1.Staged Characteristics of Mitochondrial Energy Metabolism in Chronic Heart Failure with Heart-Yang Deficiency Syndrome and Prescription Intervention from Theory of Reinforcing Yang
Zizheng WU ; Xing CHEN ; Lichong MENG ; Yao ZHANG ; Peng LUO ; Jiahao YE ; Kun LIAN ; Siyuan HU ; Zhixi HU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):129-138
Chronic heart failure (CHF) is a complex clinical syndrome caused by ventricular dysfunction, with mitochondrial energy metabolism disorder being a critical factor in disease progression. Heart-Yang deficiency syndrome, as the core pathogenesis of CHF, persists throughout the disease course. Insufficiency of heart-Yang leads to weakened warming and propelling functions, resulting in the accumulation of phlegm-fluid, blood stasis, and dampness. This eventually causes Qi stagnation with phlegm obstruction and blood stasis with water retention, forming a vicious cycle that exacerbates disease progression. According to the theory of reinforcing Yang, the clinical experience of the traditional Chinese medicine (TCM) master Tang Zuxuan in treating CHF with heart-Yang deficiency syndrome, and achievements from molecular biological studies, this study innovatively proposes an integrated research framework of "TCM syndrome differentiation and staging-mitochondrial metabolism mechanisms-intervention with Yang-reinforcing prescriptions" which is characterized by the integration of traditional Chinese and Western medicine. Heart-Yang deficiency syndrome is classified into mild (Stage Ⅰ-Ⅱ), severe (Stage Ⅲ), and critical (Stage Ⅳ) stages. The study elucidates the precise correlations between the pathogenesis of each stage and mitochondrial metabolism disorders from theoretical, pathophysiological, and therapeutic perspectives. The mild stage is characterized by impaired biogenesis and substrate-utilization imbalance, corresponding to heart-Yang deficiency and phlegm-fluid aggregation. Linggui Zhugantang and similar prescriptions can significantly improve the expression of peroxisome proliferator-activated receptor gamma co-activator-1α(PGC-1α)/silent information regulator 2 homolog 1 (SIRT1) and ATPase activity. The severe stage centers on oxidative stress and structural damage, reflecting Yang deficiency with water overflow and phlegm-blood stasis intermingling. At this stage, Zhenwu Tang and Qiangxin Tang can effectively mitigate oxidative stress damage, increase adenosine triphosphate (ATP) content, and repair mitochondrial structure. The critical stage arises from calcium overload and mitochondrial disintegration, leading to the collapse of Yin-Yang equilibrium. At this stage, Yang-restoring and crisis-resolving prescriptions such as Fuling Sini Tang and Qili Qiangxin capsules can inhibit abnormal opening of the mitochondrial permeability transition pore (MPTP), reduce cardiomyocyte apoptosis rate, and protect mitochondrial function. By summarizing the characteristics of mitochondrial energy metabolism disorders at different stages of CHF, this study explores the application of the theory of reinforcing Yang in treating heart-Yang deficiency syndrome and provides new insights for the clinical diagnosis and treatment of CHF.
