Fundam Clin Pharmacol. 2023 Jul 3. doi: 10.1111/fcp.12929. Online ahead of print.

ABSTRACT

AIM: To describe the symptoms, patient demographics, and trends over time of adverse drug reactions (ADRs) related to weak opioid analgesics reported to the French vigilance networks.

METHODS: Retrospective study of data from French Poison Control Centers and Pharmacovigilance Centers databases of weak opioid analgesics-related ADRs cases, with high causality score, in adults, in therapeutic analgesic use, without co-exposure, between 2011 and 2020.

RESULTS: The number of cases was 388 in the Poisonings database and 155 in the Pharmacovigilance database; ratio of the number of these cases to all reported cases during the study period was 0.02% and 0.03%, respectively. Tramadol was most often involved (74% and 56.1%, respectively), followed by codeine (26% and 38.7%, respectively). There was no significant variation in the number of cases reported. Cases most often involved young adults (median age: 40 years) and mostly women (76%). Gastrointestinal symptoms were mostly reported (80% and 65%, respectively) as described in the Summary of Products Characteristics. Patterns of ADRs were comparable in both databases, except for codeine-associated acute pancreatitis and anaphylaxis that were reported in the Pharmacovigilance database. No fatality was observed. Severity was more often observed in the Pharmacovigilance database (30%) than in the Poisonings database (moderate toxicity: 7%).

CONCLUSION: ADRs mostly occurred among young women using tramadol, without significant variation in the number of reported cases over time. Serious ADRs were more frequently reported to the Pharmacovigilance database, particularly for codeine. Women seemed to be at greater risk of ADRs.

PMID:37400273 | DOI:10.1111/fcp.12929

Cureus. 2023 May 30;15(5):e39692. doi: 10.7759/cureus.39692. eCollection 2023 May.

ABSTRACT

Immune checkpoint inhibitors (ICI) are a new class of pharmaceuticals that facilitate the immune system in identifying and targeting cancerous cells. However, suppressing immune regulation can often cause immune-mediated adverse events. One such downstream effect recently recognized is ICI-associated myocarditis. This case involves a 67-year-old female patient with a medical history of metastatic small-cell lung carcinoma undergoing chemotherapy with atezolizumab (third cycle) and the carboplatin-etoposide regimen (fourth cycle). The patient presented to the medical service with chest discomfort and fatigue. Elevated cardiac markers were observed, despite the absence of ischemic changes on electrocardiography and patent coronary arteries on cardiac catheterization. Cardiac magnetic resonance imaging (MRI) did not reveal any significant fibrosis in the cardiac muscle; however, an endomyocardial biopsy noted mild fibrosis. Corticosteroid treatment resulted in the normalization of cardiac enzyme levels and subsequent symptom resolution. ICI-associated myocarditis typically manifests within two months of initiating therapy. However, this case report spotlights the occurrence of a milder form of myocarditis after three months of ICI treatment.

PMID:37398769 | PMC:PMC10310539 | DOI:10.7759/cureus.39692

J Educ Health Promot. 2023 Apr 28;12:121. doi: 10.4103/jehp.jehp_1008_22. eCollection 2023.

ABSTRACT

BACKGROUND: The National Family Health Survey of India (NFHS-5) revealed a lapse in the advancement of mitigating anemia despite free supplementation of iron-folic acid tablets (IFAT) and improvement in IFAT coverage during pregnancy. The local sociocultural beliefs and community perspective toward IFAT are pivotal in reducing the gap between IFAT coverage and consumption. Hence, we proposed the study to assess adherence to IFAT among rural pregnant women and explore the associated factors.

MATERIALS AND METHODS: The present study was conducted as a mixed-methods study with a sequential exploratory design in a rural setting of the Model Rural Health Research Unit (MRHRU) from October 2020 to May 2021. Ten focus group discussions (FGDs; 8 - antenatal women, 1 - mother/mother-in-law, and 1 - health care worker) were conducted, and framework analysis was done to identify themes followed by a quantitative survey with a semi-structured questionnaire among antenatal women (n = 236). Logistic regression was used to analyze factors associated with adherence.

