Study The Effects Of Combination Between Glucocorticoid And Oxymatrine In Treating Autoimmune Hepatitis

Background Autoimmune hepatitis (AIH) is a chronic inflammatory disease of the liver triggered by an immune-mediated attack, characterized by the presence of hypergammaglobulinemia, serum autoantibodies, and interface hepatitis on histological examination. It is difficult to be aware of its onset. AIH leads to incalculable economic burden to individuals, families and whole society. Glucocorticoid, as the most recommended treatment medication, has some drawback, such as the side effects, tolerance and relapse after discontinuation. Recently, it has not been reported that whether the combination between glucocorticoid and oxymatrine could be a new method for the treatment of AIH.Objective To study whether the combination between glucocorticoid and oxymatrine could effectively treat the AIH and moderate the side effects caused by glucocorticoids alone, we perform this randomized controlled trial. This study could provide research data and theoretical guidance for preventing and treating AIH.Methods1.We recruited 42 patients with AIH-I and randomized these patients into two groups (control and treatment groups). All patients received a basic liver treatment. The patients in treatment group received glucocorticoid and oxymatrine, and the patients in control group only received glucocorticoid.2. In treatment group, patients received 60 mg prednisone per day in the first week, 40 mg prednisone per day in the second week,30 mg prednisone per day in the third week,20 mg prednisone per day in the fourth week, and 10 mg prednisone per day in the next two months. Meantime, in the first month,0.6 g oxymatrine was mixed in 250ml glucose injection. The mixture was used for intravenous infusion with an appropriate rate of about 60 drops per minute, once a day. In the next two months, patients received 0.2 g oxymatrine orally, three times a day.3. In the control group, patients received 60 mg prednisone per day in the first week, 40 mg prednisone per day in the second week,30 mg prednisone per day in the third week,30 mg prednisone per day in the fourth week, and 20 mg prednisone per day in the next two months.4. We observed the following variables before treatment, after one and three months treatment:serum albumin (ALB), serum globulin (GLB), serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), glutamyl transpeptadase (GGT), alkaline phosphatase (ALP), total bilirubin (TBIL), partial thromboplastin time, serum immunoglobulin G (IgG), autoantibodies, interleukin-17 (IL-17), renal and the side effects, such as infection, high blood glucose, high blood pressure, moon face, acne, gastrointestinal bleeding.Results1. Before treatment, these variables in two groups were comparable.2. After one month treatment, in the treatment group, the ALB, GLB, ALT, AST, GGT, ALP, TBIL, partial thromboplastin time, and renal function of patients were significantly improved (P< 0.05), and the reduction of glucocorticoid dosage did not lead to the relapse of liver function. In the control group, these variables in some patients were significantly (P< 0.05), but part of patients experienced the relapse of liver function when the glucocorticoid dosage was reduction. The vaules of ALT, GGTand GLB in the treatment group had higher improvement than that of in the control group(P< 0.05). The IgG of patients in the treatment group was improved (P<0.05), but not in patients from control group (P> 0.05).The difference of IgG in two groups was significant (P< 0.05).The number of side effects in treatment group was significantly less than in the control group (P< 0.05).3. In the next month, the glucocorticoid dosage was a maintenance dose. In the treatment group, the liver function was further improved in some patients and in a steady state in other patients. Some patients in the control group experienced the relapse of liver function. The vaules of ALT, AST, GGTand GLB in the treatment group had higher improvement than that of in the control group (P< 0.05). The IgG was further improved (P< 0.05) in the treatment group, and was still not significantly improved in the control group (P> 0.05). There was significantly difference in IgG between two groups (P< 0.05). The number of side effects in treatment group was significantly less than in the control group (P<0.05).4. The number of side effects was comparable in the first month. But it was smaller in the treatment group than that of in the control group in the second and third momth. After treatment, the value of IL-17 in the control group was higher than the treatment group. The autoantibodies positive rate in two groups was comparable.Conclusions1. The combination of glucocorticoid and oxymatrine can help the AIH paitences more smoothly reduce the dose of glucocorticoid and effectivly prevent the relapse of liver function.2. The combination of glucocorticoid and oxymatrine can help the AIH patiences stabilize the liver function and effectively prevent the recurrent during the maintenance glucocorticoid dose treatment.3. The combination of glucocorticoid and oxymatrine can effectively reduce the side effects caused by glucocorticoid.