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.Comparison of the value of LDL-C and non-HDL-C in differential diagnosis of familial hypertriglyceridemia and familial combined hyperlipidemia
Xiaoyan FU ; Huiya JIN ; Jinchun HE ; Li YAN ; Na SU ; Haitao YU ; Jing YANG
Journal of Xi'an Jiaotong University(Medical Sciences) 2017;38(3):427-430,436
Objective To evaluate the value of low-density lipoprotein-cholesterol (LDL-C) and non-high-density lipoprotein-cholesterol (non-HDL-C) in differential diagnosis of familial hypertriglyceridemia (FHTG) and familial combined hyperlipidemia (FCHL).Methods We recruited 9 FHTG pedigrees (94 subjects) and 24 FCHL pedigrees (94 subjects) and then divided them into affected groups and non-affected groups according to lipid abnormality.Another 10 normal control pedigrees (57 subjects) served as controls.We compared the routine lipid levels such as triglyceride (TAG),total cholesterol (TC),HDL-C and LDL-C and non-HDL-C between the groups.After stratification based on TAG level,we observed the relationship between LDL-C and non-HDL-C.Last we confirmed and analyzed the cut-off value of differential diagnosis between FHTG and FCHL with receiver operating characteristic (ROC) curve.Results The levels of TAG,TC,and non-HDL-C were significantly higher in the affected group of FHTG than in the non-affected group of FHTG and the normal group (P<0.01 or P<0.05).The levels of TAG,TC,HDL-C,LDL-C and non-tHDL-C wcrc significantly higher in the affected group of FCHL than in the non-affected group of FCHL and the normal group (P<0.01 or P<0.05).The levels of TAG were significantly higher (P<0.01) while TC,HDL-C,LDL-C and non-HDL-C levels were significantly lower (P< 0.01 or P<0.05) in the affected group of FHTG than in the affected group of FCHL.The association between LDL-C and non-HDL-C was positive both in FHTG and FCHL,but the relationship became weaker as TAG level increased.The cut-off value of LDL-C and non-HDL-C was 3.575 mmol/L and 4.525 mmol/L,respectively.Conclusion In addition to the routinely used lipid indexes,non-HDL-C may be a new index for differential diagnosis of FHTG and FCHL,and may be superior to LDL-C in this regard.
3.Inhibitory Effect of Total Alkaloids from Lotus Seed on Human Hepatoma Cells
Yan PENG ; Lingli ZHANG ; Xiaoqing YANG ; Jing YANG ; Na LI ; Jinchun SONG
China Pharmacist 2017;20(6):1009-1012
Objective: To study the inhibitory effect of total alkaloids from lotus seed on human hepatoma HepG2 cells.Methods: The effect of total alkaloids from lotus seed on the growth of HepG2 cells was studied by CCK-8 kit.The apoptosis rate of HepG2 cells was detected by flow cytometry.Results: When the action time was the same, with the increase of drug concentration, the inhibitory rate of total alkaloids from lotus seed on HepG2 cells increased, in a dose-dependent manner.At 72 h, the half inhibitory concentration (IC50) of total alkaloids from lotus seed on HepG2 cells was 1.501 μg·ml-1.At the same concentration, the inhibitory rate of the total alkaloids from lotus seed on HepG2 cells increased with the extension of the action time.At 72 h, the inhibition rate of 10 μg·ml-1 total alkaloids from lotus seed reached 72%.After treated with the total alkaloids from lotus seed at different concentrations, the apoptosis rate of HepG2 cells significantly increased in a dose-dependent manner.Compared with the blank control group, the difference was statistically significant (P <0.05), and the apoptosis rate of HepG2 cells was 85.6% treated with 20 μg·ml-1 total alkaloids from lotus seed.Conclusion: The total alkaloids from lotus seed can induce cell apoptosis and inhibit the proliferation of human hepatoma HepG2 cells.
