Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery

Inclusion Criteria

• •Patients aged 18 to 75 years (including cut-off) with lower limb lymphoedema (stage I-II) following gynaecological surgery for a malignant tumour without temporary surgical treatment.
• •There was no preoperative lymphedema
• •Voluntarily sign consent form
• •The performance status score had to be 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG).
• •Investigator-assessed expected survival ≥12 weeks
• •Not receiving any other treatment for lower limb lymphoedema
• •Have adequate organ and bone marrow reserve function
• •Be able to understand the requirements of the trial and be willing and able to follow the trial and follow-up procedures
• •other active malignancies within 5 years prior to the first dose. Except for locally cured tumours (such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, or carcinoma in situ of the breast);
• •Any of the following cardiovascular diseases occurring within 6 months prior to the first dose of the drug: symptomatic heart failure of New York Heart Association (NYHA) class 2 or higher, left ventricular ejection fraction (LVEF) less than 50%, unstable arrhythmia, or unstable angina, Myocardial infarction requiring treatment, pulmonary embolism, or uncontrolled hypertension, defined in this protocol as systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg after treatment and clinically significant as assessed by the investigator);
• •The presence of any other medical condition, physical examination, or laboratory test results that, in the opinion of the investigator, are unsuitable for use of the study drug;
• •combined with long-term oral vitamin K disease
• •Subjects with untreated or treated tuberculosis, including but not limited to tuberculosis; patients who received standard anti-tuberculosis treatment and were confirmed cured by the investigators were eligible.
• •Severe infection had occurred within 4 weeks or active infection had occurred within 2 weeks prior to the first medication;
• •Patients with the following diseases: human immunodeficiency virus (HIV) infection; active hepatitis B virus infection \[hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA (HBV DNA) \>200 IU/mL or 103 copies/mL\]; hepatitis C virus infection (HCV antibody and viral RNA (HCV RNA) test results were positive); patients with Treponema pallidum antibody positive and RPR positive;
• •Known hypersensitivity or delayed allergic reaction to any component of the study drug;
• •Known history of mental disorders, drug abuse, alcoholism, or substance abuse that may affect the test results;
• •the patient's lack of compliance to participate in the clinical trial or the presence of any other factor that the investigator deems inappropriate for participation in the trial.
• •patients with tumour recurrence or metastasis during follow-up.