Randomized and double -blind controlled clinical trial of dezocine injection for analgesia
- VernacularTitle:地佐辛注射液用于镇痛的随机双盲对照临床试验
- Author:
Li SUN
1
;
Guo-Zhu XU
;
Li-Yang SHEN
;
Yan-Ping DENG
;
Tian-Yue ZHU
;
Qi-Wei XIE
;
Jie-Jun WANG
;
Guang-Ru XIE
;
Jie SHI
Author Information
1. 北京大学 中国药物依赖性研究所
- Keywords:
dezocine;
pethidine;
morphine;
analgesic
- From:
The Chinese Journal of Clinical Pharmacology
2014;(4):312-314
- CountryChina
- Language:Chinese
-
Abstract:
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.
