Henry Ukachukwu Michael, Marie-Josée Brouillette, Robyn Tamblyn, Lesley K Fellows, Nancy E Mayo
{"title":"Sedative co-medication patterns across frailty states in people with HIV: a network-based study.","authors":"Henry Ukachukwu Michael, Marie-Josée Brouillette, Robyn Tamblyn, Lesley K Fellows, Nancy E Mayo","doi":"10.1007/s11096-025-01963-7","DOIUrl":"https://doi.org/10.1007/s11096-025-01963-7","url":null,"abstract":"<p><strong>Introduction: </strong>People with HIV are living longer, but frailty may increase vulnerability to adverse drug interactions, particularly with sedative medications.</p><p><strong>Aim: </strong>To describe sedative co-medication patterns across frailty states using network-based analysis, and to identify key medications driving interaction complexity.</p><p><strong>Method: </strong>This cross-sectional study analyzed 321 participants using sedatives from the Positive Brain Health Now Cohort (mean age: 53 years), categorized as robust (30.2%), prefrail (47.0%), or frail (22.7%). Sedative use was classified using the Sedative Load Model, and frailty was assessed with a modified Fried Frailty Phenotype. Co-medication networks were constructed for robust, prefrail, and frail groups, with metrics such as Neighborhood Shift Scores (NESH) and ΔBetweenness used to evaluate network dynamics. Edge-level Observed-to-Expected ratios highlighted significant drug pairings and interaction risks.</p><p><strong>Results: </strong>Frail individuals exhibited the most interconnected sedative network (graph density: 0.24; average degree: 7.31) followed by prefrail (graph density: 0.18; average degree: 6.67) and robust groups (graph density: 0.13; average degree: 4.61). Medications with high network influence included mirtazapine (robust-to-prefrail: NESH = 2.05; ΔBetweenness = 0.23), gabapentin (robust-to-frail: NESH = 2.46, ΔBetweenness = 0.10), and pregabalin (prefrail-to-frail: NESH = 2.55; ΔBetweenness = 0.71). High-risk sedative pairs in frail individuals included hydromorphone-clonazepam (Observed-to-Expected ratio: 3.07; interaction severity: D), amitriptyline-oxycodone (Observed-to-Expected ratio: 1.92; severity: D), and quetiapine-citalopram (Observed-to-Expected ratio: 2.12; severity: D). Prefrail individuals had intermediate-risk combinations, including clobazam-levetiracetam (Observed-to-Expected ratio: 81.5; severity: C), and gabapentin-hydroxyzine (Observed-to-Expected ratio: 3.58; severity: D). Robust individuals showed fewer and lower-risk patterns, such as amitriptyline-pregabalin (Observed-to-Expected ratio: 4.00; severity: C). Network differences reflect increasing polypharmacy and adverse interaction risks with advancing frailty.</p><p><strong>Conclusion: </strong>Sedative co-medication patterns vary meaningfully across frailty states in people with HIV. Frailty is associated with more complex networks and a greater likelihood of high-risk drug interactions. Medications influencing these patterns can help identify opportunities for safer prescribing. The prefrail stage may offer a timely window for interventions aimed at minimizing polypharmacy and improving safety in middle-aged and older adults with HIV.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144642520","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Global, regional, and national burden of lip and oral cavity cancer and its attributable risk factors from 1990 to 2021: an analysis of the Global Burden of Disease study 2021.","authors":"Meiling Hu, Hui Chen, Ren Wang, Ruibin Zhang, Jun Yao, Xili Qiu, Jincai Guo","doi":"10.1007/s11096-025-01961-9","DOIUrl":"https://doi.org/10.1007/s11096-025-01961-9","url":null,"abstract":"<p><strong>Background: </strong>Lip and oral cavity cancer is a significant global health concern, with increasing incidence rates in recent years. Understanding epidemiological trends and their associated risk factors is crucial for effective prevention and management.</p><p><strong>Aim: </strong>This study aimed to analyze global, regional, and national trends in lip and oral cavity cancer incidence, mortality, and disability-adjusted life-years (DALYs) from 1990 to 2021 to assess key risk factors and sociodemographic influences to support clinical pharmacy interventions and improve patient outcomes.</p><p><strong>Method: </strong>Lip and oral cavity cancer burden was analyzed by location, age, and sex. Joinpoint regression assessed trends, Spearman correlation measured sociodemographic index (SDI) associations, and decomposition analysis quantified population growth, aging, and epidemiological impacts. Cross-country disparities and risk factors were also evaluated.