双歧三联活菌片治疗小儿腹泻的Meta分析

A meta-analysis of treatment of infantile diarrhea with bifid triple viable bacterial tablet

目的探讨双歧三联活菌片治疗小儿腹泻的疗效和安全性。方法按照系统评价的要求全面检索了中国数字医院图书馆(www.chkd.cnki.net)、中国医学科学院的中国生物医学文献光盘数据库(CBMdisk),对符合纳入标准的12篇文献共计1326名患者进行了Meta分析。结果发表性偏倚分析显示12篇文献的倒漏斗图是对称的。异质性检验,双歧三联活菌片组与抗生素组、抗病毒药组、空白对照组具有临床及统计学上的同质性(P=0·66、0·67、0·85,I2=0%),可用固定效应模型进行分析;双歧三联活菌片组与蒙脱石粉组不具有统计学上的同质性(P=0·02,I2=70·9%),故用随机效应模型进行分析。合并分析显示:双歧三联活菌片组与抗生素组、抗病毒药组、空白对照组比较,疗效的差异有统计学意义,而双歧三联活菌片与蒙脱石粉的疗效差异无统计学意义。结论从现有的临床证据来看,双歧三联活菌片治疗小儿腹泻有效,安全性可能较高,但还需要严格设计的、大样本的随机双盲对照试验来进一步验证和支持。

Objective To assess the efficacy and safety of bifid triple viable bacterial tablet in treatment of infantile diarrhea.Methods According to the requirements of Cochrane systematic review, a thorough literature search was performed among Chinese Digital Hospital Library (www.chkd.cnki.net) and Chinese Biomedical Literature Disk Database (CBMdisk). A meta analysis was performed on a total of 1326 patients involved in 12 papers which met the inclusion criteria.Results Publication bias analysis showed that the funnel plot was symmetrical. Test for heterogeneity showed that the groups treated with bifid triple viable bacterial tablet and antibiotics or anti-viral agents or placebo control had clinical homogeneity and statistical homogeneity ( P =0.66,0.67,0.85, respectively, I 2 =0%), which allowed to use fixed effect model analysis. The bifid triple viable bacterial tablet and Smecta did not have statistical homogeneity( P =0.02, I 2=70.9%), therefore random effect model analysis was applied. Incorporation analysis showed that in comparison of the bifid triple viable bacterial tablet versus antibiotics or anti-viral agents or placebo control, the odds ratios were 5.34, 4.74 and 6.43,respectively, and 95% CIs were [2.81,10.16], [2.47,9.09], and [2.61,15.83], on test for overall effect, Z =5.11, 4.67 and 4.04, P <0.00001. In the forest plot the 95% CI horizontal line of incorporation odds ratio droped to the right side of the vertical line indicating the border of effectiveness. However, no statistically significant difference was found between bifid triple viable bacterial tablet and Smecta. Conclusion The clinical evidences available so far indicated that treatment of infantile diarrhea with bifid triple viable bacterial tablet is safe and effective although rigorously designed large sample size randomized double blind clinical trials are required to further demonstrate and support the conclusion.