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 association between the intake and changes in various types of food and the changes in blood pressure in patients with mild to moderate hypertension.Methods:Mild to moderate hypertension participants with complete baseline and outcome data were included from DECIDE-Diet study, a multicenter, randomized controlled trial. Dietary records and blood pressure measurements at both 7-day run-in (baseline) and 28-day intervention phases were collected for enrolled participants. Blood pressure change was defined as the difference between blood pressure at the end of trial and the baseline blood pressure. Baseline intake of food was the average daily intake during the run-in period, and the intake increment was defined as the difference between the average intake during the trial period and the average intake during the run-in period. After adjusting for age, sex, study center, intervention groups, baseline body mass index (kg/m 2), antihypertension medication use, and baseline total calorie intake, a linear regression model was used to analyze the associations of the before-after-intervention change in blood pressure with baseline intake and intake increment of foods. Results:A total of 258 patients with mild to moderate hypertension were included, including 133 males, aged (56.5±9.9) years. (1) After adjusting for confounding factors, there was no significant association between baseline intake of food and baseline blood pressure (all P>0.05). The blood pressure change was negatively associated with baseline intakes of tubers, vegetables, and vegetable oils but positively with baseline intake of meats; and was negatively associated with intake increment of whole grains and fish (all P<0.05). (2) The multiple linear regression analysis showed that baseline intake of vegetables ( β=-0.021, P=0.004), vegetable oils ( β=-0.260, P=0.002), and increment in intake of fish ( β=-0.128, P=0.026) were all significantly associated with changes in systolic blood pressure; baseline intake of vegetables ( β=-0.017, P=0.002), vegetable oils ( β=-0.182, P=0.001), dairy products ( β=0.021, P=0.022), and increment in intake of fish ( β=-0.092, P=0.010) were all significantly associated with changes in diastolic blood pressure. Conclusion:Increasing the intake of whole grains, vegetables, vegetable oils, and fish and decreasing the intake of meat may be beneficial for blood pressure control in patients with mild to moderate hypertension.

Background::A phase II trial on recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has previously shown its preliminary efficacy in ST elevation myocardial infarction (STEMI) patients. This study was designed as a pivotal postmarketing trial to compare its efficacy and safety with rrecombinant human tissue-type plasminogen activator alteplase (rt-PA) in Chinese patients with STEMI.Methods::In this multicenter, randomized, open-label, non-inferiority trial, patients with acute STEMI were randomly assigned (1:1) to receive an intravenous bolus of 16 mg rhTNK-tPA or an intravenous bolus of 8 mg rt-PA followed by an infusion of 42 mg in 90 min. The primary endpoint was recanalization defined by thrombolysis in myocardial infarction (TIMI) flow grade 2 or 3. The secondary endpoint was clinically justified recanalization. Other endpoints included 30-day major adverse cardiovascular and cerebrovascular events (MACCEs) and safety endpoints.Results::From July 2016 to September 2019, 767 eligible patients were randomly assigned to receive rhTNK-tPA ( n = 384) or rt-PA ( n = 383). Among them, 369 patients had coronary angiography data on TIMI flow, and 711 patients had data on clinically justified recanalization. Both used a –15% difference as the non-inferiority efficacy margin. In comparison to rt-PA, both the proportion of patients with TIMI grade 2 or 3 flow (78.3% [148/189] vs. 81.7% [147/180]; differences: –3.4%; 95% confidence interval [CI]: –11.5%, 4.8%) and clinically justified recanalization (85.4% [305/357] vs. 85.9% [304/354]; difference: –0.5%; 95% CI: –5.6%, 4.7%) in the rhTNK-tPA group were non-inferior. The occurrence of 30-day MACCEs (10.2% [39/384] vs. 11.0% [42/383]; hazard ratio: 0.96; 95% CI: 0.61, 1.50) did not differ significantly between groups. No safety outcomes significantly differed between groups. Conclusion::rhTNK-tPA was non-inferior to rt-PA in the effect of improving recanalization of the infarct-related artery, a validated surrogate of clinical outcomes, among Chinese patients with acute STEMI.Trial registration::www.ClinicalTrials.gov (No. NCT02835534).

