BMC Womens Health. 2023 May 19;23(1):273. doi: 10.1186/s12905-023-02375-3.

ABSTRACT

BACKGROUND: Women use modern contraceptive methods, mainly either to limit or space pregnancy and both are not identical in their choices. One method may not best fit an individual's need irrespective of the time of spacing. Cognizant of this, the context with which women base in choice of contraceptives, their lived experiences in using, and factors for early removal/ discontinuation of long-acting reversible contraceptives (LARCs) are not much investigated in the study setting and our study aimed to bridge the gap through exploring the underlying reasons.

METHOD: A phenomenological study design was used to explore sampled women's reasons and experiences. Reproductive-aged women (15-49 years) who removed long-acting methods in the past 6 months were included. A criterion sampling approach was employed to recruit study participants. Data was collected using an interview guide for in-depth (IDIs) and key informant interviews and were tape-recorded with interviewees' consent. Audio data were transcribed verbatim and translated into English. The data was first saved in plain text format and imported into Atlas.ti 7.0 software to facilitate coding and categorizing. The content analysis method was used to classify, organize data, and interpret the qualitative data according to key categories.

RESULTS: Several misconceptions about contraceptives (e.g., implants are not appropriate for daily laborers, women who use contraceptives (such as injectables) can only bear girl-child, etc.) were reported by clients and health providers. These misconceptions might not have scientific merit but they are powerful enough to affect actual behaviors toward contraceptives, including early removal. The awareness, attitude, and use of contraceptives tend to be lower in rural areas. For premature removal of LARCs, side effects, and heavy menstrual bleeding, was the most commonly identified reason. The IUCD is the least preferred method and users said it is not comfortable during sex.

CONCLUSION AND RECOMMENDATION: Our study found different reasons and misconceptions for modern contraceptive methods' non-use and discontinuation. Standardized counseling approaches like the REDI (Rapport Building, Exploration, Decision Making, and Implementation) framework should be implemented in the country consistently. Some of the concrete providers' conceptions should be well-studied considering contextual factors to bring scientific evidence.

PMID:37208658 | PMC:PMC10199468 | DOI:10.1186/s12905-023-02375-3

JNMA J Nepal Med Assoc. 2023 Jan 1;61(257):64-67. doi: 10.31729/jnma.7946.

ABSTRACT

INTRODUCTION: Intensive immunosuppressant therapy after renal transplantation has found to cause systemic and ocular side effects among them is cataracts. Studies on a similar topic have still remained explored in our setting. The aim of the study was to find out the prevalence of cataract among patients with renal transplantation in a tertiary care centre.

METHODS: This descriptive cross-sectional study was conducted among patients of renal transplantation at tertiary care centres from 1 May 2021 to 31 October 2021. The data was collected after the ethical approval from Institutional Review Committee [Reference number: 397(6-11) e2077/078]. Study proforma recorded the number of patients with cataracts, duration of steroid use, mean age and other comorbidities. A convenience sampling method was used. Point estimate and 95% Confidence Interval were calculated.

RESULTS: Out of 31 renal transplant patients, 10 (32.26%) (15.80-48.72, 95% Confidence Interval) had cataract.

CONCLUSIONS: The prevalence of cataract among renal transplantation patients was found to be lower than similar studies done in similar settings.

KEYWORDS: cataract; prevalence; renal transplantation; steroid.

PMID:37203916 | PMC:PMC10089043 | DOI:10.31729/jnma.7946

Stud Health Technol Inform. 2023 May 18;302:601-602. doi: 10.3233/SHTI230213.

ABSTRACT

In pharmacovigilance, signal assessment of a medicinal product and adverse event can involve reviewing prohibitively large numbers of case reports. A prototype of a decision support tool guided by a needs assessment was developed to help manual review of many reports. In a preliminary qualitative evaluation, users said the tool was easy to use, improved efficiency and provided new insights.

PMID:37203756 | DOI:10.3233/SHTI230213

Stud Health Technol Inform. 2023 May 18;302:551-555. doi: 10.3233/SHTI230203.

