International journal of clinical pharmacology and therapeutics最新文献

{"title":"Sarcopenia with muscle wasting in hepatic cancer predicts therapeutic outcome after hepatic artery intervention.","authors":"Yuejuan Liao","doi":"10.5414/CP204698","DOIUrl":"10.5414/CP204698","url":null,"abstract":"<p><strong>Objectives: </strong>We aimed to study sarcopenia for its significance in predicting the effect of hepatic artery intervention (HAI) plus lenvatinib on hepatitis B-related hepatocellular carcinoma (HCC) complicated with diabetes mellitus (DM).</p><p><strong>Materials and methods: </strong>Hepatitis B-related HCC patients complicated with DM (n = 102) visiting during January 2021 and December 2023 were retrospectively selected. Computed tomography was performed to detect the third lumbar vertebra for its muscle cross-sectional area. A non-sarcopenia group (59 cases) plus a sarcopenia group (43 cases, men with a skeletal muscle index ≤ 40.8 cm²/m² and women with a skeletal muscle index ≤ 34.9 cm²/m²) were established according to different skeletal muscle indexes.</p><p><strong>Results: </strong>Significant decline in body mass index (BMI) and albumin (ALB) level was observed in the sarcopenia group compared to the non-sarcopenia group (p < 0.05). The sarcopenia group, compared with the non-sarcopenia group, exhibited a significantly reduced objective response rate (53.49 vs. 74.58%) (p < 0.05), while no significant intergroup difference was discovered in the disease control rate (95.35 vs. 91.53%) (p < 0.05). Low BMI, alpha fetoprotein (AFP), low ALB, and pre-chemotherapy sarcopenia all influenced the overall clinical efficacy, as independent influencing factors (p < 0.05).</p><p><strong>Conclusion: </strong>Sarcopenia may attenuate the efficacy of HAI plus lenvatinib on hepatitis B-related HCC with DM, and BMI, AFP and ALB are factors affecting the therapeutic effect.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"70-76"},"PeriodicalIF":0.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142914581","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":"Medication reconciliation in intensive care units of a tertiary hospital in Saudi Arabia: An evaluation of medication discrepancies.","authors":"Samaher A Alatmi, Mohammad Aljawadi, Mansour Almuqbil, Sarah Aldakhil, Ebtisam M Alqahtani, Reema A Almalke, Mohammed M Alshammari, Abdullah M Alhammad","doi":"10.5414/CP204690","DOIUrl":"10.5414/CP204690","url":null,"abstract":"<p><strong>Background: </strong>Patients discharged from intensive care units (ICUs) are at higher risk for medication discrepancies, which can harm patients, increase healthcare costs, and lead to readmission. This study aimed to describe the frequency and types of medication discrepancies among ICU patients upon discharge and identify the factors associated with medication discrepancies.</p><p><strong>Materials and methods: </strong>This retrospective cohort study included patients ≥ 18 years old, admitted to medical or surgical ICUs, and discharged on one or more medications. This study was done at a tertiary university hospital in Riyadh, Saudi Arabia. Data were collected through chart review over a 3-month period in 2018. Medication discrepancy was defined as any difference identified between the documented home medication list and the medication list on ICU discharge without any clearly documented justification. χ², Fisher exact test, and logistic regression were used to analyze the data.</p><p><strong>Results: </strong>Out of 204 screened patients, 121 were included. The mean age was 51 ± 15.7 years, 57 (47.1%) were female, and 91 (75.2%) were admitted to the surgical ICU. The median ICU length of stay was 3 (2 - 7) days. In total, 216 medication discrepancies were identified; only 23 (19%) patients were discharged without any medication discrepancies. The mean medication discrepancies identified per patient were 2 ± 1. The most common type of medication discrepancies identified were no indication of therapy (43.8%), drug omissions (33.7%), and discrepancies in the duration of therapy (11.2%). Mechanically ventilated patients were less likely to have medication discrepancies upon discharge (OR = 0.24, 95% CI = (0.07 - 0.90)).</p><p><strong>Conclusion: </strong>This study demonstrated many medication discrepancies among patients discharged from ICUs at KSUMC University Hospital in Riyadh, Saudi Arabia. The lack of a systematic approach to medication reconciliation might contribute to the increased number of medication discrepancies in comparison to multiple studies in different countries exploring the medication discrepancies among ICU patients. Establishing a process that includes pharmacist-driven medication reconciliation is needed.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"63-69"},"PeriodicalIF":0.