NEJM:手术与物理疗法治疗半月板撕裂和骨关节炎效果相似
2013-05-28 NEJM 丁香园
对于有一个半月板撕裂和膝骨关节炎的、有症状的患者,目前还无法确定进行关节镜下的部分半月板切除术是否较非手术治疗可以获得更佳的功能转归。美国波士顿市布里格姆和妇女医院的Jeffrey N. Katz博士等人的研究结果显示,在意向治疗分析结果中未发现两个研究组在随机化后6个月时的功能改善方面存在显著差异,但在6个月中,30%的分配到单纯物理疗法组的患者接受了手术治疗。研究结果发表于2013年5月最新一
对于有一个半月板撕裂和膝骨关节炎的、有症状的患者,目前还无法确定进行关节镜下的部分半月板切除术是否较非手术治疗可以获得更佳的功能转归。美国波士顿市布里格姆和妇女医院的Jeffrey N. Katz博士等人的研究结果显示,在意向治疗分析结果中未发现两个研究组在随机化后6个月时的功能改善方面存在显著差异,但在6个月中,30%的分配到单纯物理疗法组的患者接受了手术治疗。研究结果发表于2013年5月最新一期的国际权威杂志NEJM在线版。
研究人员开展了一项多中心随机对照试验,试验中纳入了有症状的、年龄≥45岁、有一个半月板撕裂和影像学检查证实的轻中度膝部骨关节炎患者。研究者随机将351例患者分配接受手术加术后物理疗法或一个标准的物理疗法方案(其备选方案是经患者和外科医师慎重研究后可转为外科治疗)治疗。第6和12个月时对患者进行评估。主要终点是随机化后6个月时西安大略和麦克马斯特大学骨关节炎指数(WOMAC)身体功能评分(分数范围为0~100,得分越高,症状越重)相应变化的组间差异。
结果显示,在意向治疗分析中,手术治疗组6个月后 的WOMAC平均得分提高了20.9分[95%可信区间(CI)为17.9~23.9],物理疗法组提高了18.5分(95% CI为15.6~21.5)(平均差值为2.4分,95% CI为-1.8~6.5)。6个月时,51例(30%)被分配到单纯物理疗法组的患者在研究期间接受了手术治疗,9例(6%)被分配到手术治疗组的患者最终未接受手术。12个月时的结果与6个月时相仿。组间的不良事件发生频率无显著差异。
研究人员由此得出结论,在意向治疗分析结果中未发现两个研究组在随机化后6个月时的功能改善方面存在显著差异,但在6个月内,30%的分配到单纯物理疗法组的患者接受了手术治疗。
Surgery versus physical therapy for a meniscal tear and osteoarthritis.
BACKGROUND
Whether arthroscopic partial meniscectomy for symptomatic patients with a meniscal tear and knee osteoarthritis results in better functional outcomes than nonoperative therapy is uncertain.
METHODS
We conducted a multicenter, randomized, controlled trial involving symptomatic patients 45 years of age or older with a meniscal tear and evidence of mild-to-moderate osteoarthritis on imaging. We randomly assigned 351 patients to surgery and postoperative physical therapy or to a standardized physical-therapy regimen (with the option to cross over to surgery at the discretion of the patient and surgeon). The patients were evaluated at 6 and 12 months. The primary outcome was the difference between the groups with respect to the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical-function score (ranging from 0 to 100, with higher scores indicating more severe symptoms) 6 months after randomization.
RESULTS
In the intention-to-treat analysis, the mean improvement in the WOMAC score after 6 months was 20.9 points (95% confidence interval [CI], 17.9 to 23.9) in the surgical group and 18.5 (95% CI, 15.6 to 21.5) in the physical-therapy group (mean difference, 2.4 points; 95% CI, -1.8 to 6.5). At 6 months, 51 active participants in the study who were assigned to physical therapy alone (30%) had undergone surgery, and 9 patients assigned to surgery (6%) had not undergone surgery. The results at 12 months were similar to those at 6 months. The frequency of adverse events did not differ significantly between the groups.
CONCLUSIONS
In the intention-to-treat analysis, we did not find significant differences between the study groups in functional improvement 6 months after randomization; however, 30% of the patients who were assigned to physical therapy alone underwent surgery within 6 months. (Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases; METEOR ClinicalTrials.gov number, NCT00597012.).
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#骨关节#
61
#关节炎#
47
#半月板#
49
#物理疗法#
72