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.Analysis and Recommendations on the Current Status of Pharmaceutical Management in County Medical Communities in Hubei Province
Pei XU ; Wei FU ; Guilan JIN ; Juan LI ; Heng ZHAO ; Menghu YUAN ; Dong LIU ; Guanliang PENG
Herald of Medicine 2024;43(12):2061-2064,后插1
Objective This study aims to assess the current status of pharmaceutical management in county medical communities in Hubei province,and provide recommendations for the homogenization,standardization,and regulation of pharmaceutical management in these communities.It also intends to offer decision-making support for health administrative departments,and provide reference experiences for management in other regions.Methods The current status of pharmaceutical management in county medical communities in Hubei province was conducted through a questionnaire survey and field research.Existing problems were analyzed,key management areas were identified,and reasonable recommendations were proposed.Results Pharmaceutical management in county medical communities has significant shortcomings in organizational structure,system construction,personnel allocation,key link control,and the leading unit's outreach capabilities.These deficiencies are not aligned with the high-quality development of pharmacy in the new era.Conclusions It is recommended that county medical communities should establish a comprehensive pharmaceutical management quality control system.This can be achieved by improving organizational management,strengthening talent development,enhancing core systems,setting monitoring indicators,and increasing outreach capabilities.Additionally,evaluation standards for the quality control system of pharmaceutical management should be established to enhance management capabilities through scientific assessment and positive feedback.
3.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.
4.Based on the theory of treating impotence alone with Yang Ming to explore the intervention of finger-pressing therapy on ICU-acquired weakness in critically ill children
Yuanqing LIANG ; Yuting ZHENG ; Chengcheng WANG ; Bo XU ; Lin ZHOU ; Guilan ZHANG
Chinese Journal of Practical Nursing 2023;39(25):1935-1941
Objective:To explore the clinical feasibility of finger-pressing therapy based on the theory of treating impotence alone with Yang Ming to reduce incidence of ICU acquired weakness (ICU-AW) in critically ill children and provide a feasible nursing plan for ICU acquired asthenia in critically ill children.Methods:A quasi-experimental study was conducted. A total of 73 critically ill children were admitted to the PICU of Kunming Children′s Hospital from January 1 to April 30, 2021. According to the random number table, the subjects were divided into the observation group (37 cases) and the control group (36 cases). Children in the control group received routine PICU nursing. The children in the observation group were treated with PICU routine nursing and finger-pressing therapy based on the theory of treating impotence alone with Yang Ming. The two groups were compared in terms of limb muscle strength score (MRC-Score), incidence of ICU-AW, basic activities of life (Barthel Index, BI), limb muscle thickness.Results:After intervention, the MRC-Score of the observation group was 50 (46, 52) points, which was higher than 46 (40, 48) points of the control group, and the difference between the two groups was statistically significant ( Z=-3.70, P<0.05). The incidence of ICU-AW in the observation group was 32.43% (12/37), and the incidence of ICU-AW in the control group was 72.22% (26/36). The difference between the two groups was statistically significant ( χ2=11.58, P<0.05). The BI score of the observation group was 63 (50, 70), which was higher than 44 (40,60) of the control group, and the difference between the two groups was statistically significant ( Z=-3.94, P<0.05). The reduction degree of quadriceps femoris thickness in the observation group at D3-D1 was (-0.381 ± 0.131) cm, which was lower than (-0.762 ± 0.182) cm in the control group, and the difference between the two groups was statistically significant ( t=10.29, P<0.05). Conclusions:The application of finger-pressing therapy guided by theory of treating impotence alone with Yang Ming in the early rehabilitation of critically ill children can enhance muscle strength, prevent muscle atrophy and reduce the incidence of ICU-AW in critically ill children.
