醋酸泼尼松联合左氧氟沙星治疗Ⅲ型前列腺炎临床研究

Corticoid Combined with an Antibiotic for Chronic Nonbacterial Prostatitis

目的:评价肾上腺皮质激素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:采用随机、双盲、平行对照临床试验研究方法,通过Stamey试验、前列腺按摩液(EPS)常规及美国国立卫生研究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2例)和对照组(80例)。试验组前2周合用肾上腺皮质激素和左氧氟沙星,后2周单用左氧氟沙星,醋酸泼尼松片15mg/次,1次/d,口服,连续2周后停药;左氧氟沙星0.1mg/次,2次/d;对照组方法同上,仅将醋酸泼尼松片换为安慰剂。所有患者均行入组前、治疗第2周和第4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2周和4周,试验组NIH-CPSI总分、疼痛评分、排尿评分和生活质量评分降低分别为(9.56±2.05)、(4.59±1.18)、(2.38±1.24)、(2.59±1.20)分和(11.72±2.41)、(5.51±1.42)、(2.92±1.17)、(3.33±1.08)分;对照组NIH-CPSI总分、疼痛评分、排尿评分和生活质量评分降低分别(6.53±2.70)、(3.20±1.30)、(1.40±1.05)、(1.80±1.15)分和(8.53±2.91)、(3.88±1.44)、(2.08±1.11)、(2.55±1.33)分。两组治疗前后的自身对比差异均有显著性(P<0.01);组间比较,试验组较对照组第2周和第4周NIH-CPSI总分、疼痛、排尿和生活质量评分差异均有显著性(P<0.01)。两组治疗前后EPS中WBC计数差异有显著性(P<0.01)。组间比较,试验组较对照组第2周和第4周WBC计数差异均有显著性(P<0.01)。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:泼尼松联合左氧氟沙星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、改善患者的生活质量和减少EPS中WBC,耐受性好,但长期疗效及耐受性尚待进一步的临床研究。

Objective： To evaluate the efficacy and safety of corticoid in combination with an antibiotic in the treatment of chronic non- bacterial prostatitis （CNP）. Methods ： We used the randomized, double-blind and parallel contrasted method, selected 160 CNP patients via the Stamey test, EPS examination and NIH-CPSI scores, and equally randomized them into an experimental group （with 1 case missing） and a control group. The former received prednisone and levofloxacin for 2 weeks followed by another 2-week administration of levofloxacin only, while the latter were given levofloxacin and placebo in the first 2 weeks and placebo only in the next 2. All the patients were evaluated by NIH-CPSI scores and EPS results and followed up for adverse events after 2 and 4 weeks of treatment. Results ： The total NIH-CPSI score, the pain index, voiding index and quality of life （QOL） score in the experimental group were decreased by 9.56 ± 2.05, 4.59 ± 1.18, 2.38 ± 1.24 and 2.59 ± 1. 20 after the 2-week treatment, and 11.72 ± 2.41, 5.51 ± 1.42, 2.92 ± 1.17 and 3.33 ± 1.08 after the 4-week treatment ; while those in the control group were reduced by 6.53 ± 2.70, 3.20 ± 1.30, 1.40 ± 1.05 and 1.80 ± 1.15 after the 2-week treatment, and 8.53 ± 2.91, 3.88 ± 1.44, 2.08 ± 1.11 and 2.55 ± 1.33 after the 4-week treatment, with significant differences between the two groups as well as between pre- and post-treatment （P 〈 0.01 ）, but not between the 2- and 4-week treatment （P 〉 0.05 ）. Statistically significant differences were also observed in the count of WBCs in EPS between not only pre- and post-treatment, but also the 2- and 4-week treatment （P 〈 0.01 ）. No serious adverse events were recorded, nor were significant differences in the tolerance to corticoid and placebo. Conclusion： Prednisone in combination with an antibiotic can effectively relieve pain and voiding symptoms, improve QOL and reduce WBC in the EPS of CNP patients, and therefore well deserves to be recommended in clinical application. But its long-term efficacy and tolerance are yet to be further studied.