International journal of clinical pharmacology and therapeutics最新文献

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Rational use of short-term anorectic drugs for one-year effective treatment of obesity: An analysis of four studies. 合理使用短期厌食症药物,有效治疗肥胖症一年:对四项研究的分析。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-10-01 DOI: 10.5414/CP204585
Cynthia Galicia-Quintanar, Héctor Isaac Rocha-González, María Elena Sánchez Mendoza, Jesús Arrieta-Valencia, Juan Rodríguez-Silverio, Geovanna Nallely Quiñonez-Bastidas, Juan Carlos Huerta-Cruz, Lina Marcela Barranco-Garduño, Juan Gerardo Reyes-García
{"title":"Rational use of short-term anorectic drugs for one-year effective treatment of obesity: An analysis of four studies.","authors":"Cynthia Galicia-Quintanar, Héctor Isaac Rocha-González, María Elena Sánchez Mendoza, Jesús Arrieta-Valencia, Juan Rodríguez-Silverio, Geovanna Nallely Quiñonez-Bastidas, Juan Carlos Huerta-Cruz, Lina Marcela Barranco-Garduño, Juan Gerardo Reyes-García","doi":"10.5414/CP204585","DOIUrl":"10.5414/CP204585","url":null,"abstract":"<p><strong>Background: </strong>Obesity is a complex disease for which pharmacotherapy is often used. Anti-obesity drugs (AODs) are characterized by inducing a variable inter-subject body weight reduction (BWR), the attainment of a plateau after their maximal effect is achieved, and weight regain after drug discontinuation, which complicate individualized treatment of obesity.</p><p><strong>Objective: </strong>This exploratory analysis aimed to compare the first-month body weight reduction in kg (1mo-BWRkg) and tolerance development (moT) of four known interventions with low (placebo), intermediate (phentermine or mazindol monotherapy), and high (5 active ingredients fixed-dose combination) efficacy, as predictors of their 6-month body weight reduction efficacy in percent (6mo-BWR%). In addition, a detailed analysis of the 6-to-12-month BWR follow-up in subjects under orlistat or diet and exercise regimens was performed.</p><p><strong>Materials and methods: </strong>The analysis included 662 adult subjects with obesity. After the construction of average efficacy and weight rebound curves, subjects were grouped into various 1mo-BWRkg, moT, and 6mo-BWR% intervals, or 6-month body weight rebound parameters for further evaluation.</p><p><strong>Results: </strong>The 6mo-BWR% efficacy level of interventions was confirmed, although a general high intersubject variation was observed. 1mo-BWRkg + moT was found as an acceptable predictor of 6mo-BWR%. Between 50 and 80% of the 6-to-12-month follow-up completers maintained at least 5% BWR%.</p><p><strong>Conclusion: </strong>Short-term AODs are useful adjuvants for the 1-year rational treatment of obesity. 1mo-BWRkg + moT is an acceptable parameter to predict the 6mo-BWR% efficacy of these interventions.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"435-447"},"PeriodicalIF":0.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751653","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}
引用次数: 0
Adequate IVIG dosing is associated with an improved long-term outcome in secondary immunodeficiency: A prospective, non-interventional study. 足够的 IVIG 剂量与继发性免疫缺陷的长期疗效改善有关:一项前瞻性、非干预性研究。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-10-01 DOI: 10.5414/CP204595
Artur Bauhofer, Ümniye Balaban, Sonja Schimo, Monika Mayer, Jörg Schüttrumpf, Stephan Borte
{"title":"Adequate IVIG dosing is associated with an improved long-term outcome in secondary immunodeficiency: A prospective, non-interventional study.","authors":"Artur Bauhofer, Ümniye Balaban, Sonja Schimo, Monika Mayer, Jörg Schüttrumpf, Stephan Borte","doi":"10.5414/CP204595","DOIUrl":"10.5414/CP204595","url":null,"abstract":"<p><strong>Objective: </strong>To assess the safety, tolerability, and effectiveness of the intravenous immunoglobulin (IVIG) Intratect 50 g/L in immunoglobulin replacement therapy (IgRT) in a prospective, large-scale non-interventional study (NIS). The analysis focused upon patients with secondary immunodeficiency (SID), the most frequent indication for IgRT in this NIS.