This is a prospective, multicenter, non-randomized, controlled intervention clinical study.Patients with severe fever with thrombocytopenia syndrome who have been clinically diagnosed and met the study inclusion criteria will be included in the study for analysis. All patients with SFTS will be assigned to different groups according to the ratio of 1:3, including the non-intervention group (conventional treatment group) and the related drug intervention group. Non-intervention group:patients received conventional treatment during hospitalization. Intervention group: Part A group: Patients received methylprednisolone 1-2mg/kg/d(or other glucocorticoid equivalent to methylprednisolone 1-2mg/kg/d) + intravenous immunoglobulin (IVIG) 0.2g-0.4g/kg/d for a total of 3-5 days. If the disease progressed after treatment, the patients was given the dose of rescue therapy (methylprednisolone \> 2mg/kg/d or other glucocorticoid equivalent to methylprednisolone \> 2mg/kg/d + IVIG 0.4g/kg/d) for another 3-5 days. Part B group: Patients received tocilizumab 4mg/kg once. Part C group: Patients received low molecular weight heparin 100U/kg, qd or q12h IH for 4-7 days. If the platelet count is less than 30 × 10\^9/L, the low molecular weight heparin should be discontinued. All patients received conventional treatment. All patients were followed up from the end of treatment to day 28 after completion of treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
Methylprednisolone:1-2mg/kg/d(or other glucocorticoid equivalent to methylprednisolone 1-2mg/kg/d),ivgtt,3-5 days.If disease progression occurs after completion of treatment, the dose of salvage therapy (methylprednisolone \> 2mg/kg/d or other glucocorticoid equivalent to methylprednisolone \> 2mg/kg/d) was continued for another 3-5 days.
intravenous immunoglobulin:0.2g-0.4g/kg/d,ivgtt, 3-5 days.If disease progression occurs after completion of treatment, the dose of salvage therapy (IVIG 0.4g/kg/d) was continued for another 3-5 days.
Tocilizumab:4mg/kg, once
Low molecular weight heparin:100U/kg, qd or q 12h,IH,4-7 days
conventional treatment,including symptomatic and supportive treatment, antiviral treatment etc.
Guangshui First Peoples Hospital
Guangshui, Hubei, China
RECRUITINGHuanggang Central Hospital
Huanggang, Hubei, China
NOT_YET_RECRUITINGLuotian County Peoples Hospital
Huanggang, Hubei, China
RECRUITINGMacheng Peoples Hospital
Macheng, Hubei, China
RECRUITINGQianjiang Central Hospital
Qianjiang, Hubei, China
NOT_YET_RECRUITINGSuizhou Central Hospital
Suizhou, Hubei, China
RECRUITINGDepartment of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGXianning Central Hospital
Xianning, Hubei, China
NOT_YET_RECRUITINGYichang Third Peoples Hospital
Yichang, Hubei, China
NOT_YET_RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
NOT_YET_RECRUITING28-day survival rate
28-day survival rate was defined as the proportion of patients who were still alive 28 days after enrollment.
Time frame: From enrollment to 28 day
Incidence of complications
The complications include Respiratory system, gastrointestinal system, blood system, nervous system, liver and kidney, lymphatic system, multiple organ dysfunction syndrome may be related to Severe Fever With Thrombocytopenia Syndrome.Incidence of complications was defined as the proportion of complications occur after enrollment.
Time frame: From enrollment to 28 day
Incidence of AEs
Incidence of adverse events associated with trial drug treatment: blood glucose, electrolyte disturbances, osteoporosis, Cushing's syndrome, double infection, active bleeding, etc.
Time frame: From enrollment to 28 day
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