研究疾病:
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高血压
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研究疾病代码:
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Target disease:
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hypertension
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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整群随机分组
Cluster randomization
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研究所处阶段:
Study phase:
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上市后药物
Post-marketing clinical trial
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研究目的:
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针对社区高血压知晓率、达标控制率低,治疗依从性较差,缺乏成熟的中药辨证治疗延缓疾病进展适宜技术的状况,本课题通过中药干预对高血压进展影响的社区队列研究,提供中医辨证治疗、适合长期应用的适宜技术。为进一步提高我国人群高血压的高血压患者的治疗率和控制率,在降压同时积极保护血管,预防和逆转血管损伤,延缓高血压进展,降低心脑血管并发症的发生率,降低致残率和病死率、改善长期预后提供依据。
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Objectives of Study:
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Aiming at the community hypertension awareness rate, low compliance control rate, poor treatment adherence, and lack of a well-established state of the art of TCM syndrome differentiation treatment to delay disease progression, this topic is a community-based cohort study on the effects of TCM interventions on hypertension progression, which provides an appropriate technique of TCM syndrome differentiation treatment that is suitable for long-term application and may further improve hypertension patients in our populationThe therapeutic and control rates of AVTT provide a basis for aggressive vascular protection while lowering blood pressure, preventing and reversing vascular damage, delaying the progression of hypertension, reducing the incidence of cardiovascular and cerebrovascular complications, reducing disability and case fatality, and improving long-term outcomes.
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药物成份或治疗方案详述:
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对照组:
参照“中国高血压防治指南2018年修订版”进行生活方式干预,仍不达标,可加降压西药,根据病情可选用一线药物钙拮抗剂、ACEI、ARB、B受体阻滞剂、利尿剂等。推荐降压药物:氨氯地平,5mg,qd,Po;厄贝沙坦,150mg, qd,Po。合并用药:合并冠心病、糖尿病等按相关指南药物治疗。
试验组:
常规西药治疗同对照组,在对照组基础上辨证使用中成药(中药)。推荐药物:松龄血脉康,口服。一次3粒,一日3次。
疗程:均为12个月
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Description for medicine or protocol of treatment in detail:
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Control group:
Refer to the 2018 revision of the Chinese guidelines for the prevention and treatment of hypertensionFor lifestyle intervention, still not up to standard, can be added antihypertensive western medicine, according to the condition can be selected first-line drug calcium antagonist, ACEI, ARB, b-blocker, diuretic etc. recommended antihypertensive drug: amlodipine, 5mg, QD, Po; irbesartan, 150mg, QD, Po. Concomitant medication: concomitant medication: Coronary heart disease, diabetes mellitus and other drug treatment according to the relevant guidelines.
Trial groups:
Conventional Western medicines treat the same patient group, and Chinese patent medicines (TCM) are used syndrome differentiation on the basis of the control group. Recommended medicines: Songzhi Xuemai Kang, orally. 3 grains at a time, 3 times a day.
Course: both at 12 months
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纳入标准:
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1)年龄≥18岁
2)符合高血压病诊断标准,分级属于高血压 1、2级;
3)签署知情同意书。
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Inclusion criteria
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1) Age ≥ 18 years
2) Met the diagnostic criteria of hypertension, and the grading was classified as hypertension grade 1 or 2;
3) Signed informed consent.
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排除标准:
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1)急性心肌梗死、急性脑梗死、脑出血、不稳定型心绞痛;
2)高血压3级;继发性高血压;
3)合并恶性肿瘤和肾功能衰竭、肝硬化、重度心力衰竭等严重心、肝肾、血液、神经系统等严重疾病患者;
5)处于妊娠期;
6)伴有重度抑郁、精神分裂症等严重精神疾病。
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Exclusion criteria:
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1) AMI, acute cerebral infarction, intracerebral hemorrhage, unstable angina;
2) Hypertension grade 3; secondary hypertension;
3) Patients with severe heart, liver and kidney, blood and nervous system diseases such as malignant tumors and renal failure, liver cirrhosis and severe heart failure were combined;
5) Were in pregnancy;
6) Associated with major depression, schizophrenia and other severe mental illnesses.
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研究实施时间:
Study execute time:
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从From
2021-12-01
至To
2023-12-01
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征募观察对象时间:
Recruiting time:
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从From
2021-12-01
至To
2023-12-01
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