</p><p><strong>Materials and methods: </strong>Patients were enrolled at 123 centers in Germany. Each patient received IVIG as prescribed by the physician, guided by the Summary of Product Characteristics. Data were acquired from medical records and patients' questionnaires.</p><p><strong>Results: </strong>In the NIS, 3,563 patients were documented. The main indication for IgRT was SID (73.2%), followed by primary immunodeficiency (14.7%), immune thrombocytopenia (5.8%), and other indications (6.2%). Among the SID patients, 52.9% were male, mean age was 66.5 years, and most (63.8%) were IVIG-naïve. Their annual infection rate improved from 3.7 before documentation in the NIS to 1.1 during the first year of the study. IgG trough plasma levels increased during treatment (> 6 g/L: 44.5% of SID patients at study entry and 64.8% in long-term treatment) and were associated with a trend toward reduced infection rate (p = 0.08). A 1-year infection analysis showed a significantly lower infection risk in the medium- and high-dose groups than in the low-dose group (p = 0.028 and p = 0.017, respectively). Patients' treatment satisfaction and quality of life improved from baseline. Adverse drug reactions (ADRs) in SID occurred at a low frequency with 0.8% at infusion level. On the patient level, ADRs occurred in 251 (15.3%) SID patients, with chills (7.4%) and pyrexia (0.9%) reported most frequently.</p><p><strong>Conclusion: </strong>Effectiveness, safety, and quality of life confirmed the positive benefit-risk profile of IgRT. Higher IVIG dosages per body weight led to higher IgG plasma trough levels, in turn leading to reduced infection rates. Obese patients may need body-weight-adjusted treatment to reduce the risk of infection.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"448-459"},"PeriodicalIF":0.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11425087/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141792465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pharmacokinetic, bioequivalence, and safety assessments of two brands of 30-mg nifedipine controlled-release formulations in Chinese healthy subjects. 在中国健康受试者中对两种品牌的 30 毫克硝苯地平控释制剂进行药代动力学、生物等效性和安全性评估。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-10-01 DOI: 10.5414/CP204605
Huan Lu, Fei Zhou, Cuijie Rui, Hen You, Wenhao Zhang, Yaxin Zhang, Juefang Ding, Shunbo Zhao, Qiang Wu
{"title":"Pharmacokinetic, bioequivalence, and safety assessments of two brands of 30-mg nifedipine controlled-release formulations in Chinese healthy subjects.","authors":"Huan Lu, Fei Zhou, Cuijie Rui, Hen You, Wenhao Zhang, Yaxin Zhang, Juefang Ding, Shunbo Zhao, Qiang Wu","doi":"10.5414/CP204605","DOIUrl":"10.5414/CP204605","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to analyze the pharmacokinetic (PK) characteristics, safety, and bioequivalence (BE) of a test (T) preparation of a nifedipine controlled-release tablet and the reference (R) drug (Adalat GTIS) in Chinese study participants in the context of fasting and postprandial states.</p><p><strong>Materials and methods: </strong>An open-label, single-center, randomized, single-dose, two-period study was designed including two separate arms, one with administration under fasting conditions and one with administration under postprandial conditions (high-fat, high-calorie breakfast). After oral administration, the nifedipine concentrations in plasma were quantitatively analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) at regular intervals. Primary PK parameters, including the area under the concentration curve from 0 to infinity (AUC<sub>0-∞</sub>), the area under the concentration profile from 0 to the last measurable concentration time (AUC<sub>0-t</sub>), and maximal measured plasma concentration (C<sub>max</sub>) were log-transformed with BE limits of 80 - 125% to evaluate BE. All adverse events (AEs) were wholly supervised.</p><p><strong>Results: </strong>The PK profiles of the T and R formulations were comparable to each other under both fasting and postprandial conditions. The 90% confidence intervals (CIs) of the AUC<sub>0-∞</sub>, AUC<sub>0-t</sub>, and C<sub>max</sub> were 92.69 - 106.06%, 93.32 - 107.05%, and 99.53 - 116.71%, respectively, under the fasting state. The 90% CIs of the AUC<sub>0-∞</sub>, AUC<sub>0-t</sub>, and C<sub>max</sub> were 105.05 - 117.40%, 105.43 - 117.82%, and 102.66 - 116.30%, respectively, in the postprandial arm. 47 cases of drug-associated AEs were noted in the entire research.</p><p><strong>Conclusion: </strong>Under both the fasting and postprandial states, the two nifedipine controlled-release formulations were bioequivalent and safe in healthy Chinese subjects.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"486-496"},"PeriodicalIF":0.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141792466","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}
