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

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.

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.

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.

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 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.

OBJECTIVE: To retrospectively analyze the clinical efficacy of anterior cruciate ligament (ACL) reconstruction combined with anterolateral complex repair and ACL reconstruction combined with ALL reconstruction in the treatment of anterior cruciate ligament injuries with high-grade pivot shift. METHODS: From January 2018 to June 2022, 49 patients combined ACL and ALL injuries with high-grade pivot shift were retrospectively studied from three hospitals, 29 of them underwent ACL reconstruction with anterolateral complex repair (repair group), including 23 males and 6 females with an average age of (27.5±4.8) years old, ranged from 20 to 37 years old;the injured sides were 13 on the left and 16 on the right, and 11 patients were suffered with meniscus injury. The other 20 patients underwent ACL and ALL reconstruction (reconstruction group) including 17 males and 3 females with the mean age of (27.1±4.5) years old, ranged from 20 to 38 years old;the injured sides were 8 on the left and 12 on the right, and 6 patients were suffered with meniscus injury. Knee stability (pivot shift test, KT-2000), range of motion, knee function (Lysholm scoring scale, Cincinnati sports activity scale (CSAS) scoring scale, and Tegner activity level score between two groups were compared. RESULTS: A total of 49 patients were followed up, the repair group receiving 13 to 20(15.3±1.8) months and the reconstruction group receiving 12 to 21(16.0±2.2) months. There was no statistically significant difference in the preoperative pivot shift test grading distribution between two groups (P>0.05). At the last postoperative follow-up, there were 24 patients with grade 0 and 5 patients with grade 1 in the repair group, and there were 18 patients with grade 0 and 2 patients with grade 1 in the reconstruction group, there is no significant difference in the distribution of axial shift test grading between two groups(P>0.05). The preoperative KT-2000 tibial displacement of two groups were (9.39±0.77) mm (repair group) and (9.14±0.78) mm (reconstruction group) respectively, with no statistically significant difference (P>0.05). At the final postoperative follow-up, there were 24 patients with KT-2000 tibial displacement <3 mm and 5 patients with 3 to 5 mm in the repair group, while 18 patients with <3 mm and 2 patients with 3 to 5 mm in the reconstruction group, KT-2000 tibial displacement distribution of two groups was no significant difference (P>0.05), but the KT-2000 tibial displacement in the reconstruction group (1.30±0.86) mm was significantly smaller than that in the repair group (1.99±1.11) mm (P<0.05). The final postoperative follow-up range of motion of the contralateral side knee between two groups was no significant difference (P>0.05). The range of motion of the suffering knee in the repair group was less than that in the reconstruction group (P<0.05). There was no significant difference in preoperative Lysholm and CSAS scores between two groups (P>0.05). At the final postoperative follow-up, both groups showed significant improvement in Lysholm and CSAS scores, while the Lysholm and CSAS scores of the reconstruction group were better than those of the repair group, and the difference was statistically significant (P<0.05). Significant differences was found in Tegner scores between two groups, which 16 patients in the repair group returned to their pre-injury activity level, and 17 patients in the reconstruction group returned to their pre-injury level (P<0.05). CONCLUSION Compared to anterolateral complex repair, combined ACL and ALL reconstruction in the treatment of ACL injuries with high-grade pivot shift results in better knee joint function and stability. This is advantageous in reducing the risk of ACL reconstruction failure.
Humans ; Male ; Female ; Adult ; Anterior Cruciate Ligament Reconstruction/methods* ; Anterior Cruciate Ligament Injuries/surgery* ; Young Adult ; Retrospective Studies ; Anterior Cruciate Ligament/surgery* ; Range of Motion, Articular

OBJECTIVE: To explore characteristics, management strategies and preventive measures of fusion device displacement after oblique lateral interbody fusion (OLIF) in treating lumbar lesions. METHODS: The clinical data of 12 patients with fusion device displacement after OLIF for lumbar lesions in 4 medical centers from October 2014 to December 2018 were retrospectively analyzed, including 4 males and 8 females, aged from 53 to 81 years old;2 patients with lumbar disc degeneration, 4 patients with lumbar spinal stenosis, 3 patients with lumbar degenerative spondylolisthesis and 3 patients with lumbar degenerative kyphosis;preoperative dual-energy X-ray bone mineral density (BMD) was detected in 1 patient with T-value > -1 SD, 5 patients with T-value >-1~-2.5 SD, and 6 patients with T-value <-2.5 SD;9 patients with single-segment fusion, 1 patient with 2-segment fusion, and 2 patients with 3-segment fusion;standalone OLIF was performed in 9 patients and OLIF combined with posterior pedicle screws in 3 patients. Visual analogue scale (VAS) and Oswestry disability index (ODI) were used to evaluate low back pain and lumbar function recovery at the time of fusion graft displacement and at the latest follow-up, respectively. In addition, according to imaging results during follow-up, the fusion device subsidence or redisplacement, loosening or fracture of internal fixation, and interbody fusion were observed, and the changes in the height of interbody space on the segment with fusion device displacement were measured and compared. RESULTS: There were no necrosis or infection in skin incision of 10 patients after reoperation, and 12 patients were followed up for 12 to 48 months. VAS for low back pain decreased from 3 to 8 points at the time of fusion device displacement to 0 to 2 points at the latest follow-up. ODI recovered from 31% to 51% at the time of fusion transfer to 5% to 13% at the latest follow-up. There was no loosening or fracture of the pedicle screw system during follow-up. All 11 patients with bone grafting with fusion apparatus had fusion apparatus subsidence and no further displacement of fusion apparatus. The vertebral space height recovered from 9.0 to 12.7 mm at the time of fusion graft displacement to 8.0 to 11.8 mm at the latest follow-up. Interbody fusion was obtained in all patients except 1 with no imaging results at the latest follow-up. CONCLUSION OLIF could be used for fusion of lumbar lesions, and there is a risk of fusion organ displacement after operation, especially in cases of bone loss or osteoporosis before surgery, end-plate injury during surgery, and Stand-alone mode, and most of them occur within 3 months after operation. Surgery is required for the transposition of the fusion apparatus in the Stand-alone OLIF mode during the primary operation. Although good clinical results could be obtained by timely detection and accurate treatment, it is still necessary to emphasize the precise selection of cases before operation, the appropriate application of OLIF, and precise operation during operation to prevent displacement of fusion device.
Humans ; Spinal Fusion/instrumentation* ; Female ; Male ; Middle Aged ; Aged ; Aged, 80 and over ; Lumbar Vertebrae/surgery* ; Retrospective Studies ; Pedicle Screws