Xiaomeng Zhang, Jiarui Wu, Bing Zhang, Ling Dong
J Tradit Chin Med. 2015 Apr;35(2):125-33. doi: 10.1016/s0254-6272(15)30019-4.
To evaluate systematically the clinical efficacy and safety of potassium dehydroandrographolide succinate injection (PDS) in treatment of infantile pneumonia.
Randomized controlled trials (RCTs) of infantile pneumonia treated by PDS were searched in China National Knowledge Infrastructure Database, China Science and Technology Journal Database, Wanfang Database, Chinese Biomedical Literature Database, PubMed, and Cochrane Library, from January 1979 to July 2013. Two reviewers independently retrieved the RCTs and extracted the information. The quality of included studies was assessed by the Cochrane risk of bias, and a Meta-analysis was conducted with Review Manager 5.2 software.
A total of 9 studies with 1056 participants were included. The quality of the studies was generally no high, only one study mentioned the random method. The Meta-analysis indicated that PDS was significantly superior to the conventional therapy in the total effective rate [relative risk (RR) = 1.21, 95% CI (1.14, 1.27), P < 0.000 01], the time of temperature recovery [mean difference (MD) = -1.43, 95% CI (-1.75, -1.11), P < 0.000 01], rale disappeared and cough relieving [MD = -1.44, 95% CI (-1.93, -0.90), P < 0.000 01]. Six adverse drug reactions from five studies mainly represented rash and diarrhea, and no serious ADRs were reported.
Based on this systematic review, PDS was proved effective and relatively safe in treatment of infantile pneumonia. However the articles enrolled in the study were not high in quality, studies with higher quality should be conducted for assessment of efficacy and safety of PDS in treatment of infantile pneumonia.
系统评价穿琥宁注射液治疗小儿肺炎的临床疗效及安全性。
检索中国知网数据库、维普数据库、万方数据库、中国生物医学文献数据库、PubMed及Cochrane图书馆中1979年1月至2013年7月发表的穿琥宁注射液治疗小儿肺炎的随机对照试验。由两名评价员独立检索随机对照试验并提取资料。采用Cochrane偏倚风险评估纳入研究的质量,并用RevMan 5.2软件进行Meta分析。
共纳入9项研究,1056例患者。研究质量普遍不高,仅1项研究提及随机方法。Meta分析结果显示,穿琥宁注射液在总有效率[相对危险度(RR)=1.21,95%可信区间(CI)(1.14,1.27),P<0.000 01]、体温恢复时间[均数差(MD)=-1.43,95%CI(-1.75,-1.11),P<0.000 01]、啰音消失及咳嗽缓解方面[MD=-1.44,95%CI(-1.93,-0.90),P<0.000 01]均显著优于传统疗法。5项研究报道了6例药物不良反应,主要表现为皮疹和腹泻,未报道严重不良反应。
基于本系统评价,穿琥宁注射液治疗小儿肺炎有效且相对安全。但纳入研究的文献质量不高,需开展高质量研究进一步评价穿琥宁注射液治疗小儿肺炎的疗效及安全性。