Abstract

To evaluate the haemostatic efficacy and safety of prophylactic oral administration of Yunan Baiyao capsules on reduction of blood loss in bimaxillary orthognathic surgery. 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. 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. Prophylactic oral administration of Yunnan Baiyao capsules can effectively reduce the intra-operative blood loss in bimaxillary orthognathic surgery. Yunnan Baiyao capsule are an effective and safe haemostatic traditional Chinese medicine.

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