|
测量指标：
Outcomes：
|
|
指标中文名：
|
快感缺失量表
|
指标类型：
|
次要指标
|
|
Outcome：
|
Dimensional Anhedonia Rating Scale
|
Type：
|
Secondary indicator
|
|
测量时间点：
|
入组时，治疗后第4周±3天、8周±3天、12周±3天各检查一次，随访第36周±3天检查一次
|
测量方法：
|
问诊
|
|
Measure time point of outcome：
|
Upon enrollment, assessments will be performed at week 4 ±3 days post-treatment, week 8 ±3 days post-treatment, and week 12 ±3 days post-treatment. A follow-up assessment is scheduled at week 36 ±3 days
|
Measure method：
|
history taking
|
|
指标中文名：
|
血常规
|
指标类型：
|
副作用指标
|
|
Outcome：
|
Complete Blood Count
|
Type：
|
Adverse events
|
|
测量时间点：
|
用药前第-3~0天，治疗后第12周末±3天各检查一次
|
测量方法：
|
于 07:00～08:00 采集病人空腹肘静脉血 3mL,经离心后取血清化验
|
|
Measure time point of outcome：
|
Three to zero days before treatment, and twelve weeks after treatment, ±3 days each time.
|
Measure method：
|
Between 07:00 and 08:00, collect 3 ml of fasting venous blood from the patient's elbow, centrifuge it, and take the serum for testing.
|
|
指标中文名：
|
主要不良心脑血管事件
|
指标类型：
|
次要指标
|
|
Outcome：
|
Major Adverse Cardiovascular and Cerebrovascular Events
|
Type：
|
Secondary indicator
|
|
测量时间点：
|
入组时，治疗后第4周±3天，第8周±3天，第12周±3天，随访12周±3天、24周±3天、36周±3天各记录一次
|
测量方法：
|
问诊
|
|
Measure time point of outcome：
|
Upon enrollment, data is recorded within the range of -3 to 0 days. Subsequent records are taken at week 4, with a margin of ±3 days; at week 8, with a margin of ±3 days; at week 12, with a margin of ±3 days; followed by follow-up visits at week 12, with a margin of ±3 days; at week 24, with a margin of ±3 days; and finally at week 36, with a margin of ±3 days.
|
Measure method：
|
history taking
|
|
指标中文名：
|
促肾上腺皮质激素（ACTH）
|
指标类型：
|
次要指标
|
|
Outcome：
|
adrenocorticotropic hormone
|
Type：
|
Secondary indicator
|
|
测量时间点：
|
于入组时-3～0天、治疗后第12周±3天检查一次
|
测量方法：
|
于 07:00～08:00 采集病人空腹肘静脉血 3mL，经离心后取上清液置于 5mL 真空 乙二胺四乙酸(EDTA)抗凝采血管中备用，置于-70℃低温冰箱保存，同一批检测样本使用同一批试剂盒，采用酶联免疫吸附法检测血ACTH水平，评估治疗前后ACTH的变化。
|
|
Measure time point of outcome：
|
At the time of enrollment, assessments are conducted within the range of -3 to 0 days. Following treatment, a check-up is scheduled at week 12, with a window of ±3 days.
|
Measure method：
|
Between 07:00 and 08:00, collect 3 mL of fasting venous blood from the patient's elbow vein. After centrifugation, transfer the supernatant into a 5 mL vacuum ethylenediaminetetraacetic acid (EDTA) anticoagulant tube for storage. Preserve the sample in a -70°C ultra-low temperature freezer. Use the same batch of reagent kits for all samples within the same group. Perform an enzyme-linked immunosorbent assay (ELISA) to measure the levels of adreno
|
|
指标中文名：
|
十二导联心电图
|
指标类型：
|
副作用指标
|
|
Outcome：
|
12-Lead Electrocardiogram
|
Type：
|
Adverse events
|
|
测量时间点：
|
用药前第-3~0天，治疗后第12周末±3天各检查一次
|
测量方法：
|
我院心电图科专业执业医师进行12导联心电图检查
|
|
Measure time point of outcome：
|
Three to zero days before treatment, and twelve weeks after treatment, ±3 days each time.
|
Measure method：
|
The professional cardiologist in our hospital will conduct a 12-lead electrocardiogram.
