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葛根芩连汤联合美沙拉嗪治疗溃疡性结肠炎的疗效与安全性：一项Meta分析与系统评价

Efficacy and safety of Gegen Qinlian decoction combined with mesalazine for the treatment of UC: A meta-analysis and systematic review.

作者信息

Chen Yanjie, Li Ruoqi, Yuan Yuping, He Haomin, Yang Wei, Yuan Cheng, Xiao Jinyin, Qin Yile, Lian Min, Yang Zhouyu

机构信息

The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha, China.

The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine, Nanning, China.

出版信息

Medicine (Baltimore). 2025 Jul 25;104(30):e42266. doi: 10.1097/MD.0000000000042266.

DOI:10.1097/MD.0000000000042266
PMID:40725879
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12303433/
Abstract

BACKGROUND

To systematically evaluate the clinical efficacy and safety of a Gegen Qinlian decoction combined with mesalazine for the treatment of ulcerative colitis (UC).

METHODS

Chinese (CNKI, CSPD, CCD, and CBM) and foreign databases (PubMed, Web of Science, Cochrane Library, and Embase) were searched for randomized controlled trials related to the treatment regimen used in this study. The risk of bias of the included studies was evaluated using the Cochrane assessment tool. Revman5.0 and Stata17.0 were used for the meta-analysis and sensitivity analysis. Trial sequential analysis was used for sequential analysis. Gradepro3.6 was used to evaluate the level of evidence quality of outcome indicators.

RESULTS

Fifteen studies involving 1428 patients were included. The results of meta-analysis showed that the intervention group in the treatment of UC improved the total clinical effective rate (P < .001, relative risk = 1.22, 95% confidence interval (CI) [1.16-1.28]), the main clinical symptoms (P < .001, standard mean difference [SMD] = 1.58, 95% CI [1.86, 1.30]), intestinal mucosal barrier function (P < .001, SMD = 1.02, 95% CI [1.20, 0.84]), reduce the incidence of adverse reactions (P = .05, relative risk = 0.59, 95% CI [0.35, 1.00]), modified Mayo score (P < .001, SMD = 1.53, 95% CI [2.17, 0.89]), Baron endoscopic score (P < .001, SMD = 0.93, 95 CI [1.18, 0.68]), regulate immune function (P < .001, SMD = 0.69, 95% CI [0.47, 0.90]), inflammatory factor levels (P < .001, SMD = 0.69, 95% CI [0.47, 0.90]), intestinal flora (P = .004, SMD = 1.42, 95% CI [0.44, 2.39]), the intervention group were better than the comparison group. But there was no significant difference in oxidative stress index (P = .54, SMD = -0.44, 95% CI [-1.82, 0.95]).

CONCLUSION

Gegen Qinlian decoction combined with mesalazine has definite clinical efficacy and safety for the treatment of UC. Owing to the limited methodological quality of the included studies, high-quality randomized controlled trials are still needed for verification in the future.

摘要

背景

系统评价葛根芩连汤联合美沙拉嗪治疗溃疡性结肠炎（UC）的临床疗效及安全性。

方法

检索中国（知网、维普、万方和中国生物医学文献数据库）及国外数据库（PubMed、Web of Science、Cochrane图书馆和Embase）中与本研究治疗方案相关的随机对照试验。采用Cochrane评估工具评估纳入研究的偏倚风险。使用Revman5.0和Stata17.0进行荟萃分析和敏感性分析。采用试验序贯分析进行序贯分析。使用Gradepro3.6评估结局指标的证据质量水平。

结果

纳入15项研究，共1428例患者。荟萃分析结果显示，干预组在治疗UC时提高了总临床有效率（P < .001，相对危险度 = 1.22，95%置信区间（CI）[1.16 - 1.28]）、主要临床症状（P < .001，标准化均数差[SMD] = 1.58，95%CI [1.86, 1.30]）、肠黏膜屏障功能（P < .001，SMD = 1.02，95%CI [1.20, 0.84]），降低了不良反应发生率（P = .05，相对危险度 = 0.59，95%CI [0.35, 1.00]）、改良Mayo评分（P < .001，SMD = 1.53，95%CI [2.17, 0.89]）、Baron内镜评分（P < .001，SMD = 0.93，95%CI [1.18, 0.68]），调节免疫功能（P < .001，SMD = 0.69，95%CI [0.47, 0.90]）、炎症因子水平（P < .001，SMD = 0.69，95%CI [0.47, 0.90]）、肠道菌群（P = .004，SMD = 1.42，95%CI [0.44, 2.39]），干预组均优于对照组。但氧化应激指标差异无统计学意义（P = .54，SMD =  - 0.44，95%CI [-1.82, 0.95]）。

结论

葛根芩连汤联合美沙拉嗪治疗UC具有确切的临床疗效及安全性。由于纳入研究的方法学质量有限，未来仍需高质量随机对照试验进行验证。

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