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142914580","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":"Antibiotic treatment of ceftriaxone-susceptible Serratia marcescens bacteremia: A multicenter, retrospective cohort study.","authors":"Abdallah Mughrabi, Julian Maamari, Timothy Phillips, Afaq Alabbasi, Aislinn Brooks, Rinat Nuriev, Lisa Zenkin, Bertrand L Jaber, Claudia Nader","doi":"10.5414/CP204652","DOIUrl":"10.5414/CP204652","url":null,"abstract":"<p><strong>Background: </strong><i>Serratia marcescens</i> has recently been categorized as low-risk for AmpC β-lactamase inducible production, but research on outcomes in <i>Serratia</i> bacteremia by antibiotic choice is limited.</p><p><strong>Objectives: </strong>This study examined the clinical characteristics and outcomes of patients with ceftriaxone-susceptible <i>Serratia</i> bacteremia who received AmpC-directed β-lactam therapy vs. narrower spectrum therapies.</p><p><strong>Materials and methods: </strong>Records of hospitalized adults with at least one positive blood culture for <i>Serratia</i>, over an 8-year period, across seven hospitals in an integrated health care system, were reviewed.</p><p><strong>Results: </strong>Of the 73 identified patients, 17 (23.3%) received carbapenem-based therapy. More than half of cases were community-acquired, with urological and intravenous drug use being the most common sources. While there was a trend toward lower mortality in carbapenem-treated patients (14.8 vs. 0%; p = 0.10), this was not statistically significant. The composite outcome of clinical failure was also not significant. However, compared to non-carbapenem-treated patients, carbapenem-treated patients had longer treatment duration (13 vs. 15 days; p = 0.02), prolonged hospital stays (5 vs. 11 days; p < 0.001), and higher infection-related readmission rates (17.6 vs. 3.6%; p = 0.04). A subset analysis of the 56 non-carbapenem treated patients found no significant difference in 30-day mortality or clinical failure between cefepime and non-cefepime-containing subgroups.</p><p><strong>Conclusion: </strong>Our study found that cefepime- or carbapenem-based therapy may have limited clinical relevance in the treatment of <i>Serratia</i> bacteremia when the strains are initially susceptible to ceftriaxone, highlighting the importance of antibiotic stewardship to prevent emergence of multidrug resistant organisms.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"54-62"},"PeriodicalIF":0.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142914578","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":"Pharmacokinetics and bioequivalence of ezetimibe tablet in healthy Chinese subjects under fasting and fed conditions.","authors":"Guan Liu, Hegui Yan, Baodong Yuan, Gang Li","doi":"10.5414/CP204642","DOIUrl":"10.5414/CP204642","url":null,"abstract":"<p><strong>Objective: </strong>The purpose of this study is to evaluate the pharmacokinetics (PK) parameters of an ezetimibe 10 mg (test drug) and assess its bioequivalence to the branded reference product in healthy Chinese subjects under fasting and fed conditions.</p><p><strong>Materials and methods: </strong>A single-center, randomized, open-label, four-period, two-sequence, full replicate crossover study was conducted in 88 healthy Chinese subjects under fasting or fed conditions. Subjects received a single oral dose of 10 mg ezetimibe tablet as test or reference formulation. There was a minimum 14-day washout period between each dose. Blood samples were collected at prescribed time intervals, the plasma concentration of free ezetimibe and total ezetimibe (ezetimibe + ezetimibe glucuronide) was determined by a validated ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method. Pharmacokinetik and bioavailability parameters were estimated via non-compartmental methods. Adverse events were also recorded.</p><p><strong>Results: </strong>40 and 48 eligible healthy subjects were enrolled in the fasted and fed study. Under fasting state, total ezetimibe with 90% confidence intervals (CIs) of C_max, AUC_0-t, and AUC_0-∞ were 87.17% (81.99 - 92.66%), 95.98% (92.38-99.72%), and 96.04% (91.37 - 100.95%), respectively. Under fed state, total ezetimibe with 90% confidence intervals (CIs) of C_max, AUC_0-t, and AUC_0-∞ were 98.71% (90.11 - 108.13%), 98.32% (94.71 - 102.06%), and 97.90% (92.68 - 103.42%), respectively. The 90% CIs of the ratio of geometric means (GMRs) of C_max, AUC_0-t, AUC_0-∞ of the test and reference formulation in both fasting and fed conditions fell within the conventional bioequivalence criteria of 0.80 - 1.25. No severe adverse events were observed.