复方磷酸可待因片镇痛效果的多中心临床评价

CLINICAL EVALUATION OF ANALGESIC EFFECT OF COMPOUND CODEINE PHOSPHATE TABLETS

目的 :观察复方磷酸可待因片的临床镇痛效果和不良反应。方法 :采用多中心随机双盲对照试验和开放试验设计。以氨酚待因为对照药 ,设单次给药、3d给药、1周给药组 ;分别用于治疗牙痛、痛经、神经性头痛、癌痛和骨科慢性疼痛。镇痛效果评定指标为疼痛强度差、总疼痛强度差、疼痛缓解率、有效率。结果 :复方磷酸可待因片与氨酚待因片的效果基本一致 ,其不良反应较低 ,主要为胃不适、头晕和嗜睡等。结论

Objective : To evaluate the analgesic effect and safety of compound codeine phosphate tablets. Methods : A multicenter, randomized, double blind, parallel group controlled study was performed in 70 patients with dental pain and 60 patients with headache . Paracetamol codeine tablets were used as positive control . An open study was performed in 30 patients with chronic cancer pain,20 patients with chronic non-cancer pain and 20 patients with menorrhalgia . Results : Compound codeine phosphate tablets were effective in the control of moderate pain. There was no significant difference between compound codeine phosphate tablets and paracetamol codeine tablets . The adverse reaction of compound codeine phosphate tablets and paracetamol codeine tablets showed similar profile . They were stomach upset, dizziness and drowsiness. Conclusion : Compound codeine phosphate tablet is an effective and safe analgesic for moderate pain.