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

Bing-Hui Li; Zhao-Jun Yu; Chao-Yang Wang; Hao Zi; Xiao-Dong Li; Xing-Huan Wang; Xuan-Yi Ren; Tong-Zu Liu; Hang Zheng

doi:10.3389/fphar.2019.01426

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

Front Pharmacol. 2019 Nov 27:10:1426. doi: 10.3389/fphar.2019.01426. eCollection 2019.

Authors

Bing-Hui Li¹, Zhao-Jun Yu², Chao-Yang Wang³, Hao Zi^{1

3

4}, Xiao-Dong Li^{3

4}, Xing-Huan Wang¹, Xuan-Yi Ren⁵, Tong-Zu Liu¹, Hang Zheng¹

Affiliations

¹ Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China.
² Medical Department of Graduate School, Nanchang University, Nanchang, China.
³ Center for Evidence-Based Medicine, Institute of Evidence-Based Medicine and Knowledge Translation, Henan University, Kaifeng, China.
⁴ Department of Urology, Huaihe Hospital of Henan University, Kaifeng, China.
⁵ Department of Urology, Kaifeng Central Hospital, Kaifeng, China.

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.

Keywords: benign prostatic hyperplasia; blood transfusion; coagulation; hemocoagulase bothrops atrox; hemostasis; real world study; transurethral bipolar plasmakinetic prostatectomy.