1.Application of Engineered Exosomes in Tumor-targeted Therapy
Jia-Lu SONG ; Yi-Xin JIN ; Xing-Yu MU ; Yu-Huan JIANG ; Jing WANG
Progress in Biochemistry and Biophysics 2025;52(5):1140-1151
Tumors are the second leading cause of death worldwide. Exosomes are a type of extracellular vesicle secreted from multivesicular bodies, with particle sizes ranging from 40 to 160 nm. They regulate the tumor microenvironment, proliferation, and progression by transporting proteins, nucleic acids, and other biomolecules. Compared with other drug delivery systems, exosomes derived from different cells possess unique cellular tropism, enabling them to selectively target specific tissues and organs. This homing ability allows them to cross biological barriers that are otherwise difficult for conventional drug delivery systems to penetrate. Due to their biocompatibility and unique biological properties, exosomes can serve as drug delivery systems capable of loading various anti-tumor drugs. They can traverse biological barriers, evade immune responses, and specifically target tumor tissues, making them ideal carriers for anti-tumor therapeutics. This article systematically summarizes the methods for exosome isolation, including ultracentrifugation, ultrafiltration, size-exclusion chromatography (SEC), immunoaffinity capture, and microfluidics. However, these methods have certain limitations. A combination of multiple isolation techniques can improve isolation efficiency. For instance, combining ultrafiltration with SEC can achieve both high purity and high yield while reducing processing time. Exosome drug loading methods can be classified into post-loading and pre-loading approaches. Pre-loading is further categorized into active and passive loading. Active loading methods, including electroporation, sonication, extrusion, and freeze-thaw cycles, involve physical or chemical disruption of the exosome membrane to facilitate drug encapsulation. Passive loading relies on drug concentration gradients or hydrophobic interactions between drugs and exosomes for encapsulation. Pre-loading strategies also include genetic engineering and co-incubation methods. Additionally, we review approaches to enhance the targeting, retention, and permeability of exosomes. Genetic engineering and chemical modifications can improve their tumor-targeting capabilities. Magnetic fields can also be employed to promote the accumulation of exosomes at tumor sites. Retention time can be prolonged by inhibiting monocyte-mediated clearance or by combining exosomes with hydrogels. Engineered exosomes can also reshape the tumor microenvironment to enhance permeability. This review further discusses the current applications of exosomes in delivering various anti-tumor drugs. Specifically, exosomes can encapsulate chemotherapeutic agents such as paclitaxel to reduce side effects and increase drug concentration within tumor tissues. For instance, exosomes loaded with doxorubicin can mitigate cardiotoxicity and minimize adverse effects on healthy tissues. Furthermore, exosomes can encapsulate proteins to enhance protein stability and bioavailability or carry immunogenic cell death inducers for tumor vaccines. In addition to these applications, exosomes can deliver nucleic acids such as siRNA and miRNA to regulate gene expression, inhibit tumor proliferation, and suppress invasion. Beyond their therapeutic applications, exosomes also serve as tumor biomarkers for early cancer diagnosis. The detection of exosomal miRNA can improve the sensitivity and specificity of diagnosing prostate and pancreatic cancers. Despite their promising potential as drug delivery systems, challenges remain in the standardization and large-scale production of exosomes. This article explores the future development of engineered exosomes for targeted tumor therapy. Plant-derived exosomes hold potential due to their superior biocompatibility, lower toxicity, and abundant availability. Furthermore, the integration of exosomes with artificial intelligence may offer novel applications in diagnostics, therapeutics, and personalized medicine.
