期刊文章详细信息
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
文献类型:期刊文章
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
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)。
年 份:2021
卷 号:39
期 号:12
起止页码:150-155
语 种:中文
收录情况:BDHX、BDHX2020、CAB、CAS、IC、RCCSE、ZGKJHX、核心刊
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。
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[中西医结合类]
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