2.Danhong Injection Regulates Ventricular Remodeling in Rat Model of Chronic Heart Failure with Heart-Blood Stasis Syndrome via p38 MAPK/NF-κB Signaling Pathway
Zizheng WU ; Xing CHEN ; Jiahao YE ; Lichong MENG ; Yao ZHANG ; Junyu ZHANG ; Zhixi HU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):149-159
ObjectiveTo explore the mechanism of ventricular remodeling mediated by the p38 mitogen-activated protein kinase (MAPK)/nuclear factor kappa B (NF-κB) signaling pathway in the rat model of chronic heart failure (CHF) with heart-blood stasis syndrome, as well as the intervention effect of Danhong injection. MethodsIn vivo experiment: SPF-grade male SD rats were assigned via the random number table method into 4 groups: Sham operation, model, captopril (8.8 mg·kg-1), and Danhong injection (6.0 mL·kg-1). The model of CHF with heart-blood stasis syndrome was established by abdominal aortic constriction, and the sham operation group only underwent laparotomy without constriction. All the groups were treated continuously for 15 days. The tongue color of rats was observed. Echocardiography, hemorheology, heart mass index (HMI), and left ventricular mass index (LVMI) were measured. Hematoxylin-eosin (HE) staining and Masson staining were performed to observe the pathological and fibrotic changes of the myocardial tissue. Enzyme-linked immunosorbent assay (ELISA) was employed to quantify the levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP), interleukin-6 (IL-6), angiotensin Ⅱ (AngⅡ), tumor necrosis factor-α (TNF-α), and Creactive protein (CRP) in the serum, as well as the levels of matrix metalloproteinase-2 (MMP-2) and matrix metalloproteinase-9 (MMP-9) in the myocardial tissue. Western blot was used to quantify the protein levels of p-p38 MAPK/p38 MAPK and p-NF-κB p65/NF-κB p65 in the myocardial tissue. In vitro experiment: H9C2 cardiomyocytes were treated with 1×10-6 mol·L-1 AngⅡ to establish a model of myocardial hypertrophy. H9C2 cardiomyocytes were allocated into normal, model, inhibitor + Danhong injection, Danhong injection (20 mL·L-1), and inhibitor (SB203580, 5 μmol·L-1) groups. CCK-8 assay was used to detect the viability of H9C2 cardiomyocytes. Rhodamine-labeled phalloidin staining was used to reveal the area of cardiomyocytes. Real-time PCR was performed to determine the mRNA levels of atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP). Western blot was used to assess the protein levels of p-p38 MAPK/p38 MAPK and p-NF-κB p65/NF-κB p65. ResultsIn vivo experiment: Compared with the sham operation group, the model group showed purplish-dark tongue with decreased R, G, B values of the tongue surface (P<0.01), increased whole blood viscosity (at low, medium, and high shear rates) (P<0.01), decreased left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) (P<0.01), increased left ventricular end-diastolic diameter (LVIDd), left ventricular end-systolic diameter (LVIDs), and left ventricular posterior wall thickness at end-diastole (LVPWd) (P<0.01), raised LVMI and HMI (P<0.01), and elevated levels of NT-proBNP, TNF-α, IL-6, and CRP in the serum and MMP-2 and MMP-9 in the myocardial tissue (P<0.01). The HE and Masson staining of the myocardial tissue showed compensatory myocardial hypertrophy, fibrosis, and massive inflammatory cell infiltration in the model group. Additionally, the model group presented up-regulated protein levels of p-p38 MAPK/p38 MAPK and p-NF-κB p65/NF-κB p65 in the myocardial tissue (P<0.01). Compared with the model group, each administration group showed increased R, G, B values of the tongue surface (P<0.05, P<0.01), decreased whole blood viscosity (at low, medium, and high shear rates) (P<0.05, P<0.01), increased LVEF and LVFS (P<0.01), decreased LVIDd, LVIDs, and LVPWd (P<0.05, P<0.01), declined LVMI and HMI (P<0.05, P<0.01), and lowered levels of NT-proBNP, TNF-α, IL-6, and CRP in the serum and MMP-2 and MMP-9 in the myocardial tissue (P<0.01). HE and Masson staining showed alleviated compensatory myocardial hypertrophy, reduced fibrosis, and decreased expression of p-p38 MAPK/p38 MAPK and p-NF-κB p65/NF-κB p65 in the myocardial tissue (P<0.01). In vitro experiment: When the concentration of Danhong injection reached 20 mL·L-1, the survival rate of H9C2 cardiomyocytes was the highest (P<0.01). Compared with the normal group, the model group showed up-regulated mRNA levels of ANP and BNP (P<0.01), increased relative cell surface area (P<0.01), and raised protein levels of p-p38 MAPK/p38 MAPK and p-NF-κB p65/NF-κB p65 (P<0.01). Compared with the model group, each administration group showed down-regulated mRNA levels of ANP and BNP (P<0.01), reduced relative cell surface area (P<0.05, P<0.01), and down-regulated protein levels of p-p38 MAPK/p38 MAPK and p-NF-κB p65/NF-κB p65 (P<0.05, P<0.01). ConclusionDanhong injection can regulate ventricular remodeling through the p38 MAPK/NF-κB pathway, thereby exerting a protective effect on the rat model of CHF with heart-blood stasis syndrome.
