1.Clinical Safety Monitoring of 3 035 Cases of Juvenile Feilike Mixture After Marketing in Hospital
Jian ZHU ; Zhong WANG ; Jing LIU ; Jun LIU ; Wei YANG ; Yanan YU ; Hongli WU ; Sha ZHOU ; Zhiyu PAN ; Guang WU ; Mengmeng WU ; Zhiwei JING
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(10):194-200
ObjectiveTo explore the clinical safety of Feilike Mixture (FLK) in the real world. MethodsThe safety of all children who received FLK from 29 institutions in 12 provinces between January 21,2021 and December 25,2021 was evaluated through prospective centralized surveillance and a nested case control study. ResultsA total of 3 035 juveniles were included. There were 29 research centers involved,which are distributed across 12 provinces,including one traditional Chinese medicine (TCM) hospital and 28 general hospitals. The average age among the juveniles was (4.77±3.56) years old,and the average weight was (21.81±12.97) kg. Among them,119 cases (3.92%) of juveniles had a history of allergies. Acute bronchitis was the main diagnosis for juveniles,with 1 656 cases (54.46%). FLK was first used in 2 016 cases (66.43%),and 142 juvenile patients had special dosages,accounting for 4.68%. Among them,92 adverse drug reactions (ADRs) occurred,including 73 cases of gastrointestinal system disorders,10 cases of metabolic and nutritional disorders,eight cases of skin and subcutaneous tissue diseases,two cases of vascular and lymphatic disorders,and one case of systemic diseases and various reactions at the administration site. The manifestations of ADRs were mainly diarrhea,stool discoloration,and vomiting,and no serious ADRs occurred. The results of multi-factor analysis indicated that special dosages (the use of FLK)[odds ratio (OR) of 2.642, 95% confidence interval (CI) of 1.105-6.323],combined administration: spleen aminopeptide (OR of 4.978, 95%CI of 1.200-20.655),and reason for combined administration: anti-infection (OR of 1.814, 95%CI of 1.071-3.075) were the risk factors for ADRs caused by FLK. Conclusion92 ADRs occurred among 3 035 juveniles using FLK. The incidence of ADRs caused by FLK was 3.03%,and the severity was mainly mild or moderate. Generally,the prognosis was favorable after symptomatic treatment such as drug withdrawal or dosage reduction,suggesting that FLK has good clinical safety.
2.Which subtypes of degenerative lumbar spondylolisthesis are suitable for oblique lumbar interbody fusion? A retrospective study in China based on the clinical and radiographic degenerative spondylolisthesis classification
Xianghe WANG ; Hongwei WANG ; Xiaosheng MA ; Xinlei XIA ; Feizhou LYU ; Haocheng XU ; Hongli WANG
Asian Spine Journal 2025;19(1):112-120
Methods:
From March 2020 to March 2023, 100 inpatients with DS were classified into groups A, B, C, and D based on the CARDS classification system. Preoperative radiological data were analyzed to measure the severity of central canal stenosis, facet joint arthropathy, intervertebral disc herniation, and spinal epidural lipomatosis, osteophyte formation, range of motion (ROM), and computed tomography value of the vertebral bodies. The radiological characteristics and clinical contraindications for OLIF were compared among the groups.
Results:
Of the 100 patients, 51% had clinical contraindications for OLIF, which included 85%, 25%, 62.5%, and 20% of patients in groups A, B, C, and D, respectively. Compared with group B, group A demonstrated greater severity of central canal stenosis, whereas group C showed a higher degree of facet joint arthropathy. More patients in groups A and C had severe central canal stenosis. Regarding the ROM results, group A had segmental stiffness, whereas group D presented relatively unstable slip segments.
Conclusions
Patients with different DS subtypes have varied radiological characteristics. Groups B and D are suitable candidates for OLIF. Most patients in group A are unsuitable for OLIF because of bony hyperplasia, severe spinal stenosis, and segmental stiffness.
3.Which subtypes of degenerative lumbar spondylolisthesis are suitable for oblique lumbar interbody fusion? A retrospective study in China based on the clinical and radiographic degenerative spondylolisthesis classification
Xianghe WANG ; Hongwei WANG ; Xiaosheng MA ; Xinlei XIA ; Feizhou LYU ; Haocheng XU ; Hongli WANG
Asian Spine Journal 2025;19(1):112-120
Methods:
From March 2020 to March 2023, 100 inpatients with DS were classified into groups A, B, C, and D based on the CARDS classification system. Preoperative radiological data were analyzed to measure the severity of central canal stenosis, facet joint arthropathy, intervertebral disc herniation, and spinal epidural lipomatosis, osteophyte formation, range of motion (ROM), and computed tomography value of the vertebral bodies. The radiological characteristics and clinical contraindications for OLIF were compared among the groups.
