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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 2次能
Objectives To evaluate the efficacy and safety of tegaserod 6 mg twice daily in the treatment of constipation-predominant irritable bowel syndrome (C) by patients’ overall assessment of the symptoms of irritable bowel syndrome (IBS) and individual assessment of each IBS symptom as well as adverse reaction observations IBS) efficacy and safety. Methods This study was a multicenter, randomized, double-blind, parallel, placebo-controlled clinical study. A total of 51 0 CIBS patients with Roman II criteria were enrolled in this study. The trial consisted of 8 weeks of baseline, 2 weeks of baseline, tegaserod 6 mg twice daily or placebo for 4 weeks (tegaserod: placebo = 1: 1 ) Randomized, double-blind treatment and 2-week withdrawal follow-up. Assessment criteria: Overall assessment of the patient’s overall IBS symptoms was performed and each patient’s IBS parameters (including the severity of constipation) and safety were assessed. Results The main efficacy parameters of overall IBS symptoms in tegaserod patients were significantly improved from week 1 to the entire treatment period. The other IBS efficacy parameters (such as constipation, abdominal pain, abdominal discomfort, bloating) in the tegaserod group were still superior to those in the placebo group from the first week to the full treatment period. Tegaserod shows more obvious effect. In the discontinuation follow-up period, the curative effect scores of tegaserod and placebo group were both decreased, but still improved compared with the baseline, but the curative effect of the former was better than the latter, suggesting that tegaserod The efficacy can be sustained at least 2 weeks after discontinuation. The rates of adverse events in the tegaserod and placebo groups were 10% and 6%, respectively. The most common adverse events in the tegaserod group were diarrhea, abdominal pain and dizziness, but the incidence was low (<3%). Laboratory tests found no abnormalities. Conclusion Tegaserod 6mg 2 times a day can