1.Efficacy and safety of CM310 in moderate-to-severe atopic dermatitis: A multicenter, randomized, double-blind, placebo-controlled phase 2b trial
Yan ZHAO ; Jianzhong ZHANG ; Bin YANG ; Jingyi LI ; Yangfeng DING ; Liming WU ; Litao ZHANG ; Jinyan WANG ; Xiaohong ZHU ; Furen ZHANG ; Xiaohua TAO ; Yumei LI ; Chunlei ZHANG ; Linfeng LI ; Jianyun LU ; Qingchun DIAO ; Qianjin LU ; Xiaoyong MAN ; Fuqiu LI ; Xiujuan XIA ; Hao CHENG ; Yingmin JIA ; Guoqing ZHAO ; Jinchun YAN ; Bo CHEN
Chinese Medical Journal 2024;137(2):200-208
Background::Atopic dermatitis (AD) affects approximately 10% of adults worldwide. CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling. This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD.Methods::This multicenter, randomized, double-blind, placebo-controlled, phase 2b trial was conducted in 21 medical institutions in China from February to November 2021. Totally 120 eligible patients were enrolled and randomized (1:1:1) to receive subcutaneous injections of 300 mg CM310, 150 mg CM310, or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary endpoint was the proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (EASI-75) score from baseline at week 16. Safety and pharmacodynamics were also studied.Results::At week 16, the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups (70% [28/40] for high-dose and 65% [26/40] for low-dose) than that in the placebo group (20%[8/40]). The differences in EASI-75 response rate were 50% (high vs. placebo, 95% CI 31%–69%) and 45% (low vs. placebo, 95% CI 26%–64%), with both P values <0.0001. CM310 at both doses also significantly improved the EASI score, Investigator’s Global Assessment score, daily peak pruritus Numerical Rating Scale, AD-affected body surface area, and Dermatology Life Quality Index compared with placebo. CM310 treatment reduced levels of thymus and activation-regulated chemokine, total immunoglobulin E, lactate dehydrogenase, and blood eosinophils. The incidence of treatment-emergent adverse events (TEAEs) was similar among all three groups, with the most common TEAEs reported being upper respiratory tract infection, atopic dermatitis, hyperlipidemia, and hyperuricemia. No severe adverse events were deemed to be attributed to CM310. Conclusion::CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tolerated in adults with moderate-to-severe AD.Trial Registration::ClinicalTrials.gov, NCT04805411.
2.Analysis of radiation dose and influencing factors during interventional procedures for 94 patients with pediatric congenital heart disease
Yuxiu SHANG ; Xiancun YANG ; Ya MA ; Xiaoshan WANG ; Yingmin CHEN
Chinese Journal of Radiological Health 2023;32(6):673-678
Objective To evaluate the radiation dose of interventional procedure for children with congenital heart disease, and to analyze the differences in radiation dose and influencing factors. Methods A total of 94 children who underwent interventional procedure for congenital heart disease at a grade A tertiary hospital in Jinan, Shandong Province, China from June 2021 to September 2022 were included in this study. The patients were divided into three groups according to the type of procedure: ventricular septal defect occlusion group (VSD, 48 cases), patent ductus arteriosus occlusion group (PDA, 29 cases), and atrial septal defect occlusion group (ASD, 17 cases). The basic information of patients and postoperative dose reports were recorded. A statistical analysis was performed using SPSS software. Results The median cumulative air kerma (CAK) of VSD, PDA, and ASD was 100.5, 43.7, and 12.1 mGy, respectively. The median air kerma area product (KAP) of VSD, PDA, and ASD was 3.309, 1.313, and 0.540 Gy·cm2, respectively. The median KAP·kg−1 of VSD, PDA, and ASD was 0.179, 0.088, and 0.031 Gy·cm2·kg−1, respectively. There were significant differences in fluoroscopy time, number of cine images, CAK, KAP, and KAP·kg−1 among the three types of interventional procedures (P<0.05). Compared with PDA and ASD, VSD showed significantly higher fluoroscopy time, number of cine images, CAK, KAP, and KAP·kg−1 (P<0.05). Multiple linear regression analysis found that age (B=52.445, P<0.05), weight (B=13.077, P<0.05), fluoroscopy time (B=0.425, P<0.05), tube current (B=0.872, P<0.05), and number of cine images (B=0.660, P<0.05) were positively correlated with KAP, while there was no significant association between height and KAP (P>0.05). Conclusion There are differences in radiation dose among the three types of procedures. Reducing fluoroscopy time, tube current, and number of cine images while meeting the procedure requirements is of great significance for reducing the radiation dose received by children.
