蟾酥注射液治疗细菌感染性疾病的有效性和安全性系统评价

Systematic Review of Efficacy and Safety of the Secretio Bufonis Injection for Treating Bacterial Infectious Diseases

目的系统评价蟾酥注射液治疗细菌感染性疾病的疗效和安全性。方法计算机检索Cochrane Library,PubMed,Embase,以及中国期刊全文数据库(CNKI)、维普中文科技期刊全文数据库(VIP)、万方数据知识服务平台(WanFang Data),检索时间为自建库至2019年11月,纳入常规蟾酥注射液联合抗菌药物对比常规抗菌药物方案治疗细菌感染性疾病的随机对照试验(RCT),采用RevMan 5.3软件对纳入文献进行Meta分析。结果共纳入4篇中文文献,为蟾酥注射液联合抗菌药物与单用抗菌药物的4个RCT,联合用药组总有效率高,退热时间短,咳嗽症状缓解快,肺部罗音消失时间短,感染性疾病症状缓解时间短。仅1篇提及药物未发生不良反应。结论蟾酥注射液联合抗菌药物治疗细菌性感染的有效性优于单用抗菌药物,提示中西药联用抗感染有一定的协同增效作用,但蟾酥注射液的安全性有待进一步研究。由于纳入样本量有限,仍需更多大样本、高质量的RCT进行证实和补充。

Objective To systematically review the efficacy and safety of the secretio bufonis injection in treating bacterial infectious diseases.Methods The Cochrane Library,Pub Med database,Embase database,CNKI,VIP and WanFang Data were searched from inception to November 2019,and strict inclusion and exclusion criteria were established.Randomized controlled trials(RCTs)of the secretio bufonis injection combined with antimicrobial agents vs.conventional antimicrobial agents for bacterial infectious diseases were included for methodological quality assessment and meta-analysis.RevMan 5.3 software was used for meta-analysis.Random or fixed effect models were selected according to the degree of heterogeneity.Results Four Chinese literatures were included in the study.The four RCTs of secretio bufonis injection combined with antibacterial drugs and antibacterial drugs alone showed that secretio bufonis injection combined with antimicrobial group had high total effective rate,short antifebrile time,short cough withdrawal time,short lung rales disappearance time and short symptom relief time.Only one of the four included literatures mentioned no adverse drug reactions.Conclusion Secretio bufonis injection in bacterial injection combined with antimicrobial agents therapy effectiveness is better than the single use of antimicrobial agents,suggesting that Chinese and western medicine combination of anti-infection treatment has certain synergies,but the safety of secretio bufonis injection still needs further research.Due to limited observed cases,the above conclusions still need to be confirmed and supplemented by more large samples and high-quality RCT.