ABSTRACT

Adverse Drug Reactions (ADRs) are an important public health issue as they can impose significant health and monetary burdens. This paper presents the engineering and use case of a Knowledge Graph, supporting the prevention of ADRs as part of a Clinical Decision Support System (CDSS) developed in the context of the PrescIT project. The presented PrescIT Knowledge Graph is built upon Semantic Web technologies namely the Resource Description Framework (RDF), and integrates widely relevant data sources and ontologies, i.e., DrugBank, SemMedDB, OpenPVSignal Knowledge Graph and DINTO, resulting in a lightweight and self-contained data source for evidence-based ADRs identification.

PMID:37203746 | DOI:10.3233/SHTI230203

Stud Health Technol Inform. 2023 May 18;302:396-397. doi: 10.3233/SHTI230158.

ABSTRACT

Transfer Learning (TL) is an approach which has not yet been widely investigated in healthcare, mostly applied in image data. This study outlines a TL pipeline leveraging Individual Case Safety reports (ICSRs) and Electronic Health Records (EHR), applied for the early detection Adverse Drug Reactions (ADR), evaluated using of alopecia and docetaxel on breast cancer patients as use case.

PMID:37203703 | DOI:10.3233/SHTI230158

Stud Health Technol Inform. 2023 May 18;302:384-385. doi: 10.3233/SHTI230152.

ABSTRACT

Adverse Drug Reactions (ADRs) cause significant impact for patients' Quality of Life (QoL) and vastly increase costs, especially regarding chronic diseases. To this end, we propose a platform that aims at supporting the management of patients with Chronic Lymphocytic Leukemia (CLL), via an eHealth platform facilitating inter-physician interaction and the provision of treatment consultation by a specialized ADR management team comprised of CLL experts.

PMID:37203697 | DOI:10.3233/SHTI230152

Stud Health Technol Inform. 2023 May 18;302:382-383. doi: 10.3233/SHTI230151.

ABSTRACT

Tracking and reporting Adverse Drug Reactions (ADRs) is crucial for patient safety. This work aims to improve the data quality of the SIRAI application in Portugal by developing data validation rules and a scoring system for each record and the overall dataset. The goal is to enhance the effectiveness of the SIRAI application in monitoring adverse drug reactions.

PMID:37203696 | DOI:10.3233/SHTI230151

Gynecol Oncol. 2023 May 17;174:148-156. doi: 10.1016/j.ygyno.2023.05.007. Online ahead of print.

ABSTRACT

OBJECTIVE: Oral tyrosine kinase inhibitors (TKIs) have new indications for treatment in gynecologic malignancies. These targeted drugs have both unique and overlapping toxicities, which require careful attention and management. New combination therapies with immune-oncology agents have demonstrated promise in endometrial cancer. This review examines common adverse events associated with TKIs and provides readers with an evidence-based review on current uses and strategies for the management of these medications.

METHODS: A comprehensive review of the medical literature on TKI use in gynecologic cancer was undertaken by a committee approach. Details of each drug, its molecular target, and relevant data on both clinical efficacy and side effects were compiled and organized for clinical use. Information on drug-related secondary effects and management strategies for specific toxicities, including dose reduction and concomitant medications, were gathered.

RESULTS: TKIs can potentially offer improved response rates and durable responses for a group of patients who were previously without an effective standard second-line therapy. The combination of lenvatinib and pembrolizumab represents a more targeted approach to the drivers of endometrial cancer; however, there remains significant drug-related toxicity, and thus dose reduction and dose delay are frequently required. Toxicity management requires frequent check-ins and management strategies to help patients find the highest tolerable dose. TKIs are expensive and patient financial toxicity is as critical a measure of a drug's utility as any drug side effect. Many of these drugs have patient assistance programs, which should be fully utilized to minimize cost.

CONCLUSIONS: Future studies are needed to expand the role of TKIs into new molecularly driven groups. Attention to cost, durability of response, and long-term toxicity management is needed to ensure all eligible patients have access to treatment.

PMID:37207499 | DOI:10.1016/j.ygyno.2023.05.007

Clin Case Rep. 2023 May 16;11(5):e7184. doi: 10.1002/ccr3.7184. eCollection 2023 May.

ABSTRACT

The identification of rhabdomyolysis as a potential fatal adverse reaction to recent COVID-19 vaccines is essential. As the symptoms of rhabdomyolysis are not specific, the threshold to actively search for this complication should be low.

