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.Application of magnetic resonance imaging in patients with type 2 diabetic painful neuropathy
Shuqian WANG ; Cancan HUI ; Yuwei CHENG ; Xiujuan HU ; Xiaorong YIN ; Mengjie CUI ; Qinyi HUANG ; Yangliu YIN ; Yan SUN
Journal of Clinical Medicine in Practice 2024;28(8):16-21
Objective To observe the application effect of magnetic resonance imaging technology in evaluating the brain structure and function of patients with type 2 diabetic painful neuropathy (PDN). Methods Forty patients with type 2 diabetes mellitus hospitalized in our hospital were selected as the study objects, and were divided into diabetes mellitus (DM) group (
3.Association of time in range and glucose management indicator with the risk of type 2 diabetic nephropathy
Shuqian Wang ; Xiujuan Hu ; Xiaorong Yin ; Mengjie Cui ; qinyi Huang ; Yangliu Yin ; Cancan Hui ; Yuwei Cheng ; Ya Zhang ; Yan Sun
Acta Universitatis Medicinalis Anhui 2023;58(10):1782-1786
Objective :
To explore the association of time in range(TIR) and glucose management indicator ( GMI) with the risk of type 2 diabetic nephropathy (DN) .
Methods :
The clinical data of 215 patients with type 2 diabetes mellitus (T2DM) were collected and analyzed.According to the results of estimated glomerular filtration rate (eGFR) and urinary albumin to creatinine ratio( UACR) ,they were divided into 117 patients with T2DM and 98 patients with DN.The clinical data,biochemical indicators and continuous glucose monitoring ( CGM) indicators of the two groups were compared.Logistic regression was used to analyze the influencing factors of DN risk.The predictive value of TIR and GMI on the risk of DN was evaluated by receiver operating characteristic (ROC) curve.
Results:
There were significant differences in age,duration of diabetes,systolic blood pressure,glycosylated hemoglobin ( HbA1c) ,fasting plasma glucose (FPG) ,2 hour postprandial plasma glucose (2hPG) ,creatinine( Cr) ,UACR, eGFR between the two groups(P<0. 05) .There were statistically significant differences between the two groups in the CGM indexes of GMI,mean absolute difference of mean of daily differences ( MODD) ,glucose above target range time(TAR) and TIR(P<0. 05) .The results of logistic regression analysis showed that TIR was a protective factor of DN.In the ROC curve analysis of TIR prediction DN,the area under the ROC curve was 0. 718 (95% CI = 0. 648 ~0. 789,P<0. 001) ,and the Yoden index was 0. 38.At this time,the sensitivity was 66. 7% ,and the specificity was 71. 3%.In the ROC curve analysis of GMI prediction DN,the area under the ROC curve was 0. 701 (95% CI = 0. 629 ~0. 774,P<0. 001) ,and the Yoden index was 0. 368.At this time,the sensitivity was 63. 3% , and the specificity was 73. 5%.
Conclusion
Specifically,lower TIR and higher GMI increase the risk of DN.
4.Influence of high-density lipoprotein cholesterol on the prognosis of patients with alcohol-related hepatocellular carcinoma after radical treatment
Rui ZHANG ; Xiujuan CHANG ; Jiamin CHENG ; Zhiqin ZHAO ; Yinyin LI ; Yinying LU ; Zhen ZENG
Journal of Clinical Hepatology 2021;37(3):621-626
ObjectiveTo investigate the association of high-density lipoprotein cholesterol (HDL-C) with the prognosis of patients with alcohol-related hepatocellular carcinoma (HCC) after radical treatment. MethodsA retrospective analysis was performed for the clinical data of 43 patients with alcohol-related HCC who were admitted to The Fifth Medical Center of Chinese PLA General Hospital and underwent radical treatment from January 2008 to July 2015, and according to HDL-C level, the patients were divided into normal group with 26 patients and abnormal group with 17 patients. The two groups were compared in terms of basic information, laboratory markers, imaging indices, Barcelona Clinic Liver Cancer tumor stage, and Child-Pugh class of liver function. The t-test test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups; the chi-square test was used for comparison of categorical data between two groups. The Kaplan-Meier method was used to plot survival curves and the log-rank test was used for comparison between groups. Univariate and multivariate Cox proportional hazards models were used to analyze independent risk factors for prognosis. ResultsThere was a significant difference in prealbumin between the two groups (162.38±60.86 mg/L vs 120.06±64.08 mg/L, t=2.184, P=0.035). Number of tumors (hazard ratio [HR]=2.839, 95%confidence interval [CI]: 1.120~7.200,P=0.028), tumor size (HR=2.634, 95%CI: 1.062~6.529,P=0037), and HDL-C level (HR=2.400, 95%CI: 1.040~5.537,P=0.040) were independent risk factors for the overall survival of patients with alcohol-related HCC. There were significant differences in 1-, 3-, and 5-year cumulative survival rates between the normal group and the abnormal group (88.5%/72.4%/55.7% vs 70.6%/43.7%/17.5%, χ2=5.881, P=0.015). ConclusionThe reduction in HDL-C level might indicate poor prognosis of patients with alcohol-related HCC.
