A Preliminary, Multicenter, Prospective and Real World Study on the Hemostasis, Coagulation, and Safety of Hemocoagulase Bothrops Atrox in Patients Undergoing Transurethral Bipolar Plasmakinetic Prostatectomy

Abstract

Objective: To evaluate the hemostasis and coagulation effect of Hemocoagulase Bothrops Atrox in benign prostatic hyperplasia (BPH) patients undergoing transurethral bipolar plasmakinetic prostatectomy (TUPKP). Methods: This study adopted a multicenter, prospective, and real world design. BPH patients undergoing TUPKP were divided into two groups according to whether they adopted Hemocoagulase Bothrops Atrox (group B) or not (group A) during perioperative period. The electronic clinical data on every included subject, including the international prostate symptom score (IPSS) and the quality of life scale (QoL), maximum urinary flow rate (Qmax), complete blood count, coagulation screening test and adverse events, were measured and compared between the two groups. Results: Finally, 695 patients, 443 in group A and 252 in group B were included. Baseline characteristics showed no significant difference between two groups. In group A, compared with baseline, IPSS decreased 15.66 (95% CI = −16.45 to −14.87), QoL decreased 3.08 (95% CI = −3.30 to −2.87), prothrombin time prolonged 1.02 s (95% CI = 0.56 to 1.48), while white blood cells, neutrophils, lymphocytes, and hemoglobin also significantly changed; white blood cells, neutrophils and platelets increased, while lymphocytes decreased by 0.14×109/L (95% CI = −0.21 to −0.08) before discharge. In group B, compared with baseline, IPSS decreased 16.12 (95% CI = −17.02 to −15.21), QoL decreased 3.32 (95% CI = −3.56 to −3.07), and white blood cells, neutrophils, lymphocytes, and hemoglobin were also significantly changed, along with white blood cells and lymphocytes that tested before discharge (p < 0.01); however, prothrombin time was not significant prolonged (MD= 0.48, 95% CI = −0.05 to 1.01). When compared with group A and group B, the average hospitalization time in group A was longer than group B (p < 0.01), transfusion risk was similar in the two groups (OR = 1.582, 95% CI = 0.552 to 4.538). Parameters had no substantial difference between the two subgroups whether prostate volume was more than 80 mL or not. Conclusion: Our study indicated that Hemocoagulase Bothrops Atrox can shorten the prothrombin time, hospitalization time and is probably safe among BPH patients undergoing TUPKP, exhibiting fine hemostasis and coagulation efficacy, and would not be influenced by prostate volume.

Methodological quality (risk of bias) assessment tools for primary and secondary medical studies: what are they and which is better?

“…Comparative effectiveness research (CER) compares real-world outcomes [51] resulting from alternative treatment options that are available for a given medical condition. Its key elements include the study of effectiveness (effect in the real world), rather than efficacy (ideal effect), and the comparisons among alternative strategies [52].…”

Heamocoagulase Agkistrodon on Hemostatic Effectivity on Posterior Lumbar Operation

“…Hemocoagulase agkistrodon does not activate coagulation factor ⅩⅢ, therefore, it is not easy to cause thrombosis. At present, multiple research results indicated that Hemocoagulase agkistrodon was safe and effective for hemostasis by intravenous administration [7,16]. Relevant animal experiments also confirmed that Hemocoagulase agkistrodon does not affect the number of prothrombin and platelets in the blood, and there is no platelet aggregation in normal blood vessels.…”

“…Hemocoagulase agkistrodon for injection is an effective drug to reduce perioperative bleeding [16]. It is a hemostatic active ingredient extracted from the venom of Agkistrodon acutus.…”

A Species-Specific Strategy for the Identification of Hemocoagulase Agkistrodon halys pallas Based on LC-MS/MS-MRM

“…Hemocoagulase is one of the most important and indispensable drugs used in surgical operations. Hemocoagulase for Injection is a member of the biological product family, exhibiting a fine hemostasis and coagulation efficacy, which has been widely used as a hemostatic in China ( Li et al, 2019 ). At present, the hemagglutinin drugs on the market in China are mainly isolated from the venom of Bothrops atrox (Baquting ® ), Deinagkistrodon acutus (Suling ® ), Vipera russelli siamensis (Sulejuan ® ), and Agkistrodon halys pallas (Bangting ® ), and their main active ingredients are svTLEs.…”

“…In addition, some svTLEs can also activate plasminogen and induce platelet aggregation ( Castro et al, 2004 ; Sajevic et al, 2011 ). Hemocoagulase atrox for Injection (Reptilase ® and Baquting ® ) isolated from the venom of Bothrops atrox is the earliest and most widely used hemostatic in clinical settings ( Funk et al, 1971 ; Li et al, 2019 ). Hemocoagulase Agkistrodon for Injection (Suling ® ) is isolated from the venom of Deinagkistrodon acutus and contains a single thrombin-like component ( Li et al, 2018 ).…”