Shenyang Coloproctology Hospital, Shenyang City, Liaoning Province, China.
Weifang People's Hospital, Weifang, Shandong Province, China.
Medicine (Baltimore). 2021 Nov 19;100(46):e27706. doi: 10.1097/MD.0000000000027706.
Hemorrhoids are a common and seriously disruptive condition that seriously affects people's lives in terms of treatment. Injection therapy is an effective minimally invasive scheme for the treatment of grade II-III hemorrhoids, but its clinical application is limited by the adverse reactions caused by injection drugs. Some clinical studies have confirmed the efficacy and safety of Shaobei injection as a traditional Chinese medicine extract. However, there is no standard randomized controlled study to verify its efficacy and explore its potential mechanism.
This is a prospective, randomized, single blind, parallel controlled trial to study the efficacy of Shaobei injection in the treatment of grade II-III hemorrhoids and its effect on the expression of fibulin-3 and fibulin-5 in fibulin protein family. The patients will be randomly divided into a treatment group and control group. The treatment group will be treated with Shaobei injection, and the control group will be treated with rubber band ligation. The observation indexes include: visual analysis scale, postoperative hospital stay, total use of painkillers, fibulin-3 and fibulin-5, hemorrhoids recurrence, and adverse events. Finally, the data will be statistically analyzed by SPASS 18.0 software.
This study will compare the efficacy of Shaobei injection with the rubber band ligation method in the treatment of grade II-III haemorrhoids and investigate its effect on the expression of fibulin-3 and fibulin-5 in the fibulin protein family. The results of this study will provide a basis for the clinical use of Paeoniflora injection as an alternative to traditional sclerosing agent in the treatment of grade II-III haemorrhoids.Trial registration: OSF Registration number:DOI 10.17605/OSF.IO/MKVDB.
痔疮是一种常见且严重影响生活的疾病，尤其是在治疗方面。注射疗法是治疗 II-III 度痔疮的有效微创方案，但由于注射药物引起的不良反应，其临床应用受到限制。一些临床研究已经证实芍倍注射液作为一种中药提取物的疗效和安全性。然而，目前尚无标准的随机对照研究来验证其疗效，并探讨其潜在机制。
这是一项前瞻性、随机、单盲、平行对照试验，旨在研究芍倍注射液治疗 II-III 度痔疮的疗效及其对纤维连接蛋白家族中纤维连接蛋白-3 和纤维连接蛋白-5 表达的影响。患者将被随机分为治疗组和对照组。治疗组采用芍倍注射液治疗，对照组采用橡胶圈结扎治疗。观察指标包括：视觉分析量表、术后住院时间、止痛药总用量、纤维连接蛋白-3 和纤维连接蛋白-5、痔疮复发和不良反应。最后，使用 SPASS 18.0 软件对数据进行统计分析。
本研究将比较芍倍注射液与橡胶圈结扎法治疗 II-III 度痔的疗效，并探讨其对纤维连接蛋白家族中纤维连接蛋白-3 和纤维连接蛋白-5 表达的影响。本研究结果将为芍倍注射液作为传统硬化剂治疗 II-III 度痔的替代药物在临床应用提供依据。
OSF 注册号：DOI 10.17605/OSF.IO/MKVDB。
