1.Expert consensus on dispensing management of intravenous infusion drugs for clinical trials in PIVAS
Xingchen YANG ; Wenhuan FU ; Donghui LAO ; Jing ZHAO ; Jianzhong ZHANG ; Group PHARMACY ; Committee HOSPITAL ; Association Pharmaceutical SHANGHAI
China Pharmacy 2025;36(1):1-6
OBJECTIVE To further standardize the dispensing management standard of intravenous infusion drugs for clinical trials in pharmacy intravenous admixture services (PIVAS), and provide reference for medical institutions to provide high-quality pharmaceutical services. METHODS Initiated by PIVAS Group, Hospital Pharmacy Professional Committee, Shanghai Pharmaceutical Association, jointly led by Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Shanghai Geriatric Medical Center, a writing group was established by PIVAS experts from multiple medical institutions to discuss the basic requirements and dispensing process of intravenous infusion drugs for clinical trials in PIVAS. The experts from the leading unit sorted out, summarized, analyzed, fed back and revised the opinions, and finally reached Expert Consensus on Dispensing Management of Intravenous Infusion Drugs for Clinical Trials in PIVAS. RESULTS & CONCLUSIONS The main contents of this consensus include information management, operation process, fund management and document management of intravenous infusion drugs for clinical trials in PIVAS. This consensus establishes a more standardized model for dispensing management of intravenous infusion drugs for clinical trials in PIVAS, by standardizing clinical trail drug management operational procedures, accurately recording and preserving drug-related information, with the aim of achieving standardized and meticulous management of PIVAS’s receipt of clinical trial drugs.
2.Comparison of nutritional intervention effects at different initiation time in patients with respiratory diseases at nutritional risk
Lihong WANG ; Yuan CUI ; Shaoye HUO ; Yunhua ZHAO ; Yuhuan WEI ; Rong JIANG ; Chunhai SHAO
Chinese Journal of Clinical Medicine 2025;32(2):268-275
Objective To assess the effect of early nutritional intervention on the patients with respiratory diseases at nutritional risk. Methods A total of 130 patients with respiratory disease who were hospitalized in Shanghai Fifth People’s Hospital, Fudan University between May 2023 and December 2024 and had a nutritional risk screening 2002 score ≥3 points. Based on the initiation time of nutritional intervention, patients were divided into an early group (≤5 days, n=65) and a late group (>5 days, n=65). Results In the early group, prealbumin (P-ALB) and retinol-binding protein (RBP) levels were significantly higher (P<0.01), C-reactive protein (CRP), procalcitonin (PCT) levels were significantly lower after intervention (P<0.05). Compared with the late group, the hospital costs were lower and hospital stays were shorter in the early group (P<0.001). Spearman analysis showed ALB, P-ALB, and total protein (TP) were negatively correlated with hospital costs (r=-0.37, -0.20, and-0.22, P<0.05). RBP, ALB, P-ALB, and lymphocyte count (LYM) were negatively correlated with CRP (r=-0.30, -0.26, -0.37, -0.18, P<0.01), RBP, ALB, P-ALB, hemoglobin (HB), and TP were negatively correlated with PCT (r=-0.23,-0.36, -0.40, -0.30, -0.19, P<0.05). Conclusions For patients with respiratory diseases, early nutritional assessment should be underwent, and for patients with nutritional risk screening 2002 score ≥3 points, early nutritional intervention could improve the nutritional status and alleviate inflammatory response, promote recovery, shorten the hospital stays.
3.The Characterization and Regulation of Schwann Cells in the Tooth Germ Development and Odontogenic Differentiation
Jing HE ; Ting WANG ; Danyang LIU ; Jun YANG ; Yuanpei HE ; Shouliang ZHAO ; Yanqin JU
International Journal of Stem Cells 2024;17(4):437-448
Schwann cells (SCs), a type of glial cell in the peripheral nervous system, can serve as a source of mesenchymal stem cells (MSCs) to repair injured pulp. This study aimed to investigate the role of SCs in tooth germ development and repair of pulp injury. We performed RNA-seq and immunofluorescent staining on tooth germs at different developmental stages. The effect of L-type calcium channel (LTCC) blocker nimodipine on SCs odontogenic differentiation was analyzed by real-time polymerase chain reaction and Alizarin Red S staining. We used the PLP1-CreERT2/ Rosa26-GFP tracing mice model to examine the role of SCs and Cav 1.2 in self-repair after pulp injury. SC-specific markers expressed in rat tooth germs at different developmental stages. Nimodipine treatment enhanced mRNA levels of osteogenic markers (DSPP, DMP1, and Runx2) but decreased calcium nodule formation. SCs-derived cells increased following pulp injury and Ca v 1.2 showed a similar response pattern as SCs. The different SCs phenotypes are coordinated in the whole process to ensure tooth development. Blocking the LTCC with nimodipine promoted SCs odontogenic differentiation. Moreover, SCs participate in the process of injured dental pulp repair as a source of MSCs, and Cav 1.2 may regulate this process.
