1.A survey on the operational management issues of drug clinical trials in the yangtze river delta region
Yougen WU ; Yuting GU ; Ju XIA ; Qingqing QIAN
Journal of Pharmaceutical Practice and Service 2026;44(2):103-107
Objective To analyze the problems in the operation and management of drug clinical trials and put forward targeted suggestion. Methods An electronic questionnaire survey was conducted among medical staff in about 80 hospitals in the yangtze river delta region. Results 606 valid questionnaires were received. 71% of the respondents expressed their willingness to study and participate in drug clinical trials. There were significant differences in the cognitive demands, willingness and motivation of the respondents with different occupations and educational backgrounds about the drug clinical trial work (P<0.05). During the operation of drug clinical trials, respondents reported the main factors affecting the quality of clinical trials which including good clinical practice (GCP) awareness and subjective enthusiasm of investigators (response rate 27%), job stability of supervisors and research coordinators (27%), compliance of subjects (45%), quality control of the whole process of the circulation of test drugs, medical devices and biological samples (52%), and the informatization level of clinical trial institutions (30%). Conclusion Hospitals, institutions and project teams could take measures to cultivate and stabilize the drug clinical trial talent team, improve the quality management system of drug clinical trials, improve work efficiency, and promote the high-quality development of drug clinical trials in medical institutions.
2.Clinical application of minimally invasive mitral valvuloplasty in patients with infective endocarditis complicated with mitral valve insufficiency
Yubin ZHONG ; Yunqing SHI ; Quanlin YANG ; Songyi QIAN ; Limin XIA ; Kai SONG ; Sun PAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(05):778-783
Objective To investigate the clinical efficacy of minimally invasive mitral valvuloplasty (MVP) in the treatment of infective endocarditis (IE) with mitral regurgitation (MR). Methods A retrospective analysis was conducted on the clinical data of patients who underwent MVP for IE with MR at the Department of Cardiovascular Surgery in Zhongshan Hospital, Fudan University from 2016 to 2020. Patients were divided into two groups based on the surgical incision: those with a right mini-thoracotomy were classified as a minimally invasive surgery (MIS) group, and those with a median sternotomy (MS) were classified as an MS group. All patients had isolated mitral valve involvement. Perioperative data were analyzed, and mid- to long-term outcomes were compared between the two groups. Results A total of 86 patients were included, with 40 in the MIS group [22 males and 18 females, with a mean age of (39.78±15.36) years ranging from 14 to 75 years] and 46 in the MS group [27 males and 19 females, with a mean age of (49.94±16.13) years ranging from 14 to 71 years]. The patients in the MIS group were relatively younger (P=0.004) with better preoperative cardiac function (P=0.004). There was no statistical difference in preoperative fever, gender, or comorbidities between the two groups (P>0.05). The MIS group had shorter postoperative ventilation times, less postoperative 24-hour drainage, less blood transfusion, and shorter total hospital stays compared to the MS group (P<0.05). There was no statistical difference in cardiopulmonary bypass times or ICU stays between the two groups (P>0.05). The perioperative complication rates and mortality rates were not significantly different between the two groups (P>0.05). Follow-up was conducted for 11-92 months, with a mean duration of (49±19) months and an overall follow-up rate of 91.9%. During the follow-up, 3 patients in each group required reoperation for mitral valve issues, with no statistical difference in incidence (7.5% vs. 6.5%, P=0.691). There were no warfarin-related complications, recurrences, or deaths in either group during follow-up. Multivariate regression analysis identified age, preoperative cardiac function, and surgeon experience as influencing factors for the choice of surgical approach. Conclusion Minimally invasive MVP for IE with MR is relatively safe in the perioperative period and shows significant efficacy, with clear mid- to long-term outcomes. It is recommended for younger patients with better preoperative cardiac function and when performed by surgeons with extensive experience in mitral valvuloplasty.
