBsAb. The patient developed fever, headache, and cytopenia after Peg-INFα-2b treatment for 33 months, and laboratory studies revealed that ANA and anti dsDNA were positive. He displayed 5 features meeting the HLH-2004 criteria for diagnosis including fever, pancytopenia, hyperferritinemia, high levels of soluble CD25, and hemophagocytosis on bone marrow biopsy. The patient was initiated with a combination treatment of intravenous methylprednisolone pulse therapy, oral cyclosporine, and etoposide (VP-16), which was followed by a course of oral prednisolone, intravenous cyclophosphamide pulse therapy, and entecavir with complete response. To our knowledge, this is the first report of IFN-α induced SLE complicating with HLH. Physicians should consider the potential autoimmune side effects of IFN-α therapy and be alert to insidious HLH in patients diagnosed with SLE.

PMID:37600795 | PMC:PMC10436618 | DOI:10.3389/fimmu.2023.1223062

Oncol Lett. 2023 Jul 28;26(3):398. doi: 10.3892/ol.2023.13984. eCollection 2023 Sep.

ABSTRACT

Drug-induced thrombocytopenia is an adverse reaction characterized by accelerated platelet destruction. The present study described a case of thrombocytopenia that occurred during treatment with panitumumab. A female patient aged 49 years with metastatic rectal adenocarcinoma was treated with 9 out of 12 cycles of therapy with the standard of care, 5-fluorouacil (5-FU), oxaliplatin and folic acid, in association with panitumumab. During cycle 10, the patient developed severe thrombocytopenia, so the therapy was adjusted to a lower dosage; however, during cycle 11, after administration of panitumumab and before administration of 5-FU or oxaliplatin, the patient again presented with severe thrombocytopenia, with a platelet count <2×109/l. Immunology test results were negative apart from anti-nucleus antibodies (titration, 1:160). Naranjo's algorithm was used to establish the relationship between the use of panitumumab and thrombocytopenia onset and a score of 6 ('probable') was found. The temporal link between the onset of symptoms and administration of therapy, the relapse of thrombocytopenia after re-administration of the drug during cycle 11 (positive rechallenge) and Naranjo score of 6 ('probable') are crucial elements for establishing the causal relationship and the probability that thrombocytopenia was related to the administration of panitumumab. The patient then underwent two cycles of therapy with 5-FU, folic acid and irinotecan, in association with bevacizumab, experiencing again the same adverse event. Treatment with monoclonal antibodies was suspended altogether in favor of a switch to trifluridine/tipiracil. No other serious adverse events were reported.

PMID:37600345 | PMC:PMC10433710 | DOI:10.3892/ol.2023.13984

Front Cardiovasc Med. 2023 Aug 4;10:1156980. doi: 10.3389/fcvm.2023.1156980. eCollection 2023.

ABSTRACT

OBJECTIVES: Over the years, it has been found that colchicine offers substantial benefits in secondary prevention in patients with coronary artery disease (CAD). We studied the effects of colchicine timing because there are no guidelines about when to provide it during the perioperative period for patients with CAD.

METHODS: Up to January 1, 2023, seven electronic literature databases were screened (including three English databases and four Chinese databases). Randomized controlled trials included only treatment with colchicine in the perioperative period of CAD. The Cochrane Evaluation Tool was used to judge the risk of bias in research. Statistical analysis was performed by Stata 16.0 software.

RESULTS: We evaluated twelve studies that found colchicine to be effective in decreasing the occurrence of major adverse cardiac events (MACEs) (p < 0.00001), but it also raised the rate of adverse events (p = 0.001). Subgroup analysis showed the same benefit in lowering the incidence of MACE with continuous administration of a total daily dose of 0.5 mg postoperatively while minimizing drug-related side effects in the patients (p = 0.03). When it comes to preventing surgical stroke occurrences, postoperative administration is more effective (p = 0.006). While the effect of simultaneous preoperative and postoperative administration was marginally greater than other periods in reducing postoperative hs-CRP levels (p = 0.02).

