国内儿童应用醒脑静注射液不良反应的文献评价

Evaluation on domestic documents focusing on adverse drug reaction of the application of Xingnaojing on children

目的:用回顾性研究的方法,分析国内儿童临床应用醒脑静注射液发生不良反应(adverse drug reactions,ADR)的情况及其相关因素。方法:计算机检索万方数据库、CBM、VIP、和CNKI的同时查看纳入文献的参考文献清单,进行系统的收集并分析国内儿童临床应用醒脑静注射液的相关原始文献。结果:共纳入77项研究,共计6 073例患儿,年龄为不足1个月至16岁,包含7篇病例系列研究,64篇随机对照试验,3篇非随机试验试验和3篇不良反应报道。其中,涉及消化系统、呼吸系统、皮肤及附件、神经系统的总ADR发生率为1.47%(89/6 073)。ADR严重程度轻微,多为Ⅲ级和Ⅳ级,发生率分别为49.4%和47.2%,症状多表现为皮疹,头晕,胸闷,精神反应欠佳等,患儿均可忍受并未采取相关措施,也没有影响疾病治疗,大多自行好转。ADR发生的原因主要有醒脑静本身成分与辅料的复杂性,同时小儿用法用量、滴注速度尚未有确切规定。结论:儿童应用醒脑静的耐受性较好,严重不良反应较少,但由于受到研究质量和数量的限制,其安全性有待大样本高质量的研究证实。

Objective： To analyze the adverse drug reaction in domestic usage of XINGNAOJING on child,as well as the regarding factors. Methods： Search for document with the database powered by CBM,CNKI,VIP and WANGFANG,focusing on documents and all the quoted ones,with the systematic model of information gathering and analyzing. Results： The analyzed documents cover 77 related researches with 6 073 examples of child aging from less than 1 month to 16 years old. It also has 64 randomized controlled trails,3 non-randomized controlled trails,7 serial researches,and 3 adverse reaction reports. The rate of adverse-drug-reaction occurrence from the injection of Xingnaojing stands at 1. 47%,which effects nerve system,respiratory system,skin and its appendage and digesting system. Severity of ADR remains light,standing mostly at 3 and 4,with the rate of occurrence stands at 49. 4% and 47. 2% respectively,mostly featured with rash,dizzy head,sensing suppression at chest and delayed reaction. Most exampled children recovered without any treatment. Factors resulting ADR may include the make-up of Xingnaojing and the complicity of its auxiliary material,as well as the lack of regulation on the usage and the specific amount of injection. Conclusion： Children have a strong tolerance of Xingnaojing with extremely few serious adverse reaction sampled. However,its safety still relies on large sized sampled research due to the restriction of the sample number and the quality of this research.