摘要
目的研究和评价口服云南白药胶囊对正颌外科术中出血量的影响和安全性。方法将需行Le Fort Ⅰ型截骨术和双侧下颌升支矢状劈开截骨术(bilateral sagittal split ramus osteotomy,BSSRO)的牙-颌-面畸形患者87例根据随机数字表分为A组(43例)和B组(44例),术前3d开始分别口服云南白药胶囊或安慰剂胶囊,比较分析术中出血量差异并观察用药过程中的安全性。结果87例患者中,出血总量平均值:A组(330.5±134.4)ml,B组(420.3±175.9)ml,两组出血总量比较,差异有统计学意义(P〈0.05)。A组Le Fort Ⅰ型截骨术平均出血量(154.9±84.3)ml,B组(203.8±98.1)ml,两组比较差异有统计学意义(P〈0.05)。A组BSSRO平均出血量(175.6±81.3)ml低于B组BSSRO平均出血量(216.4±113.8)ml,两组比较差异无统计学意义(P〉0.05)。两组患者术后纤溶功能检查结果,差异无统计学意义(P〉0.05)。围手术期未发生不良反应。结论术前口服云南白药胶囊可有效减少正颌外科术中出血量,同时不会增加血栓形成风险。
Objective To evaluate the haemostatic efficacy and safety of prophylactic oral administration of Yunan Baiyao capsules on reduction of blood loss in bimaxillary orthognathic surgery. Methods Eighty-seven patients scheduled for Le Fort Ⅰ osteotomy and bilateral sagittal split ramus osteotomy(BSSRO) were enrolled in the prospective, randomized, double-blind, placebo-controlled clinical study. Forty-three patients took prophylactic oral administration of Yunnan Baiyao capsules 3 days before operation,and 44 patients without Yunnan Baiyao administration served as control. The intraoperative blood loss during Le Fort Ⅰ osteotomy and bilateral sagittal split ramus osteotomy was estimated and the safety of Yunnan Baiyao capsules was evaluated. Results The total blood loss in the Yunnan Baiyao group ( 330. 5 ± 134. 4) ml was significantly lower than that of the control group (420. 3 ± 175.9) ml. The blood loss of Le Fort I osteotomy in the Yunnan Baiyao group ( 154. 9 ± 84. 3 ) ml was also significantly lower than that of the control group ( 203. 8 ± 98.1 ) ml. The mean blood loss of BSSRO in the Yunnan Baiyao group was also lower than that of the control group, but the differences was not significant. The post-operative fibrinolysis was in the same level in both groups. Thromboemblic events or other side effects were not observed in this clinical trial. Conclusions Prophylactic oral administration of Yunnan Baiyao capsules can effectively reduce the intra-operative blood loss in bimaxiUary orthognathic surgery. Yunnan Baiyao capsule are an effective and safe haemostatic traditional Chinese medicine.
出处
《中华口腔医学杂志》
CAS
CSCD
北大核心
2008年第9期542-545,共4页
Chinese Journal of Stomatology
关键词
云南白药
失血
手术
正颌外科
Yunnan Bai Yao
Blood loss,surgical
Orthognathic surgery