</p><p><strong>Conclusion: </strong>The test and reference 10-mg ezetimibe tablets were bioequivalent under fasting and fed conditions in Chinese subjects. Both preparations showed good safety and tolerability.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"38-46"},"PeriodicalIF":0.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545335","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":"Positive effects of magnesium supplementation in metabolic syndrome.","authors":"Sophia Kisters, Klaus Kisters, Tanja Werner, Jürgen Vormann, Faruk Tokmak, Timm Westhoff, Uwe Gröber, Hans-Georg Predel, Hannes Reuter","doi":"10.5414/CP204677","DOIUrl":"10.5414/CP204677","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Recent data show that magnesium supplementation decreases systolic and diastolic blood pressure values depending on the blood pressure levels and improves metabolic parameters in cardiovascular disease.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Materials and methods: &lt;/strong&gt;In this context, we conducted a prospective, randomized, double-blind study on serum and ionized magnesium, systolic and diastolic blood pressure values, interleukin-6, vitamin D, and metabolic profile in 27 patients (13 male/14 female, age: 60.2 ± 12.5 years) with metabolic syndrome. All patients received 400 mg of oral magnesium supplementation daily. Parameters were measured before and after 6 and 12 weeks of treatment. 27 patients served as controls without additional magnesium treatment (10 male/17 female, age: 64.6 ± 13.2 years).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;There was no significant change in serum magnesium after 6 and 12 weeks of magnesium supplementation and in controls. Ionized magnesium significantly increased from 0.56 ± 0.05 to up to 0.63 ± 0.08 mmol/L (mean ± SD) (p &lt; 0.01). The ionized Ca&lt;sup&gt;++&lt;/sup&gt;/Mg&lt;sup&gt;++&lt;/sup&gt; ratio was significantly increased at baseline in about 32% of all patients; after 12 weeks of magnesium supplementation, the Ca&lt;sup&gt;++&lt;/sup&gt;/Mg&lt;sup&gt;++&lt;/sup&gt; ratio decreased significantly from 2.32 ± 0.22 to 2.04 ± 0.24 at the end of the study (mean ± SD, p &lt; 0.05). In the magnesium-treated group, there was a significant decrease in systolic and diastolic blood pressure values after 12 weeks (systolic: 134.6 ± 6.8 to 126.3 ± 5.6 mmHg, diastolic: 84.1 ± 3.9 to 79.4 ± 1.6 mmHg) (mean ± SD) (p &lt; 0.01). Additional magnesium supplementation decreased interleukin-6 values significantly from 4.94 ± 3.30 to 4.53 ± 6.89 pg/mL after 6 weeks to 3.01 ± 1.32 pg/mL after 12 weeks (mean ± SD) (p &lt; 0.01). In the control group, interleukin-6 was 3.73 ± 4.36 pg/mL before the start of the supplementation, 4.87 ± 4.35 pg/mL after 6 weeks, and 4.41 ± 3.15 pg/mL after 12 weeks (means ± SD) (n.s.). In patients receiving magnesium supplementation, vitamin D levels significantly improved from 17.93 ± 8.96 to 24.41 ± 10.20 ng/mL (mean ± SD) (p &lt; 0.05). HbA1c and serum cholesterol values improved under magnesium therapy, but the improvement did not reach significance. For statistical analysis, Mann-Whitney-U-Test was used.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Using supplementation with 400 mg magnesium for 12 weeks in patients with metabolic syndrome, ionized magnesium concentrations significantly increased, while serum magnesium did not change significantly. Both systolic and diastolic blood pressure values decreased significantly in the magnesium-treated group. Magnesium supplementation also significantly decreased interleukin-6 levels and increased vitamin D in patients. HbA1c and cholesterol levels improved with magnesium supplementation, but the improvement did not reach significance. The anti-inflammatory effects of magnesium as well as anti-arteriosclerotic eff","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"569-578"},"PeriodicalIF":0.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142390398","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":"Identification of factors associated with vancomycin-induced acute kidney injury: A retrospective analysis using the Common Data Model.","authors":"Sang-In Park, Jung-Kyeom Kim, Uijeong Yu, Ji In Park","doi":"10.5414/CP204646","DOIUrl":"10.5414/CP204646","url":null,"abstract":"<p><strong>Objective: </strong>Previous findings on predictors of vancomycin-induced acute kidney injury (AKI) are inconsistent. We aimed to identify the predictors of vancomycin-induced AKI using the Observational Medical Outcome Partnership Common Data Model.</p><p><strong>Materials and methods: </strong>We analyzed data from patients treated with vancomycin between January 1, 2012, and May 31, 2022, who were positive for <i>Staphylococcus aureus</i> and had undergone oxacillin susceptibility tests. After excluding patients without data for vancomycin or baseline serum creatinine levels, 116 patients were included in the final dataset. Data up to the third measured vancomycin concentration were collected for each patient. Logistic regression models were used to estimate the odds ratio and 95% confidence interval for each variable associated with vancomycin-induced AKI.