引用次数: 0
A case study of impaired consciousness caused by alcohol consumption in a pediatric patient taking high-dose cefixime. 服用大剂量头孢克肟的儿科患者因饮酒导致意识障碍的病例研究。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-09-01 DOI: 10.5414/CP204623
Li Zheng, Gen Li, Liaoyun Zhang
{"title":"A case study of impaired consciousness caused by alcohol consumption in a pediatric patient taking high-dose cefixime.","authors":"Li Zheng, Gen Li, Liaoyun Zhang","doi":"10.5414/CP204623","DOIUrl":"10.5414/CP204623","url":null,"abstract":"<p><p>A variety of drugs have been known to induce disulfiram-like reactions in individuals exposed to ethanol, including certain cephalosporin antibiotics with methylthiotetrazole (MTT) substituents or methylthiodioxotriazine (MTDT) rings. Among cephalosporins, cefixime is known to cause fewer disulfiram-like reactions. This case report, the first involving a pediatric patient, presents the scenario of a 14-year-old female who exhibited drowsiness, loss of consciousness, and cold extremities within an hour after ingesting 9 cefixime capsules. Upon admission, drug intoxication was considered, prompting immediate gastric lavage and toxicology tests, which revealed the presence of both cefixime and alcohol. Subsequent monitoring of vital signs, rehydration, and symptomatic treatments aimed at facilitating toxic excretion were administered during hospitalization. Following initial assessment by a clinical pharmacist, drug intoxication was deemed improbable, though an atypical disulfiram-like reaction or alcohol intoxication could not be ruled out. Further evaluation, coupled with the child's cefixime overdose, suggested an atypical disulfiram-like reaction. This case underscores the potential for disulfiram reactions even with cephalosporins lacking MTT substituents or MTDT rings. Notably, it is the first report of an atypical disulfiram-like reaction triggered by alcohol consumption following cefixime overdose, emphasizing the importance of caution in cefixime usage and avoidance of alcohol or alcohol-containing substances.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"427-430"},"PeriodicalIF":0.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734070","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}
引用次数: 0
Evidence-based clinical pharmacology using network analysis of the curcuma-containing traditional Chinese medication Changpu-Yujin: Efficacy in the treatment of insomnia. 利用网络分析法对含莪术成分的传统中药长普郁金进行循证临床药理学研究:治疗失眠的疗效。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-09-01 DOI: 10.5414/CP204535
Jianran Ma, Qian Hu, Qing Hu, Zhijie Li
{"title":"Evidence-based clinical pharmacology using network analysis of the curcuma-containing traditional Chinese medication Changpu-Yujin: Efficacy in the treatment of insomnia.","authors":"Jianran Ma, Qian Hu, Qing Hu, Zhijie Li","doi":"10.5414/CP204535","DOIUrl":"10.5414/CP204535","url":null,"abstract":"","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"431-434"},"PeriodicalIF":0.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141497996","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}
引用次数: 0
Population pharmacokinetic study and application of ticagrelor and AR-C124910XX after percutaneous coronary intervention in Chinese patients with acute coronary syndrome. 中国急性冠脉综合征患者经皮冠状动脉介入治疗后替卡格雷和AR-C124910XX的人群药代动力学研究及应用。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-09-01 DOI: 10.5414/CP204550
Meng Liu, Jun Qin, XiaoQian Chu, NaiDong Chen, Qiong Jie, ShaoJun Zheng
