2023 年第 10 期 第 18 卷

尿通卡克乃其片临床使用安全性评价

Safety evaluation of Niaotong Kakenaiqi tablets clinical application

作者：沈皓焦敏赵婷龚褔恺于鲁海滕威

英文作者：Shen Hao Jiao Min Zhao Ting Gong Fukai Yu Luhai Teng Wei

单位：新疆维吾尔自治区人民医院药学部新疆维吾尔自治区临床药学研究所新疆维吾尔自治区药品使用监测与临床综合评价中心，乌鲁木齐830001

英文单位：Department of Pharmacy People′s Hospital of Xinjiang Uygur Autonomous Region Institute of Clinical Pharmacy of Xinjiang Uygur Autonomous Region Xinjiang Uygur Autonomous Region Drug Use Monitoring and Clinical Comprehensive Evaluation Center Urumqi 830001 China

关键词：尿通卡克乃其片；药品不良反应；安全性评价

英文关键词：NiaotongKakenaiqitablets;Drugadversereaction;Safetyevaluation

• 摘要：

• 目的  探讨尿通卡克乃其片临床使用安全性。方法  检索国内外数据库自建库起至2022年9月尿通卡克乃其片相关不良反应的文献。运用医渡云系统回顾性检索新疆维吾尔自治区人民医院2018年1月至2022年9月使用尿通卡克乃其片的出院患者，对尿通卡克乃其片相关不良反应、器官损害、严重程度及患者转归进行分析。结果  共检索出涉及尿通卡克乃其片药品不良事件文献11篇，大多数文献报道患者服用尿通卡克乃其片治疗前后实验室检查未见异常，无严重不良反应报道。本院发现尿通卡克乃其片相关不良反应患者81例，以男性、年龄41~79岁、汉族和维吾尔族、体重指数＞18~30 kg/m2、无药物过敏史患者多见。81例尿通卡克乃其片相关不良反应患者中，最常见的累及器官损害为胃肠道损害，其次为皮肤及附件损害；合并用药1、2、3、＞3种患者分别为27例（33.3%）、14例（17.3%）、5例（6.2%）、21例（25.9%）；用药后12、24、48、72、≥96 h发生不良反应患者分别为2例（2.5%）、39例（48.1%）、24例（29.6%）、11例（13.6%）、2例（2.5%）。81例患者不良反应严重程度均为一般，不良反应治愈51例（63.0%）、好转27例（33.3%）、不详3例（3.7%）。结论  尿通卡克乃其片安全性良好，但临床用药期间仍应加强患者各项实验室指标监测，保障患者用药安全。

• Objective  To investigate the safety of Niaotong Kakenaiqi tablets in clinic. Methods  The literatures for adverse reactions related to Niaotong Kakenaiqi tablets in the domestical and international database were searched from the establishment of databases to September 2022. From January 2018 to September 2022, the Yidu cloud system was used to retrospectively search for the discharged patients who were treated with Niaotong Kakenaiqi tablets in the People′s Hospital of Xinjiang Uygur Autonomous Region. The analysis was conducted on the adverse reaction, organ damage, severity and the outcome of patients related to Niaotong Kakenaiqi tablets. Results  A total of 11 literatures for drug adverse events of Niaotong Kakenaiqi tablets were retrieved. Most of the literatures reported that laboratory tests before and after taking Niaotong Kakenaiqi tablets showed no abnormalities, and no serious adverse reactions were reported. A total of 81 patients in the hospital with adverse reactions related to Niaotong Kakenaiqi tablets were identified, most of whom were male, aged 41-79 years, Han and Uygur ethnicity, with a body mass index >18-30 kg/m2 and no history of drug allergies. Among the 81 patients with Niaotong Kakenaiqi tablets related adverse reaction, the most common involved organ damage was gastrointestinal damage, followed by skin and appendage damage. Patients with 1, 2, 3 and > 3 concomitant medications accounted for 27 cases (33.3%), 14 cases (17.3%), 5 cases (6.2%) and 21 cases (25.9%), respectively. Adverse reactions occurred in 12, 24, 48, 72 and ≥96 h after medication were 2 cases (2.5%), 39 cases (48.1%), 24 cases (29.6%), 11 cases (13.6%) and 2 cases (2.5%), respectively. The severity of adverse reactions in 81 patients was average, with 51 cases (63.0%) cured, 27 cases (33.3%) improved and 3 cases (3.7%) unknown. ConclusionsNiaotong Kakenaiqi tablets have good safety. However, it is still necessary to strengthen the monitoring of various laboratory indexes during clinical medication to ensure the safety of patients′ medication.