3.Integrated Optical and Magnetic Navigation for Simplified Percutaneous Transforaminal Endoscopic Lumbar Discectomy: A Novel Approach
Xing-Chen YAO ; Jun-Peng LIU ; Xin-Ru DU ; Li GUAN ; Yong HAI ; Jincai YANG ; Aixing PAN
Neurospine 2025;22(1):297-307
Objective:
This study aims to evaluate the clinical benefits of the integrated optical and magnetic surgical navigation system in assisting transforaminal endoscopic lumbar discectomy (TELD) for the treatment of lumbar disc herniation (LDH).
Methods:
A retrospective analysis was conducted on patients who underwent TELD for LDH at Beijing Chaoyang Hospital, Capital Medical University from November 2022 to December 2023. Patients treated with the integrated optical and magnetic surgical navigation system were defined as the navigation-guided TELD (Ng-TELD) group (30 cases), while those treated with the conventional x-ray fluoroscopy method were defined as the control group (31 cases). Record and compare baseline characteristics, surgical parameters, efficacy indicators, and adverse events between the 2 patient groups.
Results:
The average follow-up duration for the 61 patients was 11.8 months. Postoperatively, both groups exhibited significant relief from back and leg pain, which continued to improve over time. At the final follow-up, patients’ lumbar function and quality of life had significantly improved compared to preoperative levels (p < 0.05). The Ng-TELD group had significantly shorter total operation time (58.43 ± 12.37 minutes vs. 83.23 ± 25.90 minutes), catheter placement time (5.83 ± 1.09 minutes vs. 15.94 ± 3.00 minutes), decompression time (47.17 ± 11.98 minutes vs. 67.29 ± 24.23 minutes), and fewer intraoperative fluoroscopies (3.20 ± 1.45 vs. 16.58 ± 4.25) compared to the control group (p < 0.05). There were no significant differences between the groups in terms of efficacy evaluation indicators and hospital stay. At the final follow-up, the excellent and good rate of surgical outcomes assessed by the MacNab criteria was 98.4%, and the overall adverse event rate was 8.2%, with no statistically significant differences between the groups (p > 0.05).
Conclusion
This study demonstrates that the integrated optical and magnetic surgical navigation system can reduce the complexity of TELD, shorten operation time, and minimize radiation exposure for the surgeon, highlighting its promising clinical potential.
4.Functional requirements and construction requirements for infection prevention and control system in medical institutions
Chengxue MA ; Zhenghao YU ; Yubin XING ; Haiyan ZHOU ; Mingmei DU ; Rui HUO ; Jian LIN ; Chunping CHEN ; Yunxi LIU ; Hongwu YAO
Chinese Journal of Nosocomiology 2025;35(18):2816-2820
OBJECTIVE To systematically analyze the functional system and construction requirements for infection prevention and control('infection control system'in short)in medical institutions so as to facilitate the effective,standardized and practical construction of the infection control system.METHODS The questionnaires were de-signed based on the relevant criteria and literatures that were released in China with the combination of expect con-sultant and were distributed to experts or professionals involving multiple fields such as hospital infection manage-ment,clinical medical treatment and information technology.The questionnaires were recycled,summarized and analyzed.RESULTS The list of functions of the infection control system(consultative draft)was formulated after review of literatures and expert consultation,including fundamental functions such as data management,case sur-veillance and intervention feedback as well as the advanced functions like target surveillance,occupational protec-tion and interconnection.The surveyed subjects agreed unanimously after the questionnaire survey that all of the function modules and elements enlisted were important,the average score of importance was more than 4 points,the score of coefficient of variable(CV)for importance of the function modules was less than 0.25,indicating that there was high consistency in the opinions among the surveyed subjects.The element of tracing and epidemiologi-cal survey function was adopted and added according to the feedback suggestions from some of the subjects;two function elements including data query and clinical interaction were revised,and the list of function requirements for the infection control systems was finally defined.CONCLUSION The requirements for functions of the infection control system that are determined in the study can provide important bases and data support for the research and standardized development of future infection control system.
