1.Optimization of drug management model for investigator-initiated trial with benchmarking analysis
Yufei XI ; Tianxiao WANG ; Xue ZHANG ; Yingzhuo DING ; Li YAN ; Feng JIANG ; Xiangui HE ; Jiannan HUANG ; Qin LI
China Pharmacy 2025;36(3):280-284
OBJECTIVE To optimize the management model of drugs used in investigator-initiated trial (IIT). METHODS With benchmarking analysis, based on the practical work experience of a tertiary specialized hospital in the field of IIT drug management in Shanghai, a thorough review was conducted, involving relevant laws, regulations, and academic literature to establish benchmark criteria and the evaluation standards. Starting from the initiation of IIT projects, a detailed comparative analysis of key processes was carried out, such as the receipt, storage, distribution, use and recycling of drugs for trial. The deficiencies in the current management of IIT drugs were reviewed in detail and a series of optimization suggestions were put forward. RESULTS It was found that the authorized records of drug management were missing, the training before project implementation was insufficient, and the records of receipt and acceptance of IIT drugs were incomplete. In light of these existing problems, improvement measures were put forward, including strengthening the training of drug administrators and stipulating that only drug administrators with pharmacist qualifications be eligible to inspect and accept drugs, etc. The related systems were improved, and 17 key points of quality control for the management of IIT drugs were developed. CONCLUSIONS A preliminary IIT drug management system for medical institutions has been established, which helps to improve the institutional X2023076) framework of medical institutions in this field.
2.Construction of management index system for rational drug use of key monitoring drugs
Mingxiong ZHANG ; Wanying QIN ; Jian HUANG ; Dan WANG ; Li LI ; Yinghui BU ; Ming YAN ; Kejia LI
China Pharmacy 2025;36(7):784-788
OBJECTIVE To establish management index system for rational drug use of key monitoring drugs, and provide reference for the management of key monitoring drugs in the hospitals. METHODS First, the management index system for rational drug use of key monitoring drugs was drafted by collecting the evidence from related medical literature. Next, using a modified Delphi method, twenty experienced experts from the fields of pharmacy, medical practice, healthcare insurance, and finance were selected to participate in two rounds of questionnaire consultations. Based on the expert enthusiasm coefficient, authority coefficient, degree of opinion concentration, and degree of coordination, the final indicators were determined to establish a management index system for rational drug use of key monitored drugs in medical institutions. RESULTS The expert enthusiasm coefficients reached 100% in both rounds of consultation. In first-level, second-level and third-level indicators, the authority coefficients of experts were 0.89, 0.86 and 0.87, and coordination coefficients of the experts in importance score were 0.300 (P< 0.05), 0.125 (P<0.05) and 0.139 (P<0.05), respectively. The average score for the importance of all indicators reached over 3.5, in which the full score ratio ranged from 35% to 100%. Except that the variation coefficient of a third-level indicator “number of specifications purchased for key monitored drugs” was 0.26, the variation coefficients of rest indicators were less than or equal to 0.25. Based on the results of expert consultation, final version of the management index system established in this study, including two first-level indicators (drug procurement and use, and rational drug use), five second-level indicators (such as the accessibility, cost-effectiveness) and twenty third-level indicators (such as the number of specifications purchased for key monitored drugs, the increase in the cost of key monitored drugs). CONCLUSIONS The management index system established in this study possesses high reliability and strong operability, and may provide a reference for the management of key monitoring drugs in the hospitals.
