1.A study of the trajectory of arterial oxygen tension dynamics after successful resuscitation of cardiac arrest patients and its impact on prognosis.
Jie HU ; Lei ZHONG ; Dan ZONG ; Jianhong LU ; Bo XIE ; Xiaowei JI
Chinese Critical Care Medicine 2025;37(9):843-847
OBJECTIVE:
To construct a longitudinal trajectory model of arterial oxygen tension (PaO2) within 24 hours after cardiac arrest (CA).
METHODS:
A retrospective cohort study was conducted. CA patients admitted to the ICU from 2014 to 2015 were selected from the eICU Collaborative Research Database (eICU-CRD). Data about patients' demographic characteristics, history of comorbidities, laboratory test indicators within 24 hours of intensive care unit (ICU) admission [including all PaO2 data and arterial carbon dioxide tension (PaCO2)], vasopressor use, and clinical outcomes were extracted from the database. The primary outcome variable was all-cause in-hospital mortality. Group-based trajectory model (GBTM) were built based on the changes in PaO2 within 24 hours of ICU admission, and patients were grouped according to their initial static PaO2 values upon ICU admission. Multivariable adjusted Poisson regression analysis was used to compare the in-hospital mortality risk among patients in different PaO2 dynamic trajectory groups. Sensitivity analyses were performed using multivariable logistic regression and multivariable adjusted Poisson regression without imputation of missing values.
RESULTS:
A total of 3 866 CA patients were included. Three GBTM trajectory groups were identified based on PaO2 changes within 24 hours of ICU admission: Group-1 (low level first increased then decreased, 148 cases), Group-2 (sustained low level, 3 040 cases), and Group-3 (first high level then decreased, 678 cases). Significant differences were found among the three groups in age, body weight, maximum serum potassium, maximum PaCO2, minimum hemoglobin (Hb), vasopressor use, total hospitalization time, ICU stay, and hospital mortality. After incorporating variables with significant differences into the multivariable adjusted Poisson regression model, results showed that compared to Group-2 patients, patients in Group-1 and Group-3 had an increased risk of all-cause in-hospital mortality [Group-1 adjusted relative risk (aRR) = 1.20, 95% confidence interval (95%CI) was 1.02-1.41; Group-3 aRR = 1.11, 95%CI was 1.01-1.24]. Based on initial static PaO2 values at ICU admission, patients were divided into four groups: PaO2 < 100 mmHg (1 mmHg = 0.133 kPa; 1 217 cases), PaO2 100-200 mmHg (569 cases), PaO2 201-300 mmHg (547 cases), and PaO2 > 300 mmHg (1 082 cases). Multivariable adjusted Poisson regression analysis indicated a significant upward trend in aRR for the latter three groups compared to the PaO2 < 100 mmHg group. Sensitivity analyses revealed that compared to Group-2, patients in Group-1 and Group-3 had a significantly increased risk of all-cause in-hospital mortality (both P < 0.05).
CONCLUSIONS
Within 24 hours after return of spontaneous circulation in CA patients, PaO2 exhibits different dynamic trajectories, and patients with hyperoxia have an increased risk of in-hospital mortality.
