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依托度酸与依托度酸联合乙哌立松治疗膝骨关节炎患者的随机对照试验

Randomized Controlled Trial of Etodolac versus Combination of Etodolac and Eperisone in Patients of Knee Osteoarthritis.

作者信息

Kaur Navjot, Singh Harinder, Gupta Avinash Chander

机构信息

Department of Pharmacology, Government Medical College and Rajindra Hospital, Patiala, Punjab 147001, India ; Department of Pharmacology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India.

出版信息

Pain Res Treat. 2013;2013:273695. doi: 10.1155/2013/273695. Epub 2013 Sep 30.

Abstract

Objective. To compare the efficacy and tolerability of etodolac versus etodolac in combination with eperisone in patients of Osteoarthritis knee. Patients and Methods. A prospective, randomized, open label, parallel group, comparative study was conducted in 60 patients of knee OA over a period of 2 months. Thirty patients received etodolac 600 mg once daily and 30 patients received eperisone 50 mg thrice daily in addition to etodolac 600 mg once daily for 8 weeks. Efficacy assessment was done on the basis of improvement in mean scores of spontaneous pain on Visual analog scale (VAS), pain on movement, functional capacity, joint tenderness, swelling, erythema on Likert scale, and patient's overall arthritic condition on a five-point investigator scale at the end of study period as compared with the baseline scores. Assessment of tolerability was done by recording the occurrence of adverse events. Data was analyzed using Chi square test and students t-test. Results. All the enrolled patients completed the study and were compliant to the treatment regimens that they were allocated to. Both the treatment groups showed a statistically significant improvement in all the efficacy parameters at the end of 8 weeks as compared to baseline (P < 0.05) with no statistically significant difference between the groups. Adverse events were few and mild in nature. Conclusion. Combination of etodolac and eperisone is as effective as etodolac alone in patients of OA knee. Thus, it is concluded that additional use of muscle relaxant has no adjuvant value in patients of OA knee and is not recommended. The study is registered with the Clinical Trial Registry of India vide registration number CTRI/2013/03/003442.

摘要

目的。比较依托度酸与依托度酸联合乙哌立松对膝骨关节炎患者的疗效和耐受性。

患者与方法。对60例膝骨关节炎患者进行了一项为期2个月的前瞻性、随机、开放标签、平行组比较研究。30例患者每日一次服用依托度酸600毫克,30例患者除每日一次服用依托度酸600毫克外,还每日三次服用乙哌立松50毫克,持续8周。在研究期结束时,根据视觉模拟量表(VAS)上的自发疼痛平均评分、运动时疼痛、功能能力、关节压痛、肿胀、李克特量表上的红斑以及研究者五分制量表上患者的整体关节炎状况与基线评分相比的改善情况进行疗效评估。通过记录不良事件的发生情况来评估耐受性。使用卡方检验和学生t检验分析数据。

结果。所有入组患者均完成研究并遵守分配给他们的治疗方案。与基线相比,两个治疗组在8周结束时所有疗效参数均有统计学显著改善(P < 0.05),两组之间无统计学显著差异。不良事件数量少且性质轻微。

结论。依托度酸与乙哌立松联合使用在膝骨关节炎患者中与单独使用依托度酸一样有效。因此,得出结论,在膝骨关节炎患者中额外使用肌肉松弛剂没有辅助价值,不建议使用。该研究已在印度临床试验注册中心注册,注册号为CTRI/2013/03/003442。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eb2a/3806389/eae80789b5e4/PRT2013-273695.001.jpg

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