RESULTS: The major themes that emerged from FGDs were the sociocultural factors (gender norms, communal fallacies), lack of awareness, and drug-related factors (unpalatability, misperceptions, and experienced side effects). Around 57% were adherent to IFAT. Side effects experienced on IFAT intake (P = 0.001, OR = 2.33), misconceptions regarding IFAT, like weight gain in IFAT use (P = 0.001, OR = 2.86), a big baby with IFAT use (P = 0.000, OR = 5.93) negatively influenced adherence.

CONCLUSIONS: The significant gaps between IFAT coverage and consumption surrounded the unpleasant odor and stench of IFAT, side effects, lack of individualized counseling, and misperceptions regarding IFAT use.

PMID:37397091 | PMC:PMC10312401 | DOI:10.4103/jehp.jehp_1008_22

Am J Clin Dermatol. 2023 Jul 3. doi: 10.1007/s40257-023-00790-8. Online ahead of print.

ABSTRACT

The advent of protein kinase inhibitors and immunotherapy has profoundly improved the management of advanced melanoma. However, with these therapeutic advancements also come drug-related toxicities that have the potential to affect various organ systems. We review dermatologic adverse events from targeted (including BRAF and MEK inhibitor-related) and less commonly used melanoma treatments, with a focus on diagnosis and management. As immunotherapy-related toxicities have been extensively reviewed, herein, we discuss injectable talimogene laherparepvec and touch on recent breakthroughs in the immunotherapy space. Dermatologic adverse events may severely impact quality of life and are associated with response and survival. It is therefore essential that clinicians are aware of their diverse presentations and management strategies.

PMID:37395930 | DOI:10.1007/s40257-023-00790-8

Prog Chem Org Nat Prod. 2023;122:163-219. doi: 10.1007/978-3-031-26768-0_2.

ABSTRACT

The widespread utility of herbal products has been rising considerably worldwide, including both developed and developing countries, leading to the rapid growth of their availability in the United States and globally. This substantial increase in consumption of herbal products has witnessed the emergence of adverse effects upon oral administration of certain of these products, and thus has raised safety concerns. The adverse effects caused by the consumption of certain botanical medicines occur primarily as a result of the poor quality of plant raw materials or the finished products, which inherently may affect safety and/or efficacy. The poor quality of some herbal products can be attributed to a lack of proper quality assurance and quality control. A high demand for herbal products that surpasses production, combined with a desire for maximizing profits, along with a lack of rigorous quality control within some manufacturing facilities have led to the emergence of quality inconsistencies. The underlying causes for this involve the misidentification of plant species, or their substitution, adulteration, or contamination with harmful ingredients. Analytical assessments have revealed there to be frequent and significant compositional variations between marketed herbal products. The inconsistency of the quality of herbal products can be ascribed essentially to the inconsistency of the botanical raw material quality used to manufacture the products. Thus, the quality assurance and the quality control of the botanical raw materials is may contribute significantly to improving the quality and consistency of the quality of the end products. The current chapter focuses on the chemical evaluation of quality and consistency of herbal products, including botanical dietary supplements. Different techniques, instruments, applications, and methods used in identifying, quantifying, and generating chemical fingerprints and chemical profiles of the ingredients of the herbal products will be described. The strengths and weaknesses of the various techniques available will be addressed. Limitations of the other approaches including morphological or microscopic analysis and DNA-based analysis will be presented.

PMID:37392312 | DOI:10.1007/978-3-031-26768-0_2

Altern Ther Health Med. 2023 Jul;29(5):78-81.

ABSTRACT

BACKGROUND: Ginkgo biloba extract preparations are commonly used in ophthalmology to improve circulatory disorders and provide neurotrophic support for the treatment of optic neuropathy. However, their use also carries a higher risk of adverse drug reactions (ADRs), some of which can be severe and even life-threatening, such as anaphylactic shock. This case report highlights the importance of recognizing and managing ADRs associated with ginkgo biloba extract in ophthalmology clinical practice. This report aims to emphasize the need for appropriate patient selection, adherence to prescribing guidelines, and proactive measures to reduce ADR occurrence.