Humans
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Retrospective Studies
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Hospital Mortality
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Heart Arrest/blood*
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Prognosis
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Oxygen/blood*
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Intensive Care Units
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Cardiopulmonary Resuscitation
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Male
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Female
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Middle Aged
2.Residual cell types,molecular expression profiles and quality assessment of in vitro cultured human thymic slices
Wanqing GUAN ; Guihua LUO ; Jingxuan HAN ; Qun XIANG ; Yunfei AN ; Lu ZHAO ; Jianhong MI ; Zeqing FENG ; Yuzhang WU
Journal of Army Medical University 2025;47(9):893-903
Objective To analyze the composition and function of residual cells in pre-transplantation human thymic slices by single-cell transcriptomics sequencing(scRNA-seq),and established a quality assessment method for thymic slices based on the expression levels of molecular markers in the culture supernatant.Methods The discarded thymus from 18 patients with congenital heart disease undergoing surgical treatment in Department of Cardiothoracic Surgery of Children's Hospital Affiliated to Chongqing Medical University from May 2023 to January 2024 were collected and prepared into thymic slices.After the slices were cultured in vitro for 14 d,scRNA-seq was employed to identify the residual cell types,and gene ontology(GO)and Kyoto encyclopedia of genes and genomes(KEGG)enrichment analysis was performed to analyze the biological function of the residual cells.Then based on the literature concerning thymic slice culture,the molecular markers indicating thymocyte function were screened out.ELISA was applied to detect the changes in protein levels of molecular markers in the supernatant.Receiver operating characteristic(ROC)curve was plotted and assess the value of the molecular markers in the supernatant in evaluating the quality of thymic slices with area under the curve(AUC).Then,the qualified and unqualified thymic slices determined by our obtained molecular markers were transplanted subcutaneously into male nude mice(6~8 weeks old,weighing 14~17 g),respectively,and the male nude mice without transplantation of the thymic slices served as control group.Flow cytometry and histologic analysis were utilized to observe the immune reconstitution after transplantation.Results ① scRNA-seq identified 11 cell types in thymic slices,dominated with epithelial cells,fibroblasts,and T cells.GO and KEGG enrichment analysis showed that epithelial cells were involved in enrichment entries related to chemotaxis,epithelial cell development,cell matrix adhesion and tight junction;fibroblasts were involved in enrichment entries related to extracellular matrix,epithelial cell proliferation,negative regulation of cell migration,and regulation of actin cytoskeleton;T cells were mainly related to T cell differentiation,regulation of T cell activation,T cell apoptosis,and T cell receptor signaling.② Molecular markers,CCL19,CCL21,CXCL12,CXCL16,IL16 and SELL were identified to indicate thymocyte function.Compared with the levels of the first day,the protein secretions of CCL19,CCL21,CXCL12 and CXCL16 were significantly increased during in vitro culture(P<0.05),while the protein secretions of IL16 and L-selectin(protein form of SELL)were significantly decreased(P<0.05).The combined predictor Pre1 from subset of cytokines(IL16 and L-selectin)had the highest value in the quality assessment of thymic slices after 1 d of culture(AUC=0.883),and the combined predictor Pre2 from subset of cytokines(CCL19,CCL21,CXCL12 and CXCL16)had the highest value in the quality assessment after 14 d of culture(AUC=0.948).③ Transplantation in nude mice indicated that the qualified thymic slices could develop to thymus structure in vivo,and effectively increase the proportion of T cells in peripheral blood(P<0.01),while the unqualified thymic slices could not obtain the reconstitution of T cell development.Conclusion The main residual component cells in thymic slices are epithelial cells,fibroblasts and T cells.IL16 and L-selectin can be used as potential indicators to determine the quality of donor thymic samples.CCL19,CCL21,CXCL12 and CXCL16 can effectively evaluate the quality of thymic slices before transplantation.
