1.Characteristics analysis of pediatric medicines with priority review and approval for marketing in China
Haoyu YANG ; Kan TIAN ; Xue YOU ; Hongwei DAN ; Qian WANG ; Xiaoyong YU
China Pharmacy 2025;36(5):519-523
OBJECTIVE To analyze the characteristics of pediatric medicines with priority review and approval for marketing in China, providing a reference for promoting enterprise R&D and production, as well as improving the supply guarantee mechanism for pediatric medicines. METHODS Based on publicly available data sources such as List of Approved Information for Pediatric Medications Subject to Priority Review and Approval, Pharnexcloud biomedical database, and National Medical Insurance Drug Directory, this study conducted a comprehensive analysis of the main characteristics of pediatric medicines with priority review and approval for marketing. RESULTS As of June 30, 2024, a total of 68 pediatric medicines had been approved through the priority review and approval process, covering 12 therapeutic areas, with oral dosage forms accounting for 64.71%. The median time from application to inclusion in priority review was 35.50 days, with an average of 41.69 days. The median time from inclusion in priority review to market approval was 1.24 years, with an average of 1.42 years. This included 12 domestic new medicines, 21 domestic generic medicines, 35 imported medicines, as well as 29 pediatric-specific medicines and 21 orphan medicines. Additionally, 31 of these medicines had been included in the medical insurance catalog, representing a proportion of 45.59%. CONCLUSIONS Currently, a trend of differentiated competition is emerging between domestic and imported pediatric medicines. The therapeutic areas for pediatric medicines are continuously expanding, and the dosage forms are becoming more tailored to children’s needs. However, there are still issues such as slow progress in new medicine development, insufficient stability in the medicine review and approval process, and a need to increase the proportion of medicines included in medical insurance.
2.Construction of evaluation index system of infectious disease prevention and control ability in colleges and universities
Chinese Journal of School Health 2025;46(3):438-442
Objective:
To construct a scientific and perfect evaluation index system of infectious disease prevention and control ability in colleges and universities, so as to provide reference tools for colleges and universities to effectively respond to infectious disease.
Methods:
The initial framework of the evaluation index system of infectious disease prevention and control ability in colleges and universities was constructed by using literature analysis method. Experts familiar with infectious disease prevention and control or school health work were selected to conduct two rounds( n =16,18) of Delphi expert consultation for determining the evaluation index system. Analytical hierarchy process was used to calculate the index weights and combined weights. About 198 prevention and control personnel were conveniently selected from 3 universities in Inner Mongolia Autonomous Region to comprehensively evaluate the evaluation indicators by using fuzzy comprehensive evaluation method.
Results:
After two rounds of Delphi consultation questionnaire, the effective recovery rates were 80.0% and 90.0%, the expert authority levels were 0.89 and 0.86, the expert harmony coefficients for Kendall W were 0.166 and 0.310, and the variation coefficient of each index was <0.25. Finally, the evaluation index system of infectious disease prevention and control ability of colleges and universities included 4 first level indicators, 14 second level indicators and 75 third level indicators. The weights of prevention and monitoring and early warning, organizational system guarantee, emergency management, rehabilitation and summary were 0.176, 0.476, 0.268 and 0.080, respectively. The top 3 weights of the secondary indexes were 0.623 for infectious disease surveillance and early warning, 0.595 for loss assessment and 0.370 for emergency response. The score of fuzzy comprehensive evaluation of the index system of infectious disease prevention and control ability in colleges and universities was 79.148, suggesting a high level.
Conclusion
The established evaluation index system of infectious disease prevention and control ability in colleges and universities is scientific and reasonable, which is conducive to provide tool reference for the evaluation of infectious disease prevention and control ability in colleges and universities.
3.Introduction to Implementation Science Theories, Models, and Frameworks
Lixin SUN ; Enying GONG ; Yishu LIU ; Dan WU ; Chunyuan LI ; Shiyu LU ; Maoyi TIAN ; Qian LONG ; Dong XU ; Lijing YAN
Medical Journal of Peking Union Medical College Hospital 2025;16(5):1332-1343
Implementation Science is an interdisciplinary field dedicated to systematically studying how to effectively translate evidence-based research findings into practical application and implementation. In the health-related context, it focuses on enhancing the efficiency and quality of healthcare services, thereby facilitating the transition from scientific evidence to real-world practice. This article elaborates on Theories, Models, and Frameworks (TMF) within health-related Implementation Science, clarifying their basic concepts and classifications, and discussing their roles in guiding implementation processes. Furthermore, it reviews and prospects current research from three aspects: the constituent elements of TMF, their practical applications, and future directions. Five representative frameworks are emphasized, including the Consolidated Framework for Implementation Research (CFIR), the Practical Robust Implementation and Sustainability Model (PRISM), the Exploration, Preparation, Implementation, Sustainment (EPIS)framework, the Behavior Change Wheel (BCW), and the Normalization Process Theory (NPT). Additionally, resources such as the Dissemination & Implementation Models Webtool and the T-CaST tool are introduced to assist researchers in selecting appropriate TMFs based on project-specific needs.