CASE PRESENTATION: We present the case of a patient who experienced a severe ADR following the administration of Ginkgo biloba and Damo injection. The patient, a middle-aged individual without a history of allergies, developed anaphylactic shock within 30 minutes of medication initiation. Prompt medical intervention, including medication withdrawal, resuscitation, and intensive care unit transfer, led to symptom relief and successful recovery.

CONCLUSIONS: This case underscores the need for vigilance when prescribing ginkgo biloba extract, particularly in middle-aged and elderly patients. Despite no previous history of allergies and adherence to the prescribed dosage, severe ADR can still occur. Close monitoring of patients within the first 30 minutes of medication administration is crucial. Furthermore, strict adherence to drug instructions, proper TCM syndrome differentiation, appropriate choice of infusion solvents, and strict control of drip rates should be considered to enhance patient safety. Other factors such as patient age, allergy history, and initial medication were also identified as important considerations in preventing ADRs. This case report emphasizes the significance of early identification, immediate withdrawal of medication, vital sign monitoring, and timely administration of anti-allergy drugs in managing ADR.

PMID:37392195

Recenti Prog Med. 2023 Jul-Aug;114(7):441-446. doi: 10.1701/4062.40463.

ABSTRACT

INTRODUCTION: Air pollution and extreme temperatures have been associated with multiple adverse health effects, especially on the cardiovascular and respiratory systems. The evidence of a relationship between daily exposures and mortality from metabolic, nervous and mental causes needs to be strengthened. The aim of this study is to investigate the association between daily exposure to fine particulate matter (PM2.5) and extreme temperatures (heat and cold) with cause-specific mortality in the entire Italian population.

METHODS: The daily counts of deaths from natural, cardiovascular, respiratory, metabolic, diabetes, nervous and mental causes were provided by Istat at the municipal level for the period 2006-2015. Through the application of machine-learning models based on satellite data and spatiotemporal variables, population-weighted exposures to daily mean PM2.5 (2013-2015) and air temperature (2006-2015) were estimated at municipality level. Time-series models adjusted for seasonal and long-term trends were applied, and associations between the above exposures and different causes of death at the national level were estimated.

RESULTS: The study found a marked effect of PM2.5 on deaths from nervous causes, with a % increase of risk (IR%) of 6.55% (95% confidence interval: 3.38%-9.81%) per PM2.5 increases of 10 µg/m3. The study also highlighted significant effects of low and high temperatures on all study outcomes. The effects were greater for high temperatures. In particular, the effects of heat, expressed as a % increase in risk per temperature increase from the 75th to the 99th percentile, show the highest associations with mortality from nervous causes (58.3%; 95%CI: 49.7%-67.5%), mental causes (48.4%; 95%CI: 40.4%-56.9%), respiratory causes 45.8%; 95%CI: 39.7%-52.1%) and metabolic causes (36.9%; 95%CI: 30.6%-43.5%).

DISCUSSION: The study showed a strong association between daily exposure to PM2.5 and extreme temperatures, especially heat, with mortality outcomes, especially those under-investigated, such as diabetes, metabolic, nervous and mental causes.

PMID:37392107 | DOI:10.1701/4062.40463

Mymensingh Med J. 2023 Jul;32(3):833-840.

ABSTRACT

When performing infra-umbilical procedures, caudal epidural analgesia with bupivacaine is frequently used to provide both intra- and post-operative analgesia. Dexmedetomidine, an alpha 2 agonistsare extensively used in neuraxial blocks and peripheral nerve blocks to prolong the action of bupivacaine. To find out the effects of dexmedetomidine as an adjuvant to bupivacaine for caudal analgesia in children undergoing infra-umbilical surgery. This was a randomized, controlled double-blinded prospective observational study and was performed from July 2019 to December 2019. A total of 60 (Sixty) patients with different infra-umbilical surgical problems underwent different procedure under caudal anaesthesia in different operation theatre in Bangabandhu Sheikh Mujib Medical University, Dhaka were enrolled in this study. Elaborate personal history, meticulous clinical examinations and relevant laboratory investigations was done. Post-operative adverse effects also were monitored. All information from history of illness, clinical, laboratory findings, duration of analgesia and post-operative adverse effects were recorded in a preformed data sheet (Appendix-I) and statistical analysis was done by SPSS 22.0. Mean age of the children in Group A (dexmedetomidine + bupivacaine) was 5.50±2.61 years and in Group B (bupivacaine) was 5.66±2.75. Mean weight of the children in Group A was 19.22±8.58 kg and in Group B was 19.70±8.94 kg in this study. Mean duration of anaesthesia was 27.5±6.5 minute in Group A and 28.5±5.5 minute in Group B. The mean duration of analgesia was 4.32±0.54 hours for Group A and 2.12±0.32 hours in Group B. In Group A, 46.7% patients required 1 and 3.3% required 2 rescue analgesic but in Group B, 43.3% patients required single rescue analgesic and 33.3% required two rescue analgesics (p<0.05). In Group A, 6.7% patients had nausea/ vomiting and in Group B, 16.7% patients had nausea/ vomiting (p>0.05). It can be concluded that dexmedetomidine with bupivacaine for caudal analgesia in infra-umbilical surgery significantly prolongs the duration of postoperative analgesia when compared to bupivacaine alone without any side-effects.

