Objective To systematically evaluate the efficacy and safety of nivolumab in the treatment of non-small cell lung cancer.Methods PubMed,Embase,Cochrane Library,China National Knowledge Infrastructure(CNKI),Weipu Chinese Science and Technology Journal Database,Wanfang Medical Database were searched for articles published from the establishment of the database to March 2023.Published randomized controlled clirical trials of nivolumab in the treatment of patients with non-small cell lung cancer were selected,overall survival,progression-free survival,and adverse reaction rate as outcome indicators were used.A meta-analysis using STATA version 13.1 statistical software was conducted.Results A total of 8 phase Ⅲrandomized controlled trials involving 4 945 subjects were included.Compared with the traditional chemotherapy group,patients in the nivolumab group had significantly reduced risk of death in terms of overall survival(HR=0.73,95%CI=0.65-0.82,P<0.05),and in terms of progression-free survival,nivolumab significantly reduced the risk of recurrence compared with the traditional chemotherapy group(HR=0.74,95%CI=0.63-0.88,P<0.05).In terms of safety,there was no significant difference between the nivolumab group and the traditional chemotherapy group for diarrhea,but the incidence of nausea,neutropenia,anemia,decreased appetite,and fatigue in the nivolumab group was lower than that in the traditional chemotherapy group.However,it should be worth noting that the incidence of immune-related adverse events such as rash was higher in the nivolumab group than in the traditional chemotherapy group,and the difference was statistically significant(OR=3.85,95%CI=2.05-6.25,P<0.05).Conclusion Compared to traditional chemotherapy,the efficacy and safety of nivolumab in the treatment of non-small cell lung cancer were better,but the risk of immune-related adverse events increased.

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),x2 =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.

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),x2 =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.