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.
2.2024 annual report of interventional treatment for congenital heart disease
Changdong ZHANG ; Yucheng ZHONG ; Geng LI ; Jun TIAN ; Gejun ZHANG ; Nianguo DONG ; Yuan FENG ; Daxin ZHOU ; Yongjian WU ; Lianglong CHEN ; Xiaoke SHANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(07):909-918
In recent years, with the continuous development and increasing maturity of interventional techniques, interventional treatment for congenital heart disease (CHD) has been progressively disseminated to county- and city-level hospitals in China. Concurrently, the standardized management of adult CHD (particularly patent foramen ovale) and the lifelong management of complex CHD are gaining increasing clinical attention, while the emergence of new techniques and products continuously advances the discipline. This article aims to review the new progress made in the field of interventional treatment for congenital heart disease in China during 2024. It specifically reviews and analyzes the following key aspects: (1) annual statistics on interventional closure procedures for CHD; (2) recent insights into patent foramen ovale closure; (3) advances in transcatheter pulmonary valve replacement; (4) interventional treatment and lifelong management strategies for complex CHD; (5) new interventional techniques for acquired heart disease; and (6) the application of artificial intelligence in CHD management. Through the synthesis and discussion of these topics, this article seeks to provide a detailed analysis of the current landscape of interventional treatment for CHD in China and project its future development trends.
3.Stability study of umbilical cord mesenchymal stem cells formulation in large-scale production
Wang-long CHU ; Tong-jing LI ; Yan SHANGGUAN ; Fang-tao HE ; Jian-fu WU ; Xiu-ping ZENG ; Tao GUO ; Qing-fang WANG ; Fen ZHANG ; Zhen-zhong ZHONG ; Xiao LIANG ; Jun-yuan HU ; Mu-yun LIU
Acta Pharmaceutica Sinica 2024;59(3):743-750
Umbilical cord mesenchymal stem cells (UC-MSCs) have been widely used in regenerative medicine, but there is limited research on the stability of UC-MSCs formulation during production. This study aims to assess the stability of the cell stock solution and intermediate product throughout the production process, as well as the final product following reconstitution, in order to offer guidance for the manufacturing process and serve as a reference for formulation reconstitution methods. Three batches of cell formulation were produced and stored under low temperature (2-8 ℃) and room temperature (20-26 ℃) during cell stock solution and intermediate product stages. The storage time intervals for cell stock solution were 0, 2, 4, and 6 h, while for intermediate products, the intervals were 0, 1, 2, and 3 h. The evaluation items included visual inspection, viable cell concentration, cell viability, cell surface markers, lymphocyte proliferation inhibition rate, and sterility. Additionally, dilution and culture stability studies were performed after reconstitution of the cell product. The reconstitution diluents included 0.9% sodium chloride injection, 0.9% sodium chloride injection + 1% human serum albumin, and 0.9% sodium chloride injection + 2% human serum albumin, with dilution ratios of 10-fold and 40-fold. The storage time intervals after dilution were 0, 1, 2, 3, and 4 h. The reconstitution culture media included DMEM medium, DMEM + 2% platelet lysate, 0.9% sodium chloride injection, and 0.9% sodium chloride injection + 1% human serum albumin, and the culture duration was 24 h. The evaluation items were viable cell concentration and cell viability. The results showed that the cell stock solution remained stable for up to 6 h under both low temperature (2-8 ℃) and room temperature (20-26 ℃) conditions, while the intermediate product remained stable for up to 3 h under the same conditions. After formulation reconstitution, using sodium chloride injection diluted with 1% or 2% human serum albumin maintained a viability of over 80% within 4 h. It was observed that different dilution factors had an impact on cell viability. After formulation reconstitution, cultivation in medium with 2% platelet lysate resulted in a cell viability of over 80% after 24 h. In conclusion, the stability of cell stock solution within 6 h and intermediate product within 3 h meets the requirements. The addition of 1% or 2% human serum albumin in the reconstitution diluent can better protect the post-reconstitution cell viability.
4.Progress in cohort study of children and adolescents health
Yunqi GUAN ; Weiming ZENG ; Jun JIANG ; Yinshu PAN ; Wei JIANG ; Zhu YU ; Ke HUANG ; Wei WU ; Meng WANG ; Jieming ZHONG ; Min YU
Chinese Journal of Epidemiology 2024;45(9):1308-1314
Cohort study of children and adolescents health is an ideal method to explore health-related problems from childhood to adulthood, to which more attention has been paid. This paper summarizes the progress in cohort study of children and adolescents health conducted both at home and abroad by introducing the study design, main contents. Emphasizing the international exchange and cohort integration, continuously expanding cohort research field, and using multi-source data for high-quality follow-up have become the trend of cohort study of children and adolescents health.