4.Determination of Entrapment Efficiency of Buthionine Sulfoximine Nanoparticles in Different Entrapping Systems by HPLC
Xiaoqing YANG ; Cong WU ; Xiaoyan HE ; Yan PENG ; Lingli ZHANG ; Jinchun SONG
China Pharmacist 2016;19(7):1399-1402
Objective:To establish an HPLC method to determine the entrapment efficiency of buthionine sulfoximine (BSO) nan-oparticles in different entrapping systems .Methods:Free BSO was separated from the loaded nanoparticles by high speed centrifugation in two entrapping systems and the entrapment efficiency of buthionine sulfoximine nanoparticles was determined by HPLC .A WondaSil C18 column (250 mm ×4.6 mm, 5 μm) was used and the mobile phase was methanol-water (20 ∶80).The flow rate was 0.4 ml· min-1 and the column temperature was 30℃.The detection wavelength was set at 210 nm and the volume of injection was 20 μl.Re-sults:BSO had a good linear relationship within the range of 2.0-320.0μg· ml-1(r=0.999 7).The average recovery was 101.05%and RSD was 0.74%(n=9).The average entrapment efficiency of HP/CaCO3/CaHPO4/BSO nanoparticles and HP/PS/CaCO3/BSO hydrid nanovesicles was 25.63% and 58.62%, respectively.Conclusion:The method has good repeatability and high accuracy and sensitivity, which is applicable to determine the entrapment efficiency of BSO nanoparticles .HP/PS/CaCO3/BSO hydrid nanovesicles entrapped system is superior to HP/CaCO3/CaHPO4/BSO nanoparticles entrapped system .
5.The practice on the pharmaceutical analysis course in pharmacy college education
Yan PENG ; Zongchun WANG ; Lingli ZHANG ; Jinchun SONG
Chinese Journal of Medical Education Research 2015;14(4):388-390
To realize the object of the pharmacy college education training,some teaching ideas and methods on pharmaceutical analysis course was explored.In the teaching practice,the course hour of pharmaceutical analysis was adjusted to deepen the understanding of the theoretical knowledge;the practice basic skills training was also strengthened and the professional ethics and quality education was taken throughout the course.Besides,emphasis on the systemic college education was put forward,Pharmacy college education not only be targeted in training applied technical persons but also should meet the students' need for continuing education and continue learning development.
6.Clinical analysis on pregnant outcomes of gravidas with positive urine glucose
Ying GUO ; Ni LIU ; Yuqin LIU ; Yan WU ; Meili WU ; Jinchun HE
International Journal of Laboratory Medicine 2015;(3):345-346,349
Objective To study the effects of positive urine glucose on maternal pregnancy.Methods A total of 1 338 pregnant women were tested urine glucose.On the basis of their urine-glucose level,two groups were devided:experimental,68 cases of posi-tive urine-glucose gravidas,control group,199 cases of negative urine-glucose gravidas.Analyze on the outcome of pregnancy of the two groups.Results Compared between positive group and control group,the incidence of died(abnormal)fetus,gestational hyper-tension,abnormal amniotic fluid,fetal distress,and fetal macrosomia were not statistically different(P >0.05),but the incidence of premature rupture of membranes was statistically different (P <0.05 ).Conclusion Positive glucose urine of gravidas might in-crease the risk of premature rupture of membranes,positive urine glucose detected during pregnancy should be highly valued.
7.Association of Polymorphisms in Angiotensin Ⅱ Receptor Genes with Aldosterone-producing Adenoma
OUYANG JINZHI ; WU ZHUN ; XING JINCHUN ; YAN YONGJI ; ZHANG GUOXI ; WANG BAOJUN ; LI HONGZHAO ; MA XIN ; ZHANG XU
Journal of Huazhong University of Science and Technology (Medical Sciences) 2011;31(3):301-305
This study examined the association of polymorphisms in angiotensin Ⅱ receptor genes (AT1R and AT2R) with the risk for aldosterone-producing adenoma (APA) in a Chinese Han population.Four polymorphisms including rs5182 (573T/C) in exon 4,rs5186 (1166A/C) in 3'-untranslated region (3'-UTR) in AT1R gene and rs5194 (2274G/A) in 3'-UTR,rs1403543 (1675G/A) in intron 1 in AT2R gene were detected in 148 APA patients and 192 normal subjects (serving as control) by using a MGB-Taqman probe.The distribution of genotypes of each locus was in accordance with Hardy-Weinberg Equilibrium (HWE) in the APA and control groups (P>0.05).The allele A frequency at rs5194 was significantly higher in the APA group (0.49) than in the control group (0.35) (X2=12.08,P=0.001).Subjects with homozygotic genotype AA and heterozygotic genotype GA were at an increased risk for APA as compared to those with GG genotype (OR=2.66,95% CI=1.45-4.87; OR=1.67,95% CI=1.02-2.74).Furthermore,rs5194 single-nucleotide polymorphism (SNP) at AT2R gene was significantly associated with APA in additive (OR=1.64,95% CI=1.21-2.20,P=0.001),dominant (OR=1.94,95% CI=1.23-3.06,P=0.003),and recessive model (OR=2.01,95% CI=1.17-3.45,P=0.01).It was concluded that rs5194 polymorphism at AT2R gene was associated with the risk for APA,which may constitute a genetic marker of APA.