</p><p><strong>Results: </strong>High baseline serum creatinine levels, intensive care unit admission, and concurrent renal disorders were significantly associated with vancomycin-induced AKI. Although high trough levels or area under the curve values were not significantly associated with vancomycin-induced AKI, both were significantly higher in patients with AKI than in those without AKI at the second vancomycin concentration measurement. The proportion with trough levels > 20 mg/L was higher in patients with AKI than in those without AKI at the third measurement.</p><p><strong>Conclusion: </strong>Our findings revealed that underlying renal disease and intensive care unit admission are more significantly associated with vancomycin-induced AKI than vancomycin pharmacokinetic parameters or dosage, likely due to vancomycin concentration-based dosage adjustment in clinical settings. Our findings may help develop strategies for reducing the incidence of vancomycin-induced AKI; however, further prospective studies are essential.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"560-568"},"PeriodicalIF":0.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142307733","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":"Evaluation of metronidazole oral monotherapy in anaerobic oral infections.","authors":"Najla Dar-Odeh, Ala'a Atef, Yara Flaifl, Dilnoza Bobamuratova, Basem Akily, Rayan Meer, Osama Abu-Hammad","doi":"10.5414/CP204565","DOIUrl":"10.5414/CP204565","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the indications and dosing regimens for oral metronidazole monotherapy (OMM) for the management of oral anaerobic infections (OAIs) other than periodontitis.</p><p><strong>Materials and methods: </strong>The study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines in literature of PubMed/Medline, Scopus, and Cochrane databases. Data were retrieved from reports published in English in the period January 1, 1980 - August 30, 2023. Joanna Briggs Institute Critical Appraisal Tools were used to assess study risk of bias.</p><p><strong>Results: </strong>A total of 228 articles were retrieved from the databases of which 16 met the inclusion criteria necessary for achieving the aims of the study. OAIs in which OMM was used or recommended included pericoronitis; necrotizing ulcerative gingivitis/periodontitis/stomatitis, osteomyelitis, acute periapical infection, and cellulitis. OMM was prescribed in dosages ranging from 200 to 500 mg t.i.d. for periods ranging from 2 to 7 days. Osteomyelitis of the jaw was the only infection for which the dosage regimen of metronidazole was not clearly described.</p><p><strong>Conclusion: </strong>Evidence from the databases searched support the view that OMM has clinical efficacy in the treatment of specific OAIs namely pericoronitis and necrotizing oral infections in immune-competent and immune-compromised patients. The evidence does not support the use of OMM in \"deep tissue\" infections such as osteomyelitis, and odontogenic infections such as acute apical infection and cellulitis. Clinical trials are warranted to determine the efficacy of OMM in comparison with other antibiotic regimens.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"517-524"},"PeriodicalIF":0.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141906609","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":"A case of a geriatric patient with thrombocytopenia after partial recovery from COVID-19.","authors":"Yukako Hayashi, Kenji Momo, Mutsumi Ando, Hiroaki Koya, Tsutomu Nagai, Kazuki Shinmura, Issei Tokimatsu, Yasushi Akutsu, Masahiro Kurosawa","doi":"10.5414/CP204664","DOIUrl":"10.5414/CP204664","url":null,"abstract":"<p><p>The global emergence of -COVID-19 has prompted rapid therapeutic and vaccine advancements; however, clinical evidence remains limited. With around a 50% fatality rate for COVID-19 patients with acute respiratory distress syndrome (ARDS), early intervention is crucial. This report details a severe case of post-COVID-19 thrombocytopenia in a 79-year-old man and emphasizes its critical nature. Despite negative initial COVID-19 test results, subsequent positive results led to treatment initiation, and severe thrombocytopenia persisted resulting in bleeding complications and death. Recognized as a hematological manifestation of COVID-19, thrombocytopenia in this geriatric patient highlights the need for extended post-COVID-19 monitoring and management. This underscores the importance of vigilance and timely intervention, especially in vulnerable populations, and emphasizes the need for further research to understand the intricate relationship between COVID-19 and thrombocytopenia.