1.Construction of a health education checklist for safety management of oral antitumor drugs in tumor patients
Hongli LI ; Hong ZHANG ; Yuhan LU ; Zhichao FENG ; Miaoning YOU ; Xiaoting HOU ; Liyan ZHANG ; Jie ZHANG ; Dong PANG ; Hong YANG
Chinese Journal of Modern Nursing 2025;31(21):2906-2911
Objective:To construct a health education checklist for safety management of oral antitumor drugs in tumor patients, so as to provide a guidance for clinical nurses in practice, thereby improving the drug safety of patients taking oral antitumor drugs.Methods:Based on the cognition-behavior theoretical framework, a preliminary draft of a health education checklist for safety management of oral antitumor drugs in tumor patients was developed through literature review. The Delphi method was used to conduct consultations with 17 experts from July to September 2024 to revise and add or delete the contents of the checklist based on the experts' assignments of importance to the indicators at each level and the textual comments made.Results:A total of two rounds of expert consultation were conducted. The final established health education checklist for safety management of oral antitumor drugs in tumor patients included 4 primary and 28 secondary indicators. In the two rounds of consultation, the positive coefficient of experts was 100.0%, the coefficient of expert authority was 0.93, the coefficients of variation for the two rounds of expert ratings were 0 to 0.173 and 0 to 0.151, and the coefficients of Kendall's concordance were 0.141 (χ 2=74.461, P<0.001) and 0.113 (χ 2=59.549, P=0.002) , respectively. Conclusions:The health education checklist for safety management of oral antitumor drugs in tumor patients has good scientific, reliable and clinical practical value, which can provide scientific, standardized and convenient practical guidance for clinical nurses to implement health education on drug safety management for patients taking oral antitumor drugs.
2.Establishment of quantitative models for effective components in Yishen Xiezhuo Mixture
Zi-fang FENG ; Min-min HU ; Xiao-wei CHEN ; Wen-ming ZHANG ; Li-hong GU ; Ping QIN ; Yi PENG ; Zhen-hua BIAN ; Qing-you YANG ; Tu-lin LU
Chinese Traditional Patent Medicine 2025;47(10):3177-3184
AIM To establish the quantitative models for gallic acid,mononucleoside,loganin,resveratrol,and rhein in Yishen Xiezhuo Mixture.METHODS HPLC was adopted in the content determination of various effective components,after which the near-infrared spectroscopy(NIRS)data were collected in 128 batches of samples and pretreatment was conducted,competitive adaptive reweighting sampling(CARS)algorithm was used for screening wavelength,partial least square method(PLS)regression analysis was performed.RESULTS There were no significant differences between the predicted values obtained by PLS models and measured values obtained by HPLC for various effective components(P>0.05).CONCLUSION The quantitative models established by NIRS combined with chemometrics display good predictive performance,which can be used for the rapid determination of effective components in Yishen Xiezhuo Mixture,and provide a reference for the rapid monitoring of other traditional Chinese medicine preparations in production processes.
3.Construction of a health education checklist for safety management of oral antitumor drugs in tumor patients
Hongli LI ; Hong ZHANG ; Yuhan LU ; Zhichao FENG ; Miaoning YOU ; Xiaoting HOU ; Liyan ZHANG ; Jie ZHANG ; Dong PANG ; Hong YANG
Chinese Journal of Modern Nursing 2025;31(21):2906-2911
Objective:To construct a health education checklist for safety management of oral antitumor drugs in tumor patients, so as to provide a guidance for clinical nurses in practice, thereby improving the drug safety of patients taking oral antitumor drugs.Methods:Based on the cognition-behavior theoretical framework, a preliminary draft of a health education checklist for safety management of oral antitumor drugs in tumor patients was developed through literature review. The Delphi method was used to conduct consultations with 17 experts from July to September 2024 to revise and add or delete the contents of the checklist based on the experts' assignments of importance to the indicators at each level and the textual comments made.Results:A total of two rounds of expert consultation were conducted. The final established health education checklist for safety management of oral antitumor drugs in tumor patients included 4 primary and 28 secondary indicators. In the two rounds of consultation, the positive coefficient of experts was 100.0%, the coefficient of expert authority was 0.93, the coefficients of variation for the two rounds of expert ratings were 0 to 0.173 and 0 to 0.151, and the coefficients of Kendall's concordance were 0.141 (χ 2=74.461, P<0.001) and 0.113 (χ 2=59.549, P=0.002) , respectively. Conclusions:The health education checklist for safety management of oral antitumor drugs in tumor patients has good scientific, reliable and clinical practical value, which can provide scientific, standardized and convenient practical guidance for clinical nurses to implement health education on drug safety management for patients taking oral antitumor drugs.