CONCLUSION: Colchicine, a traditional anti-inflammatory drug, also reduces the risk of MACE by reducing inflammation after PCI. Administration at different periods had no significant effect on decreasing the occurrence of MACE, but when administered postoperatively, we advise continuous administration with a total daily dose of 0.5 mg to obtain the same benefit while minimizing the drug's side effects. Postoperative administration is the better measure to prevent postoperative stroke events. Due to the effective anti-inflammatory effect of colchicine, we recommend its use as early as possible in the perioperative period and its continued use at low doses in the postoperative period.

SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=316751, identifier CRD42022316751.

PMID:37600022 | PMC:PMC10438985 | DOI:10.3389/fcvm.2023.1156980

Gynecol Endocrinol. 2023 Dec;39(1):2247093. doi: 10.1080/09513590.2023.2247093.

ABSTRACT

The debate about contraception has become increasingly important as more and more people seek safe and effective contraception. More than 1 billion women of reproductive age worldwide need a method of family planning, and wellbeing, socio-economic status, culture, religion and more influence the reasons why a woman may ask for contraception. Different contraceptive methods exist, ranging from 'natural methods' (fertility awareness-based methods - FABMs) to barrier methods and hormonal contraceptives (HCs). Each method works on a different principle, with different effectiveness.FABMs and HCs are usually pitted against each other, although it's difficult to really compare them. FABMs are a valid alternative for women who cannot or do not want to use hormone therapy, although they may have a high failure rate if not used appropriately and require specific training. HCs are commonly used to address various clinical situations, although concerns about their possible side effects are still widespread. However, many data show that the appropriate use of HC has a low rate of adverse events, mainly related to personal predisposition.The aim of this review is to summarize the information on the efficacy and safety of FABMs and HCs to help clinicians and women choose the best contraceptive method for their needs.

PMID:37599373 | DOI:10.1080/09513590.2023.2247093

Intern Med J. 2023 Aug;53(8):1485-1488. doi: 10.1111/imj.16194.

ABSTRACT

There is a growing interest in the appropriate evaluation of penicillin adverse drug reaction (ADR) labels. We have developed machine learning models for classifying penicillin ADR labels using free-text reaction descriptions, and here report external and practical validation. The models performed comparably with expert criteria for the categorisation of allergy or intolerance and identification of high-risk allergies. These models have practical applications in detecting individuals suitable for penicillin ADR evaluation. Implementation studies are required.

PMID:37599225 | DOI:10.1111/imj.16194

Oncology. 2023 Aug 18. doi: 10.1159/000533420. Online ahead of print.

ABSTRACT

INTRODUCTION: The release of tumor-associated antigens with cytotoxic chemotherapy treatment may enhance the response to immune checkpoint blockade. Eribulin is a microtubule inhibitor with proven overall survival (OS) benefit in metastatic breast cancer (MBC), which may also enhance intratumoral vascular remodeling. Durvalumab, a humanized monoclonal antibody, targets the programmed cell death ligand-1 (PD-L1) receptor. This study sought to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of eribulin in combination with durvalumab, as well as the safety and preliminary antitumor activity of the combination in patients with previously treated HER2-negative (HER2-) MBC and recurrent ovarian cancer (ROC).

METHODS: Cohorts of 3-6 patients with HER2- MBC and ROC were treated in a modified 3+3 design. Eligible patients received escalating doses of eribulin (1.1mg/m2 or 1.4 mg/m2 IV on day 1 and day 8) with durvalumab (1.12g IV on day 1) in 21-day cycles until dose-limiting toxicity (DLT), intolerable adverse events (AEs), disease progression, or other reasons for withdrawal.

PRIMARY ENDPOINT: the rate of dose limiting toxicities (DLTs) during cycle 1 and 2 of therapy. Secondary endpoints: AE rate, Objective Response Rate (ORR), progression-free survival (PFS), and OS.

