International journal of clinical pharmacology and therapeutics最新文献

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The characteristics and regulations of adaptive designs from 2008 to 2020: An overview of European Medicines Agency approvals. 适应性设计的特点和法规,从2008年到2020年:欧洲药品管理局批准概述。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2023-10-01 DOI: 10.5414/CP204422
Xiaowei Huang, Jianbin Ma, Zhenzhen Lu, Lihong Huang
{"title":"The characteristics and regulations of adaptive designs from 2008 to 2020: An overview of European Medicines Agency approvals.","authors":"Xiaowei Huang, Jianbin Ma, Zhenzhen Lu, Lihong Huang","doi":"10.5414/CP204422","DOIUrl":"10.5414/CP204422","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study was to identify and characterize all European Medicines Agency (EMA) approvals derived from adaptive designs in clinical trials and to provide an update of the current status of these drugs.</p><p><strong>Materials and methods: </strong>Relevant files were identified in the EMA database for annual reports for the period between 2008 and 2020 using a list of suitable keywords related to adaptive designs. We recorded trial characteristics from drug approvals and used Fisher exact test to compare the characteristics.</p><p><strong>Results: </strong>A total of 1,054 EMA approvals were identified, and the percentage of EMA approvals planned with adaptive trial designs increased from 1.85% in the period 2008 - 2012 to 6.19% in between 2017 - 2020. A total of 41 approvals were identified among 91 original EMA files that contained adaptive designs. The types of adaptive designs used in clinical trials increased after 2017 where the most common type used was the most common (17/41). Most approvals (32/41) comprised pivotal trials, and most assessments had not been accelerated (38/41). Of 32 confirmatory trials planned with adaptive designs, the proportion of those with additional monitoring (AM) increased significantly (p < 0.0001) from 0% in the 2008 - 2012 period to 90.48% in the 2017 - 2020 period. The percentage of approved antitumor drugs in approved drugs in ongoing clinical trials was 82.35%, compared to 20.83% in trials that were completed (p = 0.0001). The proportion of drug approved but where clinical trials were still ongoing in companies requiring post-authorization safety studies (PASSs) or post-authorization efficacy studies (PAESs) or who were granted conditional marketing authorization (CMA) significantly differed from the group of drugs approved where clinical trials were completed (p = 0.0230).</p><p><strong>Conclusion: </strong>A trend showing an increased number of EMA approvals related to adaptive designs was observed for the period from 2008 to 2020. Different types of adaptive trial designs could be encouraged for the designation of clinical trials, especially for antitumor drugs; meanwhile, more stringent monitoring regulations seemed to be conducted for ongoing trials of antitumor drugs with adaptive design.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 10","pages":"445-454"},"PeriodicalIF":0.9,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10230115","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
Risks of malignant lymphoma in rheumatoid arthritis patients receiving methotrexate-alone and in combination therapy compared with the general population: A study based on a Japanese medical claims database. 与普通人群相比,接受甲氨蝶呤单独和联合治疗的类风湿性关节炎患者患恶性淋巴瘤的风险:一项基于日本医疗索赔数据库的研究。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2023-10-01 DOI: 10.5414/CP204372
Ryo Inose, Arisa Nakamura, Rina Omi, Shujiro Takeno, Yuichi Muraki
{"title":"Risks of malignant lymphoma in rheumatoid arthritis patients receiving methotrexate-alone and in combination therapy compared with the general population: A study based on a Japanese medical claims database.","authors":"Ryo Inose,&nbsp;Arisa Nakamura,&nbsp;Rina Omi,&nbsp;Shujiro Takeno,&nbsp;Yuichi Muraki","doi":"10.5414/CP204372","DOIUrl":"10.5414/CP204372","url":null,"abstract":"<p><strong>Objective: </strong>The risk of malignancy in patients with rheumatoid arthritis (RA) treated with methotrexate (MTX) and biological disease-modifying antirheumatic drug (bDMARD) combination therapy is unknown. This study aimed to clarify the incidence of malignancy and the recommended monitoring period in patients receiving this combination therapy.