Primary systemic lupus erythematosus with menstrual disorder
Conditions
Interventions
The observation group consisted of premenopausal women of childbearing age with systemic lupus erythematosus accompanied by menstrual disorders:None
The observation group consisting of fertile women with chronic hepatitis B who received interferon-a treatment:None
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
Female
Age
19 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 19 - 45 years old; 2. Newly diagnosed female patients with SLE (SLE diagnosis criteria comply with the SLE classification standards jointly introduced by EULAR and ACR in 2019. These standards include one inclusion criterion involving 18 criteria in 10 aspects. Each criterion needs to exclude causes such as infection, malignant tumors, and drugs. Those who previously met any of the criteria can also be scored. The highest weight score in each aspect is added to the total score. A total score of >= 10 can classify as SLE); 3. Female patients diagnosed with chronic hepatitis B in the infectious disease outpatient department and who have received interferon-a treatment for more than 3 months.
Exclusion criteria
Exclusion criteria: 1. Within the past 3 months, patients with severe heart diseases: NYHA classification of grade IV for congestive heart failure; 2. Clinically obvious liver and biliary system diseases: ALT or AST > 3 times the upper limit of normal, or total bilirubin > 34.2 µmol/L (> 2 mg/dL); 3. Severe renal dysfunction or end-stage renal disease (eGFR < 45 mL/min/1.73 m^2); 4. Within the past 3 months, patients with severe infections, severe trauma or other stress states, or those with known immunodeficiency, such as those who have undergone organ transplantation or are diagnosed with acquired immune deficiency syndrome (AIDS); 5. Patients with a history of malignant tumors within the past 3 years; 6. Other diseases causing ovulation disorders (including abnormal thyroid function, hyperprolactinemia, etc.), and diseases causing hyperandrogenemia (including Cushing syndrome, non-classical adrenal genital syndrome, and endocrine tumors secreting androgens, etc.); 7. Patients with concurrent infections of other viruses such as HBV or HCV; 8. Those with contraindications to interferon treatment; 9. According to the researchers' judgment, the subjects cannot comply with the requirements of this study protocol, or have any serious medical or mental conditions that may affect the assessment of efficacy and safety data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ovarian function indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Other serological indicators;Ovarian morphology;Demographic indicators;Types of menstrual disorders; | — |
Countries
China
Contacts
Public ContactChangqin Liu
The First Affiliated Hospital of Xiamen University
Outcome results
None listed