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康复新液灌肠联合美沙拉嗪治疗溃疡性结肠炎：一项系统评价与GRADE方法

Kangfuxinye Enema Combined with Mesalamine for Ulcerative Colitis: A Systematic Review and GRADE Approach.

作者信息

Ren Peng-Wei, Yang Wen-Jie, Wang Dan-Dan, Shan Jing-Yan, Kang De-Ying, Hong Qi, Wen Shu, Zhang Ru-Wen

机构信息

Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital, Sichuan University, Chengdu 610041, China.

West China School of Public Health, No. 4 West China Teaching Hospital, Sichuan University, Chengdu 610041, China.

出版信息

Evid Based Complement Alternat Med. 2017;2017:6019530. doi: 10.1155/2017/6019530. Epub 2017 Aug 7.

DOI:10.1155/2017/6019530
PMID:28848616
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5564127/
Abstract

OBJECTIVES

To critically appraise the efficacy and safety of Kangfuxinye enema combined with mesalamine for the ulcerative colitis (UC) patients and in addition to grade the quality of evidence by using the GRADE (grading of recommendations, assessment, development, and evaluation) approach.

METHODS

A literature search was performed in the Cochrane Library, MEDLINE, EMBASE, CBM, CNKI, VIP, and WanFang Databases. The search restrictions were patients with UC and RCTs. Studies including other treatments except Kangfuxinye with mesalamine were excluded.

RESULTS

Nineteen studies met the inclusion criteria. We found significant benefits of Kangfuxinye combined with mesalamine against mesalamine alone in improving response rate as well as reducing the recurrence rate and inflammation rate; meanwhile, the increase of the adverse events rate was not observed. Furthermore, the symptoms remission rate and the cure time were insignificant statistically. Additionally, GRADE results indicated that the quality of evidence regarding the above 6 outcomes was rated from very low to moderate quality.

CONCLUSIONS

Although Kangfuxinye enema seems effective and safe for treating UC patients in this systematic review, Kangfuxinye enema combined with mesalamine was weakly recommended due to very low to moderate quality of available evidence by the GRADE approach.

摘要

目的

严格评估康复新液灌肠联合美沙拉嗪治疗溃疡性结肠炎（UC）患者的疗效和安全性，并采用GRADE（推荐分级、评估、制定与评价）方法对证据质量进行分级。

方法

在Cochrane图书馆、MEDLINE、EMBASE、中国生物医学文献数据库、中国知网、维普数据库和万方数据库中进行文献检索。检索限定为UC患者和随机对照试验。排除除康复新液与美沙拉嗪联合治疗以外包含其他治疗方法的研究。

结果

19项研究符合纳入标准。我们发现康复新液联合美沙拉嗪相比于单用美沙拉嗪在提高缓解率、降低复发率和炎症率方面具有显著益处；同时，未观察到不良事件发生率增加。此外，症状缓解率和治愈时间在统计学上无显著差异。另外，GRADE结果表明，上述6项结局的证据质量从极低到中等质量不等。

结论

尽管在本系统评价中康复新液灌肠治疗UC患者似乎有效且安全，但由于GRADE方法评估的现有证据质量极低到中等，故对康复新液灌肠联合美沙拉嗪治疗UC仅给予弱推荐。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/957e6ec14817/ECAM2017-6019530.008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/ea47a1115b80/ECAM2017-6019530.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/f4e610e08973/ECAM2017-6019530.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/01ef0ad1eea0/ECAM2017-6019530.003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/26b65ebe8ee1/ECAM2017-6019530.004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/348b3b5a3b49/ECAM2017-6019530.005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/b3ed12b88026/ECAM2017-6019530.006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/ec737f3521b5/ECAM2017-6019530.007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/957e6ec14817/ECAM2017-6019530.008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/ea47a1115b80/ECAM2017-6019530.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/f4e610e08973/ECAM2017-6019530.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/01ef0ad1eea0/ECAM2017-6019530.003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/26b65ebe8ee1/ECAM2017-6019530.004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/348b3b5a3b49/ECAM2017-6019530.005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/b3ed12b88026/ECAM2017-6019530.006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/ec737f3521b5/ECAM2017-6019530.007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/5564127/957e6ec14817/ECAM2017-6019530.008.jpg

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