</p><p><strong>Materials and methods: </strong>A retrospective, observational study based on a large Japanese medical claims database was conducted between April 2013 and February 2020. Patients with RA were classified into MTX-alone and combination therapy groups, and the standardized incidence rates (SIR) of malignancy were calculated. The time of onset of malignancy in both groups was calculated.</p><p><strong>Results: </strong>In total, 2,052 patients received MTX-alone and 782 received combination therapy. The incidence of malignant lymphoma was significantly higher with MTX-alone therapy (SIR: 6.09, 95% confidence interval (CI): 1.58 - 10.61) and combination therapy (SIR: 20.86, 95% CI: 8.53 - 33.19) than in the general Japanese population. Furthermore, the combination therapy had a significantly higher risk of malignant lymphoma than the MTX-alone therapy (adjusted odds ratio: 4.27, 95% CI: 1.64 - 11.12). The median time from MTX prescription to the onset of malignant lymphoma was 3.58 years (interquartile range (IQR): 2.00 - 5.34 years) for MTX-alone and 3.42 years (IQR: 1.25 - 4.92 years) for combination therapy.</p><p><strong>Conclusion: </strong>The incidence of malignant lymphoma in the combination therapy group was extensively higher than that in the general Japanese population. Special attention is required for early symptoms of malignant lymphoma, particularly in the 3<sup>rd</sup> - 4<sup>th</sup> year after initiating MTX therapy.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 10","pages":"430-436"},"PeriodicalIF":0.8,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10548543/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10226194","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
Platelet count and dose, but not comorbidities, predict severe neutropenia in cabazitaxel-treated prostate cancer patients: A retrospective observational study. 血小板计数和剂量,而非合并症,预测卡巴他赛治疗的前列腺癌患者严重中性粒细胞减少:一项回顾性观察研究。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2023-09-01 DOI: 10.5414/CP204393
Noriaki Kataoka, Takeo Hata, Kouichi Hosomi, Atsushi Hirata, Emi Goto, Masami Nishihara, Teruo Inamoto, Haruhito Azuma, Masashi Neo
{"title":"Platelet count and dose, but not comorbidities, predict severe neutropenia in cabazitaxel-treated prostate cancer patients: A retrospective observational study.","authors":"Noriaki Kataoka,&nbsp;Takeo Hata,&nbsp;Kouichi Hosomi,&nbsp;Atsushi Hirata,&nbsp;Emi Goto,&nbsp;Masami Nishihara,&nbsp;Teruo Inamoto,&nbsp;Haruhito Azuma,&nbsp;Masashi Neo","doi":"10.5414/CP204393","DOIUrl":"https://doi.org/10.5414/CP204393","url":null,"abstract":"<p><strong>Objective: </strong>To determine the safety of cabazitaxel and predictors of severe neutropenia caused by cabazitaxel in a patient population that includes those with comorbidities.</p><p><strong>Materials and methods: </strong>Of 42 prostate cancer patients treated with cabazitaxel at Osaka Medical and Pharmaceutical University Hospital between September 2014 and June 2022, 33 were included in this study, whereas 6 patients who were outpatients and 3 who were discharged early within 7 days upon patient request were excluded. Logistic regression analysis was used to examine predictors of severe neutropenia.</p><p><strong>Results: </strong>Of the 33 eligible patients, 24 had comorbidities, with hypertension being the most common (n = 19), followed by dyslipidemia (n = 14) and diabetes (n = 11). There was no statistically significant difference in the rate of severe neutropenia due to any of the comorbidities, depending on the presence or absence of the comorbidity. However, the rate of severe neutropenia was significantly higher in patients with baseline platelet levels < 22.4×10<sup>4</sup>/μL and those receiving cabazitaxel doses > 34 mg/body. In the final model adjusted for age, body mass index, C-reactive protein, and monocyte count, lower baseline platelet levels and higher doses of cabazitaxel were also predictors of the development of severe neutropenia.</p><p><strong>Conclusion: </strong>Comorbidities such as hypertension, dyslipidemia, diabetes mellitus, cerebrovascular disease, chronic kidney disease, liver dysfunction, and cardiac disease did not affect the incidence of severe neutropenia in patients receiving cabazitaxel. The baseline platelet count and the dose of cabazitaxel were also suggested to be markers for the development of severe neutropenia.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 9","pages":"386-393"},"PeriodicalIF":0.8,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10112796","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
