1.Effect evaluation of pharmaceutical service based on root cause analysis combined with KAP theory on decreasing the protocol violations of investigational medicinal products rate in pediatric clinical trials
Chunyan GUO ; Yi ZHANG ; Yuxin YANG ; Yuguang LIANG ; Qian DING ; Qian WANG ; Chengyue ZHANG ; Yu SUN ; Peng GUO
China Pharmacy 2026;37(9):1206-1210
OBJECTIVE To investigate the effect of pharmaceutical services guided by root cause analysis (RCA) in a problem-oriented manner combined with knowledge-attitude-practice (KAP) theory on reducing the incidence of protocol violations of investigational medicinal products in pediatric clinical trials. METHODS A total of 617 participants from 69 drug clinical trial projects conducted in our hospital from January 2016 to December 2020 were selected as the control group, and 868 participants from 72 drug clinical trial projects from January 2022 to December 2025 as the observation group. RCA was performed on the protocol violations of investigational medicinal product in the control group to identify the types and underlying causes. The control group received routine pharmaceutical services for drug clinical trials, while the observation group was provided with precision pharmaceutical services from the three dimensions of knowledge, attitude and practice on the basis of routine pharmaceutical services, according to the root causes identified by RCA. The occurrence of investigational medicinal products protocol violations was compared between the two groups. RESULTS The total incidence of protocol violations of investigational medicinal products, as well as the incidences of minor and major protocol violations, were all significantly lower in the observation group than in the control group ( P <0.001). The main types of protocol violations in both groups included missed/under-/over-dosing of medications, non-adherence to administration time, failure to adjust dosage as required, and combined medication/vaccination in violation of the protocol. Regarding the responsible subjects of protocol violations, the incidences of protocol violations attributed to participants and their guardians as well as investigators and accidental factors were significantly lower in the observation group than in the control group ( P <0.001, P <0.001, P =0.025). However, there were no statistically significant differences in the incidences of protocol violations caused by sponsor-related reasons between the two groups ( P >0.05). CONCLUSIONS Pharmaceutical services led by pharmacists, based on problem-oriented RCA and combined with KAP theory, can effectively reduce the protocol violations of investigational medicinal products rate in pediatric clinical trials, thereby safeguarding the safety and rights of study participants.
2.Burden of influenza-associated consultations in China from 2011 to 2021 surveillance years
Yuxin SHEN ; Zhibin PENG ; Ying QIN ; Xiaoying YU ; Rina SU ; Qingyi WANG ; Jiandong ZHENG ; Hongting ZHAO ; Xiaokun YANG ; Yanping ZHANG
Chinese Journal of Epidemiology 2025;46(4):612-618
Objective:To estimate the burden of influenza-associated outpatient consultations in China from 2011 to 2021 surveillance years to provide a reference for developing influenza prevention, control strategies, and vaccination policies.Methods:Data on influenza-like illness (ILI) and virological confirmation of sentinel specimens from 2011 to 2021 surveillance years were extracted from China's national sentinel surveillance system. Generalized additive models were fitted to estimate influenza-associated excess ILI outpatient burden, accounting for seasonal baselines and meteorological factors.Results:Influenza was associated with an average of 1.66 (95% CI: 1.51-1.80) excess ILI consultations per 1 000 person-years (py) in China each year from 2011 to 2021 surveillance years. The influenza-associated outpatient burden was similar across different virus types/subtypes. Influenza A(H1N1)pdm09 led to a higher rate of influenza- associated ILI consultations [0.65 (95% CI: 0.53-0.76) per 1 000 py] compared to other types/subtypes. The age groups with the highest burdens were children aged 0-4 years and 5-14 years, with excess outpatient consultation rates of 15.23 (95% CI: 13.73-16.73) per 1 000 py and 13.53 (95% CI: 12.49-14.52) per 1 000 py, respectively. Conclusions:Influenza caused many outpatient consultations in China, particularly among children aged 0-14. Continuous influenza monitoring and disease burden assessment should be conducted, and close attention should be paid to the changing trends of various influenza virus types/subtypes. When formulating vaccination strategies, priority should be given to recommending vaccination for high-risk populations, such as children.
