To Explore the Characteristics of LKD Syndrome and PBS Syndrome of Knee Osteoarthritis Which Based on the Enhancement of Inflammatory Response Caused by the Inhibition of TGF-β/Smad Signal Pathway
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- the differences of proteomics in the cell models of disease-TCM syndrome
研究概览
简要总结
- Through research and analysis, the levels of upstream and downstream factors related to TGF-β/Smad signaling pathway and inflammatory response factor related factors in serum, blood cells, articular fluid, urine, tongue covering and discarded tissues after surgery of patients with LKD syndrome and PBS syndrome of knee osteoarthritis were obtained, and the syndrome characteristics were further obtained.
- Through research and analysis, the index levels of multiple omics detection in serum, blood cells, joint fluid, urine, tongue coating and discarded tissues of patients with LKD syndrome and PBS syndrome of knee osteoarthritis were obtained, and the syndrome characteristics were further obtained.
- The severity of syndrome was quantified by syndrome score scale and the correlation between the above results and the syndrome score of patients with knee osteoarthritis with LKD syndrome and PBS syndrome was studied in combination with imaging characteristics.
- To establish a "disease and syndrome cell model" and test relevant indicators to support the above research.
- Through the analysis of the above research results, the possible mechanism is analyzed to provide an objective basis for the biological basis of the syndrome and relevant evidence for the clinical diagnosis and treatment of knee osteoarthritis with traditional Chinese medicine.
详细描述
- Through research and analysis, the levels of upstream and downstream factors related to TGF-β/Smad signaling pathway and inflammatory response factor related factors in serum, blood cells, articular fluid, urine, tongue covering and discarded tissues after surgery of patients with liver and kidney deficiency syndrome and phlegm and blood stasis syndrome of knee osteoarthritis were obtained, and the syndrome characteristics were further obtained.
- Through research and analysis, the index levels of multiple omics detection in serum, blood cells, joint fluid, urine, tongue coating and discarded tissues of patients with liver and kidney deficiency syndrome and phlegm and blood stasis syndrome of knee osteoarthritis were obtained, and the syndrome characteristics were further obtained.
- The severity of syndrome was quantified by syndrome score scale and the correlation between the above results and the syndrome score of patients with knee osteoarthritis with liver and kidney deficiency syndrome and phlegm and blood stasis syndrome was studied in combination with imaging characteristics.
- To establish a "disease and syndrome cell model" and test relevant indicators to support the above research.
- Through the analysis of the above research results, the possible mechanism is analyzed to provide an objective basis for the biological basis of the syndrome and relevant evidence for the clinical diagnosis and treatment of knee osteoarthritis with traditional Chinese medicine.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria of liver and kidney deficiency syndrome and phlegm and blood stasis syndrome in knee osteoarthritis
- •Age 20-80 years old, in line with the diagnostic criteria of Western medicine;
- •In accordance with the diagnostic criteria of TCM syndromes, it belongs to liver and kidney deficiency syndrome and phlegm and blood stasis syndrome;
- •Patients who are willing to participate in the survey and have good compliance;
- •Voluntary signing of informed consent;
- •Inclusion criteria of normal control group
- •Age 20-80 years old.
- •Patients who are willing to participate in the survey and have good compliance.
- •It does not meet the diagnostic criteria of knee osteoarthritis.
- •Voluntarily sign informed consent.
排除标准
- •Complications affecting joints, such as psoriasis, syphilitic neuropathy, brown yellow disease, metabolic bone disease, etc;
- •There were rheumatoid arthritis and ankylosing spondylitis;
- •Late disabled and incapacitated;
- •Pregnant or lactating women;
- •Mentally ill.
- •As long as one of the above 5 articles is met, it shall be excluded.
结局指标
主要结局
the differences of proteomics in the cell models of disease-TCM syndrome
时间窗: 3 years
The differences of proteomics in the cell models of disease-TCM syndrome will be detected by proteomics.
the differences of transcriptomics
时间窗: 3 years
The differences of transcriptomics in blood, urine and tongue coating will be detected by transcriptomics in LKD group, PBS group and NC group.
the related indexes of TGF- β/ Smad signaling pathway and inflammatory response
时间窗: 3 years
Histological and pathological examination is used to detect the related indexes of TGF- β/ Smad signaling pathway and inflammatory response.
The grading scores of Kellgren Lawrence (K-L)
时间窗: 3 years
The minimum value is 0 and maximum value is 4, and higher scores mean a worse outcome.
