摘要
目的：评价甲氧氯普胺用于儿童的安全性。方法检索 PubMed、Embase、Cochrane图书馆、CNKI、VIP 和万方数据库，筛选甲氧氯普胺用于儿童的临床研究，检索时间均从建库至2014年9月。检索中国 FDA、美国 FDA、加拿大卫生部和欧洲药品管理局（EMA）关于甲氧氯普胺不良反应的通报和药物警戒信息。采用 WHO 因果关系评价体系对不良反应与甲氧氯普胺的关联性进行评价，对不良反应的特点进行描述性分析。结果共获得符合纳入标准的文献54篇，其中病例报告29篇，病例系列研究25篇，无 RCT 研究。54篇文献共报道甲氧氯普胺不良反应646例，其中29篇病例报告报道42例，25篇病例系列研究报道604例。646例患儿中男性352例，女性284例；年龄2个月至18岁，其中1岁以下者174例（26.9%），1~6岁者367例（56.8%），6~14岁者85例（13.2%），14岁以上者20例（0.03%）。病例报告报道的42例患儿中发生锥体外系反应者29例，男子乳房发育症4例，恶性综合征和呼吸暂停各2例，高醛固酮症、皮疹、血压升高、循环衰竭及右侧颞下颌关节脱臼者各1例；治愈39例，好转但留有后遗症2例，转院治疗1例。病例系列研究报道的604例患儿不良反应均为锥体外系反应，均治愈，无后遗症。2008年 CFDA 发布通报，58例甲氧氯普胺不良反应报告中儿童16例。2009和2011年，美国 FDA 和加拿大卫生部警告长期或大剂量服用甲氧氯普胺可致迟发型运动障碍。2013年，EMA 建议甲氧氯普胺限于短期使用（不超过5 d），不用于1岁以下儿童，对于1岁以上儿童，仅作为二线药物用于预防化疗和术后的恶心、呕吐。结论儿童使用常规剂量甲氧氯普胺存在发生锥体外系反应及其他严重不良反应的风险。
Objective To evaluate the safety of metoclopramide in children. Methods Reports on clinical studies involving metoclopramide treament in children were searched at PubMed,Embase, Cochrane Library,CNKI,VIP,and Wanfang Database from inception to September 2014. Adverse drug reaction information bulletins and pharmacovigilance information related to metoclopramide were searched＆amp;nbsp;from China Food and Drug Administration（CFDA）,US FDA,Health Canada,and European Medicines Agency（EMA）. The relationship between the adverse reactions and metoclopramide were evaluated using evaluation criteria of WHO and the characteristics of adverse reactions were descriptively analyzed. Results A total of 54 articles in accordance with inclusion criteria were entered in this study. No RCT was included. A total of 646 cases of adverse reactions were reported in the 54 articles. Of them,42 cases of adverse reactions in the 29 case reports were reported and 604 cases in the 25 case series reports were reported. In the 646 children,352 cases were males and 284 were females with ages from 2 months to 18 years old,of them,174 cases（26. 9% ）were 〈 1 year,367 cases（56. 8% ）were 1-6 years old,85 cases（13. 2% ） were 6 to 14 years old,and 20 cases（0. 03% ）were 〉 14 years. Among the 42 cases of adverse reactions, 29 cases had extrapyramidal reactions;4 cases had gynecomastia;2 cases had nausea syndrome and apnoea, respectively;1 case had hyperaldosteronism,skin rashes,blood pressure increase,and circulatory failure, respectively;39 cases were cured,2 cases were improved but sequelae remained,and 1 case was transferred to other hospital for treatment. All adverse reactions among the 604 cases of adverse drug reactions in the 25 case series reports were extrapyramidal reactions,all patients were cured without sequela. It was reported that 16 cases of 58 cases with adverse reactions in 2008 CFDA Bulletins were children. In 2011 and 2009, the FDA and Health Canada warned that long-term or large doses of metoclopramide
出处
《药物不良反应杂志》
CSCD
2016年第3期188-193,共6页
Adverse Drug Reactions Journal
基金
国家自然科学基金(81373381)Fund programNational Natural Science Foundation of China
