1.Equivalence of SYN008 versus omalizumab in patients with refractory chronic spontaneous urticaria: A multicenter, randomized, double-blind, parallel-group, active-controlled phase III study.
Jingyi LI ; Yunsheng LIANG ; Wenli FENG ; Liehua DENG ; Hong FANG ; Chao JI ; Youkun LIN ; Furen ZHANG ; Rushan XIA ; Chunlei ZHANG ; Shuping GUO ; Mao LIN ; Yanling LI ; Shoumin ZHANG ; Xiaojing KANG ; Liuqing CHEN ; Zhiqiang SONG ; Xu YAO ; Chengxin LI ; Xiuping HAN ; Guoxiang GUO ; Qing GUO ; Xinsuo DUAN ; Jie LI ; Juan SU ; Shanshan LI ; Qing SUN ; Juan TAO ; Yangfeng DING ; Danqi DENG ; Fuqiu LI ; Haiyun SUO ; Shunquan WU ; Jingbo QIU ; Hongmei LUO ; Linfeng LI ; Ruoyu LI
Chinese Medical Journal 2025;138(16):2040-2042
2.Clinical characteristics and influencing factors of cognitive impairment in non-dialysis patients with chronic kidney disease
Hongxia LI ; Xia XU ; Jie JIANG ; Mengxue JIA ; Wenjin LIU ; Zhe HAN ; Yushuang LIU ; Yijiao ZHU ; Dafeng HE ; Chunlei LU ; Mengyue ZHU ; Hongbin MOU ; Guangyu BI ; Rong WANG
Journal of Clinical Medicine in Practice 2025;29(11):1-6,13
Objective To explore the influencing factors of cognitive impairment in non-dialysis patients with chronic kidney disease(CKD).Methods A total of 60 hospitalized non-dialysis patients with CKD in the Department of Nephrology of Northern Jiangsu People's Hospital Affiliated to Yangzhou University from September 2022 to September 2023 were enrolled as research objects.According to the estimated glomerular filtration rate(eGFR),they were divided into stage 1 to 2 of CKD group[eGFR ≥60 mL/(min·1.73 m2)]with 23 cases,the stage 3 of CKD group[eGFR 30~<60 mL/(min·1.73 m2)]with 20 cases,and stage 4 to 5 of CKD group[eGFR<30 mL/(min·1.73 m2)]with 17 cases.The Montreal Cognitive Assessment Scale(MoCA)was used to evaluate the cognitive function of the patients.Basic data and common clinical laboratory in-dicators on hospital admission were collected to analyze the differences in cognitive function levels under different renal function statuses and to explore the influencing factors of cognitive impairment.Results The incidence rates of cognitive impairment in the stage 1 to 2 of CKD group,stage 3 of CKD group,and stage 4 to 5 of CKD group were 47.8%,85.0%,and 94.1%respectively,the median MoCA scored 26,24 and 20 respectively,with statistically significant between-group differ-ences(P<0.05).Cognitive function was significantly negatively correlated with age(r=-0.634,P<0.001),blood urea nitrogen(BUN)(r=-0.574,P<0.001),serum creatinine(Cr)(r=-0.417,P<0.001),cystatin C(Cys-C)(r=-0.327,P=0.011),serum β2-microglobulin(β2-MG)(r=-0.259,P=0.046),and N-terminal pro-brain natriuretic peptide(NT-proBNP)(r=-0.474,P<0.001),and was significantly positively correlated with hemoglobin(HB)(r=0.401,P=0.001)and eGFR(r=0.485,P<0.001).Multivariate Logistic regression analysis showed that age(P=0.006)and NT-proBNP(P=0.041)were influencing factors of cognitive im-pairment in non-dialysis patients with CKD.Receiver operating characteristic(ROC)curve analysis showed that the area under the curve(AUC),sensitivity,and specificity of age for prediction were 0.860,0.864 and 0.812 respectively,the AUC,sensitivity,and specificity of NT-proBNP for pre-diction were 0.808,0.795 and 0.875 respectively,and the combined prediction of age and NT-proBNP had an AUC,sensitivity,and specificity of 0.893,0.955,and 0.750,respectively.Conclusion As renal function deteriorates,the incidence rate and severity of cognitive impairment in non-dialysis patients with CKD tend to increase.Advanced age,renal function deterioration,high NT-proBNP level,and anemia are associated with the occurrence of cognitive impairment in non-di-alysis patients with CKD,among which age and NT-proBNP are influencing factors for cognitive im-pairment.
3.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.
4.Research progress on the mechanism of endometrial immune inflammation microenvironment regulating embryo implantation
Chunlei WU ; Xiaoli ZHAO ; Rong DONG ; Baojuan WANG ; Yunhuan QIU ; Tian XIA
Chinese Journal of Reproduction and Contraception 2024;44(9):986-989
The endometrial immune inflammatory microenvironment, composed of immune cells and cytokines, exhibits acute, low-grade, and transient pro-inflammatory characteristics during the embryo implantation window period. During this period, implantation capability is achieved by regulating blastocyst activation, promoting the endometrium to establish a receptive state, and mediating the positioning, adhesion, and invasion of the embryo. Abnormalities in the number and proportion of endometrial immune cells were associated with embryo implantation failure and altered characteristics of the immunoinflammatory microenvironment led to embryo implantation failure. The research progress on the mechanism of endometrial immunoinflammatory microenvironment regulating embryo implantation is now reviewed.