5.Ameliorative effects of tea on metabolic disorders in obesity mice induced by high-fat diet
Chen WANG ; Xiang BAN ; Jia-xing LIU ; Si-yao SANG ; Xue AO ; Ming-jie SU ; Bin-wei HU ; Hui LI
Fudan University Journal of Medical Sciences 2025;52(3):393-402
Objective To investigate the ameliorative effects and mechanisms of six types of tea(green tea,cyan tea,red tea,white tea,black tea and yellow tea)on metabolic disorders in obesity mice induced by high-fat diet(HFD).Methods Four-week-old male C57BL/6J mice were randomly divided into 8 groups with 7 mice per group.An HFD-induced obese mouse model was established,and the mice in control group maintained on standard diet followed by intragastric administration of different teas for 5 weeks.The body weight,liver weight ratio,fasting blood glucose,and lipid profile of the mice were measured to assess glucose and lipid metabolism.Serum inflammatory factors including IL-6,tumor necrosis factor-alpha(TNF-α)and oxidative stress markers[malondialdehyde(MDA)and superoxide dismutase(SOD)were measured.Additionally,liver histopathology and the expression of key glycolipid metabolism-related genes,adenosine monophosphate-activated protein kinase(AMPK)and carnitine palmitoyltransferase 1(CPT-1),were analyzed to explore underlying mechanisms.Results Cyan tea significantly suppressed weight gain,demonstrating superior weight control.White tea markedly reduced fasting blood glucose levels and decreased the area under the curve of oral glucose tolerance test(OGTT)and insulin tolerance test(ITT),indicating synergistic improvements in glucose metabolism and insulin sensitivity.Yellow tea exhibited exceptional anti-inflammatory and antioxidant effects,reducing hepatic IL-6 and MDA while enhancing SOD activity.Green tea activated the lipid oxidation pathway by upregulating AMPK/CPT-1 expression.All kinds of tea significantly attenuated hepatic lipid droplet accumulation.Conclusion All six types of tea alleviated metabolic disorders by reducing hepatic fat content in obesity mice.However,different types of tea exert their unique effects on improving metabolic disorders through differential mechanisms such as glucose metabolism regulation,lipid oxidation,and anti-inflammatory and antioxidant actions.
6.Effect of intra-aortic balloon counterpulsation combined with rhBNP on ventricular remodeling in elderly patients with acute anterior myocardial infarction before emergency PCI
Shengbo LI ; Ling FENG ; Beibei CHEN ; Fang YAO ; Yongsheng XING ; Yanbin LIU
The Journal of Practical Medicine 2025;41(5):699-703
Objective The effect of intra-aortic balloon counterpulsation combined with recombinant human brain natriuretic peptide(rhBNP)treatment on ventricular remodeling after percutaneous coronary intervention(PCI)in elderly patients with acute anterior wall myocardial infarction.Methods A retrospective analysis was con-ducted on 66 elderly patients with acute anterior myocardial infarction who underwent emergency PCI in our hospital from January 2018 to June 2023.They were divided into a control group(n=32)who underwent PCI+rhBNP,and a study group(n=32)who underwent PCI+rhBNP+intra-aortic balloon counterpulsation.Blood pressure,lactic acid level,mechanical complications,ventricular remodeling,inflammatory factors,myocardial enzymology,ox-LDL level were detected and compared between the two groups.Results Before treatment,Lactic acid,diastolic blood pressure,systolic blood pressure,left ventricular end-systolic diameter(LVESD),left ventricular end-diastolic diameter(LVEDD),left ventricular posterior wall thickness(LVPWT),left ventricular remodeling index(LVRI),left ventricular ejection fraction(LVEF),homocysteine(Hcy),interleukin-6(IL-6)and myocardial troponin were compared between the two groups.Myocardial troponin T(cTnT),lactate dehydrogenase(LDH),creatine kinase isoenzyme(CK-MB),oxidized low density lipoprotein(ox-LDL)levels(P>0.05);At 3 months follow-up after discharge,the levels of lactic acid,LVESD,LVEDD,LVPWT,LVRI,Hcy,IL-6,cTnT,LDH,CK-MB and ox-LDL were decreased,and the levels were lower in the study group,and the levels of diastolic blood pressure,systolic blood pressure and LVEF were increased,and the levels were higher in the study group(P<0.05).The pro-portion of mechanical complications between the two groups before and after treatment were compared(P>0.05).Conclusion In elderly patients with acute anterior myocardial infarction after emergency PCI,intra-aortic balloon counterpulsation combined with rhBNP could alleviate ventricular remodeling,myocardial injury,reduce inflamma-tory injury,improve oxidative stress response,and regulate tissue perfusion.