5.Diagnosis and treatment of rosacea in the real world: a survey on the current status
Jun NA ; Ruoyu LI ; Shaomin ZHONG ; Li YANG ; Yan WU
Chinese Journal of Dermatology 2024;57(2):127-133
Objective:To analyze the current status of diagnosis and treatment of rosacea in China, and to strengthen the understanding and management of this disease.Methods:A retrospective cross-sectional study was conducted, and patients with rosacea were enrolled from 23 tertiary hospitals in 6 provinces or municipalities in northern and southern China. Clinical characteristics, previous diagnosis and treatment status of these patients were collected through questionnaires. Non-normally distributed continuous data were described by M ( Q1, Q3), and compared using Mann-Whitney U test, while categorical data were compared using chi-square test. Results:Among the 593 patients with rosacea, 164 were males and 429 were females, with a male-to-female ratio of 1∶2.6; 205 patients were from southern China, and 388 from northern China; most patients (349 cases, 58.8%) were aged 20 to 40 years, and the patients from northern China were significantly older than those from southern China (median age: 37 years vs. 30 years, P < 0.001). Multiple-site involvement (371 cases, 62.6%) and coexistence of multiple phenotypes (391 cases, 65.9%) were common, the cheeks (429 cases, 72.3%) and nose (393 cases, 66.3%) were mostly affected, and skin lesions mainly manifested as persistent erythema (354 cases, 59.7%), papulopustules (344 cases, 58.0%), and telangiectasia (282 cases, 47.6%). Involvement of the cheeks was more common in the patients from southern China (160 cases, 78.0%) than in those from northern China (269 cases, 69.3%), but the nose and eyes were less involved in the patients from southern China than in those from northern China (nose: 125 cases [61.0%] vs. 268 cases [69.1%]; eyes: 3 cases [1.5%] vs. 23 cases [5.9%]; both P < 0.05). The prevalence of transient erythema and papulopustules was significantly higher in the patients from southern China (38.0% and 65.4%, respectively) than in those from northern China (20.9% and 54.1% respectively, both P < 0.05), while the patients from northern China more frequently presented with persistent erythema compared with those from southern China (64.9% vs. 49.8%, P < 0.05). The disease duration ( M [ Q1, Q3]) was 12 (4, 30) months among the patients with rosacea, and the time from the onset to diagnosis was 10 (3, 24) months. The disease duration was significantly longer (12 [4, 36] months), and the proportion of patients with disease duration > 5 years was significantly higher (16.4% [63 cases]) in the patients from northern China than in those from southern China (12 [3, 24] months, 9.4% [19 cases], respectively; both P < 0.05). The patients with varied subtypes and severity of rosacea were previously mainly treated with topical antimicrobial agents (71.9%) ; 72.7% of the patients with mild rosacea were treated with systemic drugs; poor patient compliance was observed, and only 40.6% of the patients completed more than 4 consecutive weeks of treatment at a time. Conclusions:Rosacea usually occurred in young and middle-aged people in China, mostly involved the cheeks and nose, and mainly manifested as erythema or papulopustules. Delayed diagnosis, non-standard treatment and poor patient compliance existed in clinical practice.
