替加色罗治疗肠易激综合征的系统评价

目的 评价替加色罗治疗肠易激综合征(irritable bowel syndrome,IBS)的有效性和安全性.方法 对替加色罗治疗便秘型或非腹泻型IBS的随机对照试验(RCTs)进行系统评价.结果 共纳入13项RCTs,7 189例患者.替加色罗12 mg/d和4 mg/d对总体IBS症状的改善均优于安慰剂;对腹痛/腹部不适症状的缓解与安慰剂比无显著差异;对腹胀的疗效,各研究结果不一致;腹泻发生率显著高于安慰剂,替加色罗组报道了2例缺血性心脏病,严重不良事件的发生率与安慰剂比无显著差异.结论 替加色罗能改善便秘型或非腹泻型IBS患者的总体症状;缓解腹痛/腹部不适和腹胀等症状的证据不足;腹泻是替加色罗的主要不良反应.

Tegaserod for the treatment of irritable bowel syndrome: a systematic review

Objective To assess the effectiveness and safety of tegaserod in the treatment of patients with irritable bowel syndrome(IBS).Methods A systematic review of randomized controlled trials(RCTs)of tegaserod for constipation predominant or non-diarrhoea predominant IBS was performed.Trials were identified by searching MEDLINE,EMBASE,the Cochrane Library,Chinese Biological Medicine Database,CNKI Chinese Journal Full-Text Database and the USA Food and Drug Administration(http://www.fda.gov).Results Thirteen trials involving 7 189 patients were included.For the patients with constipation predominant IBS,the responder rates for the Subjects Global Assessment(SGA)of relief at endpoint were significantly higher with tegaserod 12 mg(OR 1.33,95%CI=1.15-1.53)and 4 mg(OR 1.25,95%CI=1.03-1.53)compared with placebo,with a number needed to treat(NNT)of 14 and 20 respectively.For the patients with non-diarrhoea predominant IBS,the proportion of patients with overall satisfactory relief was greater in the tegaserod group than that in the placebo(OR 1.77,95%CI=1.39-2.26,NNT=8).Tegaserod did not significantly improve the symptom of abdominal pain/discomfort.The OR was 1.22(95%CI=0.86-1.73)and 1.14(95%CI=0.77-1.69)in tegaserod 12 mg and 4 mg compared with placebo,respectively.Effects of tegaserod on bloating were not consistent across the studies.Some GI symptoms such as number of bowel movements and stool consistency were improved with tegaserod.Diarrhoea was significantly higher in the tegaserod group compared with placebo(OR 3.40,95%CI=2.51-4.61),with a number needed to harm(NNH)of 17.Two patients with coronary artery disease were reported in the tegaserod group.There was no significant difference in serious adverse events between the tegaserod and placebo groups.The OR was 0.74(95%CI=0.35-1.58).Conclusions Tegaserod is an effective in relieving global IBS symptoms for patients with non-diarrhoea predominant IBS,but it might not improve symptoms of abdominal pain/discomfort and bloating.The major side-effect is diarrhoea.