1.Clinical efficacy of concurrent chemoradiotherapy followed by sequential sintilimab immunotherapy in el-derly patients with locally advanced esophageal cancer
Hao WANG ; Xiaoyi LU ; Wenjie WANG
The Journal of Practical Medicine 2025;41(3):365-370
Objective To investigate the safety and efficacy of Tigio capsules combined with intensity-modulated radiation therapy(IMRT),followed by sequential sintilimab immunotherapy in elderly patients with locally advanced esophageal cancer.Methods From December 2020 to December 2023,96 elderly patients with locally advanced esophageal cancer treated in Wuxi People's Hospital and Suzhou Hospital affiliated to Nanjing Medical University were selected.Using a random number table method,patients were divided into reference group(n=48)and combination group(n=48).The reference group received concurrent chemoradiotherapy,while the combination group received sequential sintilimab immunotherapy combined with concurrent chemoradiotherapy.The clinical efficacy,changes in tumor markers(CEA,CA199,AFP,CYFRA21-1),immune levels(CD4+,CD8+,CD16+CD56+NK),quality of life(QLICP-ES),and the incidence of radiation esophagitis,and immune pneumonitis,and other toxic effects were analyzed.Results After three months of treatment,the combination group showed higher ORR and DCR than the reference group(P<0.05).Levels of CEA,CA199,AFP,and CYFRA21-1 were lower in the combination group,whereas CD4+,CD16+CD56+NK levels were higher(P<0.05).Additionally,common and esophageal cancer-specific scores of the Quality of Life Instruments for Cancer Patients-Esophagus Cancer(QLICP-ES)were lower in the combination group(P<0.05).The incidence of radiation esopha-gitis,and immune pneumonitis,and related toxic effects showed no significant difference between the two groups(P>0.05).Conclusion Concurrent chemoradiotherapy followed by sequential sintilimab immunotherapy signifi-cantly improves clinical efficacy in elderly patients with locally advanced esophageal cancer and does not increase significant treatment-related toxicity.This approach enhances patients' immune function and is worthy of further clinical application.
2.Formulation and Analysis of the Standard on High-alert Medications Management
Wenya SHAN ; Kuifen MA ; Xiaoyi DU ; Jin LU ; Jiancun ZHEN ; Xiaoyang LU
Herald of Medicine 2025;44(3):412-415
To standardize the management of high-alert medications in medical institutions and ensure their safe and ef-fective use,based on relevant national regulations and normative documents,international high-alert medication management guidelines,and expert opinions,the Pharmaceutical Specialized Committee of the Chinese Hospital Association led the develop-ment of the Pharmaceutical Supply Services—Key Drugs Management—High-alert Medications.This article elaborated on the for-mulation process of this standard and provides an in-depth analysis of its key contents.It aimed to offer guidance and reference for medical personnel,helping them to thoroughly understand and master the management requirements of high-alert medications,thereby enhancing the management level of high-alert medications and ensuring the safe and effective use of medications for pa-tients.
