vascular malformations
Conditions
Interventions
Pingyangmycin Group:Inject Pingyangmycin
Pingyangmycin compound group:Inject Pingyangmycin compound
Sponsors
The First Affiliated Hospital of Sun Yat-sen University,
Eligibility
Sex/Gender
All
Age
1 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign the Informed Consent Form (ICF); 2. Meet the diagnostic criteria for venous malformations and large cystic lymphangichopathies in the guidelines for the diagnosis and treatment of hemangiomas and vascular malformations (2019 edition), excluding mixed vascular malformations; 3. The patient has measurable lesions under B-ultrasound, contrast-enhanced MRI or CT, or under direct vision; 4. The patient has not received other treatments before receiving sclerotherapy; 5. Age>= 1 year, =90 g/L; b.ANC>=1.5×10^9/L; c.PLT>=80×10^9/L; 8. Biochemical tests must meet the following criteria: a.TBIL 60 ml/min (Cockcroft-Gault formula); 9. Normal lung function.
Exclusion criteria
Exclusion criteria: 1. Allergy to fibrin gum and/or pingyangmycin; 2. Pregnant and lactating patients; 3. Concomitant severe systemic illness including, but not limited to, congestive heart failure ([NYHA]2), unstable or severe angina, severe acute myocardial infarction within 1 year prior to registration, supraventricular or ventricular arrhythmias requiring pharmacological intervention, or QT interval >=450 msec, female >=470 msec. Arterial thrombosis or venous thrombosis within 6 months. Hypertension that is not well controlled by antihypertensive drugs (systolic blood pressure >=160 mm Hg and/or diastolic blood pressure >=110 mm Hg). Proteinuria > = ( ) or total 24-hour urine protein > 1.0 g. Coagulation abnormalities (INR>2.0, PT>16s), bleeding tendency or being treated with thrombolysis or anticoagulation; 4. Known to have autoimmune diseases, including but not limited to scleroderma, systemic lupus erythematosus, rheumatoid arthritis, etc.; 5. Patients with known scar constitution; 6. Patients with pulmonary interstitial fibrosis who meet the diagnostic criteria of the 2018 guidelines for pulmonary interstitial fibrosis; 7. Patients with known malignant tumors (past or present); 8. Any other medical, psychiatric, or social condition that, in the opinion of the investigator, may compromise the subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study, or that would interfere with the interpretation of results; 9. Those who have received other sclerosing agent treatment within half a year; 10. Uncontrolled hypertension (systolic blood pressure > = 150 mmHg or diastolic blood pressure > = 100 mmHg despite optimal medical therapy); 11. Patients with serious adverse reactions caused by any previous treatment; 12. Abnormal coagulation function (prothrombin time international normalized ratio (INR) > 1.5 or prothrombin time (PT) >ULN 4 seconds or APTT >1.5 ULN), with bleeding tendency or is receiving thrombolytic or anticoagulant therapy; Note: Under the premise of INR=450 ms, females>=470 ms); According to NYHA standards, grade III.~IV cardiac insufficiency, or cardiac color ultrasound showed left ventricular ejection fraction (LVEF) <50%; 16. Factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction; 17. Significant clinically significant bleeding symptoms or definite bleeding tendency within 3 months prior to enrollment, such as respiratory tract bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood in baseline period and above, or vasculitis, etc.; Patients whose imaging shows that the tumor has invaded the perivascular area of important blood vessels or who are judged by the investigator to have a high probability of the tumor invading important blood vessels during the follow-up study period, causing fatal hemorrhage; 18. Arterior/venous thrombotic events occurred within 12 months prior to enrollmen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effective rate of pingyangmycin compound in the treatment of oral and maxillofacial venous malformations and cystic lymphangial malformations; | — |
Countries
China
Contacts
Public ContactWang Anxun
The First Affiliated Hospital of Sun Yat-sen University,
Outcome results
None listed