替加色罗治疗便秘型肠易激综合征的多中心临床研究

A randomized, double-blind, placebo-controlled, multicenters study to assess the efficacy and safety of tegaserod in Chinese patients with constipation-predominant irritable bowel syndrome

目的 通过患者对肠易激综合征 (IBS)症状的总体评估和对每个IBS症状的个别评估以及不良反应观察 ,评估替加色罗 6mg每日 2次治疗便秘型肠易激综合征 (C IBS)的疗效与安全性。方法 本研究是一项多中心、随机、双盲、平行、安慰剂对照临床研究。入选 51 0例符合罗马Ⅱ标准的C IBS患者 ,试验为期 8周 ,包括 2周基线期 ,4周替加色罗 6mg每日 2次或安慰剂 (替加色罗∶安慰剂=1∶1 )随机、双盲治疗期及 2周停药随访期。评估标准 :对患者全部IBS症状进行总体评估 ,对患者每个IBS参数 (包括便秘严重程度 )以及安全性进行评估。结果 替加色罗组患者总体IBS症状的主要疗效参数从第 1周开始至整个治疗期均有显著改善。替加色罗组其他IBS疗效参数 (如便秘、腹痛、腹部不适、腹胀 )评分从第 1周开始至整个治疗期仍均优于安慰剂组。说明替加色罗疗效更明显。在停药随访期 ,替加色罗组和安慰剂组各疗效参数评分虽有所降低 ,但相对于基线期仍均有所改善 ,但前者疗效明显优于后者 ,提示替加色罗的疗效至少可持续到停药后 2周。替加色罗组和安慰剂组发生不良事件的比例分别为 1 0 %和 6 %。替加色罗组最常见的不良事件为腹泻、腹痛和头晕 ,但发生率均较低 (<3 % )。实验室检查未发现异常。结论 替加色罗 6mg每日

Objective To determine the efficacy and safety of tegaserod 6 mg b i d in the treatment of constipation predominant irritable bowel syndrome (C IBS) Methods An 8 week, double blind, randomized, parallel group, placebo controlled, multicenter study in 510 Chinese patients who met the Rome Ⅱ criteria for C IBS The study consisted of a 2 week baseline period, a 4 week randomized, double blind treatment period with either tegaserod 6 mg b i d or placebo (tegaserod∶placebo =1∶1), followed by a 2 week withdraw period. Efficacy was assessed by patient′s perception of overall symptoms of IBS during the previous week and severity of the patient′s constipation during the last week and patient′s assessment of their individual IBS symptoms Safety was assessed by adverse events, laboratory evaluations, blood pressure and heart rates, Physical examination and ECG evaluations Results The weekly severity of patients′ perception of overall IBS symptoms was significantly lower in the tegaserod group from week 1 onwards and throughout the treatment period The effects of tegaserod on secondary IBS efficacy parameters were consistently better in the tegaserod group starting in week 1 and lasting throughout the treatment period and withdraw period Regarding adverse events during the treatment period, about 10% of the patients in the tegaserod group experienced an adverse event compared to 6% in the placebo group Diarrhea, abdominal pain and dizziness were more frequent in the tegaserod group but had a low frequency No serious adverse was observed due to tegaserod Conclusions Tegaserod 6 mg b i d was effective in relieving overall IBS symptoms, constipation, abdominal discomfort and pain, bloating , etc with significant effects starting in week 1 and continuing throughout the treatment period Tegaserod was generally well tolerated and has no clinically relevant safety findings.