2.Research on the development of entrustable professional activity indicators for residents in China: a systematic review
Jingyu ZHONG ; Yue XING ; Liangjing LÜ ; Qinghua MIN ; Zhengguang XIAO ; Caisong ZHU ; Dandan SHI ; Xiaoyu FAN ; Jingshen CHU ; Huan ZHANG ; Yi JIANG ; Weiwu YAO
Chinese Journal of Medical Education Research 2025;24(6):728-735
Objective:To systematically evaluate the current status of research on the development of indicators for entrustable professional activities (EPAs) of residents in China.Methods:We searched the China National Knowledge Infrastructure, Wanfang Data, Airiti Library, PubMed, Embase, and Web of Science databases for literature on the development of EPA indicators for residents in China published between January 1, 2005 and February 28, 2025. Two researchers independently screened the literature and extracted data, followed by descriptive analysis. The quality of the studies was assessed using the Joanna Briggs Institute critical appraisal tool for expert opinion. Quantitative data were presented as medians (ranges) and qualitative data were presented as frequencies (percentages).Results:A total of eight articles were included, in which two general EPA indicator systems and six specialty-specific EPA indicator systems were developed for residents. The overall quality of the research was high, with the main shortcomings related to the methods used in the process of constructing the consensus indicators. The number of experts recruited ranged from 22 to 45, with 100.00% response rate, high authority coefficients (0.820-0.914), and high coordination coefficients (0.157-0.741). Most of the studies used literature reviews as one source for the indicator pool (8 studies, 100.00%), employed the Delphi method to reach consensus (6 studies, 75.00%), and provided inclusion criteria for the indicators (7 studies, 87.50%). However, only one study (12.50%) explored the practical application of the developed indicators, and none of the studies set indicator weights or conducted quality assessments. The number of EPA indicators developed ranged from 10 to 38 per study. The reporting of EPA indicators was included in most studies regarding titles (8 studies, 100.00%) and the expected levels of entrustment at various stages of training (6 studies, 75.00%), but the reporting on other aspects was lacking. Among the specialty-specific EPA indicators, 38.39% overlapped with the general EPAs indicators.Conclusions:The research on the development of EPA indicators for residents in China is still in its early stages, and there is room for improvement in methodological quality and reporting coverage. There is partial overlap between specialty-specific and general EPA indicators, failing to fully reflect the unique characteristics of different specialties.
3.Accuracy and quality of answer reasoning of Chinese large language model in Chinese middle level professional qualification examination of radiology
Jingyu ZHONG ; Yue XING ; Yangfan HU ; Qinghua MIN ; Caisong ZHU ; Dandan SHI ; Xiaoyu FAN ; Jingshen CHU ; Huan ZHANG ; Weiwu YAO
Chinese Journal of Medical Education Research 2025;24(2):145-149
Objective:To compare the accuracy of a Chinese large language model (LLM) and radiologists in Chinese middle level professional qualification examination of radiology, and evaluate the quality of answer reasoning provided by the Chinese LLM.Methods:In this study, 100 high-quality questions were selected using stratified random sampling to form a test set. We asked the ERNIE Bot by dialogues on the website to provide the correct answers and answer reasoning for these questions. These questions were also answered by 15 radiologists with different levels of experience. The accuracy of Chinese LLM and that of radiologists were compared. Two radiologists evaluated the quality of answer reasoning using a 5-point semi-quantitative scale.Results:The accuracy of ERNIE Bot was 60.00%, which was lower than the median (interquartile) accuracy of 67.00% (64.00%, 73.00%) for radiologists, and the difference was statistically significant ( W=2.47, P=0.013). The word count of the reasoning provided by Ernie Bot was (196.44±99.25) words, with no significant difference in word count between correct and incorrect answer reasoning, which were (211.03±107.53) words and (174.55±81.84) words, respectively ( t=1.82, P=0.072). Among the correct answers, the quality of reasoning was scored as follows: 1 point for 3 questions, 2 points for 9 questions, 3 points for 12 questions, and 4 points for 36 questions. No reasoning received a score of 5. Conclusions:Chinese LLM demonstrates a certain level of medical knowledge and clinical reasoning ability, which can assist clinical teachers in educational activities. However, it is not yet able to independently tutor residents and lacks the ability of invitational and heuristic teaching.
