BMC Pulm Med. 2023 Mar 8;23(1):79. doi: 10.1186/s12890-023-02367-x.

ABSTRACT

BACKGROUND: With the use of targeted drugs in lung cancer patients, targeted drug-induced interstitial lung disease (ILD) has attracted more and more attention. The incidence, time, and severity of different targeted drug-induced ILD vary. Almonertinib/HS-10296 is a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Post-marketing safety and effectiveness of almonertinib have been confirmed. The reported adverse events of almonertinib were mainly an increase in creatine phosphokinase, aspartate aminotransferase, and alanine aminotransferase, and onset of rash. Almonertinib-induced ILD is rare.

CASE REPORT: This paper reported the case of a patient with lung adenocarcinoma complicated with interstitial lung abnormality (ILA). Gene detection showed L858R mutation in exon 21 of the EGFR gene. After operation, almonertinib (110 mg per day) was prescribed. 3 months later, ILD was found by chest CT due to dyspnea.

MANAGEMENT AND OUTCOME: Subsequently, almonertinib was stopped. With the administration of intravenous glucocorticoid and oxygen inhalation, the patient's dyspnea was significantly regressed and lung lesions regressed on follow-up chest CT done after discharge.

DISCUSSION: This case suggested that we should pay attention to the existence of ILD/ILA before using targeted drugs. The use of targeted drugs should be more strictly controlled and monitored in patients with previous ILA or ILD. This paper also reviewed the relevant literature on the drug characteristics and summarized the risk factors of ILD caused by EGFR-TKI.

PMID:36890493 | DOI:10.1186/s12890-023-02367-x

Ther Apher Dial. 2023 Mar 8. doi: 10.1111/1744-9987.13980. Online ahead of print.

ABSTRACT

OBJECTIVE: To observe the effect of ticagrelor on the function of tunneled cuffed catheter (TCC) in maintenance hemodialysis (MHD) patients.

METHODS: Eighty MHD patients (control group: 39 cases, observation group: 41 cases) using TCC as vascular access were enrolled from January 2019 to October 2020 in the prospective study. Patients in the control group were routinely treated with aspirin for antiplatelet therapy, while patients in the observation group were treated with ticagrelor. The catheter life time, catheter dysfunction, coagulation function and antiplatelet drug-related adverse events of the two groups were recorded.

RESULTS: The median life time of TCC in the control group was significantly higher than that in the observation group. And the log rank test showed that the difference was statistically significant (P<0.001).

CONCLUSION: Ticagrelor may reduce the incidence of catheter dysfunction and prolong the life time of the catheter by preventing and reducing the thrombosis of TCC in MHD patients, without obvious side effects.

PMID:36889934 | DOI:10.1111/1744-9987.13980

J Med Internet Res. 2023 Mar 8;25:e41100. doi: 10.2196/41100.

ABSTRACT

BACKGROUND: Drug-induced suicide has been debated as a crucial issue in both clinical and public health research. Published research articles contain valuable data on the drugs associated with suicidal adverse events. An automated process that extracts such information and rapidly detects drugs related to suicide risk is essential but has not been well established. Moreover, few data sets are available for training and validating classification models on drug-induced suicide.

OBJECTIVE: This study aimed to build a corpus of drug-suicide relations containing annotated entities for drugs, suicidal adverse events, and their relations. To confirm the effectiveness of the drug-suicide relation corpus, we evaluated the performance of a relation classification model using the corpus in conjunction with various embeddings.

METHODS: We collected the abstracts and titles of research articles associated with drugs and suicide from PubMed and manually annotated them along with their relations at the sentence level (adverse drug events, treatment, suicide means, or miscellaneous). To reduce the manual annotation effort, we preliminarily selected sentences with a pretrained zero-shot classifier or sentences containing only drug and suicide keywords. We trained a relation classification model using various Bidirectional Encoder Representations from Transformer embeddings with the proposed corpus. We then compared the performances of the model with different Bidirectional Encoder Representations from Transformer-based embeddings and selected the most suitable embedding for our corpus.

RESULTS: Our corpus comprised 11,894 sentences extracted from the titles and abstracts of the PubMed research articles. Each sentence was annotated with drug and suicide entities and the relationship between these 2 entities (adverse drug events, treatment, means, and miscellaneous). All of the tested relation classification models that were fine-tuned on the corpus accurately detected sentences of suicidal adverse events regardless of their pretrained type and data set properties.