4. Advances on cardiovascular effects of GLP-lRAs
Zhi-Qiang KE ; Chao LIU ; Zhi-Qiang KE ; Qian-Qian MA ; Zheng-Ding SU ; Dan LI ; Xin-Yuan ZHAO
Chinese Pharmacological Bulletin 2024;40(3):426-430
Glucagon-like peptide-1 ( GLP-1 ) is secreted by gut enteroendocrine cells. GLP-1 receptor agonists ( GLP-1 RAs) control glucose-related augmentation of insulin and suppress glu-cagon secretion. GLP-lRAs also inhibit gastric emptying, food intake and limit weight gain. In the past decade, significant progresses have been made in the investigation on the effects of GLP-1 RAs on cardiovascular system. The potential advantages of oral small-molecule GLP-1 RAs could improve the application of this class of drugs. This review highlights the multiple cardiovascular profiles of GLP-1 RAs in the treatment of cardiovascular diseases to provide new insights into cardiovascular benefits of GLP-1 RAs.
5.Clinical application of MR-guided radiotherapy based on MR-linac in esophageal cancer patients
Xinyu GAO ; Zhenjiang LI ; Hongfu SUN ; Dan HAN ; Qian ZHAO ; Chengxin LIU ; Wei HUANG
Journal of International Oncology 2024;51(1):37-42
Objective:To explore the application process, efficacy and safety of MR-guided radiotherapy based on MR-linac in esophageal cancer.Methods:The clinical data of patients with esophageal cancer treated with MR-linac at Shandong Cancer Hospital and Institute from September 2021 to July 2022 were retrospectively analyzed, to investigate the treatment process of esophageal cancer with MR-linac, and to analyze the efficacy and safety of patients. All patients received MR-guided radiotherapy, underwent CT and MR localization, target area delineation, and design of the Monaco treatment planning system plan. Adaptation-to-position adjustment was conducted during the pre-treatment evaluation. The median number of fractions was 25, the median single dose of planning target volume was 1.8 Gy, and the median total dose was 50.2 Gy. Median follow-up was 16 months.Results:Among the 12 patients in the whole group, there were 1 case of cervical esophageal cancer, 3 cases of upper thoracic esophageal cancer, 4 cases of middle thoracic esophageal cancer and 4 cases of lower thoracic esophageal cancer, including 3 cases of neoadjuvant radiotherapy and 9 cases of radical radiotherapy. All patients had a smooth treatment process. The median treatment time was 33 min, and the patients had good compliance. For patients with radical radiotherapy, one month after radiotherapy, the number of objective remission cases was 3, and the number of disease-control cases was 9; six months after radiotherapy, the number of objective remission cases was 3, and the number of disease-control cases was 6. All patients treated with neoadjuvant radiotherapy underwent surgery within 2 months, and one patient achieved pathological complete remission. The most common acute adverse reactions were radiation esophagitis (7 cases) and leukopenia in bone marrow suppression (8 cases), with late-stage adverse reactions being radiation pneumonia (1 case). The adverse reactions to radiotherapy were slight, and no grade 4 or above adverse reactions were observed.Conclusion:The clinical treatment process for esophageal cancer under MR-guided radiotherapy based on MR-linac is feasible, with good curative effects and mild adverse reactions.
6.Research progress on the histopathological growth patterns of colorectal liver metastasis
Guobao SUN ; Qian YANG ; Qingchun ZHUANG ; Binbin GAO ; Xiaogang SUN ; Wei SONG ; Dan SHA
Journal of International Oncology 2024;51(2):114-118
The histopathological growth patterns (HGPs) of colorectal cancer (CRC) liver metastasis reflect the complicated and varied interactions between tumor cells and host microenvironment. Exploring the tumor vascular and immunological features of HGPs, the relationship between HGPs and anti-tumor treatment efficacy, and HGPs prediction methods may have potential clinical aplication value for making optimal treatment strategies, evaluating patients' prognosis, and monitoring disease progression.
