| Eligibility |
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
Exclusion Criteria:
- A history of severe trauma to the lower limbs;
- Diseases that can cause lower limb oedema such as primary lymphatic disease, venous
thrombosis, cardiogenic, nephrogenic, hypoproteinemia and other systemic diseases that
can cause lower limb oedema.
- Colour Doppler ultrasonography of the lower limbs suggesting lower limb vascular
disease;
- Patients with a history of allogeneic cell or solid organ transplantation;
- primary central nervous system tumour or symptomatic central nervous system
metastasis, meningeal metastasis, or history of epilepsy. Patients with clinically
controlled CNS metastases that were asymptomatic or symptomatic but stable in the
opinion of the investigators were eligible if the following conditions were met: a.
Clinical symptoms were stable for more than 4 weeks prior to the first dose; b. No
evidence of CNS disease progression on contrast-enhanced MRI of the head within 4
weeks prior to the first dose; c. Prednisone =10 mg/day or equivalent hormone dose was
discontinued at least 2 weeks prior to the first dose of antiepileptic drugs.;
- 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.
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