4.Experience of Retroperitoneoscopy for Adrenal Masses in Infants Under 6 Months Old
Huashan ZHAO ; Yunpeng ZHAI ; Rui GUO ; Hongxiu XU ; Sai HUANG ; Longfei LV ; Shisong ZHANG
Chinese Journal of Minimally Invasive Surgery 2024;24(5):379-383
Objective To investigate the feasibility of retroperitoneoscopy in the treatment of adrenal masses in infants under 6 months old.Methods From January 2020 to November 2023,retroperitoneoscopic surgery was performed in 5 infants under 6 months old with adrenal tumors.Their age was from 1 month and 18 days to 4 months and 27 days,and their body weight was 5-8 kg.The lesion was found by prenatal ultrasonography in 1 case and by abdominal ultrasonography for other reasons after birth in 4 cases.Ultrasound and CT indicated a diameter of 1.7-5.5 cm for the adrenal masses.Results The operations of adrenalectomy and tumor resection were completed under retroperitoneoscopy.The operative time was 65-135 min(median,94 min).The intraoperative blood loss was less than 10 ml.The postoperative drainage tube retention time was 3-6 d(median,5 d).Pathological diagnosis showed 4 cases of adrenal neuroblastoma and 1 case of adrenal hyperplasia.Follow-ups for 1-36 months(median,3 months)with abdominal ultrasound and CT scanning showed no recurrence or metastasis.Conclusion Retroperitoneoscopy is relatively safe for the treatment of adrenal tumors in infants under 6 months old(tumors with acceptable boundaries).
5.Thoracoscopic Treatment of 27 Cases of Anterior Mediastinal Enterogenous Cysts in Children
Huashan ZHAO ; Yunpeng ZHAI ; Rui GUO ; Hongxiu XU ; Sai HUANG ; Longfei LV ; Shisong ZHANG
Chinese Journal of Minimally Invasive Surgery 2024;24(6):427-431
Objective To summarize the clinical experience of thoracoscopic treatment of anterior mediastinal enterogenous cysts.Methods From July 2019 to July 2023,27 children diagnosed as having anterior mediastinal enterogenous cysts were treated with total thoracoscopic surgery through the lateral thoracic approach(three port method)in our department.The patients were placed in a healthy lateral position.The observation hole was located in the 5th intercostal space under the scapula,and the other 2 operating holes were established based on the location of the lesion and the endoscopic diamond-shaped method,both of which were 5 mm trocars.The CO2 pneumothorax was established at a pressure of 6 mm Hg.The visceral pleura of the cyst was opened with an electric hook,the cyst was fixed and pulled by intestinal forceps,and the cyst was completely removed by forceps and electric hook separation alternately.Results No conversion to thoracotomy was required.Complete resection was performed in 26 cases,and residual cyst wall existed in 1 case.Esophageal muscular layer was opened in 9 cases.During the operation,cysts obstructed the surgical field of view in 5 cases,which was not conducive to observation.The cyst puncture and fluid extraction were performed.The operation time was 45-120 min(median,70 min).The amount of blood loss was 3-10 ml(median,5 ml).Postoperative hospitalization lasted for 2-5 d(median,3d).The 27 cases were followed up for 1-43 months(median,22 months),and there was no recurrence.The compressed trachea in 2 cases was all recovered,with emphysema fully recovered.Conclusions Thoracoscopic treatment of anterior mediastinal enterogenous cysts in children is safe and feasible.When the surrounding structure of the lesion is complex,it can be combined with bronchoscopic or gastroscopic surgery if necessary.
6.The Characterization and Regulation of Schwann Cells in the Tooth Germ Development and Odontogenic Differentiation
Jing HE ; Ting WANG ; Danyang LIU ; Jun YANG ; Yuanpei HE ; Shouliang ZHAO ; Yanqin JU
International Journal of Stem Cells 2024;17(4):437-448
Schwann cells (SCs), a type of glial cell in the peripheral nervous system, can serve as a source of mesenchymal stem cells (MSCs) to repair injured pulp. This study aimed to investigate the role of SCs in tooth germ development and repair of pulp injury. We performed RNA-seq and immunofluorescent staining on tooth germs at different developmental stages. The effect of L-type calcium channel (LTCC) blocker nimodipine on SCs odontogenic differentiation was analyzed by real-time polymerase chain reaction and Alizarin Red S staining. We used the PLP1-CreERT2/ Rosa26-GFP tracing mice model to examine the role of SCs and Cav 1.2 in self-repair after pulp injury. SC-specific markers expressed in rat tooth germs at different developmental stages. Nimodipine treatment enhanced mRNA levels of osteogenic markers (DSPP, DMP1, and Runx2) but decreased calcium nodule formation. SCs-derived cells increased following pulp injury and Ca v 1.2 showed a similar response pattern as SCs. The different SCs phenotypes are coordinated in the whole process to ensure tooth development. Blocking the LTCC with nimodipine promoted SCs odontogenic differentiation. Moreover, SCs participate in the process of injured dental pulp repair as a source of MSCs, and Cav 1.2 may regulate this process.
