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目的:探讨西帕依麦孜彼子胶囊联合盐酸坦索罗辛胶囊治疗良性前列腺增生(BPH)的有效性及安全性。方法:选取2013年7月至2014年6月在我院诊治为BPH的患者60例,分为对照组和联合用药组各30例。其中对照组年龄(62.03±10.19)岁,病程(3.24±2.18)年;联合用药组年龄(64.77±10.33)岁,病程(4.09±2.63)年,对照组单用盐酸坦索罗辛胶囊0.2 mg,每日1次。联合用药组均口服盐酸坦索罗辛胶囊0.2 mg,每日1次,西帕依麦孜彼子胶囊0.5 g,每日3次,共4周。比较两组治疗前后夜尿次数、最大尿流率(Qmax)、残余尿量、国际前列腺症状(IPSS)评分、生存质量量表(QOL)评分等,并记录不良反应发生。结果:治疗前,对照组夜尿次数(3.60±1.81)次、Qmax(10.40±3.53)ml/min、IPSS(22.47±8.58)分、QOL(4.43±1.50)分,联合用药组夜尿次数(3.43±1.61)次、Qmax(10.14±3.43)ml/min、IPSS(21.93±8.79)分、QOL(4.73±1.31)分。治疗4周后,对照组夜尿次数(2.27±1.60)次、Qmax(14.36±3.03)ml/min、IPSS(17.20±8.43)分、QOL(2.93±1.68)分,联合用药组夜尿次数(1.30±1.18)次、Qmax(13.85±3.15)ml/min、IPSS(13.00±1.53)分、QOL(2.57±1.61)分。两组在治疗后其夜尿次数、Qmax、IPSS、QOL均优于治疗前(P均<0.05),而治疗前后联合用药组改善情况:夜尿次数[-(2.13±1.11)]次、IPSS[-(8.93±6.01)]分、QOL[-(2.17±1.12)分]优于对照组:夜尿次数[-(1.73±1.07)]次、IPSS[-(4.80±3.87)分]、QOL[-(1.50±1.01)分](P<0.05),而Qmax:对照组(3.95±2.53)ml/min,联合用药组(3.72±2.28)ml/min及残余尿量:对照组[-(26.43±30.49)ml],联合用药组[-(34.30±37.43)ml]改善情况无明显差异(P>0.05)。对照组中发生不良反应3例(10.00%),联合用药组发生不良反应5例(16.67%),两组中不良反应发生率比较无统计学差异(P>0.05)。结论:西帕依麦孜彼子胶囊联合盐酸坦索罗辛胶囊可改善BPH患者症状,提高生活质量。
Objective: To investigate the efficacy and safety of Xipayiti mazizi capsule combined with tamsulosin hydrochloride capsule in the treatment of benign prostatic hyperplasia (BPH). Methods: Sixty patients with BPH diagnosed and treated in our hospital from July 2013 to June 2014 were selected and divided into control group and combination group. The control group was 62.03 ± 10.19 years old with a course of 3.24 ± 2.18 years. The combined drug group was 64.77 ± 10.33 years old with a duration of (4.09 ± 2.63) years. In the control group, tamsulosin hydrochloride capsule 0.2 mg , 1 day. The combination group were given oral tamsulosin hydrochloride capsules 0.2 mg once daily, Xipay Mai Zi Zi capsule 0.5 g three times daily for 4 weeks. The number of nocturia, maximum flow rate (Qmax), residual urine volume, International Prostate Symptom Score (IPSS) and Quality of Life Scale (QOL) were compared between the two groups before and after treatment. Adverse reactions were recorded. Results: Before treatment, the number of nocturia (3.60 ± 1.81), Qmax (10.40 ± 3.53) ml / min, IPSS (22.47 ± 8.58) and QOL (4.43 ± 1.50) 3.43 ± 1.61), Qmax (10.14 ± 3.43) ml / min, IPSS (21.93 ± 8.79), QOL (4.73 ± 1.31). After 4 weeks of treatment, the number of nocturia (2.27 ± 1.60), Qmax (17.20 ± 8.43) and QOL (2.93 ± 1.68) in control group were significantly lower than those in control group 1.30 ± 1.18), Qmax (13.85 ± 3.15) ml / min, IPSS (13.00 ± 1.53) and QOL (2.57 ± 1.61). The nocturnal urinary frequency, Qmax, IPSS and QOL in both groups were better than those before treatment (P <0.05), while the improvement in the combination group before and after treatment: the number of nocturia [- (2.13 ± 1.11)] times, IPSS QOL [- (2.17 ± 1.12) points] was superior to the control group: the number of nocturia (- 1.73 ± 1.07), IPSS (4.80 ± 3.87), QOL (1.50 ± 1.01), P <0.05, and Qmax: 3.95 ± 2.53 ml / min in the control group (3.72 ± 2.28) ml / min and residual urine volume in the control group [- 26.43 ± 30.49) ml], there was no significant difference between the combination group [- (34.30 ± 37.43) ml] (P> 0.05). There were 3 adverse reactions (10.00%) in the control group and 5 (16.67%) adverse reactions in the combination group. There was no significant difference in adverse reactions between the two groups (P> 0.05). CONCLUSIONS: Xipayiti maizizi capsule combined with tamsulosin hydrochloride capsule can improve the symptoms of BPH patients and improve their quality of life.