5.Research progress on the mechanism of endometrial immune inflammation microenvironment regulating embryo implantation
Chunlei WU ; Xiaoli ZHAO ; Rong DONG ; Baojuan WANG ; Yunhuan QIU ; Tian XIA
Chinese Journal of Reproduction and Contraception 2024;44(9):986-989
The endometrial immune inflammatory microenvironment, composed of immune cells and cytokines, exhibits acute, low-grade, and transient pro-inflammatory characteristics during the embryo implantation window period. During this period, implantation capability is achieved by regulating blastocyst activation, promoting the endometrium to establish a receptive state, and mediating the positioning, adhesion, and invasion of the embryo. Abnormalities in the number and proportion of endometrial immune cells were associated with embryo implantation failure and altered characteristics of the immunoinflammatory microenvironment led to embryo implantation failure. The research progress on the mechanism of endometrial immunoinflammatory microenvironment regulating embryo implantation is now reviewed.
6.Suppressive effect of lignans from Euphorbia neriifolia L.on esophageal squamous cancer cell
Weiyan QI ; Chunlei XIA ; Roujin AN ; Xinmei Gao ; Dongping LI ; Hanmei XU
Journal of China Pharmaceutical University 2022;53(1):93-98
Eubhorbia neriifolia L. is a plant of Euphorbia family.Five known lignans were isolated from the aerial parts of E. neriifolia L. by silica gel for column chromatography and preparative high-performance liquid chromatography (HPLC).Their potential antitumor activities were evaluated in vitro.Compound 2 exhibited proliferation inhibition and cytotoxicity against esophageal squamous cancer cells, especially KYSE-410 and KYSE-450 cells.Further analyses showed that compound 2 could significantly induce apoptosis through the activation of caspase 3/9 and down-regulation of the Bcl-2/Bax protein ratio.These results suggested that compound 2 had a significant inhibitory effect on the esophageal squamous cancer cells, especially KYSE-410, which deserves further research as a potential antitumor agent.
8.Clinical factors associated with composition of lung microbiota and important taxa predicting clinical prognosis in patients with severe community-acquired pneumonia.
Sisi DU ; Xiaojing WU ; Binbin LI ; Yimin WANG ; Lianhan SHANG ; Xu HUANG ; Yudi XIA ; Donghao YU ; Naicong LU ; Zhibo LIU ; Chunlei WANG ; Xinmeng LIU ; Zhujia XIONG ; Xiaohui ZOU ; Binghuai LU ; Yingmei LIU ; Qingyuan ZHAN ; Bin CAO
Frontiers of Medicine 2022;16(3):389-402
Few studies have described the key features and prognostic roles of lung microbiota in patients with severe community-acquired pneumonia (SCAP). We prospectively enrolled consecutive SCAP patients admitted to ICU. Bronchoscopy was performed at bedside within 48 h of ICU admission, and 16S rRNA gene sequencing was applied to the collected bronchoalveolar lavage fluid. The primary outcome was clinical improvements defined as a decrease of 2 categories and above on a 7-category ordinal scale within 14 days following bronchoscopy. Sixty-seven patients were included. Multivariable permutational multivariate analysis of variance found that positive bacteria lab test results had the strongest independent association with lung microbiota (R2 = 0.033; P = 0.018), followed by acute kidney injury (AKI; R2 = 0.032; P = 0.011) and plasma MIP-1β level (R2 = 0.027; P = 0.044). Random forest identified that the families Prevotellaceae, Moraxellaceae, and Staphylococcaceae were the biomarkers related to the positive bacteria lab test results. Multivariable Cox regression showed that the increase in α-diversity and the abundance of the families Prevotellaceae and Actinomycetaceae were associated with clinical improvements. The positive bacteria lab test results, AKI, and plasma MIP-1β level were associated with patients' lung microbiota composition on ICU admission. The families Prevotellaceae and Actinomycetaceae on admission predicted clinical improvements.
