长期应用非那雄胺治疗良性前列腺增生临床疗效及安全性

Clinical efficacy and safety analysis of long-term use of finasteride in benign prostatic hyperplasia

目的观察服用非那雄胺14年治疗良性前列腺增生（BPH）的临床疗效及安全性。方法对1994年12月至2009年2月连续服用非那雄胺（5mg／d）治疗BPH的41例患者进行临床观察，记录治疗前后患者夜尿次数、前列腺体积、血肌酐、丙氨酸氨基转移酶（ALT）、血白细胞、血清前列腺特异抗原（PSA）变化；同时记录治疗期间发生急性尿潴留、接受外科治疗及药物特殊不良作用（如乳腺癌和前列腺癌等）临床资料。结果本组41例患者观察终止时平均年龄（87．9±5．4）岁，平均治疗时间（141．1±27．1）个月。治疗前后，患者夜尿次数分别为（1．8±1．5）次和（3．2±1．3）次，差异有统计学意义（t=-4．52，P〈0．05）；前列腺体积分别为（44．9±26．6）ml和（42．8±31．3）ml，差异无统计学意义（t=0．33，P〉0．05）。分层研究发现，治疗前前列腺体积〈25ml者，治疗后体积增大17．3％（t=-0．88，P〉0．05）；治疗前体积25～40ml者，治疗后体积缩小17．2％（t=2．59，P〈0．05）；治疗前体积〉40ml者，治疗前后体积缩小1．1％（t=0．07，P〉0．05）。治疗前后患者血肌酐分别为（96．8±18．6）μmol／L和（86．4±32．3）μmol／L（t=1．79，P〉0．05），血白细胞计数分别为（6．4±1．5）×10^9／L和（6．0±1．7）×10^9／L（t=1．13，P〉0．05），PSA分别为（1．2±2．0）μg／L和（1．4±1．7）μg／L（t=-0．49，P〉0．05）。本组3例（7．3％）发生急性尿潴留，经导尿后好转；无确诊前列腺癌和乳腺癌病例。结论BPH患者长期服用非那雄胺可以有效控制BPH的临床进展，无严重并发症。

Objective To evaluate the safety and clinical efficacy of finasteride in treating patients with benign prostatic hyperplasia （BPH） during a 14-year period in a hospital. Methods Forty-one patients with BPH receiving finasterlde 5 mg daily for the treatment from December 1994 to Febrary 2009 were included in the study. The base line and the end of study data of nocturia, prostate volume, serum creatine, complete blood count and serum prostatic specific antigen （PSA） were recorded. The acute urinary retention, surgical treatment and drug adverse reaction （prostate cancer or breast cancer） during the observation periods were recorded as well. Results All the 41 cases took finasteride regularly for long-term medical therapy of BPH. At the end of this study, the average age of patients was （87.9±5.4） years old and the average duration of treatment was （141. 1±27.1） months. The numbers of nocturia were 1.8±1.5 and 3.2＋1.3 pre- and post -treatment, respectively （t=-4.52,P〈0.05）. Before and at the end of the study, the prostate volumes were （44.9±26.6） ml and （42.8±31.3） ml, respectively（t=0.33,P〉0.05）. Stratified study showed that, compared with the baseline data, the prostate volume was increased by 17.3 % in patients with prostate volume 〈25 ml（t=-0. 88,P〉0.05）; the prostate volume was decreased by 17.2% in patients with prostate volume of 25-40 ml（t=2.59,P〈0.05）; the prostate volumes were （63.3±28.9） ml and （62.6± 36.5） ml pre- and post-treatment in patients with prostate volume 〉 40 ml, and there was no significant change（t= 0.07, P〉0.05）. Before and after the treatment, the serum creatine levels were （96.8±18.6） mol/L and （86.4±32.3） mol/L, respectively（t=1. 79,P〉0.05） ; the white blood cell counts were （6.4±1.5）×10^9 L and （6.0±1.7） ×10^9 L, respectively （t=1.13,P〉0.05）; and the PSA levels were （1.2±2.0） μg/L and （1.4±1.7） μg/L, respectively （t=-0.49,P〉0.05）. Three cases （7.3 %） occurred acute urinary retention. There was no prostate cancer and breast cancer case, and no new adverse event occurred during long-time use of finasteride. Conclusions This retrospective study has demonstrated that the clinical progress of BPH can be controlled effectively by long-term administration of finasteride.