CONCLUSIONS: To our knowledge, this is the first and most extensive corpus of drug-suicide relations.

PMID:36884281 | DOI:10.2196/41100

Curr Drug Saf. 2023;18(2):138-142. doi: 10.2174/1574886317666220428125943.

ABSTRACT

There is a growing awareness of a disease at many levels, its treatment, and treatment outcomes including side effects. Alternative therapy techniques, herbal medicines and formulations are extensively acknowledged and practiced in India and around the world. Herbal medicine is usually considered being safe regardless of the absence of scientific evidence to support its claims. Several issues concerning the methods in which herbal medications are labelled, evaluated, sourced, and used are connected to herbal medicine. Herbal therapeutics in the management and treatment of diabetes, rheumatism, hepatic disorders and other mild to chronic diseases and disorders are widely accepted. However, the adversities are difficult to recognize. The idea that the nature is safe and may be taken without the prescription of a physician has resulted in widespread self-medication across the world, sometimes with disappointing results, side effects, or unpleasant after-effects. The existing pharmacovigilance paradigm and its accompanying tools were created in connection with synthetic medicines. Nevertheless, adopting these approaches to keep records of herbal medications' safety poses a distinct challenge. This might be due to the variations in the usage of non-traditional medicines, which can offer unique toxicological issues whether taken alone or in conjunction with other medications. The goal of pharmacovigilance is to identify, analyse, explain, and minimize the adverse reactions and other drug-related complications associated with herbal, traditional, and complementary medications. Systematic pharmacovigilance is required to collect accurate data on the safety of herbal medications to create adequate guidelines for effective and safe usage.

PMID:36883268 | DOI:10.2174/1574886317666220428125943

Expert Opin Drug Saf. 2023 Feb;22(2):111-114. doi: 10.1080/14740338.2023.2188189. Epub 2023 Mar 9.

NO ABSTRACT

PMID:36881668 | DOI:10.1080/14740338.2023.2188189

Sci Rep. 2023 Mar 7;13(1):3779. doi: 10.1038/s41598-023-28912-6.

ABSTRACT

As society continues to age, it is becoming increasingly important to monitor drug use in the elderly. Social media data have been used for monitoring adverse drug reactions. The aim of this study was to determine whether social network studies (SNS) are useful sources of drug side effects information. We propose a method for utilizing SNS data to plot the known side effects of geriatric drugs in a dosing map. We developed a lexicon of drug terms associated with side effects and mapped patterns from social media data. We confirmed that well-known side effects may be obtained by utilizing SNS data. Based on these results, we propose a pharmacovigilance pipeline that can be extended to unknown side effects. We propose the standard analysis pipeline Drug_SNSMiner for monitoring side effects using SNS data and evaluated it as a drug prescription platform for the elderly. We confirmed that side effects may be monitored from the consumer's perspective based on SNS data using only drug information. SNS data were deemed good sources of information to determine ADRs and obtain other complementary data. We established that these learning data are invaluable for AI requiring the acquisition of ADR posts on efficacious drugs.

PMID:36882478 | DOI:10.1038/s41598-023-28912-6

PLoS One. 2023 Mar 7;18(3):e0281983. doi: 10.1371/journal.pone.0281983. eCollection 2023.

ABSTRACT

Adverse events(AEs) related to hepatotoxicity have been reported in patients treated with immune checkpoint inhibitors (ICIs). As the number of adverse events increases, it is necessary to assess the differences in each immune checkpoint inhibitor regimen. The purpose of this study was to examine the relationship between ICIs and hepatotoxicity in a scientific and systematic manner. Data were obtained from the FDA Adverse Event Reporting System database (FAERS) and included data from the first quarter of 2014 to the fourth quarter of 2021. Disproportionality analysis assessed the association between drugs and adverse reactions based on the reporting odds ratio (ROR) and information components (IC). 9,806 liver adverse events were reported in the FAERS database. A strong signal was detected in older patients (≥65 years) associated with ICIs. hepatic adverse events were most frequently reported with Nivolumab (36.17%). Abnormal liver function, hepatitis, and autoimmune hepatitis were most frequently reported, and hepatitis and immune-mediated hepatitis signals were generated in all regimens. In clinical use, patients should be alert to these adverse effects, especially in elderly patients, who may be aggravated by the use of ICI.

