盐酸替利定口服液用于镇痛的随机双盲对照临床试验  

Randomized and double-blind controlled clinical trial of tilidine hydrochloride oral solution for analgesia

作　　者：孙莉[1] 李潇潇[1] 梁军成[1] 朱天岳[2] 谢启伟[3] 刘端祺[4] 谢广茹[5] 徐国柱[1] 邓艳萍[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]北京军区总医院,北京100700 [5]天津市肿瘤医院,天津300060

出　　处：《中国临床药理学杂志》2013年第1期6-8,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价盐酸替利定口服液的有效性和安全性。方法用多中心随机双盲平行对照方法,以盐酸吗啡片为对照药。144例手术后中、重度疼痛的患者分为2组,试验组(73例)口服替利定1支和安慰剂1片;对照组(71例):安慰剂1支和吗啡1片。58例癌性疼痛患者分为2组,试验组(26例)口服替利定每天2支×4次,同时口服安慰剂;对照组(32例)口服吗啡每天2片×4次,同时口服安慰剂,疗程均5天。以疼痛强度差(PID)作为镇痛效果主要疗效判定指标。结果术后与癌性的疼痛患者,试验组与对照组PID值的差异均无统计学意义。药物不良反应主要有头晕、恶心、呕吐等。结论替利定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,与吗啡相似,是一种强效、安全的镇痛药。Objective To evaluate the efficacy and safety of tilidine hydrochloride oral solution for analgesia. Methods A multicenter, randomized, double blind, parallel group controlled study was performed with tilidine as the test drug and morphine hydrochloride tablets as control for the treatment of moderate and severe pain. One hundres fourty - four postoperative pain patients were received single treatment with tilidine （ single oral tilidine and morphine placebo, n = 73 ） or morphine （ single oral morphine and tilidine placebo, n = 71 ）. Fifty eight cancer patients were received 5 days treatment with tilidine or morphine. 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 tilidine were dizziness, nausea and vomiting et al. Conclusion The analgesic effect and adverse effects of tilidine were similar to that of morphine, which indicated tilidine was an effective and safe analgesic for postoperative pain and chronic cancer pain that were moderate and severe pain.

关 键 词：替利定 吗啡 镇痛药 

分 类 号：R971.1[医药卫生—药品] R619[医药卫生—药学]