6.Effects of esketamine combined with sufentanil on postoperative analgesia and depression after hip arthroplasty
Jun-Jun HE ; Hong WANG ; Yuan-Yuan HU ; Lan XU ; Jing-Jing WU ; Qun CHEN ; Zhi-Peng DONG ; Li-Li ZHONG
Journal of Regional Anatomy and Operative Surgery 2024;33(3):268-271
Objective To evaluate the effects of ketamine combined with sufentanil on postoperative analgesia and depression in patients undergoing hip arthroplasty.Methods A total of 60 patients who underwent elective hip arthroplasty were selected and divided into the S group,the SK1 group and the SK2 group according to the patient-controlled intravenous analgesia regimen,with 20 cases in each group.Patients in the S group were received 2 μg/kg of sufentanil for postoperative analgesia,patients in the SK1 group were received 1 mg/kg of esketamine and 2 μg/kg of sufentanil for postoperative analgesia,and patients in the SK2 group were received 2 mg/kg of esketamine and 2 μg/kg of sufentanil for postoperative analgesia.At 1,4,24,and 48 hours after surgery,the analgesic effect of patients was evaluated using the numeric rating scale(NRS),and the sedation effect of patients was evaluated using the Ramsay sedation score.Depression of patients before and 48 hours after surgery was assessed by self-rating depression scale(SDS).The adverse reactions such as nausea and vomiting,dizziness and headache,respiratory depression,and mental symptoms within 48 hours after surgery of patients were recorded.Results The NRS scores 1,4,and 24 hours after surgery of patients in the SK1 group and the SK2 group were lower than those in the S group(P<0.05);there was no statistically significant difference in the NRS scores 48 hours after surgery of patients among the three groups(P>0.05);there was no statistically significant difference in the NRS scores at different postoperative points of patients between the SK1 and SK2 groups(P>0.05).The SDS scores 48 hours after surgery of patients in each group were lower than those before surgery(P<0.05).There was no statistically significant difference in the Ramsay scores at different postoperative points of patients among the three groups(P>0.05).The incidence of adverse reactions 48 hours after surgery in the SK2 group was higher than those in the S group and the SK1 group(P<0.05).Conclusion Using 1 mg/kg of esketamine combined with 2 μg/kg of sufentanil after hip arthroplasty has a good analgesic effect without obvious increase of adverse reactions or significant effect on improving depression of patients.
7.Downregulation of MUC1 Inhibits Proliferation and Promotes Apoptosis by Inactivating NF-κB Signaling Pathway in Human Nasopharyngeal Carcinoma
Shou-Wu WU ; Shao-Kun LIN ; Zhong-Zhu NIAN ; Xin-Wen WANG ; Wei-Nian LIN ; Li-Ming ZHUANG ; Zhi-Sheng WU ; Zhi-Wei HUANG ; A-Min WANG ; Ni-Li GAO ; Jia-Wen CHEN ; Wen-Ting YUAN ; Kai-Xian LU ; Jun LIAO
Progress in Biochemistry and Biophysics 2024;51(9):2182-2193
ObjectiveTo investigate the effect of mucin 1 (MUC1) on the proliferation and apoptosis of nasopharyngeal carcinoma (NPC) and its regulatory mechanism. MethodsThe 60 NPC and paired para-cancer normal tissues were collected from October 2020 to July 2021 in Quanzhou First Hospital. The expression of MUC1 was measured by real-time quantitative PCR (qPCR) in the patients with PNC. The 5-8F and HNE1 cells were transfected with siRNA control (si-control) or siRNA targeting MUC1 (si-MUC1). Cell proliferation was analyzed by cell counting kit-8 and colony formation assay, and apoptosis was analyzed by flow cytometry analysis in the 5-8F and HNE1 cells. The qPCR and ELISA were executed to analyze the levels of TNF-α and IL-6. Western blot was performed to measure the expression of MUC1, NF-кB and apoptosis-related proteins (Bax and Bcl-2). ResultsThe expression of MUC1 was up-regulated in the NPC tissues, and NPC patients with the high MUC1 expression were inclined to EBV infection, growth and metastasis of NPC. Loss of MUC1 restrained malignant features, including the proliferation and apoptosis, downregulated the expression of p-IкB、p-P65 and Bcl-2 and upregulated the expression of Bax in the NPC cells. ConclusionDownregulation of MUC1 restrained biological characteristics of malignancy, including cell proliferation and apoptosis, by inactivating NF-κB signaling pathway in NPC.
8.Effect of 3D-printed heart model on congenital heart disease education: A systematic review and meta-analysis
Siwei BI ; Yannan ZHOU ; Jun GU ; Zhong WU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(08):1101-1108
Objective To evaluate the effect of the 3D-printed heart model on congenital heart disease (CHD) education through systematic review and meta-analysis. Methods The literature about the application of the 3D-printed heart model in CHD education was systematically searched by computer from PubMed, Web of Science, and EMbase from inception to November 10, 2022. The two researchers independently screened the literature, extracted data and evaluated the quality of the literature. Cochrane literature evaluation standard was used to evaluate the quality of randomized controlled trials, and JBI evaluation scale was used for cross-sectional and cohort studies. Results After screening, 23 literatures were included, including 7 randomized controlled trials, 15 cross-sectional studies and 1 cohort study. Randomized controlled trials were all at low-risk, cross-sectional studies and and the cohort study had potential bias. There were 4 literatures comparing 3D printing heart model with 2D image teaching and the meta-analysis result showed that the effect of 3D printing heart model on theoretical achievement was more significant compared with 2D image teaching (SMD=0.31, 95%CI –0.28 to 0.91, P=0.05). Conclusion The application of the 3D-printed heart model in CHD education can be beneficial. But more randomized controlled trials are still needed to verify this result.