{"title":"Population pharmacokinetic study and application of ticagrelor and AR-C124910XX after percutaneous coronary intervention in Chinese patients with acute coronary syndrome.","authors":"Meng Liu, Jun Qin, XiaoQian Chu, NaiDong Chen, Qiong Jie, ShaoJun Zheng","doi":"10.5414/CP204550","DOIUrl":"10.5414/CP204550","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to understand the pharmacokinetics of ticagrelor in Chinese patients with acute coronary syndrome (ACS), identify influencing factors, and inform ticagrelor treatment optimization.</p><p><strong>Materials and methods: </strong>Data from 195 ACS patients, including 491 plasma ticagrelor concentration timepoints and clinical information, were analyzed using NONMEN for pharmacokinetic (PK) parameter factors. The model underwent internal validation with bootstrap methodology.</p><p><strong>Results: </strong>The PK curve of ticagrelor was well delineated using a one disposition compartment model with first-order absorption rate constant, 0.67/h. When the direct bilirubin levels and white plasma cell counts increased, female patients showed decreased glomerular filtration rate, decreased ticagrelor clearance rate, and increased exposure. When the direct bilirubin levels increased and body weight and hemoglobin decreased, rs6787801 was GG compared with AA and GA, the ticagrelor metabolite clearance rate decreased and exposure increased.</p><p><strong>Conclusion: </strong>The study offers key insights into ticagrelor's dose-exposure relationship post-percutaneous coronary intervention in ACS patients, highlighting factors critical for personalized treatment strategies.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"412-422"},"PeriodicalIF":0.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734071","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}
引用次数: 0
A decision tree model for predicting high mono-N-desethylamiodarone concentrations and reducing tissue toxicity in patients with low-dose amiodarone therapy: A multicentral retrospective cohort study. 预测单-N-去乙基胺碘酮高浓度并减少低剂量胺碘酮治疗患者组织毒性的决策树模型:一项多中心回顾性队列研究。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-09-01 DOI: 10.5414/CP204571
Yuki Asai, Hiroki Arihara, Saki Omote, Ena Tanio, Saena Yamashita, Takashi Higuchi, Ei Hashimoto, Momoko Yamada, Hinako Tsuji, Yoshihiro Kondo, Makoto Hayashi, Takumi Tashiro, Yuji Hayakawa, Yoshiaki Yamamoto, Takuya Iwamoto
{"title":"A decision tree model for predicting high mono-N-desethylamiodarone concentrations and reducing tissue toxicity in patients with low-dose amiodarone therapy: A multicentral retrospective cohort study.","authors":"Yuki Asai, Hiroki Arihara, Saki Omote, Ena Tanio, Saena Yamashita, Takashi Higuchi, Ei Hashimoto, Momoko Yamada, Hinako Tsuji, Yoshihiro Kondo, Makoto Hayashi, Takumi Tashiro, Yuji Hayakawa, Yoshiaki Yamamoto, Takuya Iwamoto","doi":"10.5414/CP204571","DOIUrl":"10.5414/CP204571","url":null,"abstract":"<p><strong>Objective: </strong>High plasma levels of mono-<i>N</i>-desethylamiodarone (MDEA), an active amiodarone metabolite, may be associated with tissue toxicity in heart failure (patients with heart rhythm disturbances); therefore, a tool that can identify patients for whom therapeutic drug monitoring (TDM) of MDEA is required. This multicenter study aimed to develop a decision tree (DT) model that can identify patients with heart rhythm disturbances at high MDEA concentrations.</p><p><strong>Materials and methods: </strong>A multicenter retrospective cohort study was conducted, including 157 adult patients with heart failure who received oral amiodarone treatment. A χ<sup>2</sup> automatic interaction-detection algorithm was used to construct a DT model. In the DT analysis, the dependent variable was set as an MDEA trough plasma concentration of ≥ 0.6 μg/mL during the steady-state period. Explanatory variables were selected as factors with p < 0.05 in multivariate logistic regression analysis.</p><p><strong>Results: </strong>The adjusted odds ratios for the daily dose of amiodarone and body mass index were 1.01 (95% coefficient interval: 1.008 - 1.021, p < 0.001) and 0.91 (95% confidence interval: 0.834 - 0.988, p = 0.025), respectively. For DT analysis, the risk of reaching plasma MDEA concentrations ≥ 0.6 μg/mL was relatively high, combined with a daily dose of amiodarone > 100 mg and body mass index ≤ 22.3 kg/m<sup>2</sup> at 69.0% (20/29), and its trend was also detected in the sensitivity analysis.</p><p><strong>Conclusion: </strong>Patients taking a daily amiodarone dose > 100 mg and with a body mass index ≤ 22.3 kg/m<sup>2</sup> warrant TDM implementation for MDEA to minimize the risk of MDEA-induced tissue toxicity.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"402-411"},"PeriodicalIF":0.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751651","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}
