Clinical Study on the Efficacy of Microvascular Decompression in the Treatment of Neurogenic Hypertension
试验速览
- 阶段
- 不适用
- 入组人数
- 260
- 主要终点
- Decreased systolic blood pressure
研究概览
简要总结
Hypertension has always been a threat to human health, so the prevention and treatment is of great significance. At present, the treatment of primary hypertension is mainly drug treatment, but many patients can not control their blood pressure in the normal range. Therefore, it is urgent to explore new and effective treatment methods.
Microvascular compression type of neurogenic hypertension is mainly due to abnormal tortuous vascular pulsatile compression of blood pressure center - rostral ventrolateral medulla (RVLM), resulting in the release of sympathetic active substances, leading to hypertension. The purpose of this study is to explore the efficacy and safety of microvascular decompression for hypertension in patients of hemifacial spasm complicated with hypertension, and to explore the common characteristics of patients with effective decompression.
The type of study design was prospective cohort study. According to certain inclusion and exclusion criteria, patients with RVLM compression were treated with RVLM decompression at the same time of facial nerve decompression. Patients who were followed up for 3 months were taken as control group, and the blood pressure of the two groups were measured after 3 months. The main outcome measure was 24-hour ambulatory systolic blood pressure change from baseline to 3 months.
详细描述
Research steps: If the patients with hemifacial spasm are complicated with hypertension and have the intention of surgical treatment, researchers would introduce the process, possible benefits and possible complications of the clinical trial in detail. Patients who agree to be enrolled and meet the inclusion conditions will sign the informed consent form.
The history of hypertension, the relationship between hypertension and hemifacial spasm, the highest blood pressure, oral medication, blood pressure maintenance, whether complicated with dyslipidemia, diabetes, smoking history, etc. Before operation, 24-hour ambulatory blood pressure monitoring was performed to record preoperative systolic blood pressure, diastolic blood pressure and heart rate. The measurement interval is automatically measured every 20 minutes in the daytime (8:00am ~ 10:00pm) and every 30 minutes at night (10:00pm ~ 8:00am). CBP was recorded in the morning (8:00-10:00 AM) before taking medication, and completed in the morning of 8:00-9:00 am the next day. The cuff was placed on the left upper arm. During the monitoring period, the patient was required to reduce the movement of the left upper arm as much as possible to avoid the cuff loosening or falling off, which would affect the measurement results. The record of effective monitoring times must be more than 80% and the covering time must be more than 20h, otherwise the measurement should be repeated. Patients should rest for at least 5 minutes before blood pressure measurement. The upper arm was placed at the heart level. Using OMRON electronic sphygmomanometer, the size of the cuff is suitable for the patient's upper arm circumference, covering at least 2 / 3 of the upper arm circumference. The blood pressure of both upper arms was measured, and the blood pressure of the higher side was taken as the criterion. Repeat the measurement at an interval of 1-2 min, and record the average value of the two readings. If the difference between the two readings of systolic or diastolic blood pressure is more than 5 mmHg, it should be measured again, and the average of the three readings should be taken as the baseline blood pressure measurement result.
Both the experimental group and the control group need to continue to take antihypertensive drugs orally, and the type and dose of drugs remain unchanged.
The experimental group was hospitalized and completed the corresponding hematology and imaging examination. The control group was followed up for 3 months, after the end of the follow-up can be hospitalized and improve the corresponding hematology and imaging examination. If the control group matched with the experimental group is excluded, the control group needs to be rematched. The experimental group received RVLM and (or) IX / X rez decompression at the same time of facial nerve decompression, while the control group received no operation.
Follow up: Patients should be followed up at 3 months. The following items were evaluated and recorded in CRF during follow-up
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old;
- •Preoperative MRI showed RVLM compression;
- •Primary hemifacial spasm without other secondary factors;
- •The office systolic blood pressure is higher than 140mmHg and the systolic blood pressure of ambulatory blood pressure is higher than 130mmHg;
- •Sign informed consent.
排除标准
- •Secondary hypertension, such as renal hypertension, vascular hypertension, etc;
- •No antihypertensive drugs were taken after admission and ambulatory blood pressure monitoring showed that the blood pressure was within the normal range;
- •Pregnancy plan or lactation period during pregnancy or within 2 years;
- •Patients with congestive heart failure (NYHA grade II-IV), myocardial infarction and unstable angina pectoris within 6 months before enrollment; patients with severe heart diseases, such as cardiogenic shock, arrhythmia requiring treatment, heart valve disease, etc;
- •Severe cerebrovascular diseases (hypertensive encephalopathy, cerebrovascular injury, stroke, transient ischemic attack, etc.) within 6 months before admission;
- •Patients with severe liver disease or dysfunction (ALT or AST > 2 times the upper limit of normal reference value);
- •Patients with renal impairment (male serum creatinine > 2.0mg/dl (176 μ mol / L), female serum creatinine > 1.8mg/dl (159 μ mol / L));
- •Other surgical contraindications, such as coagulation disorders, severe anemia, severe pulmonary infection, persistent state of asthma, upper respiratory tract infection, uncorrected respiratory failure, diabetic ketoacidosis, hepatic encephalopathy, hepatic coma, acute cerebral infarction, etc;
- •Type I diabetic patients; diabetic patients with poor glycemic control (FBG > 11.1 mmol / L) or type 2 diabetic patients with microalbuminuria;
- •Had Cushing's syndrome, coarctation of aorta, hyperthyroidism and other diseases in the past;
- •Patients can not cooperate with the test and follow-up, such as mental disorders, dementia, advanced tumor, etc;
- •If the antihypertensive drugs were adjusted within 2 weeks before admission, the patients were excluded or re enrolled after the blood pressure was stable for 2 weeks;
- •Preoperative anesthesia score ≥ grade III;
- •To screen those who participated in other clinical studies and used research drugs within 3 months before the trial, or planned to participate in other clinical studies during the trial period.
结局指标
主要结局
Decreased systolic blood pressure
时间窗: 3 months
After 3 months of treatment, 24 h ambulatory blood pressure was measured, systolic blood pressure was compared with baseline level, and the difference was calculated.
次要结局
- The cure rate of hypertension 3 months after treatment(3 months)
- effective rate of hypertension 3 months after treatment(3 months)
- Decreased diastolic blood pressure(3 months)
- Decreased office systolic blood pressure(3 months)
- Decreased office diastolic blood pressure(3 months)
研究者
Liu Ruen
PekingUPH
Peking University People's Hospital