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.Study on the causal relationship between gastroesophageal reflux disease and sleep disorder based on two sample Mendelian randomization
Jiaxin LIU ; Jiao DUAN ; Hui WU ; Yingmin GU ; Shaoxiang XIAN
International Journal of Traditional Chinese Medicine 2024;46(10):1277-1285
Objective:To explore the causal relationship between gastroesophageal reflux disease (GERD) and sleep disorder using Mendelian randomization (MR); To explore the diagnosis and treatment of sleep disorder with GERD by combining with the TCM theory that "gastric disharmony causing restless sleep".Methods:Genetic loci independent of each other and closely related to GERD were taken as instrumental variables by pooling data from a large-scale genome-wide association study. The causal relationship between GERD and sleep disorder was explored with Mendelian randomization methods, such as Inverse Variance Weighted (IVW), MR Egger, Weighted Median (WME), Simple Mode (SM), Weighted Mode (WM) and MR Multiple Effectiveness Residual Sum and Heteroscedasticity (MR-PRESSO) using OR as an evaluation index.Results:The results of the IVW method showed that GERD led to a 44.3% higher risk of developing sleep disorder ( P=4.96×10 -15, OR=1.443, 95% CI:1.317-1.582); horizontal pleiotropy was detected using the MR-Egger intercept, which was calculated to be P=0.646 ( P>0.05), proving that there was no horizontal pleiotropy in the results; Leave-one-out sensitivity test showed that the results were stable and there were no instrumental variables that strongly influenced the results. Conclusion:GRED is a risk factor for the development of sleep disorder, which is consistent with the TCM theory of "gastric disharmony causing restless sleep".
3.Clinical application of metagenomic next-generation sequencing in pulmonary infection for patients with AIDS
Lin JIA ; Ming CHEN ; Yongfeng WU ; Caiping GUO ; Yulin ZHANG ; Ronghua JIN ; Yingmin MA
Chinese Journal of Experimental and Clinical Virology 2022;36(4):441-447
Objective:Comparing the diagnostic performance of pulmonary infection pathogens between metagenomic next-generation sequencing (mNGS) testing and traditional assay in patients with AIDS to provide references for the diagnosis and treatment of the disease.Methods:From July 2019 to January 2021, the regular clinical assays as well as mNGS testing were performed for patients and those discharged with a diagnosis of AIDS and pulmonary infection were retrospectively reviewed in the department of infectious diseases of Beijing You An Hospital. The cases with discharge diagnosis of AIDS for whom mNGS testing was performed on samples from respiratory system were analyzed. Diagnostic performance of pathogens was compared between mNGS testing and traditional etiologyic diagnostic method. Diagnosis concordance analysis and diagnostic comparison study between mNGS and traditional etiology diagnosis method in terms of pathogens were also performed.Results:Fifty-five cases discharged with AIDS and pulmonary infection were enrolled.. For 29 cases for whom mNGS testing was performed on samples from respiratory system, the sensitivity of mNGS for diagnosing infection was higher than that of traditional etiology diagnosis method (89.7% vs. 37.9%, P<0.001) but with poor consistency (Kappa=0.249, P=0.170). A superior positivity rate in mNGS than that in traditional etiology diagnosis method for diagnosing bacterial (90.9% vs. 9.1%, P<0.001) Pneumocystis jirovecii (mNGS only), and nontuberculous mycobacteria (mNGS only). Conclusions:mNGS could yield a higher sensitivity for pulmonary pathogen identification in AIDS patients, especially for bacterial, Pneumocystis jirovecii and nontuberculous mycobacteria compared to traditional etiologic diagnostic method.
