Lemmel E M, Bolten W, Burgos-Vargas R, Platt P, Nissilä M, Sahlberg D, Björneboe O, Baumgartner H, Valat J P, Franchimont P, Bluhmki E, Hanft G, Distel M
Staatliches Rheumakrankenhaus, Baden-Baden, Germany.
J Rheumatol. 1997 Feb;24(2):282-90.
To evaluate the efficacy and safety of meloxicam, a new acidic enolic nonsteroidal anti-inflammatory drug, at doses of 7.5 and 15 mg once daily in patients with rheumatoid arthritis (RA).
Meloxicam 15 and 7.5 mg daily was administered for 21 days in this double blind, randomized, placebo controlled study. 159 patients received meloxicam 7.5 mg, 162 received meloxicam 15 mg, and 147 received placebo.
Meloxicam 15 mg once daily was significantly superior (p < 0.05) to placebo in 3 of the 4 primary endpoints (disease activity assessed by the investigator, disease activity assessed by the patient, and reduction of the number of tender/painful joints). No difference was observed regarding number of swollen joints. The difference between meloxicam 7.5 mg once daily and placebo reached statistical significance in 2 of the 4 primary endpoints, disease activity assessed by the patient and number of tender/painful joints. A statistically significant difference between meloxicam 1.5 mg and 7.5 mg was not observed for any primary endpoint. The rating of global tolerance by investigators and patients at the end of the study was similar in the 3 treatment groups, indicating that meloxicam and placebo were generally similarly well tolerated. However, there was a slightly higher incidence of gastrointestinal (GI) disturbances reported by patients receiving meloxicam 15 mg. GI adverse events were reported by 11, 11, and 16% of patients in the placebo, meloxicam 7.5 mg, and meloxicam 15 mg groups, respectively. None were serious.
Meloxicam in daily doses of 7.5 and 15 mg is effective in treating the signs and symptoms of RA.
评估新型酸性烯醇类非甾体抗炎药美洛昔康每日7.5毫克和15毫克剂量对类风湿关节炎（RA）患者的疗效和安全性。
在这项双盲、随机、安慰剂对照研究中，每日给予美洛昔康15毫克和7.5毫克，持续21天。159例患者接受美洛昔康7.5毫克，162例接受美洛昔康15毫克，147例接受安慰剂。
在4个主要终点中的3个方面（研究者评估的疾病活动度、患者评估的疾病活动度以及压痛/疼痛关节数的减少），每日一次15毫克美洛昔康显著优于安慰剂（p < 0.05）。在肿胀关节数方面未观察到差异。每日一次7.5毫克美洛昔康与安慰剂之间的差异在4个主要终点中的2个方面达到统计学意义，即患者评估的疾病活动度和压痛/疼痛关节数。在任何主要终点方面，未观察到1.5毫克与7.5毫克美洛昔康之间有统计学显著差异。研究结束时，研究者和患者对总体耐受性的评分在3个治疗组中相似，表明美洛昔康和安慰剂的总体耐受性通常相似。然而，接受15毫克美洛昔康的患者报告的胃肠道（GI）不适发生率略高。安慰剂组、美洛昔康7.5毫克组和美洛昔康15毫克组分别有11%、11%和16%的患者报告了胃肠道不良事件。均无严重事件。
每日剂量7.5毫克和15毫克的美洛昔康对治疗RA的体征和症状有效。