7.Predictive performance of white blood cell count,D-dimer and NT-proBNP for major adverse cardi-ovascular events in elderly patients with acute ST-segment elevation myocardial infarction
Wen-xing ZHANG ; Guang-yao YANG ; Lin-hu XIA ; Lu-hua PAN ; Duo-xue CHEN
Chinese Journal of cardiovascular Rehabilitation Medicine 2025;34(4):526-532
Objective:This study aims to investigate the predictive performance of serum levels of white blood cell count(WBC),D-dimer(D-D)and N-terminal pro-brain natriuretic peptide(NT-proBNP)for major adverse cardiovascular events(MACE)in elderly patients with acute ST-segment elevation myocardial infarction(ASTE-MI).Methods:A total of 70 elderly patients with ASTEMI treated in Bozhou People's Hospital between April 2020 and May 2023 were prospectively selected as observation group.Incidence of MACE during 1-year follow-up were recorded,another 50 patients with unstable angina pectoris treated in our hospital simultaneously were selected as control group.Serum levels of WBC,D-D and NT-proBNP were compared among above groups.The receiver operating characteristic(ROC)curve was used to evaluate the predictive value of serum WBC,D-D and NT-proBNP for MACE in elderly patients with ASTEMI.A nomogram was established,and calibration curve and deci-sion curve analysis(DCA)were used to evaluate the performance of model.Results:A total of 40 cases(59.70%)experienced MACE during one-year follow-up.Compared to those in control group,patients in observation group had significant higher serum WBC[(11.43±1.98)×109/Lvs.(6.30±1.99)× 109/L],D-D[(0.91±0.20)mg/L vs.(0.47±0.18)mg/L]andNT-proBNP[(192.31±63.19)pg/ml vs.(114.05±22.79)pg/ml](P<0.001 all).Compared to participants without MACE,those with MACE had significantly higher serum WBC[(13.33±1.90)× 109/L vs.(10.27±0.98)× 109/L],D-D[(1.11±0.25)mg/L vs.(0.87±0.21)mg/L]and NT-proBNP[(238.73±50.22)pg/ml vs.(150.70±39.16)pg/ml](P<0.001 all).ROC analysis showed that the ar-ea under the curve(AUC)of the combined detection of serum WBC(AUC=0.791,95%CI 0.677~0.879),D-D(AUC=0.767,95%CI 0.650~0.859)and NT-proBNP(AUC=0.733,95%CI 0.614~0.832)was 0.916(95%CI 0.825~0.969),which was significantly higher than those of single detections(Z=2.386,4.953,3.190,P=0.017,0.004,<0.001).The total score of the nomogram model constructed based on the levels of WBC,D-D and NT-proBNP ranged from 70 to 126 points.The predicted incidence was basically consistent with the actual in-cidence.For the internal verification of the model,the AUC of ROC curve of the training set and the validation set was 0.863 and 0.926 respectively.The DCA curve was located above the critical curve,indicating that the model had a net benefit and good clinical effectiveness.Conclusion:Serum WBC,D-D and NT-proBNP significantly el-evated in elderly patients with ASTEMI.The combined detection of serum WBC,D-D and NT-proBNP levels has good predictive value for MACE in these patients.