3.Efficacy and prediction model of rituximab in the treatment of idiopathic membranous nephropathy
Jingyun LE ; Huayan ZHU ; Luying LU ; Liangliang CHEN ; Xin LEI ; Lan LAN ; Yaomin WANG ; Pingping REN ; Jianghua CHEN ; Xiaoyi WANG ; Fei HAN
Chinese Journal of Nephrology 2025;41(6):427-433
Objective:To evaluate the efficacy and safety of rituximab (RTX) in the treatment of idiopathic membranous nephropathy (IMN), explore the influencing factors of the therapeutic effect and construct a nomogram model for predicting the therapeutic effect.Methods:A single retrospective study was conducted in IMN patients in the First Affiliated Hospital of Zhejiang University School of Medicine from January 2017 to December 2022. All patients received monotherapy with RTX and were followed up for at least 12 months. RTX regimen adopted a B-cell guided regimen to achieve 0 cells/μl of peripheral blood CD19+ B cells through multiple administrations, followed by monitoring every 2?3 months and adding doses as needed to maintain this state. The complete response rate, partial response rate, and composite response rate at 6 months, 12 months and the end of follow up were analyzed. Logistic stepwise regression and R language were applied to construct a nomogram model for efficacy prediction. The receiver operating characteristic (ROC) curve, calibration curve and Hosmer-Lemeshow test were used to internally validate the nomogram model.Results:A total of 147 IMN patients were included in the study, with age of 56 (47, 65) years, 99 (67.4%) males. There were 69 (46.9%) newly treated patients, 78 (53.1%) retreatment patients. The follow-up time was 14.4 (12.0, 15.0) months. The total RTX dose was 1 800 (1 200, 2 400) mg. The composite response rates at 6 months, 12 months and the end of the follow-up were 36.7% (54/147), 59.9% (88/147) and 63.3% (93/147), respectively. The complete remission rates at 6 months, 12 months and the end of the follow-up were 6.1% (9/147), 13.6% (20/147) and 19.7% (29/147), respectively. Logistic stepwise regression analysis showed that age ≥ 65 years ( OR=0.335, 95% CI 0.135?0.833), retreatment ( OR=0.333, 95% CI 0.144?0.771), high cholesterol ( OR=0.716, 95% CI 0.577?0.888), high serum creatinine ( OR=0.978, 95% CI 0.963?0.993) and B-cell reconstruction within 6 months ( OR=0.273, 95% CI 0.115?0.645) were independent correlated factors affecting composite remission. Based on these factors, a nomogram model for predicting the therapeutic effect of RTX in IMN patients was constructed. The ROC curve indicated that the accuracy of this model in predicting composite remission was good ( AUC=0.814, 95% CI 0.744-0.883). The calibration curve showed that the predicted composite response rate had a good fit with the actual response rate (Hosmer-Lemeshow test χ2=11.917, P=0.155). Conclusions:RTX has good efficacy and safety as a monotherapy for IMN patients. The constructed nomogram prediction model has high discrimination and accuracy to predict the efficacy of RTX treatment for IMN.
4.Clinical characteristics and risk factors for disease progression in patients with anti-gp210 antibody-positive primary biliary cholangitis
Ying RAN ; Xiaoyi WANG ; Zhen YANG ; Jiwen LI ; Xue ZHANG ; Meng SHEN ; Xinyu WANG ; Hao JIA ; Zongze HAN ; Hui YANG ; Lu ZHOU
Chinese Journal of Hepatology 2025;33(7):637-644
Objective:To explore the clinical characteristics and identification of the independent risk factors for disease progression in patients with anti-gp210 antibody-positive primary biliary cholangitis (PBC).Methods:A retrospective cohort study was performed. A total of 323 cases with PBC diagnosed in Tianjin Medical University General Hospital from January 2013 to June 2023 (125 patients with anti-gp210 antibody-positive and 198 patients with anti-gp210 antibody-negative) were included. Baseline and follow-up data were collected. The independent sample t-test and Mann-Whitney U rank sum test were used for comparison between groups of continuous data. The χ2 test was used to compare the data between groups for the count data. The Pearson test was used for correlation analysis between continuous variables. The Kaplan-Meier method was used to analyze the disease progression-free survival rate. The Cox regression model was used to analyze the risk factors for disease progression. Results:The male proportion (11.2% vs. 5.1%, P=0.040) and IgM level [3.29(1.88, 4.80) g/L vs. 2.56(1.44, 3.87) g/L, P=0.019] were significantly higher in patients with PBC with positive anti-gp210 antibodies than those of the negative group. Histopathological analysis showed that the Scheuer score [1(0,3) vs. 0(0,2)], bile duct inflammation [(2(1,3) vs. 1(1,2)] and bile duct reaction score [(2(1,3) vs. 1(1,2)] were higher in the positive group than those of the negative group ( P<0.05), and the maturity of the tertiary lymphoid structure was higher ( P=0.011). Kaplan-Meier analysis showed that the 5-year disease-free survival rate was significantly lower in patients with positive anti-gp210 antibodies than that of the negative group (55.8% vs. 79.7%, P=0.006) at a median follow-up of 3(2,6) years. Multivariate Cox regression analysis showed that γ-glutamyl transferase [ HR=1.002 (95% CI: 1.000~1.003)] and platelet count [ HR=0.993 (95% CI: 0.988~0.999)] were the independent influencing factors for disease progression in patients with anti-gp210 antibody-positive PBC ( P=0.002, 0.017). Conclusion:Patients with anti-gp210 antibody-positive PBC have more severe clinical pathological manifestations and a higher risk of disease progression. Higher levels of γ-glutamyl transferase and lower platelet counts during the first visit are independent risk factors for disease progression in patients with anti-gp210 antibody-positive PBC, which can be used as dynamic monitoring indicators for this population, suggesting the need for early intensive intervention.