3.Establishment of real-time fluorescence quantitative PCR method for detecting the N subgenome of SARS-CoV-2
Taoli HAN ; Zhi ZHANG ; Jiaxin ZHAO ; Pan LU ; Yang JIAO ; Jianhong ZHAO ; Yan GAO ; Shiyao ZHANG ; Kuankuan LIU ; Yujie LIU ; Ru FAN ; Wenjing LI ; Lingli SUN
Chinese Journal of Experimental and Clinical Virology 2025;39(1):96-101
Objective:To establish a fluorescent quantitative RT-PCR assay based on N_sgRNA of SARS-CoV-2 and preliminarily apply it on real samples.Methods:Recombinant plasmid, specific primers and probes of N_sgRNA were designed and synthesized based on Wuhan-Hu-1/2019_MN908947 and synthesis mechanism of subgenomic RNA (sgRNA). Using recombinant plasmid as amplification templates, the optimal reaction conditions and reaction system were screened according to the Ct value, fluorescence intensity, and shape of amplification curve and was evaluated for sensitivity, reproducibility, and specificity. Meanwhile, the possibility of practical application of the method was explored by testing 172 clinical samples and 256 municipal wastewater samples. Results:A qRT-PCR assay for N_sgRNA in SARS-CoV-2 was initially established. The detection limit of the assay was 20 copies/mL, and the variation coefficients of in-batch (0.002%~0.767%) and batch to batch repetition (0.016%~0.752%) were less than 1%. Only N_sgRNA recombinant plasmid was detected in the specificity assay. So the method is more highly sensitive, specific and reproducible. The RatiosgRNA/ gRNA of clinical samples HK.3, EG.5.1, JN.1 and their sub-lineages and their corresponding urban sewage samples in epidemic period were significantly different ( P<0.05). There is a strong correlation between the median of RatiosgRNA/ gRNA in clinical samples and sewage samples in the same period (correlation coefficient r=1.000, P=0.010). Conclusions:In this study, a qRT-PCR method for detecting N_sgRNA of SARS-CoV-2 was established and the method has the characteristics of higher sensitivity, stronger specificity and better repeatability, and it can be used to detect SARS-CoV-2 infectivity.
4.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.
5.Multicenter study on the prediction of microvascular invasion in hepatocellular carcinoma using multiphase ultrasound imaging radiomics models
Yanhong HAO ; Juan CHEN ; Qin LU ; Ruining WANG ; Yuan SU ; Shanshan SHI ; Rui SHI ; Lingjie WANG ; Jianhong WANG ; Li YANG ; Liping LIU
Chinese Journal of Ultrasonography 2025;34(11):983-991
Objective:To construct and evaluate the predictive performance of a multiphase ultrasound radiomics model for microvascular invasion(MVI)in hepatocellular carcinoma(HCC).Methods:A total of 126 patients with pathologically confirmed HCC were retrospectively enrolled from 4 medical centers between May 2018 and July 2025,including the First Hospital of Shanxi Medical University,Shanxi Province Third People's Hospital,Changzhi People's Hospital,and the Organ Transplant Center of the Affiliated Hospital of Qingdao University. A total of 630 ultrasound images of the lesions in different phases were collected,from which 1 561 radiomic features were extracted. The patients from medical institutions in Shanxi Province were chosen as the training set( n=91),and the patients from the Organ Transplant Center of the Affiliated Hospital of Qingdao University were chosen as the validation set( n=35). In the training set,37.4%(34/91)patients presented MVI(+),whereas in the validation set,54.3%(19/35)patients presented MVI(+). Radiomics features were extracted from ultrasound images,and features related to the MVI(+)were selected through dimensionality reduction analysis. Five multiple machine learning algorithms were used to construct predictive models,which were then evaluated using an external validation set. The Radscore was calculated,and a nomogram was constructed combining Radscore with ultrasound and clinical characteristics to predict MVI. Results:The model combining radiomics features from the portal venous phase and the delay phase showed the best predictive performance in both the training and validation sets,with area under curve(AUC)values of 0.835 and 0.727,respectively. The prediction model developed using radiomics Radscore and clinical indicators could be represented and presented as a nomogram.Conclusions:The radiomics model based on multi-phase ultrasound offers a novel approach for non-invasive preoperative prediction of MVI in liver cancer. Furthermore,its integration with clinical features aids in optimizing clinical treatment strategies.
