青少年特发性脊柱侧凸支具治疗的成功受支具佩戴时间的影响：Braist 和 ISICO 队列的比较有效性分析。
Adolescent Idiopathic Scoliosis Bracing Success Is Influenced by Time in Brace: Comparative Effectiveness Analysis of BrAIST and ISICO Cohorts.
机构信息
Department of Orthopaedics and Rehabilitation, University of Iowa, Iowa City, IA.
Italian Scientific Spine Institute (ISICO), Milan, Italy.
出版信息
Spine (Phila Pa 1976). 2020 Sep 1;45(17):1193-1199. doi: 10.1097/BRS.0000000000003506.
STUDY DESIGN
Comparative effectiveness study OBJECTIVE.: To evaluate factors leading to higher percentage of brace failures in a cohort of North American patients with adolescent idiopathic scoliosis relative to their peers in Italy.
SUMMARY OF BACKGROUND DATA
Studies of bracing in United States have shown worse outcomes than studies from European centers, possibly due to sample characteristics or treatment approaches.
METHODS
Sample: Braced patients, aged 10 to 15, Risser <3, Cobb 20°- to 40°, observed to Cobb ≥40° and/or ≥Risser 4 selected from prospective databases. Comparators: Bracing per Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) (TLSO) and Italian Scientific Spine Institute (ISICO) protocol (SPoRT braces with or without SEAS exercises). Baseline characteristics (sex, age, BMI, Risser, Cobb, curve type) and average hours of brace wear/day. Differences in programs (e.g., SEAS, type of brace, weaning protocol) were captured by a variable named "SITE."
OUTCOME
Treatment failure (Cobb ≥40 before Risser 4).
STATISTICS
Comparison of baseline characteristics, analyses of risk factors, treatment components, and outcomes within and between cohorts using logistic regression.
RESULTS
A total of 157 BrAIST and 81 ISICO subjects were included. Cohorts were similar at baseline but differed significantly in terms of average hours of brace wear: 18.31 in the ISICO versus 11.76 in the BrAIST cohort. Twelve percent of the ISICO and 39% of the BrAIST cohort had failed treatment. Age, Risser, Cobb, and a thoracic apex predicted failure in both groups. SITE was related to failure (odds ratio [OR] = 0.19), indicating lower odds of failure with ISICO versus BrAIST approach. With both SITE and wear time in the model, SITE loose significance. In the final model, the adjusted odds of failure were higher in boys (OR = 3.34), and those with lowest BMI (OR = 9.83); the odds increased with the Cobb angle (OR = 1.23), and decreased with age (OR = 0.41) and hours of wear (OR = 0.86).
CONCLUSION
Treatment at the ISICO resulted in a lower failure rate, primarily explained by longer average hours of brace wear.
LEVEL OF EVIDENCE
研究设计
比较效力研究
目的
评估北美的青少年特发性脊柱侧凸患者中，导致支具失败率高于意大利同龄患者的因素。
背景资料概要
美国的支具研究结果不如欧洲中心的研究结果，这可能是由于样本特征或治疗方法的不同。
方法
样本：从前瞻性数据库中选择年龄在 10 至 15 岁、Risser ＜3、Cobb 20°-40°、观察到 Cobb ＞40°和/或 Risser ＞4 的接受支具治疗的青少年特发性脊柱侧凸患者。对照组：Bracing in Adolescent Idiopathic Scoliosis Trial（BraAIST）（TLSO）和意大利脊柱科学研究所（ISICO）方案（SPoRT 支具，带或不带 SEAS 运动）中的支具治疗。基线特征（性别、年龄、BMI、Risser、Cobb、曲线类型）和每天支具佩戴时间。通过一个名为“SITE”的变量捕获方案之间的差异（例如 SEAS、支具类型、逐渐减少使用的方案）。
结果
治疗失败（Cobb 在 Risser 4 之前＞40°）。
统计学
使用逻辑回归分析在队列内和队列间比较基线特征、危险因素分析、治疗组成和结果。
结果
共纳入 157 名 BraAIST 和 81 名 ISICO 患者。两组基线相似，但支具佩戴时间有显著差异：ISICO 组平均为 18.31 小时，BraAIST 组为 11.76 小时。ISICO 组有 12%的患者和 BraAIST 组有 39%的患者治疗失败。年龄、Risser、Cobb 和胸椎顶点在两组中均预测治疗失败。SITE 与失败有关（比值比[OR]＝0.19），表明 ISICO 方法的失败几率较低。在模型中加入 SITE 和佩戴时间后，SITE 的显著性降低。在最终模型中，男孩（OR＝3.34）和最低 BMI（OR＝9.83）的患者失败的可能性更高；Cobb 角越大（OR＝1.23），年龄越小（OR＝0.41），佩戴时间越短（OR＝0.86），失败的几率越低。
结论
在 ISICO 处进行治疗的失败率较低，这主要归因于支具平均佩戴时间较长。
证据水平
3 级。
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