1.Multi-center clinical study on the efficacy and safety of combined lienal polypeptide injection therapy in children with Mycoplasma pneumoniae pneumonia
Qi CHENG ; Yunxiao SHANG ; Han ZHANG ; Jiujun LI ; Ning CHEN ; Lishen SHAN ; Nan YANG ; Lihua NING ; Xuemei BAI ; Jianhua LIU ; Yuling HAN ; Jichun WANG ; Jing LI ; Yong FENG ; Liyun LIU ; Li CHEN ; Si LIU ; Qinzhen ZHANG ; Jia ZHENG ; Fengchao LI ; Sukun LU ; Yun ZHANG ; Xiaoyi CHAI
International Journal of Pediatrics 2025;52(3):204-210
Objective:To observe the efficacy and safety of combined lienal polypeptide injection therapy in the treatment of Mycoplasma pneumoniae pneumonia(MPP)in children aged 3 to 14 years old in multiple clinical centers.Methods:A randomized,controlled,multi-center clinical study design was adopted.A total of 240 hospitalized children aged 3 to 14 years old with MPP from 7 hospitals from September 1,2023 to January 31,2024 were included.According to the severity of pneumonia,they were divided into the mild MPP group with 80 cases and the severe MPP/refractory MPP(SMPP/RMPP)group with 160 cases,and then randomly divided into the control group and the experimental group at a ratio of 1 ∶1,using the random number table method.After screening,subjects entered a treatment period of 5 to 7 days.The control group was treated with azithromycin,while the experimental group was treated with azithromycin plus lienal polypeptide injection .The recovery of lung CT,length of hospital stay,duration of fever,cough score,whether mild cases developed into severe or refractory cases,duration of hormone use,use of intravenous immunoglobulin(IVIG),bronchoscopy treatment,and immune function were observed between the two groups to evaluate the efficacy of lienal polypeptide injection.Adverse events after medication,vital signs,blood routine,urine routine,liver function,myocardial enzymes,renal function,and electrocardiogram were observed to evaluate the safety. Results:A total of 231 subjects have completed the trial in the 7 hospitals,including 118 cases in the experimental group and 113 cases in the control group.Main observation index:the rate of lung CT aggravation in the experimental group was lower than that in the control group(2.6% vs 15.3%, P<0.01),and the difference was statistically significant.Secondary indexes:there were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and immunoglobulin between the two groups(all P>0.05).However,the rate of cases of plastic bronchitis(PB)found under bronchoscopy in the experimental group was lower than that in the control group(0 vs 18.8%, P=0.03),and the difference was statistically significant.Among the mild MPP(72 cases),there were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and the improvement rate of lung CT between the two groups(all P>0.05).However,compared with the control group,the rate of cases developing into SMPP/RMPP in the experimental group was less(24.3% vs 48.6%, P=0.03),and the difference in IgG before and after treatment was small[0.53(-0.04,1.18)g/L vs 1.33(0.48,2.25)g/L, P=0.01].Among the SMPP/RMPP cases(159 cases),the rate of cases of PB found under bronchoscopy in the experimental group was less than that in the control group(0 vs 20%, P=0.04),and the rate of cases with aggravated lung CT in the experimental group was less than that in the control group(1.3% vs 19.5%, P<0.01),and the improvement rate of lung CT in the experimental group was higher than that in the control group(88.8% vs 75.3%, P=0.03),with statistically significant differences.There were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and immunoglobulin between the two groups(all P>0.05).Two cases in the experimental group developed rashes,which improved after the drug was discontinued.There were no serious adverse reactions such as abnormal vital signs like dyspnea and cyanosis due to the use of lienal polypeptide injection.There were no obvious changes in blood routine,liver function,myocardial enzymes,renal function,electrocardiogram,and urine routine values before and after medication compared with the baseline. Conclusion:The combined use of lienal polypeptide injection in the treatment of MPP in children can reduce the probability of the transformation from mild cases to SMPP/RMPP,reduce the rate of aggravation of the image findings,promote the absorption of lung inflammation,reduce the rate of PB found under bronchoscopy,and has good safety.
