首页|期刊导航|中华医学杂志（英文版）|A multicenter,phase III trial of hemocoagulase Agkistrodon:hemostasis,coagulation,and safety in patients undergoing abdominal surgery
A multicenter,phase III trial of hemocoagulase Agkistrodon:hemostasis,coagulation,and safety in patients undergoing abdominal surgery
WEI Jun-min LI Jie XU Jing-yong ZHENG Qing-shan ZHU Ming-wei ZHANG Zhong-tao JIA Zhen-geng HE Xiao-dong WAN Yuan-lian WANG Shan XIU Dian-rong TANG Yun
中华医学杂志（英文版）2010，Vol.123Issue(5)：589-593,5.
中华医学杂志（英文版）2010，Vol.123Issue(5)：589-593,5.DOI:10.3760/cma.j.issn.0366-6999.2010.05.016
A multicenter,phase III trial of hemocoagulase Agkistrodon:hemostasis,coagulation,and safety in patients undergoing abdominal surgery
A multicenter,phase III trial of hemocoagulase Agkistrodon:hemostasis,coagulation,and safety in patients undergoing abdominal surgery
摘要
Abstract
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/cm~2. In the control group, the corresponding values were (38.1±19.7) seconds, (4.00±4.75) g, and (0.095±0.101) g/cm~2, 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 trialKey words
hemocoagulase Agkistrodon/incision bleeding/hemostasis/coagulation/randomized controlled trial引用本文复制引用
WEI Jun-min,LI Jie,XU Jing-yong,ZHENG Qing-shan,ZHU Ming-wei,ZHANG Zhong-tao,JIA Zhen-geng,HE Xiao-dong,WAN Yuan-lian,WANG Shan,XIU Dian-rong,TANG Yun..A multicenter,phase III trial of hemocoagulase Agkistrodon:hemostasis,coagulation,and safety in patients undergoing abdominal surgery[J].中华医学杂志（英文版）,2010,123(5):589-593,5.基金项目
This study was supported by a grant from the High-Tech Research and Development Program of China ("863" program, No. 2003AA2Z3157). （"863" program, No. 2003AA2Z3157）
