1.Evaluation of the efficacy and safety of Xiao′er Huangjin Zhike Granules in the treatment of acute bronchitis-caused cough (syndrome of phlegm-heat obstructing the lung) in children
Jun LIU ; Mengqing WANG ; Xiuhong JIN ; Yongxue CHI ; Chunying MA ; Xiaohui LIU ; Yiqun TENG ; Meiyun XIN ; Fei SUN ; Ming LIU ; Ling LU ; Xinping PENG ; Yongxia GUO ; Rong YU ; Quanjing CHEN ; Bin WANG ; Tong SHEN ; Lan LI ; Pingping LIU ; Xiong LI ; Ming LI ; Guilan WANG ; Baoping XU
Chinese Journal of Applied Clinical Pediatrics 2024;39(10):774-779
Objective:To evaluate the efficacy and safety of Xiao′er Huangjin Zhike Granules in the treatment of cough caused by acute bronchitis in children, which is defined in TCM terms as a syndrome of phlegm-heat obstructing the lung.Methods:This was a block-randomized, double-blind, placebo-controlled, multicenter clinical trial.From January 2022 to September 2023, 359 children aged 3 to 7 years old diagnosed as acute bronchitis (lung-obstructing phlegm-heat syndrome) were enrolled from 21 participating hospitals and randomly assigned to the experimental group and placebo group in a 3︰1 ratio, and respectively treated with Xiao′er Huangjin Zhike Granules and its matching placebo.Cough resolution/general resolution rate after 7 days of treatment was used as the primary efficacy outcome for both groups.Results:(1)On the seventh day of treatment, the rate of cough disappearance/basically disappearance in the experimental group and placebo group were 73.95% and 57.61% retrospectively, which had statistically significance ( P=0.001).(2)After 7 days of treatment, the median duration of cough disappearance/basic disappearance were 5 days and 6 days in the two groups , with a statistically significant difference ( P=0.006).The area under the curve of cough symptom severity time was 7.20 ± 3.79 in the experimental group and 8.20±4.42 in the placebo group.The difference between the two groups was statistically significant ( P=0.039).(3) After 7 days of treatment, the difference between TCM syndrome score and baseline was -16.0 (-20.0, -15.0) points in the experimental group and -15.0 (-18.0, -12.0) points in the placebo group, with significant difference between the two groups ( P=0.004).In the experimental group, the clinical control rate, the markedly effective rate, the effective rate and the ineffective rate were 49.04%, 28.35%, 16.48% and 6.13% severally; and in the placebo group, the clinical control rate, the markedly effective rate, the effective rate and the ineffective rate were 38.04%, 26.09%, 29.35%, and 6.52% separately, which had statistically significant ( P=0.014).(4) There was no significant difference in the incidence of adverse events or adverse reactions during the trial between both groups.Moreover, while adverse reactions in the form of vomiting and diarrhea were occasionally reported, no serious drug-related adverse event or adverse reaction was reported.(5)The tested drug provided good treatment compliance, showing no statistically significant difference from the placebo in terms of compliance rate. Conclusions:Based on the above findings, it can be concluded that Xiao′er Huangjin Zhike Granules provides good safety, efficacy, and treatment compliance in the treatment of cough caused by acute bronchitis, and lung-obstructing phlegm-heat syndrome, in children.
2.Effectiveness of TBL combined with RBL in cultivating evidence-based nursing practice ability of undergraduate nursing students
Xiaojun CHEN ; Fengqiu GONG ; Guiyuan LUO ; Lihong XIE ; Ping WANG ; Qiuyi OUYANG ; Guilan HUANG ; Na LI ; Shufen LIAO
Modern Clinical Nursing 2024;23(9):50-55
Objective To investigate the effectiveness of team-based learning(TBL)combined with research-based learning(RBL)in enhancing evidence-based nursing practice skills of undergraduate nursing interns.Methods A total of 114 undergraduate nursing students who interned in the operating room of a ⅢA hospital in Guangzhou from July 2021 to April 2022 were selected as study subjects.A randomized cluster sampling method based on a random number table was used to divide the students into a control group and a trial group.The control group received traditional teaching methods,while the trial group was taught using a combination of TBL and RBL.The two groups were compared in terms of evidence-based practice skills,critical thinking abilities,and their evaluations on the teaching methods.Results The differences in evidence-based practice skills and critical thinking abilities before and after the internship were significantly higher in the observation group compared to the control group(t=35.108,35.897;both P<0.05).Additionally,post-internship evaluation scores for the teaching methods in the trial group were significantly higher than those in the control group(t=-17.580,P<0.05).Conclusion TBL combined with RBL effectively enhances the evidence-based nursing practice skills and critical thinking abilities of undergraduate nursing interns.This approach also improves students'evaluations on the teaching methods and fosters the cultivation of excellent clinical evidence-based nursing professionals.