PMID:37391982

J Am Pharm Assoc (2003). 2023 Jun 29:S1544-3191(23)00231-5. doi: 10.1016/j.japh.2023.06.017. Online ahead of print.

ABSTRACT

OBJECTIVES: We aim to increase pharmacists' and regulatory agencies' awareness of emerging issues regarding current practices of semaglutide use in the community which has led to increased reports of administration errors and adverse drug events to our regional poison control center.

CASE SUMMARIES: We report three cases of adverse drug events following incorrect administration of semaglutide for weight loss obtained from compounding pharmacies and an aesthetic spa. Two patients self-administered 10-fold dosing errors. All patients experienced notable symptoms of nausea, vomiting, and abdominal pain with most symptoms lasting for days. Other symptoms of headache, anorexia, weakness, and fatigue were reported in one patient. One patient sought evaluation at a healthcare facility and responded well to an antiemetic and intravenous fluids. One patient who received their medication from a compounding pharmacy reported receiving a vial with syringes for self-administration; no pharmacist counseling was provided on proper drug administration. One patient reported dosing in milliliters and units rather than in milligrams.

PRACTICE IMPLICATIONS: These three semaglutide cases highlight the potential for patient harm given current practices. Vials of compounded semaglutide do not employ safety features provided by pre-filled manufactured pens and allow for large overdoses (e.g., 10-fold dosing errors). Use of syringes not intended for semaglutide contribute to the variability of dosing units (milliliters, units, milligrams), contributing to patient confusion. To address such issues, we encourage increased vigilance in labeling, dispensing, and counseling practices to ensure patients are confident in administering their medication regardless of the formulation. We additionally encourage boards of pharmacy and other regulatory agencies to promote proper use and dispensing of compounded semaglutide. Such vigilance and promotion could decrease the risk of more severe adverse drug events and avoidable hospital utilization that may arise from dosing errors.

PMID:37392810 | DOI:10.1016/j.japh.2023.06.017

Biomed Pharmacother. 2023 Jun 29;165:115066. doi: 10.1016/j.biopha.2023.115066. Online ahead of print.

ABSTRACT

Acute myeloid leukemia (AML) is a prevalent form of leukemia in adults. As its survival rate is low, there is an urgent need for new therapeutic options. In AML, FMS-like tyrosine kinase 3 (FLT3) mutations are common and have negative outcomes. However, current FLT3-targeting agents, Midostaurin and Gilteritinib, face two significant issues, specifically the emergence of acquired resistance and drug-related adverse events leading to treatment failure. Rearranged during transfection (RET), meanwhile, is a proto-oncogene linked to various types of cancer, but its role in AML has been limited. A previous study showed that activation of RET kinase enhances FLT3 protein stability, leading to the promotion of AML cell proliferation. However, no drugs are currently available that target both FLT3 and RET. This study introduces PLM-101, a new therapeutic option derived from the traditional Chinese medicine indigo naturalis with potent in vitro and in vivo anti-leukemic activities. PLM-101 potently inhibits FLT3 kinase and induces its autophagic degradation via RET inhibition, providing a superior mechanism to that of FLT3 single-targeting agents. Single- and repeated-dose toxicity tests conducted in the present study showed no significant drug-related adverse effects. This study is the first to present a new FLT3/RET dual-targeting inhibitor, PLM-101, that shows potent anti-leukemic activity and fewer adverse effects. PLM-101, therefore, should be considered for use as a potential therapeutic agent for AML.

