中国泛珠十省市581例伊托必利药品不良反应报表分析

目的:通过分析总结中国泛珠十省市(福建省、云南省、海南省、湖南省、广东省、广西壮族自治区、江西省、四川省、贵州省、重庆市)伊托必利不良反应报表,为该药临床合理使用提供参考。方法:收集2004年7月至2017年11月中国泛珠十省市不良反应监测中心提供的伊托必利药品不良反应报表,并进行统计分析。结果:伊托必利所致ADR临床表现多样,能导致多系统-器官的ADR发生。有效的581例ADR报表中,男性298例,女性283例。ADR涉及多个系统-器官,581例患者累计发生不良反应共计970例次,其中以胃肠系统损害最常见,其次为皮肤及其附件损害、中枢及外周神经系统损害、全身性损害和神经紊乱,其他不良反应涉及呼吸系统损害、心率及心律紊乱、肌肉骨骼系统损害等。结论:伊托必利不良反应多常见且可耐受,临床用药安全性较高。

Analysis of 581 adverse drug reactions of itopride in ten provinces in China

OBJECTIVE By analyzing the reports of itopride adverse reactions in ten provinces,we pretend to provide a reference for the clinical rational use (Fujian, Yunnan, Hainan, Hunan, Guangdong, Guangxi Zhuang Autonomous Region, Jiangxi, Sichuan, Guizhou and Chongqing). METHODS The reports of itopride adverse drug reactions (ADRs) provided by the Adverse Reaction Monitoring Center of these provinces from July 2004 to November 2017 were collected and analyzed statistically. RESULTS The clinical manifestations of ADRs caused by itopride were diverse and could lead to multiple system-organ ADRs. There were 581 patients with ADRs, including 298 males and 283 females. Totally 970 cases of adverse reactions occurred in 970 patients, involving multiple systems and organs. The most common adverse reactions were gastrointestinal system disorder, followed by the skin and its annexes diseases, central and peripheral nervous diseases, generalized impairment and neurological disorders, while other adverse reactions involved the respiratory system, heart rate and heart rhythm disorders, musculoskeletal system, etc. CONCLUSION The adverse reactions of itopride are common and tolerable, and the safety of clinical medication is safe.