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.Measurement of IL-1β,IL-6,IFN-γ levels in peripheral blood of lung cancer patients using multiple microsphere flow immunofluorescence technique and correlation analysis with hs-CRP
Fang WANG ; Lianfang LIU ; Lei WANG ; Guoxin XU ; Li HE ; Qinfeng ZHOU
International Journal of Laboratory Medicine 2024;45(21):2561-2565
Objective To investigate the expression of interleukin(IL)-1β,IL-6 and interferon γ(IFN-γ)cytokines in peripheral blood of patients with lung cancer detected by multiple microsphere flow immunofluo-rescence technique and to analyze the correlation with hypersevsitive C-reactive protein(hs-CRP).Methods A retrospective study was conducted to select 30 patients with lung cancer patients admitted to De-partment of Oncology and Department of Pulmonary Diseases in Zhangjiagang Hospital of Traditional Chinese Medicine(the hospital)as the lung cancer group,select 30 patients with pneumonia admitted in the hospital during the same period as the pneumonia group,and select 30 healthy people who underwent the physical ex-amination in the hospital in the same period as the control group.The serum levels of IL-1β,IL-6 and IFN-γwere detected by multiple microsphere flow immunofluorescence technique.Meanwhile,the level of hs-CRP in peripheral blood was determined by latex enhanced immunoscattering nephelometry.Results Compared with the control group,the levels of IL-1β,IL-6 and hs-CRP in lung cancer group were significantly increased,and the differences were statistically significant(P<0.001),while the difference in the level of IFN-γ was not sta-tistically significant(P>0.05).Compared with the control group,the levels of IL-1β,IL-6,IFN-γ and hs-CRP in the pneumonia group were significantly increased,and the differences were statistically significant(P<0.001).Compared with pneumonia group,the levels of IL-6,IFN-γ and hs-CRP in lung cancer group were sig-nificantly decreased and IL-1β level was increased,and the differences were statistically significant(P<0.05).Pearson correlation analysis was conducted on the levels of IL-6 and hs-CRP in the lung cancer group and pneumonia group,but no significant correlation was observed.Conclusion IL-1β,IL-6 and IFN-γ could be used as auxiliary indexes to effectively evaluate the immune function of patients with lung cancer.The applica-tion of multiple microsphere flow immunofluorescence technique has potential clinical application value for the diagnosis and monitoring of lung cancer.
4.Effect of augmented reality training based on enriched environment on walking function after stroke
Tianqi WEI ; Jiaqi LUO ; Zijuan LI ; Xueliang WU ; Panpan XU ; Yanmei ZHANG ; Xiaomeng ZHAO ; Qinfeng WU
Chinese Journal of Rehabilitation Theory and Practice 2023;29(12):1439-1445
ObjectiveTo observe the effect of augmented reality training based on enriched environment on walking dysfunction after stroke. MethodsFrom January, 2021 to June, 2022, 36 stroke patients in the Affiliated Suzhou Hospital of Nanjing University Medical School were randomly divided into control group (n = 18) and experimental group (n = 18). Both groups received conventional rehabilitation treatment. The control group was supplemented with conventional walking training, and the experimental group was supplemented with augmented reality training based on enriched environment, for four weeks. They were assessed with Berg Balance Scale (BBS), Timed Up and Go Test (TUGT), 10-meter walk test (10MWT) and Barthel Index (BI) before and after treatment, and the gait parameter was compared. ResultsNo adverse event occurred during treatment. After treatment, the BBS score, TUGT time, 10MWT speed, BI, gait speed, gait frequency and the proportion of single-leg support on the affected side significantly improved in both groups (|t| > 5.161, P < 0.001). All the above indexes were better in the experimental group than in the control group (|t| > 2.106, P < 0.05), except for BI (t = 1.099, P = 0.282). ConclusionAugmented reality training based on enriched environment could improve the walking function of paitents after stroke, which is better than conventional walking training.
5.The effect of X-ray on microglial M1 and M2 polarization
Rongrong HUANG ; Yan ZHOU ; Ling GUO ; Liyuan LIU ; Yizhe XUE ; Panpan LAI ; Yuntao JING ; Hui XU ; Qinfeng ZHANG ; Guirong DING
Chinese Journal of Radiological Health 2021;30(3):247-252
Objective:
To investigate the effect of X-ray on the polarization of mouse microglia BV-2 cells.
Methods:
BV-2 cells at the logarithmic growth stage were randomly divided into the Sham irradiation group and 10 Gy irradiation group. The latter group was given a single X-ray irradiation at a dose of 1.28 Gy/min for 7 min 49 s. The activation rate of BV-2 cells was observed and analyzed under a microscope at 1, 3, 6, 24 h and 48 h after irradiation.The changes of cell morphology were observed by HE staining and immunofluorescence staining; The levels of M1-type activation markers (TNF-α and IL-1β) and M2-type activation marker TGF-β1 in the supernatant of BV-2 cells were detected by ELISA. The
levels of polarization-related proteins of M1-type (CD86 and iNOS) and M2-type (CD206) in BV-2 cells were detected by Western blotting.