|
|
指标中文名：
|
呼吸频率
|
指标类型：
|
副作用指标
|
|
Outcome：
|
Respiratory rate
|
Type：
|
Adverse events
|
|
测量时间点：
|
入组时，治疗后第4周±3天、8周±3天、12周±3天，随访第12、24、36周±3天各检查一次
|
测量方法：
|
秒表计数
|
|
Measure time point of outcome：
|
At baseline (enrollment), assessments will be conducted at week 4 ±3 days post-treatment, week 8 ±3 days post-treatment, and week 12 ±3 days post-treatment. Follow-up evaluations will be scheduled at weeks 12, 24, and 36 ±3 days.
|
Measure method：
|
Second counter
|
|
指标中文名：
|
SF-36生活质量量表
|
指标类型：
|
次要指标
|
|
Outcome：
|
Short Form-36 Health Survey
|
Type：
|
Secondary indicator
|
|
测量时间点：
|
入组时，治疗后第4周±3天、8周±3天、12周±3天各检查一次，随访第36周±3天检查一次
|
测量方法：
|
问诊
|
|
Measure time point of outcome：
|
Upon enrollment, assessments will be performed at week 4 ±3 days post-treatment, week 8 ±3 days post-treatment, and week 12 ±3 days post-treatment. A follow-up assessment is scheduled at week 36 ±3 days
|
Measure method：
|
history taking
|
|
指标中文名：
|
肝功能
|
指标类型：
|
副作用指标
|
|
Outcome：
|
Liver function Tests
|
Type：
|
Adverse events
|
|
测量时间点：
|
用药前第-3~0天，治疗后第12周末±3天各检查一次
|
测量方法：
|
于 07:00～08:00 采集病人空腹肘静脉血 3mL,经离心后取血清化验
|
|
Measure time point of outcome：
|
Three to zero days before treatment, and twelve weeks after treatment, ±3 days each time.
|
Measure method：
|
Between 07:00 and 08:00, collect 3 ml of fasting venous blood from the patient's elbow, centrifuge it, and take the serum for testing.
|
|
指标中文名：
|
尿常规
|
指标类型：
|
副作用指标
|
|
Outcome：
|
Urinalysis
|
Type：
|
Adverse events
|
|
测量时间点：
|
用药前第-3~0天，治疗后第12周末±3天各检查一次
|
测量方法：
|
于 07:00～08:00 收集患者中段尿10-15ml，送至检验科化验。
|
|
Measure time point of outcome：
|
Three to zero days before treatment, and twelve weeks after treatment, ±3 days each time.
|
Measure method：
|
Collect 10-15 ml of midstream urine from the patient between 07:00 and 08:00, and send it to the laboratory for testing.
|
|
指标中文名：
|
肾功能
|
指标类型：
|
副作用指标
|
|
Outcome：
|
Renal Function Tests
|
Type：
|
Adverse events
|
|
测量时间点：
|
用药前第-3~0天，治疗后第12周末±3天各检查一次
|
测量方法：
|
于 07:00～08:00 采集病人空腹肘静脉血 3mL,经离心后取血清化验
|
|
Measure time point of outcome：
|
Three to zero days before treatment, and twelve weeks after treatment, ±3 days each time.
|
Measure method：
|
Between 07:00 and 08:00, collect 3 ml of fasting venous blood from the patient's elbow, centrifuge it, and take the serum for testing.
|
|
指标中文名：
|
促肾上腺皮质激素释放因子（CRF）
|
指标类型：
|
次要指标
|
|
Outcome：
|
Corticotropin-Releasing Factor
|
Type：
|
Secondary indicator
|
|
测量时间点：
|
于入组时-3～0天、治疗后第12周±3天检查一次
|
测量方法：
|
于 07:00～08:00 采集病人空腹肘静脉血 3mL，经离心后取上清液置于 5mL 真空 乙二胺四乙酸(EDTA)抗凝采血管中备用，置于-70℃低温冰箱保存，同一批检测样本使用同一批试剂盒，采用酶联免疫吸附法检测血CRF水平，评估治疗前后CRF的变化。
|
|
Measure time point of outcome：
|
At the time of enrollment, assessments are conducted within the range of -3 to 0 days. Following treatment, a check-up is scheduled at week 12, with a window of ±3 days.
|
Measure method：
|
Collect 3 mL of fasting venous blood from the patient's elbow vein between 07:00 and 08:00. After centrifugation, transfer the supernatant into a 5 mL vacuum ethylenediaminetetraacetic acid (EDTA) anticoagulant tube for storage. Preserve the sample in a -70°C ultra-low temperature freezer. Employ the same batch of reagent kits for all samples within the same group. Conduct an enzyme-linked immunosorbent assay (ELISA) to quantify the levels of cor
|
|
指标中文名：
|
所有发生的不良事件
|
指标类型：
|
副作用指标
|
|
Outcome：
|
Adverse Events
|
Type：
|
Adverse events
|
|
测量时间点：
|
用药前第-3~0天，治疗后第12周末±3天各检查一次
|
测量方法：
|
问诊
|
|
Measure time point of outcome：
|
Three to zero days before treatment, and twelve weeks after treatment, ±3 days each time.