5.Formulation and Analysis of the Standard on High-alert Medications Management
Wenya SHAN ; Kuifen MA ; Xiaoyi DU ; Jin LU ; Jiancun ZHEN ; Xiaoyang LU
Herald of Medicine 2025;44(3):412-415
To standardize the management of high-alert medications in medical institutions and ensure their safe and ef-fective use,based on relevant national regulations and normative documents,international high-alert medication management guidelines,and expert opinions,the Pharmaceutical Specialized Committee of the Chinese Hospital Association led the develop-ment of the Pharmaceutical Supply Services—Key Drugs Management—High-alert Medications.This article elaborated on the for-mulation process of this standard and provides an in-depth analysis of its key contents.It aimed to offer guidance and reference for medical personnel,helping them to thoroughly understand and master the management requirements of high-alert medications,thereby enhancing the management level of high-alert medications and ensuring the safe and effective use of medications for pa-tients.
6.Effects of different contrast injection schemes on the image quality of triple-rule-out CT angiography
Xingru LU ; Cunzhong MENG ; Shengxi ZHENG ; Qinyi HE ; Tianyang LUO ; Hongliang HUANG ; Xinran LIU ; Hengxin GONG ; Xiaoyi ZHANG ; Junqiang LEI
Journal of Practical Radiology 2025;41(1):124-128
Objective To investigate the effects of different contrast injection schemes on the image quality of triple-rule-out com-puted tomography angiography(TRO-CTA).Methods A total of 691 patients with acute chest pain who underwent TRO-CTA exami-nation from multiple centers were prospectively selected and randomly divided into mixed group and unmixed group according to dif-ferent contrast injection methods.The image quality of aorta,pulmonary artery and coronary artery in the two groups was evaluated subjectively and objectively and the radiation dose was calculated.Results There were no significant differences in subjective image quality scores,aorta and coronary CT values,signal-to-noise ratio(SNR)and contrast-to-noise ratio(CNR)between the two groups(P>0.05),while there were significant differences in pulmo-nary CT values,SNR,CNR and radiation dose between the two groups(P<0.05).Conclusion The utilization of a mixed contrast injection scheme in TRO-CTA can satisfy diagnostic require-ments while ensuring a low proportional dosage and reduced radiation dose,which has clinical application value.
7.Exploration and practice of multi-campus hospital-associated infection management from the perspective of symbiosis theory
Qun LU ; Tong TONG ; Xiaoyi LI ; Hong WANG ; Kaiwen NI
Chinese Journal of Nosocomiology 2025;35(12):1761-1764
In the multi-campus development and construction of public hospitals,hospital-associated infection man-agement has consistently faced escalating difficulties and challenges.Throughout the long-term exploration and practice,the Second Affiliated Hospital Zhejiang University School of Medicine has adhered to the principles of"integrated planning and deployment,homogeneous and homologous training,information and data sharing,and a focus on professional features".By continuously addressing emerging infection control risk points and weak points,overcoming barriers posed by dispersed human resources,and balancing homogeneity with individualization,the hospital has actively promoted integration and collaborative development across its campuses.This approach has significantly contributed to the sustained improvement of healthcare service capacity and quality across multiple campuses.From the novel perspective of symbiosis theory,this paper analyzes the symbiotic dilemmas in multi-campus hospital-associated infection management,summarizes practical experiences,and explores future direc-tions,aiming to provide references for other public hospitals in multi-campus hospital-associated infection manage-ment.