4.Application of artificial intelligence in clinical trials of liver diseases: A methodological perspective
Lichen SHI ; Ruishi FENG ; Jidong JIA ; Hong YOU ; Yuanyuan KONG
Journal of Clinical Hepatology 2025;41(11):2227-2234
In recent years, the exploration and development of artificial intelligence (AI) technology in clinical trials for liver diseases have promoted the continuous innovation of research methods and processes in this field. AI has gradually become an important technical tool for various links of clinical trial including patient selection, risk stratification, endpoint evaluation, and result interpretation. Nevertheless, the standardized integration of AI into clinical trials still faces the methodological challenges such as data quality control, model interpretability, and causal inference. From the perspective of methodology, this article systematically reviews the principal application scenarios of AI as an object under investigation (validation trials) and as a research tool (supportive trials) in clinical trials for liver diseases, as well as the major methodological challenges of AI-related clinical trials along and the corresponding solution strategies, in order to provide methodological guidance for promoting the scientific and standardized implementation of AI technologies.
5.Processing technology of calcined Magnetitum based on concept of QbD and its XRD characteristic spectra.
De-Wen ZENG ; Jing-Wei ZHOU ; Tian-Xing HE ; Yu-Mei CHEN ; Huan-Huan XU ; Jian FENG ; Yue YANG ; Xin CHEN ; Jia-Liang ZOU ; Lin CHEN ; Hong-Ping CHEN ; Shi-Lin CHEN ; Yuan HU ; You-Ping LIU
China Journal of Chinese Materia Medica 2025;50(9):2391-2403
Guided by the concept of quality by design(QbD), this study optimizes the calcination and quenching process of calcined Magnetitum and establishes the XRD characteristic spectra of calcined Magnetitum, providing a scientific basis for the formulation of quality standards. Based on the processing methods and quality requirements of Magnetitum in the Chinese Pharmacopoeia, the critical process parameters(CPPs) identified were calcination temperature, calcination time, particle size, laying thickness, and the number of vinegar quenching cycles. The critical quality attributes(CQAs) included Fe mass fraction, Fe~(2+) dissolution, and surface color. The weight coefficients were determined by combining Analytic Hierarchy Process(AHP) and the criteria importance though intercrieria correlation(CRITIC) method, and the calcination process was optimized using orthogonal experimentation. Surface color was selected as a CQA, and based on the principle of color value, the surface color of calcined Magnetitum was objectively quantified. The vinegar quenching process was then optimized to determine the best processing conditions. X-ray diffraction(XRD) was used to establish the characteristic spectra of calcined Magnetitum, and methods such as similarity evaluation, cluster analysis, and orthogonal partial least squares-discriminant analysis(OPLS-DA) were used to evaluate the quality of the spectra. The optimized calcined Magnetitum preparation process was found to be calcination at 750 ℃ for 1 h, with a laying thickness of 4 cm, a particle size of 0.4-0.8 cm, and one vinegar quenching cycle(Magnetitum-vinegar ratio 10∶3), which was stable and feasible. The XRD characteristic spectra analysis method, featuring 9 common peaks as fingerprint information, was established. The average correlation coefficient ranged from 0.839 5-0.988 1, and the average angle cosine ranged from 0.914 4 to 0.995 6, indicating good similarity. Cluster analysis results showed that Magnetitum and calcined Magnetitum could be grouped together, with similar compositions. OPLS-DA discriminant analysis identified three key characteristic peaks, with Fe_2O_3 being the distinguishing component between the two. The final optimized processing method is stable and feasible, and the XRD characteristic spectra of calcined Magnetitum was initially established, providing a reference for subsequent quality control and the formulation of quality standards for calcined Magnetitum.
