International journal of clinical pharmacology and therapeutics最新文献

{"title":"Sleep apnea-hypopnea in children: Evidence that Lize Tongqi decoction with acupuncture, moxibustion, and Xinwu acupoint stimulation is superior to standard Western treatment using montelucast/mometasone furoate.","authors":"Yu-Jie Wang, Miao-Yuan Li, Yong Zheng, Bei Wang, Juan Wang, Min Zhang, Huo-Qing Lu, Qin-Yuan Guo","doi":"10.5414/CP205015","DOIUrl":"10.5414/CP205015","url":null,"abstract":"<p><strong>Objective: </strong>To assess the clinical efficacy of a modified Lize Tongqi decoction in combination with acupuncture, moxibustion, and local stimulation of the Xinwu acupoint in the treatment of pediatric snoring.</p><p><strong>Materials and methods: </strong>A randomized controlled trial was conducted in a cohort of 60 pediatric patients (mean age of 7.9 years) diagnosed with snoring. Patients were assigned to either a study group (n = 30) or a control group (n = 30). The study group was treated using modified Lize Tongqi decoction, acupuncture, moxibustion, and stimulation of the Xinwu acupoint (twice weekly for 8 weeks) whereas the control group was treated with conventional Western medicine (oral montelukast once nightly and mometasone furoate nasal spray once nightly for 8 weeks). The severity of symptoms including nasal congestion, nocturnal snoring, and breathing through the mouth was assessed prior to, and following the treatment intervention. Changes in the Obstructive Sleep Apnea-18 (OSA-18) quality of life score and the adenoid-to-nasopharyngeal (A/N) ratio were measured and compared between groups.</p><p><strong>Results: </strong>Post-treatment comparisons showed significantly greater improvements in nasal congestion, snoring, and breathing through the mouth in the study group, and the reductions in both OSA-18 scores and A/N ratios were significantly greater. (Between-group differences p < 0.05). No adverse events were observed in either group.</p><p><strong>Conclusion: </strong>The combination of modified Lize Tongqi decoction with acupuncture, moxibustion, and Xinwu acupoint stimulation effectively reduced symptoms of airway obstruction and improved quality of life in pediatric patients with snoring. The combination therapy is a new, non-surgical therapeutic option for the clinical management of this potentially serious disorder.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148879978","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":"Pharmacotherapy of heart failure: Impact of the 2021 guideline update on guideline-directed medical therapy assessed using a Japanese employee health insurance claims database.","authors":"Takaya Uno, Kouichi Hosomi, Satoshi Yokoyama","doi":"10.5414/CP205008","DOIUrl":"10.5414/CP205008","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the impact of the 2021 guideline update on guideline-directed medical therapy (GDMT) utilization in patients with heart failure (HF).</p><p><strong>Background: </strong>The 2021 update of the Japanese guidelines for HF management followed the introduction of sacubitril/valsartan and dapagliflozin into clinical practice. However, the impact of this guideline update on drug utilization patterns remains unclear.</p><p><strong>Materials and methods: </strong>Patient data were obtained from the Japanese employee health insurance claims database (JMDC). The simple GDMT score was determined based on the combination and dose of four key pharmacological classes: β-blockers, renin-angiotensin system inhibitors, mineralocorticoid receptor antagonists, and sodium-glucose cotransporter 2 inhibitors. Because a simple GDMT score of ≥ 5 has been associated with improved prognosis in patients with HF, patients with scores ≥ 5 were classified into the high-score group for analysis.</p><p><strong>Results: </strong>Following the guideline update, the proportion of patients in the high-score group increased from 6.97% (n = 4,013) to 9.33% (n = 6,363), standardized difference 0.09. The mean simple GDMT score also showed a small but statistically significant increase (5.72 ± 0.79 vs. 6.00 ± 1.09) with standardized difference 0.28. This upward trend was particularly marked for the prescription rates of sacubitril/valsartan and dapagliflozin (sacubitril/valsartan: 1.40% before the update vs. 22.57% after the update; standardized difference, 0.69; dapagliflozin: 12.41% before the update vs. 26.64% after the update; standardized difference, 0.36).</p><p><strong>Conclusion: </strong>The 2021 guideline update was associated with increased use of sacubitril/valsartan and dapagliflozin, resulting in greater overall GDMT intensity. However, these findings are limited to data from 2021, and further long-term studies are needed to evaluate trends in GDMT utilization.