Comparison of the acid suppression effects between low-dose esomeprazole and famotidine in healthy subjects. 健康人小剂量埃索美拉唑与法莫替丁抑酸效果比较。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2023-09-01 DOI: 10.5414/CP204391
Ha-Yeon Kim, Jun Gi Hwang, Jae-Won Kim, Chang Hwan Seong, Ji Hyeon Lee, Young-Sim Choi, Hyo Jin Min, Hyung Son Kim, Hye Yun Kim, Yu Kyong Kim, Min Kyu Park
{"title":"Comparison of the acid suppression effects between low-dose esomeprazole and famotidine in healthy subjects.","authors":"Ha-Yeon Kim,&nbsp;Jun Gi Hwang,&nbsp;Jae-Won Kim,&nbsp;Chang Hwan Seong,&nbsp;Ji Hyeon Lee,&nbsp;Young-Sim Choi,&nbsp;Hyo Jin Min,&nbsp;Hyung Son Kim,&nbsp;Hye Yun Kim,&nbsp;Yu Kyong Kim,&nbsp;Min Kyu Park","doi":"10.5414/CP204391","DOIUrl":"https://doi.org/10.5414/CP204391","url":null,"abstract":"<p><strong>Objective: </strong>Famotidine, an H<sub>2</sub> receptor antagonist (H<sub>2</sub>RA), is mainly prescribed to alleviate the early symptoms of gastritis. Our aim was to explore the possibilities of low-dose esomeprazole as a treatment of gastritis as well as the pharmacodynamic (PD) properties of esomeprazole and famotidine.</p><p><strong>Materials and methods: </strong>A randomized, multiple-dose, 6-sequence, 3-period crossover study was conducted with a 7-day washout between periods. For each period, the subjects were administered one dose of esomeprazole 10 mg or famotidine 20 mg or esomeprazole 20 mg each day. To evaluate the PDs, the 24-hour gastric pH was recorded after single and multiple doses. The mean percentage of time during which the gastric pH was above 4 was evaluated for PD assessment. To confirm the pharmacokinetic (PK) characteristics of esomeprazole, blood was collected for up to 24 hours after multiple doses.</p><p><strong>Results: </strong>26 subjects completed the study. Following the multiple doses of esomeprazole 10 mg, esomeprazole 20 mg, and famotidine 20 mg, the mean percentages of time during which the gastric pH was above 4 over the course of 24 hour were 35.77 ± 19.56%, 53.75 ± 20.55%, and 24.48 ± 17.36%, respectively. After multiple doses, the time of peak plasma concentration at steady state (t<sub>max,ss</sub>) was 1.00 and 1.25 hours for 10 and 20 mg of esomeprazole, respectively. The geometric mean ratio and its 90% confidence interval of area under the plasma drug concentration-time curve in steady state (AUC<sub>T,ss</sub>) and maximum concentration of drug in plasma in steady state (C<sub>max,ss</sub>) for esomeprazole 10 mg compared to 20 mg were 0.3654 (0.3381 - 0.3948) and 0.5066 (0.4601 - 0.5579), respectively.</p><p><strong>Conclusion: </strong>The PD parameters of esomeprazole 10 mg were comparable to those of famotidine after multiple doses. These findings provide support for further evaluating the use of 10 mg of esomeprazole as a treatment option for gastritis.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 9","pages":"377-385"},"PeriodicalIF":0.8,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10430700","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
Evaluation of the comparative pharmacokinetic properties of a new orally disintegrating tablet of tegoprazan in healthy Korean subjects. 新型替戈拉散口腔崩解片在韩国健康人体内的比较药动学特性评价。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2023-09-01 DOI: 10.5414/CP204378
Jin A Lee, In Sun Goak, Jiwon Lee, Bongtae Kim, Seol Ju Moon, Yong-Geun Kwak, Min-Gul Kim