Objective:To explore the clinical outcomes of recipients with refractory heart failure requiring an insertion of mechanical circulation support(MCS)device prior to heart transplantation(HT).Methods:From March 2017 to December 2021, retrospective review is performed for clinical data of 7 recipients with refractory heart failure requiring a bridging placement of MCS.There are 2 males and 5 females with an average age of(39.0±16.3)years(7~56 years)and an average weight of(57.6±19.9)kg(7~56 kg).The primary diseases of recipients are dilated cardiomyopathy(4 cases)severe viral myocarditis(2 cases)and ischemic cardiomyopathy(1 case).All of them develope acute decompensation of congestive heart failure.Before implanting MCS, two or more inotropic drugs are offered at maximal doses ages or IABP device, 6 cases required cardio-pulmonary resuscitation treatment and another patient for Heartcon assistance.All the patients bridge to heart transplatation.Results:Adjuvant therapy of MCS was offered for(20.0±11.5)d(7~34 d).Emergency HT is performed.Two post-HT deaths occurr due to multiple organ failure(1 case)and severe infection(1 case).The remainders recover smoothly during a follow-up period of(6~24 months).Conclusions:MCS device is recommended as a bridging too for HT recipients with refractory heart failure.It is imperative to improve clinical outcomes with MCS support before an onset of multiple organ dysfunction.Despite a perioperative mortality, long-term prognosis is generally satisfactory.

Objective: To analyze the trends in incidence of thyroid cancer in Fuling District, Chongqing Municipality from 2016 to 2020 and predict the incidence of thyroid cancer from 2021 to 2023, so as to provide insights into thyroid cancer control. Methods: The data pertaining to incidence of thyroid cancer in Fuling District from 2016 to 2020 were collected through National Central Cancer Registry of China. The crude incidence rate ( CR ) of thyroid cancer, the standardized incidence rate of thyroid cancer by Chinese standard population ( ASR China ) and by world standard population ( ASR world ) were calculated. The trend in thyroid cancer incidence was analyzed using annual percent change ( APC ). The GM ( 1, 1 ) grey model was created to predict the crude incidence of thyroid cancer in Fuling District from 2021 to 2023, and the fitting effect and predictive accuracy of the model were evaluated using posterior error ratio ( C ), small probability error ( p ) and mean absolute percent error ( MAPE ). Result: A total of 686 new cases of thyroid cancer were reported in Fuling District from 2016 to 2020, with CR of 11.84/105, ASR China of 11.93/105 and ASR world of 10.02/105. Among the 686 new cases of thyroid cancer, there were 165 male cases, with CR of 5.69/105, ASR China of 5.66/105 and ASR world of 4.81/105, and 521 female cases, with CR of 18.02/105, ASR China of 18.17/105 and ASR world of 15.24/105. The CR appeared a tendency towards a rise among the whole population and women in Fuling District from 2016 to 2021, with APC values of 38.40% ( t=3.369, P=0.043 ) and 38.68% ( t=4.035, P=0.027 ). The incidence of thyroid cancer peaked among patients at ages of 25 to 34 years and 50 to 54 years, with CR of 22.82/105 and 39.06/105, respectively. The GM ( 1, 1 ) grey model was qualified to fit the incidence of thyroid cancer among the whole population ( C=0.56, p=0.75 ) and women ( C=0.53, p=1.00 ). In addition, the CR of thyroid cancer was predicted to be 19.48/105, 22.51/105 and 26.03/105 ( MAPE=9.93% ) among the whole population, and 31.43/105, 37.37/105 and 44.46/105 ( MAPE=11.30% ) among women, respectively. Conclusions The incidence of thyroid cancer appeared a tendency towards a rise in Fuling District from 2016 to 2021, and is projected to increase among the whole population and women from 2021 to 2023. Women and the elderly are at high risk of thyroid cancer.