2.Evaluation of AlignRT-guided positioning workflow in pelvic tumor radiotherapy
Aoqiang CHEN ; Yajuan WANG ; Xiaotong HUANG ; Lu WU ; Dehuan XIE ; Xuemei CHEN
Chinese Journal of Medical Physics 2025;42(2):141-147
Objective To evaluate the accuracy and reproducibility of AlignRT-guided positioning by comparing two positioning workflows for pelvic tumor radiotherapy,and to further explore the feasibility of using it to replace skin marker alignment.Methods Forty cases of pelvic tumor treated with radiotherapy using Infinity accelerator in Sun Yat-sen University Cancer Center between March 2022 and March 2023 were included in the study,with 20 cases using the skin marker alignment workflow and the other 20 adopting AlignRT-guided positioning workflow.The translational errors(LAT,LNG,VRT)and rotational errors(Yaw,Pitch,Roll)were determined by the registration of pre-treatment cone-beam CT(CBCT)with planned CT.Both CBCT shifts and error offset distributions were analyzed;planning target volume(PTV)margins were calculated;and correlation analyses were conducted among six-dimensional errors,and between body mass index and setup errors.Results The median translational and rotational setup errors of skin marker alignment workflow vs AlignRT-guided positioning workflow were 0.19-0.34 cm vs 0.10-0.15 cm and 0.50°-1.30°vs 0.50°-0.70°,with the maximum offset ranges of 1.20-1.70 cm vs 0.42-0.47 cm and 2.00°-5.50° vs 1.80°-2.00°,respectively.Additionally,for skin marker alignment workflow,inter-fractional errors>0.5 cm and>3° were observed in 23.3%and 9.8%of fractions.The PTV margins of AlignRT-guided positioning workflow were 0.37,0.38 and 0.34 cm in the left-right,superior-inferior and anterior-posterior directions,respectively,which were much smaller than those of skin marker alignment workflow(0.67,1.22 and 0.95 cm).No correlation was found between six-dimensional errors in two positioning workflows.When using AlignRT-guided positioning workflow,the setup errors in LAT,LNG and Pitch directions had low correlations with body mass index.Conclusion In pelvic tumor radiotherapy,AlignRT-guided positioning can reduce translational and rotational errors,achieve precise setup and excellent inter-fractional reproducibility and stability,and replace traditional skin marker alignment while being used in conjunction with CBCT.
3.Ultra-long-term follow-up of renal denervation in patients with resistant hypertension and mild chronic kidney disease
Li WANG ; Hao ZHANG ; Chao LI ; Xuemei YIN ; Zhuqing LI ; Qiang HE ; Xiaoqiang SUN ; Dachuan XIA ; Deling KONG ; Chengzhi LU
Chinese Journal of Cardiology 2025;53(10):1119-1125
Objective:To investigate the ultra-long-term antihypertensive efficacy, safety, major adverse events, and survival benefits of renal denervation (RDN) in patients with resistant hypertension (rHTN) and mild chronic kidney disease (CKD).Methods:This real-world, single-center retrospective study enrolled patients with rHTN and mild CKD who underwent RDN at Tianjin First Central Hospital between October 2011 and June 2016. Office blood pressure, home self-measured blood pressure, 24-hour ambulatory blood pressure, serum creatinine, estimated glomerular filtration rate, and urine albumin-to-creatinine ratio were collected at baseline and at 1, 5, and 13 years post-RDN. The total daily defined dose of antihypertensive medications at 13 years post-RDN was recorded, along with endpoint events during follow-up, including cardiovascular death, all-cause death, hospitalization for heart failure, myocardial infarction, and stroke. Patients were stratified according to CKD stage (G1-G2 vs. G3a) and baseline systolic blood pressure (mild-to-moderate vs. severe hypertension), and follow-up data were compared across subgroups.Results:A total of 40 patients were included, aged (51±15) years, including 26 (65%) males. At the 13-year follow-up, office systolic blood pressure (SBP) and diastolic blood pressure (DBP) decreased by (-32±20) mmHg and (-15±14) mmHg (1 mmHg=0.133 kPa), respectively; reductions in home self-measured blood pressure (SBP: (-25±14) mmHg, DBP: (-10±11) mmHg) and 24-hour ambulatory blood pressure (SBP: (-16±9 mmHg, DBP: (-10±6) mmHg) were also observed, alongside a reduction in the total daily defined dose of antihypertensive medications by (1.1±0.9) compared to baseline. Renal function assessments showed no significant differences at 13 years versus baseline in serum creatinine ((105±51) μmol/L vs. (96±22) μmol/L), estimated glomerular filtration rate ((72±22) ml·min -1·1.73 m -2 vs. (78±17) ml·min -1·1.73 m -2), or urine albumin-to-creatinine ratio ((101±86) mg/g vs. (127±82) mg/g) (all P>0.05). All-cause and cardiovascular mortality rates during follow-up were 13% (5/40) and 8% (3/40), respectively. Subgroup analysis results showed that, although CKD G1-G2 patients had smaller reductions in office SBP ((-31±20) mmHg vs. (-34±19) mmHg) and DBP ((-13±10) mmHg vs. (-25±18) mmHg) compared to G3a patients at 13 years, intergroup differences were not significant (all P>0.05). In contrast, severe hypertension subgroup exhibited greater reductions in office SBP ((-55±13) mmHg vs. (-20±10) mmHg) and DBP ((-24±17) mmHg vs. (-13±10) mmHg) versus mild-to-moderate hypertension subgroup (all P<0.05). Conclusion:RDN demonstrates sustained antihypertensive efficacy with favorable renal safety in rHTN patients with mild CKD. Patients with higher baseline systolic blood pressure may exhibit better responsiveness to RDN.