5. Stress Causes Dyspepsia via Macrophage-mediated Duodenal Inflammation
Qing LI ; Hongyi QIU ; Bo WANG ; Xiujuan YAN ; Li CHENG ; Qianqian WANG ; Shengliang CHEN
Chinese Journal of Gastroenterology 2020;25(12):710-716
Background: Epidemiological evidence revealed that stress is the causative factor of dyspeptic symptoms. It has been documented that duodenal inflammation is one of the key mechanisms of dyspepsia, and macrophage is crucial for inflammation. Aims: To determine whether patients with functional dyspepsia (FD) comorbid psychological stress have duodenal inflammation. Furthermore, to identify whether macrophage is involved in the mechanisms of stress-related duodenal inflammation by using water avoidance stress (WAS)animal model. Methods: Duodenal inflammation was observed and compared between FD patients with psychological factors and asymptomatic healthy controls. WAS mouse model with 1 h stress daily for 10 days was used to evaluate the duodenal inflammation at different time points to describe its dynamic changes. The role of macrophage in the development of duodenal inflammation was determined in an interventional study, in which the resident macrophages were depleted by clodronate liposomes. In both clinical and animal studies, the severity of duodenal inflammation was assessed by HE staining and immunocyte counts, the macrophage infiltration was detected by immunohistochemistry, and the expression of inflammatory cytokines was detected by real-time PCR. Results: FD patients with psychological factors developed severe duodenal inflammation in comparison with the healthy controls (immunocytes/HPF: 138.91±7.13 vs. 81.44±23.60, P<0.000 1). At the same time, the expressions of proinflammatory cytokines (IL-1β, TNF-α, and IL-17A) were increased, while the expressions of anti-inflammatory cytokines (IL-10 and TGF-β) were decreased (all P<0.05). In WAS mouse model, a dynamic change in duodenal inflammation which peaked on day 5 was observed, and the changes of macrophage infiltrating in the duodenal tissue were consistent with the duodenal inflammation. Clodronate liposomes pretreatment could effectively deplete macrophages, protected the WAS mouse model against duodenal inflammation (immunocytes/HPF: 75.10±4.08 vs. 202.43±5.18, P<0.001), with a marked reduction of the expressions of proinflammatory cytokines (IL-1β, TNF-α, and IL-8), and a marked elevation of the expression of anti-inflammatory cytokine IL-10 (all P<0.05). Conclusions: Psychological stress may lead to dyspeptic symptoms via macrophage-mediated duodenal inflammation.