3.Clinical practice guidelines for intraoperative cell salvage in patients with malignant tumors
Changtai ZHU ; Ling LI ; Zhiqiang LI ; Xinjian WAN ; Shiyao CHEN ; Jian PAN ; Yi ZHANG ; Xiang REN ; Kun HAN ; Feng ZOU ; Aiqing WEN ; Ruiming RONG ; Rong XIA ; Baohua QIAN ; Xin MA
Chinese Journal of Blood Transfusion 2025;38(2):149-167
Intraoperative cell salvage (IOCS) has been widely applied as an important blood conservation measure in surgical operations. However, there is currently a lack of clinical practice guidelines for the implementation of IOCS in patients with malignant tumors. This report aims to provide clinicians with recommendations on the use of IOCS in patients with malignant tumors based on the review and assessment of the existed evidence. Data were derived from databases such as PubMed, Embase, the Cochrane Library and Wanfang. The guideline development team formulated recommendations based on the quality of evidence, balance of benefits and harms, patient preferences, and health economic assessments. This study constructed seven major clinical questions. The main conclusions of this guideline are as follows: 1) Compared with no perioperative allogeneic blood transfusion (NPABT), perioperative allogeneic blood transfusion (PABT) leads to a more unfavorable prognosis in cancer patients (Recommended); 2) Compared with the transfusion of allogeneic blood or no transfusion, IOCS does not lead to a more unfavorable prognosis in cancer patients (Recommended); 3) The implementation of IOCS in cancer patients is economically feasible (Recommended); 4) Leukocyte depletion filters (LDF) should be used when implementing IOCS in cancer patients (Strongly Recommended); 5) Irradiation treatment of autologous blood to be reinfused can be used when implementing IOCS in cancer patients (Recommended); 6) A careful assessment of the condition of cancer patients (meeting indications and excluding contraindications) should be conducted before implementing IOCS (Strongly Recommended); 7) Informed consent from cancer patients should be obtained when implementing IOCS, with a thorough pre-assessment of the patient's condition and the likelihood of blood loss, adherence to standardized internally audited management procedures, meeting corresponding conditions, and obtaining corresponding qualifications (Recommended). In brief, current evidence indicates that IOCS can be implemented for some malignant tumor patients who need allogeneic blood transfusion after physician full evaluation, and LDF or irradiation should be used during the implementation process.
4.Assessment and discussion of quality monitoring data for red blood cell preparations
Yun QING ; Huayou DAI ; Junhong YANG ; Qian XU ; Siqi WU ; Yunbo TIAN ; Xia HUANG
Chinese Journal of Blood Transfusion 2025;38(2):227-232
[Objective] To assess the data characteristics of quality monitoring indicators for red blood cell (RBC) preparations, so as to provide reference for continuous improvement of blood quality. [Methods] The quality inspection data of 6 types of RBC preparations from Chongqing blood center from 2019 to 2023 were summarized. For the same indicators, the numerical range of quality indicators was monitored by comparing different types of preparations with the national standard GB18469. The loss and/or damage to RBCs caused by different preparation process were compared, and the impact of different preparation processes on the quality of RBCs was discussed. [Results] The appearance and sterility test compliance rates of the six types of RBC preparations were both 100%, while the compliance rates of other items were all ≥75%. The compliance rate of hematocrit for suspended RBCs was the lowest at 75%, with a median of 0.52, which was close to the lower limit of GB18469, while the medians of hematocrit for the other types were all at the midline level of GB18469. The Hb content for different types of RBCs was significantly higher than the corresponding requirements of GB18469 (P<0.05). The hemolysis rate at the end of storage for different types of RBCs was significantly lower than the requirements of GB18469 (P<0.05). The 1 U leukoreduction process resulted in a hemoglobin content loss of about 5% and had a significant impact on the hemolysis rate at the end of storage (P<0.05). The washing process resulted in a hemoglobin content loss of <3% and had no significant impact on the hemolysis rate at the end of storage (P>0.05). The concentration process resulted in a hemoglobin content loss of <3% and had a significant impact on the hemolysis rate at the end of storage (P<0.05). [Conclusion] The impact of different processes on RBC preparations is within a controllable range and meets the requirements of GB18469. The quality monitoring data can provide a reference for clinical blood selection, effectiveness evaluation and revision of related standards.
