舍尼通和抗生素联合用药治疗慢性非细菌性前列腺炎临床研究

目的评价舍尼通(R)与抗生素联合用药治疗慢性非细菌性前列腺炎的有效性及耐受性.方法采用双盲、平行对照、多中心临床试验研究方法,通过Stamey试验、前列腺按摩液(EPS)常规及美国国立卫生院慢性前列腺炎症状评分(NIH-CPSI),筛选出160例慢性非细菌性前列腺炎患者,随机分为试验组(80例,脱落1例)和对照组(80例).试验组前4周合用舍尼通(R)和左氧氟沙星,后4周单用舍尼通(R),服用剂量为舍尼通2次/d,1片/次,左氧氟沙星2次/d,0.1g/次;对照组方法同上,仅将舍尼通(R)换为安慰剂.所有患者均行入组前、治疗第4周和第8周随访并行NIH-CPSI评分、EPS等检查及药物不良反应的评估.结果治疗后4周和8周,试验组疼痛评分降低分别为3.34±2.45,4.33±3.13,排尿评分降低分别为2.22±1.79,2.77±2.04;对照组疼痛评分降低分别为2.28±2.42,3.30±3.29,排尿评分降低分别为1.24±1.67,1.83±2.25.两组治疗前后的自身对比均差异有显著性(P＜0.01),生活质量影响评分差异也有显著性(P＜0.05).组间比较,试验组较对照组第4周和第8周疼痛和排尿评分差异均有显著性(P＜0.01或P＜0.05).两组治疗前后白细胞、卵磷脂小体差异无显著性(P＞0.05),对药物的耐受性差异无显著性(P＞0.05),无严重不良反应事件发生.结论舍尼通(R)与抗生素联合用药方案能更有效地缓解慢性非细菌性前列腺炎患者的疼痛不适症状和排尿症状,耐受性好,值得在临床上推广应用.

A Clinical Study of Prostat Combined with an Antibiotic for Chronic Nonbacterial Prostatitis

OBJECTIVE: To evaluate the efficacy and safety of Prostate in combination with an antibiotic for the treatment of chronic nonbacterial prostatitis. METHODS: A double-blind, parallel contrasted, multi-central method was applied in the study. After the Stamey test and expressed prostate secretion (EPS) examination, 160 patients with prostatitis were recruited and randomized into a trial group (80 cases with 1 case missing) and a control group (80 cases). In the trial group, the patients used the levofloxacin and Prostate during the first 4 weeks and Prostate only during the following 4 weeks. In the control group, the patients used the levofloxacin and placebo during the first 4 weeks, and placebo only during the following 4 weeks. Before and 4 and 8 weeks after the treatment, the patients were visited and evaluated by the national institute health-chronic prostatitis symptom index (NIH-CPSI), EPS, and asked about the side. RESULTS: After 4-week and 8-week treatment, the pain index dropped by 3.34 +/- 2.45 and 4.06 +/- 3.03 in the trial group, and effects. 2.28 +/- 2.42 and 3.30 +/- 3.29 in the control; the voiding index dropped by 2.22 +/- 1.79 and 2.77 +/- 2.04 in the trial group, and 1.24 +/- 1.67 and 1.83 +/- 2.25 in the control respectively. There was significant difference between pre-treatment and post-treatment in both the two groups (P < 0.01), while the difference was not significant between 4-week and 8-week post-treatment (P > 0.05). And there was significant difference between the two groups in the pain index and voiding index (P < 0.01), but not in the white blood cell count and lipid in the EPS (P > 0.05). No serious side effects were recorded, and the tolerance to Prostate and placebo showed no significant difference. CONCLUSION: Prostate in combination with an antibiotic can effectively relieve the pain and voiding symptoms and improve the life quality of the patients with nonbacterial prostatitis and well deserves to be recommended in clinical practice.