</p><p><strong>Results: </strong>In 2021, there were 421,577 (95% uncertainty interval [UI]: 389,879-449,782) new lip and oral cavity cancer cases, 208,379 (95% UI: 191,288-224,162) deaths, and 5,874,070 (95% UI: 5,326,986-6,347,557) DALYs globally, with the highest burden in South Asia. The age-standardized incidence rate (ASIR) increased significantly, while the age-standardized mortality rate (ASMR) and age-standardized DALYs rate slightly declined. Men and older adults had higher rates, but the increase was more pronounced in women and younger populations. ASIR correlated positively with SDI, while cross-country inequalities persisted, particularly in low-SDI regions. The contribution of tobacco chewing to lip and oral cavity cancer deaths and DALYs slightly increased.</p><p><strong>Conclusion: </strong>The incidence of lip and oral cavity cancer continues to increase, with a shifting burden on younger individuals and women. Targeted interventions to reduce risk factors and improve access to healthcare are essential for high-risk populations and regions.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144591112","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yuta Ibe, Tomoyuki Ishigo, Tomohiro Aigami, Satoshi Fujii, Masahide Fukudo
{"title":"Effect of discrepancy in estimated renal function on vancomycin area under the blood concentration-time curve: a retrospective cohort study comparing serum creatinine and serum cystatin C.","authors":"Yuta Ibe, Tomoyuki Ishigo, Tomohiro Aigami, Satoshi Fujii, Masahide Fukudo","doi":"10.1007/s11096-025-01960-w","DOIUrl":"https://doi.org/10.1007/s11096-025-01960-w","url":null,"abstract":"<p><strong>Background: </strong>Accurate estimation of renal function is essential for determining vancomycin (VCM) dosing. Serum creatinine (sCr)-based formulas are used to estimate renal function; however, they may overestimate the glomerular filtration rate (GFR) in patients with reduced muscle mass. Serum cystatin C (cys-C) may provide more accurate estimates of renal function in such populations.</p><p><strong>Aim: </strong>We aimed to investigate the effect of estimated GFR (eGFR) discordance on area under the blood concentration-time curve (AUC) of VCM.</p><p><strong>Method: </strong>Data from 118 patients with simultaneous sCr and cys-C data available at start of VCM therapy were analyzed. Patients were classified into eGFR discordance and concordance groups. eGFR discordance was defined as a case where the sCr-based eGFR was 30% or higher than the cys-C-based eGFR. The primary outcome was the association between eGFR discordance and upward deviation of the VCM AUC.</p><p><strong>Results: </strong>Seventy-two patients with eGFR discordance had significantly higher measurement of VCM AUC than predicted (p < 0.001). Multivariate logistic regression analysis identified age, hospital stay of ≥ 12 days, and eGFR discordance as significant predictors of AUC upward deviation. Factors associated with discordance in the eGFR included these risk factors and intensive care unit (ICU) stay.</p><p><strong>Conclusion: </strong>This study highlights the importance of measuring cys-C levels at initiation of VCM therapy identifying patients at risk of renal function overestimation and subsequent VCM overdosing. Older with extended hospitalization or ICU stay may benefit from measuring cys-C levels of optimize VCM therapy and reduce drug-induced toxicity risk.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144591111","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Effects of sodium-glucose cotransporter-2 inhibitors on serum urate levels and gout in patients with and without type 2 diabetes: a systematic review and network meta-analysis.","authors":"Qiaozhi Hu, Shiwen Yang, Bofei Zhang, Na Su","doi":"10.1007/s11096-025-01950-y","DOIUrl":"https://doi.org/10.1007/s11096-025-01950-y","url":null,"abstract":"<p><strong>Background: </strong>Sodium-glucose cotransporter-2 (SGLT-2) inhibitors can decrease serum uric acid (sUA) levels and have potential in the management of glucose levels and cardiorenal protection in patients.</p><p><strong>Aim: </strong>This systematic review and network meta-analysis aimed to investigate the effects of SGLT-2 inhibitors on sUA levels and incidence of gout in patients with or without type 2 diabetes.