Department of Gynecology, Tiantai Branch of Zhejiang Provincial People's Hospital, Tiantai, 317200, China.
Department of Gynecology, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, 310014, China.
Int J Surg. 2019 May;65:61-69. doi: 10.1016/j.ijsu.2019.03.015. Epub 2019 Mar 27.
A systematic review and meta-analysis was designed to evaluate the efficacy and safety of probiotics for prevention of radiotherapy-induced diarrhea (RID) in patients with cervical cancer. Previous studies failed to give a comprehensive analysis of the efficacy and safety of probiotics in this point.
We searched the Cochrane Library, PubMed, EMBASE and Web of Science up to June 4, 2018. We also hand searched some studies included in previous reviews. Our primary outcome aims to compare the incidence of all Common Toxicity Criteria (CTC) grades of RID and adverse events (AEs) in both probiotics groups and placebo groups. Relative risk (RR) with its 95% confidence interval (CI) was used to compare the efficacy of probiotics in prevention of RID, and the pooled RRs were estimated using a fixed- or random-effect model; heterogeneity was assessed with Cochran's Q and Higgins I test. Two reviewers assessed trial quality and extracted data independently. The analysis and bias for each of included studies were performed and assessed using Review Manager 5.2.
Nine randomized, placebo-controlled studies (N = 1508 participants) were included for assessing the efficacy of probiotics. Compared with placebo groups, participants in probiotic groups experienced much lower incidence of RID with RR of 0.61 (95% CI 0.46-0.81; P = 0.0007). In addition, significant results were also observed in CTC grade ≥2 and grade ≥3 RID, with the pooled RRs of 0.52 (95% CI 0.30-0.98; P = 0.02) and 0.32 (95% CI 0.12-0.82; P = 0.02) respectively. Eight studies, included 1410 participants (726 consuming probiotics, 657 consuming placebo, 27 lost to follow-up), were used for the analysis of safety of probiotics. Of the 8 studies, 4 studies had no AEs caused by probiotics, while another 4 studies reported varying degrees of AEs during their treatment.
Probiotics may have a beneficial effect in prevention of RID generally, especially for Grade ≥2 or 3 diarrhea. Probiotics may be safe and rarely cause severe AEs during treatment.
系统评价和荟萃分析旨在评估益生菌预防宫颈癌放疗诱导性腹泻(RID)的疗效和安全性。之前的研究未能全面分析益生菌在这方面的疗效和安全性。
我们检索了 Cochrane 图书馆、PubMed、EMBASE 和 Web of Science,检索时间截至 2018 年 6 月 4 日。我们还手动检索了之前综述中包含的一些研究。我们的主要结局旨在比较益生菌组和安慰剂组所有常见毒性标准(CTC)分级 RID 和不良事件(AE)的发生率。使用相对风险(RR)及其 95%置信区间(CI)来比较益生菌预防 RID 的疗效,使用固定或随机效应模型估计汇总 RR;异质性用 Cochran Q 和 Higgins I 检验评估。两位审查员独立评估试验质量并提取数据。使用 Review Manager 5.2 对纳入的每项研究进行分析和偏倚评估。
纳入了 9 项随机、安慰剂对照研究(N=1508 名参与者)来评估益生菌的疗效。与安慰剂组相比,益生菌组 RID 的发生率明显更低,RR 为 0.61(95% CI 0.46-0.81;P=0.0007)。此外,在 CTC 分级≥2 和分级≥3 RID 中也观察到了显著的结果,汇总 RR 分别为 0.52(95% CI 0.30-0.98;P=0.02)和 0.32(95% CI 0.12-0.82;P=0.02)。有 8 项研究,包括 1410 名参与者(726 名服用益生菌,657 名服用安慰剂,27 名失访),用于分析益生菌的安全性。这 8 项研究中,有 4 项研究没有益生菌引起的 AE,而另外 4 项研究在治疗过程中报告了不同程度的 AE。
益生菌对预防 RID 可能有一定的疗效,尤其是对 2 级或 3 级腹泻。益生菌在治疗过程中可能是安全的,很少引起严重的 AE。