7.The Characterization and Regulation of Schwann Cells in the Tooth Germ Development and Odontogenic Differentiation
Jing HE ; Ting WANG ; Danyang LIU ; Jun YANG ; Yuanpei HE ; Shouliang ZHAO ; Yanqin JU
International Journal of Stem Cells 2024;17(4):437-448
Schwann cells (SCs), a type of glial cell in the peripheral nervous system, can serve as a source of mesenchymal stem cells (MSCs) to repair injured pulp. This study aimed to investigate the role of SCs in tooth germ development and repair of pulp injury. We performed RNA-seq and immunofluorescent staining on tooth germs at different developmental stages. The effect of L-type calcium channel (LTCC) blocker nimodipine on SCs odontogenic differentiation was analyzed by real-time polymerase chain reaction and Alizarin Red S staining. We used the PLP1-CreERT2/ Rosa26-GFP tracing mice model to examine the role of SCs and Cav 1.2 in self-repair after pulp injury. SC-specific markers expressed in rat tooth germs at different developmental stages. Nimodipine treatment enhanced mRNA levels of osteogenic markers (DSPP, DMP1, and Runx2) but decreased calcium nodule formation. SCs-derived cells increased following pulp injury and Ca v 1.2 showed a similar response pattern as SCs. The different SCs phenotypes are coordinated in the whole process to ensure tooth development. Blocking the LTCC with nimodipine promoted SCs odontogenic differentiation. Moreover, SCs participate in the process of injured dental pulp repair as a source of MSCs, and Cav 1.2 may regulate this process.
8.MicroRNA-1246 Inhibits NFATc1 Phosphorylation and Regulates T Helper 17 Cell Activation in the Pathogenesis of Severe Alopecia Areata
Si-si QI ; Ying MIAO ; You-yu SHENG ; Rui-ming HU ; Jun ZHAO ; Qin-ping YANG
Annals of Dermatology 2023;35(1):46-55
Background:
We found microRNA (miR)-1246 to be significantly differentially expressed between severe active alopecia areata (AA) patients and healthy individuals.
Objective:
To explore the role and mechanism of miR-1246 in severe AA.
Methods:
Expression of miR-1246, dual-specific tyrosine phosphorylation-regulated kinase 1A (DYRK1A), and nuclear factor of activated T cells 1c (NFATc1) in peripheral CD4+ T cells and in scalp tissues of patients were detected using RT-qPCR, Western blot, and immunohistochemistry assays. Peripheral CD4+ T cells from the AA patients were transfected with lentiviral vectors overexpressing miR-1246. RT-qPCR and Western blot analysis were used to measure mRNA or protein expression of retinoic-acid-receptor-related orphan nuclear receptor gamma (ROR-γt), interleukin (IL)-17, DYRK1A, NFATc1, and phosphorylated NFATc1. Flow cytometry was used to assay the CD4+ IL-17+ cells proportion. ELISA was used to measure cytokine levels.
Results:
miR-1246 levels decreased and DYRK1A and NFATc1 mRNA levels significantly increased in the peripheral CD4+ T cells and scalp tissues of severe active AA samples.NFATc1 protein expression was also significantly increased in the peripheral CD4+ T cells but not in the scalp tissues. NFATc1 positive cells were mainly distributed among infiltrating inflammatory cells around hair follicles. In peripheral CD4+ T cells of severe active AA, overexpression of miR-1246 resulted in significant downregulation of DYRK1A, NFATc1, ROR-γt, and IL-17 mRNA and phosphorylated NFATc1 protein, as well as a decrease in the CD4+ IL-17+ cells proportion and the IL-17F level.
Conclusion
miR-1246 can inhibit NFAT signaling and Th17 cell activation, which may be beneficial in the severe AA treatment.
9.Effectiveness and safety of Shexiang Baoxin Pill (MUSKARDIA) in patients with stable coronary artery disease and concomitant diabetes mellitus: a subgroup analysis of a randomized clinical trial.
