经会阴超声治疗慢性前列腺炎临床研究

Transperineal ultrasonic therapy for chronic prostatitis

目的:观察NIH-CPSI积分、前列腺常规检查等指标,评价超声疗法治疗慢性前列腺炎的临床疗效以及安全性。方法:采用随机、双盲、多中心试验设计。共纳入96例符合标准的慢性前列腺炎患者,北京中医药大学东直门医院、卫生部中日友好医院各48例,均分为两组。A组超声治疗仪为实际真实的超声治疗仪,在治疗过程中产生超声;B组的超声治疗仪为外形、操作完全一致,但不产生超声的超声治疗仪。治疗2周,隔日治疗1次,每次10 min,共7次。比较治疗后两组有效率,治疗前与治疗后组内、组间NIH-CPSI评分、白细胞、卵磷脂小体变化。监测安全性。结果:A组总有效率为70.83%,B组总有效率为25%,差异有统计学意义(P<0.001);A组NIH-CPSI疼痛与不适评分、NIH-CPSI排尿症状评分、NIH-CPSI生活质量评分、NIH-CPSI总评分较治疗前均有显著改善(P<0.05);B组NIH-CPSI疼痛与不适评分、NIH-CPSI总评分较治疗前有显著改善(P<0.05);治疗前两组各指标积分比较无显著差异(P>0.05);治疗后两组组间比较NIH-CPSI疼痛与不适评分、NIH-CPSI排尿症状评分、NIH-CPSI总评分有显著差异(P<0.05);白细胞、卵磷脂小体治疗前后组内、组间比较均无统计学意义(P>0.05)。不良事件方面A组2例、B组1例,组间比较差别不显著(P>0.05)。结论:经会阴超声治疗慢性前列腺炎疗效显著(尤其是在改善疼痛方面),安全可靠、操作简单,患者易接受,值得进一步推广。

[Abstract] Objective： To evaluate the clinical efficacy and safety of transperineal ultrasonic therapy for chronic prostatitis （CP） by analyzing the scores of NIH-CPSI and the results of prostate fluid routine examination. Methods： We conducted a random- ized, double-blind, multi-centered trial on 96 CP patients that met the inclusion criteria. We divided the patients into groups A （trial） and B （control） of equal number, the former treated by transperineal ultrasound, while the latter with the same machine but no ultra- sound waves, 10 rain a time qd alt for 2 weeks. Then we evaluated the therapeutic effect and safety by comparing the scores of NIH-CP- SI and counts of white blood cells （WBC） and lecithin corpuscles （LC） in the prostate fluid between the two groups before and after treatment. Results： The total effectiveness rate was 70.83% in group A and 25% in group B （P 〈 0.01 ）. The scores on prostate pain, urinary symptoms and quality of life as well as the total NIH-CPSI score were significantly improved in group A as compared with pretreatment （ P 〈 0.05 ）, and so were the prostate pain score and total NIH-CPSI score in group B （ P 〈 0.05 ）. Statistically signifi-cant differences were observed between the two groups in the scores on prostate pain and urinary symptoms and total NIH-CPSI score af- ter treatment （P 〈 0.05）, but not in any of the NIH-CPSI scores before treatment （ P 〉 0.05 ）, nor were there any significant differ- ences in the counts of WBCs and LC either between the two groups or within each group before and after treatment （ P 〉 0.05 ）. Two patients experienced adverse events in group A, and 1 in group B （P 〉 0.05）. Conclusion ： Transperineal ultrasonic therapy is high- ly effective for CP, especially in relieving prostate pain. With its advantages of safety, easy operation and high acceptability, it de- serves a wider clinical application.