The Safety and Efficacy of Alverine in the Treatment of Cirrhotic Portal Hypertension

Exclusion Criteria

• •Use of non-selective β-blockers (e.g., carvedilol, propranolol) or alverine, papaverine, and its derivatives (e.g., papaverine hydrochloride, drotaverine hydrochloride) within 4 weeks prior to enrollment.
• •Previous transjugular intrahepatic portosystemic shunt (TIPS) or other interventional treatments affecting portal pressure (including splenic embolization, microwave treatment of the spleen).
• •Previous liver transplantation.
• •Occurrence of overt hepatic encephalopathy or esophageal/gastric variceal bleeding within 2 weeks prior to enrollment; endoscopic treatment of esophageal/gastric varices within 1 week prior to enrollment or planned endoscopic treatment.
• •Use of somatostatin and its analogs, vasopressin, terlipressin, dopamine, norepinephrine, and other vasoactive drugs within 1 week prior to enrollment.
• •History of alcoholism within 12 weeks prior to enrollment and inability to stop drinking during the study (equivalent ethanol intake ≥ 30 g/day for males, ≥ 20 g/day for females).
• •Serum total bilirubin level ≥ 3×ULN (for autoimmune liver disease patients, ≥ 5×ULN), serum sodium level \< 125 mmol/L, white blood cell count \< 1×10\^9/L, platelet count \< 50×10\^9/L, INR \> 1.8, or serum creatinine ≥ 1.2×ULN.
• •Presence of thrombosis in the portal venous system (including the portal vein, splenic vein, superior mesenteric vein, etc.) or cavernous transformation of the portal vein; previous portal venous system thrombosis if no definite thrombosis detected in the portal venous system within 2 weeks.
• •HBV DNA or HCV RNA above the lower limit of detection; patients undergoing active antiviral treatment for hepatitis C; antiviral treatment for hepatitis B \< 24 weeks.
• •Uncontrollable active infections (e.g., pulmonary infection, abdominal infection, HIV) within 2 weeks prior to enrollment.
• •Uncontrolled hypertension, diabetes, or other severe heart/lung diseases.
• •Diagnosis or suspicion of malignant tumors, including liver cancer.
• •Known allergy to alverine or papaverine and its derivatives (e.g., papaverine hydrochloride, drotaverine hydrochloride) or simethicone.
• •Presence of psychiatric symptoms.
• •Pregnant or breastfeeding women, or women who may be pregnant.
• •Participation in other drug trials within 4 weeks prior to enrollment.
• •Any other reasons deemed by the researchers as unsuitable for participation.