3.Comparative analysis of characteristics and functions of exosomes from human induced pluripotent stem cell-derived platelets and apheresis platelets
Weihua HUANG ; Yan ZANG ; Aihua QIN ; Ziyang FENG ; Heshan TANG ; Fei GUO ; Chuyan WU ; Qiu SHEN ; Baohua QIAN ; Haihui GU ; Zhanshan CHA
Chinese Journal of Blood Transfusion 2025;38(9):1154-1161
Objective: To compare the biological characteristics of human induced pluripotent stem cell-derived platelet exosomes (hiPSC-Plt-Exos) with those of conventional apheresis platelet exosomes (Plt-Exos), specifically focusing on their differential abilities to enhance the proliferation and migration of human umbilical cord mesenchymal stem cells (hUC-MSCs). Methods: Exosomes were isolated from hiPSC-derived Plt and apheresis Plt concentrate using size exclusion chromatography. These exosomes were then characterized through nanoparticle tracking analysis (NTA), transmission electron microscopy (TEM), and Western blotting. Co-culture experiments into hUC-MSCs were conducted with hiPSC-Plt-Exos and apheresis Plt-Exos, respectively. Their effects on the proliferation and migration of hUC-MSCs were assessed via cell proliferation assays and scratch tests. Results: hiPSC-Plt-Exos and apheresis Plt-Exos exhibited comparable particle sizes, morphological features (such as the characteristic cup-shaped structure), and surface markers (including CD9 and HSP70). Notably, hiPSC-Plt-Exos demonstrated a significantly greater ability to enhance the proliferation and migration of hUC-MSCs compared to apheresis Plt-Exos (P<0.05). These differences provide critical comparative data for their application in various clinical contexts. Conclusion: This study establishes a theoretical foundation for developing precise therapeutic strategies based on hiPSC-Plt-Exos. Furthermore, it underscores the necessity of selecting the appropriate type of exosomes according to the specific disease microenvironment to achieve optimal therapeutic outcomes.
4.Repeatability of wavefront aberration measured by adaptive optics visual simulator and agreement of OPD-Scan Ⅲ
Yan WANG ; Xuan LIAO ; Changjun LAN ; Biao LI ; Zhuang MIAO ; Qingqing TAN ; Suyun QIN ; Huan HUANG
International Eye Science 2024;24(5):810-815
AIM: To assess the repeatability and agreement of higher-order aberration obtained by adaptive optics visual simulator(VAO)compared with OPD-Scan Ⅲ.METHODS: A cross-sectional study was conducted from August to September 2023, including a total of 204 patients(204 eyes)with myopia whose right eyes were measured. The examinations were performed by the same skilled examiner using both devices separately. The VAO device was used to measure higher order aberrations of orders 3 to 6 at a pupil diameter of 4.5 mm, while both the VAO and OPD-Scan Ⅲ devices were utilized to measure total higher-order aberration(tHOA), spherical aberration(SA), coma aberration(Coma), and trefoil aberration(Trefoil)of the entire eye at pupil diameters ranging from 3 to 6 mm. Furthermore, the repeatability of whole eye aberration measurements obtained with the VAO device was evaluated and the agreement of the two devices was assessed.RESULTS: The whole-eye higher-order aberrations measured by VAO demonstrated excellent repeatability(0.767≤ICC≤0.941, Sw<0.01 μm, TRT<0.1 μm). There was no statistically significant difference in Coma measured by VAO or OPD-Scan Ⅲ for pupil diameters ranging from 4 to 6 mm(P>0.05), while a statistically significant difference was observed in whole-eye tHOA of other pupil diameters(all P<0.05). The agreement of aberration measurements for each order between VAO and OPD-Scan Ⅲ for 3 mm pupil diameters, SA at 4 and 5 mm pupil diameter and Coma at 4 mm pupil diameter showed a 95% limit of agreement(LoA)<0.1, indicating good agreement; however, poor agreement was found for the remaining aberration measurements at different pupil diameters, with a 95%LoA>0.1, and there were significant differences in higher-order aberrations measured by two devices under a pupil diameter of 3 mm(r=0.218-0.317, P<0.01), 4 mm(r=0.406-0.672, P<0.01), 5 mm(r=0.538-0.839, P<0.01 and r=0.030-0.109, P>0.01)and 6 mm(r=0.369-0.766, P<0.01).CONCLUSION: The VAO demonstrates favorable repeatability when assessing whole-eye higher order aberration under pupil diameters of 3-6 mm. However, there is inadequate agreement and interchangeability in whole-eye higher order aberration at 3-6 mm pupil diameter between VAO and OPD-Scan Ⅲ for clinical purposes.
