一项比较氯诺昔康与双氯芬酸钠治疗膝关节骨性关节炎的疗效、安全性和成本效益的随机对照临床试验

Vk Vadgama, R. Gharia, K. Mehta, R. Sanjiv, C. Tripathi
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引用次数: 6

摘要

骨关节炎是一种影响较大关节的慢性疼痛疾病;最常见的是膝关节。疼痛的药物控制是骨关节炎治疗的主要手段。许多患者使用最常用的处方药之一双氯芬酸钠,即使在每日允许的最大剂量后,也不能达到令人满意的疼痛减轻效果。氯诺昔康是印度市场上较新的分子,与标准疗法相比,有望更好地缓解腰痛和膝关节置换术后疼痛。根据氯诺昔康的特点,如果它比双氯芬酸钠更好,那么它将有助于更有效地治疗骨关节炎患者。到目前为止,还没有比较这两种药物治疗膝关节骨关节炎的临床试验。因此,为了评价这一点,我们开展了这项研究,比较氯诺昔康和双氯芬酸钠在缓解膝关节骨关节炎患者疼痛方面的安全性、有效性和成本效益。本研究是一项随机、开放标签、对照临床试验,有40名新诊断的膝关节骨关节炎患者。随机分为D组和L组(每组20例);D组给予双氯芬酸钠50 mg 12 h, L组给予氯诺昔康4 mg 8 h,疗程3个月。所有患者在治疗开始前、治疗15天、治疗1、2、3个月分别采用视觉模拟量表和100米步行测试进行评估。在研究期间监测药物不良反应和治疗费用。氯诺昔康组与双氯芬酸钠组相比,视觉模拟量表和100米步行试验时间的平均下降有统计学意义。L组1例、d组2例患者出现胃刺激,氯诺昔康较双氯芬酸钠显著缓解骨关节炎膝关节疼痛,且不影响患者耐受性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee
Osteoarthritis is a chronic painful condition affecting larger joints; most commonly knee joint. Pharmacological control of pain is the mainstay of management of osteoarthritis. Many patientsfail to achieve satisfactory reduction in pain with one of the most commonly prescribed drugs, diclofenac sodium, even after maximum daily allowed doses. Lornoxicam is a newer molecule in the Indian market promising better pain relief in context of low back pain and post knee replacement surgery pain as compared to standard therapies. As per profile of lornoxicam, if it is better than diclofenac sodium then it will be helpful in managing the patients of osteoarthritis more effectively. Till date no comparative clinical trial has been done to compare these two drugs for the management of osteoarthritis knee. So, to evaluate the same we carried out this study to compare safety, efficacy and cost effectiveness of lornoxicam and diclofenac sodium in relieving pain in patients of osteoarthritis knee. This study is a randomized, open labeled, controlled clinical trial having 40 newly diagnosed patients with osteoarthritis knee. After random allocation into two groups i.e. group D and group L (each having 20 patients); group D received diclofenac sodium 50 mg 12 hourly and group L received lornoxicam 4 mg 8 hourly for a period of 3 months. All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy. Adverse drug reactions and cost of therapy was monitored during the study period. Mean decrease in visual analogue scale and time of 100 meter walking test was statistically significant in lornoxicam group as compared to diclofenac sodium. Gastric irritation was reported in one patient from group L and two patients from group D. Lornoxicam significantly relieves pain of osteoarthritis knee than diclofenac sodium without adversely affecting the tolerability to the patients.
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