PMID:37207086 | PMC:PMC10188898 | DOI:10.1002/ccr3.7184

MMW Fortschr Med. 2023 May;165(10):18. doi: 10.1007/s15006-023-2671-z.

NO ABSTRACT

PMID:37202670 | DOI:10.1007/s15006-023-2671-z

Zhejiang Da Xue Xue Bao Yi Xue Ban. 2022 Aug 20;51(4):470-473. doi: 10.3724/zdxbyxb-2022-0245.

ABSTRACT

Six children with steroid resistant graft versus host disease (GVHD) after hematopoietic stem cell transplantation admitted in the hospital, including 4 cases of acute GVHD and 2 cases of chronic GVHD. Among the 4 acute GVHD cases, the main manifestations were large area rash and fever in 2 cases, and abdominal pain and diarrhea in 2 cases. In 2 chronic GVHD cases, one presented lichenoid dermatosis, and the other showed repeated oral ulcers with difficult mouth opening. Patients received tocilizumab (8 mg/kg per dose every 3 weeks) and ruxolitinib (5-10 mg/d, 28 d), at least 2 courses were completed. All patients had complete responses (100%), and 5 patients responded after completion of two treatment courses, with the median time of remission was 26.7 d. The median follow-up period was 11 (7-25) months, and no severe treatment-related adverse reactions were observed.

PMID:37202101 | DOI:10.3724/zdxbyxb-2022-0245

EClinicalMedicine. 2023 May 11;59:101991. doi: 10.1016/j.eclinm.2023.101991. eCollection 2023 May.

ABSTRACT

BACKGROUND: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single-tablet regimen recommended for HIV-1 treatment. The safety and efficacy of B/F/TAF as initial therapy was established in two Phase 3 studies: 1489 (vs dolutegravir [DTG]/abacavir/lamivudine) and 1490 (vs DTG + F/TAF). After 144 weeks of randomized follow-up, an open-label extension evaluated B/F/TAF to 240 weeks.

METHODS: Of 634 participants randomized to B/F/TAF, 519 completed the double-blinded treatment, and 506/634 (80%) chose the 96-week open-label B/F/TAF extension, which was completed by 444/506 (88%) participants. Efficacy was based on the secondary outcome of the proportion of participants with HIV-1 RNA <50 copies/mL at Week 240 by missing = excluded and missing = failure methods. All 634 participants who were randomized to B/F/TAF and received at least one dose of B/F/TAF were included in efficacy and safety analyses. (Study 1489: ClinicalTrials.govNCT02607930; EudraCT 2015-004024-54. Study 1490: ClinicalTrials.govNCT02607956; EudraCT 2015-003988-10).

FINDINGS: Of those with available virologic data, 98.6% (95% CI [97.0%-99.5%], 426/432) maintained HIV-1 RNA <50 copies/mL at Week 240 (missing = excluded); when missing virologic data were considered as failure, 67.2% (95% CI [63.4%-70.8%], 426/634) maintained HIV-1 RNA <50 copies/mL. Mean (SD) change in CD4+ count from baseline was +338 (236.2) cells/μL. No treatment-emergent resistance to B/F/TAF was detected. Adverse events led to drug discontinuation in 1.6% (n = 10/634) of participants (n = 5 with events considered drug-related). No discontinuations were due to renal adverse events. Median (IQR) total cholesterol increased 21 (1,42) mg/dL from baseline; the change in total cholesterol:HDL was 0.1 (-0.5,0.6). Median (IQR) weight change from baseline was +6.1 kg (2.0, 11.7) at Week 240. In Study 1489, hip and spine bone mineral density mean percent changes from baseline were ≤0.6%.

INTERPRETATION: Through 5 years of follow-up, B/F/TAF maintained high rates of virologic suppression with no treatment-emergent resistance and rare drug discontinuations due to adverse events. These results demonstrate the durability and safety of B/F/TAF in people with HIV.

FUNDING: Gilead Sciences.

PMID:37200995 | PMC:PMC10186485 | DOI:10.1016/j.eclinm.2023.101991

Am J Drug Alcohol Abuse. 2023 May 18:1-15. doi: 10.1080/00952990.2023.2207720. Online ahead of print.