8.Analysis of a case of regulatory violations by an occupational health examination institution
Chanchan QI ; Ruiyan HUANG ; Chaoting ZHAO ; Leyi XU ; Jianyong LU ; Xiaoyi LI ; Jiabin CHEN
China Occupational Medicine 2025;52(1):106-109
Objective To analyze a case of violations by an occupational medical examination (OME) institution and to explore the key control points for the supervision and management of OME institutions, as well as the core role of quality assessment in this context. Methods An OME institution suspected of illegal activities was used as the study subject. Retrospective analysis was conducted. Clues of suspected violations were identified by an on-site quality assessment. After investigation and verification by the local health authorities, legal action was taken against the institution for its violations. Results During an on-site quality assessment, the Guangdong Province OME quality control expert group discovered that the OME institution violated regulations, including unqualified personnel file, exceeding the scope of services category, issuing false reports, failing to report suspected occupational diseases on time, and failing to notify workers about suspected occupational diseases as required. The evidence was then submitted to the Guangdong Province OME Quality Control Center, which subsequently forwarded the case to local health administration department for filing and investigation. After the investigation, penalties were imposed on the OME institution for its illegal activities. Conclusion The key supervision and inspection points in the quality assessment of OME institutions include personnel file configuration, the quality control management system and its implementation, the quality of OME reports, and information reporting. Quality assessment plays a pivotal role in ensuring the legal and compliant practice of OME institutions, safeguarding the health rights and interests of workers, and enhancing the overall standard of the OME industry.
9.Multi-center clinical study on the efficacy and safety of combined lienal polypeptide injection therapy in children with Mycoplasma pneumoniae pneumonia
Qi CHENG ; Yunxiao SHANG ; Han ZHANG ; Jiujun LI ; Ning CHEN ; Lishen SHAN ; Nan YANG ; Lihua NING ; Xuemei BAI ; Jianhua LIU ; Yuling HAN ; Jichun WANG ; Jing LI ; Yong FENG ; Liyun LIU ; Li CHEN ; Si LIU ; Qinzhen ZHANG ; Jia ZHENG ; Fengchao LI ; Sukun LU ; Yun ZHANG ; Xiaoyi CHAI
International Journal of Pediatrics 2025;52(3):204-210
Objective:To observe the efficacy and safety of combined lienal polypeptide injection therapy in the treatment of Mycoplasma pneumoniae pneumonia(MPP)in children aged 3 to 14 years old in multiple clinical centers.Methods:A randomized,controlled,multi-center clinical study design was adopted.A total of 240 hospitalized children aged 3 to 14 years old with MPP from 7 hospitals from September 1,2023 to January 31,2024 were included.According to the severity of pneumonia,they were divided into the mild MPP group with 80 cases and the severe MPP/refractory MPP(SMPP/RMPP)group with 160 cases,and then randomly divided into the control group and the experimental group at a ratio of 1 ∶1,using the random number table method.After screening,subjects entered a treatment period of 5 to 7 days.The control group was treated with azithromycin,while the experimental group was treated with azithromycin plus lienal polypeptide injection .The recovery of lung CT,length of hospital stay,duration of fever,cough score,whether mild cases developed into severe or refractory cases,duration of hormone use,use of intravenous immunoglobulin(IVIG),bronchoscopy treatment,and immune function were observed between the two groups to evaluate the efficacy of lienal polypeptide injection.Adverse events after medication,vital signs,blood routine,urine routine,liver function,myocardial enzymes,renal function,and electrocardiogram were observed to evaluate the safety. Results:A total of 231 subjects have completed the trial in the 7 hospitals,including 118 cases in the experimental group and 113 cases in the control group.Main observation index:the rate of lung CT aggravation in the experimental group was lower than that in the control group(2.6% vs 15.3%, P<0.01),and the difference was statistically significant.Secondary indexes:there were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and immunoglobulin between the two groups(all P>0.05).However,the rate of cases of plastic bronchitis(PB)found under bronchoscopy in the experimental group was lower than that in the control group(0 vs 18.8%, P=0.03),and the difference was statistically