8.Cytotoxicity of self-adhesive resin cement under different light treatment modes
Junchao LIU ; Yidan WNAG ; Mao YE ; Yunbo XING ; Hailiang YAO ; Zhuo CHEN ; Huili LIU
Journal of Practical Stomatology 2025;41(5):605-609
Objective:To assess the cytotoxicity of self-adhesive resin cement RelyXTM U200 on human periodontal ligament fibro-blasts(HPDLFs)under different light treatment modes.Methods:The self-adhesive resin cement RelyXTM U200 was cured by immediate light(A),intermittent light(B),delayed light(C)and no light(D)treatment respectively.The HPDLFs were cultured with the specimen extracts under different light modes.The proliferation ability and apoptosis level of the cells in the groups were detected by CCK-8 test and flow cytometry apoptosis test.SPSS 20.0 software was used to analyze the cytotoxicity of specimens to HPDLFs.Results:At 24 h after light treatment the cytoxicity(grade)of group A,B,C and D was 1,2,3 and 4,at 72 h 1,2,2 and 3,respectively.At 72 h,the apoptosis index(%)of the cells in A,B,C and D groups was 6.38%±0.94%,16.34%±1.67%,24.13%±1.43%and 38.34%±2.75%respecitvely.Conclusion:The cytotoxicity of self-adhesive resin cement is the greatest under no light treatment mode and the least under immediate light treatment mode.
9.Effect of intra-aortic balloon counterpulsation combined with rhBNP on ventricular remodeling in elderly patients with acute anterior myocardial infarction before emergency PCI
Shengbo LI ; Ling FENG ; Beibei CHEN ; Fang YAO ; Yongsheng XING ; Yanbin LIU
The Journal of Practical Medicine 2025;41(5):699-703
Objective The effect of intra-aortic balloon counterpulsation combined with recombinant human brain natriuretic peptide(rhBNP)treatment on ventricular remodeling after percutaneous coronary intervention(PCI)in elderly patients with acute anterior wall myocardial infarction.Methods A retrospective analysis was con-ducted on 66 elderly patients with acute anterior myocardial infarction who underwent emergency PCI in our hospital from January 2018 to June 2023.They were divided into a control group(n=32)who underwent PCI+rhBNP,and a study group(n=32)who underwent PCI+rhBNP+intra-aortic balloon counterpulsation.Blood pressure,lactic acid level,mechanical complications,ventricular remodeling,inflammatory factors,myocardial enzymology,ox-LDL level were detected and compared between the two groups.Results Before treatment,Lactic acid,diastolic blood pressure,systolic blood pressure,left ventricular end-systolic diameter(LVESD),left ventricular end-diastolic diameter(LVEDD),left ventricular posterior wall thickness(LVPWT),left ventricular remodeling index(LVRI),left ventricular ejection fraction(LVEF),homocysteine(Hcy),interleukin-6(IL-6)and myocardial troponin were compared between the two groups.Myocardial troponin T(cTnT),lactate dehydrogenase(LDH),creatine kinase isoenzyme(CK-MB),oxidized low density lipoprotein(ox-LDL)levels(P>0.05);At 3 months follow-up after discharge,the levels of lactic acid,LVESD,LVEDD,LVPWT,LVRI,Hcy,IL-6,cTnT,LDH,CK-MB and ox-LDL were decreased,and the levels were lower in the study group,and the levels of diastolic blood pressure,systolic blood pressure and LVEF were increased,and the levels were higher in the study group(P<0.05).The pro-portion of mechanical complications between the two groups before and after treatment were compared(P>0.05).Conclusion In elderly patients with acute anterior myocardial infarction after emergency PCI,intra-aortic balloon counterpulsation combined with rhBNP could alleviate ventricular remodeling,myocardial injury,reduce inflamma-tory injury,improve oxidative stress response,and regulate tissue perfusion.
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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