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随机临床试验安慰剂对照组中息肉切除术后患者的结直肠腺瘤复发率:一项荟萃分析。

Colorectal adenoma recurrence rates among post-polypectomy patients in the placebo-controlled groups of randomized clinical trials: a meta-analysis.

作者信息

Shi Xin, Yang Zhiping, Wu Qiong, Fan Daiming

机构信息

State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.

出版信息

Oncotarget. 2017 May 25;8(37):62371-62381. doi: 10.18632/oncotarget.18181. eCollection 2017 Sep 22.

Abstract

BACKGROUND

Evidence regarding the benefit of therapy to prevent the post-polypectomy recurrence of colorectal adenoma is limited. Endoscopic recurrence is the main outcome according to an evaluation of trials involving recurrence prevention.

AIM

To estimate the recurrence rates of post-polypectomy colorectal adenoma in placebo-controlled arms of randomized clinical trials and to identify the prognostic factors influencing these rates.

METHODS

We combined data from all randomized controlled trials evaluating therapies for colorectal adenoma using placebo from 1988 to 2016. The data were combined in a random-effects model. Primary outcomes were endoscopic adenoma and advanced adenoma recurrence of colorectal adenoma.

RESULTS

The pooled estimates of the adenoma recurrence rates were 37% (95% confidence interval [CI], 33%-41%; range, 33%-52%) at 1 year, 47% (95% CI, 41%-54%; range, 46%-51%) at 2 years, 41% (95% CI, 33%-48%; range, 20%-61%) at 3 years, 48% (95% CI, 38%-57%; range, 37%-53%) at 4 years, and 60% (95% CI, 52%-68%; range, 48%-68%) at 5 years. The pooled estimates of the advanced adenoma recurrence rates were 10% (95% CI, 6%-15%; range, 7%-13%) at 1 year, 12% (95% CI, 8%-16%; range, 3%-19%) at 3 years, 14% (95% CI, 10%-18%; range, 13%-16%) at 4 years, and 14% (95% CI, 10%-19%; range, 9%-21%) at 5 years. Significant heterogeneity among the randomized clinical trials (P < 0.001) was observed for each recurrence rate.

CONCLUSIONS

This meta-analysis confirms the heterogeneity of recurrence rates among post-polypectomy colorectal adenoma patients who received placebo. No single design variable was identified that might explain the heterogeneity.

摘要

背景

关于预防大肠腺瘤息肉切除术后复发的治疗益处的证据有限。根据对涉及复发预防的试验评估,内镜复发是主要结果。

目的

估计随机临床试验中安慰剂对照组大肠腺瘤息肉切除术后的复发率,并确定影响这些复发率的预后因素。

方法

我们汇总了1988年至2016年期间所有使用安慰剂评估大肠腺瘤治疗方法的随机对照试验的数据。数据采用随机效应模型进行汇总。主要结局是大肠腺瘤的内镜下腺瘤和高级别腺瘤复发。

结果

腺瘤复发率的合并估计值在1年时为37%(95%置信区间[CI],33%-41%;范围,33%-52%),2年时为47%(95%CI,41%-54%;范围,46%-51%),3年时为41%(95%CI,33%-48%;范围,20%-61%),4年时为48%(95%CI,38%-57%;范围,37%-53%),5年时为60%(95%CI,52%-68%;范围,48%-68%)。高级别腺瘤复发率的合并估计值在1年时为10%(95%CI, 6%-15%;范围, 7%-13%),3年时为12%(95%CI, 8%-16%;范围, 3%-19%),4年时为14%(95%CI, 10%-18%;范围, 13%-16%),5年时为14%(95%CI, 10%-19%;范围, 9%-21%)。各复发率在随机临床试验中均观察到显著异质性(P < 0.001)。

结论

这项荟萃分析证实了接受安慰剂治疗的大肠腺瘤息肉切除术后患者复发率的异质性。未发现单一设计变量可解释这种异质性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8bfc/5617512/4148781870f2/oncotarget-08-62371-g001.jpg

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