RhBMP-2复合体促进单节段腰椎椎间融合临床疗效的Meta分析

Efficacy of rh BMP-2 Complex in Lumbar Interbody Fusion a Meta-analysis

目的:通过Meta分析方法比较rhBMP-2复合体与自体髂骨块(ICBG)在融合率及临床疗效方面的差异。方法:通过检索2000年1月—2016年12月PUBMED、MEDLINE、EMBASE、Cochrane图书馆、中国期刊全文数据库等数据库以及人工检索中、英文已发表文献中的关于rhBMP-2复合体与ICBG施行腰椎椎间融合术治疗成人单节段腰椎退行性病变的随机对照试验研究文献。筛选符合纳入标准的相关文献,评价纳入研究的方法学质量。比较内容包括:手术时间、术中出血量、住院时间、融合失败率、ODI较术前恢复情况、二次手术数,应用RevMan5.0进行统计学分析。结果:根据纳入标准,共筛选出6篇文献共计577例患者。6篇文献方法学质量较高(≥6分)。Meta分析表明,rhBMP-2复合体能够显著缩短手术及住院时间、降低出血量、减少二次手术风险。术后24个月rhBMP-2复合体组融合失败率显著低于ICBG组。术后24个月ODI评分提高不明显病例的比例rhBMP-2复合体组少于ICBG组,但无统计学意义。根据手术入路不同进行亚组分析,除住院时间异质性较大,其余指标均得到相同结果。结论:rhBMP-2用于治疗单节段腰椎退行性病变,其中远期椎间融合率明显优于自体髂骨移植,并且前者可明显缩短手术及住院时间、降低出血量、减少二次手术风险。初步证明rhBMP-2复合体在进行腰椎椎间融合时的有效性以及对自体髂骨的替代作用。

Objective： To compare the efficacy of rhBMP-2 versus ICBG in the treatment of patients with symptomatic degenerative disc disease.Methods： RCT that compared rhBMP-2 with ICBG for lumbar fusion in the treatment of patients with adult single segmental DDD were identified by computer and manual searching from January 2000 to December 2016. The risk of bias and clinical relevance of the included studies were assessed. Methodological quality, clinical relevance and Publication bias of include studies are Standardized assessed according to thecriteria and the instructionsrecommended by the CBRG. Comparisonitem： operation time, blood loss, hospital stay, 24 monthsfollow-up （fusion failure, ODI improvement, reoperation. RevMan 5.0 software was used for data analysis.Results： Six randomized controlled trials（S77 patients）met the inclusion criteria. All studies have high Methodological quality （a6 scores）. According theperioperativeperiod and 24 months follow-up results, metaanalysisshowedthat ： The use of rhBMP-2 complex significantlyshortened operation timeand hospital stay and reducedblood lossand reoperation. Compared with ICBG, the use of rhBMP-2 significantly decreased the risk of fusion failure at 24 months. There was no statistical difference in clinical improvement on the ODI, although a favorable trend in the rhBMP-2 group was found. Subgroup analyses stratified by the type of surgical procedure yielded similar results.Conclusion： RhBMP-2 complex in the treatment of patients with single segmental DDD was superior to the ICBG for achieving fusion success, shortening operation time and hospital stay, reducedblood lossand avoiding reoperation. This study preliminary evidence that rhBMP-2 complex has good efficacy for the lumbar interbody fusion, and substitution for the ICBG.