{"title":"Evaluation of the comparative pharmacokinetic properties of a new orally disintegrating tablet of tegoprazan in healthy Korean subjects.","authors":"Jin A Lee,&nbsp;In Sun Goak,&nbsp;Jiwon Lee,&nbsp;Bongtae Kim,&nbsp;Seol Ju Moon,&nbsp;Yong-Geun Kwak,&nbsp;Min-Gul Kim","doi":"10.5414/CP204378","DOIUrl":"https://doi.org/10.5414/CP204378","url":null,"abstract":"<p><strong>Purpose: </strong>Tegoprazan is a differentiated gastric acid-pump blocker and belongs to a class of potassium-competitive acid secretion blockers. An orally disintegrating tablet (ODT) of tegoprazan was developed to improve patient compliance. The purpose of this study was to compare pharmacokinetics (PK) and safety profiles between the conventional tablet (as the reference drug) and the ODT (as the test drug) of 50 mg tegoprazan in healthy Korean subjects.</p><p><strong>Materials and methods: </strong>An open-label, randomized, single-dose, 6-sequence, 3-period crossover study was conducted in 48 healthy subjects. All subjects received a single oral dose of tegoprazan 50 mg tablet with water, tegoprazan 50 mg ODT with water, and tegoprazan 50 mg ODT without water. Serial blood samples were collected up to 48 hours after dosing. Plasma concentrations of tegoprazan and its metabolite M1 were measured by LC-MS/MS, and PK parameters were calculated with a non-compartmental method. Safety was evaluated by means of assessed adverse events, physical examinations, laboratory test results as well as measurements of vital signs and ECG throughout the study.</p><p><strong>Results: </strong>A total of 47 subjects completed the study. The 90% confidence intervals of the geometric mean ratios for AUC<sub>t</sub>, C<sub>max</sub>, and AUC<sub>inf</sub> of tegoprazan were 0.8873 - 0.9729, 0.8865 - 1.0569, and 0.8835 - 0.9695 for the test drug with water to the reference drug and 0.9169 - 1.0127, 0.9569 - 1.1276, and 0.9166 - 1.0131 for the test drug without water to the reference drug, respectively. There were no serious adverse events, and all adverse events were mild.</p><p><strong>Conclusion: </strong>The PK profiles of tegoprazan were equivalent between the conventional tablet and ODT with or without water. There was no significant difference in the safety profiles. Therefore, the novel ODT of tegoprazan that can be taken without water may improve compliance among patients with acid-related diseases.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 9","pages":"410-420"},"PeriodicalIF":0.8,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10430701","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
Effects of iguratimod in the treatment of palindromic rheumatism: Case report. iguratimod治疗复发性风湿病的疗效:1例报告。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2023-09-01 DOI: 10.5414/CP204444
Fangfang Yuan, Junhong He, Jing Luo, Pingping Ye
{"title":"Effects of iguratimod in the treatment of palindromic rheumatism: Case report.","authors":"Fangfang Yuan,&nbsp;Junhong He,&nbsp;Jing Luo,&nbsp;Pingping Ye","doi":"10.5414/CP204444","DOIUrl":"https://doi.org/10.5414/CP204444","url":null,"abstract":"<p><strong>Objective: </strong>Palindromic rheumatism (PR) is characterized by interstitial inflammation, redness, and pain in joints and periarticular tissues. However, the pathogenesis and treatment of PR remain unknown. Herein, we report on the first use of iguratimod (IGU) - a novel small-molecule compound with anti-inflammatory effects - in the treatment of refractory PR.</p><p><strong>Case: </strong>A male patient aged 70 years was diagnosed with PR based on medical history, clinical manifestations, and ultrasound findings. The patient was treated with IGU (25 mg PO q.d.). The disease activity was measured by the frequency of PR flares and clinical symptoms. The patient's laboratory tests were monitored for safety reasons.</p><p><strong>Results: </strong>The use of IGU significantly improved pain symptoms and reduced flare frequency. After 28 days of treatment, abnormal levels of glutamic-pyruvic transaminase were observed. One month after discontinuation of IGU, flares occurred in the patient's second toe of both feet.</p><p><strong>Conclusion: </strong>IGU provides a new treatment option for patients with refractory PR who cannot use hydroxychloroquine. The effective treatment with IGU suggests the potential pathogenesis of PR and provides a basis for physicians to choose a new drug for PR treatment.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 9","pages":"404-409"},"PeriodicalIF":0.8,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10112797","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
Research on acute lung injury inflammatory network. 急性肺损伤炎症网络的研究。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2023-09-01 DOI: 10.5414/CP204438
