摘要
目的 :评价国产马来酸曲美布汀 (诺为 )治疗功能性消化不良的安全性和疗效。方法 :采用多中心、开放性试验 ,选择在最近一年内具有早饱或上腹胀 ,可伴有恶心、呕吐、上腹痛、烧心、厌食、嗳气等症状 ,持续或间断发作超过 12wk以上的病人 ,予诺为(普利马来酸曲美布汀片 ,2 0 0mg/片 ,一天三次 ,口服 2wk)。治疗前后分别记录一次以下症状 ,包括早饱、上腹胀、恶心、呕吐、上腹痛、烧心、厌食、嗳气、纳差等症状。症状按无、轻、中、重分级。同时治疗前后各检查一次血、尿、粪常规和肝肾功能。结果 :治疗 2wk后 86例的总改善率为 (6 7.6 4± 2 3.91) %早饱和上腹胀满等其它症状都有非常显著的改善(P <0 .0 1)。主要症状中的早饱为 72 .2 %,上腹胀满为 84 .7%,不良反应发生率为 3.4 9%。结论 :马来酸曲美布汀 (诺为 )治疗功能性消化不良是安全有效的。
AIM: To evaluate the efficacy and safety of domestic trimebutine in the treatment of functional dyspepsia. METHODS: As an open multicenter study, the inclusion criteria were the patients with early satiety and bloating which might accompany with nausea, vomiting,abdominal pain, heartburn, anorexia, belch, and the duration >12 weeks. Trimebutine was used in these patients for 2 weeks. The symptoms,including nausea, vomiting, abdominal pain, heartburn, early satiety and bloating, anorexia, belch, and bad apetite were observed before and after the treatment. The degree of above symptoms were classified into no, mild, moderate and severe. The some aboratory indexes were also tested before and after the treatment. RESULTS: 86 patients completed the whole study by per protocol analysis. The total improved rate were ( 67.64± 23.91)%. There had significant improvement for the main symptoms like early satiety and bloating (P< 0.01). The effective rate of early satiety was 72.7%, bloating was 84.7%, and the rate of side effect was 3.49%. CONCLUSION: Domestic trimebutine is effective and safe to treat functional dyspepsia.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2002年第2期150-152,共3页
Chinese Journal of Clinical Pharmacology and Therapeutics
