Table 1.
Clinical trials using compound glycyrrhizic acid injection.
| Experimental drugs | Dose and course of treatment | Combined medication | Case/control | Disease type | Indications and symptoms | Efficacy | Positive control | Side effect | Reference |
|---|---|---|---|---|---|---|---|---|---|
| Glycyrrhizin | 200 mg + NaCl 100 mL, i.v., q.d., 4 weeks |
Prednisolone (20–60 mg) |
31/14 | Acute onset autoimmune hepatitis (AIH) | Fever, general malaise, fatigue, nausea, vomiting, and right upper quadrant discomfort | Recovery rate was higher in the SNMC group than in the SNMC + CS group (P = 0.035) | Glycyrrhizin and corticosteroids (CS) | None | [21] |
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| Glycyrrhizin | 200 mg, i.v., q.d., 52 weeks | None | 374/129 | Chronic hepatitis C | Inflammatory effect | The proportion of patients with ALT reduction ≥50% after 12 weeks was significantly higher with 5×/week glycyrrhizin (28.7%, P < 0.0001) and 3×/week glycyrrhizin (29.0%, P < 0.0001) compared with placebo (7.0%). | Placebo-controlled | None | [22] |
|
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| Glycyrrhizin | 200 mg + NaCl 100 mL, i.v., 6c/week, 4 weeks |
None | 69/13 | Chronic hepatitis C | HCV and HCV-RNA positive; serum ALT at least 1.5 times; liver fibrosis or cirrhosis |
The mean percentage ALT decrease from baseline at the end of treatment was 26% and 47% for the three times per week and six times per week treatment group, respectively (both P < 0.001 versus placebo) | Placebo-controlled | None | [23] |
|
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| Glycyrrhizin | 200 mg + NaCl 100 mL, i.v., q.d. for 8 weeks, then 2–7c/week for 2–16 years |
None | 453/109 | Hepatocellular carcinoma (HCC) occurs in patients with hepatitis C virus-RNA positive chronic liver disease | Inflammatory effect after HCC | Patients treated with SNMC; the 10-year HCC appearance rates in histologic Stages I, II, and III were 3%, and 13%, respectively | Other herbal medicines | None | [24] |
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| Glycyrrhizin | 200 mg + NaCl 100 mL, i.v., q.d., 0.1–14.5 years |
None | 1249/796 | Interferon-resistant hepatitis C | Chronic hepatitis effect | Crude carcinogenesis rates in the treated and untreated group were 13.3%, 26.0% at the fifth year and 21.5% and 35.5% at the 10th year, respectively (P = 0.021) | Others without glycyrrhizin therapy | Hypertension skin rash without itching | [25] |
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| Diammonium glycyrrhizinate | 150 mg + 5–10% glucose injection liquid 250 mL, i.v., q.d., 1 month, 1-2 cycles | None | 629/127 | Chronic hepatitis, liver cirrhosis | Fatigue, gastrointestinal symptoms, and discomfort in liver area | After 17-day therapy, there are 93.3% patients with ALT normal level in treating group, but 73.3% in contrast group (P < 0.05). At day 10, the patient'srecovered normal SB were 86.7% in treatment group, but that was 40% in contrast group (P < 0.01) | Compound ammonium glycyrrhetate injection | Headache, facial edema, and blood pressure increased | [26] |
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| β-glycyrrhetinic acid | 80 mg + 10% glucose injection liquid 250 mL, i.v., q.d., 4 weeks, 100 mg, p.o. tid, 12 weeks | None | 80/40 | Chronic Hepatitis B | Chronic hepatitis effect | Compared with control group, the TBil, ALT, AST, HA, and IVC are significantly ameliorated in treatment group (P < 0.01) | α-glycyrrhizic acid | Edema, blood pressure increased, and serum potassium mildly low | [27] |
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| Magnesium isoglycyrrhizinate | 80 mg + 10% glucose injection liquid 250 mL, i.v., q.d., 4 weeks | Hepatoprotective drugs | 80/40 | Chronic Hepatitis B | Fatigue, gastrointestinal symptoms, and discomfort in liver area | Compared with control group, the TBil, ALT, AST are significantly ameliorated in treatment group (P < 0.05) | Diammonium glycyrrhizinate injection | Headache,and blood pressure increased | [28] |
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| Magnesium isoglycyrrhizinate | 150 mg + 5–10% glucose injection liquid 250 mL, i.v., q.d., 4 weeks | None | 60/30 | Chronic severe hepatitis | Fatigue, gastrointestinal symptoms, discomfort in liver area, and yellow urine | Compared with control group, the TBil, PTA, ALT, and AST are significantly ameliorated in treatment group (P < 0.01) | Hepatocyte generation drugs | None | [29] |
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| Magnesium isoglycyrrhizinate | 150 mg + 5–10% glucose injection liquid 250 mL, i.v., q.d., 2 weeks | None | 56/28 | Liver lesion induced by chemotherapy in cancer | Liver injury effect | Compared with control group, the TBil, PTA, ALT, and AST are significantly ameliorated in treatment group (P < 0.01) | Diammonium glycyrrhizinate injection | None | [30] |
GA: glycyrrhizic acid; TBil: total bilirubin; IVC: type IV collagen; ALT: alanine aminotransferase; AST: aspartate transaminase; PTA: prothrombin time activity.