Skip to content

Correlation of hydroxychloroquine metabolizing enzyme gene polymorphism and blood concentration on the efficacy and safety of patients with systemic lupus erythematosus

Correlation of hydroxychloroquine metabolizing enzyme gene polymorphism and blood concentration on the efficacy and safety of patients with systemic lupus erythematosus

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070628
Enrollment
Unknown
Registered
2023-04-18
Start date
2022-04-11
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

systemic lupus erythematosus

Interventions

Regularly taking hydroxychloroquine 200mg/d or 400mg/d for at least 3 consecutive months of treatment:None

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Willing to sign the informed consent form and follow the requirements of the research protocol, and the subjects can understand and complete the research questionnaire 2. Diagnosed with SLE according to the 1997 American College of Rheumatology Classification Criteria 3. Patients aged 18-60 years 4. Hydroxychloroquine 200 mg/day or 400 mg/day is taken regularly for treatment for at least 3 consecutive months

Exclusion criteria

Exclusion criteria: 1. Combined with other autoimmune diseases, such as rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease, etc. 2. Patients with a history of head and neck radiotherapy, hepatitis C, active AIDS, sarcoidosis, Graves disease, diabetes, combined anticholinergic drugs or other factors that may affect the diagnosis of the disease were excluded 3. Exclude patients who combine amiodarone, quinidine, propupazone, cimetidine, fluoxetine, telithromycin, clarithromycin, itraconazole, ketoconazole, indinavir and other hepatic drugs with strong enzyme inhibition or drugs such as Andriol and Diyusheng white tablets that may affect routine blood examination 4. Patients with severe organ damage or expected survival =1 mg·kg-1·d-1 prednisone or equivalent doses of other corticosteroids) were excluded Exclude patients with SLE crisis and those who need to use high-dose glucocorticoids (>= 1 mg·kg-1·d-1 prednisone or equivalent doses) 6. Patients with malignant tumors 7. Co-infected patients (including those with current and previous tuberculosis) 8. Combined pregnancy, Lactating patients 9. Exclude patients with insufficient or contaminated blood samples

Design outcomes

Primary

MeasureTime frame
SLEDAI;whole blood concentration;genotype;

Secondary

MeasureTime frame
Inflammatory indicators;

Countries

China

Contacts

Public ContactXie Han

Nanjing Drum Tower Hospital

185759811@qq.com+86 13913947823

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 19, 2026