PMID:37392657 | DOI:10.1016/j.biopha.2023.115066

Sci Rep. 2023 Jun 30;13(1):10597. doi: 10.1038/s41598-023-37584-1.

ABSTRACT

This prospective, multicentre, postmarketing surveillance were conducted to report on the long-term safety and effectiveness of intravitreal aflibercept (IVT-AFL) treatment in clinical practice of Japanese patients with neovascular age-related macular degeneration (nAMD) who newly initiated IVT-AFL treatment. The primary outcomes were the incidence of adverse events (AEs) and of adverse drug reactions (ADRs) over 36 months. Number of injections, timing of ADR occurrence, and some effectiveness index were also summarised. A total of 3,872 patients received 7.2 ± 5.8 (mean ± standard deviation) injections, and AEs occurred in 5.73% of patients. ADRs were reported in 2.76% of patients, with ocular and nonocular ADRs in 2.07% and 0.72% of patients, respectively. Most vitreo-retinal events developed within 6 months of initial IVT-AFL treatment, and most instances of increased intraocular pressure and cerebral infarction developed after 6 months of follow-up. Mean best-corrected visual acuity and central retinal thickness were numerically better throughout the follow-up period compared with baseline. These results indicated acceptable tolerability and effectiveness of IVT-AFL treatment in patients with nAMD in clinical practice in Japan. Information regarding the risk and the timing of ADRs is valuable for safe and effective long-term treatment of patients with nAMD.Trial registration number: NCT01756248.

PMID:37391547 | PMC:PMC10313657 | DOI:10.1038/s41598-023-37584-1

Stud Health Technol Inform. 2023 Jun 29;305:357-358. doi: 10.3233/SHTI230504.

ABSTRACT

The study aimed to assess the usability of the PVClinical platform, which is designed for detecting and managing Adverse Drug Reactions (ADRs). A "slider" type comparative questionnaire was designed to capture the preferences of six end-users over time between PVC clinical platform and the established clinical and pharmaceutical ADR detection software tools. The results of the questionnaire were cross-examined with the results of the usability study. The questionnaire was a quick preference-capturing tool over time and provided impactful insights. Coherence in participants' preferences for PVClinical platform was observed, but further research is needed to establish the effectiveness of the questionnaire as a preference-capturing tool.

PMID:37387038 | DOI:10.3233/SHTI230504

Stud Health Technol Inform. 2023 Jun 29;305:226-229. doi: 10.3233/SHTI230469.

ABSTRACT

Adverse Drug Reactions (ADRs) are a crucial public health issue due to the significant health and monetary burden that they can impose. Real-World Data (RWD), e.g., Electronic Health Records, claims data, etc., can support the identification of potentially unknown ADRs and thus, they could provide raw data to mine ADR prevention rules. The PrescIT project aims to create a Clinical Decision Support System (CDSS) for ADR prevention during ePrescription and uses OMOP-CDM as the main data model to mine ADR prevention rules, based on the software stack provided by the OHDSI initiative. This paper presents the deployment of OMOP-CDM infrastructure using the MIMIC-III as a testbed.

PMID:37387003 | DOI:10.3233/SHTI230469

Mol Med Rep. 2023 Aug;28(2):153. doi: 10.3892/mmr.2023.13040. Epub 2023 Jun 30.