|
Measure method：
|
history taking
|
|
指标中文名：
|
体温
|
指标类型：
|
副作用指标
|
|
Outcome：
|
Body temperature
|
Type：
|
Adverse events
|
|
测量时间点：
|
入组时，治疗后第4周±3天、8周±3天、12周±3天，随访第12、24、36周±3天各检查一次
|
测量方法：
|
体温计测量腋温
|
|
Measure time point of outcome：
|
At baseline (enrollment), assessments will be conducted at week 4 ±3 days post-treatment, week 8 ±3 days post-treatment, and week 12 ±3 days post-treatment. Follow-up evaluations will be scheduled at weeks 12, 24, and 36 ±3 days
|
Measure method：
|
Measure axillary temperature using a thermometer.
|
|
指标中文名：
|
GAD-7广泛性焦虑自评量表
|
指标类型：
|
次要指标
|
|
Outcome：
|
Generalized Anxiety Disorder-7 (GAD-7)
|
Type：
|
Secondary indicator
|
|
测量时间点：
|
入组时，治疗后第4周±3天、8周±3天、12周±3天各检查一次，随访第36周±3天检查一次
|
测量方法：
|
问诊
|
|
Measure time point of outcome：
|
Upon enrollment, assessments will be performed at week 4 ±3 days post-treatment, week 8 ±3 days post-treatment, and week 12 ±3 days post-treatment. A follow-up assessment is scheduled at week 36 ±3 days
|
Measure method：
|
history taking
|
|
指标中文名：
|
血压
|
指标类型：
|
副作用指标
|
|
Outcome：
|
Blood pressure
|
Type：
|
Adverse events
|
|
测量时间点：
|
入组时，治疗后第4周±3天、8周±3天、12周±3天，随访第12、24、36周±3天各检查一次
|
测量方法：
|
血压计于每日早上测量
|
|
Measure time point of outcome：
|
At baseline (enrollment), assessments will be conducted at week 4 ±3 days post-treatment, week 8 ±3 days post-treatment, and week 12 ±3 days post-treatment. Follow-up evaluations will be scheduled at weeks 12, 24, and 36 ±3 days.
|
Measure method：
|
Use a sphygmomanometer to measure your blood pressure every morning.
|
|
指标中文名：
|
西雅图心绞痛量表
|
指标类型：
|
次要指标
|
|
Outcome：
|
Seattle Angina Questionnaire, SAQ
|
Type：
|
Secondary indicator
|
|
测量时间点：
|
入组时，治疗后第4周±3天、8周±3天、12周±3天各检查一次，随访第36周±3天检查一次
|
测量方法：
|
问诊
|
|
Measure time point of outcome：
|
Upon enrollment, assessments will be performed at week 4 ±3 days post-treatment, week 8 ±3 days post-treatment, and week 12 ±3 days post-treatment. A follow-up assessment is scheduled at week 36 ±3 days
|
Measure method：
|
history taking
|
|
指标中文名：
|
炎症因子：IL- 1β、IL-6、GDF15、sCD40L
|
指标类型：
|
次要指标
|
|
Outcome：
|
Inflammatory Factors
|
Type：
|
Secondary indicator
|
|
测量时间点：
|
入组时-3～0天、治疗后第12周±3天检查一次
|
测量方法：
|
于 07:00～08:00 采集病人空腹肘静脉血 3mL,经离心后取上清液置于 5mL 真空 乙二胺四乙酸(EDTA)抗凝采血管中备用，置于-70℃低温冰箱保存，同一批检测样本使用同一批试剂盒，采用酶联免疫吸附法检测血炎症因子水平，评估治疗前后 炎症因子的变化。
|
|
Measure time point of outcome：
|
At the time of enrollment, assessments are conducted within the range of -3 to 0 days. Following treatment, a check-up is scheduled at week 12, with a window of ±3 days.