Yaru Li, Yanan Jiang, Hui Zhang, Juan Zhang, Junbing Ma, Zheng Yang, Min Qiu, Jing Wang
{"title":"Research on acute lung injury inflammatory network.","authors":"Yaru Li,&nbsp;Yanan Jiang,&nbsp;Hui Zhang,&nbsp;Juan Zhang,&nbsp;Junbing Ma,&nbsp;Zheng Yang,&nbsp;Min Qiu,&nbsp;Jing Wang","doi":"10.5414/CP204438","DOIUrl":"https://doi.org/10.5414/CP204438","url":null,"abstract":"<p><p>Acute lung injury (ALI) is a systemic inflammatory response syndrome in the lungs, with a high incidence and fatality rate of 30 - 40%. Despite the abundance of research on the pathogenesis of lung injury and the great progress that has been achieved, the various number of cells, cytokines and inflammatory response pathways involved in the pathogenesis of ALI and their complex relationships - which together constitute the cell network and inflammatory factor network of ALI inflammatory response - demand more attention. This study reviews the formation of this network in the pathogenesis of ALI.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 9","pages":"394-403"},"PeriodicalIF":0.8,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10059289","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
Factors affecting outcome in hospitalized patients treated according to recommendations from clinical pharmacologists. 根据临床药理学家建议治疗的住院患者影响预后的因素。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2023-08-01 DOI: 10.5414/CP204343
Marko M Folic, Slobodan M Jankovic
{"title":"Factors affecting outcome in hospitalized patients treated according to recommendations from clinical pharmacologists.","authors":"Marko M Folic,&nbsp;Slobodan M Jankovic","doi":"10.5414/CP204343","DOIUrl":"https://doi.org/10.5414/CP204343","url":null,"abstract":"<p><strong>Objective: </strong>Although some of the positive effects of consulting a clinical pharmacologist when using complex treatment schedules have been demonstrated, the factors determining treatment outcomes are largely unknown. A main aim of this study was to identify and analyze the factors associated with the treatment outcomes in hospital patients in whom a therapeutic plan proposed by a clinical pharmacologist had been accepted and implemented.</p><p><strong>Materials and methods: </strong>The research was conducted as a retrospective cohort study on a random sample of 200 inpatients in the University Clinical Center Kragujevac, Serbia. The main outcome variables were i) in-hospital mortality, ii) inadequate clinical response to the therapy or pharmacological recommendations proposed by a clinical pharmacologist, iii) the total length of hospitalization, and iv) the length of hospitalization after consulting a clinical pharmacologist. The effect of putative predictors and confounders on the study outcomes were analyzed using multivariate regression models.</p><p><strong>Results: </strong>Early integration of clinical pharmacologists in the course of patient treatment was associated with a reduction in the risk of a fatal outcome (OR = 1.146; 95% CI, 1.006 - 1.305; p = 0.040). Delay in consulting a clinical pharmacologist was associated with a longer overall length of patient hospitalization (B = 1.592; 95% CI, 1.100 - 2.084; p = 0.000). When the reasons for consulting a clinical pharmacologist involved the choice of drug or the occurrence of adverse drug reactions, the duration of hospitalization following the consultation was shorter by ~ 4 days (B = -4.337; 95% CI, -8.190 to -0.484; p = 0.028) and 12 days (B = -12.024; 95% CI, -19.108 to -4.940; p = 0.001), respectively.</p><p><strong>Conclusion: </strong>To achieve more favorable treatment outcomes in the case of difficult-to-treat hospital inpatients, clinical pharmacologists should be consulted early in the course of the disease, especially when the choice of drug is difficult, and the occurrence of adverse drug reactions is an important issue.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 8","pages":"339-345"},"PeriodicalIF":0.8,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9868025","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
Neonatal pain score after use of paracetamol: Is there a relationship with serum trough concentration at steady state in preterm and term neonates? 使用扑热息痛后新生儿疼痛评分:早产儿和足月新生儿稳定状态下的血清谷浓度是否与之相关?