PMID:36881599 | PMC:PMC9990950 | DOI:10.1371/journal.pone.0281983

In Vivo. 2023 Mar-Apr;37(2):955-961. doi: 10.21873/invivo.13168.

ABSTRACT

BACKGROUND/AIM: Pomalidomide is an immunomodulatory drug that is used to treat multiple myeloma. We examined the time-to-onset and outcome of lung adverse events (LAEs) related to pomalidomide in Japanese patients based on information obtained from the spontaneous reporting system of the Japanese Adverse Drug Event Report database (JADER) of the Pharmaceuticals and Medical Devices Agency.

PATIENTS AND METHODS: We analyzed adverse events (AEs) reports recorded between April 2004 and March 2021 from JADER. Data on LAEs were extracted, and the relative risk of AEs was estimated using the reporting odds ratio and 95% confidence interval. We analyzed 1,772,494 reports and identified 2,918 reports of AEs caused by pomalidomide. Of these, 253 LAEs were reportedly associated with pomalidomide.

RESULTS: Signals were detected for five LAEs: pneumonia, pneumocystis jirovecii pneumonia, bronchitis, pneumonia bacterial, and pneumonia pneumococcal. Pneumonia was the most frequently mentioned condition (68.8%). The median time-to-onset of pneumonia was 66 days, but some cases of pneumonia occurred as late as 20 months after the start of administration. Fatal outcomes were observed in two of the five AEs wherein signals were detected and were due to pneumonia and bacterial pneumonia.

CONCLUSION: Serious outcomes can occur after pomalidomide administration. It has been suggested that these LAEs occur relatively early after pomalidomide administration. Since some situations can result in fatal consequences, patients should be monitored for the emergence of these AEs over a prolonged period of time, especially for pneumonia.

PMID:36881059 | DOI:10.21873/invivo.13168

JAMA. 2023 Mar 7;329(9):713-715. doi: 10.1001/jama.2023.1002.

NO ABSTRACT

PMID:36881043 | DOI:10.1001/jama.2023.1002

Eur J Hosp Pharm. 2023 Mar 7:ejhpharm-2022-003645. doi: 10.1136/ejhpharm-2022-003645. Online ahead of print.

ABSTRACT

INTRODUCTION: Few if any studies have been conducted to date on the association between polypharmacy and cognitive impairment among older trauma patients. Therefore, we investigated whether polypharmacy is associated with cognitive impairment in trauma patients aged ≥70 years.

METHODS: This is a cross-sectional study of patients aged ≥70 years hospitalised due to a trauma-related injury. Cognitive impairment was defined as a Mini-Mental State Examination (MMSE) score ≤24 points. Medications were coded according to the Anatomical Therapeutic Chemical classification. Three exposures were examined: polypharmacy (≥5 medications), excessive polypharmacy (≥10 medications), and number of medications. Separate logistic regression models adjusted for age, sex, body mass index (BMI), education, smoking, independent living, frailty, multimorbidity, depression, and type of trauma were used to test the association between the three exposures and cognitive impairment.

RESULTS: A total of 198 patients were included (mean age 80.2; 64.7% women and 35.4% men), of which 148 (74.8%) had polypharmacy and 63 (31.8%) had excessive polypharmacy. The prevalence of cognitive impairment was 34.3% overall, 37.2% in the polypharmacy group and 50.8% in the excessive polypharmacy group. More than 80% of participants were taking at least one analgesic. Overall, polypharmacy was not statistically significantly associated with cognitive impairment (odds ratio (OR) 1.20 [95% confidence interval (CI) 0.46 to 3.11]). However, patients in the excessive polypharmacy group were more than two times more likely to have cognitive impairment (OR 2.88 [95% CI 1.31 to 6.37]) even after adjustments for relevant confounders. Similarly, the number of medications was associated with greater odds of cognitive impairment (OR 1.15 [95% CI 1.04 to 1.28]) after adjustments for the same relevant confounders.

CONCLUSION: Cognitive impairment is common among older trauma patients, particularly among those in the excessive polypharmacy group. Polypharmacy was not associated with cognitive impairment. Excessive polypharmacy and number of medications, on the other hand, were associated with greater odds of cognitive impairment in older trauma patients.

