厄多司坦辅助治疗呼吸道感染109例的多中心随机双盲Ⅱ期临床试验  

Erdosteine in adjuvant treatment of respiratory tract infection:a multicenter randomized double-blind controlled phase Ⅱ clinical trial

作　　者：苏欣[1] 施毅[1] 谢增华[1] 宋勇[1] 李玉[2] 姜淑娟[3] 赵蓓蕾[1] 申萍[1] 张晓琳[1] 

机构地区：[1]南京军区南京总医院呼吸科,江苏南京210002 [2]山东大学齐鲁医院国家药品临床研究基地,山东济南250012 [3]山东省立医院国家药品临床研究基地,山东济南250021

出　　处：《中国新药与临床杂志》2004年第7期397-400,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的 :评价厄多司坦胶囊辅助治疗呼吸道感染的临床疗效和安全性。方法 :呼吸道感染病人2 18例 ,按多中心随机双盲对照试验设计分成 2组。厄多司坦组 10 9例 ,口服厄多司坦胶囊 ,30 0mg,bid ,羧甲司坦组 10 9例 ,口服羧甲司坦片 ,5 0 0mg,tid ,疗程均 5～ 7d。结果 :厄多司坦组和羧甲司坦组病人黏痰消失率为 5 6 .0 %和 6 6 .1% ,咳痰消失率为 6 6 .1%和 74 .3% ,咳嗽消失率为 32 .1%和4 5 .0 % ;综合疗效分析 ,临床控制率为 6 6 .1%和6 4.2 % ,有效率为 86 .2 %和 78.0 % ,2组比较差异无显著意义 (P >0 .0 5 )。 2组不良反应发生率均较低且无显著差异 (3.7%vs 2 .8% )。结论 :厄多司坦胶囊辅助治疗呼吸道感染有效且安全。AIM: To evaluate the efficacy and safety of erdosteine capsule in adjuvant treatment of respiratory tract infection(RTI). METHODS: Two hundred and eighteen patients with RTI were divided into two groups according to multicenter randomized,double-blind and controlled study. One hundred and nine patients of erdosteine group were treated with erdosteine capsule, 300 mg , bid,for 5- 7 d,109 patients of carbocisteime group were treated with carbocisteine tablet, 500 mg ,tid for 5- 7 d . RESULTS: The rate of the mucous sputum clearance was 56.0 % and 66.1 %,respectively;the rate of the sputum disapearance was 66.1 % and 74.3 % respectively;the rate of the cough disapearance was 32.1 % and 45.0 %,respectively. No significant difference was found between two groups( P > 0.05 ). There was no significant difference in the rate of overall efficiency between two groups ( 86.2 % vs 78.0 % , P >0.05 ). It was seldom to find the adverse reactions in both groups ( 3.7 % vs 2.8 % , P > 0.05) . CONCLUSION: Erdosteine is effective and safe for adjuvant treatment of RTI.

关 键 词：呼吸道感染 随机对照试验 多中心研究 厄多司坦 羧甲司坦 

分 类 号：R974.1[医药卫生—药品] R56[医药卫生—药学]