Results :
Morphological results showed that BV-2 cells became larger, and their protrude became coarse
and shorter, showing "amoeba" like changes after 10 Gy X-ray irradiation. Compared with the Sham group, the activation rate of BV-2 cells was significantly increased at 3 h, and reached the peak at 6 h, and began to recover at 48 h after irradiation. ELISA results showed an obvious increase in the level of TNF-α and TGF-β1 48 h after irradiation.The level of IL-1β showed a transient decrease at 3~6 h, increased at 24 h, and reached the peak 48 h after irradiation. Western blotting results
showed that CD86 protein level did not change significantly at each time points after irradiation, and iNOS protein level in-
creased significantly at 1, 6, 24 h and 48 h after irradiation. A fluctuating change in CD206 protein level was found after irradiation.
Conclusion
10 Gy X-ray irradiation can induce the activation of BV-2 cells in vitro, and the polarization type
changes with the time after irradiation.
6.The effect of shoulder subluxation on the electrophysiological characteristics of the peripheral nerves in the upper limbs of stroke survivors: A self-controlled study
Xiangzhe LI ; Panpan XU ; Sheng WANG ; Xiaomeng ZHAO ; Tianqi WEI ; Xifeng LI ; Na MEI ; Wei ZHOU ; Qinfeng WU
Chinese Journal of Physical Medicine and Rehabilitation 2021;43(2):122-127
Objective:To explore the effect of shoulder subluxation on the peripheral nerves in the hemiplegic upper limbs of stroke survivors.Methods:Twenty stroke survivors with shoulder subluxation were enrolled. Conduction in their suprascapular, axillary, musculocutaneous, radial, median and ulnar nerves was monitored and needle electromyography was used to monitor activity in the supraspinatus, deltoid, biceps brachii, extensor digitorum, abductor pollicis brevis and abductor digiti minimi muscles of their affected upper limbs at rest. Upper limb and hand function were assessed using the Brunnstrom scale. The rate of change in the amplitude of the compound muscle action potentials (CMAPs) was correlated with the patient′s disease duration, age, and upper limb and hand Brunnstrom stages.Results:Compared with the healthy side, a significant decrease was observed in the CMAP amplitudes of the suprascapular, axillary, musculocutaneous, radial, median and ulnar nerves of the hemiplegic arm, and the latency of the suprascapular and axillary nerves was significantly prolonged. There was no inter-arm difference in the conduction velocity of the musculocutaneous, radial, median and ulnar nerves. The rates of change in the CMAP amplitudes of the suprascapular, axillary and musculocutaneous nerves were significantly higher than those of the radial, median and ulnar nerves. The sensory nerve action potential (SNAP) amplitudes of the median, ulnar and radial nerves on the hemiplegic side were significantly lower than on the healthy side, but there was no significant difference in the sensory conduction velocity between the two sides. On the hemiplegic side, the median nerve had the highest rate of change rate in the SNAP amplitude, followed by the radial and ulnar nerves, but there was no significant difference among them. Nor was there any significant difference in the rate of change in sensory nerve conduction velocity. The muscles of the affected upper limbs had higher potentials in the proximal than that in the distal nerves after shoulder subluxation. The rate of change in the CMAPs was not significantly correlated with a patient′s disease duration, age, or upper limb or hand Brunnstrom stage on the hemiplegic side.Conclusions:Shoulder subluxation after a stroke can cause greater damage to the peripheral nerves in the shoulder and upper arm than to those in the forearm and hand, possibly affecting the recovery of upper limb function.
7.Progress of clinical laboratory tests and molecular imaging for diagnosis of Alzheimer's disease
Wenbo ZHU ; Qinfeng XU ; Jingjing LI ; Kui ZHANG ; Bing BAI
Chinese Journal of Laboratory Medicine 2020;43(3):328-335
With the expansion of aging population, Alzheimer′s disease (AD) is increasingly imposing a substantial burden on the society. Because of irreversible neuronal death in the brain, effective control of AD relies on early diagnosis for timely therapeutic intervention, and this requires efficient laboratory tests and molecular imaging. Current laboratory tests for AD includes measurements of Aβ peptides, Tau, and a number of other recently discovered molecules in the cerebrospinal fluid and the peripheral blood. PET-based imaging of glucose metabolism, amyloid Aβ, Tau neurofibrillary tangles, TSPO protein, and neuronal receptors, has also proven to be useful in clinical finding of AD. This review will focus on the progress in studies of these biomarkers and methodologies for ADdiagnosis.
8. Whole genome analysis of human H3N2 influenza virus outbreak in a poultry farm
Chunxue XU ; Wei LIU ; Boyan JIAO ; Zhen WANG ; Ti LIU ; Lin SUN ; Qinfeng ZHANG ; Xianjun WANG
Chinese Journal of Experimental and Clinical Virology 2018;32(4):367-372
Objective:
To understand the epidemiological characteristics of outbreaks and analyze the genetic characteristics of the whole genome of influenza H3N2 virus among avian-human-swine, and to elaborate the source of influenza virus.
