补肾活血汤联合椎体成形术治疗OVCF:提高骨密度、改善生存质量的Meta分析

Meta⁃analysis of the efficacy and safety of Bushen Huoxue decoction in the treatment of Osteoporosis

目的:本研究通过系统分析补肾活血汤联合椎体成形术(PVP或PKP)治疗骨质疏松性椎体压缩骨折(OVCF)的远期疗效,为临床应用评价提供循证依据。方法:为保证研究数据的可靠性、新颖性,系统搜索自2017年1月~2023年2月之间公开发表在知网(CNKI)、万方等中文数据库及PubMed、Cochrane等英文数据库中的有关补肾活血汤联合椎体成形术治疗OVCF的RCT研究。由两位研究员独立进行文献筛选、数据提取,根据Cochrane协作网评价标准对纳入研究逐个进行质量评价,最终符合纳入标准的研究采用RevMan5.3进行分析。结果:最终纳入7篇RCT,Meta分析结果显示:在总有效率[RR=1.30,95%CI(1.14,1.47),P<0.0001]、VAS评分[SMD=1.19,95%CI(0.77,1.61),P<0.00001]、BMD评分[SMD=1.09,95%CI(0.15,2.04),P=0.02]、COQOL评分[SMD=0.99,95%CI(0.68,1.30),P<0.00001]、OPG评分[SMD=0.48,95%CI(0.18,0.77),P=0.002]、RANKL评分[SMD=1.33,95%CI(1.00,1.65),P<0.00001]方面,观察组均显著优于对照组。在ODI评分[SMD=0.27,95%CI(−0.03,0.57),P=0.08]、Cobb评分[SMD=1.52,95%CI(−1.05,4.09),P=0.25]、椎体高度评分[SMD=0.43,95%CI(−0.14,1.01),P=0.14]方面无显著性差异。结论:在提高OVCF术后患者骨密度、减轻疼痛方面,补肾活血汤联合椎体成形术具有明显优势,优于单纯应用OVCF。

Objective:To systematically evaluate the long‐term efficacy of Bushen Huoxue decoction combined with vertebroplasty(PVP or PKP)in the treatment of osteoporotic vertebral compression fractures(OVCF),in order to provide evidencebased reference for clinical application.Methods:To ensure the novelty and reliability of research data,all randomized controlled studies and clinical trials publishd between January 2017 and February 2023 at home and abroad on the treatment of OVCF with Bushen Huoxue Decoction combined with vertebroplasty in CNKI,Wanfang,Vip,PubMed,CBM,and Cochrane libraries were searched.Two researchers independently conducted literature screening and data extraction,evaluated the quality of randomized controlled trials one by one according to the Cochrane collaboration network standards,and conducted a meta statistical analysis using RevMan5.3 for studies that met the inclusion criteria.Results:A total of 684 patients were included in seven randomized controlled trials,including 342 patients in the observation group and 342 patients in the control group,with a ratio of 1:1;The metaanalysis results showed that in the observation group,the overall effective rate[RR=1.30,95%CI(1.14,1.47),P<0.0001],visual analog pain(VAS)score[SMD=1.19,95%CI(0.77,1.61),P<0.00001],bone mineral density score[SMD=1.09,95%CI(0.15,2.04),P=0.02],COQOL score[SMD=0.99,95%CI(0.68,1.30),P<0.00001],OPG score[SMD=0.48,95%CI(0.18,0.77),P=0.002]and the RANKL score[SMD=1.33,95%CI(1.00,1.65),P<0.00001]were significantly superior to the control group,with statistically significant differences.There was no significant difference in the Oswestry Disability Index(ODI)score[SMD=0.27,95%CI(−0.03,0.57),P=0.08],Cobb score[SMD=1.52,95%CI(−1.05,4.09),P=0.25],and vertebral height score[SMD=0.43,95%CI(−0.14,1.01),P=0.14].Conclusion:The results show that Bushen Huoxue decoction combined with vertebroplasty has significant advantages in improving bone mineral density and alleviating pain in patients after OVCF,which is significantly superior to using OVCF alone.