扶正化积癃闭汤治疗良性前列腺增生正虚瘀结证的临床疗效  

Clinical Efficacy of Fuzheng Huaji Longbi Decoction in Treating Benign Prostatic Hyperplasia with Syndrome of Healthy Qi Deficiency and Blood Stasis

作　　者：李凝华 王祖龙[2] 张宸铭[2] 李霄[2] 陈如兵 张琦[2] 华众 LI Ninghua;WANG Zulong;ZHANG Chenming;LI Xiao;CHEN Rubing;ZHANG Qi;HUA Zhong(Guangxi University of Chinese Medicine,Nanning 530001,China;The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450099,China;Henan University of Chinese Medicine,Zhengzhou 450046,China)

机构地区：[1]广西中医药大学,南宁530001 [2]河南中医药大学第一附属医院,郑州450099 [3]河南中医药大学,郑州450046

出　　处：《中国实验方剂学杂志》2024年第10期77-82,共6页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：河南省中医药科学研究专项(2022JDZX101,2023ZY1009,2021ZY2060)。

摘　　要：目的:评价扶正化积癃闭汤治疗良性前列腺增生(BPH)正虚瘀结证的临床疗效及安全性。方法:94例BPH患者随机分为对照组和观察组,各47例。对照组患者口服甲磺酸多沙唑嗪缓释片口服治疗,观察组患者在对照组治疗基础上联合口服扶正化积癃闭汤。两组均连续治疗8周,在治疗前后对国际前列腺症状评分(IPSS)、生活质量评分(QOL)、最大尿流率(Qmax)、膀胱残余尿量(RUV)、中医证候积分、中医单项症状评分及心电图、肝肾功能等指标变化进行评估,以评价两组临床疗效及安全性。结果:治疗8周后,对照组总有效率63.64%(28/44),观察组总有效率84.44%(38/45);两组临床疗效比较,观察组优于对照组(Z=-2.17,P=0.030);总有效率比较,观察组优于对照组(χ^(2)=5.026,P<0.05)。与同组治疗前比较,治疗后两组患者的IPSS评分、QOL评分、RUV水平及中医证候积分均明显下降,Qmax明显升高(P<0.05)。与对照组治疗后比较,观察组的IPSS、QOL、RUV及中医证候积分均明显降低(P<0.05),Qmax明显升高(P<0.05)。与本组治疗前比较,观察组中医单项症状评分均明显降低(P<0.05),对照组仅有夜尿频数、排尿困难、尿线变细、尿后余沥症状评分降低(P<0.05);与对照组治疗后比较,观察组的主证夜尿频数,次证神疲乏力、畏寒肢冷、小腹不适、大便不成形症状评分降低(P<0.05)。研究中未观察到使用扶正化积癃闭汤相关不良反应。结论:扶正化积癃闭汤治疗良性前列腺增生正虚瘀结证有较好的疗效,能够改善患者临床症状,提高生活质量,且临床应用安全可靠。Objective:To explore the clinical efficacy and safety of Fuzheng Huaji Longbi decoction in treating benign prostatic hyperplasia(BPH)in the patients with the syndrome of healthy Qi deficiency and blood stasis.Method:A total of 94 BPH patients were randomized into control and observation groups,with 47 patients in each group.The control group was treated with doxazosin mesylate sustained-release tablets,and the observation group with Fuzheng Huaji Longbi decoction on the basis of the therapy in the control group.After eight weeks,the international prostate symptom score(IPSS),quality of life(QOL)score,residual urine volume(RUV),maximum urinary flow rate(Qmax),TCM syndrome score,TCM symptom score,electrocardiogram,and liver and kidney function were determined to evaluate the clinical efficacy and safety of the two groups.Result:After 8 weeks of treatment,the total response rate in the control group was 63.64%(28/44),which was lower than that(84.44%,38/45)in the observation group(χ^(2)=5.026,P<0.05).The clinical efficacy in the observation group was higher than that in the control group(Z=-2.17,P=0.030).The treatment in both groups decreased the IPSS,QOL score,RUV,and TCM syndrome scores and increased the Qmax(P<0.05).Moreover,the observation group had lower IPSS,QOL score,RUV,and TCM syndrome score(P<0.05)and higher Qmax than the control group after treatment(P<0.05).The treatment in the observation group decreased all the TCM symptom scores(P<0.05),while that in the control group only decreased the frequency of urination at night and the scores of dysuria,weak urine stream,and post-urinary drainage(P<0.05).After treatment,the observation group had lower frequency of urination at night and lower scores of mental fatigue,cold limbs,lower abdominal discomfort,and loose stool than the control group(P<0.05).No adverse events associated with the administration of Fuzheng Huaji Longbi decoction were observed during the treatment period.Conclusion:Fuzheng Huaji Longbi decoction is effective in treating BPH in the patient

关 键 词：良性前列腺增生 癃闭 正虚瘀结证 扶正化积癃闭汤 甲磺酸多沙唑嗪缓释片 

分 类 号：R2-0[医药卫生—中医学] R242R2-031R259R697.3