ABSTRACT

Background: Medication treatment for opioid use disorder (MOUD) is an instrumental tool in combatting opioid use and overdose. Excess weight gain associated with MOUD initiation is a potential barrier that is not well understood.Objectives: Conduct a scoping review of available studies investigating the effect of MOUD on weight.Methods: Included studies consisted of adults taking any type of MOUD (e.g. methadone, buprenorphine/naloxone, naltrexone) with data on weight or body mass index for at least two time points. Evidence was synthesized using qualitative and descriptive approaches, and predictors of weight gain including demographics, comorbid substance use, and medication dose were examined.Results: Twenty-one unique studies were identified. Most studies were uncontrolled cohort studies or retrospective chart reviews testing the association between methadone and weight gain (n = 16). Studies examining 6 months of methadone treatment reported weight gain ranging from 4.2 to 23.4 pounds. Women appear to gain more weight from methadone than men, while patients using cocaine may gain less. Racial and ethnic disparities were largely unexamined. Only three case reports and two nonrandomized studies examined the effects of either buprenorphine/naloxone or naltrexone, and potential associations with weight gain were not clear.Conclusion: The use of methadone as an MOUD appears to be associated with mild to moderate weight gain. In contrast, there is little data supporting or refuting weight gain with buprenorphine/naloxone or naltrexone. Providers should discuss the potential risk for weight gain with patients as well as prevention and intervention methods for excess weight gain.

PMID:37200510 | DOI:10.1080/00952990.2023.2207720

Helicobacter. 2023 May 17:e12989. doi: 10.1111/hel.12989. Online ahead of print.

ABSTRACT

BACKGROUND: The eradication rate of Helicobacter pylori (H. pylori) remains variable for the same eradication regime even in the identical region, especially in developing countries. Herein, we conducted a systematic review to assess the effect of reinforced medication adherence on H. pylori eradication rate in developing countries.

MATERIALS AND METHODS: A systematic review was conducted in literature databases to identify relevant randomized controlled trials (RCTs) from inception to March 2023. The core indicator was the changes in eradication rate after enhanced adherence. A meta-analysis was performed to estimate the pooled relative risk (RR) or weighted mean difference (WMD) with 95% confidence intervals (CI).

RESULTS: Nineteen RCTs that included a total of 3286 patients were assessed. The measures to enhance compliance were mainly through face-to-face communication, phone calls, text messages, and social software. Compared with the control group, patients received reinforced measures showed a better medication adherence (89.6% vs. 71.4%, RR = 1.26 95% CI: 1.16-1.37), higher H. pylori eradication rate (intention-to-treat analysis: 80.2% vs. 65.9%, RR = 1.25, 95% CI: 1.12-1.31; per-protocol analysis: 86.8% vs. 74.8%, RR = 1.16, 95% CI: 1.09-1.23), higher symptom relief rates (81.8% vs. 65.1%, RR = 1.23, 95% CI: 1.09-1.38), higher degree of satisfaction (90.4% vs. 65.1%, RR = 1.26, 95% CI: 1.19-1.35), higher disease knowledge rates (SMD = 1.82, 95% CI: 0.77-2.86, p = 0.0007), and lower incidence of total adverse events (27.3% vs. 34.7%, RR = 0.72, 95% CI: 0.52-0.99).

CONCLUSION: Based on available evidence, reinforced medication adherence as a nonnegligible measure improves H. pylori eradication rate in developing countries.

PMID:37199032 | DOI:10.1111/hel.12989

PLoS One. 2023 May 17;18(5):e0284767. doi: 10.1371/journal.pone.0284767. eCollection 2023.

