非成瘾性镇痛剂丙帕他莫与盐酸哌替啶治疗中等手术后疼痛的双盲对比研究

A controlled double-blind study on the analgesic effect of the none-addictive propacetamol HCl on Moderate postoperative pain

目的 评价非成瘾性镇痛剂丙帕他莫与度冷丁治疗中等手术后疼痛的效果。方法１２０名（年龄１８～７５岁）接受腹部外科，妇科及矫形外科手术后疼痛达到中度或重度的病人参加本研究。研究组用盐酸丙帕他莫（ｐｒｏｐａｃｅｔａｍｏｌ ＨＣｌ）２ｇ溶解稀释静脉滴注，在静脉滴注时肌注生理盐水 １．０ ｍｌ；对照组用甘露醇（用作安慰剂，ｄｕｍｍｙ ｄｒｕｍ）１．６ ｇ溶解稀释静脉滴注，在静脉滴注开始时肌注盐酸哌替啶（ｄｏｌａｎｔｉｎ用作对照）５０ ｍｇ（１．０ ｍｌ）。按随机双盲原则进行治疗，每个病例的用药观察期为６小时。结果与结论 研究期间均未出现明显不良反应，也无皮疹发生。按盲后显示盐酸丙帕他莫和盐酸哌替啶具有相似的安全性和有效性。但盐酸丙帕他莫不具有成瘾性，作为中等手术后镇痛药有广泛的应用前景。

To compare the analgesic effect of the noneaddictive Propacetamol HC1 with that of Dolantin (Pethidine HC1) on moderate postoperative pain. Methods 120 patients aged 18 ?75 years old were enrolled in this study, whose postoperative pain reached moderate to severe level after abdominal surgery, gynecol6gic surgery or orthopedic surgery. In the study group, 2 g Propacetamol HC1 was diluted and infused intravenously while at the same time 1.0 ml saline was injected intramuscularly; in the control group, 1.6 g mannitol as dummy drug was diluted and infused intravenously while at the same time 50 mg (1.0 ml) Dolantin was injected intramuscularly. Treatment was carried out randomly and double-blindly with the observation period of 6 hr in each case. Results & Discussion There was no obvious adverse reaction or erythra during the study period. After decoding as planed, it was shown that Propacetamol HC1 and Pethidine HC1 had the similar safety and efficacy. Since propacetamol HCl is none-addictive, it will have a future of wide application as analgesic for moderate postoperative pain.