参苓白术散方联合西药治疗溃疡性结肠炎的系统评价和Meta分析

【目的】探讨参苓白术散方加减治疗溃疡性结肠炎的有效性和安全性,为其临床应用提供依据。【方法】纳入参苓白术散方加减联用西药对比单用西药治疗溃疡性结肠炎的随机对照试验(RCTs),用Cochrane评价方法对文献的风险偏倚进行评价;对纳入文献的临床疗效、疾病活动指数(DAI)及炎症相关因子水平改善情况进行Meta分析。【结果】共纳入19篇RCTs文献,涉及1 498例患者。Meta分析结果示:(1)与单用西药组比较,参苓白术散方加减联用西药可以提高溃疡性结肠炎治疗的有效率[相对危险度(RR)为1.55,95%可信区间(CI)为(1.39,1.72)];根据干预药物种类进行亚组分析,联合使用柳氮磺吡啶组和美沙拉嗪/奥沙拉嗪组合并的效应量RR分别为1.46[95%CI(1.19,1.77)]、1.59[95%CI(1.40,1.80)];根据干预疗程进行亚组分析,1~30 d、31~60 d、61~90 d疗程组合并的效应量RR分别为1.42[95%CI(1.18,1.70)]、1.69[95%CI(1.44,1.97)]、1.47[95%CI(1.15,1.88)],差异均有统计学意义(P0.05)。(2)参苓白术散方加减联用西药可以改善DAI评分,并降低炎症因子白细胞介素-17(IL-17)、IL-23、肿瘤坏死因子-α(TNF-α)、C-反应蛋白(CRP)水平,差异均有统计学意义(P0.05)。(3)敏感性分析和漏斗图分析显示纳入的文献同质性较强,不存在发表偏倚。【结论】与单用西药组比较,参苓白术散方加减联用西药治疗溃疡性结肠炎有更好的临床疗效,且联用美沙拉嗪一类新型5-氨基水杨酸类制剂疗效更佳,可改善疾病活动程度及炎症因子水平,适宜的疗程为30~60 d。因纳入文献的质量不高,各试验设计存在一定的不足,本结论需进一步的高质量大样本双盲随机对照试验的支持。

Meta-analysis of Shenling Baizhu Powder Combined with Western Medicine in Treating Ulcerative Colitis

Objective To make a Meta-analysis of the effectiveness and safety of Shenling Baizhu Powder (SBP) for the treatment of ulcerative colitis(UC),thus to provide evidence for the clinical treatment of ulcerative colitis.Methods Randomized controlled trials (RCTs) of SBP combined with western medicine vs western medicine in treating ulcerative colitis were included.The quality of RCTs was assessed by the Cochrane scale.A Meta-analysis was performed for the clinical efficacy,improvement of disease activity index (DAI) levels of the included trials.Results A total of 19 RCTs were included,involving 1498 cases.The results of Metaanalysis showed that compared with the western medicine group,the combined risk ratio(RR) of clinical efficacy in the SBP combined group was 1.55,95％ confidence interval (CI) being (1.39,1.72).The subgroup analysis based on control medicine showed that the combined RR of combined use of sulfasalazine or mesalazine/Olsalazine was 1.46,1.59 [95％CI (1.19,1.77) vs 95％CI (1.40,1.80)].The subgroup analysis based on different treatment courses showed that the combined RR of 1-30 days,31-60 days,61-90 days was 1.42,1.69,1.47 [95％CI (1.18,1.70) vs 95％CI (1.44,1.97) vs 95％CI (1.15,1.88)] respectively.The differences were significant (P ＜ 0.05).(2) The differences of the two groups on the improvement of DAI and inflammatory factors levels of interlekin-17(IL-17),IL-23,tumor necrosis factor alpha(TNF-α),C-reactive protein(CRP) were statistically significant(P ＜ 0.05).(3)The sensitivity analysis of the primary outcomes showed a higher homogeneity in the literatures and the funnel plot analysis showed no evidence of publication bias.Conclusion Compared with western medicine,SBP combined with western medicine has better clinical efficacy for the treatment of UC,and the combined use of mesalazine/Olsalazine medicated for 30-60 days is more effective on improving DAI and inflammatory factors levels.However,for the low quality of the included literatures and insufficient experimental design,the conclusion needs more evidence from large sample-size randomized double-blind controlled trials.