Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Unimed Scientific Inc., Wuxi, China.
J Int Med Res. 2021 Aug;49(8):3000605211039810. doi: 10.1177/03000605211039810.
In China, polyene phosphatidylcholine (PPC) is widely used to treat alanine aminotransferase (ALT) elevation associated with various liver diseases. Here, we assessed the efficacy and safety of PPC in treating drug-induced liver injury (DILI). Data from a multicenter retrospective cohort study (DILI-R) were analyzed to compare PPC and magnesium isoglycyrrhizinate (MgIG) for treatment of DILI. We used the Roussel Uclaf causality assessment method (RUCAM) to evaluate patients with DILI. Patients with RUCAM scores ≥6 were included in the study, while those with RUCAM scores <6 were further evaluated by a panel of hepatologists. The primary outcome was the proportion of patients with ALT normalization at discharge. Propensity score matching was used to identify 183 matched pairs of patients (366 patients in total) from 25,927 patients with DILI. Among the DILI patients, 64 of 183 (34.97%) achieved normal ALT levels after treatment in both the PPC and the MgIG groups. There were no significant differences in safety biomarkers including serum creatinine, blood urea nitrogen, white blood cells, platelets, hemoglobin, and albumin between patients treated with PPC or MgIG. The safety and efficacy of these two agents for treatment of DILI were comparable.
在中国，多烯磷脂酰胆碱（PPC）被广泛用于治疗与各种肝病相关的丙氨酸氨基转移酶（ALT）升高。在这里，我们评估了 PPC 治疗药物性肝损伤（DILI）的疗效和安全性。对一项多中心回顾性队列研究（DILI-R）的数据进行了分析，以比较 PPC 和镁甘氨酸（MgIG）治疗 DILI 的效果。我们使用 Roussel Uclaf 因果关系评估方法（RUCAM）来评估 DILI 患者。将 RUCAM 评分≥6 的患者纳入研究，而 RUCAM 评分<6 的患者则由一组肝病专家进一步评估。主要结局是出院时 ALT 正常化的患者比例。采用倾向性评分匹配，从 25927 例 DILI 患者中确定了 183 对匹配患者（共 366 例）。在 DILI 患者中，PPC 和 MgIG 组分别有 64/183（34.97%）例患者的 ALT 水平恢复正常。治疗后，接受 PPC 或 MgIG 治疗的患者的安全性生物标志物（包括血清肌酐、血尿素氮、白细胞、血小板、血红蛋白和白蛋白）无显著差异。这两种药物治疗 DILI 的安全性和疗效相当。