3.The relationship between positive asthma prediction index and polymorphisms of IL-13, IL-4, ADRB2, and FcER1B genes in asthmatic children
Zhaohui HE ; Xiaoqian CHEN ; Baoying HUANG ; Mingwei LIU ; Guilan WANG
Journal of Chinese Physician 2024;26(6):886-889
Objective:To investigate the relationship between positive asthma prediction index (API) and single nucleotide polymorphisms (SNPs) of interleukin (IL-13), IL-4, β 2 adrenergic receptor (ADRB2), and type I Fc ε receptor β (FcER1B) genes in asthmatic children.Methods:A prospective study was conducted on 102 asthmatic children under 5 years old admitted to Zhongshan Boai Hospital and Foshan First People′s Hospital (51 cases were API positive and 51 cases were API negative) from January 2020 to August 2023. Oral and buccal mucosal exfoliated cells were collected from the children, and genomic DNA was extracted using magnetic bead method. Four gene loci (IL-13 rs20541, IL-4 rs2243250, ADRB2 rs1042713, FcER1B rs569108) were genotyped using a matrix assisted laser desorption ionization time-of-flight mass spectrometer. Logistic regression analysis was used to evaluate the correlation between SNP typing at these four gene loci and API positivity in asthmatic children.Results:There was a statistically significant difference in the SNP typing and allele distribution frequency of IL-13 rs20541, IL-4 rs2243250, ADRB2 rs1042713, FcER1B rs569108 between the API positive and API negative groups of wheezing children (all P<0.05). Among API positive children, the proportion of IL-13 rs20541 site was higher in GG type, the proportion of IL-4 rs2243250 site was higher in TT type, the proportion of ADRB2 rs1042713 site was higher in AG type, and the proportion of FcER1B rs569108 site was higher in AA type; The results of logistic regression analysis showed that IL-13 rs20541 GG type, IL-4 rs2243250 TT type, FcER1B rs569108 AA type were associated with the risk of API positivity in asthmatic children (all P<0.05). Conclusions:IL-13, IL-4, and FcER1B genes are risk genes for the development of API positive wheezing in children under 5 years old. SNP typing of these genes can be used to evaluate the risk of API positivity in clinical practice.
4.Meta-modeling and validation of a risk prediction model for intradialytic hypotension in maintenance hemodialysis patients
Guilan LÜ ; Hunan CAO ; Hao WANG ; Rui FAN
Chinese Journal of Nursing 2024;59(21):2611-2619
Objective Meta modelling was employed to develop a risk prediction model for intradialytic hypotension(IDH)and validate the model.Methods Literature on risk factors for IDH published up to March 31,2023 was retrieved from 8 databases,including Cochrane Library,PubMed,Web of Science,EBSCO,Scopus,CINAHL,CNKI and Wanfang Database.Random effects model was used to combine ORs,and factors with P<0.05 were selected to establish the model based on their regression coefficients.286 maintenance hemodialysis patients were selected as a validation cohort to evaluate the model's discrimination,calibration and clinical utility.Results 39 studies were included,involving 25 546 patients.14 factors were identified to establish the risk prediction model.The risk score for IDH occurrence was calculated as-0.301 × male+0.015 × age+0.004 × dialysis vintage+0.988 × diabetes+0.730 × cardiovascular disease-0.042 × predialysis systolic blood pressure+0.666 × dialysis mode of hemodialysis filter+0.076 × temperature+0.159 × ultrafiltration rate+0.476 × ultrafiltration volume+1.024 × weight gain between dialysis+0.053 × serum phosphorus+0.023 × blood urea nitrogen+0.040 ×β2-microglobulin.Definition in the Kidney Disease Outcomes Quality Initiative guideline,nadir intradialytic systolic blood pressure<90 mmHg(1 mmHg=0.133 kPa),falling intradialytic systolic blood pressure ≥20 mmHg,and definition in the United Kingdom Kidney Association guideline were selected as 4 outcomes.The areas under the curve for the prediction model with respect to these 4 outcomes were 0.830,0.648,0.647,and 0.763,respectively.Calibration curves showed that the model predictive outcomes were consistent with actual outcomes for the first 2 outcomes(x2=14.824,P=0.064;x2=12.016,P=0.149).Decision curve analysis indicated that the model had better net benefit compared to either intervention/no intervention for all definitions.Conclusion The IDH risk prediction model developed by meta-modeling in this study has good predictive performance and certain application value.
