| 引用本文: | 瞿伟,张全梅,贾金铭,喻文球,王万春,刘树硕,何厚洪,陈玲芳,王如伟,吕燊.黄莪胶囊治疗良性前列腺增生症气虚血瘀、湿热阻滞证的临床观察[J].中国现代应用药学,2012,29(8):749-752. |
| QU Wei,ZHANG Quanmei,JIA Jinming,YU Wenqiu,WANG Wanchun,LIU Shushuo,HE Houhong,CHEN Lingfang,WANG Ruwei,Lü Shen.Clinical Efficacy Observation of Huang’e Capsule on Benign Prostatic Hyperplasia with Qi-deficiency and Blood-stasis, Dampness-heat and Blood-stasis Syndrome[J].Chin J Mod Appl Pharm(中国现代应用药学),2012,29(8):749-752. |
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| 黄莪胶囊治疗良性前列腺增生症气虚血瘀、湿热阻滞证的临床观察 |
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瞿伟1, 张全梅1, 贾金铭2, 喻文球3, 王万春3, 刘树硕4, 何厚洪1, 陈玲芳1, 王如伟1, 吕燊1
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1.浙江康恩贝药品研究开发有限公司，浙江省中药制药技术重点实验室，杭州 310052;2.中国中医科学院广安门医院，北京 100053;3.江西中医学院附属医院，南昌330006;4.浙江中医药大学附属第一医院，杭州 310006
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| 摘要: |
| 目的 评价黄莪胶囊治疗良性前列腺增生症气虚血瘀、湿热阻滞证临床疗效。方法 选择148例良性前列腺增生症气虚血瘀、湿热阻滞证患者，随机分为治疗组和对照组，各74例。治疗组口服黄莪胶囊，每日3次，每次4粒；对照组口服安慰剂治疗，每日3次，每次4粒。疗程均为42 d。对治疗前后前列腺症状积分(IPSS)评分、最大尿流率、中医证侯等指标进行对照分析。结果 两组终点疾病综合疗效：试验组临床显效占33.78%，有效占51.36%，总有效率为85.14%；对照组临床显效占1.35%，有效占33.78%，总有效率为35.13%，试验组和对照组比较的优效性检验有统计学意义。两组终点中医证候积分改善、I-PSS改善及最大尿流率改善情况，试验组和对照组比较的优效性检验有统计学意义。试验中未见严重不良事件和不良反应，试验组和对照组比较无统计学差异。结论 黄莪胶囊治疗良性前列腺增生症气虚血瘀、湿热阻滞证安全有效。 |
| 关键词: 黄莪胶囊 良性前列腺增生症气虚血瘀、湿热阻滞证 综合疗效 中医证侯 |
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| 基金项目:“十五”国家科技攻关计划重大项目(2001BA701A701-29)；浙江省重点实验室和中试基地计划项目(2009E10009) |
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| Clinical Efficacy Observation of Huang’e Capsule on Benign Prostatic Hyperplasia with Qi-deficiency and Blood-stasis, Dampness-heat and Blood-stasis Syndrome |
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QU Wei1, ZHANG Quanmei1, JIA Jinming2, YU Wenqiu3, WANG Wanchun3, LIU Shushuo4, HE Houhong1, CHEN Lingfang1, WANG Ruwei1, Lü Shen1
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1.Zhejiang Conba Drug Research Development Co., Ltd., Zhejiang Provincial Key Laboratory of Traditional Chinese Medicine Pharmaceutical Technology, Hangzhou 310052, China;2.Guang’anmen Hospital, China Academy of Medical Sciences, Beijing 100053, China;3.The Affiliated Hospital of Jiangxi University of TCM, Nanchang 330006, China;4.The Frist Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310006, China
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| Abstract: |
| OBJECTIVE To evaluate the clinical efficacy of Huang’e capsule on benign prostatic hyperplasia (BPH) with Qi-deficiency and Blood-stasis, Dampness-heat and blood-stasis syndrome. METHODS All of 148 patients who were diagnosed as BPH with Qi-deficiency and Blood-stasis, Dampness-heat and blood-stasis syndrome were randomly divided into treatment group and control group. Seventy-four patients in treatment group were treated with Huang’e capsule by 3 times daily, 4 capsules every time, while other 74 patients in control group were treated with placebo by 3 times daily, 4 capsules every time. IPSS scores, maximum urine flow rates and TCM syndromes of pre- and post- treatment were compared and analyzed. RESULTS The total effective rate of the treatment group was 85.14%, with 33.78% markedly effective and 51.36% effective. The total effective rate of the control group was 35.13%, 1.35% markedly effective and 33.78% effective. There was statistical significance for the superiority test between the treatment group and control group. Through superiority test, there were statistically significant differences between two groups in the end points for TCM syndrome score, I-PSS score and maximum urine flow rate improvement. No serious adverse events and adverse reactions were found in the trails. There was no significant difference between the two groups. CONCLUSION Huang’e capsule was safe and effective on BPH with Qi-deficiency and Blood-stasis, Dampness-heat and blood-stasis syndrome. |
| Key words: Huang’e capsule benign prostatic hyperplasia (BPH) with Qi-deficiency and Blood-stasis, Dampness-heat and blood-stasis syndrome total therapeutic effect TCM syndrome |
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