Thakur Deepika, Dickerson Sara, Kumar Bhutani Mohit, Junor Rod
HERON Commercialization, PAREXEL Consulting, Chandigarh, India.
Napp Pharmaceuticals Ltd, Cambridge, United Kingdom.
Clin Ther. 2015 Jan 1;37(1):212-24. doi: 10.1016/j.clinthera.2014.12.001.
The objective of this systematic review was to assess the clinical efficacy, safety, tolerability, and health-related quality of life outcomes associated with management of moderate-to-severe chronic pain with oxycodone/naloxone and tapentadol, focusing on the effect of these treatments on patients' daily functioning.
Literature from a wide range of sources, including Embase, MEDLINE, MEDLINE In-Process, and the Cochrane Central Register of Controlled Trials, was searched to identify randomized controlled trials investigating tapentadol or oxycodone/naloxone for the treatment of patients with chronic pain. A network meta-analysis was conducted to determine the relative efficacy and safety profiles of these treatments.
Oxycodone/naloxone was significantly better than tapentadol with respect to the Patient Assessment of Constipation Symptoms total score (risk ratio = -3.60; 95% credible interval, -5.36 to -2.11) and revealed a significantly lower risk of dizziness (risk ratio = 0.72; 95% credible interval, 0.42-0.98). Oxycodone/naloxone was directionally favored, although not significantly superior to tapentadol for headache, fatigue, dry mouth, dyspepsia, and withdrawals due to lack of efficacy. For the AE outcomes of constipation, nausea, and vomiting, as well as pain efficacy and all-cause withdrawals from studies, tapentadol was directionally favored without any statistical difference from oxycodone/naloxone. However, the two treatments were not wholly comparable for the evaluation of pain efficacy because of differences in on-study rescue medication and a higher baseline pain severity in the tapentadol studies.
Oxycodone/naloxone offers significant improvements in Patient Assessment of Constipation Symptoms total score and dizziness and was directionally favored for fatigue and headache compared with extended-release tapentadol, which may translate to improved patient daily functioning and health-related quality of life.
本系统评价的目的是评估羟考酮/纳洛酮和曲马多治疗中重度慢性疼痛的临床疗效、安全性、耐受性及与健康相关的生活质量结局，重点关注这些治疗对患者日常功能的影响。
检索了包括Embase、MEDLINE、MEDLINE在研数据库和Cochrane对照试验中央注册库在内的广泛来源的文献，以识别调查曲马多或羟考酮/纳洛酮治疗慢性疼痛患者的随机对照试验。进行了网络荟萃分析以确定这些治疗的相对疗效和安全性。
在便秘症状患者评估总分方面，羟考酮/纳洛酮显著优于曲马多（风险比=-3.60；95%可信区间，-5.36至-2.11），且头晕风险显著更低（风险比=0.72；95%可信区间，0.42-0.98）。在头痛、疲劳、口干、消化不良和因疗效不佳导致的戒断方面，羟考酮/纳洛酮虽未显著优于曲马多，但有一定优势。对于便秘、恶心和呕吐的不良事件结局以及疼痛疗效和研究中的全因戒断，曲马多有一定优势，但与羟考酮/纳洛酮无统计学差异。然而，由于研究中急救药物的差异以及曲马多研究中更高的基线疼痛严重程度，两种治疗在疼痛疗效评估方面并非完全可比。
与缓释曲马多相比，羟考酮/纳洛酮在便秘症状患者评估总分和头晕方面有显著改善，在疲劳和头痛方面有一定优势，这可能转化为患者日常功能和与健康相关生活质量的改善。