5.Eye Movement and Gait Variability Analysis in Chinese Patients With Huntington’s Disease
Shu-Xia QIAN ; Yu-Feng BAO ; Xiao-Yan LI ; Yi DONG ; Zhi-Ying WU
Journal of Movement Disorders 2025;18(1):65-76
Objective:
Huntington’s disease (HD) is characterized by motor, cognitive, and neuropsychiatric symptoms. Oculomotor impairments and gait variability have been independently considered as potential markers in HD. However, an integrated analysis of eye movement and gait is lacking. We performed multiple examinations of eye movement and gait variability in HTT mutation carriers, analyzed the consistency between these parameters and clinical severity, and then examined the associations between oculomotor impairments and gait deficits.
Methods:
We included 7 patients with pre-HD, 30 patients with HD and 30 age-matched controls. We collected demographic data and assessed the Unified Huntington’s Disease Rating Scale (UHDRS) score. Examinations, including saccades, smooth pursuit tests, and optokinetic (OPK) tests, were performed to evaluate eye movement function. The parameters of gait include stride length, walking velocity, step deviation, step length, and gait phase.
Results:
HD patients have significant impairments in the latency and velocity of saccades, the gain of smooth pursuit, and the gain and slow phase velocities of OPK tests. Only the speed of saccades significantly differed between pre-HD patients and controls. There are significant impairments in stride length, walking velocity, step length, and gait phase in HD patients. The parameters of eye movement and gait variability in HD patients were consistent with the UHDRS scores. There were significant correlations between eye movement and gait parameters.
Conclusion
Our results show that eye movement and gait are impaired in HD patients and that the speed of saccades is impaired early in pre-HD. Eye movement and gait abnormalities in HD patients are significantly correlated with clinical disease severity.
6.Emergency management of radial artery sheath dissection during extubation in a routine coronary angiography patient
Xueqing ZHU ; Yang GE ; Chaokai HE ; Ye ZHANG ; Meng LI ; Liting WANG ; Shaozhang TENG ; Ying XIA ; Hao QIAN
Chinese Journal of Nursing 2025;60(12):1508-1511
To summarize the nursing experience of a patient with coronary heart disease who was left in the radial artery during the removal of the radial artery sheath after coronary angiography via the radial artery pathway.Nursing points:to start the emergency transfer process,to shorten the treatment transfer time;to assist to locate the position of the sheath to provide a basis for the selection of surgical incision;to conduct dynamic assessment of hemostatic effect,prevention of radial artery occlusion;to closely monitor pain and signs to prevent vasovagal reflex;to implement the whole psychological intervention,and to reduce the psychological burden of patients and their families.The ruptured sheath tube was successfully removed by emergency surgery of vascular surgery.A total of 6 days after the operation,the patient was transferred to cardiac surgery for coronary artery bypass grafting,and was discharged 23 days later.After 3 months of follow-up,the blood supply of the limbs was good,and the incision healed well.