X-Ray Diffraction/methods*
;
Drugs, Chinese Herbal/chemistry*
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Quality Control
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Particle Size
6.Comparative efficacy of internal brace-augmeted reconstruction combined with tape tail-folding anterolateral ligament reconstruction and isolated internal brace-augmented reconstruction for high-grade pivot-shift anterior cruciate ligament injuries
Xiaocheng MAO ; Yanan HUANG ; Qingnan HONG ; Ruijin YOU ; Feng ZHAO
Chinese Journal of Trauma 2025;41(11):1086-1093
Objective:To compare the efficacy of internal brace-augmeted reconstruction combined with tape tail-folding anterolateral ligament reconstruction (ALL) and isolated internal brace-augmented reconstruction for high-grade pivot-shift anterior cruciate ligament (ACL) injuries.Methods:A retrospective cohort study was conducted to analyze the clinical data of 60 patients with high-grade pivot-shift ACL injuries who were admitted to 910th Hospital of Joint Logistics Support Force of PLA between March 2021 and March 2023, including 48 males and 12 females, aged 18-40 years [(28.4±5.6)years]. All ACL injuries were at grade III. The pivot-shift test results were classified as grade 2 in 42 patients and grade 3 in 18. According to the surgical technique, 30 patients underwent artificial internal brace-augmented ACL reconstruction combined with tape tail-folding ALL reconstruction (joint ACL reconstruction group), while the other 30 received isolated internal brace-augmented ACL reconstruction (simple ACL reconstruction group). The two groups were compared in terms of operative duration, intraoperative blood loss, improvement rate of pivot-shift at 3 months postoperatively, rate of sports function recovery at the last follow-up, Tegner and Lysholm scores preoperatively, at 3 months postoperatively, and at the last follow-up, and incidence of postoperative complications.Results:All the patients were followed up for 6-24 months [(14.8±5.8)months]. The operative duration and intraoperative blood loss were (44.6±8.2)minutes and (45.3±4.6)ml in the simple ACL reconstruction group, significantly shorter or less than (58.0±7.4)minutes and (61.8±9.1)ml in the joint ACL reconstruction group ( P<0.01). At 3 months after surgery, the improvement of pivot-shift test was 93%(28/30) in the joint ACL reconstruction group, higher than 73%(22/30) in the simple ACL reconstruction group ( P<0.05). At the last follow-up, the recovery rate of motor function was 100%(30/30) in the joint ACL reconstruction group, significantly higher than 80%(24/30) in the simple ACL reconstruction group ( P<0.05). There were no statistically significant differences in Tegner or Lysholm scores between the two groups before surgery ( P>0.05). At 3 months after surgery and at the last follow-up, the Tegner scores were (3.8±0.5)points and (5.7±1.1)points in the joint ACL reconstruction group, significantly higher than (2.5±0.6)points and (3.9±0.9)points in the simple ACL reconstruction group ( P<0.01). At 3 months after surgery and at the last follow-up, the Lysholm scores were (67.2±5.7)points and (89.4±6.4)points in the joint ACL reconstruction group, significantly higher than (56.4±5.0)points and (72.6±5.7)points in the simple ACL reconstruction group ( P<0.01). Both groups demonstrated gradual improvement in Tegner and Lysholm scores at all postoperative time points, compared to preoperative values ( P<0.05). After operation, one patient in the joint ACL reconstruction group had superficial tibial infection, with a complication rate of 3% (1/30), whereas there was one patient with superficial tibial infection, and one with ligament injury in the simple ACL reconstruction group, with a total complication rate of 7% (2/30)( P<0.05). Conclusion:For high-grade pivot-shift ACL injuries, internal brace-augmented reconstruction combined with tape tail-folding ALL reconstruction can significantly improve knee rotational stability, promote motor function recovery, and enhance knee joint outcomes, compared to isolated internal brace-augmented reconstruction.