Acute Kidney Injury/complications*
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Bacteria/classification*
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Chemokine CCL4/blood*
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Community-Acquired Infections/microbiology*
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Humans
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Lung
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Microbiota/genetics*
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Pneumonia, Bacterial/diagnosis*
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Prognosis
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RNA, Ribosomal, 16S/genetics*
9.Effect of 30 min action observation training combined with rehabilitation therapy on R-VAS,P-VAS and BDI scores in early stroke patients with hemiplegia
Chunlei LIU ; Xia LIU ; Feng LI
Chinese Journal of Primary Medicine and Pharmacy 2018;25(20):2669-2672
Objective To analyze the effect of 30 min action observation training combined with rehabilita-tion therapy on resting state visual analogue score ( R -VAS), passive movement state visual analogue score (P-VAS) and Beck depression index (BDI) scores in early stroke patients with hemiplegia .Methods From June 2016 to December 2017,86 patients with early stroke and hemiplegia treated in the Affiliated Hospital of Tai 'an Medical College were selected in the research .According to the random number table method , the patients were randomly divided into control group and combined group ,with 43 cases in each group.The control group was given routine rehabilitation treatment ,and the combined group was given 30 min action observation training on the basis of the control group.The differences of BDI,R-VAS and P-VAS were compared between the two groups before and after 1 month of treatment.Results The scores of P-VAS[(5.14 ±1.47)points]and R-VAS[(8.14 ±1.53)pionts] in the combined group were significantly lower than before treatment (t=11.42,10.31,all P<0.01),and the scores of the combined group were significantly lower than those of the control group (t=9.27,8.94,all P<0.01).The P-VAS and R -VAS scores in the control group after treatment showed no statistically significant differences compared with those before treatment(t =0.78,1.69,all P>0.05).After treatment,the BDI scale scores of the combined group and control group were significantly lower than those before treatment (t=6.43,2.29,all P<0.05), and the score of the combined group was significantly lower than that of the control group (t=4.44,P <0.05). Conclusion The 30 min exercise observation and training combined with rehabilitation therapy can effectively relieve the pain and other discomfort of early stroke patients with hemiplegia ,and can accelerate the recovery of upper limb movement function,so it has good clinical value .
10.Analysis of gastric gastrointestinal stromal tumors in Shandong Province: a midterm report of multicenter GISSG1201 study.
Qingsheng HOU ; Wenqiang LUO ; Leping LI ; Yong DAI ; Lixin JIANG ; Ailiang WANG ; Xianqun CHU ; Yuming LI ; Daogui YANG ; Chunlei LU ; Linguo YAO ; Gang CUI ; Huizhong LIN ; Gang CHEN ; Qing CUI ; Huanhu ZHANG ; Zengjun LUN ; Lijian XIA ; Yingfeng SU ; Guoxin HAN ; Xizeng HUI ; Zhixin WEI ; Zuocheng SUN ; Hongliang GUO ; Yanbing ZHOU
Chinese Journal of Gastrointestinal Surgery 2017;20(9):1025-1030
OBJECTIVETo summarize the treatment status of gastric gastrointestinal stromal tumor (GIST) in Shandong province,by analyzing the clinicopathological features and prognostic factors.
METHODSClinicopathological and follow-up data of 1 165 patients with gastric GIST between January 2000 and December 2013 from 23 tertiary referral hospitals in Shandong Province were collected to establish a database. The risk stratification of all cases was performed according to the National Institutes of Health(NIH) criteria proposed in 2008. Kaplan-Meier method was used to calculate the survival rate. Log-rank test and Cox regression model were used for univariate and multivariate prognostic analyses.
RESULTSAmong 1 165 cases of gastric GIST, 557 were male and 608 were female. The median age of onset was 60 (range 15-89) years. Primary tumors were located in the gastric fundus and cardia in 623 cases(53.5%), gastric body in 346 cases(29.7%), gastric antrum in 196 cases(16.8%). All the cases underwent resection of tumors, including endoscopic resection (n=106), local resection (n=589), subtotal gastrectomy(n=399), and total gastrectomy(n=72). Based on the NIH risk stratification, there were 256 cases (22.0%) at very low risk, 435 (37.3%) at low risk, 251 cases (21.5%) at intermediate risk, and 223 cases (19.1%) at high risk. A total of 1 116 cases(95.8%) were followed up and the median follow-up period was 40 (range, 1-60) months. During the period, 337 patients relapsed and the median time to recurrence was 34 (range 1-60) months. The 1-, 3-, and 5-year survival rates were 98.6%, 86.1% and 73.4%, respectively. The 5-year survival rates of patients at very low, low, intermediate, and high risk were 93.1%, 85.8%, 63.0% and 42.3% respectively, with a statistically significant difference (P=0.000). Multivariate analysis showed that primary tumor site (RR=0.580, 95%CI:0.402-0.835), tumor size (RR=0.450, 95%CI:0.266-0.760), intraoperative tumor rupture(RR=0.557, 95%CI:0.336-0.924), risk classification (RR=0.309, 95%CI:0.164-0.580) and the use of imatinib after surgery (RR=1.993, 95%CI:1.350-2.922) were independent prognostic factors.
CONCLUSIONSThe choice of surgical procedure for gastric GIST patients should be based on tumor size. All the routine procedures including endoscopic resection, local excision, subtotal gastrectomy and total gastrectomy can obtain satisfactory curative outcomes. NIH classification has a high value for the prediction of prognosis. Primary tumor site, tumor size, intraoperative tumor rupture, risk stratification and postoperative use of imatinib are independent prognostic factors in gastric GIST patients.

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