口服云南白药对下颌智齿拔牙创愈合影响的随机双盲对照研究

Effect of Yunnan Baiyao capsules on the socket healing of impacted mandibular third molar extraction

目的评价口服云南白药胶囊对下颌阻生智齿拔除术后拔牙创愈合过程是否有影响。方法采用多中心、随机、双盲、安慰剂平行对照的研究设计。样本量200例，试验组与对照组各100例，分别于拔牙术后口服云南白药胶囊或安慰剂胶囊，2g／d，连续用药28d。术后两个月对患者行CT扫描，测量拔牙创内的新生骨体积和新生骨密度。结果188例病例符合试验方案（试验组95例、对照组93例）。试验过程中无严重药物不良事件发生。测量新生骨体积：试验组（477．39±166．47）mm3、对照组（442．65±143．58）mm3，两组差异无统计学意义（P〉0．05）；新生骨密度：试验组（296．90±37．94）mg／cm3、对照组（298．54±40．21）mg／cm3，两组间差异无统计学意义（P〉0．05）。患牙阻生位置高低、牙根数目、是否保留牙槽间隔、术后1周拔牙创内血凝块形成情况、拔牙创是否严密缝合与新生骨体积有显著相关性[r值分别为O．304（P=0．010）、0．273（P=O．021）、0．275（P=0．019）、0．377（P=0．001）、0．405（P=0．000）]。结论①口服云南白药对下颌阻生智齿拔除术后两个月拔牙创内新生骨密度及体积未见明显影响；②患牙阻生位置、牙根数目、是否保留牙槽间隔、术后1周拔牙创内血凝块形成情况、是否严密缝合拔牙创将影响拔牙创内新骨生成体积。

Objective To investigate the effect of the traditional Chinese medicine Yunan Baiyao on the socket healing of impacted mandibular third molar extraction. Methods A total of 200 patients requiring extractions of impacted mandibular wisdom teeth were randomized into the treatment group and the control group in a double-blinded manner, and Yunan Baiyao capsules or placebo capsules （2 g/d ） were orally administered for 28 days after the operation. Dental quantitative CT scan was performed, and the volume and density of new bone at the extraction site were measured two month after operation. Results A total of 188 patients completed the study. No adverse events related to the medication occurred. The volume of new bone was （477. 39 ± 166.47）mm3 in the treatment group and （442. 65 ± 143.58）ram3 in the control group, which was not significantly different between the two groups. The density of new bone was （296. 90 ± 37.94） mg/cm3 in the treatment group and （298.54 ±40. 21 ） mg/cm3 in the control group, which was not significantly different between the two groups. The number of the teeth root, the impacted conditions, whether or not retainning the alveolar septum, suturing soft tissues of the extraction site and blood clot formation within 1 week after operation were significantly correlated with the volume of new bone. Conclusions Yunnan Baiyao capsules has no effect on the volume and density of new bone at the extraction site two months after operation following extractions of impacted mandibular third molars.