7.Establishment of quantitative models for effective components in Yishen Xiezhuo Mixture
Zi-fang FENG ; Min-min HU ; Xiao-wei CHEN ; Wen-ming ZHANG ; Li-hong GU ; Ping QIN ; Yi PENG ; Zhen-hua BIAN ; Qing-you YANG ; Tu-lin LU
Chinese Traditional Patent Medicine 2025;47(10):3177-3184
AIM To establish the quantitative models for gallic acid,mononucleoside,loganin,resveratrol,and rhein in Yishen Xiezhuo Mixture.METHODS HPLC was adopted in the content determination of various effective components,after which the near-infrared spectroscopy(NIRS)data were collected in 128 batches of samples and pretreatment was conducted,competitive adaptive reweighting sampling(CARS)algorithm was used for screening wavelength,partial least square method(PLS)regression analysis was performed.RESULTS There were no significant differences between the predicted values obtained by PLS models and measured values obtained by HPLC for various effective components(P>0.05).CONCLUSION The quantitative models established by NIRS combined with chemometrics display good predictive performance,which can be used for the rapid determination of effective components in Yishen Xiezhuo Mixture,and provide a reference for the rapid monitoring of other traditional Chinese medicine preparations in production processes.
8.Comparative efficacy of internal brace-augmeted reconstruction combined with tape tail-folding anterolateral ligament reconstruction and isolated internal brace-augmented reconstruction for high-grade pivot-shift anterior cruciate ligament injuries
Xiaocheng MAO ; Yanan HUANG ; Qingnan HONG ; Ruijin YOU ; Feng ZHAO
Chinese Journal of Trauma 2025;41(11):1086-1093
Objective:To compare the efficacy of internal brace-augmeted reconstruction combined with tape tail-folding anterolateral ligament reconstruction (ALL) and isolated internal brace-augmented reconstruction for high-grade pivot-shift anterior cruciate ligament (ACL) injuries.Methods:A retrospective cohort study was conducted to analyze the clinical data of 60 patients with high-grade pivot-shift ACL injuries who were admitted to 910th Hospital of Joint Logistics Support Force of PLA between March 2021 and March 2023, including 48 males and 12 females, aged 18-40 years [(28.4±5.6)years]. All ACL injuries were at grade III. The pivot-shift test results were classified as grade 2 in 42 patients and grade 3 in 18. According to the surgical technique, 30 patients underwent artificial internal brace-augmented ACL reconstruction combined with tape tail-folding ALL reconstruction (joint ACL reconstruction group), while the other 30 received isolated internal brace-augmented ACL reconstruction (simple ACL reconstruction group). The two groups were compared in terms of operative duration, intraoperative blood loss, improvement rate of pivot-shift at 3 months postoperatively, rate of sports function recovery at the last follow-up, Tegner and Lysholm scores preoperatively, at 3 months postoperatively, and at the last follow-up, and incidence of postoperative complications.Results:All the patients were followed up for 6-24 months [(14.8±5.8)months]. The operative duration and intraoperative blood loss were (44.6±8.2)minutes and (45.3±4.6)ml in the simple ACL reconstruction group, significantly shorter or less than (58.0±7.4)minutes and (61.8±9.1)ml in the joint ACL reconstruction group ( P<0.01). At 3 months after surgery, the improvement of pivot-shift test was 93%(28/30) in the joint ACL reconstruction group, higher than 73%(22/30) in the simple ACL reconstruction group ( P<0.05). At the last follow-up, the recovery rate of motor function was 100%(30/30) in the joint ACL reconstruction group, significantly higher than 80%(24/30) in the simple ACL