CAJ | 학술논문

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3 d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.
목적 연구화평개구복운남백약효낭대정합외과술중출혈량적영향화안전성.방법 장수행Le Fort Ⅰ형절골술화쌍측하합승지시상벽개절골술(bilateral sagittal split ramus osteotomy,BSSRO)적아.합.면기형환자87례근거수궤수자표분위A조(43례)화B조(44례),술전3 d개시분별구복운남백약효낭혹안위제효낭,비교분석술중출혈량차이병관찰용약과정중적안전성.결과 87례환자중,출혈총량평균치:A조(330.5±134.4)ml,B조(420.3±175.9)ml,량조출혈총량비교,차이유통계학의의(P<0.05).A조Le Fort Ⅰ형절골술평균출혈량(154.9±84.3)ml,B조(203.8±98.1)ml,량조비교차이유통계학의의(P<0.05).A조BSSRO평균출혈량(175.6+81.3)ml저우B조BSSRO평균출혈량(216.4±113.8)ml,량조비교차이무통계학의의(P>0.05).량조환자술후섬용공능검사결과,차이무통계학의의(P>0.05).위수술기미발생불량반응.결론 술전구복운남백약효낭가유효감소정합외과술중출혈량,동시불회증가혈전형성풍험.
Objective To evaluate the haemostatie ~cacy and safety of prophylactic oral administration of Yanan Baiyao capsules on reduction of blood loss in bimaxillary orthognathic surgery.Methods Eighty-seven patients scheduled for Le Fort I esteotomy 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 Yurman Baiyao capsules 3 days before operation, and 44 patients without Yunnan Baiyao administration served as controL The intranperative 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 osteoromy 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 Condusions Prophylactic oral administration of Yunnan Baiyao capsules can effectively reduce the intra-operative blood loss in bimaxillary orthoguathic surgery. Yunnan Baiyao capsule are an effective and safe haemostatie traditional Chinese medicine.