Methods:
The epidemic information was collected using the case investigation, the pharyngeal swab samples from influenza-like-illness cases were detected by real-time PCR and virus isolation. The phylogeny and molecular features of whole-genome were analyzed with EditSeq and MEGA 5.05 software.
Results:
The prevalence rate of this outbreak was 34.88%, 15 samples of throat swabs were collected, the positive rate of nucleic acid detection was 73.33%, 5 strains of seasonal influenza A (H3N2) influenza viruses were isolated. The phylogenetic analysis showed the eight gene segments of the isolated influenza viruses belonged to the same cluster with 2015-2016 influenza vaccine strain A/Switzerland/9715293/2013(H3N2), and no recombination was found. Compared with vaccine strain, 14 variant amino acids of protein of HA were identified, and 8 of them were located in antigenic sites. All strains were sensitive to neuraminidase inhibitors while they showed resistance to blockers of M2 ion channel. The glycosylation sites analysis showed that two new glycosylation sites NRT151-153 and NAT245-247were added.
Conclusions
The outbreak was caused by seasonal influenza A (H3N2) virus which had an antigenic drift and no genetic avian-human-swine recombination was found.
9.MSCT features of partially or completely low enhancement of pancreatic neuroendocrine tumors
Chinese Journal of Pancreatology 2017;17(3):184-188
Objective To observe MSCT features of partially or completely low enhancement of pancreas neuroendocrine tumors (PNENs).Methods The clinical data and MSCT features before pancreatectomy in 44 patients with confirmed PNENs were retrospectively reviewed.The MSCT findings were evaluated including tumor size, location, margin, density, intratumoral structure, bile duct and pancreatic ductal dilation and distant metastasis.Tumors were classified into complete enhancement type, partially or completely low enhancement type for further comparative analysis based on MSCT enhancement during pancreatic stage.Results A total of 56 PNENs in 44 patients were found, and there were 31 partially or completely low enhanced PNENs and 25 completely enhanced PNENs.The former were larger than the latter [mean tumor size, (3.3±2.2)cm vs (1.4±0.9) cm], and irregular shape and cystic components within tumors were more often observed (all P<0.05).There were no significant differences between the two types of PNENs in terms of gender, the presence of functional tumor, tumor location, clear tumor margin, intratumoral calcification, bile and pancreatic duct dilation and metastasis.76.0%(19/25) of completely enhanced PNENs reached peak enhancement in arterial phase, and 71.0%(22/31) of low enhancement PNENs reached peak in pancreatic phase.Enhanced intratumoral blood vessels in the arterial phase were more frequent in low enhancement PNENs, and the difference was statistically significant (P<0.05).There were significant differences on pathological grade between the two types of PNENs (G1=21,G2=4,G3=0 vs G1=18,G2=5, G3=8), and the difference was statistically significant (P<0.05).Conclusions Compared with complete enhancement PNENs, partially or completely low enhancement PNENs had bigger size, irregular shape, and cystic component.Intratumoral blood vessels in the arterial phase were observed, peak enhancement arrived later and the pathological grade was higher.
10.Effect of high-level spinal cord injury on myocardial energy metabolism in rats
Jinrong YI ; Qinfeng HUANG ; Chunxia SU ; Lu CHEN ; Lishuang XU ; Hui CHEN ; Caizhu LIN
Chinese Journal of Anesthesiology 2015;35(2):218-221
Objective To evaluate the effect of high-level spinal cord injury (SCI) on the myocardial energy metabolism in rats.Methods Sixty healthy male Sprague-Dawley rats,weighing 250-300 g,were randomly divided into 2 groups (n=30 each) using a random number table:sham operation (group S) and SCI group.SCI was induced in anesthetized rats by dropping a 10 g weight onto C7 spinal cord from 5 cm height falling freely inside a vertical hollow glass tube.At 6,12,24,48 and 72 h after SCI,6 rats in each group were chosen and arterial blood samples were taken for measurement of serum creatine kinase (CK) and creatine kinase isoenzyme-MB (CK-MB) activities.The rats were then sacrificed and myocardial specimens were obtained for examination of myocardial ultrastructure and for determination of ATP weight ratio,levels of Na+-K+-ATPase,Ca2+-Mg2+-ATPase,non-esterified fatty acids (NEFA) and lactic acid (LD),and expression of peroxisome proliferator-activated receptor alpha (PPARα) mRNA and protein (using fluorescent quantitative PCR and Western blot).Results Compared with group S,the serum CK and CK-MB activities were significantly increased,the ATP weight ratio,activities of Na+-K+-ATPase and Ca2+-Mg2+-ATPase and levels of NEFA and LD were decreased,and the expression of PPAR-α mRNA and protein was down-regulated in SCI group.No pathological changes of myocardium were found in group S,and the pathological changes of myocardium were obvious in SCI group.Conclusion High-level SCI can lead to decrease in the myocardial energy metabolism in rats,and down-regulated expression of PPARα is involved in the mechanism.

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