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本研究双盲随机对118例患者应用西沙必利10 mg tid或安慰剂,进行4周试验。器质性病变尤其是消化性溃疡、胆结石及慢性胰腺炎均预排除,侵蚀性幽门前病变亦被除外。两组病人的性别、年龄、体重及症状均可比。治疗后症状全部消失者其疗效评为优,仅少数症状改善为良,轻度改善但某些症状持续存在为中,无改善为无效或阴性(恶化)。结果表明,总的症状改善率,治疗2周后优或良者安慰剂为28%,而西沙必利为65%(P<0.001),4周后分别为31%及81%(P<0.001)。全部症状的强度,2周后西沙必利比安慰剂显著减轻(P<0.01),4周后更显著
This study randomized 118 patients to either cisapride 10 mg tid or placebo at a double-blind, randomized, 4-week trial. Organic disease, especially peptic ulcer, gallstone and chronic pancreatitis were pre-excluded, erosive pyloric lesions were also excluded. The two groups of patients sex, age, weight and symptoms are comparable. After treatment, all the symptoms disappeared were evaluated as excellent, only a few symptoms improved well, mild improvement, but some of the symptoms persisted as medium, without improvement as invalid or negative (worsening). The overall symptomatic improvement rate was 28% for superior or placebo versus 2 weeks after treatment, compared with 65% for cisapride (P <0.001) and 31% and 81% for 4 weeks (P <0.001, respectively) ). The intensity of all symptoms was significantly lower with cisapride than placebo after 2 weeks (P <0.01) and more pronounced after 4 weeks