奥曲肽防治肿瘤放化疗相关性腹泻的系统评价

Prophylactic and therapeutic role of octreotide in controlling chemoradiotherapy-induced diarrhea:A systematic review

目的：系统评价奥曲肽防治放化疗相关性腹泻的有效性和安全性。方法：采用计算机检索Cochrane Library、美国Clinical Trials数据库、Pub Med、EMBase、Science Direct、中国期刊全文数据库（Chinese Journal Full-text Database,CJFD）、中国生物医学文献数据库（Chinese Bio Medical Literature Database,CBM）和万方数据库,同时结合人工检索,检索时间为建库起至2015年3月。由2位评价员根据纳入/排除标准分别对文献进行筛选,提取文献资料,评价方法学质量。应用Rev Man5.2.5软件进行Meta分析。结果：纳入7项随机对照试验,共包含625例患者。在预防放化疗相关性腹泻方面,奥曲肽与安慰剂的差异无统计学意义[比值比为0.95（95%可信区间：0.65～1.39）;P=0.80]。在治疗放化疗相关性腹泻方面,奥曲肽明显优于洛哌丁胺[比值比为6.53（95%可信区间：3.03～14.09）;P〈0.000 01],说明奥曲肽治疗放化疗腹泻的效果更好。其中,在治疗化疗相关性腹泻[比值比为11.10（95%可信区间：3.52～34.98）;P〈0.000 1]、预防化疗相关性腹泻[比值比为1.15（95%可信区间：0.52～2.55）;P〉0.05]、治疗放疗相关性腹泻[比值比为3.78（95%可信区间：1.28～11.18）;P〈0.05]及预防放疗相关性腹泻[比值比为0.90（95%可信区间：0.58～1.39）;P=0.63]方面,奥曲肽的治疗效应均优于预防效应。奥曲肽的不良反应主要包括恶心、呕吐、注射部位局部疼痛及腹部轻度疼痛等。本次Meta分析纳入的研究均无患者因出现严重不良反应而影响治疗的报道。结论：奥曲肽治疗放化疗相关性腹泻疗效显著,但预防作用并不明显,与化疗还是放疗无关,且安全性较好。

Objective： To evaluate the efficacy and safety of octreotide in prevention and/or treatment of chemoradiotherapy-induced diarrhea.Methods： Cochrane Library, ClinicalTrials, PubMed, EMBase, ScienceDirect, Chinese Journal Full-text Database （CJFD）, Chinese BioMedical Literature Database （CBM） and Wanfang Data were searched. All databases had been searched up to 25th March 2015. In accordance with the inclusion and exclusion criteria for selecting research literatures, two reviewers independently selected the studies, extracted data, and assessed the quality of included studies. RevMan5.2.5 software was used for Meta-analysis.Results： A total of seven randomized controlled trials （RCTs）including 625 patients were involved in this Meta-analysis. When divided into prophylactic and therapeutic subgroups, in the prophylactic subgroup, the overall response rate （ORR） of diarrhea in octreotide group was not significantly different from that in the control group [odds ratio： 0.95 （95% confidence interval： 0.65-1.39）; P = 0.80]; in the therapeutic subgroup, the ORR of diarrhea in octreotide group was significantly higher than that in Ioperamide group [odds ratio： 6.53 （95% confidence interval： 3.03-14.09）; P 〈 0.000 01]. The therapeutic efficacy of octreotide was significantly higher as compared with its prophylactic efficacy. For treatment of chemotherapy-induced diarrhea [odds ratio： 11.10 （95% confidence interval： 3.52-34.98）; P 〈 0.0001 ], prevention of chemotherapy-induced diarrhea [odds ratio： 1.15 （95% confidence interval： 0.52-2.55）; P 〉 0.05], treatment of radiotherapy-induced diarrhea [odds ratio： 3.78 （95% confidence interval： 1.28-11.1 8）; P 〈 0.05] and prevention of radiotherapy-induced diarrhea [odds ratio： 0.90 （95% confidence interval： 0.58-1.39）; P = 0.63], octreotide was a therapeutic agent rather than a prophylactic agent against diarrhea. The adverse reactions induced by octreotide included nausea, vomiting, pain in the site of injection and mild abdominal pain. No severe side effects were reported in seven studies.Conclusion： Based on current evidence, octreotide seems to have beneficial effect in prophylaxis and therapy of chemoradiotherapy-induced diarrhea and has a good tolerance.