摘要
目的：评价国产托特罗定治疗膀胱活动过度的疗效和安全性。方法：采用多中心、随机、双盲、双模拟平行对照方法，实验组 １０１例，托特罗定 ２ｍｇ ｂｉｄ，共 ６周；对照组 １０５例，奥昔布宁 ５ｍｇ ｂｉｄ，共 ６周。于治疗前和治疗后 ６周测２４ｈ平均排尿次数，２４ｈ平均排尿量及２４ｈ平均尿失禁次数，比较两者的结果及药物不良反应。结果：托特罗定治疗后， ２４ｈ平均排尿次数由 １２１６ ± ３．４４减至７．１５±１．７８， ２４ｈ平均每次排尿量从１１７．９７±３１．８４ｍｌ增至２１３．２３±７４．７２ｍｌ， ２４ｈ平均尿失禁次数从２９８±２．４５减至０．０６±０．３１，与治疗前比较差异非常显著，与奥昔布宁比较无显著性差异。托特罗定药物不良反应发生率３２．６８％，中度占不良反应的２７．２７％；奥普布宁分别为５５．２４％和３９．６６％，两者差异非常显著。结论：国产托特罗定与奥昔布宁比较，疗效相当，药物不良反应少，是治疗胰胱活动过度的更安全、有效的药物。
OBJECTIVE: To evaluate the efficacy and safety of tolterodine in the treatment of overactive bladder. METHODS: A multicenter, randomized, doubleblind,double-imitated, and parallel trial was conducted. Mean No.of micturitions/ 24h, mean volume voided per micturition/24h and mean No.of incontinent episodes/ 24h were assessed in 206 patients with overactive bladder to establish baseline values. 101 patients of them as study group were treated with tolterodine 2mg twice daily and another 105 as control received oxybutynin 5mg twice daily. After 6 weeksi treatment,changes in the variables above,were reassessed and the results together with adverse events in and between two groups were compared. RESULTS: Mean No.of micturitions/24h were decreased to 7. 1 5 ± 1 .78,mean volume voided per micturitions/24h were increased to 213.23 ± 74.72ml and mean No.of incontinent episodes/24h were decreased to 0.06 ± 0.31 in study group. The differences were so significant from the baseline. Even so the results were no significant difference from those of control. The appearance ratio of the adverse events was 32.67% and those of moderate intensity out of all adverse events was 27.27% in study group and those of control were 55.24% and 39.66% respectively. There were so significant differences between two groups. CONCLUSION : Compared with oxybutynin, domestic tolterodine has comparable efficacy and lower adverse events. This agent is better tolerated and effective for the treatment of overactive bladder.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2001年第2期83-86,共4页
The Chinese Journal of Clinical Pharmacology
