摘要
目的 评价双倍剂量盐酸坦洛新缓释片治疗Ⅲ型前列腺炎的疗效及安全性.方法 2012年7月至2013年12月根据患者前列腺按摩液检查结果及美国国立卫生院慢性前列腺炎症状评分(National Institutes of Health chronic prostatitis symptom index,NIH-CPSI),筛选出120例Ⅲ型前列腺炎患者,并应用随机、双盲、对照方法分为单倍剂量组和双倍剂量组,各60例.单倍剂量组和双倍剂量组治疗前NIH-CPSI总分分别为26.91 ±4.08和27.31 ±4.98,疼痛评分分别为10.64 ±2.23和11.47 ±3.00,排尿症状评分分别为6.52±2.24和6.41±2.97,生命质量影响评分分别为9.68±1.81和9.45±1.79,差异均无统计学意义(P>0.05).单倍剂量组予盐酸坦洛新缓释片1片(0.2 mg)+安慰剂(淀粉片)l片,口服,1次/d;双倍剂量组予盐酸坦洛新缓释片2片(0.4 mg),口服,1次/d;两组均服药12周,比较治疗前后NIH-CPSI总分、疼痛评分、排尿症状评分、生命质量影响评分变化情况及药物不良反应.结果 单倍剂量组失访4例,双倍剂量组失访2例.单倍剂量组和双倍剂量组治疗后的NIH-CPSI总分分别为12.11±3.60和9.90±4.15,疼痛评分分别为3.57±1.67和3.21±2.21,排尿症状评分分别为2.88±1.70和2.21±2.11,生命质量影响评分分别为5.59±2.06和4.50±1.97,两组与治疗前比较差异均有统计学意义(P<0.05),双倍剂量组的改善幅度优于单倍剂量组(P<0.05).出现药物不良反应单倍剂量组2例(3.6%),包括头晕1例,头痛1例;双倍剂量组4例(6.9%),包括头晕3例,鼻炎1例,两组不良反应发生率比较差异无统计学意义(P>0.05).结论 与单倍剂量相比,双倍剂量盐酸坦洛新缓释片治疗Ⅲ型前列腺炎的疗效更好,安全性相当.
Objective To evaluate the efficacy and safety of double dosage Tamsulosin in treating patients with type Ⅲ prostatitis.Methods According to the results of prostate secretion(EPS) examination and the national institute health-chronic prostatitis symptom index(NIH-CPSI) questionnaire,120 patients with type Ⅲ prostatitis were recruited and randomly divided into single dosage group (n =60),treated with 0.2 mg Tamsulosin and placebo once daily for 12 weeks,and double dosage group (n =60),treated with 0.4mg Tamsulosin once daily for 12 weeks.Before treatment,the NIH-CPSI total scores in single and double dosage group were 26.91 ± 4.08 and 27.31 ± 4.98,respectively.The pain index in each group was 10.64±2.23 and 11.47 ± 3.00,respectively.The voiding index was 6.52 ± 2.24 and 6.41 ± 2.97 respectively.In those groups,the quality of life index was 9.68 ± 1.81 and 9.45 ± 1.79,respectively.All those items didn't show significant difference among those groups (P 〉 0.05).The patients were follow-up and evaluate by those items on weeks 12.Results Because of losing during follow-up,4 patients were excluded from single dosage group.2 patients were excluded from double dosage group.After treatment in single dosage group,the NIH-CPSI total scores were 12.11 ± 3.60,pain index were 3.57 ± 1.67,voiding index were 2.88 ± 1.70,quality of life index were5.59 ± 2.06.After treatment in double dosage group,the NIH-CPSI total scores were 9.90 ± 4.15,pain index were 3.21 ± 2.21,voiding index were 2.21 ± 2.11,quality of life index were 4.50 ± 1.97.After 12 weeks treatment,the NIH-CPSI total scores,pain index,voiding index,quality of life index in both two groups were improved (P 〈 0.05),and the double dosage group improve better(P 〈 0.05).In the course of treatment,there were 2 cases of patients (3.8%) with adverse drug reactions in single dosage group,including dizziness in 1 case,headache in 1 cases.There were 4 cases of patients (6.9%) with adverse drug reactions in double dosage group,including dizziness in 3 cases of and rhinitis in 1 case.The rate of adverse reactions had no significant differences in the two groups (P 〉 0.05).Conclusions Compared with single dosage Tamsulosin in the treatment of type Ⅲ prostatitis,double therapy had a better efficacy.Double dosage Tamsulosin therapy had an equal safety to the single dosage Tamsulosin.
出处
《中华泌尿外科杂志》
CAS
CSCD
北大核心
2015年第5期354-356,共3页
Chinese Journal of Urology