3.The effect of the out-of-plane shield on the tube current and radiation dose of CT examination
Juan ZHOU ; Yuxin HAN ; Peng QU ; Rong LÜ
Journal of Practical Radiology 2025;41(4):669-672
Objective To explore the effect of different ways of out-of-plane shield on the tube current and cumulative radiation dose of CT scan.Methods The CT water membrane was scanned using Philips 128 row iCT scanner in different scanning methods:the 1-3 times,without the out-of-plane shield,the total length of localizer was 150 mm,270 mm,and 390 mm,respectively;the fourth time,the out-of-plane shield was used but was not present in the localizer;from the 5th to 7th pass,with out-of-plane shield and develop it in the localizer,with out-of-plane shield development lengths of 60 mm,180 mm,and 300 mm,respectively,and the out-of-plane shield was not within the formal scanning range.The tube current and cumulative radiation dose of various scanning methods were compared and a line graph of the tube current for scanning each layer was figured.Results(1)There was no statistically significant difference in tube current when there was no out-of-plane shield but the length of the localizer was different(P>0.05).(2)When the pitch was 0.8,1.0,and 1.15 respectively,with out-of-plane shield but no shield object in the localizer,the scanning tube current was lower than that without shield scanning(P<0.05).(3)When scanning with three different lengths of out-of-plane shield(60 mm,180 mm,300 mm)in the localizer,regardless of the pitch,the tube current was greater than that of unshield scanning(P<0.05).(4)When there was a shield in the localizer,the closer to the shield,the higher the tube current in the formal scan.(5)The cumulative dose of scans with out-of-plane shield but without the presence of shield in the localizer was smaller than that of unshield scanning.However,with shield and the presence of shield scanning in the localizer,the cumulative radiation dose was greater than that of unshield scanning.Conclusion The presence of out-of-plane shield in the localizer may increase the tube current and radiation dose for formal scanning,and the closer to the shield,the more significant the increase in tube current.
4.Scope review of prevention and management strategies for incontinence-associated dermatitis of adult critical ill patients
Pei WANG ; Yuxin ZHAN ; Bing LI ; Peng YU
Modern Clinical Nursing 2025;24(5):83-89
Objective To review the factors affecting the occurrence of incontinence dermatitis in adults and severe patients,and provide clinical theoretical guidance for clinical nurses to reduce the incidence of incontinence dermatitis.Methods The literatures on the influencing factors of incontinence-associated dermatitis in adult patients with intensive care were searched in PubMed,Web of science,CINAHL,Embase,Cochrane Library,CNKI,Wanfang,Vip and SinoMed.The search period was from the establishment of the database to December 31th,2023(March 31,2025 updated).Results A total of 19 literatures were included,and the influencing factors of IAD mainly included 5 aspects:incontinence type,disease status,medication use,risk assessment and other factors.Conclusion There are many factors affecting the occurrence of incontinence-associated dermatitis in adult patients with intensive care,and nurses should implement diversified skin intervention strategies to reduce the incidence of IAD in adult patients with intensive care.
5.Observation on the therapeutic effect of stellate ganglion block combined with nicergoline on dysphagia after stroke
Yuting YAO ; Peng ZHAO ; Yan LI ; Yuxin YAO ; Minxiao LIU
Tianjin Medical Journal 2025;53(1):57-60
Objective To investigate the clinical efficacy of stellate ganglion block(SGB)combined with nicergoline in patients with dysphagia after stroke.Methods A total of 104 patients with dysphagia after stroke were randomly divided into the observation group and the control group.The observation group was treated with niergoline and SGB,while the control group received functional electrical stimulation.The total effective rate,swallowing condition,inflammatory factor level and adverse events were compared between the two groups.Results After treatment,the total effective rate was significantly higher in the observation group(92.31%)than that of the control group(73.08%,P<0.05).The level of interleukin-6(IL-6),the standardized swallowing assessment(SSA)score and the level of tumor necrosis factor alpha(TNF-α)were significantly lower in the observation group than those in the control group(P<0.05).The Mann swallowing ability assessment scale(MASA)score was significantly higher in the observation group than that of the control group(P<0.05).There were no significant differences in adverse reactions such as glottis closure and laryngeal spasm between the two groups(P>0.05).Conclusion The combined treatment of SGB and nicergoline can effectively improve swallowing function in patients with dysphagia after stroke,with good safety,ideal results and high clinical application value.
