1.Effectiveness of Xuanshen Yishen Decoction on Intensive Blood Pressure Control: Emulation of a Randomized Target Trial Using Real-World Data.
Xiao-Jie WANG ; Yuan-Long HU ; Jia-Ming HUAN ; Shi-Bing LIANG ; Lai-Yun XIN ; Feng JIANG ; Zhen HUA ; Zhen-Yuan WANG ; Ling-Hui KONG ; Qi-Biao WU ; Yun-Lun LI
Chinese journal of integrative medicine 2025;31(8):677-684
OBJECTIVE:
To investigate the effectiveness of Xuanshen Yishen Decoction (XYD) in the treatment of hypertension.
METHODS:
Hospital electronic medical records from 2019-2023 were utilized to emulate a randomized pragmatic clinical trial. Hypertensive participants were eligible if they were aged ⩾40 years with baseline systolic blood pressure (BP) ⩾140 mm Hg. Patients treated with XYD plus antihypertensive regimen were assigned to the treatment group, whereas those who followed only antihypertensive regimen were assigned to the control group. The primary outcome assessed was the attainment rate of intensive BP control at discharge, with the secondary outcome focusing on the 6-month all-cause readmission rate.
RESULTS:
The study included 3,302 patients, comprising 2,943 individuals in the control group and 359 in the treatment group. Compared with the control group, a higher proportion in the treatment group achieved the target BP for intensive BP control [8.09% vs. 17.5%; odds ratio (OR)=2.29, 95% confidence interval (CI)=1.68 to 3.13; P<0.001], particularly in individuals with high homocysteine levels (OR=3.13; 95% CI=1.72 to 5.71; P<0.001; P for interaction=0.041). Furthermore, the 6-month all-cause readmission rate in the treatment group was lower than in the control group (hazard ratio=0.58; 95% CI=0.36 to 0.91; P=0.019), and the robustness of the results was confirmed by sensitivity analyse.
CONCLUSIONS
XYD could be a complementary therapy for intensive BP control. Our study offers real-world evidence and guides the choice of complementary and alternative therapies. (Registration No. ChiCTR2400086589).
Adult
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Aged
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Female
;
Humans
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Male
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Middle Aged
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Antihypertensive Agents/pharmacology*
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Blood Pressure/drug effects*
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Drugs, Chinese Herbal/pharmacology*
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Hypertension/physiopathology*
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Patient Readmission
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Treatment Outcome
2.Analysis of diagnosis and treatment of IgG4-related disease involving the nasal cavity and skull base(with 8 case reports).
Wei ZHONG ; Xuan YUAN ; Lai MENG ; Jiaxin JIA ; Shaobing XIE ; Shumin XIE ; Junyi ZHANG ; Hua ZHANG ; Weihong JIANG ; Zhihai XIE
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(6):553-558
Objective:To investigate the clinical diagnosis and treatment of IgG4-related disease(IgG4-RD) primarily involving the nasal cavity and skull base. Methods:A retrospective analysis was conducted on the clinical data of 8 patients with IgG4-RD primarily involving the nasal cavity and skull base who visited the Nasal and Skull Base Surgery Department at Xiangya Hospital from October 2017 to January 2024. The cohort comprised 4 males and 4 females, aged 8 to 69 years. Clinical data, laboratory examination results, imaging findings, histopathological results, and treatment plans were collected. The clinical manifestations, diagnosis, treatment and follow-up results of IgG4-RD primarily involving nasal cavity and skull base were summarized and previous literature were also reviewed. Results:The initial symptoms in the 8 patients included nasal congestion, headache, sensory function decline, and facial deformities. Three patients also had parotid and pulmonary involvement. Among the 8 patients, 4 underwent partial surgical resection combined with glucocorticoid therapy; 1 underwent partial surgical resection combined with glucocorticoid and immunosuppressant therapy; 1 received glucocorticoid therapy alone; and 2 received glucocorticoid combined with immunosuppressant therapy. Follow-up was conducted one month after treatment, lasting from 5 to 79 months. During the follow-up period, recurrence was observed in 1 patient treated with glucocorticoid combined with immunosuppressants and in 1 patient treated with glucocorticoid alone, while the other 6 patients achieved significant remission. Conclusion:The diagnosis of nasal cavity and skull base IgG4-RD requires the combination of histopathology, laboratory tests, and imaging results. Treatment primarily includes glucocorticoids or combined immunosuppressants. For patients with significant compression symptoms, sensory function impairment, or facial deformities, surgical resection is an important treatment option. Given the high risk of recurrence, early intervention, active treatment, and long-term follow-up are crucial.