3.A pedigree study of paroxysmal exercise-induced dyskinesia with Parkinson-like symptoms associated with the expression of the PRRT2 gene in the elderly
Peng YANG ; Yingmin MO ; Minli WANG ; Youqiong LI ; Shan HUANG ; Jian HUANG
Chinese Journal of Geriatrics 2023;42(8):909-914
Objective:To study the clinical and genetic characteristics of familial paroxysmal exercise-induced dyskinesia with Parkinson-like manifestations in the elderly.Methods:Clinical data of 9 family members were analyzed, including 2 patients(both received treatment)consenting to appropriate therapy and prediction protocols.DNA was extracted from peripheral blood samples, and then second-generation sequencing mutation screening.Results:The tremor of two probands in the family was completely brought under control by oxcarbazepine treatment.In 5 family members, a heterozygous mutation of base G>C in exon 2 c. G366C: P.QCon122H at position 29824741 of the PRRT2 gene was found, resulting in the mutation of the amino acid at 122 from glutamine to histidine, which was predicted by SIFT and M-CAP to be harmful.Sanger sequencing of pedigree samples showed that the sisters, brothers and nephews of the proband were heterozygous and their nieces were of the wild type.Conclusions:Q122 of PRRT2 protein can cause the Parkinson-like limb tremor phenotype, and antiepileptic drugs are also effective for paroxysmal exercise-induced dyskinesia in the elderly.
4.Clinical efficacy of Atezolizumab and Bevacizumab in the treatment of initially borderline resectable advanced liver cancer
Bowen YAO ; Junxi XIANG ; Xin ZHENG ; Hao SUN ; Wei YANG ; Yuelang ZHANG ; Feng YE ; Dongli ZHAO ; Yingmin YAO ; Qingguang LIU ; Cheng GUO
Chinese Journal of Digestive Surgery 2022;21(2):303-306
Conversion therapy has become the core in the treatment of borderline resectable or unresectable liver cancer, which provides resectable opportunities for more advanced liver cancer patients. In accordance with the first-choice treatment regimen recommended by the guidelines, the authors reported a successful case of Atezolizumab and Bevacizumab (T+A regimen) conversion therapy. The patient with initially borderline resectable advanced liver cancer was performed liver segment resection sucessfully after conversion therapy, and non-tumor recurrence was observed at postoperative 9 months. Postoperative pathological examination showed combined hepatocellular-cholangiocarcinoma, which also indicated the important value of T+A regimen in the conversion therapy of combined hepatocellular-cholangiocarcinoma.
5. Chronic lymphocytic leukemia complicated with multiple myeloma: report of one case and review of literature
Xiaoyuan YU ; Xiao DING ; Yingmin LIU ; Hongqiong FAN ; Keju SU ; Yanping YANG ; Qiang GUO ; Fengyan JIN
Journal of Leukemia & Lymphoma 2020;29(1):50-52
Objective:
To investigate the clinical features, diagnosis, occurrence sequence and clonal origin of chronic lymphocytic leukemia complicated with multiple myeloma.
Methods:
The diagnosis and treatment of one patient with multiple myeloma and chronic lymphocytic leukemia who was admitted to the First Hospital of Jilin University in May 2018 was retrospectively analyzed, and the related literatures were reviewed.
Results:
This patient began with lumbosacral pain, and he was diagnosed as chronic lymphocytic leukemia complicated with multiple myeloma after bone marrow aspiration, flow cytometry, and blood and urine immunofixation electrophoresis. It is recommended that Rd (lenalidomide + dexamethasone) or MPV (melphalan + prednisone + bortezomib) regimen, but the patient did not receive chemotherapy and died of infectious diarrhea 1 month later.
Conclusions
The occurrence of multiple myeloma and chronic lymphoblastic leukemia may originate from the same clone or different new clone. It is very rare that multiple myeloma and chronic lymphoblastic leukemia can co-occur. Therapeutic options tend to be more aggressive multiple myeloma-based regimen.
