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.

Primary varicose veins treated with HE's fire needle therapy: a randomized controlled trial / 中国针灸

<p><b>OBJECTIVE</b>To evaluate the clinical efficacy on primary varicose veins treated with He's fire needle therapy.</p><p><b>METHODS</b>Fifty patients of primary varicose veins were randomized into an observation group (25 cases) and a control group (25 cases). In the observation group, He's fire needle therapy was applied for 8 weeks. The fire needling was done on the sites of varicose veins till the bleeding stopped automatically. Additionally, acupuncture with filiform needle was applied to Heyang (BL 55), Chengjin (BL 56), Chengshan (BL 57) and Kunlun (BL 60) on the affected side. In the control group, no intervention was given. The follow-up visit was conducted regularly and since the 8th week, the same treatment as the observation group was provided in the control group. The revised venous clinical severity score (RVCSS) was used for the evaluation of the primary outcomes. The methods for the evaluation of the secondary efficacy outcomes included the venous insufficiency epidemiologic and economic study of quality of life questionnaire scale (VEINES-QOL/sym questionnaire), the venous insufficiency epidemiologic and economic study of symptom score (VEINES-Sym score), the venous insufficiency epidemiologic and economic study of quality of life scale (VEINES-QOL score) and the Homburg varicose vein severity score (HVVSS). The evaluation was conducted at the baseline, at the end of the 4th week and the 8th week separately. The follow-up evaluation was done at the end of the 16th week in the observation group.</p><p><b>RESULTS</b>During the study, 5 cases were dropped out, accounting for 10%. RVCSS score in the observation group was lower than that in the control group at the end of the 4th and 8th weeks separately (both P < 0.05). VEINES-QOL score and HVVSS score in the observation group were higher than those in the control group at the end of the 4th and 8th weeks separately (P < 0.05, P < 0.01). VEINES-Sym score in the observation group was increased as compared with that of the control group at the end of the 4th and 8th weeks, but the difference was significant at the end of the 8th week (P < 0.01). HVVSS score at the end of the 8th and 16th weeks was reduced as compared with that at the end of the 4th week in the observation group (both P < 0.05).</p><p><b>CONCLUSION</b>HE's fire needle therapy is effective on primary varicose veins. It significantly reduces the severity of disease, the severity of symptoms and the attack frequency of symptoms so that the quality of life is improved in the patients. Additionally, the good long-term efficacy is maintained in 8 weeks after treatment. When the duration of treatment is increased from 4 weeks to 8 weeks, HE's fire needle therapy remarkably improves the efficacy for reducing the symptom severity.</p>

Movement of the hyoid bone and ventriculus laryngis in normal swallowing / 中华放射肿瘤学杂志

Objective To measure the maximum movement of the hyoid bone and ventriculus laryngis during normal swallowing. Methods Forty volunteers were selected as subjects, and an X?ray simulator was used to collect the videos of normal swallowing. Video analysis software was used to capture continuous and quick screenshots of these videos, and the maximum movement of the hyoid bone and ventriculus laryngis was measured. The difference in movement was analyzed by one?way analysis of variance. Results The mean time for swallowing in 40 volunteers was 1.13±0.28 s. During the process of swallowing, the hyoid bone and ventriculus laryngis moved upward first, then outward, and finally returned to the resting position. The maximum movement of the hyoid bone forward and backward was 0.90±0.30 cm;the maximum vertical movement of the hyoid bone was 0.93±0.36 cm. The maximum movement of the ventriculus laryngis forward and backward was 0.69± 0. 25 cm;the maximum vertical movement of the ventriculus laryngis was 1.04±0.45 cm. Further studies showed the effect of age on the time for swallowing (P=0.03), with similar results for the male and female ( P=0.13) . Sex and age had no effects on movement of the hyoid bone and ventriculus laryngis (P=0.28?0.81 and 0.20?0.88). Conclusions During normal swallowing, the hyoid bone and the ventriculus laryngis move first upward and then forward. These movements should be considered during the development of radiotherapy plan for head and neck cancer.

Comparative study of gross tumor volume shown on MRI and FDG PET/CT of nasopharyngeal carcinoma / 中华放射肿瘤学杂志

Objective To compare gross tumor volume (GTV) of nasopharyngeal carcinoma (NPC) according to MRI and FDG PET/CT and to investigated four fixed threshold methods to delineate the GTV using FDG PET/CT.Methods Fifty patients with primary biopsy-proven NPC were prospectively were enrolled into the study.FDG PET/CT scans and MRI were carried out within one week prior to pretreatment,respectively.The GTV was named GTV-MRI (GTV were delineated according to MRI),GTV-PETvis,GTV-PET30,GTV-PET40,GTV-PET50 (GTV was delineated according to the PET-based GTVs obtained by visual interpretationor,by percentage of the SUVmax (30％,40％,50％) thresholds,respectively).The differences were compared among the GTV-MRI,GTV-PETvis,GTV-PET30,GTV-PET40 and GTV-PET50 in different by Wilcoxon test.Results Of 50 patients,the median of volume descending order were: GTV-MRI 27.8 cm3,GTV-PETvis 22.2 cm3,GTV-PET30 22.7 cm3,GTV-PET40 14.4 cm3 and GTV-PET50 9.0 cm3.However,there was no significant difference between GTV-PETvis and GTV-PET30 (Z=-0.05,P=0.958),as well as GTV-MRI and GTV-PETvis or GTV-PET30 in 25 patients who were T1-2 stage (Z =-0.93,-0.93,P=0.353,O.353),the other GTVs were all different in 50 patients' (Z=-5.74-2.09,P =0.000-0.037).Conclusions All the GTVs delineated by the different methods of using FDG PET/CT were less than the GTV delineated by MRI.The potential advantages with the GTV-PETvis or GTV-PET30 delineated by FDG PET/CT are reduction of biological metabolic tumor volume in GTV delineation and reduction of the size of the GTV in NPC patients.