A multicenter, phase III trial of hemocoagulase Agkistrodon： hemostasis, coagulation, and safety in patients undergoing abdominal surgery  

作　　者：WEI Jun-min ZHU Ming-wei ZHANG Zhong-tao JIA Zhen-geng HE Xiao-dong WAN Yuan-lian WANG Shan XIU Dian-rong TANG Yun LI Jie XU Jing-yong ZHENG Qing-shan 

机构地区：[1]Department of General Surgery, Beijing Hospital, Beijing 100730, China [2]Department of General Surgery, Beijing Friendship Hospital, Beijing 100050, China [3]Department of General Surgery, China-Japan Friendship Hospital, Beijing 100029, China [4]Department of General Surgery, Peking Union Medical College Hospital, Beijing 100730, China [5]Department of General Surgery, First Affiliated Hospital of Peking University, Beijing 100034, China [6]Department of Gastrointestinal Surgery, Peking University People's Hospital, Beijing 100044, China [7]Department of General Surgery, Third Affiliated Hospital of Peking University, Beijing 100083, China [8]Department of Gastrointestinal Surgery, Chinese PLA General Hospital, Beijing 100853, China [9]Department of General Surgery, Beijing Tongren Hospital, Bejing 100730, China [10]Center for Clinical Evaluation of Drugs, Yijishan, Anhui 241000, China

出　　处：《Chinese Medical Journal》2010年第5期589-593,共5页中华医学杂志（英文版）

摘　　要：Background Hemocoagulase Agkistrodon for injection is a single component thrombin which has passed phases I and II clinical trials. The purpose of this phase III clinical trial was to evaluate the effect of Hemocoagulase Agkistrodon on hemostasis and coagulation in abdominal skin and subcutaneous incisions and to assess the safety of this agent in surgical patients. Methods This is a phase III, prospective, randomized, double-blind, and controlled multicenter clinical trial including 432 consecutive patients randomized into either a study group （injected with hemocoagulase Agkistrodon at 2 U, n=-324） or a control group （injected with hemocoagulase Atrox, n=108）. The hemostatic time, hemorrhagic volume, hemorrhagic volume per unit area, blood coagulation, and adverse events were measured and compared between the two groups. Results The mean hemostatic time in the study group was （36.8±18.7） seconds; the hemorrhagic volume was （3.77±3.93） g; and the hemorrhagic volume per unit area was （0.091±0.125） g/cm2. In the control group, the corresponding values were （38.1±19.7） seconds, （4.00±4.75） g, and （0.095±0.101） g/cm2, respectively. No significant difference in values existed between the two groups （P 〉0.05）. Blood coagulation results and hepatic and renal function were also similar between the two groups. Adverse events were reported in two cases, but were deemed non-drug-related. Conclusions Hemocoagulase Agkistrodon has good hemostatic and coagulative function and is safe for the use of arresting capillary hemorrhage that occurs while incising the abdomen during surgery.Background Hemocoagulase Agkistrodon for injection is a single component thrombin which has passed phases I and II clinical trials. The purpose of this phase III clinical trial was to evaluate the effect of Hemocoagulase Agkistrodon on hemostasis and coagulation in abdominal skin and subcutaneous incisions and to assess the safety of this agent in surgical patients. Methods This is a phase III, prospective, randomized, double-blind, and controlled multicenter clinical trial including 432 consecutive patients randomized into either a study group （injected with hemocoagulase Agkistrodon at 2 U, n=-324） or a control group （injected with hemocoagulase Atrox, n=108）. The hemostatic time, hemorrhagic volume, hemorrhagic volume per unit area, blood coagulation, and adverse events were measured and compared between the two groups. Results The mean hemostatic time in the study group was （36.8±18.7） seconds; the hemorrhagic volume was （3.77±3.93） g; and the hemorrhagic volume per unit area was （0.091±0.125） g/cm2. In the control group, the corresponding values were （38.1±19.7） seconds, （4.00±4.75） g, and （0.095±0.101） g/cm2, respectively. No significant difference in values existed between the two groups （P 〉0.05）. Blood coagulation results and hepatic and renal function were also similar between the two groups. Adverse events were reported in two cases, but were deemed non-drug-related. Conclusions Hemocoagulase Agkistrodon has good hemostatic and coagulative function and is safe for the use of arresting capillary hemorrhage that occurs while incising the abdomen during surgery.

关 键 词：hemocoagulase Agkistrodon incision bleeding HEMOSTASIS COAGULATION randomized controlled trial 

分 类 号：Q592.1[生物学—生物化学] S858.31[农业科学—临床兽医学]