桂附地黄丸联合盐酸坦洛新治疗良性前列腺增生症60例

Clinical Research of Guifu Dihuang Pills Combined Tamsulosin Hydrochloride Sustained Release Capsules in Treating 60 Patients with Benign Prostatic Hyperplasia

目的:观察桂附地黄丸联合坦洛新对良性前列腺增生(BPH)(肾阳虚证)疾病进展的影响。方法:将116例BPH患者采用随机按数字表法分为西药组56例和观察组60例。西药组口服盐酸坦洛新缓释胶囊,0.2 mg/次,1次/晚;观察组在西药组治疗的基础上加用桂附地黄丸,6 g/次,2次/d,口服。两组疗程均为12周。进行国际前列腺症状评分(I-PSS),肾阳虚证、排尿症状对生活质量(QOL)评分;测量残余尿量(PVR),最大尿流率(Qmax)和平均尿流率(Qave);采用B超检测前列腺大小和质量;记录夜尿次数,以上指标治疗前后各评价1次。结果:观察组临床疗效总有效率为91.66%,西药组为76.78%,观察组优于西药组(P<0.05);治疗后观察组I-PSS,肾阳虚证和QOL评分均比西药组低(P<0.01);治疗后观察组PVR少于西药组(P<0.01),观察组Qmax和Qave高于西药组(P<0.01);治疗后观察组前列腺大小和前列腺质量均比治疗前减少,并<西药组(P<0.01);治疗后观察组夜尿次数少于西药组(P<0.01)。结论:桂附地黄丸联合坦洛新治疗BPH(肾阳虚证)患者,能改善下尿路症状,提高患者生活质量,改善了BPH临床进展的高危因素,值得进一步的研究。

Objective： To observe the effect of Guifu Dihuang pills combined tamsulosin hydrochloride sustained release capsules in treating benign prostatic hyperplasia （BPH） disease of kidney-yang deficiency syndrome. Method： One hundred and sixteen BPH patients were randomly divided into the control group （56 cases） and the observation group （60 cases） via a digital method. Patients in the control group received 0. 2 mg tamsulosin hydrochloride sustained release capsules orally once every night. Based on the therapy of the control group, patients in the observation group added 6 g Guifu Dihuang pills orally twice daily. All patients in two groups received 12 weeks of treatment. International prostate symptom scores （I-PSS）, kidney-yang deficiency syndrome scores, and quality of life （QOL） scores caused by urination symptom were assessed. Moreover, post-void residual urine volumes （PVR）, the maximal urinary flow rates （Qma,） and average urinary flow rates （Qave） were measured. Prostate size and quality were tested through type-B ultrasonic. Enuresis nocturia frequencies were recorded. Result： The total curative effect in the observation group was 91. 66% , which was superior to 76.78% in the control group （P 〈 0.05）. Scores of I-PSS, kidney-YANG deficiency syndrome, QOL in the observation group were less than those in the control group （P 〈 0.01 ）. The PVR in the observation group was lower （P 〈 0.01 ）, the Qmax and Qave were higher than those in the control group （P 〈 0.01 ）. After therapy, prostate size and quality decreased as compared with the control group （P 〈 0.01 ）. Frequencies of enuresis nocturia were less than those in the control group （P 〈 0.01）. Conclusion： Guifu Dihuang pills combined tamsulosin could ameliorate lower urinery-tract syndrom, improve patients＇ QOL and ameliorate risk factors of clinical progression in treating BPH patients with kidney-yang syndrome, and it is worthy of further study.