4.Clinical characteristics of juvenile dermatomyositis in anti-nuclear matrix protein 2 antibody-positive patients and risk factors for severity: a national multicenter retrospective study
Huiyuan YANG ; Wanzhen GUAN ; Ling2 YANG ; Haimei LIU ; Xiaoqing3 LI ; Haiguo YU ; Meiping LU ; Jun YANG ; Xiaohui LIU ; Hongxia ZHANG ; Wei ZHANG ; Jihong XIAO ; Xiaozhong LI ; Guomin LI ; Hong CHANG ; Sheng HAO ; Yue DU ; Daliang XU ; Ling WU ; Wenjie ZHENG ; Li LIU ; Xinhui JIANG ; Shaohui ZHU ; Dongmei ZHAO ; Xuemei TANG ; Li SUN
Chinese Journal of Pediatrics 2025;63(12):1299-1305
Objective:To investigate the clinical characteristics and independent risk factors of severe disease in patients with anti-nuclear matrix protein (NXP) 2 antibody-positive juvenile dermatomyositis (JDM).Methods:A retrospective cohort study was conducted, including 219 anti-NXP2 antibody-positive JDM patients admitted to 23 children′s hospitals across China from July 2011 to July 2023. Patients were classified into severe and non-severe groups based on classification criteria for severe dermatomyositis. Demographic characteristics, clinical manifestations, and laboratory parameters were compared between the 2 groups using independent sample t-test, Mann-Whitney U test, or χ2 test. Univariate and multivariate Logistic regression analyses were performed to identify risk factors for severe disease. The receiver operating characteristic curve was employed to calculate optimal cut-off values. Results:Among the 219 patients, 108 were male and 111 were female, with an age at onset of 6.3 (3.5, 9.4) years. The severe group comprised 69 patients, and the non-severe group 150 patients. The severe group had significantly higher rates of fever, heliotrope rash, subcutaneous edema, periorbital edema, anti-Ro52 antibody positivity, as well as elevated levels of ferritin-to-albumin ratio (FAR), creatine kinase (CK), aspartate aminotransferase (AST), and lactate dehydrogenase (LDH) (all P<0.05). Multivariate analysis identified anti-Ro52 antibody positivity ( OR=13.26, 95% CI 1.37-128.29) and elevated FAR ( OR=1.90, 95% CI 1.09-2.31) as independent risk factors for severe anti-NXP2 antibody-positive JDM (both P<0.05). Receiver operating characteristic curve analysis revealed that a FAR cutoff value of 6.82 predicted severe disease with an area under the curve of 0.87 (95% CI 0.81-0.94, P<0.001), sensitivity of 0.85, and specificity of 0.70. All patients received glucocorticoid therapy, and the severe group received higher proportions of steroid pulse therapy, cyclophosphamide, mycophenolate mofetil, intravenous immunoglobulin, biologics, and adjuvant treatments compared to the non-severe group (all P<0.05). In terms of outcomes, 2 patients (2.9%) in the severe group died (due to neurological involvement and intestinal perforation, respectively), while the remaining patients achieved complete clinical response or remission. All patients in the non-severe group achieved remission. Conclusions:The primary clinical features of anti-NXP2 antibody-positive JDM included fever, heliotrope rash, subcutaneous edema, periorbital edema, anti-Ro52 antibody positivity, and elevated levels of CK, AST, LDH, and FAR. Furthermore, anti-Ro52 antibody positivity and a FAR>6.82 were identified as independent risk factors.