7.Design of 8-channel gene analyzer
Shi-hong MA ; Yu QIAN ; Song LIANG ; Xia-bin LI ; Jing-jing ZHANG ; Yuan ZHAO ; Wei WANG ; Jian-rong CAO
Chinese Medical Equipment Journal 2025;46(2):24-30
Objective To design an 8-channel gene analyzer to take the place of the widely used gene analyzer with problems in inconvenient consumable replacement and short storage time of electrophoresis polymer.Methods The 8-channel gene analyzer had its mechanical components composed of an automatic sample loading table,a polymer injection module,a high-voltage temperature control module,an optical module and an integrated U box,its electrical control system made up of a host computer(an embedded computer)and three slave computers(a sampling control board,a polymer injection control board and a high-voltage temperature control board).The automatic sample loading table involved in four motors and transmission systems for x,y,z directions and optical alignment,the transmission systems adopted mainly belt drive mode and the optical alignment motor had its threads with an anti-backlash structure;the polymer injuection module was manipulated by the polymer injection control board,and the polymer block was made of highly transparent acrylic material;the high-voltage temperature control module realized the regulation of electrophoresis voltage and the detection of electrophoresis current by the low-ripple precision high-voltage power supply,and controlled the temperature of the heating furnace by the proportional-integral-differential(PID)algorithm;the optical module consisted of an excitation module and a light-receiving module,which had the base of the reflector made of low expansion coefficient alloy material;the integrated U box had the electrophoresis polymer,capillary array,polymer block and anode buffer in a plastic housing;the host computer had the data acquisition software programmed with C# and C++,and the slave computers were controlled by STM32 SCM.Results The 8-channel gene analyzer had no significant differences with the widely used ABI3500 gene analyzer in resolution,precision accuracy and clinical results.Conclusion The 8-channel gene analyzer gains advantages in consumable replacement and storage time of electrophoresis polymer,and can meet the requirements for gene sequencing.[Chinese Medical Equipment Journal,2025,46(2):24-30]
8.Immune-microbiota crosstalk in HBV infection: diagnostic and therapeutic implications across disease stages
Huilan TU ; Xia YU ; Xinyi XU ; Longxian LYU ; Xiaohan QIAN ; Yu SHI ; Yida YANG
Chinese Journal of Clinical Infectious Diseases 2025;18(4):307-313
Hepatitis B virus(HBV)infection poses a significant global health burden,with chronic infection driving progression to cirrhosis,hepatic failure,and hepatocellular carcinoma(HCC). Mounting evidence implicates immune dysfunction and microbiota dysbiosis as core drivers of disease progression across all HBV infection stages. Gut and tissue-specific microbiota alterations disrupt innate/adaptive immunity,fueling inflammation,immunosuppression,and tumor immune evasion in chronic and end-stage disease. This review synthesizes mechanisms of immune-microbiota interplay in HBV pathogenesis and explores their translational potential for diagnostics and targeted interventions,including microbiota modulation and microbial biomarker applications.
9.Impact of thymus dose-volume parameters on radiation-induced lymphopenia in early-stage breast cancer patients during postoperative adjuvant radiotherapy
Tong XIA ; Liyan JIN ; Pengfei XING ; Sisi ZHENG ; Jianjun QIAN ; Ye TIAN ; Shang CAI
Chinese Journal of Radiation Oncology 2025;34(10):1001-1007
Objective:To analyze the correlation between thymus dose-volume parameters and lymphopenia in patients with early-stage breast cancer (BC) receiving adjuvant radiotherapy (RT).Methods:Medical records of 54 patients with early-stage BC who received postoperative adjuvant RT in the Second Affiliated Hospital of Soochow University from January to December 2019 were retrospectively analyzed. Absolute lymphocyte counts (ALC) were collected at 1 month before (baseline) and weekly during RT. Lymphopenia was graded based according to the common terminology criteria for adverse events version 5.0 and nadir/baseline ALC was calculated. The thymus was delineated according to anatomical boundaries in the original RT planning system. Dosimetric parameters were obtained from the dose volume histograms. Stepwise multiple linear regression analysis was used to explore the factors associated with nadir/baseline ALC. The cutoff values of dosimetric parameters for predicting ≥grade 3 lymphopenia were obtained using the receiver operating characteristic (ROC) curve.Results:The proportion of 54 patients experiencing ≥ grade 3 lymphopenia was 38.9%. The median value of thymus volume, mean dose, V 5 Gy, V 10 Gy were 14.02 cm 3, 4.95 Gy, 36.18%, and 6.61%, respectively. Stepwise multiple linear regression analysis revealed that baseline ALC ( P=0.005), quadrant location ( P=0.005) and mean thymus dose ( P<0.001) were significantly associated with nadir/baseline ALC. ROC curve analysis indicated that the cutoff values of thymus mean dose, V 5 Gy and V 10 Gy for predicting ≥ grade 3 lymphopenia were 6.12 Gy, 35.2%, and 7.4%, respectively. Conclusions:Lymphopenia in early-stage BC patients is significantly correlated with high dosimetric parameters of the thymus during postoperative adjuvant RT. Thymus may be considered as an organ at risk during RT.
