Merker M, Dinges G, Koch T, Kranke P, Morin A M
Klinik für Anästhesie und Intensivtherapie, Philipps-Universität Marburg, Baldingerstrasse, Marburg, Germany.
Schmerz. 2012 Feb;26(1):16-26. doi: 10.1007/s00482-011-1132-2.
Tapentadol is a new centrally acting analgesic with a dual mode of action as an agonist of the µ-opioid receptor and as a norepinephrine reuptake inhibitor. The aim of the present study was to evaluate the results from randomized controlled trials investigating the relative amount of adverse effects using tapentadol or oxycodone for the treatment of pain.
A quantitative systematic review was carried out according to the PRISMA recommendations on randomized controlled trials comparing tapentadol and oxycodone in pain treatment. The incidences of typical adverse side effects of opioid-based analgesic therapy (e.g. nausea, vomiting, obstipation or pruritus) were extracted and the pooled relative risks (RR) with corresponding 95% confidence intervals (CI) were calculated.
A total of 9 trials involving 7,948 patients were included and of these 2,810 patients were treated with oxycodone and 5,138 were treated with tapentadol in equivalent analgesic dosages as documented by an equivalent analgesic effect. The risk of typical opioid-based adverse effects, such as nausea (RR 0.61; 95% CI 0.57-0.66), vomiting (RR 0.50, 95% CI: 0.41-0.60), obstipation (RR 0.47, 95%-CI 0.40-0.56), dizziness (RR 0.86, 95% CI 0.78-0.95), somnolence (RR 0.76, 95% CI 0.67-0.86) and pruritus (RR 0.46, 95% CI 0.37-0.58) was reduced when tapentadol was used for analgesic treatment. These adverse effects were investigated in all nine trials. The risk for dryness of the mouth (6 trials, 6,218 patients, RR 1.79, 95% CI 1.40-2.29) and dyspepsia (1 trial, 646 patients, RR 2.75, 95% CI 1.09-6.94) was increased when tapentadol was used instead of oxycodone. There were no significant differences in the relative risk for any other investigated adverse effect such as dysentery, headache or fatigue.
The results show that using tapentadol significantly reduces the risk of the typical opioid-based adverse effects compared with oxycodone while providing equivalent analgesic treatment.
曲马多是一种新型中枢性镇痛药，具有双重作用模式，既是μ-阿片受体激动剂，又是去甲肾上腺素再摄取抑制剂。本研究的目的是评估随机对照试验的结果，该试验调查了使用曲马多或羟考酮治疗疼痛时不良反应的相对数量。
根据PRISMA关于比较曲马多和羟考酮治疗疼痛的随机对照试验的建议，进行了定量系统评价。提取基于阿片类镇痛药治疗的典型不良反应（如恶心、呕吐、便秘或瘙痒）的发生率，并计算合并相对风险（RR）及相应的95%置信区间（CI）。
共纳入9项试验，涉及7948例患者，其中2810例患者接受羟考酮治疗，5138例患者接受曲马多治疗，镇痛剂量相当，镇痛效果相当。使用曲马多进行镇痛治疗时，基于阿片类药物的典型不良反应风险降低，如恶心（RR 0.61；95%CI 0.57-0.66）、呕吐（RR 0.50，95%CI：0.41-0.60）、便秘（RR 0.47，95%-CI 0.40-0.56）、头晕（RR 0.86，95%CI 0.78-0.95）、嗜睡（RR 0.76，95%CI 0.67-0.86）和瘙痒（RR 0.46，95%CI 0.37-0.58）。所有9项试验均对这些不良反应进行了调查。与羟考酮相比，使用曲马多时口干（6项试验，6218例患者，RR 1.79，95%CI 1.40-2.29）和消化不良（1项试验，646例患者，RR 2.75，95%CI 1.09-6.94）的风险增加。在任何其他调查的不良反应（如痢疾、头痛或疲劳）的相对风险方面没有显著差异。
结果表明，与羟考酮相比，使用曲马多在提供等效镇痛治疗的同时，显著降低了基于阿片类药物的典型不良反应风险。