4.An investigation of the current status of Chinese-foreign cooperative education programs for medical majors
Jingyu ZHONG ; Yue XING ; Qinghua MIN ; Zhengguang XIAO ; Caisong ZHU ; Dandan SHI ; Xiaoyu FAN ; Jingshen CHU ; Huan ZHANG ; Yi JIANG ; Weiwu YAO
Chinese Journal of Medical Education Research 2025;24(5):577-582
Objective:To investigate the current status of Chinese-foreign cooperative education programs for medical majors, and to discuss the potential problems and development trends of this field.Methods:Related data were collected from the information platform of Chinese-Foreign Cooperation in Running Schools by Ministry of Education of the People's Republic of China, and the characteristics of Chinese-foreign cooperative education programs for medical majors were extracted for analysis. Categorical data were expressed as frequency (percentage), and continuous data were expressed as mean±standard deviation.Results:A total of 83 Chinese-foreign cooperative education programs for medical majors were included in the study, accounting for only 3.45% (83/2 406) of all programs. Chinese partners in these cooperative programs were mainly from East China (41 programs, 49.40%), while foreign partners were mainly from Europe (39 programs, 46.99%). The mean duration of these programs was (3.61±0.88) years, with an enrollment of (87.08±35.52) students. Most of the students were included in National General Higher Education Enrollment Plan (79 programs, 95.18%), and the main majors included nursing (39 programs, 46.99%), medical technology (19 programs, 22.89%), and clinical medicine (11 programs, 13.25%), with the main enrollment level of junior college (45 programs, 54.22%). Chinese partners in the cooperative programs mainly issued academic certificate (45 programs, 54.22%) or academic certificate plus degree certificate (36 programs, 43.37%), while most foreign partners did not issue such certificates (44 programs, 53.01%).Conclusions:There are several problems in Chinese-foreign cooperative education programs for medical majors, such as a limited number of programs, a significant regional difference, an imbalanced distribution of specialties, a low level of education, and inconsistency in issuance of certificates, which still requires further improvement and standardization. However, there are also high-level and high-quality programs for reference.
5.Effects of semen euryales mixture on kidney injury in lupus nephritis mice based on PI3K-AKT/NF-κB signaling pathway
Yiming CHEN ; Shangwen WU ; Qinghua XING ; Huan LI ; Songwei LI
Chinese Journal of Immunology 2025;41(9):2061-2066
Objective:To explore the effect and possible mechanism of Semen euryales mixture(QSHJ)on renal injury in lu-pus nephritis.Methods:The 14-week-old C57BL/6 mice were the control group of 8.The 14-week-old MRL/lpr mice were randomly di-vided into model group,QSHJ low,medium and high doses groups(7.48,14.95,29.90 g/kg),and prednisone group(5 mg/kg)of 8 mice each.The control group and the model group were given the same volume of normal saline by gavage once a day for 4 weeks.Urine was collected to detect urinary protein content.HE and PASM staining were used to observe renal tissue injury.The serum levels of Anti-dsDNA,IL-6 and TNF-α were detected by ELISA.The protein expressions of phosphatidylinositol 3-kinase(PI3K),phosphor-ylated PI3K(p-PI3K),protein kinase B(AKT),phosphorylated AKT(p-AKT),nuclear factor kappa B p65(NF-κB p65)and phos-phorylated NF-κB p65(p-NF-κB p65)were detected by Western blot.The protein expressions of PI3K,p-PI3K,AKT and p-AKT were detected by immunohistochemistry.The positive expression of NF-κB p65 was observed by immunofluorescence.Results:Com-pared with the control group,the urinary protein content in the model group increased significantly(P<0.05),the renal tissue was in-filtrated with inflammatory cells,and the tissue structure was destroyed obviously,the contents of Anti-dsDNA,IL-6 and TNF-α in se-rum were significantly increased(P<0.05),the expressions of p-PI3K/PI3K,p-AKT/AKT and p-NF-κB p65/NF-κB p65 were signifi-cantly increased(P<0.05),the protein expressions of p-PI3K and p-AKT were increased significantly(P<0.05),the positive expres-sion of NF-κB p65 was increased significantly.Compared with the model group,the urinary protein content of QSHJ low,medium and high doses groups and prednisone group decreased significantly(P<0.05),the infiltration of inflammatory cells in renal tissue was re-lieved,and the damage of tissue structure was alleviated.the contents of Anti-dsDNA,IL-6 and TNF-α in serum were significantly de-creased(P<0.05),the expressions of p-PI3K/PI3K,p-AKT/AKT and p-NF-κB p65/NF-κB p65 were significantly decreased(P<0.05),the protein expressions of p-PI3K and p-AKT were significantly decreased(P<0.05),the positive expression of NF-κB p65 flu-orescence was decreased.Conclusion:QSHJ can improve the pathological manifestations of renal tissue in MRL/lpr mice and alleviate the disease process.The mechanism may be related to the inhibition of PI3K-AKT/NF-κB signaling pathway in renal tissue and the re-duction of inflammatory response by QSHJ.