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148879990","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":"Practical antimicrobial TDM (PAT) of vancomycin in Japanese emergency and critical care units: Concentration overestimation and correction using scaling factors.","authors":"Koki Takeda, Naoki Yoshikawa, Hidehiko Koreeda, Shuhei Urata, Yuki Matsusaki, Tsubasa Yokota, Akira Okada, Ayane Higuchi, Rin Taguchi, Asako Nishimura, Nobuhito Shibata, Ryota Tanaka, Hiroki Itoh, Ryuji Ikeda","doi":"10.5414/CP205029","DOIUrl":"10.5414/CP205029","url":null,"abstract":"<p><strong>Objectives: </strong>i) To improve the accuracy of initial dosing design in vancomycin therapeutic drug monitoring (TDM) using a free web application of practical antimicrobial TDM (PAT) for vancomycin, ii) to identify patient subgroups in emergency and critical care settings with overestimated predicted population mean serum vancomycin concentrations (PRED), and iii) to calculate appropriate PRED scaling factors.</p><p><strong>Materials and methods: </strong>Vancomycin serum concentrations in patients treated at the Emergency and Critical Care Centers of the University of Miyazaki Hospital, Japan, were simulated using a population pharmacokinetic model. Patients were classified based on the ratio of observed-to-predicted serum vancomycin concentrations (OBS/PRED). Those with a ratio < 0.67 were assigned to the low-trough group, while those with values ≥ 0.67 were the control group. Changes in patient data in the period from admission to immediately before vancomycin administration were analyzed, and scaling factors minimizing the mean squared error (MSE) between PRED and OBS were determined for subgroups more common in the lowtrough group. MSE and root mean squared error (RMSE) values before and after PRED scaling were compared.</p><p><strong>Results: </strong>A total of 47 patients were analyzed, of which 23 were assigned to the low-trough group and 24 to the control group. The low-trough group showed a significantly higher prevalence of patients with creatinine clearance (CCR) < 15 mL/min, albumin < -0.5 g/dL, and trauma. For these subgroups, PRED scaling factors ranged from 0.53 to 0.64. The optimal scaling factor was 0.53 for ΔCCR > 15 mL/min, reducing the RMSE from 5.1 to 4.0 (μg/mL).</p><p><strong>Conclusion: </strong>PRED scaling factors were derived to potentially improve the accuracy of initial vancomycin dosing using PAT, and ΔCCR > 15 mL/min, ΔALB < -0.5 g/dL, and trauma were identified as key factors.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148880044","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":"Therapy challenges and child cohorts: Where the need to treat is the only option.","authors":"Barrington G Woodcock-Kloberdanz","doi":"10.5414/CP205015Edi","DOIUrl":"10.5414/CP205015Edi","url":null,"abstract":"","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148880056","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":"Pharmacokinetic evaluation of two oral formulations of chlorpromazine in healthy subjects.","authors":"Hyo-Jin Min, Jun Gi Hwang, Young-Sim Choi, Min Kyu Park","doi":"10.5414/CP204934","DOIUrl":"10.5414/CP204934","url":null,"abstract":"<p><p>Chlorpromazine is a first-generation antipsychotic agent that exerts its therapeutic effects primarily by antagonizing dopamine D2 receptors. This randomized, open-label, single-dose, two-period, two-sequence crossover study was conducted to evaluate the pharmacokinetic bioequivalence of two oral formulations of chlorpromazine 100 mg: Neomazine tablets (Whan In Pharmaceutical Co., Ltd.) and Chlorpromazine HCl tablets (Myung In Pharmaceutical Co., Ltd.). A total of 70 subjects were randomized, and 61 completed both treatment periods. Blood samples were collected at predefined intervals up to 72 hours post dose to assess pharmacokinetic parameters, including maximum plasma concentration (C_max) and the area under the plasma concentration-time curve to the last measurable concentration (AUC_last). Safety was assessed through monitoring of adverse events (AEs), clinical laboratory tests, vital signs, physical examinations, and 12-lead electrocardiograms. The geometric mean ratios (90% confidence intervals) for C_max and AUC_last were 1.0490 (0.9534 - 1.1542) and 0.9941 (0.9261 - 1.0671), respectively, falling within the accepted bioequivalence range of 0.80 - 1.25. Among the 70 subjects who received at least 1 dose, 116 AEs were reported in 48 individuals; all were mild in intensity and resolved without sequelae, and no serious AEs occurred. These findings confirm the pharmacokinetic bioequivalence and favorable tolerability of the two formulations under fasting conditions in healthy adults and support the use of Neomazine as a therapeutically equivalent and clinically interchangeable alternative to Chlorpromazine HCl.