Objective To investigate the clinical efficacy of compound Xuanju capsule works in the treatment of typeⅢ chronic prostatitis with kidney stasis syndrome, and explore it related therapeutic mechanism and etiology of chronic prostatitis. Methods A single armed, multi-center and prospective longitudinal clinical test was carried out to compare the before-after difference of 144 type Ⅲ chronic prostatitis patients with kidney stasis syndrome from 5 centers. All the patients were administered with compound Xuanju capsule as following: three times one day, three tablets one time, totally for six weeks. Total efficiency of before-after treatment, NIH-CPSI score, TCM syndrome score, the white blood cell and lecithin body in EPS, IIEF-5 score, TT, FT, IL-8, IL-10 and other indexes were used to analyzed its therapeutic mechanism and clinical efficacy on type Ⅲ chronic prostatitis. Results Clinical efficiency of Xuanju capsule was 90.97% for six weeks treatment of type Ⅲ chronic prostatitis patients with kidney stasis syndrome. The NIH-CPSI score and the white blood cells account in EPS were significantly decreased (P<0.001) whereas lecithin body increased (P<0.001). The TCM syndrome score including primary and secondary symptoms scores were significantly lower (P<0.01) than that of the control group. The IIEF-5 scores and other items had significant changes after treatment (P<0.001). The levels of FT and IL-10 elevated significantly (P<0.05), but the increase of T index and decrease of IL-8 had no significance (P>0.05). Conclusion These results suggest compound Xuanju capsule shows some improvements in alleviating clinical symptoms of type Ⅲ chronic prostatitis (kidney stasis syndrome) in different extent, especially in painful symptoms, and an obvious therapeutic effect on patients with erectile dysfunction. Moreover, changes of endocrine and inflammatory factor levels regulate and enhance the immunity of patients, which provides some cues for better clinical therapy.%目的 评价复方玄驹胶囊治疗Ⅲ型慢性前列腺炎(肾虚血瘀证)患者的临床疗效.方法 采用单臂、多中心、前瞻性纵向临床试验方法,将5家医院的144例符合Ⅲ型慢性前列腺炎(肾虚血瘀证)诊断标准的患者按照自身前后对照方法,给予患者6周复方玄驹胶囊,每次3粒,每天3次的治疗.通过观察治疗前、后总有效率,NIH-CPSI评分,中医证候评分,EPS中白细胞与卵磷脂小体数量,IIEF-5评分,以及TT、FT、IL-8、IL-10等有效指标阐述复方玄驹胶囊对该类型慢性前列腺炎的治疗机制及临床疗效.结果 通过6周观察,临床总有效率达90.97%.NIH-CPSI总分及各分项评分治疗后显著下降(P<0.001).在中医证候评分上,主症及次症评分,治疗后较治疗前显著降低(P<0.01).EPS中白细胞数量显著下降(P<0.001),卵磷脂小体显著增高(P<0.001).IIEF-5总分及5项(自信、插入次数、维持次数、完成难度、性交满足)评分,治疗前后均具有统计学差异(P<0.001).在内分泌及炎症因子方面,治疗后FT、IL-10治疗后相较治疗前显著升高(P<0.05),而T与疗前相比处于升高趋势但不显著(P>0.05);IL-8与治疗前相比处于下降趋势,但差异也不显著(P>0.05).结论 复方玄驹胶囊对Ⅲ型慢性前列腺炎(肾虚血瘀证)的临床症状有不同程度的改善,尤其是对于疼痛症状改善明显,且对伴有勃起功能障碍的患者有明显的治疗作用,且通过对患者内分泌及炎症因子的干预影响,以达到增强患者免疫、祛邪扶正的作用,为临床治疗提供一定的研究价值.
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