5.Development of a clinical practice training system for postgraduate graduates of the oral nursing profession
Lixia KUANG ; Yu ZHANG ; Lu BAI ; Guangma WANG ; Jingyan YU ; Xuemei YANG ; Liyan MAO ; Xiaoqin BI
Chinese Journal of Practical Nursing 2025;41(23):1765-1772
Objective:To construct a clinical practice training system for master′s degree students specializing in oral nursing based on the competency iceberg model for job performance, and to provide a valuable reference for the clinical training of master′s students in oral nursing.Methods:The research team initially formulated the components of the clinical practice training system through an extensive literature review and semi-structured interviews. From October 17, 2023, to November 13, 2023, the Delphi expert consultation methodology was utilized to facilitate two rounds of inquiries involving 20 specialists in the domain of oral care.Results:The positive coefficients of the two rounds of expert inquiries were 95.24% (20/21) and 100.00% (21/21). The authority coefficients were 0.925 and 0.929, while the variation coefficients ranged from 0.00 to 0.22 and from 0.05 to 0.11. Additionally, Kendall′s harmony coefficients were 0.229 and 0.319 (both P<0.01). The finalized training system included training objectives, training content, training requirements and examinations, totaling 3 first-level items, 18 second-level items and 67 third-level items. Conclusions:The training system of clinical practice for oral nursing graduate students constructed in this study is informative and reliable, and can provide reference for clinical practice of professional postgraduates in oral nursing.
6.Blood Concentration Monitoring and Influencing Factors of Unbound Teicoplanin
Jing WANG ; Zejun WU ; Lu JIN ; Xuemei LUO ; Huaijun ZHU
Herald of Medicine 2025;44(2):293-298
Teicoplanin,currently one of the preferred drugs for treating infections caused by multidrug-resistant Staphylococcus aureus and Enterococcus in clinical practice,has a high plasma protein binding rate.Most of the drug binds to protein after entering the body,only a portion of the drug exists in a free form.Since the free drug can pass through biological membranes and enter the target tissue to exert its therapeutic effect,monitoring the free teicoplanin blood concentration is clinically important and plays a role in guiding individualized drug therapy.This article summarizes and compares the current methods for determining the concentration of free teicoplanin in the blood,and analyzes their advantages and disadvantages.Based on this,it analyzes the possible factors affecting the concentration of free teicoplanin in the blood,providing a reference for the development of new methods for detecting free teicoplanin concentration and providing more accurate individualized medication plans based on free concentration.
7.Current status of orthopedic nurses' health science popularization information generation capacity and training needs in 54 hospitals in Beijing
Yaping XU ; Yao JIANG ; Yuhuan LIANG ; Shuang LI ; Sujun GUO ; Xuemei LU
Chinese Journal of Modern Nursing 2025;31(11):1472-1478
Objective:To explore the current status of orthopedic nurses' health science popularization information generation capacity and training needs in Beijing.Methods:This study was a cross-sectional survey. Convenience sampling was used to select 818 orthopedic nurses from 54 hospitals (48 Class Ⅲ hospitals and 6 ClassⅡ hospitals) in Beijing in April 2024 for the study. General Information Questionnaire, Self-assessment Scale for Orthopedic Nurses' Health Science Popularization Information Generation Capacity, and Training Needs Scale for Orthopedic Nurses' Health Science Popularization Information Generation Capacity were used to survey the study participants. Multiple linear regression was used to analyze the factors influencing orthopedic nurses' health science popularization information generation capacity. A total of 818 questionnaires were distributed and 781 valid questionnaires were recovered, with a valid recovery rate of 95.48% (781/818) .Results:The 781 orthopedic nurses had a total score of [49.00 (42.00, 57.00) ] on the Self-assessment Scale for Orthopedic Nurses' Health Science Popularization Information Generation Capacity. Multiple linear regression analysis showed that years of working experience, health status, intention to participate in health science popularization, stage of health science popularization behavior, and frequency of participation in health science popularization training were the factors influencing orthopedic nurses' health science popularization information generation capacity ( P<0.05), which explained 17.30% of the total variation. Beijing orthopedic nurses had training needs in five areas of assessing audience needs, assessing message risk, revising and improving messages, generating messages, and pretesting messages. Conclusions:The Beijing orthopedic nurses' health science popularization information generation capacity is at a medium and high level, but there is still much room for improvement. It is recommended to pay attention to the physical and mental health of orthopedic nurses, improve the work commitment, and build a long-term incentive mechanism to stimulate the enthusiasm of orthopedic nurses in health science popularization. Medical institutions or specialty societies should actively formulate training programs, build training platforms, and gradually perfect the orthopedic nurses' health science popularization training system in order to comprehensively enhance the health science popularization information generation capacity and help China's great health.
