通淋散口服治疗良性前列腺增生的有效性和安全性研究

Efficacy and safety of Tonglin Powder in the treatment of benign prostatic hyperplasia

目的：探讨口服通淋散治疗良性前列腺增生（BPH）的有效性和安全性。方法：根据随机对照原则将100例BPH患者分为治疗组50例和对照组50例，治疗组El服通淋散，对照组El服盐酸特拉唑嗪，治疗3个月后观察国际前列腺症状评分（IPSS）、生活质量评分（QoL）、前列腺体积、残余尿量、血尿常规、肝肾功能各指标的变化。结果：两组患者年龄[（48．194-10．85）岁螂（48．27±11．87）岁]、治疗前IPSS评分[（22．24±7．33）分郴（21．404-8．24）分]、QoL评分[4（2～6）分体4（2～6）分]、前列腺长度[45（30—65）mm vs45（39～65）mm]与宽度[35（21～54）mmus36（26～57）mm]及残余尿量[10（5～100）ml vs10（10～100）m1]均无统计学差异（P均〉0．05）。治疗后治疗组患者IPSS评分[（11．60±6．49）分]明显降低，与对照组[（15．38±7．34）分]相比具有统计学差异（P=0．008）；QoL评分[对照组（3（1～6）分，治疗组（2（0—5）分]亦明显降低，具有统计学差异（P=0．01）。两组患者治疗后前列腺长度[47（38～67）mmvs47．5（38～67）mm]与宽度[36（26～57）mm绑36．5（31～57）mm]及残余尿量[10（8～100）ml vs 10（8～70）m1]未见统计学差异（P〉0．05）。根据尼莫地平法对两组患者进行疗效评价，治疗组患者显效率（40％）明显高于对照组（8％），具有统计学差异（P〈0．01）；治疗组患者总有效率（82％）也显著高于对照组（64％），具有统计学差异（P=0．043）。结论：通淋散在治疗BPH方面能够有效改善患者因BPH导致的排尿困难等症状，进而改善了患者生活质量，并可恢复老年人的前列腺功能。

Objective： To investigate the effect and safety of oral Tonglin Powder in the treatment of benign prostatic hyperplasia （BPH）. Methods： We conducted a randomized controlled study on 100 BPH patients, aged 40 -85 years, treated with Tonglitt Powder （ treatment group, n = 50） or terazosin （ control group, n = 50） , all for 3 months. Then we obtained the International Prostate Symptom Score （IPSS）, quality of life score （QoL）, prostate volume, postvoid residual urine volume （PVR）, urine routine indexes, and liver and kidney function indexes from the patients and compared them between the two groups before and after treatment. Results： The baseline data of the patients in the treatment and control groups were as follows, IPSS （22.24 -7.33 ） vs （21.40 ± 8.24 ）, QoL 4 （2 - 6） vs 4 （2 - 6）, prostate length 45 （ 30 - 65 ） vs 45 （ 39 - 65 ） mm, prostate width 35 （ 21 - 54） vs 36 （26 - 57 ）mm, and PVR 10 （5 -100） vs l0 （10 -100） ml, none with statistically significant difference between the two groups （P 〉 0.05 ）. After treatment, the patients of the treatment group, in comparison with those of the control, showed remarkable decreases in IPSS （ 11.60 ± 6.49 vs 15.38 ± 7.34, P = 0. 008） and QoL （2 [ 0 - 5 ] vs 3 [ 1 - 61, P = 0.01 ）. No statistically significant differences were observed between the treatment and control groups in prostate length （47 [38 -671 vs 47.5 [38 -671 mm）, prostate width （36 [26 -571 vs 36.5 [31 -57] nun）, and PVR （10 [8 -100] vs 10 [8 -701 ml） （P〉0.05）. The Nimodipine method of evaluation showed that the excellence rate of therapeutic effectiveness was significantly higher in the treatment than in the control group （40% vs 8%, P 〈 0. 001 ）, and so was the total effectiveness rate （82% vs 64%, P = 0. 043）. Conclusion： Tonglin Powder can effectively improve the symptoms of BPH, such as difficult urination, and hence the patient＇s quality of life.