7.Effect of Photo-activated Disinfection as An Adjunctive Therapy in the Treatment of Chronic Periodontitis
Weimin QIAN ; Liangju CAO ; Yu JIANG ; Dan PU ; Fengting MU ; Yongsheng PAN
Journal of Kunming Medical University 2024;45(1):136-142
Objective To evaluate the effect of photo-activated disinfection(PAD)as a kind of adjuvant treatment on moderate to severe chronic periodontitis.Methods 21 patients with the chronic periodontitis(totally 218 selected sites)were randomly enrolled and divided into group A(minocycline hydrochloride),group B(PAD),group C(PAD + minocycline hydrochloride),and group D(no adjunctive therapy)for the adjunctive treatment after receiving the scaling and root planing(SRP).Periodontal indexs as probing depth(PD),bleeding on probing(BOP)and clinical attachment loss(CAL)were examined at the baseline,6 and 12 weeks after the treatment.Meanwhile,periodontal pathogens as Porphyromonas gingivalis(Pg)and Tannerella forsythia(Tf)from subgingival plaque of group A,B and C were detected by Real-time PCR.Results Compared with the baseline,the periodontal inflammations of all groups were improved signiffcantly at 6 and 12 weeks after the treatment(P<0.001),and group A,group B and group C were better than group D(P<0.001),group C was better than group A(P<0.001);Furthermore,the concentration of Pg and Tf was decreased significantly(P<0.001),and there was no difference among the three groups with adjunctive therapy.Conclussion As the adjunctive treatment of SRP,PAD could achieve the same and even better effect than minocycline hydrochloride ointment.
8.Alteration of cognitive function in overweight and obese adolescents and its relationship with serum FGF21 levels
Rui HAN ; Qian WU ; Dan LIU ; Di CHENG ; Ying ZHANG ; Jiacheng NI ; Piao KANG ; Anran CHEN ; Shujie YU ; Qichen FANG ; Huating LI
Journal of Shanghai Jiaotong University(Medical Science) 2024;44(1):87-97
Objective·To evaluate the changes in cognitive function in overweight and obese adolescents,and explore the association between cognitive function and fibroblast growth factor 21(FGF21).Methods·A total of 175 adolescents from a senior high school in Shanghai were divided into normal weight group(n=50),overweight group(n=50)and obese group(n=75)based on their body mass index(BMI).General information,anthropometric data and laboratory testing indicators of the adolescents were collected and compared.The cognitive function of the three groups of adolescents was assessed by using the accuracy(ACC)and reaction time of Flanker task and n-back task.Enzyme-linked immunosorbent assay(ELISA)was used to detect the serum FGF21 level of the three groups of adolescents.Partial correlation analysis and multiple linear regression model were used to evaluate the correlation between cognitive task performance and anthropometric data and laboratory testing indicators.Results·Compared with the normal weight group,systolic blood pressure,diastolic blood pressure,and the levels of fasting plasma glucose,glycosylated hemoglobin and triacylglycerol in the obese group were higher(all P<0.05).Under congruent or incongruent stimulus conditions in the Flanker task,there was no significant difference in ACC between any two groups;compared with the normal weight and overweight groups,the reaction time of the adolescents in the obese group was prolonged(all P<0.05).In the n-back task,there were no significant differences in ACC between any two groups,while the obese group had longer reaction time in the 1-back and 2-back tasks compared to the normal weight and overweight groups(all P<0.05).Compared with the normal weight group,serum FGF21 levels of the adolescents in the obese group were higher(P=0.000).Partial correlation analysis showed that the reaction time of the adolescents in Flanker and n-back tasks was correlated with their BMI,body fat mass,waist circumference,waist-to-hip ratio and FGF21 level(all P<0.05).Multiple linear regression analysis further confirmed that BMI was associated with prolonged reaction time in cognitive-related behavioral tasks in the adolescents(all P<0.05),and FGF21 level was associated with ACC in the 2-back task(P=0.000)and reaction time in the incongruent stimulus condition(P=0.048).Conclusion·Overweight and obese adolescents have cognitive impairments,and BMI and serum FGF21 levels are associated with changes in their cognitive function.