6.Survey on frequency of medical X-ray diagnosis in Shandong province
Qian LIU ; Shuhui YANG ; Gang SONG ; Nan MIN ; Fang LIU ; Fei NIU ; Rui CHEN ; Yingmin CHEN
Chinese Journal of Radiological Medicine and Protection 2019;39(5):363-369
Objective To analyze the distribution characteristics and influencing factors of X-ray diagnostic imaging in Shandong province,and to estimate the application frequency of X-ray diagnostic imaging in the province,and provide data support for X-ray equipment.Methods A random sampliug method was used to extract 32 medical institutions as respondents from 10 prefecture-level cities in Shandong province.The basic information of medical institutions and the age,sex,examination and procedure of the subjects were analyzed.The distribution of the X-ray application was analyzed and estimated by using a multiple linear regression model.Results Totally 14 694 085 subjects were surveyed,and the proportion of male and female in the sample was not completely uniform.A total of 2 099 155 X-ray diagnostic information was collected in 2016,and the frequency of conventional radiography was the highest,accounting for 59.49%.The next was CT examination,accounting for 28.34%.The frequency of the two examinations showed an increasing trend with the age of subjects.For the total frequency of conventional diagnostic radiography and CT examination,the tertiary hospitals accounted for the highest proportion of the total,up to 52.13%,while the secondary hospitals accounted for the relatively low proportion of 30.09%,and the primary hospitals the lowest with 17.77%.The chest radiography had the highest proportion in conventional radiography accounting for 32.79% of the total frequency of X-ray diagnostic imaging,and the head procedure had the highest proportion in CT examination,accounting for 10.07% of the total frequency of X-ray diagnostic imaging.The fluoroscopy,mammography and dental radiography were mainly concentrated in the tertiary hospitals,and the primary hospitals had mainly radiography.Multiple linear regression models showed that the frequency of application of conventional X-ray diagnostic imaging (including radiography,fluoroscopy,dental radiography and mammography) was positively correlated with equipment quantity,number of outpatient and emergency patients,and tertiary hospitals (t=4.334,3.615,2.339,P< 0.05).CT examination was positively correlated with equipment quantity and the number of inpatient (t =2.167,2.595,P<0.05).The frequency of conventional X-ray diagnostic imaging and CT examination in Shandong province were estimated about 491.17 examinations per 1 000 population and 258.17 examinations per 1 000 population respectively.Conclusions The frequency of X-ray exposure in Shandong province increased significantly compared with that during the " 9th Five-Year Plan" period.All relevant departments should take effective measures to strengthen medical radiation protection and reduce radiation risk.
7.Clinical risk score for invasive fungal diseases in patients with hematological malignancies undergoing chemotherapy: China Assessment of Antifungal Therapy in Hematological Diseases (CAESAR) study.
Ling WANG ; Ying WANG ; Jiong HU ; Yuqian SUN ; He HUANG ; Jing CHEN ; Jianyong LI ; Jun MA ; Juan LI ; Yingmin LIANG ; Jianmin WANG ; Yan LI ; Kang YU ; Jianda HU ; Jie JIN ; Chun WANG ; Depei WU ; Yang XIAO ; Xiaojun HUANG
Frontiers of Medicine 2019;13(3):365-377
Invasive fungal disease (IFD) is a major infectious complication in patients with hematological malignancies. In this study, we examined 4889 courses of chemotherapy in patients with hematological diseases to establish a training dataset (n = 3500) by simple random sampling to develop a weighted risk score for proven or probable IFD through multivariate regression, which included the following variables: male patients, induction chemotherapy for newly diagnosed or relapsed disease, neutropenia, neutropenia longer than 10 days, hypoalbuminemia, central-venous catheter, and history of IFD. The patients were classified into three groups, which had low (0-10, ~1.2%), intermediate (11-15, 6.4%), and high risk ( > 15, 17.5%) of IFD. In the validation set (n = 1389), the IFD incidences of the groups were ~1.4%, 5.0%, and 21.4%. In addition, we demonstrated that antifungal prophylaxis offered no benefits in low-risk patients, whereas benefits were documented in intermediate (2.1% vs. 6.6%, P = 0.007) and high-risk patients (8.4% vs. 23.3%, P = 0.007). To make the risk score applicable for clinical settings, a pre-chemo risk score that deleted all unpredictable factors before chemotherapy was established, and it confirmed that anti-fungal prophylaxis was beneficial in patients with intermediate and high risk of IFD. In conclusion, an objective, weighted risk score for IFD was developed, and it may be useful in guiding antifungal prophylaxis.