8.Association of polymorphisms in angiotensin II receptor genes with aldosterone-producing adenoma.
Jinzhi, OUYANG ; Zhun, WU ; Jinchun, XING ; Yongji, YAN ; Guoxi, ZHANG ; Baojun, WANG ; Hongzhao, LI ; Xin, MA ; Xu, ZHANG
Journal of Huazhong University of Science and Technology (Medical Sciences) 2011;31(3):301-5
This study examined the association of polymorphisms in angiotensin II receptor genes (AT (1) R and AT (2) R) with the risk for aldosterone-producing adenoma (APA) in a Chinese Han population. Four polymorphisms including rs5182 (573T/C) in exon 4, rs5186 (1166A/C) in 3'-untranslated region (3'-UTR) in AT (1) R gene and rs5194 (2274G/A) in 3'-UTR, rs1403543 (1675G/A) in intron 1 in AT (2) R gene were detected in 148 APA patients and 192 normal subjects (serving as control) by using a MGB-Taqman probe. The distribution of genotypes of each locus was in accordance with Hardy-Weinberg Equilibrium (HWE) in the APA and control groups (P>0.05). The allele A frequency at rs5194 was significantly higher in the APA group (0.49) than in the control group (0.35) (χ (2)=12.08, P=0.001). Subjects with homozygotic genotype AA and heterozygotic genotype GA were at an increased risk for APA as compared to those with GG genotype (OR=2.66, 95% CI=1.45-4.87; OR=1.67, 95% CI=1.02-2.74). Furthermore, rs5194 single-nucleotide polymorphism (SNP) at AT (2) R gene was significantly associated with APA in additive (OR=1.64, 95% CI=1.21-2.20, P=0.001), dominant (OR=1.94, 95% CI=1.23-3.06, P=0.003), and recessive model (OR=2.01, 95% CI=1.17-3.45, P=0.01). It was concluded that rs5194 polymorphism at AT (2) R gene was associated with the risk for APA, which may constitute a genetic marker of APA.
9.Relationship between the plasma resistin,obesity and insulin resistance in nonalcoholic fatty liver disease patients.
Rong LIU ; Xiang YAN ; Jinchun HE
Chinese Journal of Practical Internal Medicine 2006;0(17):-
Objective The study aimed to assess the relationship between the plasma resistin,obesity and insulin resistance and nonalcoholic fatty liver disease(NAFLD).Methods We measured fasting plasma resistin in 60 NAFLD patients and 28 matched normal control subjects from Oct.2005 to Feb.2006.The level of plasma resistin was measured by ELISA method.Insulin resistance by homeostasis model(HOMA),height,weight,waist circumstance,hip girth,waist to hip ratio(WHR),body mass index(BMI),blood pressure,blood glucose,total cholesterol,triglyceride,HDL-cholesterol,LDL-cholesterol,aspartate aminotransferase(AST),alanine aminotransferase(ALT)and fasting insulin were measured as well.Results Plasma resistin levels were higher in NAFLD patients as compared to controls(8.56?2.5 vs 6.39?2.81,P
10.Analysis of the infection of sexually transmitted diseases among high-risk population in Nanjing.
Yufeng HUANG ; Deyu CHEN ; Yifeng GE ; Baofang JIN ; Chunming YAN ; Hongying RUI ; Jinchun LU
National Journal of Andrology 2004;10(11):815-818
OBJECTIVETo survey the prevalence of sexually transmitted diseases among high-risk population in Nanjing.
METHODSA high-risk population of 1539 underwent physical examinations from September 2001 to May 2004. The results were recorded, the urogenital swabs collected to further detect Neisseria gonorrhoeae (GN), Chlamydia trachomatis (Ct), Ureaplasma urealyticum (Uu), and the blood specimens tested for syphilis and HIV antibodies.
RESULTSThe infection rates were 13.5% for GN, 10.3% for syphilis, 2.3% for condyloma acuminata, 35.9% for Ct and 22.4% for Uu respectively. Nongonococcal urethritis (NUG) was shown to be the most prevalent STD in the group. No subject was found to be positive with HIV antibody.
CONCLUSIONScreening strategy in the high risk population is useful and efficient in controlling the spread of STDs and HIV.
Adolescent ; Adult ; Antibodies, Bacterial ; blood ; Antibodies, Viral ; blood ; China ; epidemiology ; Female ; Gonorrhea ; epidemiology ; HIV ; immunology ; HIV Infections ; epidemiology ; Humans ; Incidence ; Male ; Middle Aged ; Neisseria ; immunology ; Sexually Transmitted Diseases ; epidemiology ; Syphilis ; epidemiology ; Treponema ; immunology


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