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.

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".

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.

【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.

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.

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.

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.

Objective To investigate the effect of calcium acetate in treatment of elderly patients with CAPD in peritoneal dialysis patients with hyperphosphatemia and efficacy.MethodsFrom March 2013 to January 2016,46 elderly patients with CAPD were randomly divided into experimental group and control group.The control group were used calcium 1.5mmol/L Liquor Dialysisintraperitoneus CAPD treatment,and control diet.Besides these treatments,the experimental group were given calcium acetate tablets 668mg/3 times every day after a meal, 2 tablets each time.All patients were detected before treatment and 4,6 and 10 weeks after the serum calcium, phosphorus and calcium and phosphorus in blood iPTH index, calculate the product of calcium and phosphorus,record and statistical analysis.ResultsTwo groups after 4 week of treatment, all outcome measures were decreased;the experimental group blood phosphorus decreased significantly after 6 weeks treatment;it after 10 weeks of treatment, serum calcium(t=5.202),phosphorus(t=7.767),blood iPTH(t=-10.324) and the calcium phosphorus product (t=-4.106) compared with that before treatment,there were statistically significant differences(P<0.01);the control group after 10 weeks of treatment, with all outcome measures there were no significant differences.The experimental group after 10 weeks of treatment,serum calcium(t=-4.055),phosphorus (t=-9.037),blood iPTH(t=9.940) and the calcium phosphorus product(t=-4.211)compared with the control group,the differences were statistically significant(P<0.01).ConclusionCalcium acetate treatment can significantly reduce the blood serum of aged CAPD in peritoneal dialysis patients with high phosphorus,effectively prolong the survival time and improve the quality of life during treatment.

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.

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.