5.A quantitative study on the outcome of patients with breast cancer after autologous breast reconstruction and implant breast reconstruction based on multi-scaleon
Qiu-Ping WU ; Jiong WU ; Ke-Da YU ; A-Yong CAO ; Xiao-Yan HUANG ; Sheng CHEN ; Lei WANG ; Jia-Qin GUAN
Fudan University Journal of Medical Sciences 2024;51(1):81-88,127
Objective To evaluate the patient-reported outcome(PRO)of patients with breast cancer who underwent autologous breast reconstruction and implant breast reconstruction.Methods Patients who underwent breast reconstruction in Shanghai Cancer Center,Fudan University from Jan 2020 to Jun 2021 were selected,including 111 patients who underwent autologous breast reconstruction and 108 patients who underwent implant breast reconstruction.Chinese version Breast-Q2.0 scale,breast cancer specificity scale QLQ-BR23 and EORTC quality of life scale QLQ-C30 were used to investigate the PRO of the two groups 18 months after operation.Results The rate of stage Ⅲ breast cancer in the self-weight construction group was higher than that in the implant reconstruction group(64.9%vs.44.4%,P<0.001).The preoperative neoadjuvant therapy and postoperative radiotherapy in the autologous reconstruction group were higher than those in the implant reconstruction group(P<0.001).Postoperative chemotherapy and endocrine therapy in the autologous reconstruction group were lower than those in the implant reconstruction group(P<0.001).The study based on Breast-Q scale showed that the breast satisfaction of autologous reconstruction group was higher than that of implant reconstruction(59.28±17.20 vs.54.94±14.48,P<0.05).The study based on QLQ-BR23 showed that the self-weight construction group was higher than the implant reconstruction group in the field of arm symptoms(20.02±20.80 vs.12.65±16.18,P<0.05).The study based on QLQ-C30 scale showed that there was no significant difference in all functional areas and symptom areas of patients.There was no significant difference in the number and time of social regression between the two groups.Conclusion Breast reconstruction can improve the PRO of breast cancer patients,and oncology factors will affect the choice of breast reconstruction.Patients with autologous breast reconstruction are more satisfied with breast appearance,but upper limb symptoms such as swelling and pain are more obvious than implant reconstruction,which is related to the higher proportion of axillary lymph node dissection in patients with autologous reconstruction.There is no significant difference in quality of life and social regression between the two groups.
6.A nationwide cross-sectional study of depressive symptoms among community-based patients with neoplasms in China
Hanyun LI ; Xiuting LI ; Ruixue XU ; Fuqin MU ; Yan QIN ; Yueqin HUANG ; Yibo WU ; Yan LIU
Chinese Mental Health Journal 2024;38(1):55-62
Objective:To investigate the associated factors of depressive symptoms among patients with neo-plasms.Methods:Nationwide(excluding Hong Kong,Macao,and Taiwan),30 505 residents were selected by a combination of stratified sampling and quota sampling according to the proportion of the seventh national population census.Patient Health Questionnaire-9(PHQ-9),General Anxiety Disorder-7(GAD-7),self-made questionnaire,and simplified perceived social support scale used to evaluate depressive symptoms,anxiety symptoms,behaviors,and perceived social support among patients with neoplasms.Results:Totally 359(1.2%)patients with self-repor-ted clinically diagnosed neoplasms were included,of which 151(42.1%)patients with malignant neoplasms and 208(57.9%)patients with benign neoplasms.The detection rate of depressive symptoms in patients with neo-plasms was 76.6%.Less than three days of walking for more than 10 minutes per day in the past week(OR=6.63),4-6 days of walking for more than 10 minutes per day in the past week(OR=5.00),the low(OR=4.80)or medium(OR=3.06)overall sleep quality,the lower perceived friend support(OR=4.66),and anxiety symp-toms(OR=1.74)among patients with neoplasms were risk factors for depressive symptoms.Conclusion:Patients with neoplasms generally might be at a high risk of depressive symptoms,especially for those patients with less ex-ercise,poor sleep quality,and low perceived social support.
7.Investigation on a suspected outbreak of carbapenem-resistant Acinetobacter baumannii nosocomial infection in an intensive care unit
Mei HUANG ; Xiaobo GUI ; Ya YANG ; Feng LU ; Juanxiu QIN ; Yan LI ; Shuyi ZHANG ; Wenqin ZHOU ; Xiaofang FU ; Haiqun BAN
Shanghai Journal of Preventive Medicine 2024;36(5):435-438
ObjectiveTo investigate a suspected outbreak of carbapenem-resistant Acinetobacter baumannii (CRAB) nosocomial infection in an intensive care unit (ICU) and provide scientific evidence for prevention and control of multi-drug resistant nosocomial infection. MethodsClinical and epidemiological data of 4 patients with CRAB infection were retrospectively investigated in the ICU of Renji Hospital in November 2021. Environmental hygiene monitoring and multilocus sequence typing (MLST) were conducted and intervention measures were taken. ResultsA total of 4 cases with CRAB infection were identified, among which 1 case was determined to be community-acquired and3 cases were hospital-acquired. The isolated strains shared the same drug resistance, and were all classified into ST368 type. In the surface and hand samples (n=40), 2 CRAB strains were detected in the air filter beside the bed of the first case, with a detection rate of 5%. After adopting comprehensive prevention and control strategies, including environmental cleaning and disinfection, hand hygiene, staff management and training, and supervision, no similar case with CRAB infection was found. ConclusionThis suspected outbreak of CRAB nosocomial infection may be induced by inadequate environmental cleaning and disinfection, and inadequate implementation of hand hygiene. Timely identification, investigation, and targeted measures remain crucial to effective control of possible nosocomial infection.
