乳结泰胶囊治疗2406例乳腺增生病乳房疼痛、肿块等症状的多中心、真实世界临床研究  

Clinical Efficacy of Rujietai Capsules in Treating 2406 Cases of Breast Pain,Lumps and Other Symptoms of Breast Hyperplasia:A Multicenter,Real-world Clinical Study

作　　者：韩建科[1,2] 张董晓 孙利[2] 杨立波[2] 郭晓腾[1,2] 王晓芳 高学东 HAN Jianke;ZHANG Dongxiao;SUN Li;YANG Libo;GUO Xiaoteng;WANG Xiaofang;GAO Xuedong(High-level Key Discipline of Traditional Chinese Medicine(TCM)of National Administration of TCM Chinese Collaterals,Hebei Yiling Hospital,Shijiazhuang 050091,China;State Key Laboratory for Innovation and Transformation of Luobing Theory,Shijiazhuang Yiling Pharmaceutical Co.Ltd.,Shijiazhuang 050035,China;Beijing Hospital of TCM,Capital Medical University,Beijing 100053,China)

机构地区：[1]河北以岭医院,国家中医药管理局高水平中医药重点学科-中医络病学,石家庄050091 [2]石家庄以岭药业股份有限公司,络病理论创新转化全国重点实验室,石家庄050035 [3]首都医科大学附属北京中医医院,北京100053

出　　处：《中国实验方剂学杂志》2024年第16期123-131,共9页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：河北省中医药管理局科研计划项目(2023391);石家庄市技术创新中心绩效后补助项目(237790639A)。

摘　　要：目的:评价乳结泰胶囊在广泛使用条件下治疗乳腺增生病(肝郁气滞、痰凝血瘀证)的安全性和有效性,为指导临床合理用药和完成再注册提供数据支持。方法:采用多中心、开放、单臂临床试验设计方法。共纳入38家试验中心2406例乳腺增生病肝郁气滞、痰凝血瘀证患者,给予乳结泰胶囊治疗,用法用量为口服,每次4粒,每日3次。一般在月经周期第5天开始服药,连续服用21 d,3个月经周期为1疗程。通过观察治疗前后生命体征、体格检查、实验室检查、不良事件评估安全性,观察乳腺增生病患者的乳房疼痛和乳腺靶肿块的改变,中医证候疗效评价有效性。结果:治疗3个月经周期后,乳结泰胶囊对乳腺增生病证属肝郁气滞、痰凝血瘀证患者,能显著减轻患者乳房疼痛、触痛等症状,平均乳房疼痛最疼程度评分较基线下降(2.20±1.63)分,乳房疼痛最疼程度评分缓解率54.9%(1275/2322),经前7 d疼痛程度缓解率61.5%(1427/2322)。治疗3个月经周期后乳房触痛消失率42.3%(1005/2374),触诊乳房肿块分布范围明显缩小,触诊乳房肿块消失率19.5%(463/2374),靶肿块触诊平均缩小57.6%。此外,在改善胸胁胀闷或痛、烦躁易怒、失眠多梦、心烦口苦、经行腹痛、月经量少等中医症状方面具有较好作用,中医证候总有效率79.4%,临床获益显著。试验期间未发生严重不良反应。结论:乳结泰胶囊可以改善乳腺增生病患者的疼痛症状和体征,改善中医证候,疗效确切,乳结泰胶囊在更广泛使用人群中安全性良好。Objective:To evaluate the safety and effectiveness of Rujietai capsules in the treatment of breast hyperplasia(syndrome of liver depression and Qi stagnation and syndrome of phlegm coagulation and blood stasis)under the condition of widespread use,and to provide data support for guiding clinical drug use and completing re-registration.Method:A multicenter,open,single-arm clinical trial was conducted.A total of 2406 patients with breast hyperplasia(syndrome of liver depression and Qi stagnation and syndrome of phlegm coagulation and blood stasis)treated in 38 experimental centers were included.They were treated by oral administration with Rujietai Capsules(4 capsules once,3 times a day).The drug was generally taken on the fifth day of the menstrual cycle for 21 consecutive days,and 3 menstrual cycles were taken as a course of treatment.The safety was evaluated based on vital signs,physical and laboratory examinations,and adverse events before and after treatment.The changes of breast pain,breast lumps,and TCM symptoms were observed and recorded to evaluate the effectiveness of the drug.Result:After treatment for 3 menstrual cycles,Rujietai capsules reduced breast pain and tenderness in the patients with breast hyperplasia(syndrome of liver depression and Qi stagnation and syndrome of phlegm coagulation and blood stasis)and decreased the average maximum pain score by(2.20±1.63)points.After treatment for 3 menstrual cycles,the average relief rate of breast pain was 54.9%(1275/2322),and the average pain relief rate in the first 7 days of menstruation was 61.5%(.1427/2322)The average reduction rate in breast tenderness was 42.3%(1005/2374).Palpated breast lumps showcased a significantly reduced distribution range,with the disappearance rate of 19.5%(463/2374)and the average reduction of 57.6%.In addition,Rujietai capsules alleviated TCM symptoms such as chest and hypochondriac distension or pain,irritability,insomnia,dreaminess,dysphoria,bitter mouth,abdominal pain during menstruation,and low menstrual volume.The tot

关 键 词：乳结泰胶囊 乳腺增生病 多中心 临床试验 真实世界研究 

分 类 号：R242[医药卫生—中医临床基础] R969.4[医药卫生—中医学] R256.4R856.5R2-031R655.8R271.1