Data mining of severe cutaneous adverse reactions related to immune checkpoint inhibitors in the FAERS / 中国药房

OBJECTIVE To mine and analyze severe cutaneous adverse reaction signals of 5 commonly used immune checkpoint inhibitors （ICIs）， and to provide reference for clinically safe use of drugs. METHODS Based on the FDA adverse events reporting system （FAERS） database，adverse drug events （ADEs） reports about severe cutaneous adverse reactions related to ipilimumab， nivolumab， pembrolizumab， atezolizumab and durvalumab were collected from listing in the United States to the fourth quarter of 2022. The ADE signals were mined and analyzed with reporting odds ratio （ROR） and Bayesian confidence propagation neural network （BCPNN）. RESULTS A total of 5 726 reports of severe cutaneous adverse reactions were collected， including 3 037 reports for nivolumab，1 465 reports for pembrolizumab， 130 reports for durvalumab， 429 reports for atezolizumab and 665 reports for ipilimumab. All 5 kinds of ICIs caused positive signals， the correlation degree of which was as follows： pembrolizumab＞atezolizumab＞nivolumab＞ipilimumab＞durvalumab. Stevens-Johnson syndrome（SJS） and toxic epidermal necrolysis （TEN） have been reported for all 5 ICIs， and the association was the strongest with pembrolizumab. CONCLUSIONS All 5 kinds of ICIs are associated with the risk of severe skin adverse reactions， and close attention should be paid to their clinical use， especially being cautious when using pembrolizumab. The combination of ICIs should be avoided as much as possible.

Mining and analysis of lorlatinib-induced adverse drug event signals / 中国药房

OBJECTIVE To provide references for the safe use of lorlatinib in clinical practice. METHODS The reporting odds ratio （ROR） method， Medicines and Healthcare Products Regulatory Agency comprehensive standard method （referred to as “MHRA method”） and the Bayesian confidence propagation neural network （BCPNN） method were used to detect adverse drug events （ADEs） signals of lorlatinib in the FDA Adverse Event Reporting System from the first quarter of 2019 to the fourth quarter of 2022. RESULTS & CONCLUSIONS Totally 114 overlapping ADEs signals of lorlatinib were detected by the three methods， among which there were 73 new suspicious ADEs signals which were not covered in the instruction of lorlatinib. When using loratinib in clinical practice， special attention should be paid to ADEs with a high number of cases and signals， such as various neurological diseases， psychiatric diseases， respiratory system， thoracic and mediastinal diseases； clinical manifestations included cerebral edema， cerebral infarction， pulmonary hypertension， mutism， decreased sexual desire， pleural effusion. The signals of mobile thrombophlebitis， radiation necrosis， mutism， vesicoureteral reflux not mentioned in the instructions were all strong in BCPNN detection with high specificity， to which we should pay attention in clinical application.

Efficacy of liraglutide in the treatment of nonalcoholic fatty liver disease:a Meta analysis / 重庆医学

Objective To evaluate the efficacy of liraglutide in the treatment of Nonalcoholic Fatty Liver Disease(NAFLD).Methods Randomized controlled trials(RCTs)that evaluated the efficacy of liraglutide for NAFLD treatment were searched in multiple databases,including Pubmed,EMBASE,the Cochrane library,CNKI,Wanfang database and VIP.Literature identification and data extraction were based on the inclusion and exclusion criteria.RevMan 5.3 software was used for Meta-analysis.Results A total of 7 RCTs with 500 patients of NAFLD were included.Improved liver histology,or improved the level of alanine aminotransferase[WMD=-25.32,95％CI(-37.22,-13.41),P<0.01] and aspartate aminotransferase[WMD=-24.56,95％CI(-35.10,-14.03),P<0.01] were seen in 12-48 weeks liraglutide treatment.However,liraglutide could not decreased the level of serum cholesterol[WMD=-14.38,95％CI(-48.95,-20.20),P=0.42] and triglyceride[WMD=-15.55,95％CI(-36.20,-5.10),P=0.14].Conclusion liraglutide has the therapeutic effect of NAFLD.