ABSTRACT

Adriamycin is a widely used and effective antitumor drug; however, its application is limited by various side effects, including irreversible cardiotoxicity. The central role of cardiac atrophy in Adriamycin‑induced cardiotoxicity has been revealed; however, the underlying mechanism of this process remains unclear. Artemether is a well‑known Chinese herbal medicine, and its pharmacological action is related to the regulation of mitochondrial function and redox status. The present study determined the effects of artemether on Adriamycin‑induced cardiotoxicity and investigated the underlying mechanisms. After mouse model establishment and artemether intervention, experimental methods including pathological staining, immunohistochemistry, immunofluorescence, immunoblotting, ELISA and reverse transcription‑quantitative PCR were used to evaluate the therapeutic effect. The results demonstrated that artemether prevented Adriamycin‑induced cardiac atrophy and recovered the intercombination of connexin 43 and N‑cadherin at the intercalated discs. Artemether also regulated the autophagy pathway and restored the unbalanced ratio of Bax and Bcl‑2 in myocardial cells. In addition, the increased serum H2O2 levels after Adriamycin exposure were significantly decreased by artemether, and the mitochondrial alterations and redox imbalance in myocardial cells were also improved to varying degrees. In summary, the findings of the present study provide reliable evidence that artemether could ameliorate cardiac atrophy induced by Adriamycin. This therapeutic approach may be translated to the clinic for preventing drug‑induced heart diseases.

PMID:37387406 | DOI:10.3892/mmr.2023.13040

Sci Rep. 2023 Jun 29;13(1):10525. doi: 10.1038/s41598-023-37398-1.

ABSTRACT

This study explores reasons for withdrawal use that is highly prevalent in Iran. A face-to-face semi-structured survey questionnaire was designed and 79 married women aged 15-49, who were only using withdrawal when attending five primary healthcare centers in Tehran during September-October 2021 were interviewed. Results showed that withdrawal mostly was chosen by the couple (67%), and partly by the woman alone (19%) or by the husband alone (14%). Participants evaluated withdrawal positively that has no side effect and cost, is easy to use and accessible, and increases sexual pleasure and intimacy. Most women agreed that husbands use withdrawal to protect their wife's health (76%). Women obtained contraceptive information primarily from gynecologists (42%), the internet (21%), midwives in public health centers (19%), and social networks (18%). "Side effects of modern methods" (37%), "fear of side effects" (16%), and "reduction in sexual pleasure" (14%) were the major reasons reported for using withdrawal. While 'side effects' was given mostly by women who alone or with their husband chose withdrawal (52%, 38%), 'reduction in sexual pleasure' and 'fear of side effects' were mostly reported by women whose husband was the sole decision maker in choosing withdrawal (28%, 25%). The 'fear of side effects' was reported mostly by women who had lower education (21%), used the internet for contraceptive information (23%), and whose husband alone chose withdrawal (25%). Cost of modern methods was a trivial reason for using withdrawal. Most withdrawal users (75%) would not switch to modern methods even if they were freely accessible. More educated women and their husbands would be less likely to switch to modern methods even they were provided freely (OR 0.28, CI 0.10-0.80; OR 0.20, CI 0.07-0.59). However, women who were using modern methods before, and those who alone chose withdrawal would be more likely to switch to modern methods (OR 6.4, CI 2.0-20.2; OR 3.4, CI 1.1-11.2). Access to regular contraceptive counselling and public health campaigns could help women to deal with fears of side effects of modern methods, learn their proper use, and to receive education on how to use withdrawal more effectively to avoid unintended pregnancies.

PMID:37386119 | PMC:PMC10310819 | DOI:10.1038/s41598-023-37398-1

Sci Rep. 2023 Jun 29;13(1):10544. doi: 10.1038/s41598-023-37671-3.

ABSTRACT

Renal Cell Carcinoma (RCC) is a fatal urological cancer, with one third of patients diagnosed with metastasis, resulting in a 5-year survival of only 12%. Recent advancements in therapies have increased survival in mRCC, but lack efficacy in subtypes, due to treatment resistance and toxic side effects. Currently, white blood cells, hemoglobin, and platelets are limitedly used as blood based biomarkers to help determine RCC prognosis. Cancer associated macrophage-like cells (CAMLs) are a potential mRCC biomarker which have been identified in peripheral blood of patients with malignant tumors and have been shown to predict poor clinical patient outcomes based on their number and size. In this study, blood samples from 40 RCC patients were obtained to evaluate the clinical utility of CAMLs. CAML changes were monitored during treatment regimens to evaluate their ability to predict treatment efficacy. It was observed that patients with smaller CAMLs had better progression free survival (HR = 2.84, 95% CI 1.22-6.60, p = 0.0273) and overall survival (HR = 3.95, 95% CI 1.45-10.78, p = 0.0154) versus patients with larger CAMLs. These findings suggest that CAMLs can be used as a diagnostic, prognostic, and predictive biomarker for patients with RCC which may help improve management of advanced RCC.