Results:
Of the 100 patients, 51% had clinical contraindications for OLIF, which included 85%, 25%, 62.5%, and 20% of patients in groups A, B, C, and D, respectively. Compared with group B, group A demonstrated greater severity of central canal stenosis, whereas group C showed a higher degree of facet joint arthropathy. More patients in groups A and C had severe central canal stenosis. Regarding the ROM results, group A had segmental stiffness, whereas group D presented relatively unstable slip segments.
Conclusions
Patients with different DS subtypes have varied radiological characteristics. Groups B and D are suitable candidates for OLIF. Most patients in group A are unsuitable for OLIF because of bony hyperplasia, severe spinal stenosis, and segmental stiffness.
4.Correlation between osteocalcin and visceral fat area in population with overweight/obesity
Kaishunzi LIU ; Hongli ZHANG ; Min DOU ; Qian WANG
Journal of Public Health and Preventive Medicine 2025;36(2):91-94
Objective To explore the correlation between osteocalcin (OCN) and visceral fat area (VFA) in overweight/obese population. Methods The data of 297 overweight/obese people who underwent health examinations in Health Management Department of Second Affiliated Hospital of Xi'an Jiaotong University from August 2021 to August 2024 were analyzed. According to the VFA value measured by InBody, the subjects were divided into an excessive group (VFA ≥100 cm2) and a normal group (VFA<100 cm2). The baseline data, glucose metabolism indicators, lipid metabolism indicators and OCN were compared between the two groups. Binary logistic regression analysis was used to analyze the independent risk factors affecting visceral fat deposition in overweight/obese people. Results According to the VFA value, there were 193 cases (64.98%) in the excessive group and 104 cases (35.02%) in the normal group. There were no statistical differences in gender, age and comorbidities between the two groups (P>0.05). The BMI, FPG, HbA1c, TC, TG, and LDL-C in the excessive group were higher than those in the normal group, while the HDL-C and OCN were lower than those in the normal group (P<0.05). Binary logistic regression analysis revealed that BMI, FPG, HbA1c, TC, TG and LDL-C were independent risk factors for visceral fat deposition in overweight/obese people, while HDL-C and OCN were protective factors (P<0.05). Conclusion Visceral fat deposition in overweight/obese people is closely related to OCN content, and is affected by abnormal glucolipid metabolism, which provides new ideas for the prevention and treatment of obesity-related diseases.
5.Which subtypes of degenerative lumbar spondylolisthesis are suitable for oblique lumbar interbody fusion? A retrospective study in China based on the clinical and radiographic degenerative spondylolisthesis classification
Xianghe WANG ; Hongwei WANG ; Xiaosheng MA ; Xinlei XIA ; Feizhou LYU ; Haocheng XU ; Hongli WANG
Asian Spine Journal 2025;19(1):112-120
Methods:
From March 2020 to March 2023, 100 inpatients with DS were classified into groups A, B, C, and D based on the CARDS classification system. Preoperative radiological data were analyzed to measure the severity of central canal stenosis, facet joint arthropathy, intervertebral disc herniation, and spinal epidural lipomatosis, osteophyte formation, range of motion (ROM), and computed tomography value of the vertebral bodies. The radiological characteristics and clinical contraindications for OLIF were compared among the groups.
Results:
Of the 100 patients, 51% had clinical contraindications for OLIF, which included 85%, 25%, 62.5%, and 20% of patients in groups A, B, C, and D, respectively. Compared with group B, group A demonstrated greater severity of central canal stenosis, whereas group C showed a higher degree of facet joint arthropathy. More patients in groups A and C had severe central canal stenosis. Regarding the ROM results, group A had segmental stiffness, whereas group D presented relatively unstable slip segments.
Conclusions
Patients with different DS subtypes have varied radiological characteristics. Groups B and D are suitable candidates for OLIF. Most patients in group A are unsuitable for OLIF because of bony hyperplasia, severe spinal stenosis, and segmental stiffness.
