上海交通大学学报（医学版）
上海交通大學學報（醫學版）
상해교통대학학보（의학판）
JOURNAL OF SHANGHAI JIAOTONG UNIVERSITY(MEDICAL SCIENCE)
2009年
11期
1359-1362
,共4页
胡亚蓉%陈绍行%张瑾%王佩蓉%孔燕%朱鼎良%李松华%徐荣良%吴宗贵
鬍亞蓉%陳紹行%張瑾%王珮蓉%孔燕%硃鼎良%李鬆華%徐榮良%吳宗貴
호아용%진소행%장근%왕패용%공연%주정량%리송화%서영량%오종귀
抗高血压药%疗效%安全性%奥美沙坦%氯沙坦
抗高血壓藥%療效%安全性%奧美沙坦%氯沙坦
항고혈압약%료효%안전성%오미사탄%록사탄
antihypertensive agents%efficacy%safety%olmesartan%losartan
目的 通过与氯沙坦比较,评价国产奥美沙坦单药治疗轻、中度原发性高血压的疗效和安全性.方法 采用随机、双盲、双模拟、阳性对照、多中心和平行方法进行研究.237例轻、中度原发性高血压患者分为奥美沙坦组(口服奥美沙坦20 mg+氯沙坦50 mg安慰剂)和氯沙坦组(氯沙坦50 mg+奥美沙坦20 mg安慰剂),治疗期为8周.治疗4周末,若坐位舒张压≥90 mmHg(1 mmHg=0.133 kPa),则药物剂量加倍;每2周随访1次,观察降压效果和不良反应.另选32例轻、中度原发性高血压患者单纯服用奥美沙坦,观察治疗前和治疗后8周的动态血压变化.结果 与治疗前比较,治疗8周后奥美沙坦组和氯沙坦组收缩压分别下降(15.2±13.3)mmHg和(19.5±11.8)mmHg(均P<0.001),舒张压分别下降(15.9±7.48)mmHg和(16.2±5.95)mmHg(均P<0.01),两组间比较差异无统计学意义(P>0.05).奥美沙坦组与氯沙坦组降压总有效率和不良反应发生率比较(86.9% vs 93.7%和7.63% vs 5.88%),差异均无统计学意义(P> 0.05).动态血压监测显示,收缩压和舒张压的谷峰比值分别为86%和71%.结论 国产奥美沙坦治疗轻、中度高血压与氯沙坦等效,降压平稳,安全性好.
目的 通過與氯沙坦比較,評價國產奧美沙坦單藥治療輕、中度原髮性高血壓的療效和安全性.方法 採用隨機、雙盲、雙模擬、暘性對照、多中心和平行方法進行研究.237例輕、中度原髮性高血壓患者分為奧美沙坦組(口服奧美沙坦20 mg+氯沙坦50 mg安慰劑)和氯沙坦組(氯沙坦50 mg+奧美沙坦20 mg安慰劑),治療期為8週.治療4週末,若坐位舒張壓≥90 mmHg(1 mmHg=0.133 kPa),則藥物劑量加倍;每2週隨訪1次,觀察降壓效果和不良反應.另選32例輕、中度原髮性高血壓患者單純服用奧美沙坦,觀察治療前和治療後8週的動態血壓變化.結果 與治療前比較,治療8週後奧美沙坦組和氯沙坦組收縮壓分彆下降(15.2±13.3)mmHg和(19.5±11.8)mmHg(均P<0.001),舒張壓分彆下降(15.9±7.48)mmHg和(16.2±5.95)mmHg(均P<0.01),兩組間比較差異無統計學意義(P>0.05).奧美沙坦組與氯沙坦組降壓總有效率和不良反應髮生率比較(86.9% vs 93.7%和7.63% vs 5.88%),差異均無統計學意義(P> 0.05).動態血壓鑑測顯示,收縮壓和舒張壓的穀峰比值分彆為86%和71%.結論 國產奧美沙坦治療輕、中度高血壓與氯沙坦等效,降壓平穩,安全性好.
목적 통과여록사탄비교,평개국산오미사탄단약치료경、중도원발성고혈압적료효화안전성.방법 채용수궤、쌍맹、쌍모의、양성대조、다중심화평행방법진행연구.237례경、중도원발성고혈압환자분위오미사탄조(구복오미사탄20 mg+록사탄50 mg안위제)화록사탄조(록사탄50 mg+오미사탄20 mg안위제),치료기위8주.치료4주말,약좌위서장압≥90 mmHg(1 mmHg=0.133 kPa),칙약물제량가배;매2주수방1차,관찰강압효과화불량반응.령선32례경、중도원발성고혈압환자단순복용오미사탄,관찰치료전화치료후8주적동태혈압변화.결과 여치료전비교,치료8주후오미사탄조화록사탄조수축압분별하강(15.2±13.3)mmHg화(19.5±11.8)mmHg(균P<0.001),서장압분별하강(15.9±7.48)mmHg화(16.2±5.95)mmHg(균P<0.01),량조간비교차이무통계학의의(P>0.05).오미사탄조여록사탄조강압총유효솔화불량반응발생솔비교(86.9% vs 93.7%화7.63% vs 5.88%),차이균무통계학의의(P> 0.05).동태혈압감측현시,수축압화서장압적곡봉비치분별위86%화71%.결론 국산오미사탄치료경、중도고혈압여록사탄등효,강압평은,안전성호.
Objective To evaluate the efficacy and safety of domestic olmesartan in treatment of mild to moderate essential hypertension in comparison with losartan. Methods Two hundred and thirty-seven patients with mild to moderate essential hypertension were enrolled in a randomized, double-blind, multi-center, paralleded and active-controlled trial, and were divided into olmesartan group (olmesartan 20 mg + losartan 50 mg placebo) and losartan group (losartan 50 mg + olmesartan 20 mg placebo) for a 8-week therapy. Four weeks after treatment, dosages of drugs were doubled in patients with seated diastolic blood pressure ≥90 mmHg (1 mmHg =0.133 kPa). All patients were followed up every two weeks, and the efficacy and adverse effects were observed. Another 32 patients with mild to moderate essential hypertension were enrolled and given olmesartan only, and ambulatory blood pressure monitoring was performed before and 8 weeks after treatment. Results Compared with those before treatment, both systolic blood pressure and diastolic blood pressure significantly decreased in olmesartan group and losartan group 8 weeks after treatment [(15.2 ±13.3) mmHg and (19.5 ±11.8) mmHg, respectively for systolic blood pressure (P <0.001); (15.9 ±7.48) mmHg and (16.2 ± 5.95) mmHg, respectively for diastolic blood pressure (P < 0.01) ], while there was no significant difference between these two groups (P > 0.05). There was no significant difference in total effective rate and incidence of adverse effect between these two groups (86.9% vs 93.7% and 7.63% vs 5.88% , P > 0.05) . Ambulatory blood pressure monitoring demonstrated that trough to peak ratios of systolic blood pressure and diastolic blood pressure were 86% and 71%, respectively. Conclusion Domestic olmesaratan provides an effective, safe and long action in the treatment of mild to moderate essential hypertension.
