地佐辛注射液用于镇痛的随机双盲对照临床试验  

Randomized and double- blind controlled clinical trial of dezocine injection for analgesia

作　　者：孙莉[1] 徐国柱[1] 沈黎阳[1] 邓艳萍[1] 朱天岳[2] 谢启伟[3] 王杰军[4] 谢广茹[5] 时杰[1] 

机构地区：[1]北京大学中国药物依赖性研究所,北京100191 [2]北京大学第一医院骨科,北京100034 [3]北京大学人民医院普外科,北京100044 [4]上海长征医院肿瘤科,上海200003 [5]天津市肿瘤医院,天津300060

出　　处：《中国临床药理学杂志》2014年第4期312-314,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价地佐辛注射液用于镇痛的有效性和安全性。方法用多中心、随机、双盲、平行对照的方法,单次给药以度冷丁注射液为对照药,7 d给药以硫酸吗啡注射液为对照药,试验药均为地佐辛。140例手术后中、重度疼痛患者,试验组70例,单次肌注地佐辛2支(5 mg·mL-1);对照组70例,肌注度冷丁和安慰剂各1支。56例癌性疼痛患者,试验组(31例)肌注地佐辛,每次2支;对照组(25例)肌注硫酸吗啡和硫酸吗啡模拟药,各1支,均每日4次,连续给药均7 d。以疼痛强度差(PID)作为镇痛效果主要疗效判定指标。结果地佐辛和度冷丁用于手术后疼痛以及地佐辛和吗啡用于慢性癌性疼痛,试验组与对照组PID值的差异无统计学意义。不良反应主要有恶心、呕吐、头晕等。结论地佐辛可治疗各种手术后引起的急性中、重度疼痛和慢性癌性疼痛,临床镇痛效果和不良反应与吗啡相似。Objective To evaluate the efficacy and safety of dezocine injection for analgesia.Methods A multicenter , randomized , double blind, parallel group controlled study was performed with dezocine as the test drug , and pethidine injection and morphine injection as positive con-trol for the single treatment and 7 days treatment of moderate and severe pain , respectively.The test drug was dezocine injection.One hundred of forty patients with postoperative moderate and severe pain received single treatment with dezocine （ single injection of dezocine , n=70 ） or pethi-dine （ single injection of pethidine and placebo , n =70 ）.Fifty -six cancer pain patients received 7 days treatment with dezocine or morphine as follows：the test group was intramuscularly injected two dezocines each time （ n=31 ） , and the control group was injected morphine and moe-phine simulation respectively （ n=25 , four times a day ） .Pain intensity difference （ PID） was evaluated as the primary analgesic effect criteria.Results There was no significant difference in PID between the test group and the control one both in the controlled trail of postoperative pain and that of chronic cancer pain.The most common adverse reactions of dezocine were nausea , vomiting and dizziness , et al.Conclusion The analgesic effect and adverse effects of dezocine were similar to those of morphine , which indicats dezocine is an effective and safe analgesic for postoperative pain and chronic cancer pain that are moderate and severe.

关 键 词：地佐辛 度冷丁 吗啡 镇痛药 

分 类 号：R971.2[医药卫生—药品] R969.4[医药卫生—药学]