Three-month efficacy and safety of acetaminophen extended-release for osteoarthritis pain of the hip or knee: a randomized, double-blind, placebo-controlled study
Three-month efficacy and safety of acetaminophen extended-release for osteoarthritis pain of the hip or knee: a randomized, double-blind, placebo-controlled study
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DOI：
10.1016/j.joca.2006.10.008
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发表时间：
2007-04-01
影响因子：
7
通讯作者：
Schweinle, J. E.
中科院分区：
文献类型：
--
作者：
Altman, R. D.;Zinsenheim, J. R.;Schweinle, J. E.
目的：方法：本研究采用多中心、随机、双盲、平行对照、安慰剂对照的研究方法，评价对乙酰氨基酚缓释片（ER）650 mg和1300 mg每日3次治疗中、重度髋关节或膝关节骨关节炎（OA）的疗效和安全性。主要疗效终点为西安大略和麦克马斯特大学骨关节炎指数疼痛和身体功能子量表评分从基线至12周的平均变化以及第12周时患者对治疗反应的平均总体评估。安全性评估包括监测生命体征，不良事件，研究联合评估，并在每个研究vision.Results的临床实验室结果：四百八十三名患者随机治疗，并列入意向治疗分析。除性别、体重和体重指数外，所有组在基线人口统计学方面相似。对乙酰氨基酚ER 3900 mg在所有三个主要终点方面均显著上级安慰剂;对乙酰氨基酚ER 1950 mg仅在患者对治疗反应的评估方面显著上级安慰剂。研究治疗一般耐受性良好，并有在不良事件的总体数量组之间没有显着差异。结论：对乙酰氨基酚ER 3900毫克/天给药长达12周是有效的治疗中度至中度严重的慢性OA疼痛的髋关节或膝关节，一般耐受性良好。(C)2006年国际骨关节炎研究学会。由爱思唯尔有限公司出版。保留所有权利。
Objective: To examine the efficacy and safety of two doses of long-acting acetaminophen in patients with osteoarthritis (OA) of the hip or kneeMethods: This multicenter, randomized, double-blind, parallel-group, placebo-controlled study evaluated the efficacy and safety of acetaminophen extended-release (ER) 650 mg and 1300 mg given three times daily for the treatment of moderate to moderately severe OA of the hip or knee. Primary efficacy end points were mean change from baseline through 12 weeks in the Western Ontario and McMaster Universities Osteoarthritis Index pain and physical function subscale scores and mean patient global assessment of response to therapy at week 12. Safety assessments included monitoring vital signs, adverse events, study joint assessments, and clinical laboratory results at each study visit.Results: Four hundred eighty-three patients were randomized to treatment and included in the intent-to-treat analysis. All groups were similar with respect to baseline demographics except for gender, weight, and body mass index. Acetaminophen ER 3900 mg was significantly superior to placebo for all three primary end points; acetaminophen ER 1950 mg was significantly superior to placebo only with respect to patient assessment of response to therapy. Study treatments were generally well tolerated, and there was no significant difference among the groups in the overall number of adverse events.Conclusions: Acetaminophen ER 3900 mg/d administered for up to 12 weeks was effective in treating moderate to moderately severe chronic OA pain of the hip or knee and was generally well tolerated. (C) 2006 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.