6.Differential Diagnosis of Prostate Cancer from Benign Prostatic Hyperplasia Using 5.0T Multiparametric MRI with Histogram Analysis
Chengfeng ZHENG ; Sen XING ; Xinghua LIU ; Wenbing ZENG ; Shaoxin XIANG ; Huan MA
Chinese Journal of Medical Imaging 2025;33(7):723-729
Purpose To evaluate the efficacy of ultra-high field 5.0T MRI combined with histogram analysis for diagnosing prostate cancer and benign prostatic hyperplasia.Materials and Methods This retrospective analysis included data from 63 patients with prostatic diseases at the Chongqing University Three Gorges Hospital from January to May 2024,comprising 31 cases of prostate cancer and 32 cases of benign prostatic hyperplasia.MRI sequences included T2WI,T1WI,diffusion-weighted imaging,intravoxel incoherent motion and T2 mapping.Histogram data of apparent diffusion coefficient,true diffusion coefficient,pseudo-diffusion coefficient,perfusion fraction and T2 relaxation time were calculated,and diagnostic efficacy was assessed using the area under the receiver operating characteristic curve.Results In prostate cancer,the 10th percentile,the 90th percentile,mean,median,and minimum values of histogram parameters from apparent diffusion coefficient,true diffusion coefficient,pseudo-diffusion coefficient,perfusion fraction and T2 mapping were significantly lower than those of benign prostatic hyperplasia(Z=-6.036--3.368,all P<0.05).Notably,the combined model of apparent diffusion coefficient,intravoxel incoherent motion and T2 mapping parameters achieved an the area under the curve of 0.987,with sensitivity and specificity of 96.77%and 96.87%,respectively.Conclusion This study confirms that 5.0T MRI histogram analysis technique demonstrates significant diagnostic efficacy in differentiating prostate cancer from benign prostatic hyperplasia.