5.Value of chromosomal microarray analysis for genetic evaluation of fetal ultrasound abnormality
Linling XIAO ; Jun XU ; Xiaohong ZHANG ; Guilan GUO ; Jufang TAN ; Li HE ; Shuang ZHANG
Chinese Journal of Radiological Health 2022;31(5):611-614
Objective To evaluate the value of chromosomal microarray analysis (CMA) for genetic evaluation of fetal ultrasound abnormality. Methods A total of 180 pregnant women with fetal abnormality detected by prenatal ultrasound diagnosis in the first trimester during the period from January 2020 through May 2022 were enrolled as the study subjects. All prenatal fetal screening samples were subjected to G-band karyotyping and CMA. Results G-band karyotyping detected normal karyotypes in 168 samples (93.85%) and abnormal karyotypes in 11 samples (6.15%), and CMA detected 17 positive samples (9.44%) and 163 negative samples (90.56%). The seventeen positive samples included 11 pathogenic copy number variations (CNVs) and 6 variants of unknown significance (VOUS), and there were 11 CMA-positive results consistent with G-band karyotyping, and 6 additional pathogenic CNVs mainly included microdeletion and microduplication syndromes. The detection rates of pathogenic CNVs were 11.11%, 2.63%, 2.78%, 4.00%, 0, 0, 11.11% and 0 among the fetuses with abnormal structure of the cardiovascular system, the lymphatic system, the nervous system, the digestive system, the cranial and face system, the skeletal system, the urinary system, and other system (χ2 =8.188, P = 0.316). All eleven fetuses with pathogenic CNVs detected by CMA were all induced for abortion. Conclusion CMA improves the detection of genetic abnormality among fetuses with ultrasound abnormality in relative to G-band karyotyping, which is feasible for prenatal cytogenetic diagnosis among fetuses with ultrasound abnormality
6.Clinical value of 18F-FDG PET/CT imaging for detecting immune related adverse events of the combined immunotherapy in hepatobiliary carcinoma
Xuezhu WANG ; Jingnan WANG ; Guilan HU ; Jie DING ; Chao REN ; Xu YANG ; Haitao ZHAO ; Fang LI ; Li HUO
Chinese Journal of Nuclear Medicine and Molecular Imaging 2022;42(6):352-356
Objective:To investigate the capability of 18F-FDG PET/CT imaging in monitoring combined immunotherapy response and detecting immune related adverse events (irAEs) in patients with advanced hepatobiliary carcinoma. Methods:From August 2018 to July 2019, 21 patients (14 males, 7 females, age (58.5±10.0) years) with advanced hepatobiliary carcinoma routinely underwent 66 18F-FDG PET/CT examinations in Peking Union Medical College Hospital. SUV max, the occurrence time and symptoms of irAEs were obtained and analyzed. Therapy response (complete metabolic response (CMR), partial metabolic response (PMR), stable metabolic disease (SMD), progressive metabolic disease (PMD)) was evaluated according to PET response criteria in solid tumors (PERCIST). Results:(1) Clinical results. Twenty-two irAEs occurred in 16 patients, while were not found in 5 patients. Six organs were involved, including thyroiditis(8), colitis(5), pneumonitis(4), rash(2), hepatitis(2), myositis and fasciitis(1). The appearance time of each irAEs were (103.0±58.0), (141.6±103.5), 34.0(6.0, 308.8), 9 and 117, 62 and 67, and 87 d after therapy, respectively. PET/CT detected all pneumonitis and myositis and fasciitis, but no rash and hepatitis were found. For colitis and thyroiditis, PET/CT detected 4 and 6 times respectively. (2) PET/CT signs of irAEs. Except thyroiditis, all irAEs lesions exhibited exudative changes in CT and high-avidity in PET. SUV max of the lesions were 9.0(7.9, 17.6) (colitis), 7.1±3.2 (thyroiditis), 5.3 and 8.6 (pneumonitis), 4.1 (myositis and fasciitis), respectively. (3) Therapy assessment. Among 21 patients, there were 7 for PMR, 9 for SMD, 5 for PMD, which were 7, 8, 1 in patients with irAEs and 0, 1, 4 in patients without irAEs. Conclusions:Patients with advanced hepatobiliary carcinoma can benefit from combined immunotherapy. 18F-FDG PET/CT can be used to evaluate the efficacy of immunotherapy by detecting the changes of tumor lesions and the occurrence of irAEs simultaneously. However, it is necessary to use CT to distinguish tumor progression from irAEs.
7.Effects of WeChat-based health education on management of hypertensive outpatients under medical consortium
Guilan SUN ; Mengping HE ; Yuanwen XU ; Liu SU ; Lili SHUANG ; Yuan TIAN ; Lili SONG ; Jin HUANG ; Xiao ZHANG ; Zhenqiu YU
Chinese Journal of Modern Nursing 2020;26(17):2355-2360
Objective:To explore the effects of WeChat-based health education on management of hypertensive outpatients under medical consortium.Methods:Totally 180 hypertensive patients who attended the Multidisciplinary Clinics of Beijing Anzhen Hospital, Capital Medical University, and Datun Community Health Service Center from communities under our medical consortium from November 2018 to April 2019 were selected and divided into the observation group ( n=91) and the control group ( n=89) according to the visit time. Patients in the control group received routine health education, while patients in the observation group received WeChat-based health education under medical consortium for 6 months. The self-management ability (using Hypertension Patients Behavior Rating Scale, HPSMBRS) , treatment compliance (using Therapeutic Adherence Scale for Hypertensive Patients, TASHP) , the 24 h average systolic and diastolic blood pressure, the average systolic and diastolic blood pressure at daytime, and the average systolic blood pressure and diastolic blood pressure at night were compared between the two groups. Results:After the intervention, the diet management, medication management, disease monitoring, exercise management, work and rest and emotional management scores of the observation group were higher than those of the control group, and the differences were statistically significant ( P<0.05) . After the intervention, the medication-taking behavior, bad medication-taking behavior, daily activity management behavior and tobacco and alcohol addiction scores were higher than those of the control group, and the differences were statistically significant ( P<0.05) . After the intervention, the 24 h average systolic and diastolic blood pressure, average systolic and diastolic blood pressure at daytime and average systolic and diastolic blood pressure at night decreased in the observation group, and the differences were statistically significant compared with the control group ( P<0.05) . Conclusions:The WeChat platform under medical consortium provides standardized, consistent, continuous and effective health education, which can improve the self-management ability and treatment compliance of hypertensive outpatients, and can effectively control blood pressure levels. It shows sound effects in clinical use.
