|A multicenter, phase III trial of hemocoagulase Agkistrodon: hemostasis, coagulation, and safety in patients undergoing abdominal surgery|
|Wei Jun-min1; Zhu Ming-wei1; Zhang Zhong-tao2; Jia Zhen-geng3; He Xiao-dong4; Wan Yuan-lian5; Wang Shan6; Xu Dian-rong7; Tang Yun8; Li Jie9; Xu Jing-yong1; Zheng Qing-shan10|
|关键词||Hemocoagulase Agkistrodon Incision Bleeding Hemostasis Coagulation Randomized Controlled Trial|
|刊名||CHINESE MEDICAL JOURNAL|
|WOS标题词||Science & Technology|
|类目[WOS]||Medicine, General & Internal|
|研究领域[WOS]||General & Internal Medicine|
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. Chin Med J 2010;123(5):589-593
|作者单位||1.Beijing Hosp, Dept Gen Surg, Beijing 100730, Peoples R China|
2.Ctr Clin Evaluat Drugs, Yijishan 241000, Anhui, Peoples R China
3.Beijing Friendship Hosp, Dept Gen Surg, Beijing 100050, Peoples R China
4.China Japan Friendship Hosp, Dept Gen Surg, Beijing 100029, Peoples R China
5.Beijing Union Med Coll Hosp, Dept Gen Surg, Beijing 100730, Peoples R China
6.Peking Univ, Dept Gen Surg, Affiliated Hosp 1, Beijing 100034, Peoples R China
7.Peking Univ, Peoples Hosp, Dept Gastrointestinal Surg, Beijing 100044, Peoples R China
8.Peking Univ, Dept Gen Surg, Affiliated Hosp 3, Beijing 100083, Peoples R China
9.Chinese Peoples Liberat Army Gen Hosp, Dept Gastrointestinal Surg, Beijing 100853, Peoples R China
10.Beijing Tongren Hosp, Dept Gen Surg, Beijing 100730, Peoples R China
|Wei Jun-min,Zhu Ming-wei,Zhang Zhong-tao,et al. A multicenter, phase III trial of hemocoagulase Agkistrodon: hemostasis, coagulation, and safety in patients undergoing abdominal surgery[J]. CHINESE MEDICAL JOURNAL,2010,123(5):589-593.|
|APA||Wei Jun-min.,Zhu Ming-wei.,Zhang Zhong-tao.,Jia Zhen-geng.,He Xiao-dong.,...&Zheng Qing-shan.(2010).A multicenter, phase III trial of hemocoagulase Agkistrodon: hemostasis, coagulation, and safety in patients undergoing abdominal surgery.CHINESE MEDICAL JOURNAL,123(5),589-593.|
|MLA||Wei Jun-min,et al."A multicenter, phase III trial of hemocoagulase Agkistrodon: hemostasis, coagulation, and safety in patients undergoing abdominal surgery".CHINESE MEDICAL JOURNAL 123.5(2010):589-593.|