Humans
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Male
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Skull Base/pathology*
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Female
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Middle Aged
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Retrospective Studies
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Aged
;
Nasal Cavity/pathology*
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Adult
;
Immunoglobulin G4-Related Disease/therapy*
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Immunoglobulin G
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Child
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Young Adult
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Adolescent
3.Association of higher serum follicle-stimulating hormone levels with successful microdissection testicular sperm extraction outcomes in nonobstructive azoospermic men with reduced testicular volumes.
Ming-Zhe SONG ; Li-Jun YE ; Wei-Qiang XIAO ; Wen-Si HUANG ; Wu-Biao WEN ; Shun DAI ; Li-Yun LAI ; Yue-Qin PENG ; Tong-Hua WU ; Qing SUN ; Yong ZENG ; Jing CAI
Asian Journal of Andrology 2025;27(3):440-446
To investigate the impact of preoperative serum follicle-stimulating hormone (FSH) levels on the probability of testicular sperm retrieval, we conducted a study of nonobstructive azoospermic (NOA) men with different testicular volumes (TVs) who underwent microdissection testicular sperm extraction (micro-TESE). A total of 177 NOA patients undergoing micro-TESE for the first time from April 2019 to November 2022 in Shenzhen Zhongshan Obstetrics and Gynecology Hospital (formerly Shenzhen Zhongshan Urology Hospital, Shenzhen, China) were retrospectively reviewed. The subjects were divided into four groups based on average TV quartiles. Serum hormone levels in each TV group were compared between positive and negative sperm retrieval subgroups. Overall sperm retrieval rate was 57.6%. FSH levels (median [interquartile range]) were higher in the positive sperm retrieval subgroup compared with the negative outcome subgroup when average TV was <5 ml (first quartile [Q1: TV <3 ml]: 43.32 [17.92] IU l -1 vs 32.95 [18.56] IU l -1 , P = 0.048; second quartile [Q2: 3 ml ≤ TV <5 ml]: 31.31 [15.37] IU l -1 vs 25.59 [18.40] IU l -1 , P = 0.042). Elevated serum FSH levels were associated with successful micro-TESE sperm retrieval in NOA men whose average TVs were <5 ml (adjusted odds ratio [OR]: 1.06 per unit increase; 95% confidence interval [CI]: 1.01-1.11; P = 0.011). In men with TVs ≥5 ml, larger TVs were associated with lower odds of sperm retrieval (adjusted OR: 0.84 per 1 ml increase; 95% CI: 0.71-0.98; P = 0.029). In conclusion, elevated serum FSH levels were associated with positive sperm retrieval in micro-TESE in NOA men with TVs <5 ml. In men with TV ≥5 ml, increases in average TVs were associated with lower odds of sperm retrieval.
Humans
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Male
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Azoospermia/surgery*
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Sperm Retrieval/statistics & numerical data*
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Adult
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Follicle Stimulating Hormone/blood*
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Retrospective Studies
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Testis/pathology*
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Microdissection
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Organ Size
4.Predictive value of bpMRI for pelvic lymph node metastasis in prostate cancer patients with PSA≤20 μg/L.
Lai DONG ; Rong-Jie SHI ; Jin-Wei SHANG ; Zhi-Yi SHEN ; Kai-Yu ZHANG ; Cheng-Long ZHANG ; Bin YANG ; Tian-Bao HUANG ; Ya-Min WANG ; Rui-Zhe ZHAO ; Wei XIA ; Shang-Qian WANG ; Gong CHENG ; Li-Xin HUA
National Journal of Andrology 2025;31(5):426-431
Objective: The aim of this study is to explore the predictive value of biparametric magnetic resonance imaging(bpMRI)for pelvic lymph node metastasis in prostate cancer patients with PSA≤20 μg/L and establish a nomogram. Methods: The imaging data and clinical data of 363 patients undergoing radical prostatectomy and pelvic lymph node dissection in the First Affiliated Hospital of Nanjing Medical University from July 2018 to December 2023 were retrospectively analyzed. Univariate analysis and multivariate logistic regression were used to screen independent risk factors for pelvic lymph node metastasis in prostate cancer, and a nomogram of the clinical prediction model was established. Calibration curves were drawn to evaluate the accuracy of the model. Results: Multivariate logistic regression analysis showed extrocapusular extension (OR=8.08,95%CI=2.62-24.97, P<0.01), enlargement of pelvic lymph nodes (OR=4.45,95%CI=1.16-17.11,P=0.030), and biopsy ISUP grade(OR=1.97,95%CI=1.12-3.46, P=0.018)were independent risk factors for pelvic lymph node metastasis. The C-index of the prediction model was 0.834, which indicated that the model had a good prediction ability. The actual value of the model calibration curve and the prediction probability of the model fitted well, indicating that the model had a good accuracy. Further analysis of DCA curve showed that the model had good clinical application value when the risk threshold ranged from 0.05 to 0.70.Conclusion: For prostate cancer patients with PSA≤20 μg/L, bpMRI has a good predictive value for the pelvic lymph node metastasis of prostate cancer with extrocapusular extension, enlargement of pelvic lymph nodes and ISUP grade≥4.
