前列解毒胶囊治疗慢性前列腺炎的疗效和安全性

目的 评估前列解毒胶囊治疗慢性前列腺炎的有效性及安全性. 方法 209例慢性前列腺炎患者随机分为试验组和对照组,行多中心、随机、双盲双模拟、阳性药平行对照.试验组(107例)予前列解毒胶囊口服2次/d,4粒/次;前列泰片安慰片,3次/d,5片/次.对照组(102例)予前列泰片口服3次/d,5片/次;前列解毒安慰胶囊,口服2次/d,4粒/次.疗程为4周.疗效判断标准分4级:治愈:症状程度评分较治疗前减少≥90%;显效:症状程度评分较治疗前减少60%～89%;有效:症状程度评分较治疗前减少30%～59%;无效:症状程度评分较治疗前减少＜30%.结果 试验组完成试验102例,治愈11例、显效49例、有效28例、无效14例,总有效率86.2%(88/102);对照组完成试验98例,治愈4例、显效38例、有效35例、无效21例,总有效率78.6%(77/98),2组疗效比较差异有统计学意义(P＜0.05).2组患者尿频、尿不尽、下腹疼痛、尿道刺痛、会阴不适、腰骶疼痛、阴囊潮湿、睾丸疼痛症状均改善,试验组各症状缓解率依次为87.6%、82.1%、74.5%、84.1%、93.7%、80.3%、82.5%、82.3%;对照组分别为74.7%、73.O%、71.0%、74.2%、71.4%、67.9%、72.3%、76.2%;试验组尿频症状改善程度与对照组相比差异有统计学意义(P＜0.05),2组其他症状改善比较差异无统计学意义(P＞0.05).试验组治疗前前列腺液镜检白细胞(WBC)10～19个者28例、20～29个者33例、≥30个者41例,治疗后WBC＜10个者45例、10～19个者34例、20～29个者20例、≥30个者3例;对照组治疗前前列腺液镜检WBC 10～19个者26例、20～29个者35例、≥30个者37例,治疗后WBC＜10个者42例、10～19个者33例、20～29个者15例、≥30个者8例,2组组内治疗前后比较差异有统计学意义(P＜0.05),但2组间比较差异无统计学意义.试验组2例、对照组3例患者治疗期间出现轻度不良反应,主要为恶心、上腹不适、大便稀.结论 前列解毒胶囊治疗慢性前列腺炎安全、有效.

Efficacy and safety of Qianliejiedu capsule in the treatment of chronic prostatitis

Objective To evaluate the efficacy and safety of Qianliejiedu capsule in the treatment of chronic prostatitis. Methods A multi-central,randomized,double-blind clinical trial was conducted.A total of 209 patients diagnosed as chronic prostatitis were randomly divided into two groups:the trial group were treated with Qianliejiedu Capsule,5 pills were taken orally for each time,twice a day;the control group were given Qianlietai Pill,5 pills were taken orally for each time and 3 times a day.All patients of the tWO groups were treated for 4 weeks,The efficacy was evaluated by urethra irritating,painful or discomfortable symptoms,and the WBC count in EPS after the treatment.Clinical criteria divided into 4 types,cure:symptom score compared with a decrease≥90%;markedly effective:symptom score compared with a decrease of 60%to 89%;effective:symptom score comparedwith a decrease of 30%to 59%;invalid:symptom score compared with a decrease of＜30%.Results There were 102 patients in the treatment group,11 got cured,49 cases were remarkably effectire,28 eases were effective,14 eases were ineffective and the total effective rate was 86.2%(88/102).There were 98 patients in the treatment group,4 got cured,38 cases were remarkably effective,35 cases were effective,21 cases were ineffective,and the total effective rate was 78.6%(77/98).The trial group and the control group could improve the symptoms such as frequent micturition,the remaining urine,the lower abdomen ache,the urethra stabbing pain,the unwell perineum,the waist and sacrum ache,the moist scrotum,and the testicle ache.The vanishing rate of the trial group was 87.6%,82.1%,74.5%,84.1%,93.7%,80.3%,82.5%,82.3%;and the control group was 74.7%,73.0%,71.0%,74.2%,71.4%,67.9%,72.3%,76.2%.The vanishing rates of frequent micturition symptom of the 2 groups were significantly different(P=0.032).The result of WBC of the trial group before treatment was as follows:WBC 10-19 28 cases,WBC 20-29 33 cases,WBC≥30 41 cases.The result of WBC of the trial group after treatment was as follows:WBC＜10 45cases,WBC 10-19 34 cases,WBC 20-29 20 cases,WBC≥30 3 cases.The result of WBC of the control group before treatment was as follows:WBC 10-19 26 cases,WBC 20-29 35 cases,WBC:≥30 37 cases.The result of WBC of the control group after treatment was as follows:WBC＜10 42 caaes,WBC 10-19 33 cases,WBC 20-29 15 cases,WBC≥30 8 cases.There were significant differences between the before and after treatment results(P＜0.05).Two cases in the trial group and 3 cases in the control group had mild adverse reactions such as nausea,epigastric discomfort,and watery stool. Conclusion Qianliejiedu capsule is effective and safe for the treatment of chronic prostatitis.