4.Rivaroxaban versus low-molecular weight heparin plus warfarin prevents portal vein system thrombosis after splenectomy and pericardial devascularization: A randomized clinical trial
Wei YAO ; Yongan FENG ; Ting LIU ; Mei ZHANG ; Yingmin YAO ; Shengli WU
Journal of Xi'an Jiaotong University(Medical Sciences) 2021;42(5):740-746
【Objective】 To evaluate the safety and efficacy of rivaroxaban in preventing portal vein system thrombosis (PVST) in patients with liver cirrhosis after splenectomy and pericardial devascularization. 【Methods】 Totally 76 cirrhotic patients underwent splenectomy and pericardial devascularization were randomly assigned to rivaroxaban treatment group (n=38) or low-molecular weight heparin (LMWH) plus warfarin treatment group (n=38). The experimental group was given rivaroxaban 10 mg orally, once a day, for 30 days. The control group was given subcutaneous injection of 5000 IU low molecular weight heparin (LMWH) twice a day for 5 days and warfarin (initial dose 2.5 mg) orally once a day for 30 days. Both groups were followed up for 1 year. We compared the two groups in the incidence of PVST, recovery of liver function and coagulation function, decompensation of liver function, incidence of liver cancer, and active bleeding. 【Results】 Totally 18 patients (47.4%) in rivaroxaban group developed PVST, compared with 29 patients (76.3%) in LMWH plus warfarin group (P=0.024). The incidence of PVST during the first year after operation was significantly lower in rivaroxaban group than in LMWH plus warfarin group (F=7.852, P=0.007). The intra-group comparisons versus baseline showed that the liver function improved from POD 21 to POM 1, and coagulation function improved from POM 2 in rivaroxaban group. In contrast, the liver function improved from POM 1 to POM 2, and coagulation function improved from POM 4 in LMWH plus warfarin group. The two groups did not significantly differ in liver function decompensation, incidence of liver cancer, or active bleeding (all P>0.05). 【Conclusion】 The prophylactic use of rivaroxaban significantly decreases the incidence of PVST after splenectomy and pericardial devascularization in cirrhotic patients compared to LMWH plus warfarin treatment. Besides, rivaroxaban treatment is safe and effective and is associated with improved liver and coagulation functions than LMWH plus warfarin treatment.
5.A study on the adoption and perceived utility of mobile healthcare by primary healthcare workers
Chinese Journal of Hospital Administration 2020;36(5):397-401
Objective:To understand the current situation of mobile healthcare adoption and perceived utility of primary healthcare workers, and to provide strategic suggestions for primary medical and health institutions to reduce their burden, increase efficiency and empowerment through informatization.Methods:In July 2019, 91 employees of different positions from 11 primary medical and healthcare institutions were interviewed on the topic of " adoption and perceived utility of mobile healthcare" . Nvivo11 qualitative research software was used to code and catalogue the interview records. Response rate, penetration rate and contingency table were used to describe the distribution of perceived utility.Results:Mobile healthcare is widely adopted by primary healthcare workers in the surveyed areas, mainly including smart phone applications and portable medical devices; the response rates of perceived utility positive and negative utility were 78.97% and 21.03% respectively, and the top five perceived utilities were work innovation, work efficiency improvement, network effect, data-driven resource allocation and technology overload, with a cumulative response rate of 73.80%. There were statistical differences in perceived utility among different posts. The penetration of management and public healthcare personnel was higher than others.Conclusions:The development of mobile healthcare is in the primary stage, evolving into an integrated stage. The initial effects for innovation and efficiency have emerged. The high utility of network effect, resource allocation and clinical decision support is more promising. Meanwhile, the double-edged sword effects of mobile healthcare call for attention, as such challenges in development as technology overload, technology investment and digital divide should be treated with caution and care.
6.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.
7.Social Influence Factors for Utilization Rate of Medical and Health App
Journal of Medical Informatics 2017;38(2):13-17,47
Addressing the problems that the unitization rate of medical and health App are generally low,based on the empirical approach,the paper demonstrates the positive influence of social factors on the utilization rate of mobile health App,and deeply analyzes the action mechanism and linkage effect of social factors such as social relation network,social support and subjective norms,so as to nationally design the socialized development strategies for mobile health App,thus providing the decision-making basis for the sustainable development and user cultivation of m-Health.