RESULTS: Nine patients with a median of 4 prior therapies for advanced disease were treated: 5 patients with HER2- MBC (1 with triple negative disease and 4 with hormone positive disease) and 4 patients with ROC. The RP2D of eribulin was 1.4mg/m2 in combination with durvalumab. There were no DLTs experienced during the first two cycles of therapy. The most common treatment-related AEs (>50%) were fatigue, neutropenia, decreased white blood cell count, anemia, AST and alkaline phosphatase elevation, hyperglycemia, and nausea; most were grade 1 or 2. There was one immune-related AE of grade 3 (hepatitis) after 5 cycles of treatment, for which patient came off study. Two other patients discontinued study drug related to toxicity [neutropenia (n=1), hepatic toxicity (n=1)]. ORR was 55% and 4 additional patients experienced 3 stable disease. All MBC patients exhibited a response to therapy. Median PFS was 6.2 months. Median OS was 15.0 months.

CONCLUSION: The combination of eribulin at a dose of 1.4 mg/m2 with standard dose durvalumab had a favorable AE profile in patients with previously treated HER2- MBC and ROC. The early anti-tumor activity observed in all MBC patients enrolled in the study suggests that further investigation of this combination is warranted.

PMID:37598677 | DOI:10.1159/000533420

Z Rheumatol. 2023 Aug 19. doi: 10.1007/s00393-023-01398-3. Online ahead of print.

ABSTRACT

Modulation of the parasympathetic tone leads to extensive physiological reactions at several levels, including the decreased production of proinflammatory cytokines. Many studies have demonstrated that chronic inflammatory diseases are associated with reduced parasympathetic and increased sympathetic activities. Moreover, it was demonstrated that a low parasympathetic and a high sympathetic activity in patients with rheumatoid arthritis (RA) predicts a poor therapeutic response to anti-tumor necrosis factor (TNF) treatment compared to RA patients with a more balanced autonomic nervous system. The autonomic equilibrium could be restored by electrical stimulation of the vagus nerve. Considering the patients who do not sufficiently respond to the available drugs, patients for whom the effectiveness of the drugs wanes over time, or have drug-related adverse events, a nonpharmacological approach such as bioelectronics might be a useful supplement as an instrument in the successful extension of the therapeutic armamentarium for rheumatic diseases; however, there is a great need for further studies and the development of novel therapeutic strategies in the field of neuroimmunology.

PMID:37597013 | DOI:10.1007/s00393-023-01398-3

BMC Public Health. 2023 Aug 18;23(1):1576. doi: 10.1186/s12889-023-16446-5.

ABSTRACT

BACKGROUND: Working as a hairdresser involves combined exposure to multiple chemicals in hair treatment products that may induce symptoms in airways and skin.

METHODS: In this cross-sectional study, perceived symptoms among Swedish hairdressers at 10 hair salons were surveyed through a questionnaire. Associations with personal exposure to volatile organic compounds (VOCs), including aldehydes, and their corresponding hazard index (HI), based on the estimated risk for non-cancer health effects, were examined. The prevalence of four out of 11 symptoms was compared to available reference datasets from two other studies of office workers and school staff.

RESULTS: All 11 surveyed symptoms were reported among the hairdressers (n = 38). For the whole study group, the most prevalent symptoms were dripping nose (n = 7) and headache (n = 7), followed by eczema (n = 6), stuffed nose (n = 5), cough (n = 5) and discomfort with strong odors (n = 5). Significant relationships between exposure and symptoms were scarce. The exception was total VOC (TVOC) exposure adjusted to worked years in the profession; a difference was observed for any symptom between hairdressers in the group with 20 + years compared to 0-5 years in the profession (logistic regression, OR 0.03, 95% CI 0.001-0.70). Out of the four symptoms available for comparison, the prevalence of headache and cough was significantly higher in hairdressers than in controls (OR 5.18, 95% CI 1.86-13.43 and OR 4.68, 95% CI 1.17-16.07, respectively).

