Clinique de l'Europe, Rouen, France.
Curr Med Res Opin. 2011 May;27(5):1013-20. doi: 10.1185/03007995.2011.565045. Epub 2011 Mar 14.
To evaluate the efficacy and safety of the paracetamol-tramadol combination (PTC) in treating moderate-to-severe pain, in patients aged 65 years and over within general practitioner (GP) practice centers.
This was an observational, non-interventional, longitudinal, multicenter, open, non-comparative, prospective study. This intermediary analysis was of patients recruited before the French Health Authority confirmation (25th June, 2009) of the EMEA decision to withdraw all analgesics containing dextropropoxyphen. Trial registration information: This study has been submitted for approval to the CNIL and French Medical Council (CNOM) only.
A total of 2663 patients aged 65 years or over were assessed 1 month after inclusion in the study. PTC was prescribed as first-line treatment in 30% of patients and, in the other cases, after failed or inadequate efficacy (69.8%), and/or as a result of safety problems (7.8%) with at least one other analgesic. During the month of the study period 14.7% of patients received an additional rescue analgesic. The study confirmed the efficacy of PTC with regard to pain intensity (-3.1 points reduction of pain scored 6.1 points on inclusion), pain relief (64.8% of patients experienced significant pain relief), patient satisfaction (90.5% of patients satisfied or completely satisfied) and clinical global impression evaluated by the patient (78.7% much or very much improved), regardless of the pain etiologies or duration of the underlying pathology. PTC was well-tolerated in this patient group, who had a mean age of 73.6 ± 6.6 years. A total of 119 patients (4.5%) reported at least one adverse event (AE). All were known and predictable AEs. This percentage is comparable to that found under similar conditions in patients of all ages (4.2%).
PTC, due to the complementary action of its two analgesics, is effective in treating the different types of pain in a GP's practice setting and is well-tolerated, even in an elderly population. Study limitations include all those inherent to non-interventional and open-label observations.
评估对乙酰氨基酚-曲马多复方制剂（PTC）在治疗 65 岁及以上年龄组患者中中重度疼痛的疗效和安全性，这些患者均来自全科医生（GP）诊所。
这是一项观察性、非干预性、纵向、多中心、开放、非对照、前瞻性研究。本次中间分析纳入了在法国药品管理局（2009 年 6 月 25 日）确认撤回所有含有右旋丙氧吩的镇痛药的欧洲药品管理局（EMEA）决定之前招募的患者。试验注册信息：该研究已仅向 CNIL 和法国医学委员会（CNOM）提交批准。
共有 2663 名 65 岁及以上患者在研究纳入后 1 个月进行了评估。PTC 被作为一线治疗处方开具，占 30%；而对于其他情况，在其他镇痛药治疗失败或效果欠佳（69.8%），以及/或者出现至少 1 种其他镇痛药的安全性问题（7.8%）后开具。在研究期间，14.7%的患者接受了额外的解救性镇痛药物。研究证实 PTC 可有效缓解疼痛强度（疼痛评分从纳入时的 6.1 分降低 3.1 分）、缓解疼痛（64.8%的患者疼痛显著缓解）、患者满意度（90.5%的患者满意或非常满意）以及患者的临床总体印象（78.7%的患者改善非常显著或显著），无论疼痛病因或基础疾病持续时间如何。在该患者群体中，PTC 具有良好的耐受性，患者平均年龄为 73.6±6.6 岁。共有 119 例（4.5%）患者报告至少 1 例不良事件（AE）。所有 AE 均为已知且可预测的 AE。该百分比与在所有年龄段患者中观察到的相似条件下的发生率（4.2%）相当。
由于其两种镇痛药的协同作用，PTC 可有效治疗全科医生实践环境中的不同类型疼痛，且具有良好的耐受性，即使在老年人群中也是如此。研究局限性包括所有非干预性和开放性观察研究固有的局限性。