Humans
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Male
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Prostatic Neoplasms/diagnostic imaging*
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Lymphatic Metastasis
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Retrospective Studies
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Nomograms
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Prostate-Specific Antigen/blood*
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Lymph Nodes/pathology*
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Pelvis
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Predictive Value of Tests
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Prostatectomy
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Lymph Node Excision
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Risk Factors
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Magnetic Resonance Imaging
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Logistic Models
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Middle Aged
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Aged
5.Expert consensus on evaluation index system construction for new traditional Chinese medicine(TCM) from TCM clinical practice in medical institutions.
Li LIU ; Lei ZHANG ; Wei-An YUAN ; Zhong-Qi YANG ; Jun-Hua ZHANG ; Bao-He WANG ; Si-Yuan HU ; Zu-Guang YE ; Ling HAN ; Yue-Hua ZHOU ; Zi-Feng YANG ; Rui GAO ; Ming YANG ; Ting WANG ; Jie-Lai XIA ; Shi-Shan YU ; Xiao-Hui FAN ; Hua HUA ; Jia HE ; Yin LU ; Zhong WANG ; Jin-Hui DOU ; Geng LI ; Yu DONG ; Hao YU ; Li-Ping QU ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2025;50(12):3474-3482
Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards*
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Humans
;
Consensus
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Drugs, Chinese Herbal/therapeutic use*
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Surveys and Questionnaires
6.Investigation of 90Sr radioactivity levels in drinking water and food around the Qinshan Nuclear Power Plant from 2012 to 2022
Lei ZHOU ; Yiyao CAO ; Hua ZOU ; Rui WANG ; Hong REN ; Peng WANG ; Shunfei YU ; Zhiqiang XUAN ; Zhongjun LAI
Chinese Journal of Radiological Medicine and Protection 2025;45(5):449-453
Objective:To investigate the radioactivity levels and variation trends of 90Sr in drinking water and food around the Qinshan Nuclear Power Plant in operation. Methods:From 2012 to 2022, the source, factory, and tap water was collected within 30 km around the Qinshan Nuclear Power Plant during the wet and dry seasons (i.e., May and October, respectively) each year to determine the 90Sr concentration in water. According to the dietary habits of local residents, four kinds of food, including rice, cabbage, mullet, and crucian carp, were collected to determine and analyze the 90Sr radioactivity concentration in food using the bis-(2-ethylhexyl) phosphoric acid extraction chromatographic method. Results:From 2012 to 2022, the 90Sr radioactivity concentrations in the source, factory, and tap water around the Qinshan Nuclear Power Plant ranged from 3.73 to 11.89 mBq/L, 2.95 to 9.83 mBq/L, and 3.12 to 8.70 mBq/L, respectively, showing nonsignificant fluctuations over the years. The 90Sr radioactivity concentrations in rice, cabbage, mullet, and crucian carp ranged from 0.02 to 0.46 Bq/kg (dry weight), 0.26 to 1.07 Bq/kg (fresh weight), 0.38 to 1.05 Bq/kg (fresh weight), and 0.08 to 1.32 Bq/kg (fresh weight), respectively, all below the national standard limits. Conclusions:From 2012 to 2022, the 90Sr radioactivity levels in drinking water and food around the Qinshan Nuclear Power Plant were at the background level and remained stable.