CONCLUSIONS: Adverse health effects related to occupation was common among the hairdressers, implying a need for exposure control measures in hair salons. Symptoms of headache and cough were more frequently reported by hairdressers than staff in offices and schools. A healthy worker effect among the hairdressers was indicated in the group with 20 + years compared to 0-5 years in the profession. Significant relationships between measured exposure and symptoms were scarce but gave information about advantages and disadvantages of the different exposure measures. The study design could be improved by increasing the size of the study population, using a better match of reference data and increasing the applicability and representability over time of the measured exposure.

PMID:37596583 | PMC:PMC10436395 | DOI:10.1186/s12889-023-16446-5

BMC Womens Health. 2023 Aug 18;23(1):436. doi: 10.1186/s12905-023-02561-3.

ABSTRACT

BACKGROUND: Globally, hormonal contraceptives have proved to be effective in the prevention of unwanted pregnancies. However, despite evidence of the many benefits associated with the use of hormonal contraceptives, concerns related to their safety and side effects have been reported. We conducted a study to explore the perspectives on the side effects of hormonal contraceptives among women of reproductive age in Kitwe district of Zambia.

METHODS: An explorative qualitative study was done among 32 women of reproductive age (18-45 years). Participants were selected conveniently as they accessed family planning services at a designated reproductive, maternal, and child health facility. Data collection was done through in-depth interviews (IDIs). Recruitment of participants and data collection continued until the saturation point was reached. The interviews were recorded, translated, and transcribed verbatim. Data were imported into NVivo.x64 for coding and node generation after which categories and themes were developed manually.

RESULTS: Overall, participants demonstrated a considerable amount of knowledge of family planning, recounting the economic and health benefits as well as demerits of family planning use. The main reasons for discontinuing and switching hormonal contraceptive methods were the desire to get pregnant and the fear of unpleasant side effects, including excessive bleeding or prolonged menstruation, headache, dizziness, lower abdominal/back pain, and weight gain. Most importantly, participants cited concerns about the delay in the resumption of fertility after the termination of contraception and how the side effects disrupted their daily activities at home.

CONCLUSION: There is a need for family planning providers to offer family planning services that address the side effects of hormonal contraceptives during counselling and how women can manage them. Family planning services should adopt a patient-centred approach that takes into consideration the concerns regarding side effects and how this affects the quality of life among women. Also, there is a need to extend family planning services to include scheduled follow-ups and clinical management of contraceptive side effects among women.

PMID:37596577 | PMC:PMC10439553 | DOI:10.1186/s12905-023-02561-3

Lancet Psychiatry. 2023 Sep;10(9):693-705. doi: 10.1016/S2215-0366(23)00199-2.

ABSTRACT

BACKGROUND: Bipolar depression constitutes a major public health problem due to its substantial burden of disease. Although pharmacological interventions are available, guidelines required updated evidence synthesis to improve their current recommendations. In order to inform evidence-based prescribing, we investigated the comparative efficacy and tolerability of pharmacological interventions for acute bipolar depression.

METHODS: We conducted a systematic review and network meta-analysis. We searched for randomised controlled trials comparing pharmacological interventions with each other or placebo in adults with acute bipolar depression (type I, type II, or not otherwise specified), excluding those with substance misuse, unipolar depression, or schizophrenia, in MEDLINE, Embase, PsycINFO, Google Scholar, Cochrane Library, Web of Knowledge, CINAHL, and LILACS from database inception up to April 13, 2023. Criteria for eligibility were a duration of 2-16 weeks with masked outcome assessments, and we included combination, add-on design, and monotherapy studies. The co-primary outcomes were depressive symptoms, examined with standardised mean differences (SMDs), and manic switch, examined with odds ratios (ORs). We also investigated dropouts due to any reason, inefficacy, adverse events, and important side-effects as secondary outcomes. The confidence in the evidence was evaluated using Confidence-In-Network-Meta-Analysis (CINeMA). The study was registered with PROSPERO, CRD42020171726.