引用次数: 0
Chronic myeloid leukemia in an ulcerative colitis patient receiving azathioprine: A case report. 接受硫唑嘌呤治疗的溃疡性结肠炎患者患上慢性髓性白血病:病例报告。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-09-01 DOI: 10.5414/CP204603
Asma Mensi, Nouha Trad, Raoudha Mansouri, Wiem Ayed, Emna BelHadj Mabrouk, Yosra Said, Radhouane Debbeche
{"title":"Chronic myeloid leukemia in an ulcerative colitis patient receiving azathioprine: A case report.","authors":"Asma Mensi, Nouha Trad, Raoudha Mansouri, Wiem Ayed, Emna BelHadj Mabrouk, Yosra Said, Radhouane Debbeche","doi":"10.5414/CP204603","DOIUrl":"10.5414/CP204603","url":null,"abstract":"<p><p>Ulcerative colitis (UC) is a chronic inflammatory bowel disease usually treated by azathioprine. It is a well-established risk factor for colorectal cancers and extraintestinal malignancies. Nevertheless, the risk of myeloid leukemia in patients with UC is less known. We report a case of a 51-year-old patient, with a history of extensive ulcerative colitis, who was treated with azathioprine at a dose of 2.5 mg/kg/day. Seven years later, he presented an increased count of white blood cells at 25,400/μL and of platelets at 1,382,000/μL. Peripheral blood smear showed 1% blasts and 20% myelemia. The karyotype showed the Philadelphia chromosome and the RT-PCR revealed the BCR-ABL transcript. Thus, chronic myeloid leukemia (CML) was confirmed and imatinib was prescribed. This case reported a rare and serious event in a UC patient and illustrates the importance of closely monitoring this population.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"423-426"},"PeriodicalIF":0.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751652","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}
引用次数: 0
Alleviation of severe chronic arthritic pain using polyvalent immunoglobulins (KMP01): Two case reports. 使用多价免疫球蛋白(KMP01)缓解严重的慢性关节炎疼痛:两个病例报告。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-08-01 DOI: 10.5414/CP204615
Barry G Woodcock, Peter Braun, Martin Gasser, Laura Sly, Reinhard Lissner
{"title":"Alleviation of severe chronic arthritic pain using polyvalent immunoglobulins (KMP01): Two case reports.","authors":"Barry G Woodcock, Peter Braun, Martin Gasser, Laura Sly, Reinhard Lissner","doi":"10.5414/CP204615","DOIUrl":"10.5414/CP204615","url":null,"abstract":"<p><strong>Background: </strong>Treatment of arthritis is carried out using corticosteroids, methotrexate, sulfasalazine-like agents, and TNF-α-blocking agents such as infliximab and adalimumab. The disadvantages of these agents are high-cost, severe side effects including leucopenia, and in some cases the necessity of administration by injection. Polyvalent immunoglobulin formulations derived from bovine colostrum and marketed as a standardized formulation for oral application, are reported to be efficacious in chronic pain syndromes but are rarely, if ever, used as an alternative medication in such patients.</p><p><strong>Aims: </strong>To treat arthritis in a real-world setting using polyvalent immunoglobulins in 2 patients, in one case where no alternative treatment modality was available and in another patient in whom the use of polyvalent immunoglobulins appeared to be a suitable option.</p><p><strong>Materials and methods: </strong>Two male subjects aged 46 and 82 years with confirmed diagnosis but not well-controlled arthritis/polyarthritis receiving either high-dose NSAIDS, corticosteroids, methotrexate injections, with previous use of, or recommendations for treatment with monoclonal antibodies (etanercept and adalimumab) were treated with oral polyvalent immunoglobulins (KMP01; dose range 10 - 20 g daily) in real-world settings, in one case during a field excursion in Peru.