5.Combining 18F-PSMA PET/CT and biparametric MRI predicts pathological upgrading after radical prostatectomy for prostate cancer
Wen LIU ; Miao WANG ; Guilan HU ; Jiangyu MA ; Chunmei LI ; Wei ZHANG ; Hui ZHU ; Min CHEN ; Li HUO ; Ming LIU
Chinese Journal of Urology 2024;45(3):180-186
Objective:To investigate the application value of the maximum standardized uptake value (SUVmax) of 18F prostate-specific membrane antigen (PSMA) PET/CT combined with the minimum apparent diffusion coefficient (ADCmin) of biparametric magnetic resonance imaging (bpMRI) in predicting pathological upgrading after radical prostatectomy (RP) for prostate cancer. Methods:The data of 89 patients with localized prostate cancer treated at Beijing Hospital from April 2019 to October 2023 were retrospectively analysed. The average age of patients was (68.4±7.0) years old, with prostate-specific antigen (PSA) level of 7.7 (5.4, 12.9) ng/ml, prostate volume of 34.6 (26.9, 47.1) ml, tumor diameter of 1.3 (1.0, 1.8) cm, prostate imaging reporting and data system(PI-RADS) score of 5 in 29 cases (32.6%), clinical stage ≥T 3 in 13 cases (14.6%). There were 31 cases (34.8%) in group 1 of targeted biopsy International Society of Urological Pathology (ISUP)grading groups, 36 cases (40.4%) in group 2, 11 cases (12.4%) in group 3, and 11 cases (12.4%) in group 4. All patients underwent 18F-PSMA PET/CT and bpMRI examinations before RP. The index lesion, identified as the highest Gleason score in pathological whole-mount sections, were outlined. SUVmax and ADCmin values were calculated from the images' region of interest. Pathological upgrading was defined as the post-RP grade group higher than the targeted-biopsy grade group. Clinical data of patients with and without pathological upgrading were compared. Spearman correlation coefficient analysis was used to assess the correlation between SUVmax and ADCmin. Multivariate logistic regression analysis was conducted to evaluate the factors influencing pathological upgrading. Receiver operating characteristic (ROC) curve analysis was employed to assess the predictive value of each indicator for pathological upgrading. Results:Among the 89 cases, 31 cases (34.8%) experienced pathological upgrading. Compared with the patients without pathological upgrading, the SUVmax [11.3 (8.1, 16.4) vs. 6.7 (4.6, 9.2)], SUVmax/ADCmin ratio [3.1 (2.0, 4.6) vs. 1.4 (0.9, 2.1)], PSA [9.8 (6.3, 15.6) ng/ml vs. 7.1 (5.1, 10.5) ng/ml], PSA density [0.3 (0.2, 0.5) ng/ml 2 vs. 0.2 (0.1, 0.3) ng/ml 2], and post-RP ISUP grade group [≥3 group 17 cases (54.8%) vs. 13 cases(22.4%) ]were higher in patients with pathological upgrading, while ADCmin [3.8 (3.0, 5.3) ×10 -4 mm 2/s vs. 5.2 (3.6, 6.1)×10 -4 mm 2/s] and targeted biopsy ISUP grade group [≤2 group 27 cases(87.1%) vs. 40 cases(69.0%) ] were lower (all P<0.05). Spearman analysis showed a negative correlation between SUVmax and ADCmin ( R = -0.227, P = 0.032). Multivariate logistic regression analysis revealed that SUVmax ( OR = 1.108, 95% CI 1.020-1.238), ADCmin ( OR=0.607, 95% CI 0.390-0.874), and SUVmax/ADCmin ratio ( OR = 1.815, 95% CI 1.282-2.949) independently predicted pathological upgrading. The AUC of the SUVmax/ADCmin ratio for predicting pathological upgrading (AUC = 0.817) was higher than that of SUVmax (AUC = 0.774) and ADCmin (AUC=0.686), indicating a higher predictive efficiency. Conclusions:SUVmax, ADCmin, and SUVmax/ADCmin ratio can independently predict pathological upgrading in targeted biopsy of prostate cancer. The SUVmax/ADCmin ratio has a stronger predictive value for pathological upgrading.