RESULTS: We analysed data from 101 randomised controlled trials covering 20 081 participants, 8063 men (41·7%) and 11 263 women (58·3%; sex not available in four studies), mean age 41·0 years (range of means 28·7-53·6 years), and 68 medications and placebo. Ethnicity data were not available. With moderate confidence in the evidence, olanzapine plus fluoxetine, quetiapine, olanzapine, lurasidone, lumateperone, cariprazine, and lamotrigine were more efficacious than placebo in reducing depressive symptoms, with SMDs ranging from 0·41 (95% CI 0·19-0·64) for olanzapine plus fluoxetine to 0·16 (0·03-0·29) for lamotrigine. Several other drugs might also be efficacious, but the confidence in the evidence was very low to low. Antidepressants as a class seem to be efficacious, but had a higher risk for manic switch compared to antipsychotics. Medications differed in their side-effect profiles.

INTERPRETATION: This is, to our knowledge, the largest network meta-analysis of pharmacotherapy for bipolar depression to date. Olanzapine plus fluoxetine, quetiapine, olanzapine, lurasidone, lumateperone, cariprazine, and lamotrigine were found to be more efficacious than placebo in adults with acute bipolar depression, with good confidence in the evidence, and to differ in their side-effect profiles. These findings can inform evidence-based care and the development of treatment guidelines internationally.

FUNDING: None.

PMID:37595997 | DOI:10.1016/S2215-0366(23)00199-2

Cochrane Database Syst Rev. 2023 Aug 18;8(8):CD013244. doi: 10.1002/14651858.CD013244.pub2.

ABSTRACT

BACKGROUND: 'Blue-light filtering', or 'blue-light blocking', spectacle lenses filter ultraviolet radiation and varying portions of short-wavelength visible light from reaching the eye. Various blue-light filtering lenses are commercially available. Some claims exist that they can improve visual performance with digital device use, provide retinal protection, and promote sleep quality. We investigated clinical trial evidence for these suggested effects, and considered any potential adverse effects.

OBJECTIVES: To assess the effects of blue-light filtering lenses compared with non-blue-light filtering lenses, for improving visual performance, providing macular protection, and improving sleep quality in adults.

SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; containing the Cochrane Eyes and Vision Trials Register; 2022, Issue 3); Ovid MEDLINE; Ovid Embase; LILACS; the ISRCTN registry; ClinicalTrials.gov and WHO ICTRP, with no date or language restrictions. We last searched the electronic databases on 22 March 2022.

SELECTION CRITERIA: We included randomised controlled trials (RCTs), involving adult participants, where blue-light filtering spectacle lenses were compared with non-blue-light filtering spectacle lenses.

DATA COLLECTION AND ANALYSIS: Primary outcomes were the change in visual fatigue score and critical flicker-fusion frequency (CFF), as continuous outcomes, between baseline and one month of follow-up. Secondary outcomes included best-corrected visual acuity (BCVA), contrast sensitivity, discomfort glare, proportion of eyes with a pathological macular finding, colour discrimination, proportion of participants with reduced daytime alertness, serum melatonin levels, subjective sleep quality, and patient satisfaction with their visual performance. We evaluated findings related to ocular and systemic adverse effects. We followed standard Cochrane methods for data extraction and assessed risk of bias using the Cochrane Risk of Bias 1 (RoB 1) tool. We used GRADE to assess the certainty of the evidence for each outcome.

