1.Data mining of severe cutaneous adverse reactions related to immune checkpoint inhibitors in the FAERS
Xia LONG ; Mengwen HUANG ; Shiyun PU ; Lichen WANG ; Mengjiao TANG ; Houfeng ZHOU
China Pharmacy 2023;34(22):2760-2765
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.
2.Mining and analysis of lorlatinib-induced adverse drug event signals
Xia LONG ; Mengwen HUANG ; Shiyun PU ; Lichen WANG ; Mengjiao TANG ; Houfeng ZHOU
China Pharmacy 2023;34(20):2513-2518
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.
3.Analysis of clinical features of retroperitoneal bronchogenic cyst.
Houfeng HUANG ; Guanghua LIU ; Hanzhong LI ; Weigang YAN ; Yushi ZHANG ; Zhigang JI ; Email: JZHGPUMCH@163.COM.
Chinese Journal of Surgery 2015;53(11):856-859
OBJECTIVETo analyze the clinical features of retroperitoneal bronchogenic cyst.
METHODSThe clinical data of 6 cases with retroperitoneal brochogenic cyst treated in Peking Union Medical College Hospital from April 1996 to October 2014 were retrospectively analyzed. The clinical manifestation, diagnosis, treatment and prognosis were analyzed.
RESULTSOf the patients, 1 was male and 5 were female aging from 31 to 50 years with a mean age of 38.3 years. Three cases were diagnosed from physical examination, 2 cases from upper abdominal pain and 1 case from left flank pain. The cysts located in the left adrenal region, between the liver and the pancreas, and anterior aspect of the tail of the pancreas were seen in 4 cases, 1 case and 1 case, respectively. The major diameter was from 5 cm to 13 cm, and the mean major diameter was 7 cm. Ultrasonography and CT scan could reveal cystic, cystic-solid or solid masses. Color doppler flow imaging showed no obvious blood flow, and contrast-enhanced CT scans showed no enhancement or no obvious enhancement. Six cases were all misdiagnosed preoperatively. They all underwent operations via retroperitoneal laparoscopic resection for 3 cases, laparotomy for 2 cases and open flank resection for 1 case respectively. The pathological diagnoses were all bronchogenic cysts. Three symptomatic patients became asymptomatic after operations. Five patients had been followed up. During the follow-up of 2 months to 15 years, no recurrence had been found with CT scan.
CONCLUSIONSRetroperitoneal bronchogenic cyst is rare and easily misdiagnosed. It should be considered in the differential diagnosis of a retroperitoneal mass. Most cysts are positioned in the left adrenal region and adjacent regions. Some cysts demonstrate soft tissue characteristics in image. After surgical removal, the patients have a good prognosis.
Adult ; Bronchogenic Cyst ; diagnosis ; pathology ; Diagnosis, Differential ; Female ; Humans ; Laparoscopy ; Laparotomy ; Liver ; pathology ; Male ; Middle Aged ; Pancreas ; pathology ; Prognosis ; Retroperitoneal Space ; pathology ; Retrospective Studies ; Tomography, X-Ray Computed