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"538-542"},"PeriodicalIF":0.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142140000","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":"Bioequivalence study of two formulations of afatinib dimaleate tablets in healthy subjects under fasting conditions: A randomized, open-label, single-dose, crossover trial.","authors":"Yanping Liu, Lang Lü, Man Xu, Juanmin Tao, Yuping Ning, Yan Shi, Yanfen Dong, Qingqing Cao, Jun Ma, Yan Qiu","doi":"10.5414/CP204514","DOIUrl":"10.5414/CP204514","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the bioequivalence of two different afatinib dimaleate formulations in healthy Chinese subjects under fasting conditions and to assess their pharmacokinetic and safety profiles.</p><p><strong>Materials and methods: </strong>This randomized, open-label, 2-period, crossover, bioequivalence study included 32 healthy Chinese subjects. The subjects were assigned to receive a single 40-mg dose of generic or brand-named afatinib dimaleate tablet. Blood samples were collected pre-dose and up to 120 hours after dosing. Healthy subjects orally took the trial preparation (T) (afatinib maleate tablets developed by Jiangxi Shanxiang Pharmaceutical Co., Ltd., Gan Zhou, China) and the reference preparation (R) (afatinib maleate tablets developed by Boehringer Ingelheim Pharma GmbH & Co., Ingelheim, Germany) under fasting conditions in the appropriate period according to the randomization. We measured the blood concentrations, calculated the pharmacokinetic parameters of the two preparations in the human body, and evaluated whether formulations were bioequivalent. Safety of the preparations in healthy subjects was monitored during the whole trial. Safety assessment was conducted by vital signs, physical examination, laboratory examination, and 12-lead electrocardiogram during the study, i.e., from the time the subject received the test drug to the end of the last visit.</p><p><strong>Results: </strong>Under fasting conditions, the 90% confidence intervals (CIs) of the geometric mean ratios of the test/reference for afatinib dimaleate were 93.34 - 103.92% for AUC_0-t, 90.26 - 105.52% for C_max, and 93.49 - 104.05% for AUC_0-∞.</p><p><strong>Conclusion: </strong>The 90% CI for the geometric mean ratios (test/reference) of C_max, AUC_0-t, and AUC_0-∞ were within the range of 80.00 - 125.00%, indicating that the test formulation was equivalent to the reference formulation in healthy Chinese subjects under fasting conditions. Both products were similar in terms of safety.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"479-485"},"PeriodicalIF":0.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999825","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":"Pulmonary fibrosis insights and therapy targets from disease models and administration of the lipophilic diterpene, sodium tanshinone IIA sulfonate: Review and meta-analysis.","authors":"Li-Ying Peng, Jun-Jun Shi, Yue Liang, Yang Li, Yan Tang, Tuo Kai, Andong Yang, Zi-Yue Xiong","doi":"10.5414/CP204622","DOIUrl":"10.5414/CP204622","url":null,"abstract":"<p><p>Pulmonary fibrosis (PF) is a chronic and progressive pulmonary interstitial disease of unknown etiology and is also a sequela in severe patients with the Coronavirus Disease 2019 (COVID-19). Seven databases were systematically searched to evaluate the preclinical evidence of Tanshinone IIA (Tan IIA) on PF. The quality of the included studies was assessed using a 10-item risk of bias tool, and data were analyzed using RevMan 5.3 software. 22 experiments from 12 studies on a total of 248 animals were included. The results showed that PF phenotype, such as fibrotic score, collagen I (Col-I), collagen III (Col-III), hydroxyproline (Hyp), in the group treated with Tan IIA were significantly lower than those in the model group (p < 0.00001). The potential mechanisms of Tan IIA improvement of PF involve reducing inflammation, antioxidation, and suppressing activation of transforming growth factor beta 1 (TGF-β1). The subgroup analysis of different models, different rat species, and different dosage time showed significant reduction in fibrotic scores and Hyp levels with Tan IIA. The preclinical evidence indicated that Tan IIA might be a potent and promising agent for PF, but this conclusion should be further confirmed with more research.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"460-478"},"PeriodicalIF":0.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141906610","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}