MAIN RESULTS: We included 17 RCTs, with sample sizes ranging from five to 156 participants, and intervention follow-up periods from less than one day to five weeks. About half of included trials used a parallel-arm design; the rest adopted a cross-over design. A variety of participant characteristics was represented across the studies, ranging from healthy adults to individuals with mental health and sleep disorders. None of the studies had a low risk of bias in all seven Cochrane RoB 1 domains. We judged 65% of studies to have a high risk of bias due to outcome assessors not being masked (detection bias) and 59% to be at high risk of bias of performance bias as participants and personnel were not masked. Thirty-five per cent of studies were pre-registered on a trial registry. We did not perform meta-analyses for any of the outcome measures, due to lack of available quantitative data, heterogenous study populations, and differences in intervention follow-up periods. There may be no difference in subjective visual fatigue scores with blue-light filtering lenses compared to non-blue-light filtering lenses, at less than one week of follow-up (low-certainty evidence). One RCT reported no difference between intervention arms (mean difference (MD) 9.76 units (indicating worse symptoms), 95% confidence interval (CI) -33.95 to 53.47; 120 participants). Further, two studies (46 participants, combined) that measured visual fatigue scores reported no significant difference between intervention arms. There may be little to no difference in CFF with blue-light filtering lenses compared to non-blue-light filtering lenses, measured at less than one day of follow-up (low-certainty evidence). One study reported no significant difference between intervention arms (MD - 1.13 Hz lower (indicating poorer performance), 95% CI - 3.00 to 0.74; 120 participants). Another study reported a less negative change in CFF (indicating less visual fatigue) with high- compared to low-blue-light filtering and no blue-light filtering lenses. Compared to non-blue-light filtering lenses, there is probably little or no effect with blue-light filtering lenses on visual performance (BCVA) (MD 0.00 logMAR units, 95% CI -0.02 to 0.02; 1 study, 156 participants; moderate-certainty evidence), and unknown effects on daytime alertness (2 RCTs, 42 participants; very low-certainty evidence); uncertainty in these effects was due to lack of available data and the small number of studies reporting these outcomes. We do not know if blue-light filtering spectacle lenses are equivalent or superior to non-blue-light filtering spectacle lenses with respect to sleep quality (very low-certainty evidence). Inconsistent findings were evident across six RCTs (148 participants); three studies reported a significant improvement in sleep scores with blue-light filtering lenses compared to non-blue-light filtering lenses, and the other three studies reported no significant difference between intervention arms. We noted differences in the populations across studies and a lack of quantitative data. Device-related adverse effects were not consistently reported (9 RCTs, 333 participants; low-certainty evidence). Nine studies reported on adverse events related to study interventions; three studies described the occurrence of such events. Reported adverse events related to blue-light filtering lenses were infrequent, but included increased depressive symptoms, headache, discomfort wearing the glasses, and lower mood. Adverse events associated with non-blue-light filtering lenses were occasional hyperthymia, and discomfort wearing the spectacles. We were unable to determine whether blue-light filtering lenses affect contrast sensitivity, colour discrimination, discomfort glare, macular health, serum melatonin levels or overall patient visual satisfaction, compared to non-blue-light filtering lenses, as none of the studies evaluated these outcomes.

AUTHORS' CONCLUSIONS: This systematic review found that blue-light filtering spectacle lenses may not attenuate symptoms of eye strain with computer use, over a short-term follow-up period, compared to non-blue-light filtering lenses. Further, this review found no clinically meaningful difference in changes to CFF with blue-light filtering lenses compared to non-blue-light filtering lenses. Based on the current best available evidence, there is probably little or no effect of blue-light filtering lenses on BCVA compared with non-blue-light filtering lenses. Potential effects on sleep quality were also indeterminate, with included trials reporting mixed outcomes among heterogeneous study populations. There was no evidence from RCT publications relating to the outcomes of contrast sensitivity, colour discrimination, discomfort glare, macular health, serum melatonin levels, or overall patient visual satisfaction. Future high-quality randomised trials are required to define more clearly the effects of blue-light filtering lenses on visual performance, macular health and sleep, in adult populations.