Clinical data
时间窗: 3 years
Collect clinical data and formulate a unified questionnaire, including the name, age, gender, outpatient / inpatient number, past history, current medical history, imaging images and other relevant data of patients with knee osteoarthritis.
Concentration of Eotaxin-2 (MPIF-2/CCL24) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of Eotaxin-2 (MPIF-2/CCL24) will be detected by ELISA in the cell models of disease-TCM.
Concentration of GM-CSF
时间窗: 3 years
Concentration of GM-CSF will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-1 alpha (IL-1 F1) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-1 alpha (IL-1 F1) will be detected by ELISA in the cell models of disease-TCM syndrome.
the differences of metabonomics in the cell models of disease-TCM syndrome
时间窗: 3 years
The differences of metabonomics in the cell models of disease-TCM syndrome will be detected by metabonomics.
the differences of transcriptomics in the cell models of disease-TCM syndrome
时间窗: 3 years
The differences of transcriptomics in the cell models of disease-TCM syndrome will be detected by transcriptomics.
the differences of metabonomics
时间窗: 3 years
The differences of metabonomics in blood, urine and tongue coating will be detected by metabonomics in LKD group, PBS group and NC group.
the differences of proteomics
时间窗: 3 years
The differences of proteomics in blood, urine and tongue coating will be detected by proteomics in LKD group, PBS group and NC group.
The clinical TCM scores of PBS
时间窗: 3 years
The minimum value is 0 and maximum value is 41, and higher scores mean a worse outcome.
The grading scores of Yulish
时间窗: 3 years
The minimum value is 0 and maximum value is 4, and higher scores mean a worse outcome.
The clinical TCM scores of LKD
时间窗: 3 years
The minimum value is 0 and maximum value is 38, and higher scores mean a worse outcome.
Concentration of Eotaxin-1 (CCL11)
时间窗: 3 years
Concentration of Eotaxin-1 (CCL11) will be detected by ELISA will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of Eotaxin-1 (CCL11) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of Eotaxin-1 (CCL11) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of GCSF
时间窗: 3 years
Concentration of GCSF will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of I-309 (TCA-3/CCL1) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of I-309 (TCA-3/CCL1) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of ICAM-1(CD54)
时间窗: 3 years
Concentration of ICAM-1(CD54) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of ICAM-1(CD54) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of ICAM-1(CD54) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IFN-gamma
时间窗: 3 years
Concentration of IFN-gamma will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IFN-gamma in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IFN-gamma will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of BLC (CXCL13) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of BLC (CXCL13) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of Eotaxin-2 (MPIF-2/CCL24)
时间窗: 3 years
Concentration of Eotaxin-2 (MPIF-2/CCL24) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of GM-CSF in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of GM-CSF will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of I-309 (TCA-3/CCL1)
时间窗: 3 years
Concentration of I-309 (TCA-3/CCL1) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-8(CXCL8) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-8(CXCL8) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-11
时间窗: 3 years
Concentration of IL-11 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-12 p70
时间窗: 3 years
Concentration of IL-12 p70 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of BLC (CXCL13)
时间窗: 3 years
Concentration of BLC (CXCL13) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of GCSF in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of GCSF will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-1 beta (IL-1 F2)
时间窗: 3 years
Concentration of IL-1 beta (IL-1 F2) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-1 ra (IL-1 F3)
时间窗: 3 years
Concentration of IL-1 ra (IL-1 F3) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-1 beta (IL-1 F2) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-1 beta (IL-1 F2) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-1 alpha (IL-1 F1)
时间窗: 3 years
Concentration of IL-1 alpha (IL-1 F1) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-5
时间窗: 3 years
Concentration of IL-5 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-5 in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-5 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-6R in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-6R will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-2 in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-2 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-4
时间窗: 3 years
Concentration of IL-4 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-4 in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-4 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-6
时间窗: 3 years
Concentration of IL-6 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-6R
时间窗: 3 years
Concentration of IL-6R will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-1 ra (IL-1 F3) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-1 ra (IL-1 F3) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-2
时间窗: 3 years
Concentration of IL-2 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-6 in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-6 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-7
时间窗: 3 years
Concentration of IL-7 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-7 in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-7 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-8(CXCL8)
时间窗: 3 years
Concentration of IL-8(CXCL8) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-10
时间窗: 3 years
Concentration of IL-10 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-10 in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-10 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-12 p40
时间窗: 3 years
Concentration of IL-12 p40 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-13
时间窗: 3 years
