十味香鹿胶囊治疗乳腺增生(肝郁兼痰凝证)的开放、单臂、多中心临床研究  

Efficacy and Safety of Shiwei Xianglu Capsule(十味香鹿胶囊)for Hyperplasia of Breast with Damp-Heat Liver Depression and Phlegm Coagulation Syndrome:An Open,Single-Arm Multicenter Trial

作　　者：王宽宇[1] 徐文丽 孙丽娟 张宇峰 李祖彬 李春来[5] 刘长山 叶村[7] 周伟[8] 姜德昕 王茅[10] 李新 孙晓霞 钟琰 陈娜[7] 吴刚 孙亚华 张延勇 肖平 孙骁龙 孔祥定 李承[1] 杨朋来 王旭[1] 饶旭东 郭二雅 李富平 李晓彤 陈静[1] 喻昆霖 罗思 邵丽雅 晏涛[17] 于海涛 李娜 刘海鸥 赵月生 孙乐源 王欣 宫博 周维维 靳海霞 任振华 付培亭 郝玉香[5] WANG Kuanyu;XU Wenli;SUN Lijuan;ZHANG Yufeng;LI Zubing;LI Chunlai;LIU Changshan;YE Cun;ZHU Wei;JIANG Dexin;WANG Mao;LI Xin;SUN Xiaoxia;ZHONG Yan;CHEN Na;WU Gang;SUN Yahua;ZHANG Yanyong;XIAO Ping;SUN Xiaoling;KNG Xiangding;LI Cheng;YANG Penglai;WANG Xu;RAO Xudong;GUO Erya;LI Fuping;LI Xiaotong;CHEN Jing;YU Kunlin;LUO Si;SHAO Liya;YAN Tao;YU Haitao;LI Na;LIU Haiou;ZHAO Yuesheng;SUN Leyuan;WANG Xin;GONG Bo;ZHOU Weiwei;JIN Haixia;REN Zhenhua;FU Peiting;HAO Yuxiang(The First Affiliated Hospital of Helongjiang Traditional Chinese Medicine University,Harfaing 150036,Helongjiang,China;Mulan Hospital of Traditional Chinese Medicine,Mulan 157900,Helongjiang,China;People's Hospital of Hebi,Hebi 458030,Henan,China;The Third Affiliated Hospital of Qiqihar Medical University,Qiqihar 161000,Helongjiang,China;The First People's Hospital of Mudanjiang,Mudanjiang 157000,Helongjiang,China;The People’s Hospital of Yichun,Yichun 336000,Jiangxi,China;The Fourth Affiliated Hospital of Nanchang University,Nanchang 330009,Jiangxi,China;The People's Hospital of Yifeng,Yifeng 336300,Jiangxi,China;The Third Affiliated Hospital of Helongjiang Traditional Chinese Medicine University,Harbing 150090,Helongjiang,China;The Second People's Hospital of Huanbing,Huanbing 464400,Henan,China;Shenzhen Baoan District Maternal And Child Health Hospital,Shenzhen 518133,Guangdong,China;The Zaozhuang Hospital of Traditional Chinese Medicine,Zaozhuang 277000,Shangdong,China;Affiliated Hospital of Jiujiang College,Jiujiang 332000,Jiangxi,China;The Traditional Chinese Medicine Hospital of Luohe,Luohe 462000,Henan,China;The First Traditional Chinese Medicine Hospital of Luoyang,Luoyang 471000,Henan,China;The People's Hospital of Xinyu,Xinyu 338000,Jiangxi,China;Shanggao Hospital of Traditional Chinese Medicine,Shanggao 336400,Jiangxi,China)

机构地区：[1]黑龙江中医药大学附属第一医院,黑龙江哈尔滨150036 [2]木兰县中医医院,黑龙江木兰157900 [3]鹤壁市人民医院,河南鹤壁458030 [4]齐齐哈尔医学院附属第三医院,黑龙江齐齐哈尔161000 [5]牡丹江市第一人民医院,黑龙江牡丹江157000 [6]宜春市人民医院,江西宜春336000 [7]南昌大学第四附属医院,江西南昌330009 [8]宜丰县人民医院,江西宜丰336300 [9]黑龙江中医药大学附属第三医院,黑龙江哈尔滨150090 [10]淮滨县第二人民医院,河南淮滨464400 [11]深圳市宝安区妇幼保健院,广东深圳518133 [12]山东省枣庄市中医医院,山东枣庄277000 [13]九江学院附属医院,江西九江332000 [14]漯河市中医院,河南漯河462000 [15]洛阳市第一中医院,河南洛阳471000 [16]新余市人民医院,江西新余338000 [17]上高县中医院,江西上高336400

出　　处：《中华中医药学刊》2021年第12期150-155,共6页Chinese Archives of Traditional Chinese Medicine

基　　金：吉林省科技成果转化计划重大科技成果转化项目(原“双十工程”重大科技成果转化项目)(20170301001YY)。

摘　　要：目的评价十味香鹿胶囊治疗乳腺增生(肝郁兼痰凝证)的有效性和安全性。方法采用开放、单臂的试验设计,在27个平行中心进行观察。2200例患者口服十味香鹿胶囊,5粒/次,3次/d,疗程8周(2个月经周期)。比较观察时间内患者每个月经周期的经期前7 d乳房疼痛NRS变化,乳房肿块大小、质地和范围,双侧乳腺超声结果(BI-RADS分级)和安全性。结果与治疗前相比,治疗28 d、治疗56 d的月经前7 d乳房疼痛NRS评分,乳房肿块大小、质地和范围评分明显降低,中医证候疗效明显增加,随着疗程的延长改善更为明显;治疗56 d的BI-RADS分级明显改善。治疗过程中不良反应发生率低。结论十味香鹿胶囊治疗乳腺增生(肝郁兼痰凝证)安全有效。Objective To observe the clinical effects and safety of Shiwei Xianglu Capsule(十味香鹿胶囊)for hyperplasia of breast with liver depression and phlegm coagulation syndrome.Methods Open,single-arm multi-center trial design was adopted,and 2200 cases were enrolled in 27 parallel hospitals.The patients took Shiwei Xianglu Capsule orally,5 capsule per time,three times/day.All were treated for 8 weeks(2 menstrual cycles).Numerical Rating Scale(NRS)score of breast pain of 7 days before menstruation cycle,the size,texture and extent of breast lump,the bilateral breast ultrasound results(BI-RADS grading)at different time points and safety were compared.Results Compared with those before treatment,at 28 days and 56 days of treatment,the NRS score of breast pain of 7 days before menstruation cycle,the scores of size,texture and extent of breast lump were decreased greatly.The TCM syndrome efficacy was increased greatly,and the improvement was more obvious with the prolongation of the treatment course.The Breast Imaging Reporting and Data System(BI-RADS)grading at 56 days of treatment were improved greatly.The occurrence rate of adverse events was low.Conclusion Shiwei Xianglu Capsule is safe and effective for hyperplasia of breast with liver depression and phlegm coagulation syndrome.

关 键 词：十味香鹿胶囊 乳腺增生 肝郁兼痰凝证 有效性 安全性 临床试验 

分 类 号：R269.558[医药卫生—中西医结合]