参苓白术散加减对比西药治疗溃疡性结肠炎的疗效和安全性Meta分析

通过探讨参苓白术散加减治疗溃疡性结肠炎(UC)的有效性和安全性,为临床推广提供科学依据。计算机检索CNKI,CBM,万方,维普等数据库,纳入参苓白术散加减对比单用西药治疗溃疡性结肠炎的随机对照试验文献(randomized control trials,RCTs),用Cochrane评价方法进行风险偏倚评估;收集纳入研究的有效率、主要症状(腹泻、腹痛、便脓血、发热)的改善时间和肠镜下黏膜疗效,并进行Meta分析。本研究共纳入13篇RCTs,总例数1 285例,参苓白术散组659例,单用西药组598例。对比单用西药,参苓白术散加减有较高临床疗效(RR=1.17,95%CI1.13,1.22],P0.001),能明显缩短腹泻、腹痛、便脓血、发热症状的改善时间,其合并效应量分别为(RR=-12.32,95%CI-14.27,-10.37],P0.001),(RR=-8.06,95%CI-9.88,-6.24],P0.001),(RR=-9.89,95%CI-10.77,-9.00],P0.001),(RR=-8.29,95%CI-9.59,-6.98],P0.001),减少不良反应事件的发生(RR=0.06,95%CI0.01,0.40],P=0.004)。参苓白术散加减治疗UC的肠镜下黏膜疗效比较没有统计学意义。对比单用西药,参苓白术散加减治疗溃疡性结肠炎有更好的疗效和安全性,适合临床推广使用,但由于纳入文献数目较少,质量较低,需要高质量的大样本双盲随机对照试验的支持。

Meta-analysis on Effectiveness and Safety of Modified Shenling Baizhu San and Western Medicines in Treating Ulcerative Colitis

To systematically review the effectiveness and safety of modified Shenling Baizhu San in the treatment of ulcerative colitis (UC), in order to provide a scientific basis for clinical promotion. Randomized clinical trials (RCT) for comparing the efficacy of Shenling Baizhu San with western medicines in treating ulcerative colitis were searched in CBM, CNKI, VIP and Wanfang databases. The studies were screened. The following data were extracted, such as effective rate, improvement time of main symptoms, endoscopic improvement and adverse events. The risk bias of included studies was assessed by the Cochrane scale. Meta-analysis was performed using RevMan 5.3 software. A total of 13 RCTs were eventually included. A total of 1 285 cases were included, including 659 cases in Shenling Baizhu San group and 598 in western medicine group. Compared with the western medicine group, the combined RR of the effective rate in the Shenling Baizhu San group was 1.17, (95%CI 1.13,1.22], P<0.001), the Shenling Baizhu powder group showed a shorter improvement time of diarrhea, abdominal pain, sepsis, and fever, with the effect size (RR=-12.32, 95%CI-14.27,-10.37], P<0.001), (RR=-8.06, 95%CI-9.88,-6.24], P<0.001), (RR=-9.89, 95%CI-10.77,-9.00], P<0.001), (RR=-8.29, 95%CI-9.59,-6.98], P<0.001). The adverse events were statistically significant (RR=0.06, 95%CI 0.01, 0.40], P=0.004). The endoscopic examination showed no significant difference. The effectiveness and safety of Shenling Baizhu San in the treatment of ulcerative colitis are more superior to western medicines, so it is suitable for clinical use. However, more large-sample-size double-blind RCTs shall be included to support this conclusion.