Zheng Yunxi, Guo Ruoyi, Tian Qi, Du Yan, Wang Li, Zhu Zhiling, Yu Erkai, Sun Jing, Yi Xiaofang, Xu Congjian
Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, 200011, China.
Department of Obstetrics and Gynecology, Shanghai Medical School, Fudan University, Shanghai, 200011, China.
Contemp Clin Trials Commun. 2023 Jun 20;34:101179. doi: 10.1016/j.conctc.2023.101179. eCollection 2023 Aug.
Endometriosis is a common benign gynecological disorder with high risk of recurrence and adverse impact on fertility-sparing. This study aims to evaluate the effectiveness and safety of SanJieZhenTong Capsules, a traditional Chinese medicine, in the long-term management of endometriosis postoperatively.
and analysis: A prospective, double-blinded, double-dummy parallel-group randomized controlled trial will be conducted at three university-based medical centers in China. A total of 600 patients with rAFS III-IV endometriosis diagnosed by laparoscopy will be enrolled. After fundamental treatment (gonadotropin-releasing hormone agonists injection starts on the first day of menstruation postoperatively, and repeats 3 times every 28 days), participants will be randomly allocated to the oral contraceptive group (oral contraceptive + dummy A) or SanJieZhenTong Capsules group (SanJieZhenTong Capsules + dummy B) in a 1:1 ratio. All participants will be treated and followed up for 52 weeks. The primary outcome is a recurrence rate based on endometriosis-related symptoms, physical examination, and/or ultrasound/MRI findings. The secondary outcome includes changes in quality of life and organic function outcome via the 36-item Short-Form scores and gastrointestinal function score.
The current trial could provide rigorous evidence on SanJieZhenTong Capsules application in the long-term management of advanced-stage endometriosis.
子宫内膜异位症是一种常见的良性妇科疾病，复发风险高，对保留生育功能有不利影响。本研究旨在评估中药散结镇痛胶囊在子宫内膜异位症术后长期管理中的有效性和安全性。
一项前瞻性、双盲、双模拟平行组随机对照试验将在中国的三个大学附属医院进行。总共将纳入600例经腹腔镜诊断为rAFS III-IV期子宫内膜异位症的患者。在进行基础治疗（术后月经第一天开始注射促性腺激素释放激素激动剂，每28天重复3次）后，参与者将按1:1的比例随机分配至口服避孕药组（口服避孕药 + 模拟剂A）或散结镇痛胶囊组（散结镇痛胶囊 + 模拟剂B）。所有参与者将接受52周的治疗和随访。主要结局是基于子宫内膜异位症相关症状、体格检查和/或超声/MRI检查结果的复发率。次要结局包括通过36项简明健康状况调查量表评分和胃肠功能评分得出的生活质量变化和器官功能结局。
本试验可为散结镇痛胶囊应用于晚期子宫内膜异位症的长期管理提供严谨的证据。