Jingmin ZHOU ; Haiming SHI ; Fusui JI ; Yang WU ; Yulan ZHAO ; Jun QIAN ; Junbo GE
Chinese Medical Journal 2023;136(1):82-87
BACKGROUND:
Preliminary studies have indicated that Shexiang Baoxin Pill (MUSKARDIA) has a coronary artery dilation effect and increases the coronary blood flow, relieving the symptoms of angina. This study aimed to evaluate the benefit of MUSKARDIA on patients with stable coronary artery disease (CAD) and diabetes mellitus (DM).
METHODS:
This was a subgroup analysis of a multicenter, randomized, placebo-controlled phase IV trial. CAD patients with a medical history of DM or baseline fasting blood glucose (FBG) ≥7.0 mmol/L were grouped according to the treatment (standard therapy plus MUSKARDIA or placebo). The primary outcome was major adverse cardiovascular events (MACEs), which was the composite outcome of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. The secondary outcome was the composite outcome of all-cause death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina or heart failure, and coronary angioplasty.
RESULTS:
MACEs occurred in 2.6% (9/340) and 4.8% (18/376) of patients in the MUSKARDIA and placebo groups, respectively ( P = 0.192). Secondary composite outcome was significantly less frequent with MUSKARDIA than with placebo (15.3% [52/340] vs . 22.6% [85/376], P = 0.017). Risk of MACEs (hazard ratio [HR] = 0.69, 95% confidence interval [CI]: 0.31-1.57) was comparable between two groups. In patients with uncontrolled DM (≥4 measurements of FBG ≥7 mmol/L in five times of follow-up), the risk of secondary outcome was significantly lower with MUSKARDIA (5/83, 6.0%) than with placebo (15/91, 16.5%) (HR = 0.35, 95%CI: 0.13-0.95).
CONCLUSION:
As an add-on to standard therapy, MUSKARDIA shows a trend of reduced MACEs in patients with stable CAD and DM. Furthermore, MUSKARDIA may reduce the frequency of all-cause death, hospitalization, and coronary angioplasty in this population, especially in those with uncontrolled DM.
TRIAL REGISTRATION
ChiCTR.org.cn, ChiCTR-TRC-12003513.
Humans
;
Coronary Artery Disease/complications*
;
Diabetes Mellitus, Type 2/drug therapy*
;
Myocardial Infarction/complications*
;
Stroke/epidemiology*
10.Continuation, reduction, or withdrawal of tofacitinib in patients with rheumatoid arthritis achieving sustained disease control: a multicenter, open-label, randomized controlled trial.
Mengyan WANG ; Yu XUE ; Fang DU ; Lili MA ; Liang-Jing LU ; Lindi JIANG ; Yi-Li TAO ; Chengde YANG ; Hui SHI ; Honglei LIU ; Xiaobing CHENG ; Junna YE ; Yutong SU ; Dongbao ZHAO ; Sheng-Ming DAI ; Jialin TENG ; Qiongyi HU
Chinese Medical Journal 2023;136(3):331-340
BACKGROUND:
Rheumatoid arthritis (RA), a chronic systemic autoimmune disease, is characterized by synovitis and progressive damage to the bone and cartilage of the joints, leading to disability and reduced quality of life. This study was a randomized clinical trial comparing the outcomes between withdrawal and dose reduction of tofacitinib in patients with RA who achieved sustained disease control.
METHODS:
The study was designed as a multicenter, open-label, randomized controlled trial. Eligible patients who were taking tofacitinib (5 mg twice daily) and had achieved sustained RA remission or low disease activity (disease activity score in 28 joints [DAS28] ≤3.2) for at least 3 months were enrolled at six centers in Shanghai, China. Patients were randomly assigned (1:1:1) to one of three treatment groups: continuation of tofacitinib (5 mg twice daily); reduction in tofacitinib dose (5 mg daily); and withdrawal of tofacitinib. Efficacy and safety were assessed up to 6 months.
RESULTS:
Overall, 122 eligible patients were enrolled, with 41 in the continuation group, 42 in the dose-reduction group, and 39 in the withdrawal group. After 6 months, the percentage of patients with a DAS28-erythrocyte sedimentation rate (ESR) of <3.2 was significantly lower in the withdrawal group than that in the reduction and continuation groups (20.5%, 64.3%, and 95.1%, respectively; P < 0.0001 for both comparisons). The average flare-free time was 5.8 months for the continuation group, 4.7 months for the dose reduction group, and 2.4 months for the withdrawal group.
CONCLUSION:
Withdrawal of tofacitinib in patients with RA with stable disease control resulted in a rapid and significant loss of efficacy, while standard or reduced doses of tofacitinib maintained a favorable state.
TRIAL REGISTRATION
Chictr.org, ChiCTR2000039799.
Humans
;
Quality of Life
;
China
;
Arthritis, Rheumatoid/drug therapy*
;
Piperidines/therapeutic use*
;
Treatment Outcome
;
Antirheumatic Agents/therapeutic use*
;
Pyrroles/therapeutic use*

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