6.Analysis of the current status and countermeasures of safety content control of traditional Chinese medicine based on the revision announcement of the instruction and the national adverse drug reaction monitoring report
Jian ZHU ; Zhong WANG ; Hongli WU ; Zhiwei JING
China Pharmacy 2025;36(17):2092-2096
OBJECTIVE To provide a reference for revising the safety content of traditional Chinese medicine(TCM) instructions. METHODS A systematic analysis was conducted on the relevant announcements on the revision of TCM instruction from 2013 to 2024, including the year of publication, drug name, drug formulation, announcement release time, and the average number of revisions made to three safety contents (contraindication, adverse drug reaction, and precaution). According to the report data of national adverse drug reaction monitoring from 2013 to 2024, analyze the proportion of TCM in all adverse drug reactions, the composition ratio of adverse drug reaction of different dosage forms of drugs [TCM injection, oral TCM, other (topical) TCM]. RESULTS From 2013 to 2024, the National Medical Products Administration issued a total of 101 notices on the revision of TCM instruction, involving 241 types of TCM. Among them, there were 163 types of oral TCM, 25 types of TCM injection, and 53 types of other (topical) TCM. There were 3, 10 and 0 types of TCM injection, oral TCM, and other (topical) TCM with missing safety content, respectively. The main source of adverse drug reaction data for TCM injections was post- marketing monitoring data (accounting for 48.00%); the main source of adverse drug reaction data for oral TCM was monitoring data (accounting for 71.17%); 73.58% of other (topical) TCM did not mention the source of adverse drug reaction data. The report on national adverse drug reaction monitoring showed that the proportion of all adverse drug reactions of TCM had decreased from 17.3% in 2013 to 12.1% in 2024. Among them, the proportion of adverse drug reaction of TCM injection in the three dosage forms of TCM had decreased from 61.3% in 2015 to 24.6% in 2024, while the proportion of adverse drug reaction of oral TCM in the three dosage forms of TCM had increased from 34.7% in 2015 to 64.0% in 2024. CONCLUSIONS The risk management of TCM safety content has achieved results in China, but still faces three major challenges: strongdependence on passive monitoring, insufficient data traceability, and missing key content. It is urgent to improve safety content by dosage form, optimize data sources, and fully utilize real-world evidence to supplement safety content.
7.Ablation ranges of single and double needle microwave ablation of pig lung in vivo
Na KOU ; Fuliang LUO ; Hongli LI ; Jun TENG ; Mengfei ZHAO ; Ronghua JIANG ; Mengyuan ZHAO ; Hongwu WANG
Chinese Journal of Interventional Imaging and Therapy 2024;21(8):491-494
Objective To compare ablation ranges of single and double needle microwave ablation(MWA)of pig lung in vivo.Methods Five healthy Bama miniature pigs were enrolled.Single needle(single needle group)and parallel double needle MWA(double needle group)were performed successively on bilateral lungs,respectively.Adverse event during MWA was evaluated according to common terminology criteria for adverse events(CTCAE).The long diameter(D1CT),short diameter(D2CT),longitudinal diameter(D3CT)and volume(V)of ablation foci were measured and calculated based on CT images immediately after MWA,whereas D1,s D2s and sphericity of ablation foci were also obtained based on specimen and compared between groups.Results D1CT,D2CT,D3CT and V,as well as D1S,D2S and sphericity of ablation foci in single needle group were all significantly smaller than those in double needle group(all P<0.01).Mild pneumothorax(CTCAE grade 1)was found in 1 pig(1/5,20.00%)in single needle group,while mild pneumothorax and pulmonary hemorrhage(both CTCAE grade 1)occurred in 1 pig(1/5,20.00%)in double needle group.No other adverse event was observed.Conclusion Compared with single needle MWA,double needle MWA of pig lung in vivo resulted larger ablation range and more spherically shaped ablation foci.
8.Predictive values of Osteoporosis Self-Assessment Screening Tool for Asians(OSTA)score and body mass index(BMI)in patients with lumbar degenerative disease and osteoporosis
Cong NIE ; Hongli WANG ; Xiaosheng MA
Chinese Journal of Spine and Spinal Cord 2024;34(7):743-749
Objectives:To analyze the epidemiological characteristics of osteoporosis and osteopenia in patients with lumbar degenerative diseases,and to evaluate the predictive values of Osteoporosis Self-Assess-ment Screening Tool for Asians(OSTA)score and body mass index(BMI)for osteoporosis in this population.Methods:The clinical data of 432 patients with lumbar degenerative diseases admitted to the Department of Orthopedics of Huashan Hospital from January 2020 to December 2022 were analyzed retrospectively,including 120 males with an average age of 72.0±5.4 years and 312 females with an average age of 67.2±31.1 years old.All the patients underwent dual-energy X-ray absorptiometry(DXA)examination and lumbar CT scan in our hospital within 3 months before admission or after admission.OSTA score and BMI were calculated based on patient's age,height,and weight.Chi-square test was used to compare the incidence rates of osteoporosis and osteopenia in patients of different ages and genders.Receiver operating characteristics(ROC)curve was constructed and the area under the curve(AUC)was calculated.After determining the optimal cutoff value,the sensitivity,specificity,positive predictive value,and negative predictive value were calculated at this cutoff value.Results:According to the DXA examination results,the prevalence rates of osteoporosis in male patients over 65 years old and female patients over 50 years old were 14.17%and 37.50%respectively,and the prevalence rates of osteopenia were 52.50%and 48.08%respectively.The diagnostic compliance rate of lumbar and total hip DXA was 60.2%.In female patients of different age groups,the prevalence of osteoporosis or osteopenia increased in older age group,but the difference was not statistically significant.The prevalence of osteoporosis in women over 65 years old was greater than in men over 65 years old(P=0.000).Among the 297 patients diagnosed with osteopenia or normal bone mass by DXA,11.78%of them met the diagnostic criteria for osteoporosis in CT examination.The sensitivity of the OSTA score in predicting osteoporosis in male and female patients with lumbar degenerative disease was both 55.56%,and the negative predictive values were 89.04%and 79.19%,respectively,indicating limited predictive value for osteoporosis.The AUC of BMI in male and female patients with lumbar degenerative disease were 0.672 and 0.668 respectively,with sensitivities of 77.78%and 73.50%,and the negative predictive values of 93.10%and 76.69%respectively.The BMI had certain predictive value for osteoporosis.After correcting the diagnosis of osteoporosis with lumbar CT examination,the screening efficacy of OSTA score and BMI improved in both male and female patient populations.Conclusions:The epidemiological characteristics of osteoporosis in patients with lumbar degenerative diseases are high prevalence and low treatment rate.The prevalence of osteoporosis in women is significantly higher than that in men.The OSTA score has limited value in predicting osteoporosis,while BMI can be used as one of the initial screening tools for osteoporosis in this population.
