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 Hemocoagul...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.展开更多
Background Snake venom contains a number of components with different pharmacological and biological activities, especially in cancer therapy, and has increasingly become a research focus. This study was designed to i...Background Snake venom contains a number of components with different pharmacological and biological activities, especially in cancer therapy, and has increasingly become a research focus. This study was designed to isolate and purify a novel anti-clotting protein component from the venom of Agkistrodon acutus, and to explore its physico-chemical properties and biological activity. Methods The venom of Agkistrodon was isolated and purified by ion-exchange chromatography on diethylaminoethyl （DEAE）-Sepharose Fast Flow, molecular sieve filtration through Sephadex G75, SP-Sepharose Fast Flow and molecular sieve filtration through Sephadex G50. We detected the activated partial thromboplastin time （APTT） of the eluant to select the anti-clotting protein component of interest. The molecular weight was determined by sodium dodecyl sulfate-polyacrylamid gel electrphoresis （SDS-PAGE） and liquid chromatography. Its protein content was detected by bicinchoninic acid （BCA）. Results SDS-PAGE vertical gel electrophoresis showed that the anticoagulant factor is a tripolymer composed of three proteins whose molecular weights are 25 KDa, 30 KDa and 50 KDa. The factor contains about 65% percent protein. Conclusions A novel anti-clotting protein component was purified by ion-exchange chromatography and molecular sieve filtration from the venom of Agkistrodon acutus and was found to be composed of three kinds of proteins.展开更多
Objectives： To determine the effective dosage and formulation of agkistrodon in collagen-induced arthritis（CIA） rats. Methods： CIA was induced by injection of collagen in complete/incomplete Freund＇s adjuvant. Ag...Objectives： To determine the effective dosage and formulation of agkistrodon in collagen-induced arthritis（CIA） rats. Methods： CIA was induced by injection of collagen in complete/incomplete Freund＇s adjuvant. Agkistrodon decoction, agkistrodon powder, and agkistrodon wine were administered daily starting from the onset of arthritis. Paw swelling degree was measured by using a volume-measuring instrument every 7 days after primary immunization. Arthritis index was measured and calculated using the ＂five scoring method＂ every 7 days. The levels of serum interleukin-1β（IL-1β） and type Ⅱ collagen Ig G antibodies were detected by enzyme-linked immunosorbent assay. Finally, all ankles were removed, and X-ray radiography was performed with In-vivo Imaging System FX. Samples were counterstained with hematoxylin and eosin for analysis. Results： Among the various dosage formulations of agkistrodon, high-dose powder, which was equivalent to an amount of 6 g/day in adults, showed better effects on the inhibition of joint swelling and reduction of arthritis index score. The relatively low levels of serum IL-1 and anti-type Ⅱ collagen Ig G antibodies, as well as the X-ray radiography and pathology results, further proved the superiority of the high-dose powder over the other formulations. The effect of decoction on inhibiting joint swelling was inversely proportional to the dosage. Other effects, such as reduction of arthritis index score and the levels of serum IL-1 and anti-type Ⅱ collagen Ig G antibodies, were directly proportional to the dosage. While the use of large dose agkistrodon wine led to negative effects. Conclusions： These data highlight the potential function of high-dose agkistrodon powder, which was equivalent to an amount of 6 g/day in adults. The powder can quickly relieve the symptoms of rheumatoid arthritis and prevent aggravation of disease, especially during the early period.展开更多
文摘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.
文摘Background Snake venom contains a number of components with different pharmacological and biological activities, especially in cancer therapy, and has increasingly become a research focus. This study was designed to isolate and purify a novel anti-clotting protein component from the venom of Agkistrodon acutus, and to explore its physico-chemical properties and biological activity. Methods The venom of Agkistrodon was isolated and purified by ion-exchange chromatography on diethylaminoethyl （DEAE）-Sepharose Fast Flow, molecular sieve filtration through Sephadex G75, SP-Sepharose Fast Flow and molecular sieve filtration through Sephadex G50. We detected the activated partial thromboplastin time （APTT） of the eluant to select the anti-clotting protein component of interest. The molecular weight was determined by sodium dodecyl sulfate-polyacrylamid gel electrphoresis （SDS-PAGE） and liquid chromatography. Its protein content was detected by bicinchoninic acid （BCA）. Results SDS-PAGE vertical gel electrophoresis showed that the anticoagulant factor is a tripolymer composed of three proteins whose molecular weights are 25 KDa, 30 KDa and 50 KDa. The factor contains about 65% percent protein. Conclusions A novel anti-clotting protein component was purified by ion-exchange chromatography and molecular sieve filtration from the venom of Agkistrodon acutus and was found to be composed of three kinds of proteins.
基金Supported by the Traditional Chinese Medicine Scientific Research Fund of Zhejiang Province,China(No.2013ZA063 and No.2012ZB062)the Key Scientific and Technological Innovation Team Plan of Zhejiang Province,China(No.2009R50042-002)the Third Level of 151 Talents Project of Zhejiang Province,China
文摘Objectives： To determine the effective dosage and formulation of agkistrodon in collagen-induced arthritis（CIA） rats. Methods： CIA was induced by injection of collagen in complete/incomplete Freund＇s adjuvant. Agkistrodon decoction, agkistrodon powder, and agkistrodon wine were administered daily starting from the onset of arthritis. Paw swelling degree was measured by using a volume-measuring instrument every 7 days after primary immunization. Arthritis index was measured and calculated using the ＂five scoring method＂ every 7 days. The levels of serum interleukin-1β（IL-1β） and type Ⅱ collagen Ig G antibodies were detected by enzyme-linked immunosorbent assay. Finally, all ankles were removed, and X-ray radiography was performed with In-vivo Imaging System FX. Samples were counterstained with hematoxylin and eosin for analysis. Results： Among the various dosage formulations of agkistrodon, high-dose powder, which was equivalent to an amount of 6 g/day in adults, showed better effects on the inhibition of joint swelling and reduction of arthritis index score. The relatively low levels of serum IL-1 and anti-type Ⅱ collagen Ig G antibodies, as well as the X-ray radiography and pathology results, further proved the superiority of the high-dose powder over the other formulations. The effect of decoction on inhibiting joint swelling was inversely proportional to the dosage. Other effects, such as reduction of arthritis index score and the levels of serum IL-1 and anti-type Ⅱ collagen Ig G antibodies, were directly proportional to the dosage. While the use of large dose agkistrodon wine led to negative effects. Conclusions： These data highlight the potential function of high-dose agkistrodon powder, which was equivalent to an amount of 6 g/day in adults. The powder can quickly relieve the symptoms of rheumatoid arthritis and prevent aggravation of disease, especially during the early period.
