α_1肾上腺素能受体阻滞剂萘哌地尔治疗慢性非细菌性前列腺炎的临床研究

Clinical Application of α_1 Adrenoceptor Antagonist Naftopidil to the Treatment of Chronic Non-Bacterial Prostatitis

目的:探讨α1肾上腺素能受体阻滞剂萘哌地尔(Naftopidil)治疗慢性非细菌性前列腺炎的有效性及安全性。方法:采用开放、自身对照、多中心的临床试验方法,应用萘哌地尔25mg,每日1次,对106例慢性非细菌性前列腺炎(NBP)患者进行了为期4周的治疗。以美国国立卫生院慢性前列腺炎症状评分(NIHCPSI)、前列腺液(EPS)WBC计数及最大尿流率(MFR)为疗效指标,对其有效性及安全性进行观察。结果:服药4周后,可评价病例105例。全组患者NIHCPSI总评分治疗前后平均减低12.0分(P<0.001),症状评分平均减低7.9分(P<0.001),生活质量评分平均减低4.1分(P<0.001)。EPS中WBC计数治疗前及治疗后分别为(15.2±15.1)、(9.5±12.0)个/HP(P<0.01)。MFR治疗前及治疗后分别为(19.2±4.8)、(22.7±4.9)ml/s(P<0.01)。按症状改善评价,治愈2例(1.9%),显效32例(30.5%),有效55例(52.4%),无效16例(15.2%)。总显效率为32.4%,总有效率为84.8%。3例有轻度头晕,1例食欲不佳,不良事件发生率3.81%。结论:萘哌地尔治疗慢性非细菌性前列腺炎安全、有效。

Objective ： To study the efficacy and safety of α1 adrenoceptor antagonist Naftopidil in the treatment of chronic non-bacterial prostatitis. Methods ： An opened, self-controlled, muhicentral clinical trial was conducted. One hundred and six cases of patients who had been diagnosed as chronic non-bacterial prostatitis（NBP） were treated with Naftopidil （25 mg once a day） for 4 weeks. The efficacy was evaluated by the NIH Chronic Prsatatitis Symptom Index （NIH-CPSI） and the WBC in the examination of prostatic secretion（EPS） after the treatment. Results： After 4 weeks therapy, 105 cases were evaluable. After treatment, NIH-CPSI total score were averagely decreased 12.0 points （ P 〈 0.001 ）, symptom score 7.9 points （ P 〈 0.001 ） and QOL score 4.1 points （ P 〈 0.001 ）. There was a statistically significant difference in WBC count （ [ （ 15.2 ± 15.1 ）/HP vs （9.5 ± 12.0）/HP, P 〈 0.01 ] and max flow rate（MFR） [ （19.2±4.8） ml/s vs （22.7±4.9） mE/s, P〈0.01]. The total effective rate were 84.8% in the whole group. The clinical adverse rate was 3.81%, including 3 cases of mild dizziness and 1 case of mild inappetence. Conclusion： α1 adrenoceptor antagonist Naftopidil is effective and safe for the treatment of chronic non-bacterial prostatitis. Natl J Android2006,12（3） ：234-236,239