6.Impact of perineural invasion upon chemotherapy duration and survival benefit in stageⅢ colon cancer
Jianxun CHEN ; Weili ZHANG ; Weifeng WANG ; Jibin LI ; Xiaojun WU ; Zhenhai LU ; Dongbo XU ; Junzhong LIN ; Jianhong PENG
Chinese Journal of Gastrointestinal Surgery 2025;28(1):58-66
Objective:To investigate the prognostic impact of perineural invasion in patients with stageⅢ colon cancer and to clarify its guidance value for the duration of postoperative adjuvant chemotherapy.Methods:This study employed a retrospective cohort study method. It analyzed 426 patients with stageⅢ colon cancer who underwent radical surgery at Sun Yat-sen University Cancer Center and Longyan First Affiliated Hospital of Fujian Medical University, between April 2008 and June 2020. Inclusion criteria: patients received at least 3 months of adjuvant CapeOX therapy post-surgery, had complete pathological data, and were followed up for at least 12 months after the last chemotherapy. Among these patients, 231 were male, the median age was 59 (50~67) years, and 263 tumors were located in the right-sided colon. Postoperative pathology indicated that 107 cases (25.12%) had neural invasion, and 131 patients (30.75%) had vascular tumor thrombus. All patients received at least 4 cycles of postoperative CapeOX adjuvant chemotherapy, with 193 patients receiving 8 cycles and 233 patients receiving 4 to 7 cycles of adjuvant chemotherapy. The study analyzed the impact of neural invasion status and the duration of adjuvant chemotherapy on disease-free survival (DFS). Furthermore, within subgroups stratified by different risk levels (referencing the criteria proposed by the IDEA study: high risk: T4, N2 or T4N2; low risk: T3N1) and different neural invasion statuses, the impact of the duration of adjuvant chemotherapy on prognosis was analyzed.Results:The median follow-up time for the entire cohort was 94.00 months (55.27-128.80 months). Multivariate Cox analysis indicated that pathological T stage T4 (HR = 2.457, 95%CI: 1.499-4.029, P<0.001) and postoperative pathological confirmation of perineural invasion (HR = 2.465, 95% CI: 1.519-4.000, P<0.001) were independent adverse prognostic factors for 5-year DFS. In the perineural invasion-positive group, the 5-year DFS for patients who received 8 cycles of postoperative adjuvant CapeOX chemotherapy was 86.90%, compared to 58.22% for those who received 4-7 cycles, with statistically significant differences (both P<0.05). In the perineural invasion-negative group, the 5-year DFS for patients who received 8 cycles was 88.66%, compared to 90.99% for those who received 4-7 cycles, with no statistically significant differences ( P=0.929). Among IDEA high-risk patients with perineural invasion, the 5-year DFS was 91.81% for those who received 8 cycles versus 50.66% for those who received 4-7 cycles, showing a statistically significant difference ( P=0.003). In IDEA high-risk patients without perineural invasion, the 5-year DFS for those who received 8 cycles was 82.28% compared to 87.32% for those who received 4-7 cycles, with no statistically significant difference ( P=0.806). In the IDEA low-risk patients, no differences were observed in the 5-year DFS between patients receiving 8 cycles and those receiving 4-7 cycles of adjuvant CapeOX chemotherapy in both perineural invasion-positive and negative subgroups (both P>0.05). Conclusion:Perineural invasion serves as a significant prognostic factor for 5-year DFS in stage Ⅲ colon cancer patients who have undergone radical surgery and postoperative adjuvant chemotherapy. It can also be considered an important reference factor in deciding the duration of postoperative adjuvant chemotherapy.
7.Construction of entrustable professional activity indicators for non-anesthesiology residents during rotation in the department of anesthesiology
Xinxin SHAO ; Jianhong YE ; Xiaodan WU ; Lu YANG ; Qingchun LIANG ; Qin ZHOU
Chinese Journal of Medical Education Research 2025;24(9):1212-1217
Objective:To establish a framework of entrustable professional activity indicators for non-anesthesiology residents during rotation in the Department of Anesthesiology, standardize the training process, and provide an effective evaluation method.Methods:Based on literature review and discussions, a preliminary expert consultation questionnaire was developed. From July to November 2024, a modified Delphi method was adopted and relevant experts were invited to assess the importance, validity, and feasibility of each indicator using a 5-point Likert scale. The results were used to screen and refine the entrustable professional activity indicators for non-anesthesiology residents during rotation in the Department of Anesthesiology.Results:In the two rounds of expert consultation, the valid questionnaire return rate reached 100.00%, with an expert judgment basis coefficient of 0.73 and a familiarity coefficient of 0.90. Based on expert feedback, the final framework retained 3 first-level indicators and 12 second-level indicators. Modifications included renaming "Anesthesia Management" to "Anesthetic Drug Management", swapping the order of "Intraoperative Emergency Management" and "Airway Management", and removing the indicator "Resuscitation Assessment".Conclusions:This study preliminarily developed a framework of entrustable professional activity indicators for non-anesthesiology residents during rotation in the Department of Anesthesiology. The framework provides a simple and practical competency evaluation method for standardized training, which can enhance training quality and effectiveness.