PMID:36882299 | DOI:10.1136/ejhpharm-2022-003645

Drug Ther Bull. 2023 Mar 7:dtb-2023-000012. doi: 10.1136/dtb.2023.000012. Online ahead of print.

ABSTRACT

Overview of: Shrestha S, Poudel A, Cardona M, et al Impact of deprescribing dual-purpose medications on patient-related outcomes for older adults near end-of-life: a systematic review and meta-analysis. Ther Adv Drug Saf 2021;12:1-16.

PMID:36882298 | DOI:10.1136/dtb.2023.000012

Drug Ther Bull. 2023 Mar 7:dtb-2023-000016. doi: 10.1136/dtb.2023.000016. Online ahead of print.

ABSTRACT

The BNF is jointly published by the Royal Pharmaceutical Society and BMJ. BNF is published in print twice a year and interim updates are issued and published monthly in the digital versions. The following summary provides a brief description of some of the key changes that have been made to BNF content.

PMID:36882297 | DOI:10.1136/dtb.2023.000016

Eur Arch Otorhinolaryngol. 2023 Mar 7. doi: 10.1007/s00405-023-07896-z. Online ahead of print.

ABSTRACT

PURPOSE: Disturbance of cochlear microcirculation is discussed as final common pathway of various inner ear diseases. Hyperfibrinogenemia causing increased plasma viscosity is a possible factor for a critical reduction of cochlear blood flow that might lead to sudden sensorineural hearing loss (SSHL). The aim was to determine the efficacy and safety of drug-induced defibrinogenation by ancrod for SSHL.

METHODS: Double-blind, randomized, placebo-controlled, multicenter, parallel group, phase II (proof-of-concept) study (planned enrollment: 99 patients). Patients received an infusion of ancrod or placebo (day 1) followed by subcutaneous administrations (day 2, 4, 6). Primary outcome was the change in pure tone audiogram air conduction average until day 8.

RESULTS: The study was terminated early due to slow recruiting (31 enrolled patients: 22 ancrod, 9 placebo). A significant improvement of hearing loss was registered in both groups (ancrod: - 14.3 dB ± 20.4 dB, - 39.9% ± 50.4%; placebo: - 22.3 dB ± 13.7 dB, - 59.1% ± 38.0%). A statistically significant group-difference was not detected (p = 0.374). Placebo response of 33.3% complete and 85.7% at least partial recovery was observed. Plasma fibrinogen levels were reduced significantly by ancrod (baseline: 325.2 mg/dL, day 2: 107.2 mg/dL). Ancrod was tolerated well, no adverse drug reaction was of severe intensity, no serious adverse events occurred.

CONCLUSION: Ancrod reduced fibrinogen levels that support its mechanism of action. The safety profile can be rated positively. Since the planned number of patients could not be enrolled, no efficacy conclusion can be drawn. The high rate of placebo response challenges clinical trials for SSHL and needs to be considered in future investigations. Trial registrations This study was registered in the EU Clinical Trials Register, EudraCT-No. 2012-000066-37 at 2012-07-02.

PMID:36881166 | DOI:10.1007/s00405-023-07896-z

JAMA. 2023 Mar 7;329(9):725-734. doi: 10.1001/jama.2023.1084.

ABSTRACT

IMPORTANCE: Olamkicept, a soluble gp130-Fc-fusion-protein, selectively inhibits interleukin 6 (IL-6) trans-signaling by binding the soluble IL-6 receptor/IL-6 complex. It has anti-inflammatory activities in inflammatory murine models without immune suppression.

OBJECTIVE: To assess the effect of olamkicept as induction therapy in patients with active ulcerative colitis.

DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled phase 2 trial of olamkicept in 91 adults with active ulcerative colitis (full Mayo score ≥5, rectal bleeding score ≥1, endoscopy score ≥2) and an inadequate response to conventional therapy. The study was conducted at 22 clinical study sites in East Asia. Patients were recruited beginning in February 2018. Final follow-up occurred in December 2020.

INTERVENTIONS: Eligible patients were randomized 1:1:1 to receive a biweekly intravenous infusion of olamkicept 600 mg (n = 30) or 300 mg (n = 31) or placebo (n = 30) for 12 weeks.

MAIN OUTCOMES AND MEASURES: The primary end point was clinical response at week 12 (defined as ≥3 and ≥30% decrease from baseline total Mayo score; range, 0-12 [worst] with ≥1 decrease and ≤1 in rectal bleeding [range, 0-3 {worst}]). There were 25 secondary efficacy outcomes, including clinical remission and mucosal healing at week 12.

