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康复新液联合氨基水杨酸治疗溃疡性结肠炎的疗效与安全性：一项系统评价与Meta分析

Efficacy and safety of Kangfuxin liquid combined with aminosalicylic acid for the treatment of ulcerative colitis: A systematic review and meta-analysis.

作者信息

Li Hui-Biao, Chen Mu-Yuan, Qiu Zhen-Wen, Cai Qing-Qun, Li De-Tang, Tang Hong-Mei, Chen Xin-Lin

机构信息

The First Clinical College, The First Affiliated Hospital School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.

出版信息

Medicine (Baltimore). 2018 May;97(21):e10807. doi: 10.1097/MD.0000000000010807.

DOI:10.1097/MD.0000000000010807
PMID:29794765
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6392804/
Abstract

BACKGROUND

To systematically evaluate the clinical efficacy and safety of Kangfuxin liquid (KFXL) combined with aminosalicylic acid (ASA) in treating ulcerative colitis (UC).

METHODS

The PubMed, Cochrane Library, Embase, CBM, Wan fang, the Chinese Scientific Journal Database (VIP), and Chinese National Knowledge Infrastructure (CNKI) databases were systematically searched for randomized controlled trials of KFXL combined with ASA for UC from the inception dates to March 3, 2017. Two researchers independently screened the literature, extracted data, and evaluated the methodological quality according to the inclusion criteria. The meta-analysis was performed using Review Manager software (RevMan, Version 5.3, Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014), and the risk of bias was assessed using the Cochrane Collaboration Tool.

RESULTS

A total of 39 randomized controlled trials (RCTs) involving 3204 patients fulfilled the inclusion criteria. Compared with ASA alone, KFXL combined with ASA significantly improved the clinical effectiveness rate [RR = 1.19, 95% CI: (1.16, 1.23), P < .00001], reduced the relapse rate [RR = 0.26, 95% CI: (0.18, 0.38), P < .00001], reduced the inflammation factor levels of TNF-a, IL-1, IL-6, IL-8, and C-reactive protein, reduced the coagulation index of fibrinogen, increased the coagulation index of prothrombin time, and mean platelet volume, and reduced the clinical symptoms of abdominal pain, diarrhoea, pus and bloody stool, and tenesmus. However, KFXL combined with ASA did not increase the adverse event incidence [RR = 0.74, 95% CI (0.42, 1.32), P = .31], and no severe adverse events were reported.

CONCLUSION

KFXL combined with ASA has good therapeutic effect for UC and might be a safe approach in managing UC. More high-quality, multicenter randomized, double-blind trials with a large sample size are required to generate a high level of clinical evidence.

摘要

背景

系统评价康复新液（KFXL）联合氨基水杨酸（ASA）治疗溃疡性结肠炎（UC）的临床疗效及安全性。

方法

系统检索PubMed、Cochrane图书馆、Embase、中国生物医学文献数据库（CBM）、万方数据库、维普中文科技期刊数据库（VIP）和中国知网（CNKI）数据库，收集自建库至2017年3月3日期间KFXL联合ASA治疗UC的随机对照试验。两名研究人员独立筛选文献、提取数据，并根据纳入标准评估方法学质量。采用Review Manager软件（RevMan，版本5.3，哥本哈根：北欧Cochrane中心，Cochrane协作网，2014）进行荟萃分析，使用Cochrane协作网工具评估偏倚风险。

结果

共纳入39项随机对照试验（RCT），涉及3204例患者。与单用ASA相比，KFXL联合ASA显著提高临床有效率[RR = 1.19，95%CI：（1.16，1.23），P <.00001]，降低复发率[RR = 0.26，95%CI：（0.18，0.38），P <.00001]，降低肿瘤坏死因子-α、白细胞介素-1、白细胞介素-6、白细胞介素-8和C反应蛋白等炎症因子水平，降低纤维蛋白原凝血指标，提高凝血酶原时间和平均血小板体积等凝血指标，并减轻腹痛、腹泻、脓血便和里急后重等临床症状。然而，KFXL联合ASA并未增加不良事件发生率[RR = 0.74，95%CI（0.42，1.32），P = 0.31]，且未报告严重不良事件。

结论

KFXL联合ASA治疗UC疗效良好，可能是一种安全的治疗方法。需要更多高质量、多中心、大样本的随机双盲试验以获得高水平的临床证据。

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