中药注射剂辅助治疗儿童支原体肺炎不良反应的Meta分析

Meta-Analysis of adverse reaction of Chinese medicine injections in adjuvant treatment of children's mycoplasma pneumoniae pneumonia

关键词:  中药注射剂  儿童  支原体肺炎  不良反应  Meta分析

Key words:  Chinese medicine injection  children  mycoplasma pneumoniae pneumonia  adverse reaction  Meta-analysis

摘要:

[目的] 采用Meta分析方法评价中药注射剂辅助治疗儿童支原体肺炎的不良反应，分析其临床安全性。[方法] 计算机检索中国期刊全文数据库、万方、中国生物医学文献数据库（CBM）、Cochrane Library、PubMed，检索时限均为建库至2018年9月，由2位研究者独立对纳入研究进行文献筛选和数据提取，采用RevMan 5.2软件进行Meta分析，同时对不同反应类型和不同干预措施的不良反应进行亚组分析。[结果] 共纳入81篇文献，入选7 772例患儿。Meta分析结果显示，治疗组不良反应发生率与对照组相比[OR=0.40（0.32，0.50）]有统计学意义（P<0.05）；不良反应症状报道最多的3个表现类型依次为消化系统、注射部位、皮肤及黏膜损伤，发生率分别为[OR=0.41（0.33，0.51）]、[OR=0.86（0.53，1.39）]、[OR=0.53（0.33，0.86）]；在以消化系统为主要表现的不良反应类型中，痰热清注射液、黄芪注射液和双黄连注射液组不良反应发生率的差异具有统计学意义（P<0.05），其他亚组均无统计学意义。[结论] 临床使用中药注射剂辅助治疗儿童支原体肺炎时，应提前做好相应的防治措施，确保其安全使用。

Abstract:

[Objective] To evaluate the clinical safety of Chinese medicine injections in adjuvant treatment of mycoplasma pneumoniae pneumonia in children by Meta-analysis.[Methods] Literature was searched from CNKI,WANFANG Database,CBM,Cochrane Library,PubMed from the beginning of the database building to September 2018. Two researchers screened literature,extracted data and assessed the methodological quality of included studies independently. Meta-analysis was conducted using RevMan 5.2 software. At the same time,the adverse reaction of different reaction types and different interventions were analyzed by subgroup analysis.[Results] The 81 RCTs were included,involving 7 772 patients. The results of Meta-analysis showed that the incidence of adverse reaction in the treatment group was higher than that in the control group[OR=0.40 (0.32,0.50)],and the comparison between the two groups was statistically significant (P<0.05). Three most frequent types of adverse reaction symptoms reported were digestive system,the injection site,and skin and mucosa,with an incidence of[OR=0.41 (0.33,0.51)],[OR=0.86 (0.53,1.39)],and[OR=0.53 (0.33,0.86)]. In the digestive system as the main types of adverse reaction,the incidence of adverse reaction in the groups of Tanreqing injection,Huangqi injection and Shuanghuanglian injection was statistically significant (P<0.05),while that in the other subgroups was not statistically significant.[Conclusion] In the clinical treatment of mycoplasma pneumoniae pneumonia in children,it is necessary to take corresponding safety measures in advance to ensure safety.