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2023-08-01 DOI: 10.5414/CP204431
Roland B van den Berg, A R Céleste Laarman, Lourens T Bloem, Jacob A Dijkstra, Agnes I Veldkamp, Karel Allegaert, Eleonora L Swart, Mirjam M van Weissenbruch
{"title":"Neonatal pain score after use of paracetamol: Is there a relationship with serum trough concentration at steady state in preterm and term neonates?","authors":"Roland B van den Berg,&nbsp;A R Céleste Laarman,&nbsp;Lourens T Bloem,&nbsp;Jacob A Dijkstra,&nbsp;Agnes I Veldkamp,&nbsp;Karel Allegaert,&nbsp;Eleonora L Swart,&nbsp;Mirjam M van Weissenbruch","doi":"10.5414/CP204431","DOIUrl":"https://doi.org/10.5414/CP204431","url":null,"abstract":"<p><strong>Objective: </strong>An easy to establish and patient-friendly biomarker to guide dosing of paracetamol in neonates is currently not available. The aim of this study was to determine the potential association between the serum trough concentration and area under the curve (AUC) of paracetamol at steady state and differences in pain scores in preterm and term neonates.</p><p><strong>Materials and methods: </strong>A retrospective observational study was performed, using an academic hospital database to identify neonates treated with intravenous or rectal paracetamol for at least 48 hours. At steady state, serum trough concentrations and the 24-hour AUC were determined. Pain was measured by COMFORTneo scores, before the 1<sup>st</sup> and 6<sup>th</sup> dose. Linear regression was performed to assess the association between serum trough concentration and 24-hour AUC and differences in pain scores. Subgroup analyses were performed for patients who received paracetamol due to a COMFORTneo score ≥ 14 (group 1) or who received prophylactic paracetamol because of upcoming surgery (group 2).</p><p><strong>Results: </strong>21 neonates were included. The median (interquartile range (IQR)) serum trough concentration of paracetamol before the 6<sup>th</sup> dose was 4.5 mg/L (2.7 - 8.5 mg/L). In subgroup 1, the median (IQR) COMFORTneo scores before the 1<sup>st</sup> and 6<sup>th</sup> dose were 17 (16.5 - 20) and 12 (11 - 16.5), respectively. In subgroup 2, the median (IQR) scores were 9 (8 - 10) and 11 (9 - 12), respectively. The serum trough concentration and 24-hour AUC were not associated with reduced pain scores (p = 0.12 and p = 0.67, respectively).</p><p><strong>Conclusion: </strong>No association was found between the serum trough concentration and 24-hour AUC of paracetamol at steady state and differences in pain scores in preterm and term neonates. Future research is needed to prospectively determine a patient-friendly biomarker to optimize the treatment with paracetamol.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 8","pages":"354-362"},"PeriodicalIF":0.8,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9868026","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: 1
Corrigendum to Article CP203292. CP203292条款的勘误表。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2023-08-01 DOI: 10.5414/CP203292Corr
Cecilia Fernández Del Valle-Laisequilla, Cristian Trejo-Jasso, Juan Carlos Huerta-Cruz, Lina Marcela Barranco-Garduño, Juan Rodríguez-Silverio, Héctor Isaac Rocha-González, Juan Gerardo Reyes-García
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