Objective  To evaluate the efficacy and safety of white-browed venom hemocoagulase for injection in surgical tresis vulnus.

Methods  Wanfang, VIP, and CNKI were computerized searched to collect randomized controlled trials (RCTs) of white-browed snake venom thrombin for hemostasis in surgical incisions from the construction of databases to December 1, 2023. Meta-analysis was performed using RevMan 5.4 software.

Results  A total of 13 RCTs with 1 027 patients were included. Meta-analysis showed that the mean hemostasis time, bleeding per unit area, intraoperative bleeding, and thrombin time (TT) on the first postoperative day in the white-browed snake venom hemocoagulase group were smaller than those in the control group (P<0.05); the activated partial thromboplastin time (APTT), prothrombin time (PT), and fibrinogen (FIB) content between the two groups were not statistically significant (P>0.05). Subgroup analysis showed that among different types of surgical incisions, the hemostasis time, bleeding per unit area and intraoperative bleeding were reduced in the white-browed snake venom hemocoagulase group (P<0.05). PT in the white-brow snake venom hemocoagulase group was greater than that in the control group on the first postoperative day of neurosurgical incisions (P<0.05), and the differences in TT, APTT, and FIB between the two groups were not statistically significant (P>0.05); in the first postoperative day of nasal endoscopic surgery and general surgical incisions, there were no statistically significant differences between the two groups in terms of TT, APTT, PT, and FIB (P>0.05); and in the first postoperative day of gynecological incisions, the TT and PT of the white-browed snake venom hemocoagulase group were lower than those of the control group (P<0.05), and the differences in APTT and FIB between the two groups were not statistically significant (P>0.05). A total of six studies reported adverse reactions after the use of white-browed snake venom hemocoagulase, of which four studies did not observe any adverse reactions.

Conclusion  Compared with the control group, white-browed snake venom hemocoagulase has better hemostatic efficacy for surgical incisions, and has less effect on the coagulation function of patients, without increasing the occurrence of adverse events, and has a better safety profile.

1.吴广通, 张夏华, 石玉岚. 注射用白眉蛇毒血凝酶止血机制初步研究[J]. 中国医药导报, 2011, 8(11): 47-49. [Wu GT, Zhang XH, Shi YL. Haemostasis mechanism of action of hemocoagulase for injection[J]. China Medical Herald, 2011, 8(11): 47-49]. DOI: 10.3969/j.issn.1673-7210.2011.11.022.

2.黄俊何. 白眉蝮蛇毒血凝酶的药理作用和临床应用 [J].  蛇志, 2010, 22(1): 39-41. DOI: 10.3969/j.issn.1001- 5639.2010.01.015.

3.注射用白眉蛇毒血凝酶说明书. 2009年版. 锦州奥鸿药业有限责任公司.

4.《中国国家处方集》编委会. 中国国家处方集 [M]. 北京: 人民军医出版社, 2010: 321.

5.刘中民, 主编. 急诊与灾难医学. 第3版[M]. 北京: 人民卫生出版社, 2018: 106, 117.

6.杨拔贤, 李文志, 主编. 麻醉学. 第3版[M]. 北京: 人民卫生出版社, 2013: 166.

7.陈孝平, 汪建平, 主编. 外科学. 第8版[M]. 北京: 人民卫生出版社, 2013: 356.

8.王卫平, 孙锟, 常立文, 主编. 儿科学. 第9版[M]. 北京: 人民卫生出版社, 2018: 104.

9.冯华, 季楠, 史录文, 主编. 蛇毒血凝酶临床应用指南 [M]. 北京: 中国协和医科大学出版社, 2017: 1-189.

10.The Cochrane Collaboration. Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0.[EB/ OL]. (2021-03)[2023-10-26] http://handbook-5-1.cochrane.org.

11.何黎明, 刘保国, 陈招, 等. 注射用白眉蛇毒血凝酶在创伤性脑损伤患者围术期中的应用[J]. 实用临床医药杂志, 2016, 20(13): 11-14. [He LM, Liu BG, Chen Z, et al. Clinical application of hemocoagulase for injection in perioperative patients with traumatic brain injury[J]. Journal of Clinical Medicine in Practice, 2016, 20(13): 11-14.] DOI: 10.7619/jcmp.201613004.

12.齐洪武, 乔民, 刘岩松, 等. 注射用白眉蛇毒血凝酶用于颅脑手术头皮切口止血疗效观察[J]. 中国药师, 2018, 21(10): 1807-1809. [Qi HW, Qiao M, Liu YS, et al. Clinical hemostasis effect of hemocoagulase for injection in scalp incision in craniocerebral surgery[J]. China Pharmacist, 2018, 21(10): 1807-1809.] DOI: 10.3969/j.issn.1008-049X.2018.10.027.

13.梁海烈. 白眉蛇毒血凝酶在鼻内镜手术中的止血疗效观察[J]. 现代保健: 医学创新研究, 2007, 4(11): 109.[Liang HL. Observation of hemostatic effect of white-browed snake venom hemocoagulase in nasal endoscopic surgery[J]. Modern Health (Medicine Innovation Research), 2007, 4(11): 109.] https://d.wanfangdata.com.cn/periodical/xdbj-yxcxyj200711090.

14.蔡晓菁, 严喆, 张家雄. 白眉蛇毒血凝酶在鼻内镜手术中的作用[J]. 同济大学学报(医学版), 2014, 35(1): 118-119, 123. [Cai XJ, Yan Z, Zhang JX, et al. Application of hemocoagulase in functional endoscopic sinus surgery[J]. Journal of Tongji University (Medical Science), 2014, 35(1): 118-119, 123.] DOI: 10.3969/j.issn 1008-0392.2014.01.027.

