疗效和耐受性alosetron治疗肠易激综合症的女性和男性:一个荟萃分析的八个随机、安慰剂对照,12周的试验。
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拉希米R, Nikfar年代,Abdollahi M
疗效和耐受性alosetron治疗肠易激综合症的女性和男性:一个荟萃分析的八个随机、安慰剂对照,12周的试验。
未来。2008,(5):884 - 901。doi: 10.1016 / j.clinthera.2008.05.002。
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18555935 (在PubMed]
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背景:刺激5-hydroxytryptamine-3(5 -(3)受体促进肠道蠕动,分泌,和感觉,效果相关的已知的肠易激综合征(IBS)的病理生理学。之前的6个随机对照试验的荟萃分析5 -(3)受体拮抗剂alosetron发现这个代理是与全球改善症状,疼痛,IBS患者和不适。目的:这是一个荟萃分析的随机、安慰剂对照试验,评估疗效和耐受性的alosetron IBS的管理。它更新和扩展以前的荟萃分析。方法:PubMed和EMBASE,斯高帕斯、网络科学、和cochrane对照试验的中心注册搜索从1966年到2007年9月的安慰剂对照试验检查的有效性和耐受性alosetron在IBS的管理。搜索词alosetron, 5、肠易激,功能性肠道疾病和过敏性结肠。没有语言限制应用。数据分析的两个主要结果:全球改善IBS症状和肠易激综合症得到充分缓解的疼痛和不适。结果:8个多中心、随机、安慰剂对照,12周的临床试验符合入选标准的荟萃分析。研究包括4170名IBS(女80%)患者被随机分配接受alosetron或安慰剂。 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.