9.Effects of bacterial lysates on immune function in elderly mice with pulmonary fibrosis
Li QIAN ; Ziyue SUN ; Xiangrui GUO ; Dan LI ; Xuejun LIU ; Yongkang HAN ; Yufeng DU
Chinese Journal of Geriatrics 2024;43(2):209-215
Objective:To investigate the correlation between immune function and age-related pulmonary fibrosis, as well as the potential impact of bacterial lysates on this condition.Methods:Twenty-four healthy male C57BL/6 mice, aged 24, were randomly divided into three groups: a control group(Group N), a pulmonary fibrosis group(Group M), and a pulmonary fibrosis+ bacterial lysis product intervention group(Group P). Mice in Groups M and P were intratracheally injected with bleomycin(5 mg/kg)to induce a mouse pulmonary fibrosis model, while mice in Group N were injected with saline.After modeling, mice in Group P were orally administered 0.4 ml of a bacterial lysis product once a day.After 28 days, lung tissue and blood samples were collected for analysis.Pathological changes in lung tissue were assessed using hematoxylin and tosin staining(HE)and Masson staining and the Ashcroft score.The expression of CD4+ and CD8+ in lung tissue was evaluated using immunohistochemistry.The levels of serum interferon-γ(INF-γ), interleukin-3(IL-13), and immunoglobulin A(IgA)protein were measured using Enzyme-linked Immuno Sorbent Assay(ELISA). The levels of INF-γ and IL-13 mRNA in lung tissue were determined using Real-Time Quantitative Transcription PCR(RT-qPCR). Additionally, the protein expression levels of matrix metalloprotein-9(MMP-9)and tissue inhibitor of metalloproteincise 1(TIMP-1)in lung tissue were assessed using blot analysis.Results:The degree of lung fibrosis was significantly reduced in mice in group P compared with group M when treated with bacterial lysis products.Group M showed a significant decrease in the expression of CD4+ T cells and an increase in the expression of CD8+ T cells( P<0.05)compared to group N. Additionally, the content of IgA was decreased( P<0.05)in group M. On the other hand, group P showed a significant increase in the expression of CD4+ T cells and a decrease in the expression of CD8+ T cells( P<0.05)compared to group M. Furthermore, the content of IgA was elevated( P<0.05)in group P. After bacterial lysis product intervention, mRNA and protein expression levels of IFN-γ were elevated( P<0.05), while mRNA and protein expression levels of IL-13 were reduced( P<0.05). Moreover, protein expression of MMP-9 and TIMP-1 was significantly up-regulated in group M compared with group N( P<0.05), and decreased after bacterial lysis product intervention( P<0.05). Conclusions:It is well-known that immune mechanisms play a crucial role in the development of pulmonary fibrosis.The use of bacterial lysates has been found to effectively regulate immune balance and mitigate the severity of pulmonary fibrosis in elderly mice.
10.Study on the management model of elderly patients with hypertension by multi-disciplinary comprehensive management team of tertiary hospital collaborated with community pharmacists
Dan HAN ; Li NIE ; Meihua WANG ; Jinli WU ; Simin YAN ; Fuchao LI ; Yun QIAN ; Youli XI
China Pharmacy 2024;35(16):2033-2037
OBJECTIVE To explore the effects of multi-disciplinary comprehensive management team of tertiary hospital collaborated with the pharmacists from community health service center (hereinafter referred to as “community pharmacists”) on elderly patients with hypertension in the community. METHODS Elderly patients with hypertension from May 2020 to May 2021 in Yuhua Community Health Service Center of Nanjing were divided into control group (76 cases) and observation group (76 cases) according to the management style. The control group was treated with regular community medical services and the observation group received regular community medical services plus pharmaceutical care provided by the comprehensive management team collaborated with community pharmacists. The compliance, blood pressure control status and hypertension-related complications were compared between 2 groups before management and after 24 months of management. RESULTS After 24 months of management, the compliance and blood pressure compliance rates in both groups were higher than before management; meanwhile, the observation group was significantly higher than control group at the corresponding period (P<0.05 or P< 0.01). The blood pressure levels of both groups were significantly lower than before management, and the systolic blood pressure as well as the incidences of the whole complications and cerebrovascular injury in the observation group were significantly lower than control group at the 583867635@qq.com corresponding period (P<0.05). There was statistical significance in the effects of the rate of reaching the standard of blood pressure on the complications (P<0.01). CONCLUSIONS The hypertension management mode of comprehensive management team collaborated with community pharmacists can significantly improve the compliance and blood pressure compliance rate of elderly patients with hypertension, and reduce the incidence of hypertension-related complications.


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