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* ; Quality Control ; Particle Size

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.

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.

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.

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.

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.

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.

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.

The growth of three plague phages from Qinghai Plateau in two Yersinia pestis strains(plague vaccine strains EV76 and 614F)and four non-Yersinia pestis strains(Yersinia pseudotuberculosis PTB3,PTB5,Escherichia coli V517,and Yersinia enterocolitica 52302-2)were detected through a micromethod based on the OmniLogTM microbial identification system and by the drop method,to provide a scientific basis for future ecological studies and classification based on the host range.For plague vaccine strains EV76 and 614F,successful phage infection and subsequent phage growth were observed in the host bacte-rium.Diminished bacterial growth and respiration and a concomitant decrease in color were observed with the OmniLogTM mi-crobial identification system at 33 ℃ for 48 h.Yersinia pseudotuberculosis PTB5 was sensitive to Yersinia pestis phage 476,but Yersinia pseudotuberculosis PST5 was insensitive to phage 087 and 072204.Three strains of non-Yersinia pestis(Yersinia pseudotuberculosis PTB3,Escherichia coli V517,and Yersinia enterocolitica 52302-2)were insensitive to Yersinia pestis pha-ges 087,072204,and 476 showed similar growth curves.The growth of phages 476 and 087,as determined with the drop method,in two Yersinia pestis strains(plague vaccine strains EV76 and 614F)and four non-Yersinia pestis strains(Yersinia pseudotuberculosis PTB3,Escherichia coli V517,and Yersin-ia enterocolitica 52302-2)showed the same results at 37 ℃,on the basis of comparisons with the OmniLogTM microbial i-dentification system;in contrast,phages 072204 did not show plaques on solid medium at 37 ℃ with plague vaccine strains EV76 and 614F.Determination based on the OmniLogTM detection system can be used as an alternative to the traditional determination of the host range,thus providing favorable application val-ue for determining the interaction between the phage and host bacteria.

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.