1.Comparison of efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children: a multicenter, randomized, controlled clinical trial
Xing XIAO ; Shan WANG ; Huan YANG ; Hong SHU ; Yanping GUO ; Jinping CHEN ; Yao LU ; Qinfeng LI ; Yuan LIANG ; Mutong ZHAO ; Xiaoyan LUO ; Limin MIAO ; Rui XU ; Xuemei LI ; Sha LAI ; Jianhong LI ; Zhen LUO ; Lu YU ; Lu XING ; Meitan WANG ; Xiaoli LI ; Haitao XU ; Ping LI ; Hua WANG ; Lin MA
Chinese Journal of Dermatology 2025;58(5):425-430
Objective:To compare the efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged 2 years or older.Methods:A multicenter, randomized, open-label, controlled clinical trial was conducted. A total of 120 pediatric patients aged 2 - 17 years with mild to moderate atopic dermatitis were enrolled from departments of dermatology of 8 hospitals in China between March 2022 and February 2023. The participants were randomly assigned in a 1∶1 ratio to the crisaborole group and the pimecrolimus group, and received the treatment with crisaborole ointment 2% and pimecrolimus cream 1% respectively, twice a day for 4 weeks. Visits were scheduled at baseline/on day 1, as well as on days 8, 15, and 29. The primary efficacy outcome was the percentage of patients achieving the Investigator's Static Global Assessment (ISGA) success (defined as clear [0] or almost clear [1] on the ISGA scale, combined with ≥ 2‐grade improvement from baseline) on day 29. The secondary efficacy outcomes included changes in the Eczema Area and Severity Index (EASI) total scores from baseline to day 29, percentages of patients achieving ISGA improvement (defined as clear [0] or almost clear [1] on the ISGA scale), as well as changes in the Peak Pruritus Numerical Rating Scale (NRS) scores, Dermatology Life Quality Index (DLQI) /Infants' Dermatology Life Quality Index (IDLQI) /Children's Dermatology Life Quality Index (CDLQI) scores, and in the Dermatitis Family Impact (DFI) scores. Drug safety was evaluated according to the incidence of adverse events. Categorical data were compared using the chi-square test. Since measurement data did not follow a normal distribution, the rank sum test was used for comparisons of measurement data between groups.Results:A total of 106 children with mild to moderate atopic dermatitis were included in the per-protocol analysis set, with 52 in the crisaborole group (26 males and 26 females) and 54 in the pimecrolimus group (27 males and 27 females). There were no significant differences in age, disease duration, ISGA and EASI scores at baseline between the two groups (all P > 0.05). On day 29, 22 patients (42.31%) in the crisaborole group and 25 (46.30%) in the pimecrolimus group achieved ISGA success, with no significant difference between the two groups ( χ2 = 0.17, P = 0.68) ; 35 patients (67.31%) in the crisaborole group and 45 (83.33%) in the pimecrolimus group achieved ISGA improvement, also with no significant difference between the two groups ( χ2 = 3.68, P = 0.06) ; additionally, there were no significant differences in the EASI, pruritus NRS, DLQI/IDLQI/CDLQI, or DFI scores between the two groups (all P > 0.05). Adverse reactions to the two topical agents were mainly local reactions such as mild to moderate pain, itching, or worsening of itching, and no obvious systemic adverse reactions occurred. The incidence of drug-related adverse reactions was 46.15% (24 cases) in the crisaborole group and 37.04% (20 cases) in the pimecrolimus group, with no significant difference between the two groups ( χ2 = 0.91, P = 0.34) . Conclusion:The efficacy of crisaborole ointment 2% was comparable to that of pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged ≥ 2 years, and it yielded early and rapid improvement in the quality of life of patients and their families, with good safety and tolerability profiles.
