The purpose of this study is to explore the efficacy and the safety of polyene phosphatidylcholine Injection in patients with acute drug-induced liver injury after 2-4 weeks of treatment.
This study is a phase IV study in subjects with acute drug-induced liver injury. As designed, the study will include a screening period of up to 1 week, 2 to 4 weeks of treatment, and 1 week of safety follow-up. The eligible subjects will randomly be assigned to polyene phosphatidylcholine group or magnesium isoglycyrrhizinate group to receive single-blind treatment with a ratio of 1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
73
Polyene phosphatidylcholine injection 930mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks.
Magnesium isoglycyrrhizinate injection 200mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks.
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Chest Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Serum ALT normalization rate
The serum ALT normalization rate of treatment for 2-4 weeks
Time frame: After 2-4 weeks treatment
The serum ALT normalization rate for 1, 2 and 3 weeks
Time frame: After 1, 2 and 3 weeks treatment
Changes in serum ALT compared to the baseline for 1, 2, 3 and 4 weeks
Time frame: After 1, 2, 3 and 4 weeks treatment
The ratio of subjects whose ALT declined more than 50% compared to the base line for 1, 2, 3 and 4 weeks
Time frame: After 1, 2, 3 and 4 weeks treatment
The serum AST normalization rate for 1, 2, 3 and 4 weeks
Time frame: After 1, 2, 3 and 4 weeks treatment
Changes in serum AST compared to the baseline for 1, 2, 3 and 4 weeks
Time frame: After 1, 2, 3 and 4 weeks treatment
The serum TBIL normalization rate for 1, 2, 3 and 4 weeks
Time frame: After 1, 2, 3 and 4 weeks treatment
Changes in serum TBIL compared to the baseline for 1, 2, 3 and 4 weeks
Time frame: After 1, 2, 3 and 4 weeks treatment
Changes in serum ALP and GGT compared to the baseline for 1, 2, 3 and 4 weeks
Time frame: After 1, 2, 3 and 4 weeks treatment
The Incidence of Treatment-Emergent Adverse Events over time
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Shenzhen People's Hospital
Shenzhen, Guangdong, China
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan, China
The Third Hospital of Zhenjiang Affiliated Jiangsu University
Zhenjiang, Jiangsu, China
Renji Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Tongji Hospital
Shanghai, Shanghai Municipality, China
Time frame: After 2 to 4 weeks of treatment and 1 week of safety follow-up