The Efficacy and Safety of Alverine in the Treatment of Portal Hypertension in Patients With Liver Cirrhosis

Exclusion Criteria

• •1. Use of non-selective beta-blockers such as Carvedilol, Propranolol, or Alverine, Papaverine, and their derivatives (e.g., Papaverine Hydrochloride, Drotaverine Hydrochloride) within 4 weeks prior to enrollment.
• •2. Previous surgeries including transjugular intrahepatic portosystemic shunt (TIPS) or liver transplantation.
• •3. History or current occurrence of overt hepatic encephalopathy, esophagogastric variceal bleeding, or grade 3 ascites.
• •4. Use of vasoactive drugs such as somatostatin and its analogs, vasopressin, terlipressin, dopamine, norepinephrine within 1 week prior to enrollment.
• •5. History of heavy alcohol consumption within 12 weeks prior to enrollment and inability to abstain from heavy drinking during the study (equivalent to ethanol intake ≥30 g/day for males, ≥20 g/day for females).
• •6. Serum total bilirubin level ≥3×ULN (≥5×ULN for autoimmune liver disease patients), or serum sodium level \<125 mmol/L, or white blood cell count \<1×10\^9/L, or platelet count \<30×10\^9/L, or International Normalized Ratio (INR) \>2.3.
• •7. Significant renal insufficiency (eGFR (CKD-EPI formula) \<20 mL/min/1.73 m²).
• •8. Presence of thrombosis or cavernous transformation in the portal venous system (including portal vein, splenic vein, superior mesenteric vein); patients with a history of portal vein thrombosis can be enrolled if no definite thrombosis is detected in the portal venous system within 2 weeks.
• •9. HBV DNA or HCV RNA \> the lower limit of detection; patients with active HCV antiviral treatment; patients on anti-HBV treatment for less than 24 weeks.
• •10. Uncontrollable active infections (such as lung infection, abdominal infection, HIV, etc.) within 4 weeks prior to enrollment.
• •11. Poorly controlled hypertension, diabetes, or other severe heart or lung diseases.
• •12. Diagnosed or suspected malignancies, including liver cancer.
• •13. Known allergy to Alverine, Papaverine and their derivatives (e.g., Papaverine Hydrochloride, Drotaverine Hydrochloride) or Carvedilol; contraindications for Carvedilol: NYHA class IV decompensated heart failure requiring intravenous inotropic drugs; asthma, chronic obstructive pulmonary disease (COPD) with bronchospasm; second or third degree atrioventricular block, severe bradycardia (heart rate less than 50 bpm), sick sinus syndrome (including sinoatrial block); cardiogenic shock; severe hypotension (systolic blood pressure less than 85 mmHg).
• •14. Patients with glaucoma.
• •15. Patients with psychiatric disorders.
• •16. Pregnant or lactating women, or women with potential for pregnancy.
• •17. Participation in other drug trials within 4 weeks prior to enrollment.
• •18. Other reasons deemed unsuitable by the researchers.