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甲磺酸多沙唑嗪治疗高血压的多中心随机双盲临床研究

Double blind randomized multicenter clinical study on doxazosin mesylate for treatment of hypertension

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【作者】 高荣沈潞华姚晨谢安云唐映红李耘杨天仑李向平孟庆玉

【Author】 GAO Rong, SHENLu-hua, YAOChen, XIEAn-yun, TANG Ying-hong, LI Yun , YANG Tian-lun , LI Xiang-ping , MEN Qing-yu( Hunan Institute of Pharmaceutical Industry Research, Changsha 410014,China; Beijing Friendship Hospital, Beijing 100053, China; Gerneral Hospital ofPLA, Beijing 100853, China; Beijing Xuanwu Hospital, Beijing 100053, China;S.Xiangya Hospital, Changsha 410008,China; Xiangya Second Hospital, Changsha 410008, China)

【机构】 湖南医药工业研究所北京友谊医院解放军总医院北京宣武医院湘雅医院湘雅二医院湖南医药工业研究所 湖南 长沙 410014北京 100053北京 100853湖南 长沙 410014湖南 长沙 410008湖南 长沙 410014

【摘要】 目的 评价甲磺酸多沙唑嗪片对轻中度原发性高血压的降压疗效及安全性。方法 以盐酸特拉唑嗪为对照,用随机双盲平行多中心临床实验方法,完成病例226例(试验组111例,对照组115例)。起始剂量为每日2 mg,2周末,若舒张压≥90 mmHg,则分别增至每日4 mg,直至增董最高剂量每日6 mg,疗程共8周。另20例开放服用甲磺酸多沙唑嗪的患者,进行动态血压观测,以进行T/P比值分析。结果 两组药物治疗后血压即开始下降。治疗8周末,试验组平均收缩压与舒张压分别下降13.6%和16.1%,对照组分别下降13.7%和16.7%;两组药物的总有效率分别为92.3%和89.2%,两组间临床疗效差异无统计学意义。药物不良反应发生率试验组为17.1%,对照组为15.7%,两组间药物不良反应发生率差异7己统计学意义。结论甲磺酸多沙唑嗪片与盐酸特拉唑嗪片一样,对轻、中度高血压患者的降压疗效确切,药物不良反应轻,病人耐受性好。

【Abstract】 Objective To evaluate the efficacy and safety of doxazosin mesylate tablets on mild to moderate essential hypertension. Methods This multicenter clinical trial used terzazosin hydrochloride as control, and it was double blind and randomly parallel. There were 226 patients in clinical trial (111 patients of trial group and 115 patients of control group). The start doses were 2 mg each once daily, respectively. After two weeks, if the diastolic blood pressure (DBP) was higher than or equal to 90 mmHg, the doses were added to 4 mg each once daily, respectively. The largest doses were 6 mg each once daily, respectively. The total course of treatment was 8 weeks. Twenty patients of open treatment were carried out ambulatory blood pressure monitoring before and after treatment, then analyzed T/P ratio. Results Blood pressure began to decline in the second week of treatment. After 8 weeks, the mean systolic blood pressure (SBP) and DBF of treatment group declined 13.6% and 16.1%, respectively, and those of control group declined 13.7% and 16.7%, respectively. The total efficiency rates of the two kinds of drug were 92.3% and 89.2%. There was no remarkable difference between the clinical efficiency rates of the two kinds of drug. The rates of adverse reaction of the two kinds of drug were 17.1% and 15.7%. There was no remarkable difference between the adverse reaction rates of the two kinds of drug. Conclusion Doxazosin mesylate was comparable to terzazosin hydrochloride, which has affirmed effect on mild to moderate hypertension, with little side effect, good patient tolerance.

  • 【文献出处】 中国临床药理学杂志 ,The Chinese Journal of Clinical Pharmacology , 编辑部邮箱 ,2004年02期
  • 【分类号】R544.1
  • 【被引频次】4
  • 【下载频次】169
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