</p><p><strong>Method: </strong>A systematic search of PubMed, Embase, Cochrane Central Register of Controlled Trials, and Clinical Trials databases was performed to retrieve relevant articles published from inception to April 27, 2025, focusing on the impact of SGLT-2 inhibitors on sUA levels or the incidence of gout in the study participants. We performed a Bayesian random-effects network meta-analysis of the included studies using the Markov Chain Monte Carlo simulation techniques. The grading of recommendations, assessment, development, and evaluation approach was used to assess the certainty of the evidence.</p><p><strong>Results: </strong>A total of 57 trials were included. All SGLT-2 inhibitors reduced sUA levels. These inhibitors demonstrated a spectrum of sUA-lowering effects, with empagliflozin and dapagliflozin exhibiting particularly robust efficacy. Specifically, empagliflozin (10 mg: - 43 [95% CI - 52.45 to - 33.66]; 25 mg: - 41.99 [95% CI - 51.93 to - 31.9]; 50 mg: - 35.77 [95% CI - 68.04 to - 3.53]) and dapagliflozin (5 mg: - 36.91 [95% CI - 49.5 to - 24.46]; 10 mg: - 34.98 [95% CI - 43.75 to - 26.44]) displayed superior reductions in sUA levels compared to other agents within the class. Although there was a potential reduction in the incidence of gout associated with SGLT-2 inhibitors, the difference was not statistically significant.</p><p><strong>Conclusion: </strong>Future long-term studies should consider SGLT-2 inhibitors for individuals requiring sUA reduction and gout management. These results could serve as a reference for future guidelines addressing the treatment of individuals with diabetes, necessitating sUA lowering and gout management. Trial Registration PROSPERO registration number CRD42024521695.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144540128","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Cardiovascular toxicities associated with vascular endothelial growth factor receptor tyrosine kinase inhibitors: a pharmacovigilance study based on FDA adverse event reporting system.","authors":"Yao Zhang, Junge Deng, Jize Wang","doi":"10.1007/s11096-025-01962-8","DOIUrl":"https://doi.org/10.1007/s11096-025-01962-8","url":null,"abstract":"<p><strong>Background: </strong>Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) are widely used in the treatment of various cancers. However, post-marketing evidence regarding their cardiovascular toxicities remains limited.</p><p><strong>Aim: </strong>This pharmacovigilance study aimed to comprehensively evaluate the association between VEGFR-TKIs and cardiovascular toxicities in cancer patients.</p><p><strong>Method: </strong>We retrieved and analyzed cardiovascular toxicity reports related to VEGFR-TKIs from the FDA Adverse Event Reporting System (FAERS). Disproportionality analyses were performed using the proportional reporting ratio (PRR), reporting odds ratio (ROR), information component (IC), and empirical Bayes geometric mean (EBGM) to detect safety signals of cardiovascular toxicities associated with VEGFR-TKIs.</p><p><strong>Results: </strong>A total of 12,726 cancer patients experienced cardiovascular toxicities associated with VEGFR-TKI treatment. All eleven VEGFR-TKIs were associated with cardiovascular toxicities, with hypertension being the most consistently reported event across all agents. Among them, cabozantinib was associated with the highest number of cardiovascular events, whereas lenvatinib exhibited the strongest signal. Notably, lenvatinib was associated with cardiac failure (ROR = 2.521, PRR = 2.479, IC = 1.308, EBGM = 2.476) and cardiomyopathy (ROR = 2.801, PRR = 2.788, IC = 1.476, EBGM = 2.782); sunitinib with cardiac failure (ROR = 2.745, PRR = 2.693, IC = 1.426, EBGM = 2.687) and cardiomyopathy (ROR = 3.020, PRR = 3.004, IC = 1.584, EBGM = 2.997); ponatinib with cardiomyopathy (ROR = 3.393, PRR = 3.372, IC = 1.752, EBGM = 3.368); and vandetanib with Torsade de pointes/QT prolongation (ROR = 27.930, PRR = 26.101, IC = 4.703, EBGM = 26.051).</p><p><strong>Conclusion: </strong>VEGFR-TKIs were associated with cardiovascular toxicities, particularly hypertension. Notably, lenvatinib and sunitinib were associated with cardiac failure and cardiomyopathy, ponatinib with cardiomyopathy, and vandetanib with Torsade de pointes and QT prolongation. Future prospective studies are warranted to further clarify the causal relationships between these agents and cardiovascular toxicities.