牙槽突裂二期植骨中的可吸收胶原膜:安全有效性系统评价

Absorbable collagen membrane for secondary alveolar bone grafting in alveolar cleft surgery: safety and effectiveness

背景:理论上将可吸收胶原膜应用于牙槽突裂二期植骨可提高移植骨的保存率,减缓骨吸收,然而目前所报道的研究结果并不一致。目的:系统评价可吸收胶原膜在牙槽突裂二期植骨中的作用与安全性。方法:应用计算机电子检索Medline、荷兰医学文摘、中国生物医学文献数据库和中国学术期刊网络出版总库,同时对文献的引文进行追索,获取研究可吸收胶原膜对牙槽突裂二期植骨作用的临床随机对照试验和临床对照试验,试验组接受可吸收胶原膜的骨移植物,对照组仅接受骨移植物,对两组植骨临床成功率、受区并发症发生率进行Meta分析。结果与结论:最终纳入文献5篇,共387例患者,涉及植骨裂隙416侧。Meta分析显示,以新骨形成高度≥牙槽突高度50%为标准定义植骨临床成功率,试验组植骨临床成功率高于对照组(P=0.002,相对危险度RR=1.33,95%可信区间[1.11,1.60]);以新骨形成高度≥牙槽突高度75%为标准定义植骨临床成功率,试验组植骨临床成功率虽高于对照组,但差异无显著性意义(P=0.06,相对危险度RR=1.40,95%可信区间[0.99,1.99]);两组受区并发症发生率无差异(P=0.35,相对危险度RR=0.66,95%可信区间[0.28,1.58])。表明使用可吸收胶原膜能提高牙槽突裂二期植骨的临床成功率,并且是安全的,该结论还需要更多临床随机对照试验的证实。

BACKGROUND： Absorbable collagen membrane can be theoretically applied to secondary alveolar bone grafting in alveolar cleft surgery, which can improve the bone preservation and slow bone resorption. However, there is still no unified conclusion. OBJECTIVE： To assess the efficacy and safety of absorbable collagen membrane for secondary alveolar bone grafting via a systematic review. METHODS： MEDLINE, EMBASE, CBM and CAJD were searched for eligible articles addressing clinical randomized controlled or controlled trials of absorbable collagen membrane for secondary alveolar bone grafting. Test group received bone grafting with absorbable collagen membrane and control group only received bone grafting. Meta-analysis on the clinical success rate of bone grafting and incidence of complications in the recipient region was delivered with Revman 5.3. RESULTS AND CONCLUSION： Five clinical trials, involving 416 cleft sites and 387 participants, were included. Two had high risk of bias and the rest had unclear risk of bias. If ＂the height of new bone is ≥ 50% ofalveolar height＂ was adopted as clinical success, the clinical success rate of the test group was significantly higher than that of the control group（P=0.002, relative risk value=1.33, 95% confidence interval [1.11, 1.60]）. If ＂the height of new bone is ≥ 75% of alveolar height＂ was chosen as clinical success, the clinical success rate of the test group was higher than that of the control group, but there was no significant difference between the two groups（P=0.06, relative risk value=1.40, 95% confidence interval [0.99, 1.99]）. For safety, the use of absorbable collagen membrane could not increase the complications incidence（P=0.35, relative risk value=0.66, 95% confidence interval [0.28, 1.58]）. So, the use of absorbable collagen membrane is safe to improve the clinical success rate of secondary alveolar bone grafting in alveolar cleft surgery. More randomized controlled trials should be considered to reinforce the conclusion.