非成瘾性盐酸丙帕他莫术后镇痛疗效的随机双盲对照临床研究

目的 以前瞻性、随机、双盲、对照临床研究,比较非成瘾性盐酸丙帕他莫(普鲁百服宁)注射剂与阳性对照药度冷丁在术后镇痛治疗中的安全性和有效性。方法 胸腹部术后患者完全清醒时,据其对疼痛强度的四级语言表达尺度及视觉模拟尺疼痛强度值的主观陈述,连续选择疼痛达到中度或重度(相当于美国麻醉协会分类为Ⅰ或Ⅱ)的40名40—70岁患者,按随机号生成软件随机分为研究组及对照组。两组患者用药前在年龄、性别、身高／体重指数、病种、手术类型、麻醉方式、麻醉时间、生命体征、肝肾功能、血、尿常规等方面差异均无显著性差异(P=0．06—0．93)。研究组：将溶于100ml生理盐水的盐酸丙帕他莫2g于15min内静脉滴注完,同时予以生理盐水1．0ml(作为度冷丁的安慰剂对照)肌注;对照组：将溶于100ml生理盐水的甘露醇(作为盐酸丙帕他莫的安慰剂对照)1．6g于15min内静脉滴注完,同时肌注度冷丁(作为盐酸丙帕他莫的阳性对照药)50mg(1．0m1)。在给药后6h内观察两组的安全性及有效性指标。待全部病例研究完成、两组患者的安全性及有效性数据全部输入电脑后才揭盲进行统计学处理。结果 两组的“疼痛强度减轻值-时间”曲线下面积差异无显著性(P=0．93),镇痛起效时间(15-30min)及持续时间(6h)相似,镇痛的优良效率一致(90％)。两组仅有轻度不良反应,但无统计学差异(P=0．35)。结论 在术后镇痛方面,非成瘾性盐酸丙帕他莫注射剂2g静脉滴注,与度冷丁50mg肌肉注射同样安全有效。

A randomized,double blind,and controlled clinical trial of the non-addictive propacetamol in postoperative analgesia

OBJECTIVE: To compare the postoperative analgesic efficacy and safety of the non-addictive propacetamol hydrochloride (Pro-Bufferin) injection and dolantin in a prospective, randomized, double blind and controlled clinical trial. METHODS: After the pain intensity was assessed when the patients were undergone thoracic and abdominal selective surgery became fully conscious, 40 consecutive patients with moderate to severe postoperative pain (equivalent to Pain Grade I and II of American Anesthesia Association classification) were randomized into the study against the control groups. The two groups were similar for age, sex, height/weight, disease categories, operation categories, anesthesia methods and duration, vital signs, hepatorenal function, and blood cell count (P = 0.06-0.93). In the study group, 2 g propacetamol in 100 ml normal saline (NS) intravenously with 1.0 ml NS intramuscularly as the placebo control to dolantin were administered. In the control group, 1.6 g mannitose in 100 ml NS intravenously as the placebo control to propacetamol with 50 mg dolantin (1.0 ml) intramuscularly as the positive control to propacetamol were administered. The intensity change of postoperative pain was then evaluated 10 times with visual analog scale and verbal describing scale during 6 h from the beginning of propacetamol infusion. Vital signs and adverse reactions were also documented. After all data were put into the computer, the blinding codes were decoded and the statistic analysis was then made. RESULTS: There was no significant difference (P = 0.93) about the area under the curve of "Pain Relieve Score vs. Time". The "starting to effect" time (15-30 min), analgesic duration (6 h) and the percentage of excellent or good analgesic effect (90%) in the two groups were the same. Adverse reactions didn't reached the statistic different level (P = 0.35). CONCLUSIONS: Propacetamol HCL injection 2 g intravenously could be an alternative to dolantin 50 mg intramuscularly for moderate to severe postoperative pain with its advantage of being non-addictive.