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144540120","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Real-world data and Mendelian randomization analysis in assessing adverse reactions of rilonacept.","authors":"Lihong Liu, Zhenfei Chi, Zhe Zhang","doi":"10.1007/s11096-025-01932-0","DOIUrl":"https://doi.org/10.1007/s11096-025-01932-0","url":null,"abstract":"<p><strong>Background: </strong>Rilonacept, an interleukin-1 (IL-1) \"trap,\" is FDA-approved for recurrent pericarditis, but research on its adverse reactions is limited due to its recent introduction.</p><p><strong>Aim: </strong>This study aimed to identify potential adverse reactions associated with rilonacept using the FDA Adverse Event Reporting System (FAERS) and to evaluate long-term effects through Mendelian randomization (MR) analysis.</p><p><strong>Method: </strong>We analyzed all adverse event reports related to rilonacept from the FAERS database between January 2021 and June 2024. Positive signals for adverse reactions were extracted using reporting odds ratios (ROR) and information components (IC). MR analysis was conducted using genetic variants as instrumental variables to explore causal relationships between rilonacept and identified adverse reactions, with sensitivity analyses performed for robustness.</p><p><strong>Results: </strong>A total of 419 adverse event reports were analyzed, documenting 1847 AEs. Common events included COVID-19, injection site rash, pain, and injection site reaction, categorized into 27 System Organ Classes (SOCs). Notable frequencies were found in Infections and Infestations, Nervous System Disorders, and Skin and Subcutaneous Tissue Disorders. Disproportionality analysis identified positive signals primarily in Skin and Subcutaneous Tissue Disorders, Cardiac Disorders, and Immune System Disorders, with 11 AEs showing positive signals in both Preferred Terms (PTs) and SOCs. MR analysis revealed significant associations between IL-1RN (rilonacept) and allergic urticaria (OR: 1.56), rash (OR: 0.64), and myocarditis (OR: 2.26).</p><p><strong>Conclusion: </strong>Rilonacept is effective for certain inflammatory conditions, but careful monitoring for adverse reactions, particularly involving the immune system, skin, and cardiac issues, is essential.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144540130","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hui-Fang Jiang, Wei Hu, Ting-Ting Jin, Hai-Li Shan, Tao Zhu, Jun-Jun Xu, Yang-Min Hu, Hai-Bin Dai
{"title":"Genetic links between psychological distress, sleep disorders, and sepsis risk: a Mendelian randomization study.","authors":"Hui-Fang Jiang, Wei Hu, Ting-Ting Jin, Hai-Li Shan, Tao Zhu, Jun-Jun Xu, Yang-Min Hu, Hai-Bin Dai","doi":"10.1007/s11096-025-01931-1","DOIUrl":"https://doi.org/10.1007/s11096-025-01931-1","url":null,"abstract":"<p><strong>Background: </strong>Psychological distress and sleep disorders have been associated with increased sepsis risk and mortality, but their causal genetic relationships remain unclear.</p><p><strong>Aim: </strong>This study aimed to evaluate the causal relationship between genetically predicted psychological distress, sleep disorders, and sepsis risk, using a two-sample Mendelian randomization approach.</p><p><strong>Method: </strong>Genetic instrumental variables were identified for anxiety disorders, depression, post-traumatic stress disorders (PTSD), insomnia, and sleep-wake schedule disorders. Genome-wide association study (GWAS) data were used as exposure datasets, and five sepsis severity levels were analyzed. The inverse-variance weighted (IVW) method was the primary analysis, supported by the MR-Egger and weighted median methods. Heterogeneity was assessed using Cochran's Q test and pleiotropy was evaluated using the MR-Egger intercept test. A Leave-one-out sensitivity analysis was conducted to ensure robustness.</p><p><strong>Results: </strong>MR analysis found that genetically predicted depression was significantly associated with increased sepsis risk in individuals under 75 years of age (OR 1.15, 95% CI 1.03-1.28; P = 0.016), while PTSD was associated with a higher likelihood of requiring critical care for sepsis (OR 1.11, 95% CI 1.04-1.18; P = 0.002). No significant associations were found between other psychological distress factors, sleep disorders, and the risk of sepsis. Sensitivity analyses confirmed the stability of these results.