中华泌尿外科杂志
中華泌尿外科雜誌
중화비뇨외과잡지
CHINESE JOURNAL OF UROLOGY
2008年
8期
524-527
,共4页
郭军%霍红旭%JIN Xun-bo%张兆峰
郭軍%霍紅旭%JIN Xun-bo%張兆峰
곽군%곽홍욱%JIN Xun-bo%장조봉
前列腺炎%治疗学%临床研究%前列解毒胶囊
前列腺炎%治療學%臨床研究%前列解毒膠囊
전렬선염%치료학%림상연구%전렬해독효낭
Prostatitis%Therapeutics%Clinical trial%Qianliejiedu capsule
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.
目的 評估前列解毒膠囊治療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隨機分為試驗組和對照組,行多中心、隨機、雙盲雙模擬、暘性藥平行對照.試驗組(107例)予前列解毒膠囊口服2次/d,4粒/次;前列泰片安慰片,3次/d,5片/次.對照組(102例)予前列泰片口服3次/d,5片/次;前列解毒安慰膠囊,口服2次/d,4粒/次.療程為4週.療效判斷標準分4級:治愈:癥狀程度評分較治療前減少≥90%;顯效:癥狀程度評分較治療前減少60%～89%;有效:癥狀程度評分較治療前減少30%～59%;無效:癥狀程度評分較治療前減少＜30%.結果 試驗組完成試驗102例,治愈11例、顯效49例、有效28例、無效14例,總有效率86.2%(88/102);對照組完成試驗98例,治愈4例、顯效38例、有效35例、無效21例,總有效率78.6%(77/98),2組療效比較差異有統計學意義(P＜0.05).2組患者尿頻、尿不儘、下腹疼痛、尿道刺痛、會陰不適、腰骶疼痛、陰囊潮濕、睪汍疼痛癥狀均改善,試驗組各癥狀緩解率依次為87.6%、82.1%、74.5%、84.1%、93.7%、80.3%、82.5%、82.3%;對照組分彆為74.7%、73.O%、71.0%、74.2%、71.4%、67.9%、72.3%、76.2%;試驗組尿頻癥狀改善程度與對照組相比差異有統計學意義(P＜0.05),2組其他癥狀改善比較差異無統計學意義(P＞0.05).試驗組治療前前列腺液鏡檢白細胞(WBC)10～19箇者28例、20～29箇者33例、≥30箇者41例,治療後WBC＜10箇者45例、10～19箇者34例、20～29箇者20例、≥30箇者3例;對照組治療前前列腺液鏡檢WBC 10～19箇者26例、20～29箇者35例、≥30箇者37例,治療後WBC＜10箇者42例、10～19箇者33例、20～29箇者15例、≥30箇者8例,2組組內治療前後比較差異有統計學意義(P＜0.05),但2組間比較差異無統計學意義.試驗組2例、對照組3例患者治療期間齣現輕度不良反應,主要為噁心、上腹不適、大便稀.結論 前列解毒膠囊治療慢性前列腺炎安全、有效.
목적 평고전렬해독효낭치료만성전렬선염적유효성급안전성. 방법 209례만성전렬선염환자수궤분위시험조화대조조,행다중심、수궤、쌍맹쌍모의、양성약평행대조.시험조(107례)여전렬해독효낭구복2차/d,4립/차;전렬태편안위편,3차/d,5편/차.대조조(102례)여전렬태편구복3차/d,5편/차;전렬해독안위효낭,구복2차/d,4립/차.료정위4주.료효판단표준분4급:치유:증상정도평분교치료전감소≥90%;현효:증상정도평분교치료전감소60%～89%;유효:증상정도평분교치료전감소30%～59%;무효:증상정도평분교치료전감소＜30%.결과 시험조완성시험102례,치유11례、현효49례、유효28례、무효14례,총유효솔86.2%(88/102);대조조완성시험98례,치유4례、현효38례、유효35례、무효21례,총유효솔78.6%(77/98),2조료효비교차이유통계학의의(P＜0.05).2조환자뇨빈、뇨불진、하복동통、뇨도자통、회음불괄、요저동통、음낭조습、고환동통증상균개선,시험조각증상완해솔의차위87.6%、82.1%、74.5%、84.1%、93.7%、80.3%、82.5%、82.3%;대조조분별위74.7%、73.O%、71.0%、74.2%、71.4%、67.9%、72.3%、76.2%;시험조뇨빈증상개선정도여대조조상비차이유통계학의의(P＜0.05),2조기타증상개선비교차이무통계학의의(P＞0.05).시험조치료전전렬선액경검백세포(WBC)10～19개자28례、20～29개자33례、≥30개자41례,치료후WBC＜10개자45례、10～19개자34례、20～29개자20례、≥30개자3례;대조조치료전전렬선액경검WBC 10～19개자26례、20～29개자35례、≥30개자37례,치료후WBC＜10개자42례、10～19개자33례、20～29개자15례、≥30개자8례,2조조내치료전후비교차이유통계학의의(P＜0.05),단2조간비교차이무통계학의의.시험조2례、대조조3례환자치료기간출현경도불량반응,주요위악심、상복불괄、대편희.결론 전렬해독효낭치료만성전렬선염안전、유효.
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.