9.A qualitative study on the symptom perception and coping experience of patients with low anterior resection syndrome after anus-preserving surgery for rectal cancer
Mengni WANG ; Fang WANG ; Jian YANG ; Hongli WANG ; Chenchen PANG ; Mengdan HAN
Chinese Journal of Modern Nursing 2024;30(3):330-335
Objective:To explore the symptom perception and coping experiences of patients with low anterior resection syndrome (LARS) after anus-preserving surgery for rectal cancer.Methods:This study adopted the phenomenological research method in qualitative research. From October 2022 to January 2023, purposive sampling was used to select 15 postoperative LARS patients with rectal cancer who underwent anus-preserving surgery and underwent outpatient follow-up or hospitalization at Henan Cancer Hospital as the research subject for semi-structured in-depth interviews. Colaizzi 7-step analysis method was used to analyze, summarize, and extract themes from interview data.Results:Four themes were extracted, including attitudes and emotional responses towards symptoms, daily activities influenced by symptoms, coping status with symptom management strategies, and the need for multidimensional support for symptoms.Conclusions:LARS patients after anus-preserving surgery for rectal cancer have many discomfort symptoms and are eager to receive support and assistance. Medical and nursing staff should pay attention to the complexity of patient symptom management and promptly conduct effective symptom assessment and intervention, providing patient-centered comprehensive supportive nursing, and improving their quality of life.
10.Effects of PBL combined with CBL in health education of insulin injection for patients with type 2 diabetes mellitus
Jingjing HE ; Lixia HUANG ; Yuping WANG ; Hongli ZHANG
Chinese Journal of Modern Nursing 2024;30(4):521-526
Objective:To explore the effect of problem-based learning (PBL) combined with case-based learning (CBL) in insulin injection patients with type 2 diabetes mellitus (T2DM) .Methods:From August to October 2022, convenience sampling was used to select 120 patients with T2DM treated with insulin injection from the Endocrinology Department of Yiwu Central Hospital as the study subject. According to the admission time, patients were divided into a control group and an intervention group, with 60 cases each. The 60 patients admitted from August 1st to 31st were in the control group and received routine health education, and 60 patients admitted from October 1st to 31st were included in the intervention group and received PBL combined with CBL. This study analyzed and compared the awareness rate of insulin injection knowledge and assessment scores of insulin injection between two groups of patients, and counted the passing rate and improvement rate of assessment scores after intervention. Before and after three months of intervention, this study evaluated the patient's blood glucose status [fasting blood glucose (FPG), 2-hour postprandial blood glucose (2hPG), and glycated hemoglobin (HbA1c) ], and counted the incidence of insulin injection related complications.Results:After four weeks of intervention, the overall awareness rate of insulin injection knowledge in the intervention group was higher than that in the control group, with a statistically significant difference ( P<0.05). The insulin injection assessment score (90.35±4.68), passing rate of assessment score 91.67%, and improvement rate of assessment score (35.48±6.84) % in the intervention group were higher than those [ (84.69±6.72), 75.00%, and (26.28±5.46) %] in the control group, and the differences were statistical ( P<0.05). After three months of intervention, the FPG, 2hPG, and HbA1c of the intervention group patients were lower than those of the control group, with statistically significant differences ( P<0.05). Within three months after intervention, the total incidence of complications in the intervention group was lower than that in the control group, and the difference was statistically significant ( P<0.05) . Conclusions:PBL combined with CBL for insulin injection patients can help to increase their knowledge and operational level of insulin injection, improve blood glucose control, and reduce insulin injection related complications.


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