Efficacy and safety of the combined use of celecoxib, diacerein and a combination of glucosamine and chondroitin for the control of musculoskeletal pain associated with osteoarthritis and nonspecific back pain

A. E. Karateev, E. Yu. Polishchuk, A. M. Lila, A. N. Ananyev, L. V. Ananyeva, A. V. Bondarev, A. A. Bondareva, A. R. Bukanbaeva, S. V. Vorster, S. A. Gadzhieva, D. G. Danilov, R. I. Eliseev, I. S. Zabelin, M. Yu. Ignatenko, I. V. Itkina, A. E. Kolesnikov, M. Yu. Konoplyanskaya, Yu. G. Krasnoyarova, S. I. Kukushkin, V. A. Lila, O. V. Makareva, V. S. Myagkikh, I. V. Nelgovskaya, N. V. Ocheredko, R. A. Panov, I. A. Polyakov, A. S. Prozorov, S. S. Rubina, M. E. Ryabochkina, M. A. Takhaev, E. R. Tokareva, T. V. Tolbina, M. I. Fominykh, V. V. Tsarev, E. I. Sharipova, M. V. Sheven, G. I. Shcherbakov, S. A. Yanchenkova
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Abstract

The combined use of drugs with different mechanisms of action is the main principle of musculoskeletal pain control in rheumatic diseases. However, there are few studies evaluating the efficacy of this approach in real practice.Objective: to determine the efficacy and safety of the combined use of celecoxib, diacerein, and the combination of glucosamine + chondroitin in osteoarthritis (OA) and chronic nonspecific low back pain (NSLBP). Material and methods. Statistical analysis of data obtained during a 3-month open observational study was performed. We included 1569 patients (63.6 % women and 36.4 % men, mean age 58.7 ± 11.0 years) with knee OA (kOA), hip OA (hOA), generalized OA (gOA), and chronic NSLBP with moderate/severe pain (≥ 4 on a numeric rating scale, NRS 0–10) who required nonsteroidal anti-inflammatory drugs. Celecoxib 200 mg twice daily was prescribed, with the dose reduced to 200 mg per day or taken “as needed" after significant pain relief; diacerein 50 mg twice daily; and a medication of glucosamine 250 mg and chondroitin 200 mg, 2 capsules 2–3 times daily. Outcomes were assessed after 3 months using the dynamics of pain, fatigue, dysfunction (according to NRS), and the “Patient Acceptable Symptom State” (PASS) indicator. Results and discussion. 80.2 % of patients completed the 3 month course of treatment, 4.4 % discontinued treatment due to adverse events (AEs), and for 15.4 % of patients there was no follow-up. After 3 months of treatment ≥ 50 % decrease (from baseline) in the severity of symptoms was noted in 83.4 % of patients for pain on movement, in 83.7 % for pain at rest, in 78.6 % for pain at night, in 80.8 % for dysfunction, and in 83.4 % for fatigue. 87.7 % of patients reported PASS. There were no significant differences in treatment outcomes for different localizations of OA and NSLBP: a ≥ 50 % pain reduction in kOA was achieved in 81.6 % of patients, in hOA – in 82.2 %, in gOA – in 85.0 %, in NSLBP – in 88.1 %. AEs were registered in 350 (22.4 %) patients, the most frequent was dyspepsia (n = 280, 17.8 %), diarrhea was recorded in 37 (2.4 %) cases. No serious AEs requiring hospitalization were registered. Conclusion. Combination therapy with celecoxib, diacerein, and a combination of glucosamine and chondroitin significantly reduces the severity of symptoms of OA and NSLBS.
塞来昔布、地塞青素联合使用以及葡萄糖胺和软骨素联合使用对骨关节炎和非特异性背部疼痛相关的肌肉骨骼疼痛的疗效和安全性
联合使用不同作用机制的药物是风湿性疾病肌肉骨骼疼痛控制的主要原则。然而,很少有研究评估这种方法在实际实践中的有效性。目的:探讨塞来昔布联合地赛精、葡萄糖胺+软骨素联合治疗骨关节炎(OA)和慢性非特异性腰痛(NSLBP)的疗效和安全性。材料和方法。对为期3个月的开放观察性研究中获得的数据进行统计分析。我们纳入了1569例患者(63.6%为女性,36.4%为男性,平均年龄58.7±11.0岁),患有膝关节OA (kOA),髋关节OA (hOA),广泛性OA (gOA)和慢性非甾体性bp,伴有中度/重度疼痛(数值评分≥4,NRS 0-10),需要非甾体抗炎药。塞来昔布200毫克,每日两次,剂量减少到每天200毫克,或在明显缓解疼痛后“根据需要”服用;肾上腺素50毫克,每日2次;葡萄糖胺250毫克,软骨素200毫克,每天2 - 3次,2粒胶囊。3个月后使用疼痛、疲劳、功能障碍(根据NRS)和“患者可接受症状状态”(PASS)指标评估结果。结果和讨论。80.2%的患者完成了3个月的疗程,4.4%的患者因不良事件(ae)而停止治疗,15.4%的患者没有随访。治疗3个月后,83.4%的运动疼痛患者、83.7%的休息疼痛患者、78.6%的夜间疼痛患者、80.8%的功能障碍患者和83.4%的疲劳患者的症状严重程度(较基线)降低≥50%。87.7%的患者报告PASS。不同部位OA和NSLBP的治疗结果无显著差异:81.6%的kOA患者疼痛减轻≥50%,hOA患者为82.2%,gOA患者为85.0%,NSLBP患者为88.1%。不良反应350例(22.4%),最常见的是消化不良(280例,17.8%),腹泻37例(2.4%)。没有登记需要住院治疗的严重突发事件。结论。塞来昔布、二乙酰氨基酚、葡萄糖胺和软骨素联合治疗可显著降低OA和NSLBS症状的严重程度。
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