6.Construction of a prognostic model for pancreatic ductal adenocarcinoma based on m6A-and m5C-related lncRNAs and its relationship with the immune microenvironment
Jie WANG ; Junxi LIAO ; Yi QIU ; Yuanna JIANG ; Yuxin SHI ; Jie PENG
Chinese Journal of General Surgery 2025;34(3):475-484
Background and Aims:Pancreatic ductal adenocarcinoma(PDAC)is a highly malignant digestive system tumor with an inferior prognosis,and its early diagnosis and treatment remain significant challenges.In recent years,RNA methylation modifications(such as m6A and m5C)have attracted considerable attention for their roles in tumor development;however,their regulatory mechanisms and clinical significance in PDAC remain unclear.This study was conducted to identify prognosis-related long noncoding RNAs(lncRNAs)associated with m6A and m5C in PDAC,construct a reliable prognostic prediction model,and explore their relationship with the tumor immune microenvironment.Methods:Based on RNA-seq data from the TCGA-PDAC cohort,differentially expressed lncRNAs(DElncRNAs)related to m6A and m5C were identified through differential expression analysis and Pearson correlation analysis.The samples were randomly divided into a training set(n=89)and a validation set(n=89).Key DElncRNAs were selected using LASSO-Cox regression to construct a prognostic model,and patients were categorized into high-and low-risk groups based on risk scores.Kaplan-Meier survival analysis,ROC curves,and multivariate Cox regression were used to evaluate the model's predictive performance.Furthermore,CIBERSORT and ESTIMATE scores were used to analyze immune cell infiltration characteristics and tumor microenvironment(TME)differences between the high-and low-risk groups.Results:To construct the prognostic model,four m6A-and m5C-related DElncRNAs(LINC00857,LINC02038,TSPOAP1-AS1,and TRPC7-AS1)were identified.Patients in the high-risk group had significantly lower overall survival than those in the low-risk group(P<0.05),and the risk score was an independent prognostic factor for PDAC(HR=1.551,95%CI=1.297-1.854,P<0.001).ROC curve analysis showed that the risk score model exhibited high predictive efficiency in both the training and validation sets(AUC values for 1,3,and 5 years:0.766,0.875,0.879;0.685,0.711,0.792,respectively).Immune analysis revealed increased infiltration of M0 macrophages with lower TME scores in the high-risk group(all P<0.05),suggesting an immunosuppressive microenvironment.Conclusion:This study successfully established a PDAC prognostic model based on m6A-and m5C-related DElncRNAs and confirmed its independent predictive value.High-risk patients exhibited M0 macrophage enrichment and immunosuppressive microenvironment characteristics,possibly contributing to poor prognosis.
7.Optimizing Standardization Systems and Standardizing Clinical Practice:Interpretation of Quality Standards for Medical 68 Ge/68 Ga Generators and 68 Ga Radiopharmaceuticals and Quality Standards for Medical 177 Lu and Its Radiopharmaceuticals
Yuxin LAI ; Yumeng PENG ; Guochang WANG
Medical Journal of Peking Union Medical College Hospital 2025;16(4):867-873
On January 1,2022,the China International Association for the Promotion of Science and Technology(CIAPST)officially implemented two pivotal standards:Quality Standards for Medical Germanium-68/Gallium-68(68 Ge/68 Ga)Generators and Gallium-68 Radiopharmaceuticals(T/CI 046-2021)and Quality Standards for Medical Lutetium-177(177 Lu)and Its Radiopharmaceuticals(T/CI 047-2021).These standards introduce innovative requirements for quality control and clinical application of radiopharmaceuticals,marking a significant advancement in China's regulatory framework for nuclear medicine.This article provides a compre-hensive analysis of the technical rationale,QC protocols,and clinical implications outlined in the standards.Against the backdrop of China's evolving nuclear medicine landscape,we further identify challenges in imple-mentation(e.g.,production consistency,regulatory compliance)and propose actionable strategies to optimize radiopharmaceutical quality management systems.Our perspective aims to support the standardization and global integration of China's radiopharmaceutical industry.