Concentration of IL-13 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-13 in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-13 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-15
时间窗: 3 years
Concentration of IL-15 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-15 in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-15 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-16
时间窗: 3 years
Concentration of IL-16 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-17A in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-17A will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of M-CSF
时间窗: 3 years
Concentration of M-CSF will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-12 p40 in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-12 p40 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of MCP-1 (CCL2)
时间窗: 3 years
Concentration of MCP-1 (CCL2) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of MCP-1 (CCL2) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of MCP-1 (CCL2) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of MIG (CXCL9) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of MIG (CXCL9) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of MIP-1
时间窗: 3 years
Concentration of MIP-1 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-12 p70 in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-12 p70 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-16 in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-16 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-17A
时间窗: 3 years
Concentration of IL-17A will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of MIP-1 in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of MIP-1 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of alpha (CCL3)
时间窗: 3 years
Concentration of alpha (CCL3) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of MIP-1 delta (CCL15)
时间窗: 3 years
Concentration of MIP-1 delta (CCL15) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of M-CSF in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of M-CSF will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of alpha (CCL3) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of alpha (CCL3) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of MIP-1 beta (CCL4) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of MIP-1 beta (CCL4) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of MIG (CXCL9)
时间窗: 3 years
Concentration of MIG (CXCL9) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of MIP-1 beta (CCL4)
时间窗: 3 years
Concentration of MIP-1 beta (CCL4) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of MIP-1 delta (CCL15) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of MIP-1 delta (CCL15) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of TIMP-1
时间窗: 3 years
Concentration of TIMP-1 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of TIMP-1 in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of TIMP-1 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of TNF beta (TNFSF1B) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of TNF beta (TNFSF1B) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of TNF RI (TNFRSF1A)
时间窗: 3 years
Concentration of TNF RI (TNFRSF1A) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of Routine Blood Examination （Concentration of WBC, LYMPH%, MONO, NEUT%, LYMPH, MONO%, NEUT, BASO%, BASO, MCH, MCHC,ROW-CV, MPV, PLT, PDW, EO%, P-LCR, RBC, Hb, HCT）
时间窗: 3 years
LKD group, PBS group and NC group's Routine Blood Examination will be detect by automated hematology analyzer.
Concentration of RANTES (CCL5) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of RANTES (CCL5) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of TIMP-2
时间窗: 3 years
Concentration of TIMP-2 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of TNF alpha
时间窗: 3 years
Concentration of TNF alpha will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of TNF RI (TNFRSF1A) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of TNF RI (TNFRSF1A) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of Signaling pathway indicator in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of Signaling pathway indicator will be detected by ELISA, metabonomics, proteomics, transcriptomics in the cell models of disease-TCM syndrome.
Concentration of Routine Urine Examination (Concentration of LEU, NIT, PRO, GLU-U, KET, URO, BIL, PH-U, SG, BLU)
时间窗: 3 years
LKD group, PBS group and NC group's Routine Urine Examination will be detect by Urine analyzer.
Concentration of PDGF-BB
时间窗: 3 years
Concentration of PDGF-BB will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of PDGF-BB in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of PDGF-BB will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of RANTES (CCL5)
时间窗: 3 years
Concentration of RANTES (CCL5) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of TIMP-2 in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of TIMP-2 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of TNF alpha in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of TNF alpha will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of TNF beta (TNFSF1B)
时间窗: 3 years
Concentration of TNF beta (TNFSF1B) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of TNF RII(TNFRSF1B)
时间窗: 3 years
Concentration of TNF RII(TNFRSF1B) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of Signaling pathway indicator
时间窗: 3 years
Concentration of Signaling pathway indicator will be detected by ELISA, metabonomics, proteomics, transcriptomics in LKD group, PBS group and NC group.
Concentration of TNF RII(TNFRSF1B) in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of TNF RII(TNFRSF1B) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of Blood Biochemistry (Concentration of TC, TG, HDL-C, LDL-C, Urea, Cr, UA, GLu, ALT, AST, TP, ALB, ALP, GGT, TBIL, DBIL, Mg, K, Na, Cl, Ca, P, Fe, CO2)
时间窗: 3 years
LKD group, PBS group and NC group's Blood Biochemistry will be detect by automatic biochemical analyzer.
Concentration of IL-11 in the cell models of disease-TCM syndrome
时间窗: 3 years
Concentration of IL-11 will be detected by ELISA in the cell models of disease-TCM syndrome.
次要结局
未报告次要终点
研究者
Chao Ye
Principal Investigator
Dongzhimen Hospital, Beijing