8.Development of an evaluation index system for discharge preparation management in elderly patients with hip fractures
Yaping XU ; Qingxia LIU ; Jiaqi LIU ; Shizhen ZHAO ; Yunyang JIA ; Xuemei LU
Chinese Journal of Modern Nursing 2025;31(21):2882-2888
Objective:To develop an evaluation index system for discharge preparation management in elderly patients with hip fractures, providing a reference for clinical discharge planning.Methods:Guided by the operational definition of discharge readiness, a preliminary index system was constructed through literature review, semi-structured interviews, and expert group discussions. Using purposeful sampling, 22 experts were recruited for two rounds of expert consultation conducted between July and August 2024. The final index system was established based on expert consensus.Results:The effective response rates for the two Delphi rounds were 95.65% (22/23) and 100.00% (22/22) , respectively. The rates of feedback comments were 77.27% (17/22) and 40.91% (9/22) . The expert authority coefficients were 0.955 and 0.934, and the Kendall's coordination coefficients were 0.129 and 0.104, respectively (both P<0.01) . The final index system consisted of four first-level indicators, 16 second-level indicators, and 39 third-level indicators. Conclusions:The constructed evaluation index system demonstrates good scientific rigor and practical applicability. It can serve as a reference for the discharge preparation management of elderly patients with hip fractures.
9.Clinical features of recompensation in autoimmune hepatitis-related decompensated cirrhosis and related predictive factors
Xiaolong LU ; Lin HAN ; Huan XIE ; Lilong YAN ; Xuemei MA ; Dongyan LIU ; Xun LI ; Qingsheng LIANG ; Zhengsheng ZOU ; Caizhe GU ; Ying SUN
Journal of Clinical Hepatology 2025;41(9):1808-1817
ObjectiveTo investigate the clinical features and outcomes of recompensation in patients with autoimmune hepatitis (AIH)-related decompensated cirrhosis, to identify independent predictive factors, and to construct a nomogram prediction model for the probability of recompensation. MethodsA retrospective cohort study was conducted among the adult patients with AIH-related decompensated cirrhosis who were admitted to The Fifth Medical Center of PLA General Hospital from January 2015 to August 2023 (n=211). The primary endpoint was achievement of recompensation, and the secondary endpoint was liver-related death or liver transplantation. According to the outcome of the patients at the end of the follow-up, the patients were divided into the recompensation group (n=16) and the persistent decompensation group(n=150).The independent-samples t test was used for comparison of normally distributed continuous data with homogeneity of variance, and the Mann-Whitney U rank sum test was used for comparison of non-normally distributed continuous data with heterogeneity of variance; the chi-square test or the Fisher’s exact test was used for comparison of categorical data between groups; the Kaplan-Meier method was used for survival analysis; the Cox proportional-hazards regression model was used to identify independent predictive factors, and a nomogram model was constructed and validated. ResultsA total of 211 patients were enrolled, with a median age of 55.0 years and a median follow-up time of 44.0 months, and female patients accounted for 87.2%. Among the 211 patients, 61 (with a cumulative proportion of 35.5%) achieved recompensation. Compared with the persistent decompensation group, the recompensation group had significantly higher white blood cell count, platelet count (PLT), total bilirubin (TBil), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bile acid, prothrombin time, international normalized ratio (INR), SMA positive rate, Model for End-Stage Liver Disease (MELD) score, Child-Pugh score, and rate of use of glucocorticoids (all P0.05), as well as significantly lower age at baseline, number of complications, and death/liver transplantation rate (all P0.05). At 3 and 12 months after treatment, the recompensation group had continuous improvements in AST, TBil, INR, IgG, MELD score, and Child-Pugh score, which were significantly lower than the values in the persistent decompensation group (all P0.05), alongside with continuous increases in PLT and albumin, which were significantly higher than the values in the persistent decompensation group (P0.05). The multivariate Cox regression analysis showed that baseline ALT (hazard ratio [HR]=1.067, 95% confidence interval [CI]: 1.010 — 1.127, P=0.021), IgG (HR=0.463,95%CI:0.258 — 0.833, P=0.010), SMA positivity (HR=3.122,95%CI:1.768 — 5.515, P0.001), and glucocorticoid therapy (HR=20.651,95%CI:8.744 — 48.770, P0.001) were independent predictive factors for recompensation, and the nomogram model based on these predictive factors showed excellent predictive performance (C-index=0.87,95%CI:0.84 — 0.90). ConclusionAchieving recompensation significantly improves clinical outcomes in patients with AIH-related decompensated cirrhosis. Baseline SMA positivity, a high level of ALT, a low level of IgG, and corticosteroid therapy are independent predictive factors for recompensation. The predictive model constructed based on these factors can provide a basis for decision-making in individualized clinical management.
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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