</p><p><strong>Conclusion: </strong>This study provides genetic evidence linking depression and PTSD to sepsis risk and severity, emphasizing the need for clinical awareness and targeted interventions in at-risk individuals.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144540129","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Integrative genetic analysis of shared genetic architecture of stroke and coronary artery disease: implications for pharmacist-led precision medicine.","authors":"Weizhong Shi, Luofei Zhang, Zhigang Zhao, Kefu Yu","doi":"10.1007/s11096-025-01952-w","DOIUrl":"https://doi.org/10.1007/s11096-025-01952-w","url":null,"abstract":"<p><strong>Introduction: </strong>Coronary artery disease (CAD) and stroke are leading causes of global morbidity and mortality. Their frequent comorbidities and overlapping risk profiles highlight the importance of understanding shared genetic mechanisms, particularly in identifying therapeutic targets relevant to personalized pharmacotherapy.</p><p><strong>Aim: </strong>This study aimed to explore the shared genetic architecture between stroke and CAD, identify common therapeutic targets, and provide implications for clinical pharmacy practice.</p><p><strong>Method: </strong>We integrated multi-ancestry genome-wide association study (GWAS) summary statistics (stroke: 110,182 cases; CAD: 210,842 cases) and employed linkage disequilibrium score regression to assess genetic correlations. Bidirectional two-sample Mendelian randomization (MR) was employed to infer causal inference. Shared genetic variants were identified through cross-trait meta-analyses (MTAG and CPASSOC) and validated using Bayesian colocalization. Pharmacogenomic pathways associated with shared genes were linked to approved drugs using a pathway-pairing score to assess the therapeutic alignment. A score of ≥ 0.5 indicated a strong alignment between a drug's pharmacological mechanism and the disease's genetic pathophysiology.</p><p><strong>Results: </strong>A significant genetic correlation was observed between stroke and CAD (rg = 0.48, P = 3.38 × 10<sup>-34</sup>). Eight pleiotropic SNPs and five colocalized causal variants were identified, implicating ten disease-shared genes. Drug-target analyses prioritized the 19 approved cardiovascular agents. Beta-blockers (e.g., bisoprolol, esmolol) and antihypertensives (e.g., fenoldopam bromide/mesylate) demonstrated strong therapeutic potential (pathway score ≥ 0.5).</p><p><strong>Conclusion: </strong>This study provides genomic evidence to support integrated therapeutic strategies for stroke and CAD. Pharmacogenomic insights into shared genetic determinants can assist clinical pharmacists in optimizing treatment selection, mitigating polypharmacy risks, and guiding precision medicine in patients with dual cardiocerebrovascular risks.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144527844","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zhenzhen Zhou, Weili Li, Yanfeng Liu, Fujian Si, Dongmei Wang, Xu Sun, Nan Song, Wenjing Chen, Huilan Du
{"title":"Efficacy and safety of Jingqianshu granules in patients with premenstrual syndrome: a multicenter, randomized, double-blind, placebo-controlled trial.","authors":"Zhenzhen Zhou, Weili Li, Yanfeng Liu, Fujian Si, Dongmei Wang, Xu Sun, Nan Song, Wenjing Chen, Huilan Du","doi":"10.1007/s11096-025-01949-5","DOIUrl":"https://doi.org/10.1007/s11096-025-01949-5","url":null,"abstract":"<p><strong>Introduction: </strong>Premenstrual syndrome (PMS) is a common disorder characterized by recurring somatic, emotional, and behavioral symptoms during the luteal phase of the menstrual cycle. Core manifestations include irritability, anxiety, insomnia, mood swings, breast tenderness, and headache. In Traditional Chinese Medicine (TCM), PMS with liver and qi stagnation is considered a pattern resulting from internal organ imbalance. Jingqianshu granules (JQS), a Chinese patented medicine, are traditionally used to soothe the liver, relieve depression, regulate qi, and alleviate pain.</p><p><strong>Aim: </strong>This study aimed to evaluate the clinical efficacy and safety of JQS in women with PMS characterized by liver stagnation and qi stagnation.</p><p><strong>Method: </strong>A total of 156 eligible participants were randomly assigned in a 2:1 ratio to receive JQS (n = 104) or placebo (n = 52) over three menstrual cycles, followed by a three-cycle post-treatment follow-up. The primary outcome was the change in the Daily Record of Severity of Problems (DRSP) scores. Secondary outcomes included TCM syndrome scores and improvements in individual symptoms. Safety was assessed by adverse event reporting and laboratory monitoring.