酒石酸双氢可待因片用于镇痛的随机双盲对照临床试验  

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

作　　者：沈黎阳[1] 邓艳萍[1] 徐国柱[1] 朱天岳[2] 张璐芳[3] 王杰军[4] 

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]北京大学第三医院妇产科,北京100083 [4]上海长征医院肿瘤科,上海200003

出　　处：《中国药物依赖性杂志》2004年第2期115-120,共6页Chinese Journal of Drug Dependence

摘　　要：目的 :评价国产Ⅳ类新药双氢可待因片的临床镇痛效果和药物不良反应。方法 :采用多中心随机双盲平行对照的方法 ,以磷酸可待因片为对照药 ;用单次给药治疗术后疼痛 ;多次给药治疗癌痛。以疼痛强度差、总疼痛强度差、疼痛缓解率、有效率等为镇痛效果判定指标。结果 :用于术后疼痛时 ,试验组各时点的疼痛强度差均高于对照组 ,用药后 1h两组疼痛强度差的差异有显著性 (P <0 0 5 ) ;用药后 6h两组中度以上缓解度的差异有显著性 (P <0 0 5 )。用于癌痛时 ,在试验组患者的平均体重明显大于对照组 (P <0 0 5 ) ,而平均用药剂量无明显差异的情况下 ,两组镇痛效果差异无显著性 ,即表明试验药的镇痛效果略强于对照药。两药最常见的不良反应均为便秘、恶心和胃不适。结论 :双氢可待因片是安全有效的二阶梯镇痛药。Objective: To evaluate the clinical analgesic effect and adverse reactions of dihydrocodeine tartrate tablets. Methods: A multicenter, randomized, double blind, parallel group controlled study was performed in 64 patients with postoperative pain and 61 patients with cancer pain. Codeine phosphate tablets were used as positive control. The patients with post-operative pain were given single dose dihydrocodeine tartrate (30 mg) or codeine phosphate (30 mg) by means of double-blind methods. The patients with cancer pain were given dihydrocodeine (30-60 mg) or codeine phosphate (30-60 mg) 3 to 4 times daily for 3 to 7 days by means of double-blind methods. Results: In the controlled trial of postoperative pain patients, the PID of test group was greater than that of control group, there was significant difference between the two groups 1 h after administration (P<0.05) and 6 h after administration, there was significant difference between the two groups in 2-4 PAR(P<0.05). In the controlled trial of cancer pain patients, there was significant difference between the two groups in the mean weight (P<0.05). There was no significant difference between the two groups in clinical analgesic effect. The most common adverse reactions of both drugs were constipation, nausea and stomach upset. There was no significant difference in the incidence of them (P>0.05). Conclusion: Dihydrocodeine tartrate tablet is an effective and safe analgesic for moderate pain.

关 键 词：酒石酸双氢可待因片 镇痛作用 随机双盲 镇痛药 磷酸可待因 

分 类 号：R971[医药卫生—药品]