reconstruction group ( P<0.05). There were no statistically significant differences in Tegner or Lysholm scores between the two groups before surgery ( P>0.05). At 3 months after surgery and at the last follow-up, the Tegner scores were (3.8±0.5)points and (5.7±1.1)points in the joint ACL reconstruction group, significantly higher than (2.5±0.6)points and (3.9±0.9)points in the simple ACL reconstruction group ( P<0.01). At 3 months after surgery and at the last follow-up, the Lysholm scores were (67.2±5.7)points and (89.4±6.4)points in the joint ACL reconstruction group, significantly higher than (56.4±5.0)points and (72.6±5.7)points in the simple ACL reconstruction group ( P<0.01). Both groups demonstrated gradual improvement in Tegner and Lysholm scores at all postoperative time points, compared to preoperative values ( P<0.05). After operation, one patient in the joint ACL reconstruction group had superficial tibial infection, with a complication rate of 3% (1/30), whereas there was one patient with superficial tibial infection, and one with ligament injury in the simple ACL reconstruction group, with a total complication rate of 7% (2/30)( P<0.05). Conclusion:For high-grade pivot-shift ACL injuries, internal brace-augmented reconstruction combined with tape tail-folding ALL reconstruction can significantly improve knee rotational stability, promote motor function recovery, and enhance knee joint outcomes, compared to isolated internal brace-augmented reconstruction.
9.Antimicrobial resistance profile of clinical isolates in hospitals across China:report from the CHINET Antimicrobial Resistance Surveillance Program,2023
Yan GUO ; Fupin HU ; Demei ZHU ; Fu WANG ; Xiaofei JIANG ; Yingchun XU ; Xiaojiang ZHANG ; Fengbo ZHANG ; Ping JI ; Yi XIE ; Yuling XIAO ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Jingyong SUN ; Qing CHEN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yunmin XU ; Sufang GUO ; Yanyan WANG ; Lianhua WEI ; Keke LI ; Hong ZHANG ; Fen PAN ; Yunjian HU ; Xiaoman AI ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Wei LI ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Qian SUN ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanqing ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Hua FANG ; Penghui ZHANG ; Bixia YU ; Ping GONG ; Haixia SHI ; Kaizhen WEN ; Yirong ZHANG ; Xiuli YANG ; Yiqin ZHAO ; Longfeng LIAO ; Jinhua WU ; Hongqin GU ; Lin JIANG ; Meifang HU ; Wen HE ; Jiao FENG ; Lingling YOU ; Dongmei WANG ; Dong'e WANG ; Yanyan LIU ; Yong AN ; Wenhui HUANG ; Juan LI ; Quangui SHI ; Juan YANG ; Abulimiti REZIWAGULI ; Lili HUANG ; Xuejun SHAO ; Xiaoyan REN ; Dong LI ; Qun ZHANG ; Xue CHEN ; Rihai LI ; Jieli XU ; Kaijie GAO ; Lu XU ; Lin LIN ; Zhuo ZHANG ; Jianlong LIU ; Min FU ; Yinghui GUO ; Wenchao ZHANG ; Zengguo WANG ; Kai JIA ; Yun XIA ; Shan SUN ; Huimin YANG ; Yan MIAO ; Jianping WANG ; Mingming ZHOU ; Shihai ZHANG ; Hongjuan LIU ; Nan CHEN ; Chan LI ; Cunshan KOU ; Shunhong XUE ; Jilu SHEN ; Wanqi MEN ; Peng WANG ; Xiaowei ZHANG ; Xiaoyan ZENG ; Wen LI ; Yan GENG ; Zeshi LIU
Chinese Journal of Infection and Chemotherapy 2024;24(6):627-637
Objective To monitor the susceptibility of clinical isolates to antimicrobial agents in healthcare facilities in major regions of China in 2023.Methods Clinical isolates collected from 73 hospitals across China were tested for antimicrobial susceptibility using a unified protocol based on disc diffusion method or automated testing systems.Results were interpreted using the 2023 Clinical & Laboratory Standards Institute (CLSI) breakpoints.Results A total of 445199 clinical isolates were collected in 2023,of which 29.0% were gram-positive and 71.0% were gram-negative.The prevalence of