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"498-504"},"PeriodicalIF":0.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147981747","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":"Treatment patterns and reoperation rates in periprosthetic joint infection identified 1 - 6 months after arthroplasty in Japan: A descriptive analysis using nationwide claims data.","authors":"Risa Someya, Kosuke Takata, Takeshi Uchikura, Yusuke Oshita, Kenji Momo","doi":"10.5414/CP204966","DOIUrl":"https://doi.org/10.5414/CP204966","url":null,"abstract":"<p><strong>Objective: </strong>To describe the treatment patterns and reoperation rates after claims-defined postoperative periprosthetic joint infection (PJI) identified 1 - 6 months after total knee or hip arthroplasty using a Japanese nationwide claims database.</p><p><strong>Materials and methods: </strong>Patients who underwent total knee or hip arthroplasty between 2005 and 2017 were identified. Claims-defined postoperative PJI was operationally defined as infection-related claims accompanied by systemic antibacterial treatment in 1 - 6 months after arthroplasty. The agents targeting methicillin-resistant <i>Staphylococcus aureus</i> (MRSA) included vancomycin, daptomycin, linezolid, and teicoplanin. The primary outcome was reoperation after claims-defined postoperative PJI.</p><p><strong>Results: </strong>Among the 2,805 patients, 59 (2.1%) developed postoperative PJI 1 - 6 months after arthroplasty. Of these, 8 underwent immediate surgical intervention, and the remaining 51 patients were initially managed with antibiotic treatment without surgical intervention. Of these, 12 received anti-MRSA agents and 39 received non-MRSA agents. Reoperation was performed in 3 of 12 (25.0%) patients who received anti-MRSA agents and 6 of 39 (15.4%) patients who did not receive anti-MRSA agents. Among the patients treated with anti-MRSA agents, 11 of 12 (91.7%) required second- or third-line therapy. Diabetes mellitus was present in 66.7% and 83.3% of the reoperated patients who received and did not receive anti-MRSA agents, respectively; liver disease was observed in 66.7% and 16.7% of the patients, respectively.</p><p><strong>Conclusion: </strong>This claims-based descriptive analysis indicated that treatment escalation and reoperation were observed after claims-defined postoperative PJI identified 1 - 6 months after arthroplasty. Because pathogen data were unavailable and receipt of anti-MRSA agents was used as a treatment-based classification, these findings should be interpreted as descriptive treatment-pattern data rather than microbiologically confirmed comparisons.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148864790","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":"Methotrexate in rheumatoid arthritis: Old habits die hard.","authors":"Barrington G Woodcock-Kloberdanz","doi":"10.5414/CPP64505","DOIUrl":"https://doi.org/10.5414/CPP64505","url":null,"abstract":"","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148864809","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":"Tranilast/roxithromycin with topical tacrolimus in refractory atopic facial eczema: Case report.","authors":"Yasuhiro Horiuchi","doi":"10.5414/CP204924","DOIUrl":"10.5414/CP204924","url":null,"abstract":"<p><p>One challenge in atopic dermatitis is facial eczema, which requires delicate management because of the sensitive nature of facial skin. This report presents a 30-year-old male patient with facial eczema associated with atopic dermatitis, which could not be cured by conventional treatment, even with the continuation of oral betamethasone. The facial lesions were treated with pediatric 0.03% tacrolimus ointment. The patient was administered 200 mg/day tranilast and 300 mg/day roxithromycin. Within 3 weeks, his eczematous lesions on the face, as well as the severe itching, were completely cured. Addition of this combination therapy may be a promising therapeutic strategy for treating uncontrollable atopic dermatitis, particularly for facial eczema and itching.