摘要
目的:评价黄莪胶囊治疗良性前列腺增生(气虚血瘀、湿热阻滞证)的有效性及安全性。方法:浙、皖2省40家医院2014年6月至2017年7月1456例良性前列腺增生(BPH)门诊患者,年龄40~85岁,给予口服黄莪胶囊治疗,3次/d,每次4粒,疗程为6周。观察患者开始用药前及用药后2、4、6周国际前列腺症状评分(IPSS),并对影响疗效的因素(如年龄、分期、合并用药)进行分层分析。结果:受试者IPSS用药6周后下降了(8. 4±5. 4)分,显著低于治疗前的(19. 2±6. 8)分(P <0. 05);下降变化率为(42. 9±22. 7)%,总显效率23. 1%,总有效率71. 9%。BPH分期I期用药6周后IPSS下降了(7. 3±6. 8)分,总有效率69. 5%;Ⅱ期下降了(6. 6±4. 3)分,总有效率为70. 1%;Ⅲ期下降了(11. 0±5. 5)分,总有效率为74. 7%; BPH不同分期的IPSS治疗前后变化差异有统计学意义(P <0. 05)。治疗6周后,50岁以下患者IPSS下降了(7. 4±5. 8)分,51~60岁患者下降了(7. 9±5. 3)分,61~70岁患者下降了(8. 7±5. 6)分,70岁以上患者下降了(8. 6±5. 1)分,不同年龄组之间IPSS治疗前后变化值差异无统计学意义(P> 0. 05)。合并使用泌尿生殖系统和生殖激素类药物的患者,治疗6周后IPSS下降了(7. 1±5. 9)分,合并其他药物患者下降了(8. 7±5. 4)分,而未合并用药患者则下降了(8. 4±5. 3)分,不同合并用药组之间IPSS治疗前后变化值差异无统计学意义(P> 0. 05)。结论:黄莪胶囊能明显改善BPH患者的症状,不同BPH分期患者服用黄莪胶囊的临床疗效存在差异,Ⅲ期患者疗效最佳;不同年龄的患者、合并不同用药及不合并用药对黄莪胶囊的疗效没有影响。
Objective： To evaluate the efficacy and safety of Huang＇e Capsules in the treatment of BPH with Qi-deficiency, blood stasis and damp heat block. Methods ： This study included 1 456 cases of BPH with Qi-deficiency, blood stasis and damp heat block from 40 hospitals of Zhejiang and Anhui Provinces between June 2014 and July 2017. The patients were aged 40-85 years and treated with Huang＇e Capsules at a dose of 4 capsules, rid, for a course of 6 weeks. The IPSSs of the patients were obtained before and after 2, 4 and 6 weeks of medication, and a stratified analysis was made on the factors influencing the therapeutic effects, such as age, the stage of BPH, and concomitant medication of urogenital and reproductive hormone drugs. Results ： After 6 weeks of medication, the IPSS of the patients was decreased by 8. 4 ± 5.4 （[42.9 ± 22.7] %） as compared with the baseline （19.2 ± 6.8） （P 〈 0.05 ） , with a total effectiveness rate of 71.9% and an excellence rate of 23.1%. After 6 weeks of medication, the IPSSs of the pa-tients with stage- Ⅰ , - Ⅱ and Ⅲ BPH were decreased by 7.3 ± 6.8, 6.6 ± 4.3 and 11.0 ± 5.5, with total effective rates of 69.5% , 70.1% and 74.7% , respectively, with statistically significant differences among the three stages （P 〈 0.05） , and so were those in the patients aged ≤50 years （by 7.4 ± 5.8）, 51 - 60 years （by 7.9 ± 5.3）, 61 - 70 years （ by 8.7 ± 5.6） and 〉 70 years （ by 8.6 ± 5.1 ）, but with no statistically significant differences among different age groups （ P 〉 0.05 ）. At 6 weeks, the IPSS was reduced by 7. l ± 5.9 by concomitant medication of urogenital and reproductive hormone drugs, 8.7 ± 5.4 by concomitant medi-cation of other drugs, and 8.4 ± 5.3 by non-concomitant medication, with no statistically significant differences among the three types of medication （P 〉 0. 05 ）. Conclusion： Huang＇e Capsules can evidently improve the symptoms of BPH, with the best effect on stage-Ⅲ BPH, and the effect does not d
作者
江少波
徐智慧
徐洪明
瞿伟
吴华铃
周昊
周祥
贾金铭
JIANG Shao-bo;XU Zhi-hui;XU Hong-ming;QU Wei;WU Hua-ling;ZHOU Hao;ZHOU Xiang;JIA Jin-ming(Department of Urology,The First Hospital Affiliated to Zhejiang University of Chinese Medicine,Hangzhou,Zhe-jiang 310006,China;Department of Urology,Zhejiang People＇s Hospital,Hangzhou,Zhejiang 310014,China;Zhejiang CONBA Pharmaceutical Co.,LTD,Hangzhou,Zhejiang 310052,China;Zhejiang Provincial Key Laboratory of Traditional Chinese Medicine Pharmacecutical Technology,Hangzhou,Zhejiang 310052,China;Department of Andrology,Guanganmen Hospital of the China Academy of Chinese Medical Sciences,Beijing 100053,China)
出处
《中华男科学杂志》
CAS
CSCD
北大核心
2018年第9期819-823,共5页
National Journal of Andrology
基金
浙江省重大科技专项重点社会发展项目(2013C03005)~~
关键词
黄莪胶囊
良性前列腺增生
国际前列腺症状评分
分层研究
Huang＇e Capsules
benign prostatic hyperplasia
International Prostate Symptoms Score
stratified analysis