7.Analysis of factors influencing postoperative pathological upgrading in prostate cancer with target biopsy Gleason score 3 + 3 and development of a predictive model
Rongjie SHI ; Lai DONG ; Zhiyi SHEN ; Kaiyu ZHANG ; Chenglong ZHANG ; Yamin WANG ; Ruizhe ZHAO ; Shangqian WANG ; Gong CHENG ; Lixin HUA
Chinese Journal of Urology 2025;46(9):684-690
Objective:To explore the influencing factors for pathological upgrading in prostate cancer patients with a Gleason score of 3 + 3 undergoing targeted biopsy,and to establish a nomogram prediction model.Methods:A retrospective analysis was conducted on 191 patients with localized prostate cancer diagnosed with a Gleason score of 3 + 3 through targeted biopsies at the First Affiliated Hospital of Nanjing Medical University from January 2020 to June 2024. The age of the patients was 67(61,73)years,with prostate-specific antigen(PSA)level of 7.44(5.53,10.19)ng/ml,prostate volume of 35.64(26.59,48.97)ml,and PSA density(PSAD)of 0.20(0.14,0.31)ng/ml 2. Among them,61 cases(31.94%)had a Prostate Imaging Reporting and Data System(PI-RADS)score of 3,104 cases(54.45%)had a score of 4,and 26 cases(13.61%)had a score of 5. The diameter of the main lesion was 10.75(7.86,14.00)mm. The lesions were located in the peripheral zone in 78 cases(40.84%),the transition zone in 99 cases(51.83%),and the anterior fibromuscular stroma in 14 cases(7.33%). The lesions were found at the apex in 56 cases(29.32%),in the body in 120 cases(62.83%),and at the base in 15 cases(7.85%). MRI revealed only one lesion with a PI-RADS score ≥ 3 in 131 cases,two suspected lesions in 43 cases,three suspected lesions in 12 cases,and four suspected lesions in 5 cases. Systematic biopsy was positive in 121 cases(63.4%)and negative in 70 cases(36.6%). The lesions were confined to the left lobe in 63 cases(32.98%),right lobe in 68 cases(35.60%),and involved both lobes in 60 cases(31.41%). The interval between biopsy and surgery was 9.0(7.0,14.0)days. Univariate analyses were performed using Mann-Whitney U tests or χ2 tests,and multivariate logistic regression was used to identify independent predictors of pathological upgrading. A nomogram model was constructed based on these independent predictors. The model’s discriminative ability was assessed using the area under the receiver operating characteristic(ROC)curve(AUC),and internal validation of the model’s consistency was conducted using the bootstrap resampling method. Decision curve analysis(DCA)was performed to assess clinical utility. Results:Among the 191 cases,60(31.4%)had no pathological upgrading after surgery,while 131(68.6%)showed upgrading. Univariate analysis showed that the maximum diameter of the main lesion[9.0(6.0,13.2)mm vs. 11.0(8.4,14.0)mm],number of suspicious lesions on MRI[1.0(1.0,1.0)vs. 1.0(1.0,2.0)],number of positive systematic biopsy cores[1.0(0,2.0)vs. 1.0(0,3.0)],percentage of positive systematic biopsy cores[0.08(0,0.17)vs. 0.12(0,0.25)],number of positive targeted biopsy cores[2.0(1.0,3.0)vs. 3.0(1.0,4.0)],percentage of positive targeted biopsy cores[0.37(0.24,0.75)vs. 0.50(0.38,0.85)],level of the index lesion,location of the index lesion,and PI-RADS score were associated with pathological upgrading( P < 0.05). Multivariate logistic regression analysis showed that PI-RADS score 4( OR = 5.88,95% CI 2.41 - 14.35),number of suspicious lesions on MRI( OR = 4.15,95% CI 1.88 - 9.17),location of the index lesion in the transition zone( OR = 6.86,95% CI 2.81 - 16.73),and percentage of positive targeted biopsy cores( OR = 4.37,95% CI 1.38 - 14.90)were independent risk factors for pathological upgrading( P < 0.05). The nomogram model constructed using these predictors had an AUC of 0.845. Internal validation using the Bootstrap method yielded an AUC value of 0.812,indicating high predictive accuracy of the model. The calibration curve indicated good calibration. Decision curve analysis showed that the threshold range for net benefit in the model was between 12% - 100%. Conclusions:The PI-RADS score 4,the number of lesions with PI-RADS ≥ 3,the location of the main lesion in the transition zone,and the percentage of positive needles in targeted biopsy are independent risk factors for pathological upgrading from Gleason score 3 + 3. The nomogram model constructed from these factors demonstrates good predictive performance and provides a reference for clinical decision-making.