6.Effects of Shizidaiping formula on MIN6 cell apoptosis and expressions of MEK1/2 and ERK1/2
Ruiting CHENG ; Yushan DONG ; Jian LI ; Xiaojin LA ; Chunyu TIAN ; Xiujuan GAO ; Xuemei ZHOU ; Qianru FU ; Bo WU ; Siqi DONG
Chinese Journal of Tissue Engineering Research 2017;21(4):603-608
BACKGROUND:Apoptosis of islet cel s is closely related to the long-term hyperglycemia-and hyperlipemia-induced injuries. OBJECTIVE:To observe the effect of Shizidaiping formula on the apoptosis and insulin secretion in MIN6 cel s under the high glucose and lipid environment, and to explore the protective effect of Shizidaiping formula and the related apoptosis mechanism. METHODS:MIN6 cel s were divided into normal, model, melbine, low-, medium-and high-dose Shizidaiping formula groups. The cel activity was examined by cel counting kit-8, the insulin secretion was measured by ELISA, the rate of apoptosis was measured by Annexin V-FITC&PI and the expression levels of MEK1/2, ERK1/2 and p-ERK1/2 were examined by western blot assay. RESULTS AND CONCLUSION:Shizidaiping formula significantly improved MIN6 cel activity under high glucose and lipid condition (P<0.05), decreased early cel apoptosis, increased the level of insulin stimulated by low glucose in cel supernatant (P<0.05), and improved the expression levels of MEK1/2, ERK1/2 and p-ERK1/2 (P<0.05). These results suggest that Shizidaiping formula can protect islet cel s from hyperglycemia and hyperlipemia damage by improving the activity of MIN6 cel s, reducing the insulin secretion and inhibiting the apoptosis of pancreaticβcel s in MIN6 cel s.
7.Effects of Xuebijing Injection on Blood Coagulation Function and Prognosis of Sepsis Patients
Xiujuan LIN ; Jiwen TANG ; Lihong ZHONG ; Xiaoming CHENG
China Pharmacy 2016;27(5):653-654
OBJECTIVE:To investigate the effect of Xuebijing injection on coagulation function and prognosis in patients with sepsis. METHODS:50 patients with sepsis were randomly divided into control group and observation group according to the hospi-talization sequence,with 25 cases in each group. Control group received conventional treatment,and observation group was addi-tionally given Xuebijing injection(50 ml added into 5% Glucose solution or 0.9% Sodium chloride solution 250 ml intravenously, bid) on the basis of conventional treatment. Treatment course lasted for 7 d. The coagulation function,APACHE Ⅱscore after 7 days of treatment and 28 d mortality were compared between 2 groups. RESULTS:After 7 d treatment,the coagulation indexes were improved significantly in 2 groups compared with before treatment,and the APACHEⅡscores were decreased significantly in both groups;the observation group were significantly better than the control group,with statistical significance (P<0.05). After followed up for 28 d,the mortality rate of 2 groups were 16% and 28%,there was no statistical significance (P>0.05). CON-CLUSIONS:Xuebijing injection can inhibit blood clotting activation,correct the coagulation disorders,and improve the sepsis se-verity.
8.Analysis of citations of literatures of nursing staff from quotations of five nursing periodicals from year 2010 to 2012
Jinlian CHENG ; Yinping CHU ; Shifan HAN ; Xiujuan YE
Chinese Journal of Medical Science Research Management 2016;29(2):139-143
Objective To investigate the habits that literatures using by nursing staffs during 2010 to 2012 in China.Methods The publication from Chinese Journal of Nursing, Nursing Research, Chinese Journal of Practical Nursing, Journal of Nurses Training and Journal of Nursing Science from year of 2010 to 2012 were statistically analyzed using literature metrology method.The statistics results were compared with data from 2007 to 2009.Results In past 3 years, the quantity,quantity of papers with citations, average number of citations, citations of theses with citations published in-mentioned above five periodicals increased year by year.In 2010 to 2012, the average number of citations and citations rate of papers also improved compared with 2007 to 2009.The type citation is mainly from Journals,and the language was mainly in Chinese.Conclusions In the past 3 years, the nursing staff's literature utilization was improved.However, in the situation of using references with foreign language, nursing staff was poor comparing with medical personnel.On the scientific research ability of nursing personnel training should be strengthened,and the application of new technology and new theory in domestic and international should be strengthened as well..
