经皮椎体成形术结合补肾壮骨汤治疗骨质疏松性胸腰椎压缩骨折的Meta分析

摘要

目的 系统评价经皮椎体成形术 (PVP) 结合补肾壮骨汤与单纯经皮椎体成形术 (PVP) 治疗骨质疏松性胸腰椎压缩骨折的疗效与安全性, 为骨质疏松性胸腰椎压缩骨折的治疗提供更好的科学依据.方法 计算机检索Pubmed、Embase、Cochrane图书馆、CNKI、中国生物医学文献数据库 (CBM) 、万方医学网等数据库, 人工检索Spine等期刊, 收集比较经皮椎体成形术 (PVP) 结合补肾壮骨汤与单纯经皮椎体成形术 (PVP) 治疗骨质疏松性胸腰椎压缩骨折的临床随机对照试验, 并评价纳入研究的方法学质量.使用Review Manager 5.3软件对数据进行Meta分析, 观察指标包括术后椎体高度恢复情况、治疗有效率、Cobb角、骨密度 (BMD) 、VAS评分、Oswestry功能障碍指数 (ODI) 及新发骨折率.结果 最终纳入9项随机对照试验 (randomized controlled trial, RCT), 共745例患者, 其中PVP结合补肾壮骨汤组381例, 单纯PVP组364例.Meta分析结果示, 与单纯PVP组相比, PVP结合补肾壮骨汤组治疗有效率高[OR=5.11, 95％CI (2.51～10.40), P＜0.00001], 骨密度 (BMD) 提高程度大[MD=0.09, 95％CI (0.01～0.16), P=0.04], VAS评分低[MD=-1.03, 95％CI (-1.51～-0.55), P＜0.0001], Oswestry功能障碍指数 (ODI) 低[MD=-4.90, 95％CI (-6.93～-2.86), P＜0.00001], 新发骨折率低[OR=0.10, 95％CI (0.02～0.55), P=0.008], 而两者在Cobb角改善[MD=-0.46, 95％CI (-2.39～1.48), P=0.64]方面, 差异无统计学意义.结论 与单纯PVP相比, PVP结合补肾壮骨汤能明显提高骨密度及治疗有效率, 有效降低VAS评分、Oswestry功能障碍指数及新发骨折率, 进而显著提升患者的生活质量.%Objective To evaluate the efficacy and safety of percutaneous vertebroplasty (PVP) combined with nourishing kidney and strong bone decoction versus simple PVP on the treatment of osteoporotic thoracolumbar vertebral compression fractures, and to provide a better scientific basis for the treatment of thoracolumbar compression fractures. Methods The clinical randomized controlled trails (RCTs) of PVP combined with nourishing kidney and strong bone decoction versus simple PVP on the treatment of osteoporotic thoracolumbar vertebral compression fractures were retrieved from databases such as Pubmed, Embase, Cochrane Library, CNKI, China Biomedical Literature Database (CBM), Wanfang Medical Network, and manually searched Spine and other journals and were compared. The quality of the method ology included in the studies was evaluated. Meta-analysis was performed on the data using Review Manager 5.3 software. The indicators included vertebral height of postoperative, treatment efficiency rate, Cobb's angle, bone mineral density (BMD), VAS score, Oswestry disability index (ODI), and new fracture rate. Results Nine RCTs were included in the study. A total of 745 patients were enrolled, of which 381 were in PVP combined with nourishing kidney and strong bone decoction group and 364 were in simple PVP group. Meta-analysis result showed that compared with simple PVP group, PVP combined with nourishing kidney and strong bone decoction group had higher treatment efficiency rate [OR=5.11, 95％ CI (2.51-10.40), P ＜0.00001], increased BMD [MD=0.09, 95％ CI (0.01-0.16), P=0.04], lower VAS score [MD=-1.03, 95％ CI (-1.51——0.55), P＜0.0001], lower ODI [MD=-4.90, 95％ CI (-6.93——2.86), P＜0.00001], and lower new fracture rate [OR=0.10, 95％ CI (0.02-0.55), P=0.008]. There was no significant difference in Cobb's angle improvement [MD=-0.46, 95％ CI (-2.39-1.48), P=0.64] between the two groups. Conclusion Compared with simple PVP, PVP combined with nourishing kidney and strong bone decoction significantly improves BMD and treatment efficiency rate, effectively reduces VAS score, ODI, and new fracture rate, and significantly improves the quality of life of the patients.