significant.Among the mild MPP(72 cases),there were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and the improvement rate of lung CT between the two groups(all P>0.05).However,compared with the control group,the rate of cases developing into SMPP/RMPP in the experimental group was less(24.3% vs 48.6%, P=0.03),and the difference in IgG before and after treatment was small[0.53(-0.04,1.18)g/L vs 1.33(0.48,2.25)g/L, P=0.01].Among the SMPP/RMPP cases(159 cases),the rate of cases of PB found under bronchoscopy in the experimental group was less than that in the control group(0 vs 20%, P=0.04),and the rate of cases with aggravated lung CT in the experimental group was less than that in the control group(1.3% vs 19.5%, P<0.01),and the improvement rate of lung CT in the experimental group was higher than that in the control group(88.8% vs 75.3%, P=0.03),with statistically significant differences.There were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and immunoglobulin between the two groups(all P>0.05).Two cases in the experimental group developed rashes,which improved after the drug was discontinued.There were no serious adverse reactions such as abnormal vital signs like dyspnea and cyanosis due to the use of lienal polypeptide injection.There were no obvious changes in blood routine,liver function,myocardial enzymes,renal function,electrocardiogram,and urine routine values before and after medication compared with the baseline. Conclusion:The combined use of lienal polypeptide injection in the treatment of MPP in children can reduce the probability of the transformation from mild cases to SMPP/RMPP,reduce the rate of aggravation of the image findings,promote the absorption of lung inflammation,reduce the rate of PB found under bronchoscopy,and has good safety.
10.Evidence-based study on postoperative chemotherapy guidelines/consensuses for ovarian epithelial tumor
Xiandan LUO ; Yanli LU ; Yihang WU ; Yanxiang GUO ; Xiaoyi YAN ; Yongchao HUO ; Hui YAN ; Zhenjiang YANG ; Hongliang ZHANG
China Pharmacy 2025;36(18):2328-2333
OBJECTIVE To systematically evaluate the methodological quality of the postoperative chemotherapy guidelines/ consensuses for ovarian epithelial tumor. METHODS A search was conducted across databases including PubMed, Embase, Web of Science, CBM, VIP, Chinese Medical Journal Data, Wanfang Data, and CNKI, as well as the official websites of GIN, NICE, Medlive, AHRQ, CSCO, ASCO, and NCCN. The search period was from the establishment of the databases/websites to March 10, 2025. The quality of the included guidelines/consensus was evaluated by using the AGREE-Ⅱ tool. RESULTS A total of 16 guidelines/consensuses were included. The domain scores of AGREE-Ⅱ evaluation were as follows: scope and purpose of 85.07%, participants of 47.92%, rigor of development of 57.49%, clarity of presentation of 88.02%, applicability of 8.20%, and independence of 53.39%. Among them, 14 were recommended at grade B and 2 were recommended at grade C. The subgroup analysis by different countries/regions and different types of studies showed that the scores for participants, rigor of development, and independence of the guidelines/consensuses in China were significantly lower than foreign countries (P<0.05); the scores for participants and rigor of development of the guidelines were significantly higher than consensuses (P<0.05). The guideline/ consensus recommendation results indicated that grade B guidelines/consensus recommend platinum-based combination chemotherapy as the preferred adjuvant chemotherapy regimen for stage Ⅰ high-grade serous carcinoma patients;platinum-based combination chemotherapy±bevacizumab was recommended as the preferred adjuvant chemotherapy regimen for stage Ⅱ-Ⅳ high- grade serous carcinoma patients and for platinum-sensitive recurrent high-grade serous carcinoma patients; non-platinum single- agent chemotherapy±bevacizumab was recommended as the preferred chemotherapy regimen for platinum-resistant recurrent high- grade serous carcinoma patients. CONCLUSIONS The overall quality of postoperative chemotherapy guidelines/consensuses for ovarian epithelial tumor is not high. The methodological quality of guidelines/consensuses in China is still lagging behind that of foreign countries. The recommendations differ from those in foreign countries. It is recommended to improve the aspects of participants, rigor of development, and independence, to recommend treatment plans based on the different stages of ovarian cancer, and develop guidelines/consensuses that align with China’s national conditions.

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