摘要
目的评价儿童使用多潘立酮的安全性。方法检索PubMed、Embase、Cochrane图书馆、中国生物医学文献光盘数据库、CNKI、VIP和万方数据库，筛选多潘立酮用于儿童的临床研究。检索WHOPharmaceuticalsNewsletter和国家药品不良反应监测中心发布的《药品不良反应信息通报》，收集多潘立酮上市后不良反应／事件监测报告。检索欧洲药品管理局（EMA）、美国FDA、英国药物和保健产品监管署（MHRA）、加拿大卫生部和澳大利亚医疗产品局网站，收集官方发布的多潘立酮风险和利益评估、适应证修改等信息。对RCT采用RevMan5．2软件进行Meta分析，对其他文献进行描述性统计分析。采用WHO药品不良反应监测合作中心ADR因果关系评估标准分析不良反应与多潘立酮的相关性，采用美国卫生及公共服务部常见不良反应评价标准（CTCAE4．03）评价不良反应／事件严重程度。结果共纳入RCT文献9篇，队列研究1篇，自身对照研究4篇，病例报告24篇。9篇RCT文献的Meta分析结果显示，多潘立酮组儿童不良反应发生率与应用安慰剂、莫沙必利或西沙比利的对照组差异无统计学意义，低于甲氧氯普胺（RR=0．44，95％C／：0．23—0．86，P=0．02），高于中成药（RR=16．09，95％C／：2．01～129．04，P=0．01）。9项RCT研究中均未见多潘立酮严重不良反应报道。4项自身对照研究中，1项研究显示新生儿使用多潘立酮与QT间期延长相关。24篇病例报告报道多潘立酮不良反应101例，轻中度不良反应（CTCAE1-2级）80例（79．2％），重度不良反应（CTCAE3级）21例（20．8％），未见CTCAE4—5级不良反应报道。因果关系评价结果显示2例不良反应与多潘立酮肯定有关，76例很可能有关；15例患者用药过量，2例联用其他可致相同不良反应的药物。2014年4月EMA建议限制多潘立酮的适应证和临床用量。同年9月，MHRA宣�
Objective To evaluate the safety of domperidone in children. Methods Clinical studies involving domperidone used in children were searched from PubMed, Embase, Cochrane Library, Chinese Biology Medical disc, CNKI, VIP, and Wanfang Database. Adverse drug reaction information bulletins which were reported by WHO Pharmaceuticals Newsletter and National Center for adverse drug reaction monitoring were searched and adverse drug reactions （ADR）/adverse drug events （ADE） related to domperidone were collected. Websites of European Medicines Agency, Food and Drug Administration of United States, Medicines and Healthcare Products Regulatory Agency （MHRA）, Health Canada, and Therapeutic Goods Administration were searched and information of risks and benefits related to domperidone treatment were collected. Randomized controlled trails （ RCTs ） were Meta-analyzed using RevMan 5.2 software and other data were descriptively analyzed. Correlation analysis of domperidone and adverse drug reactions was performed using evaluation criteria of WHO. Severity of ADR/ADE was evaluated using criteria CTCAE 4.03 of United States Department of Health and Human Services. Results A total of 9 RCTs, 1 cohort study, 4 self-controlled studies, and 24 case reports were entered in this study. Metaanalysis of 9 RCTs showed the following results. There were no statistical significance in the incidence of ADR in children between the domperidone group and the control groups of placebo, cisapride, and mosapride. The incidence of ADR in children in the domperidone group was lower than that in the metoclopramide （RR=0.44, 95% CI： 0. 23-0.86, P =0.02）, and higher than that in the Traditional Chinese Medicine group （RR = 16.09, 95% CI： 2.01-129.04, P = 0.01 ）. There were no serious adverse events of domperidone reported in the 9 RCTs. It was showed in the self-controlled study that oral domperidone was associated with QTc prolongation in neonates. One hundred and one cases of ADR were reported in 24 case reports. Of them, 80 c
出处
《药物不良反应杂志》
CSCD
2016年第2期88-94,共7页
Adverse Drug Reactions Journal
基金
国家自然科学基金（81373381）