9.Intensive blood pressure control on arterial stiffness among older patients with hypertension
Shuyuan ZHANG ; Yixuan ZHONG ; Shouling WU ; Hailei WU ; Jun CAI ; Weili ZHANG
Chinese Medical Journal 2024;137(9):1078-1087
Background::Arterial stiffening increases with age and blood pressure and is associated with cardiovascular disease (CVD), but the relationship between blood pressure lowering and arterial stiffening is still uncertain, especially in older people. This study aimed to evaluate the effect of intensive blood pressure treatment on the progression of arterial stiffness and risk of CVD in older patients with hypertension.Methods::The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial was a multicenter, randomized, controlled trial performed at 42 clinical centers throughout China, and 8511 patients aged 60–80 years with essential hypertension were enrolled and randomly assigned to systolic blood pressure (SBP) target of 110 mmHg to <130 mmHg (intensive treatment) or 130 mmHg to <150 mmHg (standard treatment). Patients underwent repeated examinations of the brachial-ankle pulse wave velocity (baPWV) and ankle-brachial index (ABI) at baseline, and the arterial stiffness was evaluated at the 3-year follow-up. A total of 5339 patients who had twice repeated measurements were included in this study. Changes in arterial stiffness between the intensive and standard treatment groups were analyzed using a multivariate linear regression model. The Cox proportional hazard regression model was used to evaluate the effect of intensive treatment on primary CVD outcomes.Results::The changes in baPWV were 61.5 cm/s (95% confidence interval [CI]: 49.8–73.2 cm/s) in the intensive treatment group and 98.4 cm/s (95% CI: 86.7–110.1 cm/s) in the standard treatment group ( P <0.001). Intensive treatment significantly delayed the progression of arterial stiffness, with an annual change of 23.1 cm·s –1·year –1vs. 36.7 cm·s –1·year -1 of baPWV in the intensive and standard treatment groups, respectively. During a median follow-up period of 3.36 years, primary CVD outcomes occurred in 77 (2.9%) patients in the intensive treatment group compared with 93 (3.5%) in the standard treatment group. Intensive treatment resulted in a significantly lower CVD risk in patients aged 70–80 years or with SBP <140 mmHg. Conclusion::Intensive blood pressure control with an SBP target of 110 mmHg to <130 mmHg could delay the progression of arterial stiffness and reduce the risk of CVD in older patients with hypertension.Clinical trial registration::http://www.clinicaltrials.gov; No. NCT03015311.
10.Role of school tuberculosis demonstration screening in prevention and control of tuberculosis epidemic situation
Jun FAN ; Bo WU ; Jiyuan ZHONG
Chongqing Medicine 2024;53(13):2039-2041,2046
Objective To evaluate the role of school tuberculosis demonstration screening in the preven-tion and control of tuberculosis(TB)epidemic situation.Methods First,the investigators were trained by the school TB screening techniques,the standardized quality control system that can be promoted at the primary level was established.Then,the TB demonstration screening was carried out in 18 schools in 16 districts and counties of Chongqing City by adopting the cross-sectional survey from September to November 2022,and the screening subjects were 25 968 students in the grade one of junior school,grade one,grade two and grade three of high school,and the training results and screening results were analyzed.Results A total of 530 medical and health professionals participated in the technical training of TB screening in schools,and 391 persons com-pleted the theoretical assessment,operation of tuberculin skin test(TST)and the result interpretation assess-ment,with a pass rate of 61.89%(242/391)and a basic pass rate of 12.02%(47/391).Among the 25 968 students,the strongly positive rate of TST was 13.92%,and the positive rate of Mycobacterium tuberculosis recombinant protein skin test(TBST)was 5.55%.The strongly positive rate of TST had statistically signifi-cant difference among different grades(P<0.05).The positive rate of TBST in the grade two of high school was higher than that in the grade one,and the difference was statistically significant(P<0.05).Through screening,12 students were found to have active tuberculosis,the discovery rate was 46.21/100 000,and the proportion of grade two of high school was maximal(75.00%),but there was no statistical difference in the discovery rate of active TB among the grade one of junior school,grade one and two of high school(P>0.05).Conclusion The school tuberculosis demonstration screening accurately assesses the students'latent tuberculosis infection burden.

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