15.许航宇, 舒海荣. 白眉蛇毒血凝酶在内镜鼻窦手术中的止血效果[J]. 中国生化药物杂志, 2011(1): 54-56. [Xu HY, Shu HR. The effect of Hemocoagulase in the functional endoscopic sinus surgery[J]. Chinese Journal of Biochemical Pharmaceutics, 2011(1): 54-56.] DOI: 10.1007/s11606-010-1517-4.

16.杜苏明, 张小进, 江艺. 注射用白眉蛇毒血凝酶预防腹腔镜下胆囊切除术中出血的疗效和安全性观察 [J]. 临床普外科电子杂志, 2015, 3(4): 31-33. [Du SM, Zhang XJ, Jiang Y. Observation on clinical efficacy and safety of hemocoagulase for injection to prevent bleeding in laparoscopic cholecystectomy[J]. Journal of General Surgery for Clinicians (Electronic Version), 2015, 3(4): 31-33.] DOI: CNKI:SUN:LCPW.0.2015-04-011.

17.田先平, 方华, 沈国英, 等. 邦亭在肝功能受损病人手术中的应用[J]. 浙江临床医学, 2005, 7(9): 988. [Tian XP, Fang H, Shen GY, et al. The application of Bangting in surgery for patients with liver dysfunction[J]. Zhejiang Clinical Medical Journal, 2005, 7(9): 988.] DOI: 10.3969/j.issn.1008-7664.2005.09.089.

18.周兵, 冯强. 比较邦亭与止血芳酸在急性结石性胆囊炎围手术期的止血效果[J]. 当代医药论丛, 2013, 11(1): 179. [Zhou B, Feng Q. Comparison of the hemostatic effects of Bangting and hemostatic aromatic acid during the perioperative period of acute calculous cholecystitis[J]. Seek Medical and Ask the Medicine, 2013, 11(1): 179.] https://d.wanfangdata.com.cn/periodical/qywy-xsb201301186.

19.于洪儒. 白眉蛇毒血凝酶及其提取方法与应用: 中国专利, CN200710099163.X[P]. 2007-10-31.

20.邓佳, 兰志勋. 注射用白眉蛇毒血凝酶在甲状腺手术中的应用[J]. 四川医学, 2015, 36(12): 1674-1676. [Deng J, Lan ZX. Injection browed hemocoagulase in thyroid surgery[J]. Sichuan Medical Journal, 2015, 36(12): 1674-1676.] DOI: 10.16252/j.cnki.issn1004-0501-2015.12.018.

21.李晓勇, 贺爱军. 注射用白眉蛇毒血凝酶在普通外科手术中的应用研究[J]. 中国综合临床, 2008, 24(8): 826-827. [Li XY, He AJ. Application of injectable white eyebrow snake venom hemagglutinin in general surgical procedures[J]. Clinical Medicine of China, 2008, 24(8): 826-827.] DOI: 10.3760/cma.j.issn.1008-6315.2008.08.038.

22.郑放明, 唐万彪, 龙从凤, 等. 白眉蛇毒血凝酶在子宫肌瘤切除术中的应用[J]. 现代医药卫生, 2013, 29(18): 2807-2808. [Zheng FM, Tang WB, Long CF, et al. Application of white eyebrow snake venom hemocoagulase in hysteromyomectomy[J]. Journal of Modern Medicine & Health, 2013, 29(18): 2807-2808.] DOI: 10.3969/j.issn.1009-5519.2013.18.048.

23.王雷. 注射用白眉蛇毒血凝酶在妇科手术中的应用 [J]. 河北医药, 2011(3): 377-378. [Wang L. Application of injectable white eyebrow snake venom hemagglutinin in gynecological surgery[J]. Hebei Medical Journal, 2011(3): 377-378.] DOI: 10.3969/j.issn.1002-7386.2011.03.029.

24.金有豫. 注射用血凝酶及其止血作用机制[J]. 中国医院用药评价与分析, 2012, 12(6): 488-490. [Injectable hemagglutinin and its hemostatic mechanism[J]. Evaluation and Analysis of Drug-Use in Hospitals of China, 2012, 12(6): 488-490.] DOI: CNKI:SUN:YYPF.0.2012-06-006.

25.马增新, 倪广臻, 胡雪伟, 等. 外科患者大量输血后不同时间凝血功能指标变化的动态分析[J]. 中国伤残医学, 2014, 22(9): 3. [Ma ZX, Ni GZ, Hu XW, et al. A large number of different time after blood transfusion blood coagulation function in patients with surgical index changes of dynamic analysis[J]. Chinese Journal of Trauma and Disability Medicine, 2014, 22(9): 3.] DOI: CNKI:SUN:XCYZ.0.2014-09-021.

26.邵千航, 刘雪梅, 黄琳, 等. 4种蛇毒血凝酶联合质子泵抑制剂用于非静脉曲张上消化道出血疗效和安全性的网状Meta分析[J]. 中国药房, 2023, 34(5): 600-606. [Shao QH, Liu XM, Huang L, et al. Efficacy and safety of 4 kinds of hemocoagulases combined with proton pump inhibitor for nonvariceal upper gastrointestinal bleeding: a network meta-analysis[J]. China Pharmacy, 2023, 34(5): 600-606]. DOI: 10.6039/j.issn.1001-0408.2023.05.17.