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2026-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148812746","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":"Blinatumomab-induced catastrophic immune effector cell-associated neurotoxicity with diffuse cerebral edema in a patient with ALL: Case report.","authors":"Xuemei Guo, Yuting Wei, Yongjun Fang, Rufeng Lin","doi":"10.5414/CP205012","DOIUrl":"10.5414/CP205012","url":null,"abstract":"<p><strong>Background: </strong>Blinatumomab, a bispecific T-cell engager that targets CD19, has emerged as a significant therapeutic option for relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). While immune effector cell-associated neurotoxicity syndrome (ICANS) is a recognized complication, most neurological adverse events are mild to moderate and generally reversible. Catastrophic and fatal neurotoxicity, however, remains exceedingly rare, particularly among pediatric patients.</p><p><strong>Case presentation: </strong>We present a case involving a 13-year-old boy diagnosed with MLL-AF4-positive precursor B-ALL who experienced catastrophic neurotoxicity during blinatumomab therapy. Following the achievement of molecular remission and successful tolerance of the first treatment cycle without neurological complications, the patient developed an abrupt-onset fever on day 13 of the second cycle. Despite the immediate discontinuation of blinatumomab and the administration of dexamethasone, his condition rapidly deteriorated, leading to confusion, refractory seizures, and coma within hours. Cranial computed tomography revealed diffuse cerebral edema with suspected subarachnoid hemorrhage and impending brain herniation. Intensive supportive management, which included osmotic therapy, antiepileptic treatment, mechanical ventilation, and vasopressor support, failed to reverse the neurological decline. Ultimately, the patient developed irreversible loss of brainstem reflexes and deep coma.</p><p><strong>Conclusion: </strong>This case underscores a previously unrecognized and severe pattern of delayed-onset, fatal neurotoxicity associated with blinatumomab, which can occur beyond the conventional early treatment window and despite prior tolerance to the drug. Clinicians must remain vigilant for neurological symptoms linked to fever throughout all treatment phases. Further research is urgently required to elucidate risk factors, identify predictive biomarkers, and refine monitoring strategies to avert catastrophic central nervous system injury in pediatric patients undergoing T-cell-engaging immunotherapy.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2026-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148812762","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":"Tislelizumab-induced hyperamylasemia: Case report and safety analysis using the FAERS database.","authors":"Wusimanjiang Aimaiti, Shidan Yu, Yulong Huang, Lijuan Yang, Shuowen Wang, Shengying Gu","doi":"10.5414/CP204996","DOIUrl":"https://doi.org/10.5414/CP204996","url":null,"abstract":"<p><strong>Objective: </strong>To present a case report involving hyperamylasemia caused by tislelizumab and to assess the safety of tislelizumab using the FDA Adverse Event Reporting System (FAERS) database.</p><p><strong>Background: </strong>Although the anti-PD-1 monoclonal antibody tislelizumab is approved by the FDA, the small cohort sample sizes in clinical trials fail to support a thorough safety assessment, especially for immune-related adverse reactions.</p><p><strong>Case report: </strong>A 69-year-old patient developed tislelizumab-related hyperamylasemia after 6 cycles of combination immunotherapy with pemetrexed, tislelizumab, and carboplatin. A total of 5,778 tislelizumab-associated adverse event reports, mainly from China, were retrieved from the FAERS database. Four positive signals were identified at the system organ class (SOC) level and 122 positive signals at the preferred term (PT) level. At the SOC level, tislelizumab exhibited the strongest correlation with blood and lymphatic system disorders (ROR = 24.11, 95% CI: 23.11 - 25.14). At the PT level, myelosuppression was the most significant adverse signal (ROR = 737.29, 95% CI: 705.23 - 770.82). In the SOC category of Investigations, tislelizumab was correlated with decreased counts of neutrophils, white blood cells, platelets and lymphocytes, elevated hepatic enzymes, and increased amylase levels, which was consistent with the manifestation of our presented case.</p><p><strong>Conclusion: </strong>Tislelizumab is associated with multisystem adverse events. Close monitoring of serum amylase levels, as well as regular hematological and biochemical examinations, is essential during clinical medication.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2026-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148792718","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}