PMID:37386095 | PMC:PMC10310728 | DOI:10.1038/s41598-023-37671-3

PLoS One. 2023 Jun 29;18(6):e0287627. doi: 10.1371/journal.pone.0287627. eCollection 2023.

ABSTRACT

BACKGROUND: Adolescents in sub-Saharan Africa (SSA) remain vulnerable to HIV infection. While pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV transmission as a daily or on-demand regimen, tailored approaches are necessary. The Combined HIV Adolescent PrEP and Prevention Study (CHAPS) is a mixed-methods research program investigating the acceptability and feasibility of implementing daily and on-demand PrEP among young people in SSA. It also aims to determine an on-demand dosing schedule for insertive sex. For this paper, we explored preferences for daily versus on-demand PrEP amongst adolescents as part of CHAPS.

METHODS: Purposive sampling was used to recruit participants from Soweto and Cape Town (South Africa), Wakiso district (Uganda) and Chitungwiza (Zimbabwe). At the time of the study in 2018/2019, Uganda had not rolled out PrEP to the general population; in Zimbabwe, PrEP for young people was only available at selected sites with one located within the study recruitment area. In South Africa, PrEP was made available to selected high-risk groups. We conducted 60 in-depth interviews and 24 group discussions amongst young people aged 13-24 without HIV in South Africa, Uganda, and Zimbabwe. All in-depth interviews and group discussions were audio-recorded, transcribed verbatim and translated to English. Data were analysed using framework analysis. The main themes were centered around preferences for daily and on-demand PrEP.

RESULTS: Reasons for on-demand preferences included stigma, pill fatigue, adherence and side effects. Reasons for daily PrEP preferences included factors related to sexual risk behaviour, continuous protection against incidents of unintentional exposure, and the increased efficacy of a daily dose. Participants at all sites preferring daily PrEP identified the same reasons, with more males than females citing inadvertent blood contact or perceived increased efficacy. Similarly, participants at all sites preferring on-demand PrEP gave the same reasons for their preferences for on-demand PrEP; the exception was South Africans who did not mention the hope of having fewer side effects by not taking daily PrEP. Additionally, more males than females cited intermittent sex as a reason for opting for on-demand PrEP.

CONCLUSIONS: Our study is the first known to explore and describe youth preferences for daily versus on-demand PrEP. While the choice is clear-cut, the reasons cited in the different options provide invaluable insights into their decisions, and the actual and perceived facilitators and barriers to access to PrEP. Further education is needed amongst young people, not only about PrEP but also in other areas of comprehensive sexuality education. Exploring all options of HIV prevention is crucial to provide a tailored, one-size-does-not-fit-all approach to adolescent care in SSA to reduce and, the continued and increasing risk of this preventable infection.

PMID:37384792 | PMC:PMC10310032 | DOI:10.1371/journal.pone.0287627

Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(6):52-56. doi: 10.17116/jnevro202312306152.

ABSTRACT

OBJECTIVE: Study of the effectiveness of monotherapy with potassium N-acetylaminosuccinate (Cogitum) for asthenic syndrome (fatigue) in individuals, uncharacteristic somatic, neurological diseases, anxiety disorders, depression and other diseases that may interfere with asthenia.

MATERIAL AND METHODS: Patients with fatigue scores of 22 or more on the Fatigue Assessment Scale (FAS) were randomly divided into the main group (MG) - 37 people, mean age 22 years [21; 24] and the control group (CG) - 34 people, mean age 21 years [19; 23]. The Trail Making Test (TMT-A and TMT-B), the assessment of general well-being on a visual analogue scale (VAS), where 0 is the worst state of health, 10 is the state of absolute well-being, was assessed. MG patients received a solution of potassium N-acetylaminosuccinate (Cogitum) 750 mg per day in a sterile container, CG patients received sterile water with banana flavor in a sterile container. The duration of the study was 21 days.

