Yocum D, Fleischmann R, Dalgin P, Caldwell J, Hall D, Roszko P
Arizona Arthritis Center, University of Arizona, 1501 N Campbell Ave, POBox 245093, Tucson, AZ 85724-5018, USA.
Arch Intern Med. 2000 Oct 23;160(19):2947-54. doi: 10.1001/archinte.160.19.2947.
Meloxicam (Mobic; Boehringer Ingelheim, Ridgefield, Conn) is an enolic acid derivative of the oxicam group of nonsteroidal anti-inflammatory drugs (NSAIDs) whose mechanism of action may be related to prostaglandin (cyclooxygenase) synthetase inhibition. In previous studies, meloxicam has been found to be safe and effective in the treatment of osteoarthritis (OA) at doses of 7.5 to 15 mg daily. To evaluate a lower dose and a different patient population, we evaluated the efficacy and safety of 3 doses of meloxicam vs placebo and diclofenac for the treatment of OA among patients with symptom exacerbations.
In this double-blind, double-dummy, parallel-group, multicenter study, 774 patients with confirmed OA of the hip or knee and a flare were randomized and treated with daily oral administration of meloxicam tablets (at dosages of 3.75, 7.5, or 15 mg/d), diclofenac (100 mg [50 mg twice daily]), or placebo. Treatment was for 12 weeks, with regular assessments for drug safety and efficacy. Safety was assessed by evaluation of adverse events, vital signs, and laboratory data. Primary efficacy variables included the Western Ontario and McMaster University Osteoarthritis (WOMAC) index, the patient's overall assessment of pain, and the patient's and investigator's overall assessment of disease activity.
The incidence of all adverse events was lower at each dosage of meloxicam than for diclofenac but greater than for placebo. However, the incidence of gastrointestinal adverse events and dropout rates because of such events was the same for meloxicam as for placebo and lower than for diclofenac. Meloxicam, at 7.5 and 15 mg/d, and diclofenac were statistically significantly more effective than placebo for all end points, while the 3.75-mg/d dosage of meloxicam did not always reach statistical significance for all end points. Efficacy was evident after 2 weeks of treatment, improved with increasing doses, and was maintained until the end of the trial.
Meloxicam is a safe and effective medication for the symptomatic treatment of OA. The data support consideration of 7.5 to 15 mg of meloxicam once daily to treat the pain and stiffness of OA, with gastrointestinal tolerability comparable to that of placebo. Arch Intern Med. 2000;160:2947-2954
美洛昔康（莫比可；勃林格殷格翰公司，康涅狄格州里奇菲尔德）是一种烯醇酸衍生物，属于非甾体抗炎药（NSAIDs）的昔康类，其作用机制可能与抑制前列腺素（环氧化酶）合成酶有关。在以往的研究中，已发现美洛昔康以每日7.5至15毫克的剂量治疗骨关节炎（OA）是安全有效的。为了评估更低剂量以及不同的患者群体，我们评估了3种剂量的美洛昔康与安慰剂和双氯芬酸相比，在症状加重的OA患者中治疗OA的疗效和安全性。
在这项双盲、双模拟、平行组、多中心研究中，774例确诊为髋或膝OA且病情发作的患者被随机分组，每日口服美洛昔康片（剂量为3.75、7.5或15毫克/天）、双氯芬酸（100毫克[每日两次，每次50毫克]）或安慰剂进行治疗。治疗为期12周，定期评估药物安全性和疗效。通过评估不良事件、生命体征和实验室数据来评估安全性。主要疗效变量包括西安大略和麦克马斯特大学骨关节炎指数（WOMAC）、患者对疼痛的总体评估以及患者和研究者对疾病活动的总体评估。
美洛昔康各剂量组的所有不良事件发生率均低于双氯芬酸组，但高于安慰剂组。然而，美洛昔康的胃肠道不良事件发生率以及因此类事件导致的退出率与安慰剂组相同，且低于双氯芬酸组。美洛昔康7.5毫克/天和15毫克/天剂量组以及双氯芬酸组在所有终点指标上均比安慰剂组有统计学显著更高的疗效，而美洛昔康3.75毫克/天剂量组并非在所有终点指标上都达到统计学显著差异。治疗2周后疗效明显，随着剂量增加而改善，并维持至试验结束。
美洛昔康是一种治疗OA症状的安全有效药物。这些数据支持考虑每日一次服用7.5至15毫克美洛昔康来治疗OA的疼痛和僵硬，其胃肠道耐受性与安慰剂相当。《内科学文献》。2000年；160:2947 - 2954
