Effects of bracing in adolescents with idiopathic scoliosis.
Effects of bracing in adolescents with idiopathic scoliosis.
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DOI：
10.1056/nejmoa1307337
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发表时间：
2013-10-17
期刊：
影响因子：
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通讯作者：
Dobbs MB
中科院分区：
文献类型：
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作者：
Weinstein SL;Dolan LA;Wright JG;Dobbs MB
支具在青少年特发性脊柱侧凸患者中的作用存在争议，这些患者有弯曲进展和最终手术的风险。我们进行了一项多中心研究，纳入了因年龄、骨骼不成熟和脊柱侧凸程度而具有典型支具适应症的患者。随机队列和偏好队列均入组。在纳入分析的242名患者中，116名被随机分配到支具或观察组，126名在支具和观察之间进行选择。支具组的患者被指示每天至少佩戴支具18小时。主要结局是弯曲进展至50度或以上（治疗失败）和骨骼成熟度无此程度的弯曲进展（治疗成功）。由于支具的有效性，试验提前停止。在一项包括随机队列和偏好队列的分析中，支具治疗后的成功率为72%，而观察后为48%（治疗成功的倾向评分调整比值比为1.93; 95%置信区间[CI]为1.08至3.46）。在意向治疗分析中，随机分配到支具组的患者治疗成功率为75%，而随机分配到观察组的患者治疗成功率为42%（比值比，4.11; 95%CI，1.85 - 9.16）。支具佩戴时间与治疗成功率呈显著正相关（P<0.001）。在青少年特发性脊柱侧凸患者中，支具显著降低了高风险曲线的进展至手术阈值。这种好处随着支具佩戴时间的延长而增加。（由国家关节炎、肌肉骨骼和皮肤疾病研究所等资助; BRAIST ClinicalTrials.gov编号，NCT 00448448。
The role of bracing in patients with adolescent idiopathic scoliosis who are at risk for curve progression and eventual surgery is controversial. We conducted a multicenter study that included patients with typical indications for bracing due to their age, skeletal immaturity, and degree of scoliosis. Both a randomized cohort and a preference cohort were enrolled. Of 242 patients included in the analysis, 116 were randomly assigned to bracing or observation, and 126 chose between bracing and observation. Patients in the bracing group were instructed to wear the brace at least 18 hours per day. The primary outcomes were curve progression to 50 degrees or more (treatment failure) and skeletal maturity without this degree of curve progression (treatment success). The trial was stopped early owing to the efficacy of bracing. In an analysis that included both the randomized and preference cohorts, the rate of treatment success was 72% after bracing, as compared with 48% after observation (propensity-score–adjusted odds ratio for treatment success, 1.93; 95% confidence interval [CI], 1.08 to 3.46). In the intention-to-treat analysis, the rate of treatment success was 75% among patients randomly assigned to bracing, as compared with 42% among those randomly assigned to observation (odds ratio, 4.11; 95% CI, 1.85 to 9.16). There was a significant positive association between hours of brace wear and rate of treatment success (P<0.001). Bracing significantly decreased the progression of high-risk curves to the threshold for surgery in patients with adolescent idiopathic scoliosis. The benefit increased with longer hours of brace wear. (Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and others; BRAIST ClinicalTrials.gov number, NCT00448448.)