8. Effect of 1q21 amplification on bortezomib therapeutic response and prognosis of newly diagnosed multiple myeloma patients
Xuelian LIU ; Peiyu YANG ; Xiaoyuan YU ; Jingcheng CHEN ; Xiaoliang LIU ; Jing BAI ; Yingmin LIU ; Hua HE ; Jingnan SUN ; Hongqiong FAN ; Chen ZHANG ; Ye ZHANG ; Keju SU ; Chunshui LIU ; Yehui TAN ; Sujun GAO ; Wei LI ; Fengyan JIN
Chinese Journal of Hematology 2018;39(5):408-413
Objective:
To investigate the effect of 1q21 amplification (1q) on the therapeutic response and prognosis of bortezomib(Btz) in the treatment of newly diagnosed multiple myeloma (MM) patients.
Methods:
A total of 180 newly diagnosed MM were included for analyses of clinical characteristics, cytogenetics, objective response rate (ORR), progression-free survival (PFS) and overall survival (OS), retrospectively. Gene expression profiling (GEP) was analyzed using publicly available R2 platform.
Results:
① In 180 patients, 1q was found in 51.1% cases. Of them, 174 patients had complete follow-up data, including 88 cases with 1q and 86 without 1q (non-1q). ②Incidence of 1q was positively associated with percentage of IGH rearrangement (72.2%,
9.Susceptibility and prevalence of blaKPC gene in carbapenem-resistant Klebsiella pneumoniae
Yingmin BI ; Zhen SHEN ; Dong DONG ; Shi WU ; Fupin HU ; Fan YANG
Chinese Journal of Infection and Chemotherapy 2017;17(3):298-302
Objective To examine the antimicrobial susceptibility and prevalence of blaKPC gene in carbapenem-resistant Klebsiella pneumoniae (CRKP) strains isolated in Huashan Hospital,Fudan University.Methods The CRKP strains isolated in Huashan Hospital from January to December of 2014 were included in this study.The MICs of antibiotics were determined using CLSI broth dilution method.The blaKPC gene was amplified by polymerase chain reaction (PCR).Results A total of 205 CRKP strains were isolated,mainly from respiratory tract (76.1%,156/205) and urine specimens (18.5%,38/205).Antimicrobial susceptibility test indicated that CRKP isolates had higher resistance rates (85%-100%) to the antimicrobial agents except colistin (1.5%),tigecycline (0.5%),trimethoprim-sulfamethoxazole (51.0%) and amikacin (74.9%).Most (87.8%,180/205) of the CRKP strains were positive for blaKPC gene.Conclusions CRKP are mostly isolated from patients with lower respiratory tract infection and/or urinary tract infection in Huashan Hospital.The strains were highly resistant to the antibacterial agents tested except colistin and tigecycline.Production of KPC-type carbapenemase is the common mechanism of carbapenem resistance in these K.pneumoniae isolates.
10.Distribution regulation of night emergency operation and meticulous management countermeasure in children′s hospital
Zhen WANG ; Yan LI ; Yingmin LIU ; Xia YANG
Chinese Journal of Modern Nursing 2017;23(8):1160-1163
Objective To analyze the distribution regulation of night emergency operation and promote the meticulous management of the operating room. Methods A total of 1117 cases of night emergency operations in children's hospital from January 2015 to December 2015 were included in the study. Statistic data were collected and analyzed. Results The night emergency operations were mostly from orthopedics department and general sur-gery department. The amount of night emergency operations obviously increased in April and May as well as in July and August. The peak time of night emergency operation was at 17:00—23:00 and 6:00—7:00. Conclusions According to the distribution regulation of emergency operation at night,rational allocation of nursing resources in operating room,reinforcement of the integration management of the Supply Room-Operation Room and attention of the perioperative nursing of children's operation will offer valuable references for scientific and meticulous manage-ment of emergency operations in children's hospital.

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