</p><p><strong>Results: </strong>The full analysis set (FAS) included 155 participants, and the per-protocol set (PPS) included 137. After three treatment cycles, DRSP scores were significantly reduced in the JQS group compared to placebo (FAS: - 14.3 ± 8.85 vs. - 10.1 ± 7.61; PPS: - 14.5 ± 8.61 vs. - 10.2 ± 7.13; both P < 0.001) with a moderate effect size (Cohen's d = 0.51), indicating clinical relevance. TCM syndrome scores also showed greater improvement in the JQS group (FAS: 7.7 ± 3.11 vs. 9.0 ± 4.13; PPS: 7.7 ± 3.19 vs. 9.4 ± 4.23; P < 0.05). The JQS group exhibited significant improvements in individual DRSP symptoms including anxiety, fatigue, emotional instability, concentration difficulty, and breast tenderness (P < 0.05). Adverse events were mild and comparable between the groups (4.81% in JQS vs. 3.92% in placebo; P > 0.05), with no serious events reported.</p><p><strong>Conclusion: </strong>Jingqianshu granules significantly alleviated PMS symptoms and demonstrated good tolerability, supporting their use as a safe and effective treatment option for women with liver and qi stagnation-type PMS.</p><p><strong>Trial registration: </strong>This trial was registered in the Chinese Clinical Trials Registry (ChiCTR2200058599).</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144527842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Exploring community pharmacy manager/ pharmacist perceptions and responses to China's dual-channel policy for improving access and rational use of innovative drugs: a qualitative study.","authors":"Xingmiao Zhu, Hao Hu, Dongning Yao","doi":"10.1007/s11096-025-01957-5","DOIUrl":"https://doi.org/10.1007/s11096-025-01957-5","url":null,"abstract":"<p><strong>Introduction: </strong>To improve access to innovative medications, the Chinese government introduced a dual-channel policy, allowing community pharmacies to dispense innovative drugs listed in the National Reimbursement Drug List of the national healthcare security system. However, research on how community pharmacies interpret and respond to these policies remains limited.</p><p><strong>Aim: </strong>To investigate community pharmacy manager/ pharmacist perceptions of and responses to the dual-channel policy, with a focus on improving accessibility and the rational use of innovative drugs for patients in China.</p><p><strong>Method: </strong>A qualitative research design, involving semi-structured interviews, was conducted in Jiangsu Province, China. The interview guide was developed to address key domains relevant to community and licensed pharmacists. The participants were recruited through purposive and snowball sampling to ensure diverse perspectives. The interviews were audio-recorded, transcribed, and analyzed using the framework method. NVivo software was used for coding and theme development, until theoretical saturation was achieved.</p><p><strong>Results: </strong>The participants viewed the dual-channel policy as an opportunity to expand business operations and enhance market competitiveness. However, they also identified several challenges, including space and storage constraints, regional inconsistencies in electronic prescription systems, limited influence on hospital prescription flows, selective partnerships with pharmaceutical companies, and elevated service expectations from patients. In response, pharmacies have implemented a range of hardware-focused strategies, such as upgrading service areas, integrating insurance billing systems, and developing patient management platforms, as well as soft competence strategies, including pharmacist training on innovative drugs and disease knowledge, interpretation of reimbursement policies, and emergency response preparedness.</p><p><strong>Conclusion: </strong>This study demonstrates that participation in a dual-channel policy is widely perceived by community pharmacies as a strategic opportunity, despite the associated operational and systemic challenges. Proactive engagement with the policy not only strengthened their competitive positioning but also contributed to improved pharmaceutical services and patient care outcomes.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144527843","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}