RESULTS: Ninety-one patients (mean age, 41 years; 25 women [27.5%]) were randomized; 79 (86.8%) completed the trial. At week 12, more patients receiving olamkicept 600 mg (17/29 [58.6%]) or 300 mg (13/30 [43.3%]) achieved clinical response than placebo (10/29 [34.5%]), with adjusted difference vs placebo of 26.6% (90% CI, 6.2% to 47.1%; P = .03) for 600 mg and 8.3% (90% CI, -12.6% to 29.1%; P = .52) for 300 mg. Among patients randomized to receive 600 mg olamkicept, 16 of 25 secondary outcomes were statistically significant compared with placebo. Among patients randomized to receive 300 mg, 6 of 25 secondary outcomes were statistically significant compared with placebo. Treatment-related adverse events occurred in 53.3% (16/30) of patients receiving 600 mg olamkicept, 58.1% (18/31) receiving 300 mg olamkicept, and 50% (15/30) receiving placebo. The most common drug-related adverse events were bilirubin presence in the urine, hyperuricemia, and increased aspartate aminotransferase levels, and all were more common in the olamkicept groups compared with placebo.

CONCLUSIONS AND RELEVANCE: Among patients with active ulcerative colitis, biweekly infusion of olamkicept 600 mg, but not 300 mg, resulted in a greater likelihood of clinical response at 12 weeks compared with placebo. Further research is needed for replication and to assess longer-term efficacy and safety.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03235752.

PMID:36881032 | DOI:10.1001/jama.2023.1084

Clin Ophthalmol. 2023 Feb 27;17:657-665. doi: 10.2147/OPTH.S399590. eCollection 2023.

ABSTRACT

PURPOSE: To evaluate real-world experience using intravitreal brolucizumab (IVBr), alone or in combination with aflibercept, in eyes with neovascular age-related macular degeneration (nAMD) treated previously with other inhibitors of VEGF (anti-VEGF).

METHODS: This was a retrospective study of all eyes with nAMD treated with IVBr on a treat-and-extend protocol at a single center. Best-corrected visual acuity (BCVA), optical coherence tomography (OCT) at baseline and final visit, and drug-related adverse events were analyzed. Eyes with recurrent macular fluid on IVBr every 8 weeks were treated with a combination therapy alternating between IVBr and aflibercept every month.

RESULTS: Among 52 eyes (40 patients) on IVBr, all had been previously treated with other anti-VEGF therapy, with 73% having persistent macular fluid. After a mean follow-up of 46.2±27.4 weeks on IVBr, the mean treatment interval for intravitreal therapy increased to 8.8±2.1 weeks on IVBr from a baseline of 6.1±3.1 weeks (p<0.001). Macular fluid decreased and BCVA was stable/improved in 61.5% of eyes on IVBr. Ten eyes with increased macular fluid on IVBr monotherapy when extended to every 8 weeks were treated with combination therapy alternating between IVBr and aflibercept every 4 weeks. In these eyes, 80% had improved macular fluid on OCT and 70% stable or improved BCVA after a median follow-up of 53 weeks on combination therapy. Mild intraocular inflammation developed in four eyes, all occurring on IVBr monotherapy, and none had associated vision loss.

CONCLUSION: In the real world, IVBr used to treat eyes with nAMD previously treated with other anti-VEGF therapies appears to be well tolerated and associated with an improvement in macular fluid, stabilization of BCVA, and/or increase in intravitreal treatment interval. Combination therapy alternating between IVBr and aflibercept monthly appears to be well tolerated and can be considered for eyes with macular fluid on IVBr every 8 weeks.

PMID:36880020 | PMC:PMC9984903 | DOI:10.2147/OPTH.S399590

BMC Public Health. 2023 Mar 6;23(1):427. doi: 10.1186/s12889-023-15358-8.

ABSTRACT

BACKGROUND: Sleep apnea exerts adverse health effects due to inflammation and metabolic disruption. It is associated with metabolic diseases. However, the evidence of its relationship with depression is inconsistent. Therefore, this study aimed to investigate the relationship between sleep apnea and depressive symptoms in adults in the United States.