8.Burden of influenza-associated consultations in China from 2011 to 2021 surveillance years
Yuxin SHEN ; Zhibin PENG ; Ying QIN ; Xiaoying YU ; Rina SU ; Qingyi WANG ; Jiandong ZHENG ; Hongting ZHAO ; Xiaokun YANG ; Yanping ZHANG
Chinese Journal of Epidemiology 2025;46(4):612-618
Objective:To estimate the burden of influenza-associated outpatient consultations in China from 2011 to 2021 surveillance years to provide a reference for developing influenza prevention, control strategies, and vaccination policies.Methods:Data on influenza-like illness (ILI) and virological confirmation of sentinel specimens from 2011 to 2021 surveillance years were extracted from China's national sentinel surveillance system. Generalized additive models were fitted to estimate influenza-associated excess ILI outpatient burden, accounting for seasonal baselines and meteorological factors.Results:Influenza was associated with an average of 1.66 (95% CI: 1.51-1.80) excess ILI consultations per 1 000 person-years (py) in China each year from 2011 to 2021 surveillance years. The influenza-associated outpatient burden was similar across different virus types/subtypes. Influenza A(H1N1)pdm09 led to a higher rate of influenza- associated ILI consultations [0.65 (95% CI: 0.53-0.76) per 1 000 py] compared to other types/subtypes. The age groups with the highest burdens were children aged 0-4 years and 5-14 years, with excess outpatient consultation rates of 15.23 (95% CI: 13.73-16.73) per 1 000 py and 13.53 (95% CI: 12.49-14.52) per 1 000 py, respectively. Conclusions:Influenza caused many outpatient consultations in China, particularly among children aged 0-14. Continuous influenza monitoring and disease burden assessment should be conducted, and close attention should be paid to the changing trends of various influenza virus types/subtypes. When formulating vaccination strategies, priority should be given to recommending vaccination for high-risk populations, such as children.
9.The effect of the out-of-plane shield on the tube current and radiation dose of CT examination
Juan ZHOU ; Yuxin HAN ; Peng QU ; Rong LÜ
Journal of Practical Radiology 2025;41(4):669-672
Objective To explore the effect of different ways of out-of-plane shield on the tube current and cumulative radiation dose of CT scan.Methods The CT water membrane was scanned using Philips 128 row iCT scanner in different scanning methods:the 1-3 times,without the out-of-plane shield,the total length of localizer was 150 mm,270 mm,and 390 mm,respectively;the fourth time,the out-of-plane shield was used but was not present in the localizer;from the 5th to 7th pass,with out-of-plane shield and develop it in the localizer,with out-of-plane shield development lengths of 60 mm,180 mm,and 300 mm,respectively,and the out-of-plane shield was not within the formal scanning range.The tube current and cumulative radiation dose of various scanning methods were compared and a line graph of the tube current for scanning each layer was figured.Results(1)There was no statistically significant difference in tube current when there was no out-of-plane shield but the length of the localizer was different(P>0.05).(2)When the pitch was 0.8,1.0,and 1.15 respectively,with out-of-plane shield but no shield object in the localizer,the scanning tube current was lower than that without shield scanning(P<0.05).(3)When scanning with three different lengths of out-of-plane shield(60 mm,180 mm,300 mm)in the localizer,regardless of the pitch,the tube current was greater than that of unshield scanning(P<0.05).(4)When there was a shield in the localizer,the closer to the shield,the higher the tube current in the formal scan.(5)The cumulative dose of scans with out-of-plane shield but without the presence of shield in the localizer was smaller than that of unshield scanning.However,with shield and the presence of shield scanning in the localizer,the cumulative radiation dose was greater than that of unshield scanning.Conclusion The presence of out-of-plane shield in the localizer may increase the tube current and radiation dose for formal scanning,and the closer to the shield,the more significant the increase in tube current.
10.Optimizing Standardization Systems and Standardizing Clinical Practice:Interpretation of Quality Standards for Medical 68 Ge/68 Ga Generators and 68 Ga Radiopharmaceuticals and Quality Standards for Medical 177 Lu and Its Radiopharmaceuticals
Yuxin LAI ; Yumeng PENG ; Guochang WANG
Medical Journal of Peking Union Medical College Hospital 2025;16(4):867-873
On January 1,2022,the China International Association for the Promotion of Science and Technology(CIAPST)officially implemented two pivotal standards:Quality Standards for Medical Germanium-68/Gallium-68(68 Ge/68 Ga)Generators and Gallium-68 Radiopharmaceuticals(T/CI 046-2021)and Quality Standards for Medical Lutetium-177(177 Lu)and Its Radiopharmaceuticals(T/CI 047-2021).These standards introduce innovative requirements for quality control and clinical application of radiopharmaceuticals,marking a significant advancement in China's regulatory framework for nuclear medicine.This article provides a compre-hensive analysis of the technical rationale,QC protocols,and clinical implications outlined in the standards.Against the backdrop of China's evolving nuclear medicine landscape,we further identify challenges in imple-mentation(e.g.,production consistency,regulatory compliance)and propose actionable strategies to optimize radiopharmaceutical quality management systems.Our perspective aims to support the standardization and global integration of China's radiopharmaceutical industry.

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