ABSTRACT

Nigeria adopted dolutegravir (DTG) as part of first line (1L) antiretroviral therapy (ART) in 2017. However, there is limited documented experience using DTG in sub-Saharan Africa. Our study assessed DTG acceptability from the patient's perspective as well as treatment outcomes at 3 high-volume facilities in Nigeria. This is a mixed method prospective cohort study with 12 months of follow-up between July 2017 and January 2019. Patients who had intolerance or contraindications to non-nucleoside reverse-transcriptase inhibitors were included. Patient acceptability was assessed through one-on-one interviews at 2, 6, and 12 months following DTG initiation. ART-experienced participants were asked about side effects and regimen preference compared to their previous regimen. Viral load (VL) and CD4+ cell count tests were assessed according to the national schedule. Data were analysed in MS Excel and SAS 9.4. A total of 271 participants were enrolled on the study, the median age of participants was 45 years, 62% were female. 229 (206 ART-experienced, 23 ART-naive) of enrolled participants were interviewed at 12 months. 99.5% of ART-experienced study participants preferred DTG to their previous regimen. 32% of particpants reported at least one side effect. "Increase in appetite" was most frequently reported (15%), followed by insomnia (10%) and bad dreams (10%). Average adherence as measured by drug pick-up was 99% and 3% reported a missed dose in the 3 days preceding their interview. Among participants with VL results (n = 199), 99% were virally suppressed (<1000 copies/ml), and 94% had VL <50 copies/ml at 12 months. This study is among the first to document self-reported patient experiences with DTG in sub-Saharan Africa and demonstrated high acceptability of DTG-based regimens among patients. The viral suppression rate was higher than the national average of 82%. Our findings support the recommendation of DTG-based regimen as the preferred 1L ART.

PMID:37196012 | DOI:10.1371/journal.pone.0284767

Brain Nerve. 2023 May;75(5):658-662. doi: 10.11477/mf.1416202394.

ABSTRACT

Older adults are likely to develop adverse drug events owing to age-related changes in pharmacokinetics and polypharmacy. In terms of pharmacokinetics, the drug should be prescribed at a reduced dose, which should be reconsidered and reduced during long-term use. For polypharmacy, "List of drugs to be prescribed with special caution" should be referred and deprescription should be practiced in consideration of the priority of treatment. Because older adults often show reduced ability to manage their medication due to cognitive dysfunction, low visual acuity, and hearing loss, measures should be taken to maintain their adherence.

PMID:37194547 | DOI:10.11477/mf.1416202394

Biol Pharm Bull. 2023 May 17. doi: 10.1248/bpb.b23-00108. Online ahead of print.

ABSTRACT

Anticancer drugs exhibit many side effects, including skin pigmentation, which often lowers patient quality of life. However, the mechanism of pigmentation caused by anticancer drugs remains unknown. The purpose of this study was to elucidate the mechanism of anticancer drug-induced skin pigmentation using 5-fluorouracil (5-FU), a widely used anticancer drug. Specific pathogen-free, 9-week-old Hos:HRM-2 male mice were intraperitoneally administered 5-FU daily for 8 weeks. Skin pigmentation was observed at the end of the study. Mice treated with 5-FU were also administered inhibitors of cAMP, α-melanocyte-stimulating hormone (α-MSH), and adrenocorticotropic hormone (ACTH) for analysis. Administration of oxidative stress, nuclear factor-kappa B (NF-κB), cAMP, and ACTH inhibitors reduced pigmentation in 5-FU-treated mice. These results indicate that the oxidative stress/NF-κB/ACTH/cAMP/tyrosinase pathway plays an important role in pigmentation in 5-FU-treated mice.

PMID:37197927 | DOI:10.1248/bpb.b23-00108

J Clin Oncol. 2023 May 20;41(15):2682-2690. doi: 10.1200/JCO.22.02546.

ABSTRACT

PURPOSE: To compare the efficacy and toxicity of pemetrexed versus docetaxel in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with chemotherapy.

PATIENTS AND METHODS: Eligible patients had a performance status 0 to 2, previous treatment with one prior chemotherapy regimen for advanced NSCLC, and adequate organ function. Patients received pemetrexed 500 mg/m2 intravenously (IV) day 1 with vitamin B12, folic acid, and dexamethasone or docetaxel 75 mg/m2 IV day 1 with dexamethasone every 21 days. The primary end point was overall survival.

RESULTS: Five hundred seventy-one patients were randomly assigned. Overall response rates were 9.1% and 8.8% (analysis of variance P = .105) for pemetrexed and docetaxel, respectively. Median progression-free survival was 2.9 months for each arm, and median survival time was 8.3 versus 7.9 months (P = not significant) for pemetrexed and docetaxel, respectively. The 1-year survival rate for each arm was 29.7%. Patients receiving docetaxel were more likely to have grade 3 or 4 neutropenia (40.2% v 5.3%; P < .001), febrile neutropenia (12.7% v 1.9%; P < .001), neutropenia with infections (3.3% v 0.0%; P = .004), hospitalizations for neutropenic fever (13.4% v 1.5%; P < .001), hospitalizations due to other drug related adverse events (10.5% v 6.4%; P = .092), use of granulocyte colony-stimulating factor support (19.2% v 2.6%, P < .001) and all grade alopecia (37.7% v 6.4%; P < .001) compared with patients receiving pemetrexed.

