Montané E, Vallano A, Aguilera C, Vidal X, Laporte J R
Fundació Institut Català de Farmacologia and Servei de Farmacologia Clínica, Hospital Universitari Vall d'Hebron, 08035, Barcelona, Spain.
Eur J Clin Pharmacol. 2006 Nov;62(11):971-88. doi: 10.1007/s00228-006-0185-0. Epub 2006 Sep 21.
To assess analgesic drugs in the treatment of postoperative pain after traumatic and orthopaedic surgery (TOS).
A systematic review of randomised clinical trials (RCTs).
Electronic PubMed, EMBASE, The Cochrane Library, and hand searches.
RCTs of analgesics administered by oral, intramuscular, intravenous, subcutaneous or rectal route, were compared to other analgesics or placebo, in patients under TOS. Study design, characteristics of the study population, analgesic drugs tested, pain intensity and pain relief scores, and adverse effects were assessed.
Ninety-two RCTs (9,596 patients) met our inclusion criteria. Forty-two (46%) were placebo-controlled, and 50 (54%) were direct comparisons between non-opioid, opioid, and/or combinations of both. Patients' mean age (SD) was 49 years (18). In most trials, gastrointestinal ulcer, liver and renal diseases were exclusion criteria. Only 30 trials (33%) were double-blind and reported standardised outcomes of pain intensity and pain relief; 19 of these were single-dose, and follow up of analgesic effects lasted no more than 12 h in 23 (77%). Globally, only nine trials (10%) were double blind, described dropouts or withdrawals, performed analysis by intention to treat, and reported the effects magnitude.
Evidence from RCTs on the treatment of postoperative pain after TOS is inadequate for clinical decision making. Assessment of analgesics in pain after TOS should be based on agreed clinically relevant outcomes, in representative patients, and for longer observation periods. In addition, it should include direct comparisons between candidate drugs or their combinations and between various drug administration schedules.
评估镇痛药在创伤和骨科手术后疼痛(TOS)治疗中的效果。
对随机临床试验(RCT)进行系统评价。
电子数据库PubMed、EMBASE、Cochrane图书馆,并进行手工检索。
比较口服、肌肉注射、静脉注射、皮下注射或直肠给药的镇痛药与其他镇痛药或安慰剂在TOS患者中的疗效。评估研究设计、研究人群特征、测试的镇痛药、疼痛强度和疼痛缓解评分以及不良反应。
92项RCT(9596例患者)符合纳入标准。42项(46%)为安慰剂对照试验,50项(54%)为非阿片类、阿片类和/或两者组合之间的直接比较。患者的平均年龄(标准差)为49岁(18岁)。在大多数试验中,胃溃疡、肝脏和肾脏疾病为排除标准。只有30项试验(33%)为双盲试验,并报告了疼痛强度和疼痛缓解的标准化结果;其中19项为单剂量试验,23项(77%)的镇痛效果随访时间不超过12小时。总体而言,只有9项试验(10%)为双盲试验,描述了失访或退出情况,采用意向性分析,并报告了效应大小。
RCT关于TOS术后疼痛治疗的证据不足以用于临床决策。TOS术后疼痛的镇痛药评估应基于商定的临床相关结果,在具有代表性的患者中进行,并进行更长时间的观察。此外,应包括候选药物或其组合之间以及不同给药方案之间的直接比较。