2.Comparison of efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children: a multicenter, randomized, controlled clinical trial
Xing XIAO ; Shan WANG ; Huan YANG ; Hong SHU ; Yanping GUO ; Jinping CHEN ; Yao LU ; Qinfeng LI ; Yuan LIANG ; Mutong ZHAO ; Xiaoyan LUO ; Limin MIAO ; Rui XU ; Xuemei LI ; Sha LAI ; Jianhong LI ; Zhen LUO ; Lu YU ; Lu XING ; Meitan WANG ; Xiaoli LI ; Haitao XU ; Ping LI ; Hua WANG ; Lin MA
Chinese Journal of Dermatology 2025;58(5):425-430
Objective:To compare the efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged 2 years or older.Methods:A multicenter, randomized, open-label, controlled clinical trial was conducted. A total of 120 pediatric patients aged 2 - 17 years with mild to moderate atopic dermatitis were enrolled from departments of dermatology of 8 hospitals in China between March 2022 and February 2023. The participants were randomly assigned in a 1∶1 ratio to the crisaborole group and the pimecrolimus group, and received the treatment with crisaborole ointment 2% and pimecrolimus cream 1% respectively, twice a day for 4 weeks. Visits were scheduled at baseline/on day 1, as well as on days 8, 15, and 29. The primary efficacy outcome was the percentage of patients achieving the Investigator's Static Global Assessment (ISGA) success (defined as clear [0] or almost clear [1] on the ISGA scale, combined with ≥ 2‐grade improvement from baseline) on day 29. The secondary efficacy outcomes included changes in the Eczema Area and Severity Index (EASI) total scores from baseline to day 29, percentages of patients achieving ISGA improvement (defined as clear [0] or almost clear [1] on the ISGA scale), as well as changes in the Peak Pruritus Numerical Rating Scale (NRS) scores, Dermatology Life Quality Index (DLQI) /Infants' Dermatology Life Quality Index (IDLQI) /Children's Dermatology Life Quality Index (CDLQI) scores, and in the Dermatitis Family Impact (DFI) scores. Drug safety was evaluated according to the incidence of adverse events. Categorical data were compared using the chi-square test. Since measurement data did not follow a normal distribution, the rank sum test was used for comparisons of measurement data between groups.Results:A total of 106 children with mild to moderate atopic dermatitis were included in the per-protocol analysis set, with 52 in the crisaborole group (26 males and 26 females) and 54 in the pimecrolimus group (27 males and 27 females). There were no significant differences in age, disease duration, ISGA and EASI scores at baseline between the two groups (all P > 0.05). On day 29, 22 patients (42.31%) in the crisaborole group and 25 (46.30%) in the pimecrolimus group achieved ISGA success, with no significant difference between the two groups ( χ2 = 0.17, P = 0.68) ; 35 patients (67.31%) in the crisaborole group and 45 (83.33%) in the pimecrolimus group achieved ISGA improvement, also with no significant difference between the two groups ( χ2 = 3.68, P = 0.06) ; additionally, there were no significant differences in the EASI, pruritus NRS, DLQI/IDLQI/CDLQI, or DFI scores between the two groups (all P > 0.05). Adverse reactions to the two topical agents were mainly local reactions such as mild to moderate pain, itching, or worsening of itching, and no obvious systemic adverse reactions occurred. The incidence of drug-related adverse reactions was 46.15% (24 cases) in the crisaborole group and 37.04% (20 cases) in the pimecrolimus group, with no significant difference between the two groups ( χ2 = 0.91, P = 0.34) . Conclusion:The efficacy of crisaborole ointment 2% was comparable to that of pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged ≥ 2 years, and it yielded early and rapid improvement in the quality of life of patients and their families, with good safety and tolerability profiles.
3.Expression and function analysis of FaCO gene in Festuca arundinacea.
Xi CHEN ; Ying CHEN ; Xiaoxia LIU ; Jianhong SHU ; Xiaoli WANG ; Degang ZHAO
Chinese Journal of Biotechnology 2021;37(4):1324-1333
Photoperiod plays an important role in transformation from vegetative growth to reproductive growth in plants. CONSTANS (CO), as a unique gene in the photoperiod pathway, responds to changes of day length to initiate flowering in the plant. In this study, the expression level of FaCONSTANS (FaCO) gene under long-day, short-day, continuous light and continuous darkness conditions was analyzed by real-time quantitative PCR. We constructed the over-expression vector p1300-FaCO and infected into Arabidopsis thaliana by Agrobacterium-mediated method. We constructed the silencing vector p1300-FaCO-RNAi and infected into Festuca arundinacea by Agrobacterium-mediated method. The expression of FaCO gene was regulated by photoperiod. The over-expression of FaCO promoted flowering in wild type of Arabidopsis thaliana under long day condition and rescued the late flowering phenotype in co-2 mutant of Arabidopsis thaliana. Silencing FaCO gene in Festuca arundinacea by RNAi showed late-flowering phenotype or always kept in the vegetative growth stage. Our understanding the function of FaCO in flowering regulation will help further understand biological function of this gene in Festuca arundinacea.