methicillin-resistant strains in Staphylococcus aureus,Staphylococcus epidermidis and other coagulase-negative Staphylococcus species (excluding Staphylococcus pseudintermedius and Staphylococcus schleiferi) (MRSA,MRSE and MRCNS) was 29.6%,81.9% and 78.5%,respectively.Methicillin-resistant strains showed significantly higher resistance rates to most antimicrobial agents than methicillin-susceptible strains (MSSA,MSSE and MSCNS).Overall,92.9% of MRSA strains were susceptible to trimethoprim-sulfamethoxazole and 91.4% of MRSE strains were susceptible to rifampicin.No vancomycin-resistant strains were found.Enterococcus faecalis had significantly lower resistance rates to most antimicrobial agents tested than Enterococcus faecium.A few vancomycin-resistant strains were identified in both E.faecalis and E.faecium.The prevalence of penicillin-susceptible Streptococcus pneumoniae was 93.1% in the isolates from children and and 95.9% in the isolates from adults.The resistance rate to carbapenems was lower than 15.0% for most Enterobacterales species except for Klebsiella,22.5% and 23.6% of which were resistant to imipenem and meropenem,respectively .Most Enterobacterales isolates were highly susceptible to tigecycline,colistin and polymyxin B,with resistance rates ranging from 0.6% to 10.0%.The resistance rate to imipenem and meropenem was 21.9% and 17.4% for Pseudomonas aeruginosa,respectively,and 67.5% and 68.1% for Acinetobacter baumannii,respectively.Conclusions Increasing resistance to the commonly used antimicrobial agents is still observed in clinical bacterial isolates.However,the prevalence of important crabapenem-resistant organisms such as crabapenem-resistant K.pneumoniae,P.aeruginosa,and A.baumannii showed a slightly decreasing trend.This finding suggests that strengthening bacterial resistance surveillance and multidisciplinary linkage are important for preventing the occurrence and development of bacterial resistance.
10.Molecular epidemiological analysis of plague at the border area of Yunnan Province
Feng-Yi YANG ; Rong YANG ; Si-Ru LI ; Jin-Jiao KONG ; Hong-Li TAN ; Hai-Peng ZHANG ; Peng WANG ; You-Hong ZHONG ; Li-Yuan SHI ; Zhi-Zhong SONG
Chinese Journal of Zoonoses 2024;40(5):401-407
This study was aimed at exploring the epidemiological characteristics of plague,and the evolutionary relation-ships among the isolated plague strains in the Yunnan border area,to provide clues for further studying epidemic causes and ep-idemiological patterns.Plague epidemic data in the border area during the second epidemic period(1982-2007)were collected and analyzed with descriptive epidemiological methods.Whole genome sequences of 262 strains of Yersinia pestis in the border area were obtained for phylogenetic analysis.Plague outbreaks occurred in 17 counties(cities)among 25 border counties(cit-ies);a total of 552 epidemic foci and 123 human cases were identified.The 1.ORI2,1.ORI3,1.IN3,2.ANT and 2.MED geno-types were identified among Yersinia pestis isolated from the Yunnan border area,among which the 1.ORI2 population was dominant.A total of 258 strains of Yersinia pestis from the 1.OR12 population belonged to four subclusters.The Myanmar and Vietnam clade was embedded within the Yunnan clade in the overall phylogeny.The above results indicated that during the sec-ond period of the epidemic,the intensity of plague epidemics in Yunnan's border areas was high,showing a trend of devel-opment from west to south and east.Our findings indicated a risk of cross-border transmission of plague between Yunnan and neighboring countries;therefore,the surveillance,pre-vention,and control of plague in border areas should be strengthened.

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