测量指标:
Outcomes:
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指标中文名:
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尿常规
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指标类型:
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附加指标
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Outcome:
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Urinalysis
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Type:
|
Additional indicator
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测量时间点:
|
入选治疗时,服药后4周,8周,12周
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测量方法:
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测尿常规
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Measure time point of outcome:
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When enrolled in treatment, 4 weeks, 8 weeks, 12 weeks after taking the drug.
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Measure method:
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Test urinalysis
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指标中文名:
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各时点血尿酸较基线的变化值
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指标类型:
|
主要指标
|
Outcome:
|
Change from baseline in blood uric acid at each time point
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Type:
|
Primary indicator
|
测量时间点:
|
服药后4周,8周,12周
|
测量方法:
|
计算各时点血尿酸较基线的变化值
|
Measure time point of outcome:
|
4 weeks, 8 weeks, 12 weeks post-dose
|
Measure method:
|
Calculate the change from baseline in blood uric acid at each time point
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指标中文名:
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血脂(总胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、甘油三酯)
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指标类型:
|
附加指标
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Outcome:
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Lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)
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Type:
|
Additional indicator
|
测量时间点:
|
入选治疗时,服药后12周
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测量方法:
|
检测总胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、甘油三酯
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Measure time point of outcome:
|
When enrolled in treatment, 12 weeks after taking the drug
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Measure method:
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Test for total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
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指标中文名:
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炎症指标(C反应蛋白、血沉)
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指标类型:
|
次要指标
|
Outcome:
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Inflammation indicators (C-reactive protein, blood sedimentation)
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Type:
|
Secondary indicator
|
测量时间点:
|
入选治疗时,服药后12周
|
测量方法:
|
血液检测C反应蛋白、血沉)
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Measure time point of outcome:
|
When enrolled in treatment, 12 weeks after taking the drug
|
Measure method:
|
Blood test for C-reactive protein, blood sedimentation
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指标中文名:
|
肾功能(血清肌酐,尿素氮,肾小球滤过率)
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指标类型:
|
次要指标
|
Outcome:
|
Kidney function (Serum creatinine, urea nitrogen, glomerular filtration rate)
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Type:
|
Secondary indicator
|
测量时间点:
|
入选治疗时,服药后4周,8周,12周
|
测量方法:
|
血液检测血清肌酐和尿素氮,计算肾小球滤过率
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Measure time point of outcome:
|
When enrolled in treatment, 4 weeks, 8 weeks, 12 weeks after taking the drug
|
Measure method:
|
Blood is measured for serum creatinine and urea nitrogen and glomerular filtration rate is calculated
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指标中文名:
|
痛风急性发作次数
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指标类型:
|
次要指标
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Outcome:
|
The frequency of acute gout attack
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Type:
|
Secondary indicator
|
测量时间点:
|
服药后12周内
|
测量方法:
|
记录服药12周内急性痛风的发作次数
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Measure time point of outcome:
|
Within 12 weeks after taking the drug
|
Measure method:
|
The number of episodes of acute gout within 12 weeks of taking the drug was recorded
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指标中文名:
|
血常规
|
指标类型:
|
附加指标
|
Outcome:
|
Blood routine
|
Type:
|
Additional indicator
|
测量时间点:
|
入选治疗时,服药后4周,8周,12周
|
测量方法:
|
测血常规
|
Measure time point of outcome:
|
入选治疗时,服药后4周,8周,12周
|
Measure method:
|
Test blood routine
|
指标中文名:
|
体重和体重指数
|
指标类型:
|
附加指标
|
Outcome:
|
weight and BMI
|
Type:
|
Additional indicator
|
测量时间点:
|
入选治疗时,服药后12周
|
测量方法:
|
入选治疗时,服药后12周
|
Measure time point of outcome:
|
When enrolled in treatment, 12 weeks after taking the drug
|
Measure method:
|
Measure weight, height, and calculate body mass index
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指标中文名:
|
血尿酸达标率
|
指标类型:
|
主要指标
|
Outcome:
|
Blood uric acid compliance rate
|
Type:
|
Primary indicator
|
测量时间点:
|
服药前,服药后4周,8周,12周
|
测量方法:
|
计算尿酸服药12周后血尿酸降至360μmol/Ll的痛风患者比例
|
Measure time point of outcome:
|
Pre-dose 4 weeks 8 weeks 12 weeks post-dose
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Measure method:
|
Calculate the percentage of gout patients whose blood uric acid dropped to 360 μmol/Ll after 12 weeks of medication.
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指标中文名:
|
空腹血糖
|
指标类型:
|
附加指标
|
Outcome:
|
Fasting blood sugar
|
Type:
|
Additional indicator
|
测量时间点:
|
入选治疗时,服药后12周
|
测量方法:
|
检测空腹血糖
|
Measure time point of outcome:
|
When enrolled in treatment, 12 weeks after taking the drug
|
Measure method:
|
Test fasting blood glucose
|
指标中文名:
|
各时点血尿酸较基线变化的百分比
|
指标类型:
|
主要指标
|
Outcome:
|
Percentage change from baseline in blood uric acid at each time point
|
Type:
|
Primary indicator
|
测量时间点:
|
服药后4周,8周,12周
|
测量方法:
|
计算各时点血尿酸较基线下降的百分比
|
Measure time point of outcome:
|
4 weeks, 8 weeks, 12 weeks post-dose
|
Measure method:
|
Calculate the percentage decrease in blood uric acid from baseline at each time point
|
指标中文名:
|
心电图
|
指标类型:
|
附加指标
|
Outcome:
|
electrocardiogram
|
Type:
|
Additional indicator
|
测量时间点:
|
入选治疗时,服药后12周
|
测量方法:
|
做心电图
|
Measure time point of outcome:
|
When enrolled in treatment, 12 weeks after taking the drug.
|
Measure method:
|
Do an electrocardiogram
|
指标中文名:
|
肠道菌群变化情况
|
指标类型:
|
次要指标
|
Outcome:
|
Changes in the intestinal flora
|
Type:
|
Secondary indicator
|
测量时间点:
|
入选治疗时,服药后12周
|
测量方法:
|
肠道微生物高通量测序和生物信息学分析
|
Measure time point of outcome:
|
When enrolled in treatment, 12 weeks after taking the drug.
|
Measure method:
|
Detection of alanine aminotransferase, glutamate aminotransferase
|
指标中文名:
|
中医证候评分
|
指标类型:
|
次要指标
|
Outcome:
|
TCM syndrome score
|
Type:
|
Secondary indicator
|
测量时间点:
|
入选治疗时,服药后12周
|
测量方法:
|
中医证候评分量表计算评分
|
Measure time point of outcome:
|
When enrolled in treatment, 12 weeks after taking the drug
|
Measure method:
|
The TCM Syndrome Rating Scale calculates the score
|
指标中文名:
|
肝功能(谷丙转氨酶,谷草转氨酶)
|
指标类型:
|
附加指标
|
Outcome:
|
Liver function (ALT,AST)
|
Type:
|
Additional indicator
|
测量时间点:
|
入选治疗时,服药后4周,8周,12周
|
测量方法:
|
检测谷丙转氨酶,谷草转氨酶
|
Measure time point of outcome:
|
When enrolled in treatment, 4 weeks, 8 weeks, 12 weeks after taking the drug.
|
Measure method:
|
Detection of alanine aminotransferase, glutamate aminotransferase
|
|