9.Analysis of distribution and drug resistance of 1 705 strains of common pathogenic bacteria in primary hospital
Xiujuan CAI ; Jiahong YANG ; Cheng WU ; Yi WU
Chongqing Medicine 2015;(35):4977-4979,4984
Objective To understand the regional distribution and drug resistance of clinical isolates of bacteria flora ,in order to provide the basis for the diagnosis and treatment of bacterial infection .Methods According to the national clinical test proce‐dures operation separation strains ,HX‐21 bacteria identification/susceptibility analyzer bacteria identification and drug sensitive test .Results Among 1 705 strains of isolated bacteria ,Gram‐positive cocci accounted for 39 .8% ,Gram‐negative bacteria accounted for 60 .2% ;separation rate from high to low were:benzene azole resistance westwood 13 .3% coagulase negative staphylococcus , pseudomonas aeruginosa ,12 .0% benzene azole resistance westwood staphylococcus aureus 11 .3% ,did not produce the ultra broad spectrum beta lactamase 10 .7% ,e .coli to produce ultra broad spectrum beta‐lactamase e .coli 9 .9% ,acinetobacter was 7 .1% ,pro‐ducing ultra broad spectrum beta‐lactamase pneumonia klebsiella bacteria 5 .9% ,did not produce the ultra broad spectrum beta‐lac‐tamase pneumonia klebsiella bacteria 5 .7% ,benzene azole westwood sensitive coagulase negative staphylococcus 4 .8% ,enterococ‐cus was 4 .8% ,benzene azole westwood sensitive staphylococcus aureus 4 .5% ,etc .Conclusion The common pathogenic bacteria is gram‐negative bacilli in the common pathogenic bacteria .In negative bacilli infection ,acinetobacter ,pseudomonas aeruginosa ,e .coli , klebsiella pneumoniae ,etc were more common .In staphylococcus aureus strains ,benzene azole westwood drug‐resistant strain ratio is higher than benzene azole westwood sensitive strain rate for 3 times .In addition to the vancomycin and teicoplanin sensitive ,other commonly used antibiotics shows different degrees of resistance .
10.Retroperitoneal Hodgkin's lymphoma involving right ureter misdiagnosed as right ureteral carcinoma with lymphadenopathy: a case report and review of literature
Xinwen KE ; Jianjun CHENG ; Lina HU ; Xiujuan ZHAO ; Zhenguo MI ; Yangang ZHANG
Chinese Journal of Urology 2014;35(5):333-336
Objective To investigate the clinical and pathological features,diagnosis,differential diagnosis,treatment and prognosis of secondary Hodgkin's lymphoma of ureter.Methods We retrospectively analyzed one case with retroperitoneal Hodgkin's lymphoma involving right ureter.A 63-year-old male patient was referred to our hospital on January 22th,2013 with right hydronephrosis for 15 days,detected by abdominal color Doppler ultrasound due to constipation and difficult defecation without any urinary symptoms.Urinary CT scan revealed that there were dilation and hydrops of right pelvic and ureter in the middle and upper segment.The distal portion of ureteral wall was thick with a stenosis lumen.There was multiple larged lymph nodes surrounding the abdominal aorta.So,it was clinically diagnosed as right ureteral carcinoma with lymphadenopathy and right hydronephrosis.The patient was then performed ureteroscopic inspection under general anesthesia.There was too narrow to go through smoothly the proximal ureter when the ureteroscope ascended 15 cm.Then,the exploratory surgery of right ureter was subsequently undergone.During operation,periureteral nodular mass and thickened wall were seen in the distal segment of ureter.Then the ureter lesion was partially excised with 1 cm and fast frozen pathology was undergone during operation.The result suggested chronic inflammation of ureteral.A 6Fr double J stent was left in the ureter.Then,the ureter was closed by 3-0 monocryl suture.Results The final pathological diagnosis was retroperitoneal Hodgkin's lymphoma with the lymph node involving the right ureter.After 40 days,the patient manifested high fever,night sweat,general lymphoadenomegalies.So,the clinical stage was classified as stage Ⅱ EB and poor prognosis group.Then,the patient received regular chemotherapy according to the ABVD (pirarubicin 20 mg/m2,bleomycin 10 mg/m2,vinblastine 1.4 mg/m2,dacarbazine 375 mg/m2) regimen over 8 cycles.Finally the symptomatology and diagnostic reassessment (hemato-chemical examinations and PET/CT) showed a clinical complete recovery after the follow-up period of 3 months.The follow-up plan is ongoing.Conclusions Because secondary Hodgkin's lymphoma of ureter is rare with concealed onset feature,lacking of characteristic clinical manifestations,it is relatively difficult to achieve the diagnosis and differential diagnosis.Therefore,pathology and immunohistochemistry should be assigned to confirm the diagnosis.It is stressed that physicians should be aware of the possibility of malignant lymphoma when unexplained hydronephrosis and thickness of the ureteral wall are found clinically.Generally it has a good prognosis and combination therapy for the treatment is given priority to with chemotherapy.


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