6.Influence factors of treatment compliance in patients undergoing intracranial aneurysm surgery based on latent growth mixture model
Su WU ; Jingjing WANG ; Guilan CAI ; Yong ZHEN
Journal of Clinical Medicine in Practice 2024;28(8):99-103
Objective To analyze the influencing factors of treatment compliance in patients undergoing intracranial aneurysm (IA) surgery based on based on latent growth mixture model (LGMM). Methods A total of 150 patients who underwent IA surgery were selected as the study objects. The general data of patients were collected and the compliance scale was used to evaluate the compliance of patients. LGMM was used to predict the change track of treatment compliance of patients with IA after surgery, and the influencing factors of treatment compliance of patients with IA were analyzed by multivariate Logistic regression analysis. Results A total of 138 valid questionnaires were collected in this study, and the effective questionnaire recovery rate was 92.00%. The treatment compliance score of patients with IA was (5.18±1.59) points. After LGMM fitting, 3 potential profiles were selected. There were 37 patients with good compliance (26.81%), 42 patients with moderate compliance (30.43%), and 59 patients with poor compliance (42.75%). The potential profile category attribution probability matrix was 97.29% for patients with good compliance, 95.24% for patients with moderate compliance, and 98.31% for patients with poor compliance. The proportion of poor compliance patients with age of 30 to 50 years old, junior high school education level or below, combined with two or more diseases, out-of-pocket (medical expenses) and Hunt-Hess grade Ⅲ was significantly higher than those with good compliance and moderate compliance (
7.Construction and application of a risk prediction model for lower limb deep vein thrombosis in patients with aneurysmal subarachnoid hemorrhage
Jingjing WANG ; Su WU ; Guilan CAI ; Yong ZHEN
Journal of Clinical Medicine in Practice 2024;28(19):95-99
Objective To investigate the construction and application of a risk prediction model for deep vein thrombosis (DVT) in patients with aneurysmal subarachnoid hemorrhage (aSAH). Methods A total of 250 patients with aSAH were enrolled in this study and divided into DVT (
8.Relationship Between Pathogenesis of "Kidney Deficiency and Blood Stasis in Collateral, Miniature Mass of Renal Collateral" and Autophagy Dysfunction in Renal Interstitial Fibrosis
Jiansheng LI ; Yingming WANG ; Yanshun YAN ; Jianlin CHENG ; Wennian ZHANG ; Guilan KANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(2):186-194
Renal interstitial fibrosis (RIF) is the main pathological feature of chronic kidney disease caused by a variety of factors. "Kidney deficiency and blood stasis in collateral, miniature mass of renal collateral" is the main pathogenesis of RIF. The deficiency of healthy Qi will influence the kidney Qi, resulting in kidney deficiency and unsmooth qi transformation. As a result, phlegm, heat, stasis, toxin and other excess pathogens block the kidney collaterals, forming miniature masses. The masses accumulate in the renal collaterals, finally leading to RIF. Autophagy is a key process that keeps your body's cells in proper balance by taking aged or damaged components in a cell and recycling them. It is involved in the occurrence and development of RIF. The metabolism of excess pathogens such as phlegm, heat, stasis, and toxin in vivo is related to the degradation and reabsorption of autophagy. Autophagy is a way to eliminate phlegm, heat, stasis, toxin and other excess pathogens. Autophagy dysfunction will cause the accumulation of phlegm, heat, blood stasis, toxin and other excess pathogens, further the stasis of the kidney collaterals, miniature mass in kidney, and finally RIF. Kidney deficiency and blood stasis in collateral are the root cause of autophagy dysfunction, and the miniature mass of renal collateral is the manifestation of autophagy dysfunction. Autophagy dysfunction and miniature mass of renal collateral have the same pathological evolution. In this paper, based on the pathogenesis of "kidney deficiency and blood stasis in collateral, miniature mass of renal collateral" of RIF and RIF-autophagy relationship, this paper discusses the "kidney deficiency and blood stasis in collateral-autophagy dysfunction-miniature mass of renal collateral" relationship in RIF and comprehensively interprets the scientific connotation of the pathogenesis of "kidney deficiency and blood stasis in collateral, miniature mass of renal collateral", which is expected to lay a basis for explaining the role of autophagy in TCM theory and for the treatment of RIF and research on the mechanism.
9.Rapid identification of chronic kidney disease in electronic health record database using computable phenotype combining a common data model.