|
Measure method：
|
Collect 3 mL of fasting venous blood from the patient's elbow vein between 07:00 and 08:00. After centrifugation, transfer the supernatant into a 5 mL vacuum ethylenediaminetetraacetic acid (EDTA) anticoagulant tube for storage. Store the sample at -70°C in a low-temperature freezer. Use the same batch of reagent kits for the same batch of samples. Employ enzyme-linked immunosorbent assay (ELISA) to measure the levels of inflammatory cytokines in
|
|
指标中文名：
|
脑源性神经营养因子：BDNF
|
指标类型：
|
次要指标
|
|
Outcome：
|
Brain-Derived Neurotrophic Factor
|
Type：
|
Secondary indicator
|
|
测量时间点：
|
入组时-3～0天、治疗后第12周±3天检查一次
|
测量方法：
|
于 07:00～08:00 采集病人空腹肘静脉血 3mL，经离心后取上清液置于 5mL 真空 乙二胺四乙酸(EDTA)抗凝采血管中备用，置于-70℃低温冰箱保存，同一批检测样本使用同一批试剂盒，采用酶联免疫吸附法检测血BDNF水平，评估治疗前后BDNF的变化。
|
|
Measure time point of outcome：
|
At the time of enrollment, assessments are conducted within the range of -3 to 0 days. Following treatment, a check-up is scheduled at week 12, with a window of ±3 days.
|
Measure method：
|
Obtain 3 mL of fasting venous blood from the patient's elbow vein between 07:00 and 08:00. Following centrifugation, carefully extract the supernatant and place it into a 5 mL vacuum ethylenediaminetetraacetic acid (EDTA) anticoagulant tube for temporary storage. Preserve the sample in a -70°C ultra-low temperature freezer. Utilize the same batch of reagent kits for all samples within the same group. Conduct an enzyme-linked immunosorbent assay (
|
|
指标中文名：
|
HAMA焦虑量表
|
指标类型：
|
次要指标
|
|
Outcome：
|
Hamilton Anxiety Rating Scale (HAMA)
|
Type：
|
Secondary indicator
|
|
测量时间点：
|
入组时，治疗后第4周±3天、8周±3天、12周±3天各检查一次，随访第36周±3天检查一次
|
测量方法：
|
问诊
|
|
Measure time point of outcome：
|
Upon enrollment, assessments will be performed at week 4 ±3 days post-treatment, week 8 ±3 days post-treatment, and week 12 ±3 days post-treatment. A follow-up assessment is scheduled at week 36 ±3 days
|
Measure method：
|
history taking
|
|
指标中文名：
|
PHQ-9健康问卷
|
指标类型：
|
次要指标
|
|
Outcome：
|
Patient Health Questionnaire-9 (PHQ-9)
|
Type：
|
Secondary indicator
|
|
测量时间点：
|
入组时，治疗后第4周±3天、8周±3天、12周±3天各检查一次，随访第36周±3天检查一次
|
测量方法：
|
问诊
|
|
Measure time point of outcome：
|
Upon enrollment, assessments will be performed at week 4 ±3 days post-treatment, week 8 ±3 days post-treatment, and week 12 ±3 days post-treatment. A follow-up assessment is scheduled at week 36 ±3 days
|
Measure method：
|
history taking
|
|
指标中文名：
|
HAMD-17抑郁量表
|
指标类型：
|
主要指标
|
|
Outcome：
|
Hamilton Depression Rating Scale - 17 items
|
Type：
|
Primary indicator
|
|
测量时间点：
|
入组时，治疗后第4周±3天、8周±3天、12周±3天，随访第12、24、36周±3天各检查一次
|
测量方法：
|
问诊
|
|
Measure time point of outcome：
|
At baseline (enrollment), assessments will be conducted at week 4 ±3 days post-treatment, week 8 ±3 days post-treatment, and week 12 ±3 days post-treatment. Follow-up evaluations will be scheduled at weeks 12, 24, and 36 ±3 days.
|
Measure method：
|
history taking
|
|
指标中文名：
|
心肺运动试验
|
指标类型：
|
次要指标
|
|
Outcome：
|
Cardiopulmonary Exercise Testing
|
Type：
|
Secondary indicator
|
|
测量时间点：
|
入组时-3～0天、治疗后第12周±3天检查一次
|
测量方法：
|
在病人处于静息状态时，测定其静态心电图、血压情况以及肺功能指标；病人先在车上休息3分钟，然后开始骑行。随着试验进行，功率车会逐渐增加功率，由医生检测病人在不同负荷下机体摄氧量（O2）和二氧化碳排出量（CO2）的动态变化；如果在试验过程中出现不适，应立即停止试验并就诊
|
|
Measure time point of outcome：
|
At the time of enrollment, assessments are conducted within the range of -3 to 0 days. Following treatment, acheck-up is scheduled at week 12, with a window of ±3 days.
