中国大陆人工颈椎间盘置换术后异位骨化发生率的Meta分析

The incidence of heterotopic ossification in cervical artificial disc replacement in Chinese mainland population： A meta-analysis

【摘要】目的了解中国大陆人群人工颈椎间盘置换术后异位骨化的发生率。方法系统检索1997年1月至2012年6月公开发表的文献，检索的英文数据库包括Pubmed、Ovid、Cochranelibrary和Embase，中文数据库包括中国生物医学文献数据库（CBM）、中国期刊全文数据库（CNKI）、维普数据库（VIP）和万方数据库，检索时间为2012年6月。制定文献的纳入及排除标准，严格按照纳入、排除标准进行文献的筛选；制定文献摘录表，采用独立双摘录；采用Meta．Analyst软件进行统计分析。计算，以检验研究之间的异质性，当严≥25％时，采用随机效应模型。按照置换节段数量、人工椎间盘品牌和置换后随访时间进行亚组分析。根据样本量是否≥20进行敏感性分析。结果共纳入分析文献40篇，中文36篇，英文4篇。40篇文献中包括患者1822例，男女比例为1．53：1。单节段置换12篇，混合节段置换27篇，未说明1篇。加权合并的异位骨化发生率为7．3％（95％CI为4．7％，11．0％），单节段置换和混合节段置换的发生率分别为11．6％和5．8％。Bryan椎间盘异位骨化发生率为7．2％，单节段置换和混合节段置换的发生率分别为13．8％和5．4％。不管是单节段置换或者混合节段置换，异位骨化的发生率逐年升高。经敏感性分析，研究结果相对稳定。结论中国大陆人群人工颈椎间盘置换术后异位骨化的发生率较高，但低于国外人群；有必要监测其远期发生率。

Objective To investigate the incidence of heterotopic ossification in cervical artificial disc replacement in Chinese mainland population by meta-analysis. Methods The related literatures pub- lished between 1997 and June 2012 were collected from both English databases, including Pubmed, Ovid, Cochrane library and Embase, and Chinese databases including Chinese Biomedical Literature Database, China National Knowledge Infrastructure, VIP database and Wanfang database. Literatures were selected in strict accordance with the inclusion and exclusion criteria. Studies providing data of prevalence of hetero- topic ossification after cervical artificial disc replacement in Chinese mainland population were included. The information of literatures was extracted by excerpts questionnaire, and recorded by two independent re- searchers. /2 was calculated to test heterogeneity among studies. A random effects model was used if F I〉 25%. Subgroup analysis was done according to the number of levels of disc replacement, brands of implants and duration of follow-up. Sensitivity analysis was done according to the sample size. The Meta-Analyst soft- ware was used for statistical analysis. Results A total of forty studies （1822 cases） were included in this study. The pooled incidence of heterotopic ossification was 7.3% （95%C1：4.7% to 11.0%）. For single and mixed level disc replacement, the incidence was 11.6% and 5.8%, respectively. For single and mixed level disc replacement using Bryan disc, the incidence was 13.8% and 5.4%, respectively, and the total incidence was 7.2%. No matter the single or mixed level disc replacement, the incidence of heterotopic ossification in- creased with follow-up. Conclusion The incidence of heterotopic ossification in cervical artificial disc re- placement is high in Chinese mainland population, while it is lower than in foreigners. However, it is neces- sary to monitor its long-term incidence due to its increase with follow-up.