Huai-Yu WANG ; Jian DU ; Yu YANG ; Hongbo LIN ; Beiyan BAO ; Guohui DING ; Chao YANG ; Guilan KONG ; Luxia ZHANG
Chinese Medical Journal 2023;136(7):874-876
10.Efficacy and safety of Omalizumab for the treatment of pediatric allergic asthma: a retrospective multicenter real-world study in China
Li XIANG ; Baoping XU ; Huijie HUANG ; Mian WEI ; Dehui CHEN ; Yingying ZHAI ; Yingju ZHANG ; Dan LIANG ; Chunhui HE ; Wei HOU ; Yang ZHANG ; Zhimin CHEN ; Jingling LIU ; Changshan LIU ; Xueyan WANG ; Shan HUA ; Ning ZHANG ; Ming LI ; Quan ZHANG ; Leping YE ; Wei DING ; Wei ZHOU ; Ling LIU ; Ling WANG ; Yingyu QUAN ; Yanping CHEN ; Yanni MENG ; Qiusheng GE ; Qi ZHANG ; Jie CHEN ; Guilan WANG ; Dongming HUANG ; Yong YIN ; Mingyu TANG ; Kunling SHEN
Chinese Journal of Applied Clinical Pediatrics 2023;38(1):64-71
Objective:To assess the clinical effectiveness and safety of Omalizumab for treating pediatric allergic asthma in real world in China.Methods:The clinical data of children aged 6 to 11 years with allergic asthma who received Omalizumab treatment in 17 hospitals in China between July 6, 2018 and September 30, 2020 were retrospectively analyzed.Such information as the demographic characteristics, allergic history, family history, total immunoglobulin E (IgE) levels, specific IgE levels, skin prick test, exhaled nitric oxide (FeNO) levels, eosinophil (EOS) counts, and comorbidities at baseline were collected.Descriptive analysis of the Omalizumab treatment mode was made, and the difference in the first dose, injection frequency and course of treatment between the Omalizumab treatment mode and the mode recommended in the instruction was investigated.Global Evaluation of Treatment Effectiveness (GETE) analysis was made after Omalizumab treatment.The moderate-to-severe asthma exacerbation rate, inhaled corticosteroid (ICS) dose, lung functions were compared before and after Omalizumab treatment.Changes in the Childhood Asthma Control Test (C-ACT) and Pediatric Asthma Quality of Life Questionnaire (PAQLQ) results from baseline to 4, 8, 12, 16, 24, and 52 weeks after Omalizumab treatment were studied.The commodity improvement was assessed.The adverse event (AE) and serious adverse event (SAE) were analyzed for the evaluation of Omalizumab treatment safety.The difference in the annual rate of moderate-to-severe asthma exacerbation and ICS reduction was investigated by using t test.The significance level was set to 0.05.Other parameters were all subject to descriptive analysis.A total of 200 allergic asthma patients were enrolled, including 75.5% ( n=151) males and 24.5% ( n=49) females.The patients aged (8.20±1.81) years. Results:The median total IgE level of the 200 patients was 513.5 (24.4-11 600.0) IU/mL.Their median treatment time with Omalizumab was 112 (1-666) days.Their first dose of Omalizumab was 300 (150-600) mg.Of the 200 cases, 114 cases (57.0%) followed the first Omalizumab dosage recommended in the instruction.After 4-6 months of Omalizumab treatment, 88.5% of the patients enrolled ( n=117) responded to Omalizumab.After 4 weeks of treatment with Omalizumab, asthma was well-controlled, with an increased C-ACT score [from (22.70±3.70) points to (18.90±3.74) points at baseline]. Four-six months after Omalizumab administration, the annual rate of moderate-to-severe asthma exacerbation had a reduction of (2.00±5.68) per patient year( t=4.702 5, P<0.001), the median ICS daily dose was lowered [0 (0-240) μg vs. 160 (50-4 000) μg at baseline] ( P<0.001), the PAQLQ score was improved [(154.90±8.57) points vs. (122.80±27.15) points at baseline], and the forced expiratory volume in one second % predicted (FEV 1%pred) was increased [(92.80±10.50)% vs. (89.70±18.17)% at baseline]. In patients with available evaluations for comorbidities, including allergic rhinitis, atopic dermatitis or eczema, urticaria, allergic conjunctivitis and sinusitis, 92.8%-100.0% showed improved symptoms.A total of 124 AE were reported in 58 (29.0%) of the 200 patients, and the annual incidence was 0(0-15.1) per patient year.In 53 patients who suffered AE, 44 patients (83.0%) and 9 patients (17.0%) reported mild and moderate AE, respectively.No severe AE were observed in patients.The annual incidence of SAE was 0(0-1.9) per patient year.Most common drug-related AE were abdominal pain (2 patients, 1.0%) and fever (2 patients, 1.0%). No patient withdrew Omalizumab due to AE. Conclusions:Omalizumab shows good effectiveness and safety for the treatment of asthma in children.It can reduce the moderate-to-severe asthma exacerbation rate, reduce the ICS dose, improve asthma control levels, and improve lung functions and quality of life of patients.


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