CONCLUSION: Treatment with pemetrexed resulted in clinically equivalent efficacy outcomes, but with significantly fewer side effects compared with docetaxel in the second-line treatment of patients with advanced NSCLC and should be considered a standard treatment option for second-line NSCLC when available.

PMID:37196429 | DOI:10.1200/JCO.22.02546

Clin Neuropharmacol. 2023 May-Jun 01;46(3):105-111. doi: 10.1097/WNF.0000000000000552. Epub 2023 Apr 11.

ABSTRACT

OBJECTIVES: Cladribine is a selective and oral immunological reconstitution treatment, approved in Europe for very active multiple sclerosis (MS) with relapses. Aims were to assess the safety and effectiveness of cladribine in real-world setting, during treatment follow-up.

METHODS: This was a multicentric, longitudinal, observational study with retrospective and prospective data collection of clinical, laboratory, and imaging data. This interim analysis reports data from July 1, 2018 (study onset), to March 31, 2021.

RESULTS: A total of 182 patients were enrolled: 68.7% were female; mean age at onset was 30.1 ± 10.0 years, and mean age at first cycle of cladribine treatment was 41.1 ± 12.1; 88.5% were diagnosed with relapse-remitting MS and 11.5% with secondary progressive MS. Mean disease duration at cladribine start was 8.9 ± 7.7 years. Most patients (86.1%) were not naive, and median number of previous disease-modifying therapies was 2 (interquartile range, 1-3). At 12 months, we observed no significant Expanded Disability Status Scale score worsening ( P = 0.843, Mann-Whitney U test) and a significantly lower annualized relapse rate (0.9 at baseline to 0.2; 78% reduction). Cladribine treatment discontinuation was registered in 8% of patients, mainly (69.2%) due to disease activity persistence. Most frequent adverse reactions were lymphocytopenia (55%), infections (25.2%), and fatigue (10.7%). Serious adverse effects were reported in 3.3%. No patient has discontinued cladribine treatment because of adverse effects.

CONCLUSION: Our study confirms the clinical efficacy and the safety profile of cladribine for treating MS patients with a long-term active disease in the real-world setting. Our data contribute to the body of knowledge of the clinical management of MS patients and the improvement of related clinical outcomes.

PMID:37191564 | DOI:10.1097/WNF.0000000000000552

Clin Neuropharmacol. 2023 May-Jun 01;46(3):89-94. doi: 10.1097/WNF.0000000000000548. Epub 2023 Mar 13.

ABSTRACT

OBJECTIVES: This is a case series and a review of the literature of therapeutic outcomes of botulinum toxin (BT) injections for anterocollis.

METHODS: Data collected included gender, age, age at onset, muscles targeted, and doses injected. Routine forms were filled out during each visit: Patient Global Impression of Change, Clinician Global Impression of Severity, Tsui scale. The effect duration and side effects (SEs) of the previous treatment were noted.

RESULTS: We described 4 patients (3 men, 13 visits) with anterocollis, as primary postural abnormality of the neck, emphasizing the therapeutic response to BT injection. Mean age at onset was 75.3 ± 7.0 years, age at first injection was 80.7 ± 3.5 years. The mean total dose per treatment was 290.0 ± 95.6 units. Patient Global Impression of Change with any grade of favorable effect was reported in 27.3% of the treatments. In objective assessment, Global Impression of Severity and Tsui scores did not show a consistent tendency of improvement. Neck weakness was prevalent in 18.2% of the visits of the anterocollis group while no other SEs were noted. We found 15 articles describing experience with BT for anterocollis in 67 patients (19 in deep and 48 in superficial neck muscles).

CONCLUSIONS: This case series describes the poor outcome of BT treatment for anterocollis, with low efficacy and bothersome SE. Levator scapulae injection for anterocollis is not effective and is highly associated with head drop and should perhaps be abandoned. Injection to the longus colli might give some benefit in non-responders.

PMID:37191561 | DOI:10.1097/WNF.0000000000000548