中华泌尿外科杂志
中華泌尿外科雜誌
중화비뇨외과잡지
CHINESE JOURNAL OF UROLOGY
2010年
5期
343-346
,共4页
杜广辉%齐隽%宋健%丁强%王行环%孔垂泽%靳风烁%蔡松良%张炜%叶章群%那彦群
杜廣輝%齊雋%宋健%丁彊%王行環%孔垂澤%靳風爍%蔡鬆良%張煒%葉章群%那彥群
두엄휘%제준%송건%정강%왕행배%공수택%근풍삭%채송량%장위%협장군%나언군
盐酸特拉唑嗪%前列腺增生%治疗结果%药物毒性%病人依从
鹽痠特拉唑嗪%前列腺增生%治療結果%藥物毒性%病人依從
염산특랍서진%전렬선증생%치료결과%약물독성%병인의종
Terazosin%Prostatic hyperplasia%Treatment outcome%Drug toxicity%Patient compliance
目的 评价维持剂量盐酸特拉唑嗪治疗中国人群BPH患者的有效性、安全性和依从性. 方法2007年6月至2008年3月在中国32家泌尿外科中心开展了多中心、前瞻性临床研究,方案为口服盐酸特拉唑嗪1～4 mg,1次/d,共4周.主要评价指标是治疗2、4周时患者IPSS变化值;次要指标是治疗4周时Qmax,QOL变化值,治疗2、4周时血压变化值以及4周内脱落率.并通过对不良事件的分析评估其安全性. 结果共纳入1006例BPH患者(FAS集),资料合格者992例(PP集),合并高血压病344例.FAS集患者IPSS从基线的22.32±6.13降至2周时的16.98±5.92以及4周时的14.00±5.52(P＜0.01);PP集患者IPSS从基线的22.32±6.15降至2周时的16.96±5.93及4周时的13.95±5.52(P＜0.01).以IPSS与基线相比下降＞30%定义为有效,2周末有效率为26.54%,4周末为60.64%.治疗4周后Qmax 和QOL均有显著增高,分别改善32%和45%(P＜0.01).对于血压正常或高血压获得控制的患者,盐酸特拉唑嗪对血压的影响较小;而对伴有未治疗或未能控制血压的高血压患者,盐酸特拉唑嗪能一定程度降低血压(P＜0.05).治疗中不良事件发生率低,最常见为头晕(3.68%).研究结束时960例仍继续服药. 结论盐酸特拉唑嗪能有效改善中国人群BPH患者症状,显著提高生活质量,同时具有良好的安全性和依从性.
目的 評價維持劑量鹽痠特拉唑嗪治療中國人群BPH患者的有效性、安全性和依從性. 方法2007年6月至2008年3月在中國32傢泌尿外科中心開展瞭多中心、前瞻性臨床研究,方案為口服鹽痠特拉唑嗪1～4 mg,1次/d,共4週.主要評價指標是治療2、4週時患者IPSS變化值;次要指標是治療4週時Qmax,QOL變化值,治療2、4週時血壓變化值以及4週內脫落率.併通過對不良事件的分析評估其安全性. 結果共納入1006例BPH患者(FAS集),資料閤格者992例(PP集),閤併高血壓病344例.FAS集患者IPSS從基線的22.32±6.13降至2週時的16.98±5.92以及4週時的14.00±5.52(P＜0.01);PP集患者IPSS從基線的22.32±6.15降至2週時的16.96±5.93及4週時的13.95±5.52(P＜0.01).以IPSS與基線相比下降＞30%定義為有效,2週末有效率為26.54%,4週末為60.64%.治療4週後Qmax 和QOL均有顯著增高,分彆改善32%和45%(P＜0.01).對于血壓正常或高血壓穫得控製的患者,鹽痠特拉唑嗪對血壓的影響較小;而對伴有未治療或未能控製血壓的高血壓患者,鹽痠特拉唑嗪能一定程度降低血壓(P＜0.05).治療中不良事件髮生率低,最常見為頭暈(3.68%).研究結束時960例仍繼續服藥. 結論鹽痠特拉唑嗪能有效改善中國人群BPH患者癥狀,顯著提高生活質量,同時具有良好的安全性和依從性.