METHODS: This study utilized data from the National Health and Nutrition Examination Survey (NHANES), wherein the data from 2005 to 2018 of 9,817 individuals were obtained. Sleep apnea was self-reported by the participants using a questionnaire on sleep disorders. The 9-item Patient Health Questionnaire (PHQ-9) was used to assess depressive symptoms. We implemented multivariable logistic regression and stratified analyses to assess the correlation between sleep apnea and depressive symptoms.

RESULTS: A total of 515 (6.6%) participants among 7,853 non-sleep apnea participants and 269 (13.7%) subjects among 1,964 sleep apnea participants had a depression score ≥ 10, they were deemed to have depressive symptoms. The multivariable regression model, showed that individuals with sleep apnea were 1.36-fold more likely to experience depressive symptoms when adjusted for potential covariates (odds ratios [OR] with 95% confidence intervals of 2.36 [1.71-3.25]), and a positive correlation between depressive symptoms and sleep apnea severity was found. The stratified analyses, revealed that sleep apnea was related to an increased incidence of depressive symptoms in most subgroups, except for those with coronary heart disease. Further, there was no interaction between sleep apnea and the covariates.

CONCLUSIONS: Adults with sleep apnea in the US have a relatively high prevalence of depressive symptoms. and the severity of sleep apnea positively correlated with the depressive symptoms.

PMID:36879197 | DOI:10.1186/s12889-023-15358-8

J Immunother Cancer. 2023 Mar;11(3):e005841. doi: 10.1136/jitc-2022-005841.

ABSTRACT

Immune checkpoint inhibitors (ICIs) are associated with a wide range of immune-related adverse events. As oncological indications for ICIs widen, their rare side effects become increasingly visible in clinical practice and impact therapy decisions.Here, we report a rare case of early-onset, mild cytokine release syndrome (CRS) in a patient who received ICIs for a metastasized renal cell carcinoma, which led to treatment discontinuation.We further provide a systematic review of the literature of CRS and related life-threatening side effects of ICI treatment, such as hemophagocytic lymphohistiocytosis (HLH). We searched Medline, Embase and the Web of Science Core Collection from inception to October 2021 for reports on CRS, cytokine storm, macrophage activation syndrome, HLH, and related hyperinflammatory disorders in patients with solid cancers receiving ICIs. We found n=1866 articles, which were assessed for eligibility independently by two examiners. Of those, n=49 articles reporting on n=189 individuals were eligible for review. We found that the median time from last infusion to the occurrence of CRS/HLH was approximately nine days, while the onset of symptoms varied from immediately after infusion to one month after treatment. Most patients were treated with either corticosteroids or the anti-interleukin 6 (IL-6) antibody tocilizumab, and although the majority of patients recovered, a few cases were fatal. Concomitant IL-6 and ICI treatment were reported as beneficial for both the antitumoral effect and for limiting side effects. Data from international pharmacovigilance databases underscored that ICI-related CRS and HLH are rare events, but we identified significant differences in reported frequencies, which might suggest substantial under-reporting.The results from this first systematic review of CRS/HLH due to ICI therapy highlight that life-threatening systemic inflammatory complications of ICIs are rare and might be associated with fatal outcome in approximately 10% of patients. Limited data support the use of IL-6 inhibitors in combination with ICIs to augment the antitumoral effect and reduce hyperinflammation.

PMID:36878533 | PMC:PMC9990684 | DOI:10.1136/jitc-2022-005841

Chin Med J (Engl). 2023 Jan 5;136(1):45-52. doi: 10.1097/CM9.0000000000002259.

ABSTRACT

BACKGROUND: Managing acute postoperative pain is challenging for anesthesiologists, surgeons, and patients, leading to adverse events despite making significant progress. Patient-controlled intravenous analgesia (PCIA) is a recommended solution, where oxycodone has depicted unique advantages in recent years. However, controversy still exists in clinical practice and this study aimed to compare two drugs in PCIA.

METHODS: We performed a literature search in PubMed, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, Chinese National Knowledge Infrastructure, Wanfang, and VIP databases up to December 2020 to select specific randomized controlled trials (RCTs) comparing the efficacy of oxycodone with sufentanil in PCIA. The analgesic effect was the primary outcome and the secondary outcome included PCIA consumption, the Ramsay sedation scale, patients' satisfaction and side effects.