8.Study on the association between different feeding methods during the first six months after birth and physical growth of children aged 3 to 5 years based on the Taicang and Wuqiang mother-child cohort study in China
Yifan DUAN ; Zhenyu YANG ; Ye BI ; Changqing LIU ; Yongli ZHAO ; Xuyang GU ; Jingtao DUAN ; Hua ZHAO ; Jianqiang LAI
Chinese Journal of Preventive Medicine 2025;59(1):30-38
Objective:To explore the association between different feeding methods during the first six months after birth and the physical growth of children aged 3 to 5 years.Methods:Data were from the "Taicang and Wuqiang mother-child cohort study"(TAWS) in China. Children were enrolled at birth between November 2016 and September 2020 and followed up at 1, 2, 3, 6, 8, 12, 18, and 24 months, as well as at ages 3 to 5 years. Based on feeding methods within six months of age, children were categorized into an "exclusive breastfeeding group" and a "formula-feeding group". Birth-related information and feeding practices between 8 and 24 months were collected, alongside dietary habits, physical activity, and illness during preschool years. Height and weight of preschool children were measured to calculate height-for-age Z-score (HAZ), weight-for-age Z-score (WAZ), body mass index-for-age Z-score (BAZ), and the rates of stunting, underweight, wasting, overweight, and obesity. After adjusting for demographic factors, birth-related information, feeding practices between 8 to 24 months, preschool dietary habits, physical activity, and health status, multiple linear regression and logistic regression were adopted to analyze the influence of feeding methods within six months of age on the physical growth of children aged 3 to 5 years.Results:A total of 1 233 children were included, comprising 629 boys and 604 girls. The number of children aged 3, 4, and 5 years was 436, 406, and 391, respectively. About 754 children were categorized into the exclusive breastfeeding group and 479 into the formula-feeding group. Children who were introduced to formula milk within six months of age had higher HAZ (0.09±0.99), WAZ (0.24±1.07) and BAZ (0.26±1.11) scores at ages 3 to 5 compared to the exclusive breastfeeding group [HAZ, WAZ, and BAZ were (-0.04±0.92), (0.06±1.02) and (0.11±1.08), respectively]. After adjusting for confounding factors, multiple linear regression analysis showed that the β (95% CI) values for HAZ, WAZ and BAZ in the formula-feeding group were 0.16 (0.06-0.25), 0.17 (0.06-0.29) and 0.15 (0.02-0.27), respectively, compared to the exclusive breastfeeding group. After adjusting for confounding factors, the results of the multivariate logistic regression model indicated that there were no statistically significant differences in the risks of stunting, underweight, wasting, overweight, and obesity during the preschool years between the exclusive breastfeeding group and the formula-feeding group, with OR (95% CI) values of 1.04 (0.41-2.62), 0.99 (0.27-3.57), 1.63 (0.53-4.95), 1.08 (0.66-1.74), and 1.58 (0.70-3.60), respectively. Conclusion:Exclusive breastfeeding within six months of age does not increase the risk of undernutrition (including stunting, underweight or wasting) during preschool years. However, the introduction of formula feeding within six months of age significantly increases the physical growth level of the preschool stage.
9.Chemical constituents from the roots of Siraitia grosvenorii and their α-glucosidase inhibitory activities
Si-yu WEI ; Yu-lu WEI ; Feng-lai LU ; Wen-long LONG ; Xiao-hua JIANG
Chinese Traditional Patent Medicine 2025;47(4):1181-1188
AIM To study the chemical constituents from the roots of Siraitia grosvenorii(Swingle)C.Jeffrey and their α-glucosidase inhibitory activities.METHODS The 95%ethanol extract was isolated and purified by silica gel,MCI,ODS and HSCCC,then the structures of obtained compounds were identified by physicochemical properties and spectral data.The α-glucosidase inhibitory activities were evaluated by PNPG method,after which molecular docking was performed.RESULTS Twenty-one compounds were isolated and identified as vanillin(1),siraitic acid B(2),cucurbitacin B(3),salicylic acid(4),ferulic acid(5),p-hydroxybenzaldehyde(6),(+)-lariciresinol(7),(+)-isolariciresinol(8),liballinol(9),3-(hydroxyacetyl)indole(10),2E-4-hydroxy-nonenoic acid(11),vomifolilol(12),vanillic acid(13),indole-3-carboxylic acid(14),ω-hydroxypropioguaiacone(15),p-hydroxybenzoic acid(16),p-coumaric acid(17),dehydrodipinocarpine(18),secoisolariciresinol(19),sesquimarocanol A(20),threo-guaiacylglycerol-β-O-4-lariciresinol ether(21).IC50 values of compounds 4,10,18 and 21 were(0.42±0.060)-(0.89±0.037)mg/mL.CONCLUSION Compounds 4,10-12,15,16,18,and 21 are isolated from the roots of this plant for the first time.Compounds 4,10,18,21 have α-glucosidase inhibitory activities,and 18 has the strongest activity.
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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