Ni Wenjing, Liu Tao, Liu Yujing, Lu Lu, Zhou Bingduo, Dai Yancheng, Zhao Hang, Xu Hanchen, Ji Guang
Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Shanghai Frontier Research Center of Disease and Syndrome Biology of Inflammatory Cancer Transformation, Shanghai, China.
Front Pharmacol. 2023 Apr 5;14:1175811. doi: 10.3389/fphar.2023.1175811. eCollection 2023.
The recurrence of colorectal adenomas (CRAs) after endoscopy predisposes patients to a risk of colorectal cancer. Guided by the traditional Chinese medicine (TCM), patients with colorectal diseases usually manifest with spleen deficiency syndrome (SDS) and are treated with Sijunzi decoction (SJZD). Therefore, this trial aims to explore the efficacy and safety of SJZD in the prevention and treatment of CRAs recurrence. SJZD on prevention and treatment of CRAs recurrence after resection: a multicenter, randomized, double-blind, placebo-controlled trial was designed. Patients who undergo polypectomy of CRAs will be recruited and randomized into a SJZD group and a placebo group in a 1:1 ratio. The intervention phase will be 12 months. The follow-up period will last 24 months. The primary outcome is the CRA recurrence rate after intervention. The secondary outcomes include the CRA recurrence rate at the second year post-polypectomy, the pathological type of adenoma and the alterations in SDS scores after intervention. Previous clinical practice has observed the sound effect of SJZD in the context of gastrointestinal diseases. A number of experiments have also validated the active components in SJZD. This trial aims to provide tangible evidence for the usage of SJZD, hoping to reduce the recurrence of CRAs.
结肠镜检查后大肠腺瘤（CRAs）的复发使患者面临患结直肠癌的风险。在中医的指导下，患有大肠疾病的患者通常表现为脾虚证（SDS），并采用四君子汤（SJZD）进行治疗。因此，本试验旨在探讨SJZD预防和治疗CRAs复发的有效性和安全性。SJZD对切除术后CRAs复发的预防和治疗：设计了一项多中心、随机、双盲、安慰剂对照试验。将招募接受CRAs息肉切除术的患者，并按1:1的比例随机分为SJZD组和安慰剂组。干预阶段为12个月。随访期将持续24个月。主要结局是干预后CRA复发率。次要结局包括息肉切除术后第二年的CRA复发率、腺瘤的病理类型以及干预后SDS评分的变化。以往的临床实践观察到SJZD在胃肠道疾病方面的良好效果。多项实验也验证了SJZD中的活性成分。本试验旨在为SJZD的使用提供切实证据，希望降低CRAs的复发率。