8.Synergistic immunoreaction of acupuncture-like dissolving microneedles containing thymopentin at acupoints in immune-suppressed rats.
Qian ZHANG ; Chuncao XU ; Shiqi LIN ; Huanbin ZHOU ; Gangtao YAO ; Hu LIU ; Lili WANG ; Xin PAN ; Guilan QUAN ; Chuanbin WU
Acta Pharmaceutica Sinica B 2018;8(3):449-457
Dissolving microneedles carried drug molecules can effectively penetrate the stratum corneum of skin to improve the transdermal drug delivery. The traditional Chinese medicine acupuncture is based on the needle stimulation at a specific location (acupoint) to generate and transmit biochemical and physiological signals which alter the pathophysiological state of patients. However, the pain associated with conventional acupuncture needles and the requirement of highly trained professionals limit the development of acupuncture in non-Asian countries. The purpose of this study is to investigate whether the dissolving microneedles can be utilized as a self-administered painless replacement for acupuncture and locally released drug molecules can achieve expected therapeutic outcomes. Immunosuppressive rats were treated with acupuncture at Zusanli (ST36) acupoint using microneedles containing thymopentin. The immune functions and psychological mood of the immunosuppressed animals were examined. The proliferation of splenocytes was examined by CCK-8 assay. CD4 and CD8 expression patterns in spleen cells were detected by flow cytometry. The current study showed that use of either microneedles containing thymopentin or conventional acupuncture both resulted in immune cell proliferation, which was confirmed by flow cytometry. Furthermore, either conventional acupuncture or microneedles were able to effectively mitigate the anxiety caused by immune-suppression when applied on the ST36.
9.Development and application of new-type digital electric plum-blossom needle instrument.
Ming XU ; Guilan HUANG ; Hong ZHANG ; Xiuting YIN ; Jian ZHANG ; Yuqi CHEN ; Yong PENG ; Mingxuan ZHANG
Chinese Acupuncture & Moxibustion 2017;37(5):567-570
A new-type digital electric plum-blossom needle instrument of controllable and adjustable parameters was developed to achieve an automatic tapping instead of manual tapping technique and integrate the function of plum-blossom needle with that of micropulse electrical phase. The alternating current of periodic variation changes the direction of magnetic field around, induces the vibration of the cone head and tapping movement, outputs the micropulse current and acts on the affected area in treatment. The new-type digital electric plum-blossom needle instrument achieves the automatic tapping movement, precisely adjusts the stimulating strength and frequency according to diseases and integrates the tapping stimulation with pulse current to form circulation loop on the skin and intensify the therapeutic effects. This instrument is the big innovation of traditional plum-blossom needle. It is not only applicable for clinical treatment or family healthcare, but also for scientific research with the adoptable digital therapeutic parameters, which benefits the application and development of plum-blossom needle therapy.
10.Reviews on acupuncture for cellular signal transduction in spinal cord injury.
Jisheng LIU ; Hong ZHANG ; Guilan HUANG ; Ming XU ; Jian ZHANG ; Xiuting YIN
Chinese Acupuncture & Moxibustion 2017;37(6):680-684
Investigating the influence of acupuncture on cellular signal transduction is an efficient pathway to reveal the action mechanism of acupuncture on spinal cord injury (SCI). In this study, the experiment research literature regarding acupuncture for SCI during past 10 years was reviewed and analyzed. As a result, it was found that acupuncture could regulate the expression of the first intercellular messenger as well as the second signal molecules including cyclic adenosine monophosphate, cyclic guanosine monophosphate, Ca2+, nitric oxide to intervene the apoptotic signaling pathway, Rho/Rock signaling pathway, Wnt signaling pathway, MAPK signaling pathway, Notch signaling pathway, etc., which could improve regeneration and repair of SCI. In conclusion, in future researches more attention should be paid to the cellular signal transduction networks and different effects among various acupoint combinations and acupuncture modalities on cellular signal transduction, which have an essential role for revelation of clinical application rules and optimization of clinical treatment protocol.

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