Ringe Johann D, Miethe Dirk, Pittrow David, Wegscheider Karl
Medical Clinic IV, Leverkusen Medical Center, University of Cologne, Cologne, Germany.
Arzneimittelforschung. 2003;53(7):496-502. doi: 10.1055/s-0031-1297139.
Although chronic pain in elderly patients with osteoporosis is extremely common it has rarely been addressed in pharmacotherapy studies. The efficacy and tolerability of flupirtine (CAS 56995-20-1, Trancopal Dolo) up to 600 mg/day was investigated under daily practice conditions.
This was an open-label, multicentre, prospective, observational phase IV study on 869 patients performed in 290 practices (mainly orthopedists) throughout Germany.
Decrease in pain scores on a visual analogue scale (VAS, from 0 = none to 10 = maximum) after an average 3-week therapy, and evaluation of adverse events. Multivariate analyses were performed to identify factors associated with the efficacy of pain reduction.
81% of patients were female; the mean age of all patients was 67 years, and the mean body mass index was 25.7 kg/m2. 81% of patients had reduced bone density, 30% had a family history of osteoporosis, and 32% had previous bone fractures. The mean daily flupirtine dose was 270 +/- 12 mg. The mean baseline pain VAS scores were 7.1 (low back pain), 5.8 (neck pain), 5.6 (shoulder-arm pain), and 6.6 (other pain). Mean pain reduction at the end of flupirtine treatment was 43% for low back pain, 44% for neck pain, 40% for shoulder-arm pain, and 40% for other pain (all reductions p < 0.05 vs. baseline). Rates of pain reduction at the various sites were closely correlated, and the efficacy of pain reduction was independent of age. The pain reduction was more pronounced in patients with recent onset of pain and with higher pain intensity at entry. Tolerability of treatment was excellent with only 2.4% of patients reporting adverse events and only 12 patients (1.4%) withdrawing from the trial.
This trial performed under daily practice conditions in a large unselected sample of patients confirms the efficacy and safety of flupirtine in the treatment of chronic pain in patients with osteoporosis, independent of the age of the patient.
尽管老年骨质疏松患者的慢性疼痛极为常见，但药物治疗研究中很少涉及。在日常临床实践条件下，研究了每日剂量高达600 mg的氟吡汀（CAS 56995-20-1，曲马多）的疗效和耐受性。
这是一项在德国290家医疗机构（主要是骨科医生）针对869例患者开展的开放标签、多中心、前瞻性、观察性IV期研究。
平均3周治疗后视觉模拟评分（VAS，从0 =无疼痛至10 =最剧烈疼痛）的疼痛评分降低情况，以及不良事件评估。进行多变量分析以确定与疼痛减轻疗效相关的因素。
81%的患者为女性；所有患者的平均年龄为67岁，平均体重指数为25.7 kg/m²。81%的患者骨密度降低，30%有骨质疏松家族史，32%既往有骨折史。氟吡汀的平均日剂量为270±12 mg。平均基线疼痛VAS评分为：下背痛7.1分、颈部疼痛5.8分、肩臂痛5.6分、其他疼痛6.6分。氟吡汀治疗结束时，下背痛的平均疼痛减轻43%，颈部疼痛减轻44%，肩臂痛减轻40%，其他疼痛减轻40%（与基线相比，所有减轻均p < 0.05）。各个部位的疼痛减轻率密切相关，疼痛减轻疗效与年龄无关。疼痛新近发作且入组时疼痛强度较高的患者疼痛减轻更为明显。治疗耐受性良好，仅2.4%的患者报告有不良事件，仅12例患者（1.4%）退出试验。
在日常临床实践条件下，对大量未经挑选的患者样本进行的该试验证实了氟吡汀治疗骨质疏松患者慢性疼痛的疗效和安全性，且与患者年龄无关。
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