CAJ | 학술논문

目的评价盐酸特拉唑嗪治疗良性前列腺增生(BPH)合并原发性高血压患者的有效性、安全性及依从性.方法 2006年3月至2010年3月我中心开展了单中心、前瞻性临床研究.患者睡前口服盐酸特拉唑嗪1 ～6 mg,随访3个月.主要评价指标是治疗后4周末和3个月末患者国际前列腺症状评分(IPSS)变化值、血压变化值；次要指标是治疗后4周末和3个月末患者最大尿流率(Qmax)变化值,同时对不良事件进行分析.共纳入212例患者,其中189例资料合格,均为临床BPH合并高血压患者.随机分为两组进行统计学分析.结果血压控制良好组IPSS从基线的(22.31 ±5.18)分降至4周末的(15.64±3.91)分(P＞0.05)和3个月末的(13.16±3.53)分(t=7.984,P＜0.01),Qmax从基线的(7.87±2.41)％提高至4周末的(14.19±2.64)％ (P ＞0.05)和3个月末的(15.69 ±2.77)％(t=-11.334,P＜0.01),盐酸特拉唑嗪有轻度的降血压作用(t=0.539,P＜0.05),但患者血压均在正常范围内.血压未控制良好组IPSS从基线的(21.55±4.82)分降至4周末的(15.44±3.66)分(P＞0.05)和3个月末的( 12.96±3.11)分(t=4.325,P＜0.01),Qmax从基线的(8.27±2.27)％提高至4周末的(14.26 ±2.87)％ (P ＞0.05)和3个月末的(15.51±2.92)％(t=- 10.721,P＜0.01).未出现明显严重不良反应.研究结束时189例患者继续坚持服药,进行长期随访.结论盐酸特拉唑嗪能有效改善BPH合并高血压患者症状,显著提高生活质量,同时能协助控制血压,具有良好的安全性和依从性.
목적 평개염산특랍서진치료량성전렬선증생(BPH)합병원발성고혈압환자적유효성、안전성급의종성.방법 2006년3월지2010년3월아중심개전료단중심、전첨성림상연구.환자수전구복염산특랍서진1 ～6 mg,수방3개월.주요평개지표시치료후4주말화3개월말환자국제전렬선증상평분(IPSS)변화치、혈압변화치；차요지표시치료후4주말화3개월말환자최대뇨류솔(Qmax)변화치,동시대불량사건진행분석.공납입212례환자,기중189례자료합격,균위림상BPH합병고혈압환자.수궤분위량조진행통계학분석.결과 혈압공제량호조IPSS종기선적(22.31 ±5.18)분강지4주말적(15.64±3.91)분(P＞0.05)화3개월말적(13.16±3.53)분(t=7.984,P＜0.01),Qmax종기선적(7.87±2.41)％제고지4주말적(14.19±2.64)％ (P ＞0.05)화3개월말적(15.69 ±2.77)％(t=-11.334,P＜0.01),염산특랍서진유경도적강혈압작용(t=0.539,P＜0.05),단환자혈압균재정상범위내.혈압미공제량호조IPSS종기선적(21.55±4.82)분강지4주말적(15.44±3.66)분(P＞0.05)화3개월말적( 12.96±3.11)분(t=4.325,P＜0.01),Qmax종기선적(8.27±2.27)％제고지4주말적(14.26 ±2.87)％ (P ＞0.05)화3개월말적(15.51±2.92)％(t=- 10.721,P＜0.01).미출현명현엄중 불량반응.연구결속시189례환자계속견지복약,진행장기수방.결론 염산특랍서진능유효개선BPH합병고혈압환자증상,현저제고생활질량,동시능협조공제혈압,구유량호적안전성화의종성.
Objective To evaluate the effectiveness and safety of terazosin in the treatment of benign prostatic hyperplasia (BPH)patients with concomitant hypertension.Methods A singlecenter prospective clinical observational study was conducted from March,2006 to March,2010 in our center.The main endpoints were the changes of IPSS total score,diastolic and systolic blood pressures at the end of 4 weeks and 3 monthes compared with the baseline,The second endpoints were Qmax value at the end of 4 weeks and 3 monthes compared with the baseline,Safety was assessed by adverse events.Results There were 212 patients in the study recruited,and 189 patients completed the study.All patients had BPH combined with hepertension.All patients were randomly devided into two statistical analysis group,blood pressure well controled and not well controled group,In the well controlled group,the IPSS socre reduced from 22.31 ± 5.18 at baseline to 15.64 ±3.91 at the end of the 4th weeks and 13.16 ± 3.53 at the end of 3rd monthes in the blood pressure well controled group populatin( P ＜ 0.01 ).The Qmax were improved significantly from (7.87 ± 2.41 ) ％ at baseline to (14.19 ±2.64)％ at the end of the 4th weeks and (15.69 ±2.77)％ at the end of3rd monthes in the blood pressure well controled group populatin( P ＜ 0.01 ).Terazosin had moderate effect in blood pressure decreasing (P ＜ 0.05 ),and all patients were within normal blood pressure range.In the uncontrolled group,the IPSS socre reduced from 21.55 ± 4.82 at baseline to 15.44 ± 3.66 at the end of the 4th weeks and 12.96 ± 3.11 at the end of 3rd monthes in the blood pressure well controled group populatin (P ＜ 0.01 ).The Qmax were improved significantly from ( 8.27 ± 2.27 ) ％ at baseline to ( 14.26 ± 2.87) ％ at the end of the 4th weeks and ( 15.51 ±2.92) ％ at the end of 3rd monthes in the blood pressure well controled group populatin( P ＜ 0.01 ).Terazosin decreased BPH patient blood pressure with controlled patients and unctrolled patients additionaly to other blood pressure medicine (P ＜ 0.05 ),and no severe side effect occured.At the end of the study,all patients were taking drug continuously and were followed.Conclnsion Terazosin can significantly improve the symptoms and quality of life in BPH patients with hypertension with good safety and compliance.