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.Association between plasma growth differentiation factor 15 levels and pre-eclampsia in China
Shuhong XU ; Yicheng LU ; Mengxin YAO ; Zhuoqiao YANG ; Yan CHEN ; Yaling DING ; Yue XIAO ; Fei LIANG ; Jiani QIAN ; Jinchun MA ; Songliang LIU ; Shilan YAN ; Jieyun YIN ; Qiuping MA
Chronic Diseases and Translational Medicine 2024;10(2):140-145
Background::Growth differentiation factor-15 (GDF-15) is a stress response protein and is related to cardiovascular diseases (CVD). This study aimed to investigate the association between GDF-15 and pre-eclampsia (PE).Method::The study involved 299 pregnant women, out of which 236 had normal pregnancies, while 63 participants had PE. Maternal serum levels of GDF-15 were measured by using enzyme-linked immunosorbent assay kits and then translated into multiple of median (MOM) to avoid the influence of gestational week at blood sampling. Logistic models were performed to estimate the association between GDF-15 MOM and PE, presenting as odd ratios (ORs) and 95% confidence intervals (CIs).Results::MOM of GDF-15 in PE participants was higher compared with controls (1.588 vs. 1.000, p < 0.001). In the logistic model, pregnant women with higher MOM of GDF-15 (>1) had a 4.74-fold (95% CI= 2.23-10.08, p < 0.001) increased risk of PE, adjusted by age, preconceptional body mass index, gravidity, and parity. Conclusions::These results demonstrated that higher levels of serum GDF-15 were associated with PE. GDF-15 may serve as a biomarker for diagnosing PE.
3.Association between plasma growth differentiation factor 15 levels and pre-eclampsia in China
Shuhong XU ; Yicheng LU ; Mengxin YAO ; Zhuoqiao YANG ; Yan CHEN ; Yaling DING ; Yue XIAO ; Fei LIANG ; Jiani QIAN ; Jinchun MA ; Songliang LIU ; Shilan YAN ; Jieyun YIN ; Qiuping MA
Chronic Diseases and Translational Medicine 2024;10(2):140-145
Background::Growth differentiation factor-15 (GDF-15) is a stress response protein and is related to cardiovascular diseases (CVD). This study aimed to investigate the association between GDF-15 and pre-eclampsia (PE).Method::The study involved 299 pregnant women, out of which 236 had normal pregnancies, while 63 participants had PE. Maternal serum levels of GDF-15 were measured by using enzyme-linked immunosorbent assay kits and then translated into multiple of median (MOM) to avoid the influence of gestational week at blood sampling. Logistic models were performed to estimate the association between GDF-15 MOM and PE, presenting as odd ratios (ORs) and 95% confidence intervals (CIs).Results::MOM of GDF-15 in PE participants was higher compared with controls (1.588 vs. 1.000, p < 0.001). In the logistic model, pregnant women with higher MOM of GDF-15 (>1) had a 4.74-fold (95% CI= 2.23-10.08, p < 0.001) increased risk of PE, adjusted by age, preconceptional body mass index, gravidity, and parity. Conclusions::These results demonstrated that higher levels of serum GDF-15 were associated with PE. GDF-15 may serve as a biomarker for diagnosing PE.
4.Acute severe liver injury induced by Xingqi Sanjie cream (行气散结膏)
Adverse Drug Reactions Journal 2022;24(12):667-669
A 38-year-old female patient with thyroid nodule received Xingqi Sanjie cream 30 g orally twice daily for 4 treatment courses in total. Each treatment course was 1 month and the interval between the 2 courses was 14 days. On the 29th day of the 4th treatment course, the patient developed poor appetite, yellowish skin and sclera, and dark urine. Laboratory tests showed alanine aminotransferase (ALT) 3 201 U/L, aspartate aminotransferase (AST) 2 262 U/L, total bilirubin (TBil) 257.2 μmol/L, direct bilirubin (DBil) 186.9 μmol/L, and alkaline phosphatase (ALP) 159 U/L. Drug-induced liver injury (severe) was diagnosed, which was considered to be related to Xingqi Sanjie cream. The drug was stopped, and symptomatic and supportive treatments including hepatoprotection and rehydration were given. Twenty-two days later, the above symptoms in the patient were improved. Laboratory tests showed ALT 209 U/L, AST 117 U/L, TBil 92.7 μmol/L, DBil 63.2 μmol/L, and ALP 82 U/L. Fifty-one days later, the yellowish skin and sclera in the patient subsided, and the urine color returned to normal. Laboratory tests showed ALT 37 U/L, AST 22 U/L, TBil 30.3 μmol/L, DBil 14.7 μ mol/L, and ALP 58 U/L.
5.Acute severe liver injury induced by Xingqi Sanjie cream (行气散结膏)
Adverse Drug Reactions Journal 2022;24(12):667-669
A 38-year-old female patient with thyroid nodule received Xingqi Sanjie cream 30 g orally twice daily for 4 treatment courses in total. Each treatment course was 1 month and the interval between the 2 courses was 14 days. On the 29th day of the 4th treatment course, the patient developed poor appetite, yellowish skin and sclera, and dark urine. Laboratory tests showed alanine aminotransferase (ALT) 3 201 U/L, aspartate aminotransferase (AST) 2 262 U/L, total bilirubin (TBil) 257.2 μmol/L, direct bilirubin (DBil) 186.9 μmol/L, and alkaline phosphatase (ALP) 159 U/L. Drug-induced liver injury (severe) was diagnosed, which was considered to be related to Xingqi Sanjie cream. The drug was stopped, and symptomatic and supportive treatments including hepatoprotection and rehydration were given. Twenty-two days later, the above symptoms in the patient were improved. Laboratory tests showed ALT 209 U/L, AST 117 U/L, TBil 92.7 μmol/L, DBil 63.2 μmol/L, and ALP 82 U/L. Fifty-one days later, the yellowish skin and sclera in the patient subsided, and the urine color returned to normal. Laboratory tests showed ALT 37 U/L, AST 22 U/L, TBil 30.3 μmol/L, DBil 14.7 μ mol/L, and ALP 58 U/L.
6.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.
7.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.
8.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 .
9.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.
10.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.

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