8.Effect of hand hygiene intervention on healthcare-associated case infection incidence from 2014 to 2022
Jia-Yan DING ; Rui-Hong SHEN ; Wen-Qin ZHOU ; Ya-Yun YUAN ; Mei HUANG ; Ya YANG ; Bing-Chao CAI ; Hai-Qun BAN ; Xiao-Fang FU
Chinese Journal of Infection Control 2024;23(2):208-213
Objective To observe the effect of multi-modal hand hygiene(HH)intervention on HH compliance,as well as the relationship between HH compliance and the healthcare-associated(HA)case infection incidence.Methods From 2014 to 2022,the infection control team in a tertiary first-class hospital implemented multi-modal HH intervention for health care workers(HCWs).The changing trend of HH monitoring data,the correlation be-tween HH compliance rate and HA case infection incidence were analyzed retrospectively.Results The consump-tion of HH products in the wards showed a stable upward trend;HH compliance rate increased from 64.98%in 2014 to 85.01%in 2022(P<0.001),and HA case infection incidence decreased from 1.21%to 0.83%(P<0.05).HH compliance rate was negatively correlated with HA case infection incidence(r=-0.369,P=0.027).HH compliance rates in different regions and job posts in each quarter were increased(P<0.001).For 5 different HH moments in each quarter,HH compliance rate fluctuated slightly before sterile manipulation and after touching patient;presented rising trend after touching surroundings around patient,and decreased before touching patient and after touching patient's body fluid since 2020(P<0.001).Conclusion Multi-modal HH intervention can im-prove the HH compliance of HCWs,improving their HH awareness is conducive to reducing HA case infection incidence.
9.Advances in antitumor research of bifunctional small molecule inhibitors targeting heat shock protein 90
Hong-ping ZHU ; Xin XIE ; Rui QIN ; Wei HUANG ; Yan-qing LIU ; Cheng PENG ; Gu HE ; Bo HAN
Acta Pharmaceutica Sinica 2024;59(1):1-16
The heat shock protein 90 (Hsp90) protein family is a cluster of highly conserved molecules that play an important role in maintaining cellular homeostasis. Hsp90 and its co-chaperones regulate a variety of pathways and cellular functions, such as cell growth, cell cycle control and apoptosis. Hsp90 is closely associated with the occurrence and development of tumors and other diseases, making it an attractive target for cancer therapeutics. Inhibition of Hsp90 expression can affect multiple oncogenic pathways simultaneously. Most Hsp90 small molecule inhibitors are in clinical trials due to their low efficacy, toxicity or drug resistance, but they have obvious synergistic anti-tumor effect when used with histone deacetylase (HDAC) inhibitors, tubulin inhibitors or topoisomerase II (Topo II) inhibitors. To address this issue, the design of Hsp90 dual-target inhibitors can improve efficacy and reduce drug resistance, making it an effective tumor treatment strategy. In this paper, the domain and biological function of Hsp90 are briefly introduced, and the design, discovery and structure-activity relationship of Hsp90 dual inhibitors are discussed, in order to provide reference for the discovery of novel Hsp90 dual inhibitors and clinical drug research from the perspective of medicinal chemistry.
10.Specific DNA barcodes screening, germplasm resource identification, and genetic diversity analysis of Platycodon grandiflorum
Xin WANG ; Yue SHI ; Jin-hui MAN ; Yu-ying HUANG ; Xiao-qin ZHANG ; Ke-lu AN ; Gao-jie HE ; Zi-qi LIU ; Fan-yuan GUAN ; Yu-yan ZHENG ; Xiao-hui WANG ; Sheng-li WEI
Acta Pharmaceutica Sinica 2024;59(1):243-252
Platycodonis Radix is the dry root of

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