阿洛司琼治疗男女肠易激综合征的疗效和耐受性:8项随机、安慰剂对照、12周试验的荟萃分析
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Rahimi R, Nikfar S, Abdollahi M
阿洛司琼治疗男女肠易激综合征的疗效和耐受性:8项随机、安慰剂对照、12周试验的荟萃分析
中华临床杂志，2008;30(5):884-901。doi: 10.1016 / j.clinthera.2008.05.002。
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18555935 (PubMed视图］
- 摘要
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背景:受刺激的5-羟色胺-3 (5-HT(3))受体促进肠道运动、分泌和感觉，这些作用与肠易激综合征(IBS)的已知病理生理学有关。先前对5-HT(3)受体拮抗剂阿洛司琼的6项随机对照试验的荟萃分析发现，该药物与IBS患者的症状、疼痛和不适的整体改善有关。目的:这是一项随机、安慰剂对照试验的荟萃分析，评估阿洛司琼治疗IBS的疗效和耐受性。它更新并扩展了之前的荟萃分析。方法:检索PubMed、EMBASE、SCOPUS、Web of Science和cochrane中央对照试验注册库(central Register of controlled Trials)，从1966年到2007必威国际app年9月，检索检验阿洛司琼治疗IBS疗效和耐受性的安慰剂对照试验。搜索词是必威国际app阿洛司琼，5-羟色胺，肠易激，功能性肠病和肠易激。没有使用语言限制。数据根据两个主要结果进行分析:IBS症状的全面改善和IBS疼痛和不适的充分缓解。结果:8个多中心、随机、安慰剂对照、为期12周的临床试验符合纳入meta分析的标准。研究包括4170名肠易激综合征患者(80%为女性)，随机接受阿洛司琼或安慰剂治疗。 All patients met the Rome criteria for IBS, and all subtypes of IBS were represented. Most patients had diarrhea-predominant IBS; only 2.6% of patients had constipation-predominant IBS. In the 3 trials included in the analysis of global improvement in symptoms, alosetron was significantly more effective than placebo (relative risk [RR] = 1.60; 95% CI, 1.44-1.76; P <0.001). In the 6 trials included in the analysis of adequate relief of IBS pain and discomfort, there was also a significant difference in favor of alosetron (RR = 1.31; 95% CI, 1.20-1.43; P < 0.001). Analysis of adequate relief of IBS pain and discomfort by sex also indicated significant differences between alosetron and placebo in both sexes (female: RR = 1.34 [95% cI, 1.21-1.48]; male: RR = 1.23 [95% CI, 1.02-1.47]). The analysis of tolerability, which was based on data from 7 studies, found a significant difference between alosetron and placebo (RR = 1.19; 95% cI, 1.07-1.31; P<0.001). The only adverse events that occurred with a significantly higher incidence in those treated with alosetron compared with placebo were constipation in 8 trials (RR = 4.35; 95% CI, 3.01-6.26; P < 0.001) and abdominal pain and discomfort in 5 trials (RR = 1.96; 95% CI, 1.46-2.64; P < 0.001). In the alosetron group, there were 4 cases of ischemic colitis (0.16%) and 2 cases of serious complications of constipation (0.08%); neither of these was reported in the placebo group. Alosetron was not associated with any deaths. CONCLUSIONS: Alosetron was effective in these men and women with IBS. constipation was the most frequently reported adverse event associated with alosetron therapy. Ischemic colitis and serious complications of constipation were reported in a small number of patients treated with alosetron.