Arabidopsis/metabolism*
;
Arabidopsis Proteins/genetics*
;
Festuca/metabolism*
;
Flowers/genetics*
;
Gene Expression Regulation, Plant
;
Photoperiod
4.Correlation of vascular endothelial cell dysfunction to vascular restenosis following coronary artery stent implantation
Jinchuan LAI ; Biao CHENG ; Jie LI ; Hong KONG ; Yan SHU ; Jianhong TAO ; Rongjian JIANG ; Chunmei LI ; Yan DENG
Chinese Journal of Tissue Engineering Research 2008;12(22):4357-4360
BACKGROUND: Dysfunction of endothelial cells is independently associated with coronary atherosclerotic heart disease. Correlation of dysfunction of endothelial cells to restenosis after stent implantation is not yet clearly determined.OBJECTIVE: To evaluate the correlation of vascular endothelial dysfunction to restenosis after stent implantation. DESIGN, TIME AND SETTING: A case control study was performed at the Department of Cardiology and Department of Heart Ultrasound, Sichuan People's Hospital from March 2005 to January 2007.PARTICIPANTS: After review, coronary angiography showed that 11 patients who occurred restenosis at the lesion region after stent implantation were included in a restenosis group, and an additional 15 patients who did not develop in-stent restenosis were included in a control group. Patients in the following conditions were excluded: over 70 years old, histories of long-term smoking, diabetes mellitus, multivessel disease, long coronary lesion and chronic total occlusion, heart failure (Killip's class Ⅲ or above), severe hepatic and/or renal insufficiency.METHODS: High-resolution ultrasound was used to assess the percentage of flow-mediated dilatation of brachial artery. Differences in endothelial function were compared between both groups.MAIN OUTCOME MEASURES: Ultrasound parameter of the brachial artery in both groups; Partial correlation analysis on control variable including sex, age, blood lipid level, diseased region and stent type.RESULTS: No significant difference was found in basic diameter of brachial artery in both groups. During reactive hyperemia, inner diameter and its absolute variation of brachial artery were smaller in the restenosis group than in the control group (P<0.01). The percentage of brachial artery flow-mediated dilatation was lower in the restenosis group compared with the control group (P=0.013). The partial correlation coefficient between the percentage of flow-mediated dilatation of brachial artery and in-stent restenosis was 0.47 (P=0.04).CONCLUSION: The endothelial dysfunction significantly decreases in patients with restenosis compared with controls following stent implantation. There is a correlation between endothelial dysfunction and restenosis.
6.The Influence of Sera,Gonadotropins,EGF and Water on In vitro Maturation of Goat Oocytes
Chao WANG ; Zhiqing WEI ; Xiangchen LI ; Zhixin AN ; Zhiping ZHANG ; Jianhong SHU ; Yong ZHANG
Chinese Journal of Veterinary Science 2004;24(6):599-602
In present study,comparisons were carried out to develop and improve in vitro mauration(IVM) systems of goat oocytes. Oocytes were cultured in TCM-199 supplemented with(1)10% sera (either estrous goat serum (EGS) or fetal bovine serum(FBS)) + 20 mg/L luteinizing hormone (LH) + 10 mg/L follicle stimulating hormone (FSH) + 1 mg/L estradiol (E2); (2)10% EGS with different gonadotropins(LH: FSH) at a concentration of 5 mg/L: 0.5 mg/L or at 20 mg/L: 10 mg/L with0. 075 IU/mL human menopausal gonadotropin(HMG),1 mg/L estradiol 17β; (3)10% EGS+ 0. 075 mg/L HMG+10-20 μg/EGF. The culture was also performed by M199 supplemented with 10% EGS+0. 075 mg/L HMG+ 10-20 μg/L EGF into ultra-filtrated water which was derived either from self-producing or from purchased for use. The oocytes were cultured at 38 ℃,5% CO2 in air for 24 h,and the meterphase Ⅱ stage oocytes were examined under dissecting microscope. The results showed that EGS was better than FBS in supporting goat oocyte IVM. An addition of HMG in M199 could improve oocyte maturation and induce a higher percentage of metaphase Ⅱ oocytes compared to gonadotropins. 10-20 μg/L EGF improved goat oocyte maturation but the influence was not significant. Fresh,high quality water was vital for oocyte IVM. In conclusion,under our conditions with IVM ,the best result in maturation of goat oocyte has been M199 supplemented with 10% EGS+0.075 IU/mL HMG+10-20 μg/L EGF and prepared in fresh purified water.

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