DECIDE-Diet trial was taken as a case to introduce the methods of blinding and blinding assessment for feeding trials, report the details of blinding, conduct a blinding survey and calculate Jame's BI and Bang's BI. Jame's BI was 0.683 (95% CI: 0.593~0.772). The Bang's BI for the intervention group was 0.340 (95% CI: 0.199~0.481), and for the control group was 0.086 (95% CI: -0.060~0.231). The blinding of the DECIDE)-Diet was generally successful, but the intervention group may infer their group to a certain extent. Feeding trials should report the details of blinding and consider blinding assessment.

Objective To establish the quality control system of the Capital's Funds for Health(CFH),strengthen the process management,and improve the clinical research capacity.Methods The framework,contents and implementation method of the quality control system were developed with comprehensively adopting methodologies of literature analysis,expert discussion,summaries of policy and practice experiences.Results This quality control system of the Capital's Funds for Health is comprised of three tiers.The first tier is self-assessment,the principle investigator takes the responsibility;the second tier is the sponsor verification,the sponsor organization takes the responsibility;the third tier is the independent audit,the CFH office takes the responsibility.The contents of quality control focus on the compliance with ethical approval and informed consent,data authenticity,protocol deviation,progress of project,and quality assurance methods taken during the project implementation.Conclusions This three-tier quality control system of the Capital's Funds for Health provides a new idea and scheme for the quality control of clinical research projects supported by funding agencies in China,and its impacts will be evaluated in next implementation practices.

Objective To evaluate the influence of 125I seed implantation brachytherapy on QOL of patients with salivary gland malignant tumor which couldn't be treated by conventional surgery and its influence factors. Methods 23 patients with malignant salivary gland cancer which couldn't be treated by conventional surgery were selected from Peking University School of Stomatology from 2013 to 2017. The patients were treated by 125I seed implantation brachytherapy. EORTC QLQ-C30 ( V3. 0 ) as well as QLQ-H&N35 QOL scale ( Chinese version) were used for the assessment of post-treatment QOL. Results The survival rate of one year and three years after treatment in 23 patients was 100％ and 67％, respectively. The score of the quality of life before and after treatment was 201. 48 and 199. 48, respectively. The difference was not significant after the test ( P>0. 05 ) . The level of total QOL and function score were relatively high. Among the influence factors, location of tumor significantly influenced QOL( F=9. 127,P<0. 05). Other factors still needed research based on larger sample. Conclusions 125I seed implantaion brachytherapy can better protect the head and neck function and maintain the quality of life of patients with salivary gland malignant tumor.

Objective More and more investigator initiated studies have been funded in China.Both institutions and investigators should take the responsibility for meeting the scientific validity,ethical requirement,feasibility and interdisciplinary management requirements during the clinial research project design and initiation.This article hereby analyzed and summarized the most common review comments on clinical research applications.Methods Summarize the problems identified during the review of Shenzhen Second People's Hospital Clinical Research Program applications.Results The most common findings in turn as follows:inappropriate sample size calculation,study design,parameters,unclear study aims,insufficient study rational.Conclusions To fund clinical research programs with significant scientific values and appropriate design,it is vital for the research management department to provide more supervision and technology support.

Objective Through summarizing quality management practices of international cooperative academic clinical studies funded by Peking University Health Science Center,analyzing its present major challenges of implementation in China,this paper proposed related measurements and suggestions to improve the quality of clinical research.Methods To sort the project management archive data,as well as descriptive analysis of the common monitoring/auditing findings.Results From the year 2011 to 2016,there were 14 such studies funded by Peking University health science center,common findings during monitoring and or auditing were classified as following categories,study files problem (100.0％),ethics problem (71.4％),protocol noncompliance (64.3％),data quality issues (71.4％),communication problem in study teams (14.3％),export problems of bio-specimens (14.3 ％),recruiting delay (14.3 ％) and cooperation termination in advance (7.1 ％).Conclusions In order to obtain credible and reliable data,peer recognized research conclusion and accurate answered scientific questions,it is essential for investigators to comply with laws and regulations and being strongly supported.Furthermore,researchers also need to establish and strictly follow study protocols,standard operating procedures (SOPs),research quality management system and relevant national laws and regulations that are comply with actual requirements in China.