球囊椎体后凸成形术与保守治疗对预后不良的急性骨质疏松性椎体骨折的疗效比较：来自两项前瞻性多中心研究数据的倾向性评分匹配分析。
Balloon Kyphoplasty Versus Conservative Treatment for Acute Osteoporotic Vertebral Fractures With Poor Prognostic Factors: Propensity Score Matched Analysis Using Data From Two Prospective Multicenter Studies.
机构信息
Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan.
Department of Orthopaedic Surgery, Osaka General Hospital of West Japan Railway Company, Osaka, Japan.
出版信息
Spine (Phila Pa 1976). 2019 Jan 15;44(2):110-117. doi: 10.1097/BRS.0000000000002769.
STUDY DESIGN
A multicenter, prospective, single-arm, intervention study.
OBJECTIVE
The aim of this study was to investigate efficacy of balloon kyphoplasty (BKP) for acute osteoporotic vertebral fractures (OVFs) in patients with poor prognostic factors.
SUMMARY OF BACKGROUND DATA
The indications for BKP remain unclear. Characteristic magnetic resonance imaging (MRI) findings (high-intensity or diffuse low-intensity area in fractured vertebrae on T2-weighted images) were reportedly predictive of delayed union.
METHODS
This study enrolled 106 patients with poor prognostic MRI findings who underwent BKP within 2 months after injury, and 116 controls with acute OVFs and the same poor prognostic factors who underwent conservative treatment. Patients were propensity score matched in a logistic regression model adjusted for age, sex, number of baseline old fractures, and fracture level. The primary outcome was reduction in activities of daily living (ADLs) at 6 months after fracture, and the secondary outcomes were improvement in short-form (SF)-36 subscales, back pain visual analog scale (VAS) score, and vertebral body deformity.
RESULTS
A decrease in ADLs occurred in 5.6% of patients in the BKP group and 25.6% of patients in the conservative treatment group (P < 0.001). The SF-36 vitality subscale score improved by 26.9 ± 25.9 points in the BKP group and 14.5 ± 29.4 points in the control group (P = 0.03). The VAS pain score improved by 43.4 ± 34.4 in the BKP group and 52.2 ± 29.8 in the control group (P = 0.44). The vertebral body wedge angle improved by 5.5 ± 6.2° in the BKP group and -6.3 ± 5.0° in the control group (P < 0.0001). The percent vertebral body height improved by 15.2 ± 19.2% in the BKP group and -20.6 ± 14.2% in the control group (P < 0.0001).
CONCLUSION
ADLs, quality of life, and vertebral deformity showed greater improvement with BKP intervention for acute OVF with poor prognostic factors than with conservative treatment at 6 months after injury. Our treatment strategy uses BKP intervention according to the presence or absence of poor prognostic MRI findings.
LEVEL OF EVIDENCE
研究设计
一项多中心、前瞻性、单臂、干预研究。
目的
本研究旨在探讨球囊扩张椎体后凸成形术（BKP）治疗伴有不良预后因素的急性骨质疏松性椎体骨折（OVF）的疗效。
背景资料概要
BKP 的适应证仍不明确。据报道，特征性磁共振成像（MRI）表现（T2 加权图像上骨折椎体的高信号或弥漫性低信号区）与延迟愈合相关。
方法
本研究纳入了 106 例伴有不良预后 MRI 表现的患者，这些患者在损伤后 2 个月内行 BKP 治疗，同时纳入了 116 例伴有相同不良预后因素且接受保守治疗的急性 OVF 对照患者。通过逻辑回归模型对年龄、性别、基线陈旧骨折数量和骨折水平进行调整，对患者进行倾向评分匹配。主要结局为骨折后 6 个月时日常生活活动（ADL）的减少，次要结局为简明健康状况量表（SF）-36 子量表、腰背疼痛视觉模拟评分（VAS）和椎体畸形的改善。
结果
BKP 组中 5.6%的患者 ADL 下降，而保守治疗组中 25.6%的患者 ADL 下降（P＜0.001）。BKP 组 SF-36 活力子量表评分改善 26.9±25.9 分，对照组改善 14.5±29.4 分（P=0.03）。BKP 组 VAS 疼痛评分改善 43.4±34.4 分，对照组改善 52.2±29.8 分（P=0.44）。BKP 组椎体楔形角改善 5.5±6.2°，对照组改善-6.3±5.0°（P＜0.0001）。BKP 组椎体高度百分比改善 15.2±19.2%，对照组改善-20.6±14.2%（P＜0.0001）。
结论
与保守治疗相比，对于伴有不良预后因素的急性 OVF，BKP 干预治疗在骨折后 6 个月时，ADL、生活质量和椎体畸形改善更明显。我们的治疗策略是根据不良预后 MRI 表现的有无来选择 BKP 干预治疗。
证据等级
4 级。
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