Richards B Stephens, Bernstein Robert M, D'Amato Charles R, Thompson George H
Department of Orthopaedic Surgery, Texas Scottish Rite Hospital for Children, Dallas, TX 75219, USA.
Spine (Phila Pa 1976). 2005 Sep 15;30(18):2068-75; discussion 2076-7. doi: 10.1097/01.brs.0000178819.90239.d0.
Literature review.
To establish consistent parameters for future adolescent idiopathic scoliosis bracing studies so that valid and reliable comparisons can be made.
Current bracing literature lacks consistency for both inclusion criteria and the definitions of brace effectiveness.
A total of 32 brace treatment studies and the current bracing in adolescent idiopathic scoliosis proposal were analyzed to: (1) determine inclusion criteria that will best identify those patients most at risk for progression, (2) determine the most appropriate definitions for bracing effectiveness, and (3) identify additional variables that would provide valuable information.
Early brace studies lacked clarity in their inclusion criteria. In more recent studies, inclusion criteria have narrowed considerably to include primarily those patients most at risk for curve progression who may benefit from the use of a brace. Brace effectiveness was usually defined by various degrees of curve progression at maturity. Less frequently, it was defined by the resultant curve magnitude at maturity, whether or not surgical intervention was needed, or if there was change to another brace.
Optimal inclusion criteria for future adolescent idiopathic scoliosis brace studies consist of: age is 10 years or older when brace is prescribed, Risser 0-2, primary curve angles 25 degrees -40 degrees , no prior treatment, and, if female, either premenarchal or less than 1 year postmenarchal. Assessment of brace effectiveness should include: (1) the percentage of patients who have < or =5 degrees curve progression and the percentage of patients who have > or =6 degrees progression at maturity, (2) the percentage of patients with curves exceeding 45 degrees at maturity and the percentage who have had surgery recommended/undertaken, and (3) 2-year follow-up beyond maturity to determine the percentage of patients who subsequently undergo surgery. All patients, regardless of subjective reports on compliance, should be included in the results (intent to treat). Every study should provide results stratified by curve type and size grouping.
文献综述。
为未来青少年特发性脊柱侧弯支具治疗研究建立一致的参数，以便进行有效且可靠的比较。
目前的支具治疗文献在纳入标准和支具疗效定义方面缺乏一致性。
共分析了32项支具治疗研究以及当前青少年特发性脊柱侧弯支具治疗方案，以：（1）确定最能识别那些进展风险最高患者的纳入标准；（2）确定支具疗效的最合适定义；（3）识别能提供有价值信息的其他变量。
早期的支具研究纳入标准不明确。在最近的研究中，纳入标准已大幅缩小，主要包括那些侧弯进展风险最高且可能从支具使用中获益的患者。支具疗效通常根据成熟时不同程度的侧弯进展来定义。较少情况下，根据成熟时最终的侧弯度数、是否需要手术干预或是否更换为另一种支具来定义。
未来青少年特发性脊柱侧弯支具治疗研究的最佳纳入标准包括：开出处方时年龄为10岁或以上，Risser分级0 - 2级，主弯角度25度 - 40度，未接受过先前治疗，且如果是女性，月经初潮前或月经初潮后不到1年。支具疗效评估应包括：（1）成熟时侧弯进展≤5度的患者百分比和进展≥6度的患者百分比；（2）成熟时侧弯超过45度的患者百分比以及建议/接受手术的患者百分比；（3）成熟后2年随访以确定随后接受手术的患者百分比。所有患者，无论关于依从性的主观报告如何，均应纳入结果（意向性分析）。每项研究都应提供按侧弯类型和大小分组分层的结果。