8.Analysis of high-value medical supplies price setting policy under the disease fee payment system reform in China: A case of Endoscopic Retrograde Cholangio-Pancreatography (ECRP)
Yingmin WU ; Maojuan HUANG ; Tian REN ; Mei ZHANG
Chinese Journal of Health Policy 2017;10(6):49-53
This paper analyzes the ERCP price setting policy and its impact on the patient''s cost and it puts forward possible price setting policy recommendations, according to the current situation of the disease payment system reform and promotion prospects of ERCP.ERCP belongs to the low-price high-value medical supplies, but hospitalization expenses data of 9 types of diseases show that consumables accounted for 35.81~48.25%.The main factor hindering widely the application of ERCP lies in high-ratio self-payment and high medical cost, in other words, as the ERCP supplies are not included in the scope of medical insurance payments, the current rate of patients with high surgical expenses, medical costs are expensive.As per the analysis of this paper, the following are the policy recommendations to put forward 1)Paying attention to historical settlement data and scientific formulation of disease charges;2)Considering different treatment methods and allocate appropriate disease payment standards;3)Standardize operation code to ensure the information quality of accurate disease expenses calculation.
9.Effects of Loading-dose of Rosuvastatin before PCI on Reperfusion Arrhythmias in Patients with Acute Non-ST-segment Elevation Myocardial Infarction
Hongsong LI ; Xiangdong XU ; Guolin WU ; Fangliang ZHANG ; Li ZHANG ; Xia CHEN ; Yingmin CHEN
China Pharmacy 2017;28(36):5064-5067
OBJECTIVE:To investigate the effects of loading-dose rosuvastain before early percutaneous coronary intervention (PCI) on reperfusion arrhythmias in patients with acute non-ST-segment elevation myocardial infarction (NSTEMI).METHODS:A total of 136 patients with NSTEMI were randomly divided into loading-dose group (68 cases) and control group (68 cases).Both groups who were not given anti-platelet drugs were given loading-dose of Aspirin enteric-coated tablets 300 mg+Clopidogrel sulfate tablets 600 mg immediately after admission.The patients who were given aspirin regularly were given loading-dose of Clopidogrel sulfate tablets 600 mg only once after admission.The patients who were given clopidogrel regularly were given loading-dose of Aspirin enteric-coated tablets 300 mg only once.Those received PCI 12-24 h after medication.After PCI,they took Aspirin enteric-coated tablets 100 mg for life+Clopidogrel bisulfate tablets 75 mg at least 12 months.Loading-dose group was given loading-dose of Rosuvastatin calcium tablets 20 mg orally,12 h before surgery.All patients began to take Rosuvastatin calcium tablets 10 mg,once a day,since the night after the operation.Coronary angiography and the occurrence of reperfusion arrhythmia were observed in 2 groups.The levels of CK-MB and cTnT,major adverse cardiovascular events (MACE) were observed before and after surgery.RESULTS:There was no statistical significance in the number of diseased vessels,culprit vessels,the degree of culprit vessels stenosis or the incidence of MACE between 2 groups (P> 0.05).The incidence of reperfusion arrhythmia in loading-dose group was significantly lower than control group,with statistical significance (P<0.01).There was no statistical significance in the degree of culprit vessels stenosis between 2 groups (P>0.05).Before surgery,there was no statistical significance in the levels of CK-MB or cTnT between 2 groups (P>0.05).After surgery,the levels of CK-MB and cTnT in 2 groups were significantly higher than before surgery,but the loading-dose group was significantly lower than the control group,with statistical significance (P<0.01).CONCLUSIONS:Preoperative loading-dose of rosuvastatin before PCI can reduce the incidence of reperfusion arrhythmias in NSTEMI patients.
10.Service Supply Change of Mobile Health in China's Public Hospitals: Empirical Study of Science and Technology Top 100 Hospitals in China
Yingmin WU ; Yingqiang HE ; Mei ZHANG
Chinese Hospital Management 2017;37(8):42-45
In order to understand the representative situation of medical services supply for China's public hospital in the mobile side,the research takes China hospital technology (comprehensive) influence ranked top 100 hospitals as the research object.From service supply channels,service content,providing mode,supply cooperation,comparative analysis of public hospitals from the traditional medical treatment to the mobile health reform is done.The 100 hospitals attaches great importance to the channel construction of mobile terminals,and App and WeChat have been mostly layout;On the basis of the medical process,a variety of service content is derived and innovated;Service providers change gradually to the context of navigation and mobile O2O medicine;The cooperation between hospitals and the technology companies is becoming more and more frequent.At the same time,these changes will also in turn promote the hospital process optimization,interconnection and multi game deepening governance.

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