PMID:37593770 | PMC:PMC10436683 | DOI:10.1002/14651858.CD013244.pub2

Pathol Oncol Res. 2023 Aug 2;29:1611300. doi: 10.3389/pore.2023.1611300. eCollection 2023.

ABSTRACT

Recent studies have highlighted a possible correlation between microbiota composition and the pathogenesis of various oncological diseases. Also, many bacterial groups are now directly or indirectly associated with the capability of stimulating or inhibiting carcinogenic pathways. However, little is known about the importance and impact of microbiota patterns related to the efficacy and toxicity of cancer treatments. We have recently begun to understand how oncological therapies and the microbiota are closely interconnected and could influence each other. Chemotherapy effectiveness, for example, appears to be strongly influenced by the presence of some microorganisms capable of modulating the pharmacokinetics and pharmacodynamics of the compounds used, thus varying the real response and therefore the efficacy of the oncological treatment. Similarly, chemotherapeutic agents can modulate the microbiota with variations that could facilitate or avoid the onset of important side effects. This finding has or could have considerable relevance as it is possible that our ability to modulate and modify the microbial structure before, during, and after treatment could influence all the clinical parameters related to pharmacological treatments and, eventually, the prognosis of the disease.

PMID:37593337 | PMC:PMC10427764 | DOI:10.3389/pore.2023.1611300

Pharmazie. 2023 Aug 1;78(8):141-149. doi: 10.1691/ph.2023.3554.

ABSTRACT

This study aimed to investigate adverse reactions to medications administered during palliative care and compare the responses of Board-Certified Pharmacists in Palliative Pharmacy (BCPPP) and non-BCPPP professionals. Methods: This multicentre prospective survey included hospital and community pharmacists who are members of the Japanese Society for Pharmaceutical Palliative Care and Sciences. Study participants included patients who experienced new drug reactions during the study period and responded to the requested survey items. The follow-up period for each eligible patient began on the day the pharmacists initiated the intervention and ended at discharge, death, or after one month of intervention. The primary endpoint was the impact of pharmacist intervention on adverse drug reactions. The pharmacists included in the study evaluated the severity of adverse drug reactions to assess the effect of their intervention using an integrated palliative care outcome scale before and after the intervention. Key findings: During the survey period, 79 adverse drug reaction intervention reports from 69 patients were obtained from 54 pharmacists (28 certified and 26 non-certified). The response rate was 1.62% (54/3,343). The management of palliative pharmacotherapy side effects by BCPPP and non-BCPPP significantly improved the patients' activities of daily living (P < 0.001). The BCPPP group intervened for significantly more patients with adverse drug reactions and overall adverse drug reactions than the non-BCPPP group (P < 0.023 and P < 0.013, respectively). Conclusion: BCPPP interventions can improve symptom management.

PMID:37592417 | DOI:10.1691/ph.2023.3554

Exp Parasitol. 2023 Aug 16:108593. doi: 10.1016/j.exppara.2023.108593. Online ahead of print.

ABSTRACT

Targeted delivery has not been achieved for anthelmintic treatment, resulting in the requirement of excess drug dose leading to side effects and therapeutic resistance. Gastrointestinal helminths take up lipid droplets from digestive fluid for energy production, egg development, and defense which inspired us to develop biocompatible and orally administrable albendazole-loaded solid lipid nanoparticles (SLN-A) that were derived from beeswax and showed drug loading efficiency of 83.3 ± 6.5 mg/g and sustained-release properties with 84.8 ± 2.5% of drug released at pH 6.4 within 24 h at 37 °C. Rhodamine B-loaded SLN showed time-dependent release and distribution of dye in-vitro in Haemonchus contortus. The sustained-release property was shown by the particles that caused enhancement of albendazole potency up to 50 folds. Therefore, this formulation has immense potential as an anthelminthic drug delivery vehicle that will be able to reduce the dose and drug-induced side effects by enhancing the bioavailability of the drug.