|
Measure method：
|
While the patient is in a resting state, measure their resting electrocardiogram (ECG), blood pressure, and pulmonary function indices. The patient first rests in the vehicle for 3 minutes, then begins cycling. As the test progresses, the ergometer will gradually increase power output. A physician will monitor the dynamic changes in the patient's oxygen uptake (O2) and carbon dioxide output (CO2) at different workloads. If discomfort occurs durin
|
|
指标中文名：
|
凝血功能
|
指标类型：
|
副作用指标
|
|
Outcome：
|
Coagulation Tests
|
Type：
|
Adverse events
|
|
测量时间点：
|
用药前第-3~0天，治疗后第12周末±3天各检查一次
|
测量方法：
|
于 07:00～08:00 采集病人空腹肘静脉血 3mL,经离心后取血清化验
|
|
Measure time point of outcome：
|
Three to zero days before treatment, and twelve weeks after treatment, ±3 days each time.
|
Measure method：
|
Between 07:00 and 08:00, collect 3 ml of fasting venous blood from the patient's elbow, centrifuge it, and take the serum for testing.
|
|
指标中文名：
|
皮质醇（Cortisol）
|
指标类型：
|
次要指标
|
|
Outcome：
|
Cortisol
|
Type：
|
Secondary indicator
|
|
测量时间点：
|
于入组时-3～0天、治疗后第12周±3天检查一次
|
测量方法：
|
于 07:00～08:00 采集病人空腹肘静脉血 3mL，经离心后取上清液置于 5mL 真空 乙二胺四乙酸(EDTA)抗凝采血管中备用，置于-70℃低温冰箱保存，同一批检测样本使用同一批试剂盒，采用酶联免疫吸附法检测血皮质醇水平，评估治疗前后皮质醇的变化。
|
|
Measure time point of outcome：
|
At the time of enrollment, assessments are conducted within the range of -3 to 0 days. Following treatment, a check-up is scheduled at week 12, with a window of ±3 days.
|
Measure method：
|
Between 07:00 and 08:00, draw 3 mL of fasting venous blood from the patient's elbow vein. Following centrifugation, decant the supernatant into a 5 mL vacuum ethylenediaminetetraacetic acid (EDTA) anticoagulant tube for temporary storage. Store the sample in a -70°C ultra-low temperature freezer. Utilize the same batch of assay kits for all samples within the same group. Execute an enzyme-linked immunosorbent assay (ELISA) to determine the cortis
|
|
指标中文名：
|
蒙特利尔认知评估量表
|
指标类型：
|
次要指标
|
|
Outcome：
|
Montreal Cognitive Assessment
|
Type：
|
Secondary indicator
|
|
测量时间点：
|
入组时，治疗后第4周±3天、8周±3天、12周±3天各检查一次，随访第36周±3天检查一次
|
测量方法：
|
问诊
|
|
Measure time point of outcome：
|
Upon enrollment, assessments will be performed at week 4 ±3 days post-treatment, week 8 ±3 days post-treatment, and week 12 ±3 days post-treatment. A follow-up assessment is scheduled at week 36 ±3 days
|
Measure method：
|
history taking
|
|
指标中文名：
|
心率
|
指标类型：
|
副作用指标
|
|
Outcome：
|
Heart rate
|
Type：
|
Adverse events
|
|
测量时间点：
|
入组时，治疗后第4周±3天、8周±3天、12周±3天，随访第12、24、36周±3天各检查一次
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测量方法：
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血压计测量
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Measure time point of outcome：
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At baseline (enrollment), assessments will be conducted at week 4 ±3 days post-treatment, week 8 ±3 days post-treatment, and week 12 ±3 days post-treatment. Follow-up evaluations will be scheduled at weeks 12, 24, and 36 ±3 days.
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Measure method：
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Use a stethoscope to listen to the patient's heart rate.
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指标中文名：
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心肌酶（肌钙蛋白I或肌钙蛋白T）检测
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指标类型：
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副作用指标
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Outcome：
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Myocardial enzyme(（TnI or TnT) testing
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Type：
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Adverse events
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测量时间点：
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入组时
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测量方法：
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于 07:00～08:00 采集病人空腹肘静脉血 3mL,经离心后取血清化验
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Measure time point of outcome：
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Upon enrollment
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Measure method：
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Between 07:00 and 08:00 collect 3 ml of fasting venous blood from the patient's elbow centrifuge it and take the serum for testing.
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