天智颗粒治疗血管性痴呆伴肝阳上亢证低血压发生率队列研究  

Cohort Study on the Incidence of Hypotension in Patients with Vascular Dementia and Gan-yang Hyperactivity Syndrome Treated with Tianzhi Granule

作　　者：宋哲[1] 于逢春[2] 姜海荣 毕齐 SONG Zhe;YU Feng-chun;JIANG Hai-rong;BI Qi(Department of Neurology,Beijing Anzhen Hospital,Capital Medical University,Bejing,100029;Department of Neurology,Bejing Haidian Hospital,Bejing,100029;Education Department,The Third Affliated Hospital of Bejing University of Chinese Medicine,Beijing,100029;Bejing Neurology Association,Bejing,100029)

机构地区：[1]首都医科大学附属北京安贞医院神经内科,北京100029 [2]北京市海淀医院神经内科,北京100080 [3]北京中医药大学第三附属医院教育处,北京100029 [4]北京神经内科学会,北京100019

出　　处：《中国中西医结合杂志》2022年第12期1447-1451,共5页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：国家“十二五”科技重大专项/重大新药创制项目[No.卫科药专项管办(2012)52-104203]。

摘　　要：目的 研究天智颗粒在血管性痴呆伴肝阳上亢证治疗过程中低血压发生情况。方法 回顾性筛选2013年1月—2017年12月天智颗粒Ⅳ期临床试验研究数据库中血管性痴呆伴肝阳上亢证患者1 606例,最终纳入1 465例,分为天智颗粒组(服用天智颗粒)、非天智颗粒组(服用盐酸多奈哌齐或安慰剂)。收集分析基线(0周)、服药4周、12周和24周的4次血压数据。将低血压定义为收缩压(SBP)<90 mmHg和(或)舒张压(DBP)<60 mmHg,比较两组间各时点血压差异及低血压总发生率。结果共纳入血管性痴呆伴肝阳上亢证患者共1 465例,其中天智颗粒组占73.7%(1 080/1 465例),非天智颗粒组占26.3%(385/1 465例);两组间基线资料年龄、身高、体重、静息心率差异有统计学意义(P<0.05),天智颗粒组低血压发生率为1.1%(12/1 080例),非天智颗粒组低血压发生率为1.3%(5/385例),两组间低血压发生率比较差异无统计学意义(P>0.05)。第12、24周非天智颗粒组舒张压低于天智颗粒组(P<0.05)。天智颗粒组共12例低血压患者,最低DBP为50 mmHg,临床均无与低血压相关的临床表现,未做特殊处理继续试验,并顺利完成试验。结论 服用天智颗粒后低血压发生率低,与服用多奈哌齐或安慰剂者低血压发生率无差异,服药后血压不低于服用多奈哌齐或安慰剂者。Objective To investigate the occurrence of hypotension in the treatment of vascular dementia with Gan-yang hyperactivity syndrome by Tianzhi Granule. Methods Totally 1 606 cases of vascular dementia and Gan-yang hyperactivity syndrome in the Tianzhi Granules phase Ⅳ clinical trial database from January 2013to December 2017 were retrospectively screened. And 1 465 cases were included,which were assigned to Tianzhi Ganules group(taking Tianzhi Granules)and non Tianzhi Granules group(taking donepezil hydrochloride or placebo). The blood pressure data were collected and analyzed at four points:baseline(0 week),4 weeks,12 weeks and 24 weeks after administration. Hypotension was defined as systolic blood pressure(SBP)<90 mmHg and/or diastolic blood pressure(DBP)<60 mmHg. The difference of blood pressure at each time point and the total incidence of hypotension were compared between the two groups. Results A total of 1 465 cases of vascular dementia with Gan-yang hyperactivity syndrome were included,of which 73.7%(1 080/1 465 cases)were in the Tianzhi Granule group and 26.3%(385/1 465 cases)were in the non Tianzhi Granule group;There were significant differences in age,height,weight and resting heart rate between the two groups(P<0.05).The incidence of hypotension in Tianzhi Granules group was 1.1%(12/1080 cases),while that in non Tianzhi Granules group was 1.3%(5/385 cases). There was no statistical difference between the two groups(P>0.05).At the 12th and 24th week,the diastolic blood pressure of non Tianzhi Granule group was lower than that of Tianzhi Granule group(P<0.05). There were 12 hypotensive patients in the Tianzhi Granule group,with the lowest DBP of 50 mmHg. There was no clinical manifestation related to hypotension in the clinic,and the trail was continued without special treatment,and successfully completed. Conclusions The incidence of hypotension after taking Tianzhi Granules was smilar as that of those taking donepezil or placebo. The blood pressure after taking Tianzhi Granule is not lower than that

关 键 词：天智颗粒 低血压 血管性痴呆 肝阳上亢证 不良反应 

分 类 号：R277.7[医药卫生—中医学]