PMID:37595879 | DOI:10.1016/j.exppara.2023.108593

Urol Pract. 2016 Jan;3(1):7-11. doi: 10.1016/j.urpr.2015.04.004. Epub 2015 Oct 22.

ABSTRACT

INTRODUCTION: We reviewed the current literature for recommendations or guidelines for regular monitoring of patients 65 years old or older on long-term nitrofurantoin prophylaxis to prevent/detect adverse reactions.

METHODS: The 2012 Beers criteria recommended avoiding nitrofurantoin for long-term suppression due to potential pulmonary toxicity and the availability of safer alternatives. We performed a literature search on PubMed® for national organizations, textbooks and any report or publication advocating methods of followup to detect and/or prevent long-term nitrofurantoin related adverse reactions. Articles not in English and those related to children or pregnant women were excluded from analysis.

RESULTS: A total of 13 sources recommended various methods to improve the safety of patients on long-term nitrofurantoin suppression. Monitoring recommendations were vague, calling for increased scrutiny and education in general in 5 studies or on the part of the physician in 10 and/or the patient in 3. One study from 2008 and one from 2012 recommended biannual chest x-rays, liver function tests and kidney function monitoring but with no supportive prospective data to justify these guidelines. No study documented the role of these preventive guidelines in the early detection of long-term nitrofurantoin related adverse reactions and none addressed the cost-effectiveness of these additional monitoring tests.

CONCLUSIONS: While many sources give a variety of recommendations on monitoring an older patient on long-term nitrofurantoin prophylaxis, none appeared to be scientifically tested in the long term to detect adverse reactions or prevent them altogether.

PMID:37592466 | DOI:10.1016/j.urpr.2015.04.004

J Patient Saf. 2023 Oct 1;19(6):379-385. doi: 10.1097/PTS.0000000000001144.

ABSTRACT

OBJECTIVES: Older adults undergoing orthopedic procedures are commonly discharged from the hospital on opioids, but risk factors for postdischarge opioid-related adverse drug events (ORADEs) have not been previously examined. We aimed to identify risk factors for ORADEs after hospital discharge following orthopedic procedures.

METHODS: This is a retrospective cohort study of a national sample of Medicare beneficiaries 65 years or older, who underwent major orthopedic surgery during hospitalization in 2016 and had an opioid fill within 2 days of discharge. We excluded beneficiaries with hospice claims and those admitted from or discharged to a facility. We used billing codes and medication claims to define potential ORADEs requiring a hospital revisit within 30 days of discharge.

RESULTS: Among 30,514 hospitalizations with a major orthopedic procedure (89.7% arthroplasty, 5.6% treatment of fracture of dislocation, 4.7% other) and an opioid claim, a potential ORADE requiring hospital revisit occurred in 750 (2.5%). Independent risk factors included age of 80 years or older (hazard ratio [HR], 1.65; 95% confidence interval, 1.38-1.97), female sex (HR, 1.34 [1.16-1.56]), and clinical conditions, including heart failure (HR, 1.34 [1.10-1.62]), respiratory illness (HR, 1.23 [1.03-1.46]), kidney disease (HR, 1.23 [1.04-1.47]), dementia/delirium (HR, 1.63 [1.26-2.10]), anxiety disorder (HR, 1.42 [1.18-1.71]), and musculoskeletal/nervous system injuries (HR, 1.54 [1.24-1.90]). Prior opioid use, coprescribed sedating medications, and opioid prescription characteristics were not associated with ORADEs after adjustment for patient characteristics.

CONCLUSIONS: Potential ORADEs occurred in 2.5% of older adults discharged with opioids after orthopedic surgery. These risk factors can inform clinician decision making, conversations with older adults, and targeting of harm reduction strategies.

PMID:37589954 | DOI:10.1097/PTS.0000000000001144