RESULTS: Prior to the start of the study, there were no statistically significant differences in FAS, TMT, and VAS between MG and CG. After 21 days, the FAS score in the MG decreased (p=0.00001), the time of TMT-A (p=0.000012) and TMT-B (p=0.000033) decreased, the VAS score increased (p=0.00024). There were no statistically significant changes in the CG. Placebo effect was noted in 10 patients of the CG (29.4%).

CONCLUSION: Potassium aminosuccinate (Cogitum) at a daily dose of 750 mg and a duration of treatment of 21 days effectively eliminates the symptoms of asthenic syndrome (fatigue), while accompanied by an improvement in complex cognitive functions. The results of our study suggest that fatigue (asthenic syndrome) and cognitive impairment may have a common pathogenetic mechanism - a deficiency of systems in which mediators are N-acetylaspartate and N-acetylaspartylglutamate. Cogitum had no side effects and was well tolerated. Cogitum is superior to placebo in the treatment of fatigue (asthenic syndrome).

PMID:37382978 | DOI:10.17116/jnevro202312306152

Immun Inflamm Dis. 2023 Jun;11(6):e899. doi: 10.1002/iid3.899.

ABSTRACT

INTRODUCTION: In malaria-stricken regions, malaria continues to be one of the primary causes of mortality for children. The number of malaria-related fatalities has drastically decreased because of artemisinin-based pharmacological regimens.

METHODS: Two independent researchers did a comprehensive literature search using PubMed/MEDLINE and Google Scholar from its inception to September 2022.

RESULTS: After evaluating RTS, S/AS01 for its safety, effectiveness, and feasibility, the European Medicines Agency (EMA) issued a favorable conclusion. It was suggested that the RTS, S malaria vaccine be used extensively by the World Health Organization on October 6, 2021. The successful pilot program testing the malaria vaccine in Ghana, Kenya, and Malawi served as the basis for this proposal.

CONCLUSION: Several challenges need to be addressed to ensure the success of vaccination programs. From the acceptability perspective, issues such as inadequate community engagement, concerns about side effects, and issues with the delivery and quality of healthcare services can affect the acceptance of the vaccine. From the feasibility standpoint, factors such as lack of transportation or long distances to healthcare facilities and the perception of completion of the vaccination calendar can affect the feasibility of the vaccine. Lastly, the availability of the vaccine is also a major concern as it may not be readily available to meet the demands.

PMID:37382251 | DOI:10.1002/iid3.899

Zhongguo Zhong Yao Za Zhi. 2023 Jun;48(11):2856-2867. doi: 10.19540/j.cnki.cjcmm.20230315.601.

ABSTRACT

Hyperplasia of mammary glands is a benign breast disease with disordered breast structure. Nowadays, the incidence rate of breast hyperplasia in women is increasing year by year, and the etiology is related to the imbalance of estrogen and progesterone in the body. The symptoms include breast pain, breast nodules, or nipple discharge, which can develop into breast cancer in the context of psychological pressure. Therefore, it is timely and effectively necessary for people to treat the symptoms. At present, traditional Chinese medicine(TCM) often treats breast hyperplasia by oral drug, external application, acupuncture, moxibustion, and massage, while western medicine often uses hormone therapy or surgery. TCM can regulate hormone levels to treat breast hyperplasia. Acupuncture, moxibustion, and other methods can stimulate acupoints to reduce breast lumps. However, since TCM is easy to produce hepatorenal toxicity after long-term use and simple external treatment is slow to take effect, rapid and effective treatment is difficult to be achieved. Although western medicine can inhibit the disease, it is easy to produce toxic and side effects if taken for a long time. In addition, surgery can only remove the focus and the recurrence rate is high. Some studies have found that the combination of oral and external use of TCM compounds has a significant effect, with mild toxic and side effects, few adverse reactions, and a low recurrence rate. Based on the relevant literature in recent years, this article reviewed the combination of oral and external treatment of TCM in the treatment of hyperplasia of mammary glands, discussed the effectiveness, clinical evaluation indexes, and mechanism, and pointed out the existing shortcomings to explore a comprehensive therapy worthy of clinical application.

PMID:37381948 | DOI:10.19540/j.cnki.cjcmm.20230315.601