Cases analysis of liver injury associated with Qubai Babuqi tablets (驱白巴布期片)

Objective To explore the clinical characteristics and influencing factors of liver injury associated with Qubai Babuqi tablets. Methods Case reports of liver injury associated with Qubai Babuqi tablets in the National Adverse Drug Reaction Monitoring System (ADRMS) from 2012 to 2016 and clinical information of patients with liver injury induced by Qubai Babuqi tablets, who were admitted to the Fifth Medical Center of PLA General Hospital from 2008 to 2017, were collected and retrospectively analyzed. Results A total of 64 patients (59 from case reports in ADRMS and 5 from the Fifth Medical Center of PLA General Hospital) with liver injury induced by Qubai Babuqi tablets were enrolled, including 32 males and 32 females, aged from 10 to 73 years with an average age of (34±13) years. Thirty-three patients (51.6%) were treated with Qubai Babuqi tablets alone, 31 patients (48.4%) had combined medication, and 3 of the 64 patients suffered from liver injury again after their remedication of Qubai Babuqi tablets. The median time from medication to liver injury was 33 (2-210) days and the median cumulative dose of Qubai Babuqi tablets was 184.5 (8.0-868.5) g. There were 35 patients (54.7%) with severe liver injury. No significant association was found between the severity of liver injury and the dose of the drug (P>0.05). But the proportion of patients with severe liver injury treated with combined medication was significantly higher than that of patients with severe liver injury treated with Qubai Babuqi tablets alone [67.7% (21/31) vs. 42.4% (14/33), χ2=4.282, P=0.042]. Among the 64 patients, the liver injury was cured in 31 patients, improved in 21 patients, did not improve in 2 patients, worsened in 2 patients (developed to hepatic encephalopathy and cirrhosis, respectively), and had unknown outcomes in 8 patients. Conclusions About half of the liver injuries caused by Qubai Babuqi tablets were severe ones. The prognosis of liver injury was relatively good and it could be cured or improved in most patients. The combination of other drugs might be the influencing factor of severe liver injury caused by Qubai Babuqi tablets. Key words: Adverse drug reaction reporting systems; Chemical and drug induced liver injury; Drugs, Chinese herbal; Psoralens; Qubai Babuqi tablet