7.Clinical trial on alendronate sodium combined with teriparatide in the treatment of patients with postmenopausal osteoporosis patients
Yan ZHU ; Lei-yu QIU ; Huan-xing LU
The Chinese Journal of Clinical Pharmacology 2025;41(1):26-30
Objective To explore the clinical efficacy and safety of alendronate sodium tablet combined with injection of recombinant teriparatide and calcium carbonate D3 tablet in the treatment of postmenopausal osteoporosis(PMDP).Methods The patients with postmenopausal osteoporosis were divided into control group and treatment group according to the cohort method according to the treatment regimen.The control group was treated with calcium carbonate D3 tablet(600 mg,1 tablet a day)and alendronate sodium tablet(70 mg,once a week),while the treatment group was given injection of reacombinant teriparatide(200 U/20 μg,20 μg every day)on the basis of the control group.Both groups were continuously treated for 6 months.The clinical efficacy was compared after 6 months of treatment.The bone mineral density(BMD)of lumbar spine,total hip and femoral neck and levels of bone metabolism indicators[osteocalcin(OCN),tartrate-resistant acid phosphatase-5b(TRAP-5b),procollagen type Ⅰ amino-terminal propeptide(PINP),C-terminal cross-linked peptide of type Ⅰ collagen(CTX-Ⅰ)]before treatment and after 6 months of treatment and bone pain[visual analogue scale(VAS)]and quality of life[European Foundation Osteoporosis Quality of Life Questionnaire(ECOS-16)]before treatment and after 3 and 6 months of treatment were recorded,and the adverse drug reactions within 6 months of treatment were compared.Results Fifty-two cases in treatment group and 64 cases in control group were enrolled.After treatment,the total effective rates in treatment group and control group were 87.80%(36 cases/41 cases)and 68.29%(28 cases/41 cases),respectively(P<0.05).The BMD values of lumbar spine in treatment group and control group after treatment were(0.69±0.15)and(0.79±0.18)g·cm-2;the BMD values of total hip were(0.70±0.11)and(0.77±0.15)g·cm-2;the BMD values of femoral neck were(0.79±0.19)and(0.87±0.15)g·cm-2,respectively;the OCN levels were(7.42±1.53)and(5.37±1.16)μg·L-1;the PINP levels were(85.31±5.66)and(76.30±5.49)ng·mL-1;the TRAP-5b levels were(3.27±0.46)and(5.16±0.72)U·L-1;the CTX-Ⅰ levels were(3.37±0.54)and(5.08±0.70)ng·mL-1;the VAS scores were(1.48±0.13)and(2.07±0.24)points;the ECOS-16 scores were(24.84±4.62)and(32.71±6.07)points,and there were statistical differences in the above indicators between treatment group and control group(all P<0.05).The main adverse drug reactions in treatment group were rash,dizziness and limb pain,and the main adverse drug reactions in control group were rash,dizziness,nausea,and limb pain,and the total incidence rates of adverse reactions in treatment group and control group were 12.20%(5 cases/41 cases)and 19.51%(8 cases/41 cases)(P>0.05).Conclusion Alendronate sodium tablet combined with injection of recombinant teriparatide and calcium carbonate D3 tablet has a significant short-term efficacy on PMOP patients,and it can help to enhance the bone mineral density,reduce the symptoms of bone pain,and relieve the osteoporosis.
8.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.
9.Survey on service needs of family members of Neurosurgical Intensive Care Unit patients based on the Kano model
Ran ZHANG ; Fei WU ; Xin WANG ; Huan WANG ; Yana XING ; Weixin CAI
Chinese Journal of Modern Nursing 2025;31(6):705-712
Objective:To investigate and analyze the service needs of family members of Neurosurgical Intensive Care Unit patients and provide references for improving Neurosurgical Intensive Care Unit nursing services.Methods:Totally 270 family members of neurosurgical patients hospitalized between March and May 2024 at Intensive Care Unit of Beijing Tiantan Hospital, Capital Medical University were selected by convenience sampling. Kano Model-based Questionnaire on the Needs of Family Members of Neurosurgical Intensive Care Unit Patients designed based on literature review and expert consultation, was distributed to investigate their families service needs. The Kano model analysis was applied to categorize service needs and prioritize them, followed by constructing a satisfaction-importance quadrant diagram.Results:A total of 270 questionnaires were distributed, with 248 valid responses collected, yielding an effective response rate of 91.85% (248/270) . The Kano attribute analysis revealed that all service needs were classified as "expected attributes". The satisfaction-importance quadrant diagram indicated that 10 items were located in the "advantage zone", nine items in the "retention zone", four items in the "observation zone", and seven items in the "improvement zone".Conclusions:The Kano model-based analysis of service needs helps healthcare providers identify the diverse needs of family members of Neurosurgical Intensive Care Unit patients. It is recommended that while maintaining the provision of services in the "advantage zone", healthcare providers integrate hospital resources to continuously improve services in the "improvement zone" to enhance family satisfaction and strengthen hospital competitiveness.
10.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.

Result Analysis
Print
Save
E-mail