Original Article
Effect of Huisheng oral solution on coagulation function in perioperative period in patients with primary lung cancer Xiaoguang Yang1, Helin Zhang2, Fanyi Kong3, Guochen Wang4, Qianyu Gu5, Zheng Zhao1, Tiezhi Li2, Mingming Ren3, Zuosheng Li4, Yang Guo5 1
Handan Central Hospital, Handan 056001, China; 2The Second Hospital of Hebei Medical University, Shijiazhuang 050000, China; 3Cangzhou
Central Hospital, Cangzhou 061001, China; 4North China University of Science and Technology Affiliated Hospital, Tangshan 063000, China; 5
Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, Shijiazhuang 050000, China
Contributions: (I) Conception and design: Y Guo; (II) Administrative support: Y Guo; (III) Provision of study materials or patients: X Yang, H Zhang, F Kong, G Wang, Q Gu, Z Zhao, T Li, M Ren, Z Li; (IV) Collection and assembly of data: X Yang, H Zhang, F Kong, G Wang, Q Gu, Z Zhao, T Li, M Ren, Z Li; (V) Data analysis and interpretation: X Yang, Y Guo; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors. Correspondence to: Yang Guo. Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, Shijiazhuang 050000, China. Email: [email protected].
Background: The incidence of venous thromboembolism (VTE) is about 4–10% in lung cancer patients. Huisheng oral solution (HSOS) has been previously demonstrated to inhibit carageenan induced acute thrombosis in rats, reduce the incidence of thrombosis in the lungs and mesentery of tumor-bearing mice and inhibit tumor cell metastasis. The purpose of this study was to assess the anticoagulant effect of HSOS in lung cancer patients in the perioperative period. Methods: This study was a multicenter, randomized, single-blind, blank-controlled clinical trial. A total of patients at five hospitals in Hebei Province, China were included. The patients were randomly divided into study group or control group according to random number table. The primary outcome was the blood test indices in both groups. The study group was given oral HSOS (20 mL, bid) from admission until 24 h before surgery. If no active bleeding was observed, the patients were given oral HSOS (20 mL, tid) from 24 h to 24 d postoperatively. The patients in the study group did not receive any other anticoagulation therapy during the study period and the control group only underwent surgery. The study protocol was approved by the local ethics committee of principal investigator hospital. Blood samples were taken at admission (before therapy), 24 h, 72 h, 10 d (before discharge) and 24 d (first visit after discharge) after surgery. Routine blood tests [red blood cell (RBC) count, white blood cell (WBC) count, hemoglobin (HGB), and platelet (PLT) count] and coagulation function test [prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB), and plasma D-dimer] were performed. The changes in outcome measures over time were analyzed by repeated measures analysis of variance to compare the differences between groups and between different time points and assess the impact of tumor stage and mode of surgery on them. All tests were two-tailed, and P values
Effect of Huisheng oral solution on coagulation function in perioperative period in patients with primary lung cancer Xiaoguang Yang1, Helin Zhang2, Fanyi Kong3, Guochen Wang4, Qianyu Gu5, Zheng Zhao1, Tiezhi Li2, Mingming Ren3, Zuosheng Li4, Yang Guo5 1
Handan Central Hospital, Handan 056001, China; 2The Second Hospital of Hebei Medical University, Shijiazhuang 050000, China; 3Cangzhou
Central Hospital, Cangzhou 061001, China; 4North China University of Science and Technology Affiliated Hospital, Tangshan 063000, China; 5
Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, Shijiazhuang 050000, China
Contributions: (I) Conception and design: Y Guo; (II) Administrative support: Y Guo; (III) Provision of study materials or patients: X Yang, H Zhang, F Kong, G Wang, Q Gu, Z Zhao, T Li, M Ren, Z Li; (IV) Collection and assembly of data: X Yang, H Zhang, F Kong, G Wang, Q Gu, Z Zhao, T Li, M Ren, Z Li; (V) Data analysis and interpretation: X Yang, Y Guo; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors. Correspondence to: Yang Guo. Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, Shijiazhuang 050000, China. Email: [email protected].
Background: The incidence of venous thromboembolism (VTE) is about 4–10% in lung cancer patients. Huisheng oral solution (HSOS) has been previously demonstrated to inhibit carageenan induced acute thrombosis in rats, reduce the incidence of thrombosis in the lungs and mesentery of tumor-bearing mice and inhibit tumor cell metastasis. The purpose of this study was to assess the anticoagulant effect of HSOS in lung cancer patients in the perioperative period. Methods: This study was a multicenter, randomized, single-blind, blank-controlled clinical trial. A total of patients at five hospitals in Hebei Province, China were included. The patients were randomly divided into study group or control group according to random number table. The primary outcome was the blood test indices in both groups. The study group was given oral HSOS (20 mL, bid) from admission until 24 h before surgery. If no active bleeding was observed, the patients were given oral HSOS (20 mL, tid) from 24 h to 24 d postoperatively. The patients in the study group did not receive any other anticoagulation therapy during the study period and the control group only underwent surgery. The study protocol was approved by the local ethics committee of principal investigator hospital. Blood samples were taken at admission (before therapy), 24 h, 72 h, 10 d (before discharge) and 24 d (first visit after discharge) after surgery. Routine blood tests [red blood cell (RBC) count, white blood cell (WBC) count, hemoglobin (HGB), and platelet (PLT) count] and coagulation function test [prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB), and plasma D-dimer] were performed. The changes in outcome measures over time were analyzed by repeated measures analysis of variance to compare the differences between groups and between different time points and assess the impact of tumor stage and mode of surgery on them. All tests were two-tailed, and P values
