椎体成形术与非手术治疗骨质疏松性椎体压缩骨折的系统评价
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摘要
目的:通过系统评价的方法对椎体成形术与非手术治疗骨质疏松性椎体压缩骨折的疗效进行评价。方法:计算机检索Cochrane Library(2011年第1期)、PubMed (1966/2011-01)、EMBASE(1974/2011-01)、CBM (1978/2011-01)、CNKI(1994/2011-01)、和万方数据库(1997/2011-01)。纳入椎体成形术治疗骨质疏松性椎体压缩骨折的随机对照试验,按照Cochrane Handbook5.0进行严格的质量评估,采用RevMan5.0.17软件进行Meta分析。结果:共纳入4个随机对照试验,共445例患者。Meta分析结果显示:椎体成形术与保守治疗组随访1周、1月、6月、12月的VAS评分分别为[WMD=-2.10,95%CI(-2.81,-1.39)]、[WMD=-2.40,95%CI (-3.13,-1.67)]、[WMD=-1.60,95%CI (-2.37,-0.83)]、[WMD=-1.60,95%CI(-2.45,-0.75)],两组差异均有统计学意义;干预后相邻椎体骨折发生率[OR=0.71,95%CI(0.35,1.43)],两组差异无统计学意义。椎体成形术与安慰剂组随访1月时VAS评分、RDQ评分、EQ-5D评分分别为[WMD=-0.13,95%CI(-1.39,1.13)]、[WMD=-0.22,95%CI (-2.01,1.57)]、[WMD=-0.05,95%CI (-0.01,0.11)],两组差异均无统计学意义;干预后相邻椎体骨折发生率[OR=0.75,95%CI(0.16,3.62)],两组差异无统计学意义;干预不良事件发生率[OR=1.28,95%CI (0.53,3.11)],两组差异无统计学意义。结论:现有研究结果显示,与保守治疗相比,随访1周、1月、6月、12月时椎体成形术在缓解疼痛方面更明显,在相邻椎体骨折发生方面,两种治疗方法没有差别;与安慰剂相比,随访1月时椎体成形术在缓解疼痛、提高腰部功能活动及改善生活质量方面并无明显优势,随访期间相邻椎体骨折和不良事件的发生椎体成形术与安慰剂两组之间无明显差别。受本系统评价纳入研究数量以及质量的限制,上述结论尚需要更多高质量的随机对照试验进一步验证。
Objective:To evaluate the effectiveness of vertebroplasty versus nonoperative in treatment of vertebral compression fractures. Methods:Randomized controlled trials (RCTs) related to vertebroplasty in treatment of vertebral compression fractures were identified from The Cochrane Library (the first issue of 2011),PubMed (1966 to Jan. 2011), EMBASE (1974 to Jan.2011), CBM (1978 to Jan.2011), CNKI (1994 to Jan. 2011), and WANFANG Databases (1997 to Jan.2011). The quality of included studies was evaluated according to the criteria provided by Cochrane Collaboration. Meta-analyses were performed by RevMan 5.0.17 software. Results:4 RCTs involving 445 patients were included. The results of meta-analyses indicated that there were significant differences between the vertebroplasty and conservative treatment follow-up 1th week and1th,6th and 12th month in VAS scores [WMD=-2.10,95%CI(-2.81,-1.39)], [WMD=-2.40,95%CI (-3.13,-1.67)], [WMD=-1.60,95%CI(-2.37,-0.83)], [WMD=-1.60, 95%CI(-2.45,-0.75)], While the rates of new adjacent vertebral compression fractures [OR=0.71,95%CI (0.35,1.43)]. There were no significant differences between the vertebroplasty and placebo follow-up 1th month in VAS scores [WMD=-0.13,95%CI (-1.39,1.13)], RDQ scores [WMD=-0.22,95%CI(-2.01,1.57)], EQ-5D scores [WMD=-0.05,95%CI (-0.01,0.11)], and there were no significant differences between the vertebroplasty and placebo the rates of new adjacent vertebral compression fractures [OR=0.75,95%CI (0.16,3.62)], the rates of adverse events [OR=1.28,95%CI (0.53, 3.11)]. Conclusion:The evidence indicates that compared with conservative treatment group, vertebroplasty could significantly relief pain throughout follow-up, however, compared with the placebo group, there is no advantage for the vertebroplasty group over the placebo group in back-pain relief, functional disability, and quality of life. More RCTs are required to verify these conclusions owing to the limitations of the present study.
引文
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