</p><p><strong>Results: </strong>The treatment produced a rapid alleviation of pain in both patients, in one patient where the symptoms were severe and debilitating. In the second patient methotrexate SC injections could be discontinued, and there was a progressive reversal of leucopenia (leucocyte count 3.9 × 10<sup>3</sup>/µL) over a period of ~ 3 months.</p><p><strong>Discussion: </strong>Polyvalent immunoglobulins have been shown previously to reduce the expression of interleukin-6 and C-reactive protein in peripheral blood monocytes, events attributed to the neutralization of gut-derived endotoxin ligands lipopolysaccharides (LPS) driving the basal immune response. The mode of action of KMP01 on cytokine expression is therefore similar to the TNF-α-blocking agents etanercept and adalimumab.</p><p><strong>Conclusion: </strong>Findings from two case reports support the rationale for using polyvalent immunoglobulins as an effective and safe alternative in arthritis patients receiving standard treatments, in particular, methotrexate and TNF-α-blocking agents.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"377-385"},"PeriodicalIF":0.9,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141446113","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}
引用次数: 0
Pegylated-interferon alpha (PEG-IFNα)-induced interstitial lung disease in a patient with chronic hepatitis B: A case report and literature review. 一名慢性乙型肝炎患者由聚乙二醇干扰素α(PEG-IFNα)诱发的间质性肺病:病例报告和文献综述。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-08-01 DOI: 10.5414/CP204504
Minghui Shi, Shiyao Wang, Yanhong Ren, Ling Zhao, Min Liu, Lulu Yang, Ting Yang
{"title":"Pegylated-interferon alpha (PEG-IFNα)-induced interstitial lung disease in a patient with chronic hepatitis B: A case report and literature review.","authors":"Minghui Shi, Shiyao Wang, Yanhong Ren, Ling Zhao, Min Liu, Lulu Yang, Ting Yang","doi":"10.5414/CP204504","DOIUrl":"10.5414/CP204504","url":null,"abstract":"<p><strong>Objectives: </strong>Interferon (IFN)-induced lung injury is a rare but severe complication. Studies are needed to elucidate the demographic characteristics, clinical manifestations, and prognostic features of IFN-induced interstitial lung disease (ILD).</p><p><strong>Case report: </strong>We report a patient with chronic hepatitis who developed ILD after interferon monotherapy. To further clarify the clinical characteristics of such patients, we searched for cases in which lung injury was documented as a side effect of hepatitis treatment and systematically analyzed all case reports for clinical manifestations, type of treatment, and outcomes.</p><p><strong>Results: </strong>This is a 61-year-old male with a previous medical history of chronic hepatitis B. After 2 months of pegylated-interferon alpha (PEG-IFNα) application, he gradually developed cough and exertional dyspnea. Repeated chest images suggested progressive ILD, and lung biopsy revealed subacute lung injury. The diagnosis of PEG-IFNα-induced ILD was made. Including our case, 35 articles containing 45 patients were involved in our review. IFN-induced ILDs, often with a subacute onset, are characterized by nonproductive cough, dyspnea, and pulmonary infiltrates on chest radiograph. Most patients(62%, 28/45) required additional systemic steroid, and 5 (11%) patients who were co-administered ribavirin died of ILD progression despite steroid treatment.</p><p><strong>Conclusion: </strong>Although rare, IFN-induced ILD can lead to decreased lung function, and sometimes become fatal despite intensive treatment. Most previously reported cases were with chronic hepatitis C, and most of the medication was in combination with ribavirin. IFN-induced ILD should be monitored during IFN therapy, and appropriate steroid is recommended in patients with progressive manifestations.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"386-394"},"PeriodicalIF":0.9,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140857066","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}
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