右酮洛芬胶囊用于镇痛的随机双盲对照临床试验  

A RANDOMIZED AND DOUBLE-BLIND CONTROLLED CLINICAL TRIAL OF DEXKETOPROFEN FOR ANALGESIA

作　　者：孙莉[1] 邓艳萍[1] 沈黎阳[1] 朱天岳[2] 张伟滨[3] 曹斌融[4] 徐国柱[1] 

机构地区：[1]北京大学中国药物依赖性研究所,北京100083 [2]北京大学第一医院骨科,北京100034 [3]上海第二医科大学瑞金医院骨科,上海200003 [4]上海复旦大学医学院附属妇产科医院,上海200003

出　　处：《中国药物依赖性杂志》2007年第5期349-354,366,共7页Chinese Journal of Drug Dependence

摘　　要：目的:评价右酮洛芬(dexketoprofen)胶囊的临床镇痛效果和不良反应。方法:采用多中心随机双盲平行对照的方法,以酮洛芬(ketoprofen)胶囊为对照药,用于治疗轻、中度疼痛;1d给药用于治疗痛经,一周给药用于治疗骨科慢性疼痛。以疼痛强度差(PID)、疼痛缓解率(PAR)、有效率等作为镇痛效果判定指标。结果:治疗痛经时,试验组与对照组PID值的差异无统计学意义。用于骨科慢性疼痛时,用药后PID增加,用药4d后PID值基本稳定,试验组与对照组PID值的差异无统计学意义。1d给药和一周给药试验组与对照组的完全缓解率、明显缓解率组间差异均无统计学意义。1d给药和一周给药的试验组与对照组的总有效率都在90%以上;两组总有效率差值的95%置信区间在(-15.0%,15%)等效界值内,表明试验药与对照药等效。不良反应主要有胃不适、恶心等。结论:右酮洛芬为治疗轻、中度疼痛的镇痛药。其不良反应较轻。25mg的右酮洛芬与50mg酮洛芬镇痛效果等效。Objective： To evaluate the clinical analgesic effect and adverse reactions of dexketoprofen capsule. Methods： A multicenter, randomized, double blind, parallel group controlled study was performed, with dexketoprofen as the test drug and ketoprofen capsule as positive control for the treatment of light and moderate pain. Patients with dysmenorrhea were treated with one day administration and patients with chronic ache of orthopedics were treated with one week administration. Pain intensity difference（ PID）, pain relief（ PAR）, and efficiency rate were evaluated as analgesic effect criteria. Results：In the controlled trial of dysmenorrheal patients, there was no significant difference between the test group and the control. In the controlled trial of chronic orthopedics pain, the PID value increased after drug administration, and then became stable after 4 d, showing no significant difference between the two groups. There was no significant difference between the two groups in complete PAR and obvious PAR. The total efficacy rate, obtained from both groups of one - day and one - week administration, was above 90%. The 95% confidence interval of the total efficacy rate difference between two groups was among（ - 15.0%, 15% ）, indicating that the test drug and the control was equivalent.The most common adverse reactions of dexketoprofen were stomach upset and nausea. Conclusion： Dexketoprofen capsule was an effective and safe analgesic for light and moderate pain. The analgesic effect of 25 mg dexketoprofen is equal to that of 50 mg ketoprofen

关 键 词：右酮洛芬 酮洛芬 镇痛药 临床试验 

分 类 号：R756[医药卫生—皮肤病学与性病学]