拉米夫定联合扶正化瘀胶囊治疗慢性乙型肝炎肝纤维化疗效的Meta分析

Meta-analysis of Lamivudine Combined Fuzheng Huayu Capsule in Treatment of Chronic Hepatitis B Liver Fibrosis

目的:探讨拉米夫定联合扶正化瘀胶囊治疗慢性乙型肝炎肝纤维化的疗效。方法:计算机检索Pub Med、中国知网(CNKI)、中国生物医学数据库(CBM)、万方(Wan Fang)、重庆维普(CQVIP)数据库中拉米夫定联合扶正化瘀胶囊治疗慢性乙型肝炎肝纤维化的临床随机对照试验,所有检索时间均为自建库-2015年09月20日。采用Jadad评分法进行文献质量评价,运用Rev Man 5.2软件进行Meta分析。计数资料用比值比(OR),计量资料用加权均数差(WMD),计算95%可信区间(CI)。纳入文献异质性检验结果 P>0.05,采用固定效应模型作Meta分析;反之,采用随机效应模型;文章的发表偏倚采用漏斗图分析。结果:本研究共纳入临床随机对照试验10项,共745名患者,其中拉米夫定联合扶正化瘀胶囊试验组379例,单用拉米夫定对照组366例,Meta分析结果显示:透明质酸(HA)改善[Z=4.82,P<0.00001,WMD=-90.1,95%CI(-126.62,-53.40)];层黏连蛋白(LN)改善[Z=4.55,P<0.00001,WMD=-31.84,95%CI(-45.49,-18.11)];Ⅲ型前胶原(PCⅢ)改善[Z=4.25,P<0.0001,WMD=-41.58,95%CI(-60.74,-22.42)];IV型胶原(IV-C)改善[Z=3.43,P=0.0006,WMD=-35.22,95%CI(-55.35,-15.09)];丙氨酸氨基转移酶(ALT)改善[Z=2.70,P=0.007,WMD=-31.03,95%CI(-53.54,-8.52)]。结论:现有的临床证据初步表明,抗病毒药拉米夫定联合抗肝纤维化中药扶正化瘀胶囊在治疗乙型肝炎肝纤维化的疗效优于单纯使用拉米夫定,值得进一步推广,由于目前相关临床随机对照试验相对较少,还应进行多中心、大样本、高质量和以组织病理学为最终疗效评价标准的的临床随机对照试验进一步证明。

Objective： To investigate the effectiveness of Lamivudine combined Fuzheng Huayu Capsule in the treatment of chronic hepatitis B liver fibrosis. Methods： Pub Med,CNKI,CBM,Wanfang and VIP database were retrieved to select the randomized controlled trials about lamivudine combined Fuzheng Huayu Capsule in the treatment of chronic hepatitis B liver fibrosis since the construction of the database to September 20 th,2015. It also used the Jadad score method for quality assessment of standard literature and performed the analysis through the Rev Man5. 2 Meta-analysis software provided by the Cochrane collaboration. If the final result had high homogeneity,we would combine random variable models. If not,we would combine the fixed effects models. Use the weighted mean differences（ WMD） as an outcome variable and calculate the interval estimate about 95% confidence interval（ CI）. The publication bias of the article was analyzed by funnel plot. Results： The research contained 10 clinical randomized controlled trials,in which 745 patients took part in. Among them,379 participants took LAM combining with Fuzheng Huayu Capsule while 366 of them took LAM alone. The Results of Meta-analysis showed that HA improvement [Z = 4. 82,P〈0. 00001,WMD =-90. 1,95% CI（-126. 62,-53. 40） ],LN improvement[Z = 4. 55,P〈0. 00001,WMD =-31. 84,95% CI（-45. 49,-18. 11） ],PCⅢ improvement[Z = 4. 25,P〈0. 0001,WMD =-41. 58,95% CI（-60. 74,-22. 42） ],IV-C improvement[Z = 3. 43,P = 0. 0006,WMD =-35. 22,95% CI（-55. 35,-15. 09） ],ALT improvement[Z = 2. 70,P =0. 007,WMD =-31. 03,95% CI（-53. 54,-8. 52） ]. Conclusion： The present clinical evidence tells us that the curative effect of taking LAM combining with Fuzheng Huayu Capsule is better then taking LAM alone. As a result,it deserves to popularize the curative method. But we still need more randomized clinical trials with multicenter,large sample and high quality and the final therapeutic evaluation based on histology to prove the result at the same time.