10.Effect and mechanism of Tamarix chinensis Lour.on streptozotocin-induced diabetic rats based on network pharmacology,molecular docking and experimental validation
Qian LI ; Zhenxiang WANG ; Yanting LIANG ; Weiwei MA ; Zhen ZHANG ; Xia WANG ; Qiong AN
Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(7):907-920
AIM:To investigate the mechanism of action of Tamarix chinensis Lour.on streptozotocin-induced type 2 diabetes mellitus(T2DM)through network pharmacology,molecular docking and ex-perimental validation.METHODS:Using the TCSMP database and Swiss Target Prediction tools screen the active components and predict potential tar-gets in Tamarix chinensis Lour..Retrieving potential disease targets associated with T2DM from data-bases such as GeneCards,OMIM,and DisGeNET.The intersection targets of Tamarix chinensis Lour.and T2DM disease was obtained through Venny platform.The STRING database was used to con-structed PPI network,and Cytoscape 3.8.0 soft-ware was use to visualized.GO function enrich-ment and KEGG pathway enrichment analysis were performed through the Metascape database.Dock-ing of important target proteins and compounds was carried out by AutoDock software.SPF grade male rats were randomly divided into normal group,model group,MET group(88.5 mg/kg),TE high-dose(800 mg/kg)group,TE medium-dose(400 mg/kg)group and TE low-dose(200 mg/kg)group(n=10).High-fat and high sugar feed com-bined with low dose STZ(45 mg/kg)was used to in-duce T2DM rat model,and the rats were adminis-tered orally for 5 weeks.Fasting blood glucose(FBG),insulin(FINS)level and HOMA-IR index,bio-chemical indicators[superoxide dismutase(SOD),malondialdehyde(MDA),glycosylated hemoglobin A1c(HbA1c)and inflammatory factor[interleukin-1β(IL-1β),tumor necrosis factor α(TNF-α),vascu-lar cell adhesion molecular(VCAM-1)levels of the rats were also observed;morphological changes of renal tissue was observe by HE staining.RESULTS:Based on the screening conditions of oral bioavail-ability(OB)≥ 30%and drug like properties(DL)≥0.18,a total of 19 main active ingredients with po-tential therapeutic effects on T2DM were screened from Tamarix chinensis Lour.,including ergosta-5,24(28)-dien-3,7,16-triol,quercetin-3,3'-dimethyl ether,kaempferol,quercetin,and others.By analyz-ing the potential targets of Tamarix chinensis Lour.for treating T2DM,a total of 185 potential target genes were screened,including SRC,EGFR,HSP90AA1,AKT1,ESR1,H1F1A,TNF,PIK3R1,etc,in-volving cancer signaling pathways,insulin resis-tance,MAPK signaling pathways,PI3K Akt signaling pathways,etc.Molecular docking results showed that the binding energies were all less than-5.0 kcal/mol,indicating that a strong binding abili-ty between the active ingredients screened by Tam-arix chinensis Lour.and the potential targets for the treatment of T2DM.The animal experiment re-sults showed that compared with the model group,the weight loss of rats in the MET and TE groups was slowed down,and the levels of FBG,FINS,MDA,HbA1c,IL-1β,TNF-α,VCAM-1,HOMA-IR in-dex were reduced,the SOD level was increased,and the differences were statistically significant(P<0.05,P<0.01),Renal tissue cellular morphology also showed notable improvement.Most importantly,all these results demonstrating dose-dependent ef-fects.CONCLUSION:Tamarix chinensis Lour.dis-plays a significant therapeutic effect on T2DM through multi-component,multi-target,and multi-pathway synergistic actions to improve blood glu-cose levels.The findings of this study provide a the-oretical basis for the clinical application of Tamarix chinensis Lour.in the treatment of T2DM.

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