Adis, a Wolters Kluwer Business, Auckland, New Zealand.
Clin Drug Investig. 2010;30(10):711-38. doi: 10.2165/11205830-000000000-00000.
Tramadol/paracetamol 37.5 mg/325 mg (Tramacet, Zaldiar, Ixprim, Kolibri) is an orally administered fixed-dose combination of the atypical opioid tramadol and paracetamol, which is indicated in the EU for the symptomatic treatment of moderate to severe pain. This article reviews the pharmacological properties, clinical efficacy and tolerability of tramadol/paracetamol in adults with moderate to severe pain. Fixed-dose tramadol/paracetamol is a rapidly-acting, longer-duration, multimodal analgesic, which is effective and generally well tolerated in patients with moderate to severe pain. In several well designed, clinical studies, single- or multiple-dose tramadol/paracetamol was effective in providing pain relief in adult patients with postoperative pain after minor surgery, musculoskeletal pain (acute, subacute or chronic), painful diabetic peripheral neuropathy or migraine pain. It was also effective as an add-on analgesic in patients who were experiencing moderate to severe musculoskeletal pain (e.g. osteoarthritis or rheumatoid arthritis pain) despite ongoing NSAID and/or disease-modifying antirheumatic drug therapy. Moreover, in patients with postoperative pain, ankle sprain pain or subacute lower back pain, the analgesic efficacy of tramadol/paracetamol was better than that of paracetamol, generally similar to, or better than that, of tramadol, and generally similar to that of ibuprofen or the fixed-dose combinations hydrocodone/paracetamol, codeine/paracetamol and codeine/paracetamol/ibuprofen. In addition, the analgesic efficacy of tramadol/paracetamol did not differ significantly from that of gabapentin in patients with chronic pain associated with diabetic peripheral neuropathy. Tramadol/paracetamol had no additional tolerability issues relative to its components and, overall, the tolerability profile of tramadol/paracetamol was generally similar to that of other active comparators (fixed-dose combinations or single-agents); however, incidences of some adverse events were lower in tramadol/paracetamol than in active comparator recipients. Although additional comparative and long-term studies would help to definitively position tramadol/paracetamol with respect to other analgesics, available clinical data suggest that tramadol/paracetamol is a useful treatment option for providing multimodal analgesia in patients with moderate to severe pain.
曲马多/对乙酰氨基酚 37.5 毫克/325 毫克（Tramacet、Zaldiar、Ixprim、Kolibri）是一种口服固定剂量组合的非典型阿片类药物曲马多和对乙酰氨基酚，在欧盟被批准用于治疗中度至重度疼痛的症状。本文综述了曲马多/对乙酰氨基酚在成人中度至重度疼痛患者中的药理学特性、临床疗效和耐受性。固定剂量的曲马多/对乙酰氨基酚是一种快速起效、持续时间较长的多模式镇痛药，对中度至重度疼痛患者有效，且一般耐受性良好。在几项设计良好的临床研究中，单剂量或多剂量曲马多/对乙酰氨基酚在接受小手术后、肌肉骨骼疼痛（急性、亚急性或慢性）、痛性糖尿病周围神经病变或偏头痛疼痛的成年患者中有效缓解疼痛。在接受非甾体抗炎药和/或疾病修饰抗风湿药物治疗的同时仍有中度至重度肌肉骨骼疼痛（如骨关节炎或类风湿关节炎疼痛）的患者中，作为辅助镇痛剂也有效。此外，在接受术后疼痛、踝关节扭伤疼痛或亚急性下腰痛的患者中，曲马多/对乙酰氨基酚的镇痛疗效优于对乙酰氨基酚，一般与曲马多相当，或优于布洛芬，且与氢可酮/对乙酰氨基酚、可待因/对乙酰氨基酚和可待因/对乙酰氨基酚/布洛芬的固定剂量组合相当。此外，曲马多/对乙酰氨基酚的镇痛疗效与慢性痛伴糖尿病周围神经病变患者的加巴喷丁无显著差异。曲马多/对乙酰氨基酚与药物成分相比没有额外的耐受性问题，总的来说，曲马多/对乙酰氨基酚的耐受性与其他活性对照药物（固定剂量组合或单一药物）相当；然而，一些不良反应的发生率在曲马多/对乙酰氨基酚组比在活性对照药物组低。尽管需要更多的比较和长期研究来明确曲马多/对乙酰氨基酚与其他镇痛药的定位，但现有的临床数据表明，曲马多/对乙酰氨基酚是治疗中度至重度疼痛患者多模式镇痛的一种有效治疗选择。