8.Establishment and application of colloidal gold double-antibody sandwich assay for detection of Getah virus
Jiaxin TIAN ; Lijie CHANG ; Mingzhu ZHANG ; Jianhong LIU ; Xiangshu QIU ; Xinyu CAO ; Xiuxia HE ; Huijun LU
Chinese Journal of Veterinary Science 2025;45(8):1672-1678
Getah virus(GETV)is an arbovirus capable of infecting humans and vertebrates such as horses and pigs via blood-sucking mosquitoes,which is extremely harmful to the livestock indus-try.Current monitoring methods are time-consuming,costly,and dependent on specialized instru-ments.These characteristics hinder rapid detection in clinical samples.Therefore,the development of a simple,rapid,specific,and sensitive method for detecting GETV antigen is crucial for the pre-vention and control of GETV.In this study,a GETV E1 monoclonal antibody strain SD17/09-E1-mAb was prepared by a prokaryotic expression system for GETV E1 protein expression,and a col-loidal gold double-antibody sandwich assay encapsulating two strains of GETV E1 monoclonal an-tibody wasestablished.The results showed that the prepared colloidal gold test strips had good sen-sitivity and did not cross-react with other common porcine virus-positive tissue samples;the test strips had a high compliance rate with the IFA assay for GETV,and could be stored at 37 ℃ for one month and at room temperature for at least three months.In this study,a colloidal gold anti-surveillance test strip for rapid detection of GETV was successfully prepared,which provides a powerful tool for GETV detection.
9.Construction and Validation of a Predictive Model for Influencing Factors of Serum Uric Acid in Preeclampsia
Kun YAN ; Jin LU ; Jianhong ZHOU
Journal of Medical Research 2025;54(9):98-102,192
Objective To construct and validate a predictive model for influencing factors of serum uric acid(SUA)in preeclampsia(PE),providing a scientific basis for early identification and intervention.Methods This study collects 19 variables from 171 PE preg-nant women admitted to the Department of Obstetrics at Bengbu Third People's Hospital between March 1,2021 to June 30,2024 inclu-ding hospitalization number,age,height,weight,urine protein,gestational week,SUA,oral glucose tolerance test(OGTT),alanine aminotransferase(ALT),hemoglobin(HB),albumin(ALB),aspartate aminotransferase(AST),serum creatinine(SCR),triglycer-ides(TG),total cholesterol(TC),serum urea(SUR),low-density lipoprotein cholesterol(LDL),high-density lipoprotein choles-terol(HDL),and D-dimer(D2D).According to the expression level of SUA,the important variables affecting SUA were screened by LASSO,multi-factor Logistic and neural network model,and the nomogram prediction model was constructed.The predictive perform-ance and clinical utility of the model were validated using the receiver operating characteristic(ROC)curve,decision curve analysis(DCA),and calibration curve.Results Three variables-ALB(OR=0.893,95%CI:0.808-0.986),AST(OR=4.292,95%CI:2.043-9.016)and SCR(OR=4.2,95%CI:1.495-11.801)-were identified as significant influencing factors of SUA in PE pregnant women through LASSO,multivariate Logistic regression,and neural network models.A nomogram prediction model for SUA was success-fully established,achieving an ROC value of 0.7646.The net benefit range of DCA was 20%-100%,and the calibration curve showed high consistency with the ideal curve.Conclusion ALB,AST,and SCR are critical variables influencing SUA in PE pregnant women,offering a scientific basis for early prediction and intervention.
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.

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