목적 평개유지제량염산특랍서진치료중국인군BPH환자적유효성、안전성화의종성. 방법2007년6월지2008년3월재중국32가비뇨외과중심개전료다중심、전첨성림상연구,방안위구복염산특랍서진1～4 mg,1차/d,공4주.주요평개지표시치료2、4주시환자IPSS변화치;차요지표시치료4주시Qmax,QOL변화치,치료2、4주시혈압변화치이급4주내탈락솔.병통과대불량사건적분석평고기안전성. 결과공납입1006례BPH환자(FAS집),자료합격자992례(PP집),합병고혈압병344례.FAS집환자IPSS종기선적22.32±6.13강지2주시적16.98±5.92이급4주시적14.00±5.52(P＜0.01);PP집환자IPSS종기선적22.32±6.15강지2주시적16.96±5.93급4주시적13.95±5.52(P＜0.01).이IPSS여기선상비하강＞30%정의위유효,2주말유효솔위26.54%,4주말위60.64%.치료4주후Qmax 화QOL균유현저증고,분별개선32%화45%(P＜0.01).대우혈압정상혹고혈압획득공제적환자,염산특랍서진대혈압적영향교소;이대반유미치료혹미능공제혈압적고혈압환자,염산특랍서진능일정정도강저혈압(P＜0.05).치료중불량사건발생솔저,최상견위두훈(3.68%).연구결속시960례잉계속복약. 결론염산특랍서진능유효개선중국인군BPH환자증상,현저제고생활질량,동시구유량호적안전성화의종성.
Objective To evaluate the effectiveness and safety of terazosin in the treatment of Chinese benign prostatic hyperplasia (BPH) patients. Methods A multicenter prospective postmarketing observational study was conducted from June 2007 to March 2008 in 32 urologic centers.Patients were given terazosin for 4 weeks according to the routine medical care procedures following instructions. Effectiveness evaluation included the primary endpoint focusing on the changes in IPSS total score at the end of 2nd and 4th week compared with the baseline. The secondary endpoints were the changes in Qmax and QOL at the end of 4th week, diastolic and systolic blood pressures at the end of 2nd and 4th week compared with the baseline and the discontinuation rate of terazosin within the four weeks. Safety was assessed by adverse events. Results There were 1006 patients included in this study (FAS) and 992 patients (PP) completed the study. Among them, there were 344 patients having hypertension. The total IPSS score reduced from 22.32±6. 13 at baseline to 16. 98±5.92 at the end of the 2nd week and to 14.00±5. 52 at the end of the 4th week in FAS population (P＜0. 01).The total IPSS score changed from 22.32±6.15 at baseline to 16. 96±5.93 at the end of the 2nd week and to 13. 95±5.52 at the end of the 4th week in the PP population (P＜0.01). The efficacy rate was 26.54% at the 2-week treatment and 60.64% at the 4-week treatment, which was defined as obtaining improvement by 30% compared with the baseline. Patient's IPSS in different age groups with different prostatic hyperplasia levels and patients combined with or without 5-α reductase inhibitors were all decreased significantly(P＜0.01). With 4-week treatment of terazosin, Qmax and QOL were improved significantly by 32% and 45% (P＜0.01). Terazosin decreased BPH patient blood pressure with untreated or uncontrolled hypertension (P＜0.05), but had little influence on normal blood pressure of those under control. The incidence of adverse reactions was low. The most common adverse event was dizziness (3.68%). At the end of the study, 960 subjects (95%) were taking drug continuously.Conclasions Terazosin can significantly improve the symptoms and quality of life in Chinese BPH patients with good safety and compliance.