RESULTS: Fifteen RCTs were included in the meta-analysis. Compared with sufentanil, oxycodone showed lower Numerical Rating Scale scores (mean difference [MD] = -0.71, 95% confidence interval [CI]: -1.01 to -0.41; P < 0.001; I2 = 93%), demonstrated better relief from visceral pain (MD = -1.22, 95% CI: -1.58 to -0.85; P < 0.001; I2 = 90%), promoted a deeper sedative level as confirmed by the Ramsay Score (MD = 0.77, 95% CI: 0.35-1.19; P < 0.001; I2 = 97%), and resulted in fewer side effects (odds ratio [OR] = 0.46, 95% CI: 0.35-0.60; P < 0.001; I2 = 11%). There was no statistical difference in the degree of patients' satisfaction (OR = 1.13, 95% CI: 0.88-1.44; P = 0.33; I2 = 72%) and drug consumption (MD = -5.55, 95% CI: -14.18 to 3.08; P = 0.21; I2 = 93%).

CONCLUSION: Oxycodone improves postoperative analgesia and causes fewer adverse effects, and could be recommended for PCIA, especially after abdominal surgeries.

REGISTRATION: PROSPERO; https://www.crd.york.ac.uk/PROSPERO/; CRD42021229973.

PMID:36878002 | DOI:10.1097/CM9.0000000000002259

J Drugs Dermatol. 2023 Mar 1;22(3):288-296. doi: 10.36849/JDD.7253.

ABSTRACT

Managing chronic conditions is an essential aspect of dermatologic care, especially regarding the resolution of inflammatory dermatologic disease and recovery of skin lesions. Short-term complications of healing include infection, edema, dehiscence, hematoma formation, and tissue necrosis. At the same time, longer-term sequelae may consist of scarring and scar widening, hypertrophic scars, keloids, and pigmentary changes. This review will focus on dermatologic complications of chronic wound healing in patients with Fitzpatrick skin type (FPS) IV-VI or skin of color (SOC), with an emphasis on hypertrophy/scarring and dyschromias. It will focus on current treatment protocols and the potential complications specific to patients with FPS IV-VI.&nbsp; Observations: There are multiple complications of wound healing that are more prevalent in SOC, including dyschromias and hypertrophic scarring. These complications are challenging to treat, and current protocols are not without complications and side effects that must be considered when offering therapy to patients with FPS IV-VI.&nbsp; Conclusions and Relevance: When treating pigmentary and scarring disorders in patients with skin types FPS IV-VI, it is essential to implement a stepwise approach to management that is conscious of the side effect profile of current interventions. J Drugs Dermatol. 2023;22(3):288-296. doi:10.36849/JDD.7253.

PMID:36877886 | DOI:10.36849/JDD.7253

Cochrane Database Syst Rev. 2023 Mar 6;3(3):CD012349. doi: 10.1002/14651858.CD012349.pub3.

ABSTRACT

BACKGROUND: Regularly transfused people with sickle cell disease (SCD) and people with thalassaemia are at risk of iron overload. Iron overload can lead to iron toxicity in vulnerable organs such as the heart, liver and endocrine glands, which can be prevented and treated with iron-chelating agents. The intensive demands and uncomfortable side effects of therapy can have a negative impact on daily activities and wellbeing, which may affect adherence.

OBJECTIVES: To identify and assess the effectiveness of different types of interventions (psychological and psychosocial, educational, medication interventions, or multi-component interventions) and interventions specific to different age groups, to improve adherence to iron chelation therapy compared to another listed intervention, or standard care in people with SCD or thalassaemia.

SEARCH METHODS: We searched CENTRAL (Cochrane Library), MEDLINE, PubMed, Embase, CINAHL, PsycINFO, ProQuest Dissertations & Global Theses, Web of Science & Social Sciences Conference Proceedings Indexes and ongoing trial databases (13 December 2021). We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register (1 August 2022).

SELECTION CRITERIA: For trials comparing medications or medication changes, only randomised controlled trials (RCTs) were eligible for inclusion. For studies including psychological and psychosocial interventions, educational interventions, or multi-component interventions, non-randomised studies of interventions (NRSIs), controlled before-after studies, and interrupted time series studies with adherence as a primary outcome were also eligible for inclusion.

DATA COLLECTION AND ANALYSIS: For this update, two authors independently assessed trial eligibility and risk of bias, and extracted data. We assessed the certainty of the evidence using GRADE.

