评估硫酸软骨素注射剂疗程对骨关节炎患者病情缓解时间和生活质量的影响

P. Kovalenko, I. S. Dydykina, O. G. Alekseeva, E. L. Shakhramanova, A. S. Potapova, S. Glukhova, E. Zotkin
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The open prospective observational study involved 35 patients (mainly women) aged 50–75 years with stage II–III KOA. All patients were prescribed intramuscular therapy with a CS solution (Mucosat® solution), with the first three injections of 1 ml, followed by 2 ml every second day (25 injections in total). Standard indices and questionnaires were used to assess the main clinical indicators at baseline and over time (14, 30, 60 days, 5 and 8 months after the start of treatment), as well as the results of ultrasound examination of the knee at baseline and at the end of treatment.Results and discussion. 14 days after the start of therapy, a statistically significant decrease in pain was observed applying the visual analogue scale (VAS), and after 2 months, 94% of patients had a significant decrease in knee pain according to VAS, Lequesne index and WOMAC index (total score and components). The KOOS parameters and quality of life according to EQ-5D-3L improved significantly. 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引用次数: 0

摘要

确保疗效持久和安全性是治疗骨关节炎(OA)患者的重要任务。用于OA背景治疗的肠外硫酸软骨素(CS)具有公认的疗效和安全性,与口服药物相比,其生物利用度更高、症状改善效果起效更快、缓解效果维持更稳定,可显著改善患者的生活质量。目的:评估膝关节OA(KOA)患者使用注射CS进行为期两个月治疗的临床疗效和安全性,以及治疗结束后积极动态变化的持续时间。这项开放性前瞻性观察研究涉及 35 名年龄在 50-75 岁之间的 II-III 期 KOA 患者(主要为女性)。所有患者均接受了 CS 溶液(Mucosat® 溶液)的肌肉注射治疗,前三次注射量为 1 毫升,之后每隔一天注射 2 毫升(共注射 25 次)。采用标准指数和调查问卷评估基线和一段时间(治疗开始后 14、30、60 天、5 和 8 个月)的主要临床指标,以及基线和治疗结束时的膝关节超声波检查结果。治疗开始 14 天后,根据视觉模拟量表(VAS),膝关节疼痛明显减轻;2 个月后,根据视觉模拟量表、勒克斯指数和 WOMAC 指数(总分和组成部分),94% 的患者膝关节疼痛明显减轻。根据EQ-5D-3L,KOOS参数和生活质量均有明显改善。54%的患者没有疼痛或仅有轻微疼痛(VAS ≤40毫米)。需要经常服用非甾体抗炎药(NSAID)的患者人数减少了三倍,偶尔服用的人数减少了五倍。膝关节滑膜的厚度和出现滑膜炎症状的患者人数明显减少。在治疗结束后的 3 个月和 6 个月,大多数患者(60%)仍有轻微疼痛(根据 VAS 值≤40 毫米),对非甾体抗炎药的需求与基线相比明显降低。注射 CS 的耐受性良好,未发现药物不良反应。我们证明了注射 CS 的安全性和有效性,以及在大多数 OA 患者对非甾体抗炎药需求较低的背景下,注射 CS 的临床效果(治疗结束后 6 个月)仍能长期保持。
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Evaluation of the impact of a course of therapy with an injectable form of chondroitin sulfate on the duration of remission and quality of life in patients with osteoarthritis
Ensuring a long-lasting effect of the therapy and its safety are important tasks in the treatment of patients with osteoarthritis (OA). Parenteral forms of chondroitin sulfate (CS) used for the background therapy of OA are characterized by proven efficacy and safety and, compared to oral forms, have greater bioavailability, faster onset of symptom-modifying effect and maintenance of more stable remission, which can significantly improve patients' quality of life.Objective: to evaluate the clinical efficacy and safety of two-month therapy with injectable CS and the duration of positive dynamics after the end of treatment in patients with knee OA (KOA).Material and methods. The open prospective observational study involved 35 patients (mainly women) aged 50–75 years with stage II–III KOA. All patients were prescribed intramuscular therapy with a CS solution (Mucosat® solution), with the first three injections of 1 ml, followed by 2 ml every second day (25 injections in total). Standard indices and questionnaires were used to assess the main clinical indicators at baseline and over time (14, 30, 60 days, 5 and 8 months after the start of treatment), as well as the results of ultrasound examination of the knee at baseline and at the end of treatment.Results and discussion. 14 days after the start of therapy, a statistically significant decrease in pain was observed applying the visual analogue scale (VAS), and after 2 months, 94% of patients had a significant decrease in knee pain according to VAS, Lequesne index and WOMAC index (total score and components). The KOOS parameters and quality of life according to EQ-5D-3L improved significantly. There was no pain or only minor pain (VAS ≤40 mm) in 54% of patients. The number of patients who had to take nonsteroidal anti-inflammatory drugs (NSAIDs) constantly fell threefold, while occasional use fell fivefold. The thickness of the synovial membrane of the knee joint and the number of patients with signs of synovitis decreased significantly. At 3 and 6 months after the end of therapy, most patients (60%) still had minor pain (≤40 mm according to VAS) and a significantly lower need for NSAIDs compared to baseline. The injectable CS was well tolerated and no adverse drug events were noted.Conclusion. We demonstrated both safety and efficacy and long-term maintenance of the clinical effect (6 months after the end of therapy) of injectable CS in the majority of OA patients, against the background of a low need for NSAIDs.
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