针对中度至重度慢性疼痛的患者特异性因素以及曲马多缓释片治疗的疗效和耐受性的汇总分析。
A pooled analysis of patient-specific factors and efficacy and tolerability of tapentadol extended release treatment for moderate to severe chronic pain.
作者信息
Etropolski Mila, Lange Bernd, Goldberg Jutta, Steup Achim, Rauschkolb Christine
机构信息
Senior Director/Clinical Leader, Janssen Research & Development, LLC, Raritan, New Jersey.
Associate International Clinical Lead, Grünenthal GmbH, Aachen, Germany.
出版信息
J Opioid Manag. 2013 Sep-Oct;9(5):343-56. doi: 10.5055/jom.2013.0177.
OBJECTIVE
To evaluate via retrospective analysis the efficacy and tolerability of tapentadol extended release (ER; 100-250 mg bid) based on patient-specific factors, including baseline pain intensity, prior opioid experience, gender, and body mass index (BMI).
DESIGN
Data were pooled from three randomized, double-blind phase III studies of similar design that evaluated the efficacy and tolerability of tapentadol ER for the management of moderate to severe, chronic osteoarthritis knee pain (NCT00421928, NCT00486811) or low back pain (NCT00449176).
SETTING
In the original trials, patients were recruited at primary, secondary, and tertiary care centers, institutional settings, and private practices in North America, Europe, Australia, and New Zealand.
PATIENTS
Data were analyzed separately for groups of patients divided by baseline pain intensity, prior opioid experience, gender, and BMI.
INTERVENTIONS
Patients received twice-daily placebo, tapentadol ER (100-250 mg), or oxycodone HCl controlled release (CR; 20-50 mg) for a 3-week titration and 12-week maintenance period.
MAIN OUTCOME MEASURES
Changes from baseline in average pain intensity (11-point numerical rating scale) at week 12 of the maintenance period and for the overall maintenance period.
RESULTS
Efficacy and tolerability were evaluated in 2,968 and 2,974 patients, respectively. The efficacy of tapentadol ER was shown in subpopulations divided by baseline pain intensity, prior opioid experience, gender, and BMI. Tapentadol ER was also shown to be well tolerated and associated with better gastrointestinal tolerability than oxycodone CR in the evaluated subpopulations (divided by prior opioid experience and gender).
CONCLUSIONS
Results suggest that tapentadol ER (100-250 mg bid) provides similar pain relief and tolerability, regardless of baseline pain intensity, prior opioid experience, gender, or BMI.
目的
通过回顾性分析，根据患者的特定因素，包括基线疼痛强度、既往阿片类药物使用经验、性别和体重指数（BMI），评估缓释他喷他多（ER；100 - 250 mg，每日两次）的疗效和耐受性。
设计
数据来自三项设计相似的随机、双盲III期研究，这些研究评估了缓释他喷他多治疗中度至重度慢性膝骨关节炎疼痛（NCT00421928、NCT00486811）或腰痛（NCT00449176）的疗效和耐受性。
背景
在最初的试验中，患者在北美、欧洲、澳大利亚和新西兰的初级、二级和三级护理中心、机构场所及私人诊所招募。
患者
根据基线疼痛强度、既往阿片类药物使用经验、性别和BMI对患者分组，分别进行数据分析。
干预措施
患者接受每日两次的安慰剂、缓释他喷他多（100 - 250 mg）或盐酸羟考酮控释片（CR；20 - 50 mg），进行为期3周的滴定期和12周的维持期。
主要观察指标
维持期第12周及整个维持期平均疼痛强度（11点数字评定量表）相对于基线的变化。
结果
分别对2968例和2974例患者评估了疗效和耐受性。在根据基线疼痛强度、既往阿片类药物使用经验、性别和BMI划分的亚组中显示了缓释他喷他多的疗效。在评估的亚组（根据既往阿片类药物使用经验和性别划分）中，缓释他喷他多也显示出耐受性良好，且与比羟考酮控释片更好的胃肠道耐受性相关。
结论
结果表明，无论基线疼痛强度、既往阿片类药物使用经验、性别或BMI如何，缓释他喷他多（100 - 250 mg，每日两次）均能提供相似的疼痛缓解效果和耐受性。
Zotero 插件