MAIN RESULTS: We included 19 RCTs and one NRSI published between 1997 and 2021. One trial assessed medication management, one assessed an education intervention (NRSI) and 18 RCTs were of medication interventions. Medications assessed were subcutaneous deferoxamine, and two oral chelating agents, deferiprone and deferasirox. We rated the certainty of evidence as very low to low across all outcomes identified in this review. Four trials measured quality of life (QoL) with validated instruments, but provided no analysable data and reported no difference in QoL. We identified nine comparisons of interest. 1. Deferiprone versus deferoxamine We are uncertain whether or not deferiprone affects adherence to iron chelation therapy (four RCTs, unpooled, very low-certainty evidence), all-cause mortality (risk ratio (RR) 0.47, 95% confidence interval (CI) 0.18 to 1.21; 3 RCTs, 376 participants; very low-certainty evidence), or serious adverse events (SAEs) (RR 1.43, 95% CI 0.83 to 2.46; 1 RCT, 228 participants; very low-certainty evidence). Adherence was reported as "good", "high" or "excellent" by all seven trials, though the data could not be analysed formally: adherence ranged from 69% to 95% (deferiprone, mean 86.6%), and 71% to 93% (deferoxamine, mean 78.8%), based on five trials (474 participants) only. 2. Deferasirox versus deferoxamine We are uncertain whether or not deferasirox affects adherence to iron chelation therapy (three RCTs, unpooled, very low-certainty evidence), although medication adherence was high in all trials. We are uncertain whether or not there is any difference between the drug therapies in serious adverse events (SAEs) (SCD or thalassaemia) or all-cause mortality (thalassaemia). 3. Deferiprone versus deferasirox We are uncertain if there is a difference between oral deferiprone and deferasirox based on a single trial in children (average age 9 to 10 years) with any hereditary haemoglobinopathy in adherence, SAEs and all-cause mortality. 4. Deferasirox film-coated tablet (FCT) versus deferasirox dispersible tablet (DT) One RCT compared deferasirox in different tablet forms. There may be a preference for FCTs, shown through a trend for greater adherence (RR 1.10, 95% CI 0.99 to 1.22; 1 RCT, 88 participants), although medication adherence was high in both groups (FCT 92.9%; DT 85.3%). We are uncertain if there is a benefit in chelation-related AEs with FCTs. We are uncertain if there is a difference in the incidence of SAEs, all-cause mortality or sustained adherence. 5. Deferiprone and deferoxamine combined versus deferiprone alone We are uncertain if there is a difference in adherence, though reporting was usually narrative as triallists report it was "excellent" in both groups (three RCTs, unpooled). We are uncertain if there is a difference in the incidence of SAEs and all-cause mortality. 6. Deferiprone and deferoxamine combined versus deferoxamine alone We are uncertain if there is a difference in adherence (four RCTs), SAEs (none reported in the trial period) and all-cause mortality (no deaths reported in the trial period). There was high adherence in all trials. 7. Deferiprone and deferoxamine combined versus deferiprone and deferasirox combined There may be a difference in favour of deferiprone and deferasirox (combined) in rates of adherence (RR 0.84, 95% CI 0.72 to 0.99) (one RCT), although it was high (> 80%) in both groups. We are uncertain if there is a difference in SAEs, and no deaths were reported in the trial, so we cannot draw conclusions based on these data (one RCT). 8. Medication management versus standard care We are uncertain if there is a difference in QoL (one RCT), and we could not assess adherence due to a lack of reporting in the control group. 9. Education versus standard care One quasi-experimental (NRSI) study could not be analysed due to the severe baseline confounding.

AUTHORS' CONCLUSIONS: The medication comparisons included in this review had higher than average adherence rates not accounted for by differences in medication administration or side effects, though often follow-up was not good (high dropout over longer trials), with adherence based on a per protocol analysis. Participants may have been selected based on higher adherence to trial medications at baseline. Also, within the clinical trial context, there is increased attention and involvement of clinicians, thus high adherence rates may be an artefact of trial participation. Real-world, pragmatic trials in community and clinic settings are needed that examine both confirmed or unconfirmed adherence strategies that may increase adherence to iron chelation therapy. Due to lack of evidence this review cannot comment on intervention strategies for different age groups.

PMID:36877640 | PMC:PMC9987409 | DOI:10.1002/14651858.CD012349.pub3