1.Identification of impurities in nafamostat mesylate using HPLC-IT-TOF/MS: A series of double-charged ions
Yuxin ZHANG ; Lufan AN ; Lin ZHANG ; Rulin WANG ; Yuan TIAN ; Zunjian ZHANG
Journal of Pharmaceutical Analysis 2020;10(4):346-350
Nafamostat mesylate is a serine protease inhibitor used in the treatment of acute pancreatitis. The im-purities in nafamostat mesylate, the active pharmaceutical ingredient (API), were profiled via high performance liquid chromatography tandem ion trap coupled with time-of-flight mass spectrometer (HPLC-IT-TOF/MS). The chromatography was performed on an ACE-3 C18 column (200 mm × 4.6 mm, 3μm) using methanol and 0.1% formic acid in purified water as mobile phase at a flow rate of 1.0 mL/min. The ions were detected by IT-TOF/MS with a full-scan mass analysis from m/z 100 to 800. In total, eleven impurities were detected in nafamostat mesylate API. The impurity profile was estimated based on the HPLC-IT-TOF/MS data, including accurate masses, MSn fingerprints of fragmentation pathways and a series of double-charged ions. Finally, seven impurities were identified and reported for the first time. The results will provide technical support for the quality control and clinical safety of nafamostat mesylate.
2.Construction and validation of risk prediction model for constipation in patients with cerebral hemorrhage
Huijie ZHANG ; Li LIU ; Shasha MA ; Liyun LIU ; Minmin SUN ; Lufan WANG ; Haili DONG
Chinese Journal of Practical Nursing 2023;39(29):2285-2291
Objective:To investigate the influencing factors of constipation in patients with cerebral hemorrhage, construct a risk prediction model, and verify the predictive effect of the model to scientifically guide subsequent treatment and nursing.Methods:A total of 254 patients with cerebral hemorrhage hospitalized in Affiliated Hospital of Binzhou Medical Collegefrom May 2022 to November 2022 were selected in a prospective cohort study, and they were divided into constipation group ( n = 150) and non-constipation group ( n = 104) according to whether constipation occurred. Univariate analysis and logistic regression were used to analyze the influencing factors of constipation in patients with cerebral hemorrhage, and a risk prediction model was established and a nomogram was drawn. A total of 110 patients with cerebral hemorrhage hospitalized in the same hospital from December 2022 to March 2023 were selected as the validation group, and the Hosmer-Lemeshow test and ROC curve were used to verify the model. Results:In this study, four risk factors of hospital stay, Koubmwater swallowing test score, nutrition and diuretics were finally included to construct a risk prediction model, and the area under the ROC curve of the modeling group was 0.918, the 95% CI was 0.848 to 0.963, the optimal cut-off value was 0.7225, the sensitivity was 0.885, and the specificity was 0.837. External verification results showed a sensitivity of 0.926 and specificity of 0.611. Conclusions:The risk prediction model constructed in this study has good effect and can provide reference for clinical assessment of whether patients with cerebral hemorrhage have the risk of constipation.
3.Comparison of screw placement guided by O-arm navigation and ultrasound volume navigation in minimally invasive transforaminal lumbar interbody fusion.
Xuxin LIN ; Qing CHANG ; Lijie SHANG ; Suhong SHEN ; Zhuo FU ; Yifan WANG ; Lufan ZHOU ; Hao FU ; Gang ZHAO
Chinese Journal of Reparative and Reconstructive Surgery 2023;37(11):1403-1409
OBJECTIVE:
To compare the effectiveness of O-arm navigation and ultrasound volume navigation (UVN) in guiding screw placement during minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) surgery.
METHODS:
Sixty patients who underwent MIS-TLIF surgery for lumbar disc herniation between June 2022 and June 2023 and met the selection criteria were included in the study. They were randomly assigned to group A (screw placement guided by UVN during MIS-TLIF) or group B (screw placement guided by O-arm navigation during MIS-TLIF), with 30 cases in each group. There was no significant difference in baseline data, including gender, age, body mass index, and surgical segment, between the two groups ( P>0.05). Intraoperative data, including average single screw placement time, total radiation dose, and average single screw effective radiation dose, were recorded and calculated. Postoperatively, X-ray film and CT scans were performed at 10 days to evaluate screw placement accuracy and assess facet joint violation. Pearson correlation and Spearman correlation analyses were used to observe the relationship between the studied parameters (average single screw placement time and screw placement accuracy grading) and BMI.
RESULTS:
The average single screw placement time in group B was significantly shorter than that in group A, and the total radiation dose of single segment and multi-segment and the average single screw effective radiation dose in group B were significantly higher than those in group A ( P<0.05). There was no significant difference in the total radiation dose between single segment and multiple segments in group B ( P>0.05), while the total radiation dose of multiple segments was significantly higher than that of single segment in group A ( P<0.05). No significant difference was found in the accuracy of screw implantation between the two groups ( P>0.05). In both groups, the grade 1 and grade 2 screws broke through the outer wall of the pedicle, and no screw broke through the inner wall of the pedicle. There was no significant difference in the rate of facet joint violation between the two groups ( P>0.05). In group A, both the average single screw placement time and screw placement accuracy grading were positively correlated with BMI ( r=0.677, P<0.001; r=0.222, P=0.012), while in group B, neither of them was correlated with BMI ( r=0.224, P=0.233; r=0.034, P=0.697).
CONCLUSION
UVN-guided screw placement in MIS-TLIF surgery demonstrates comparable efficiency, visualization, and accuracy to O-arm navigation, while significantly reducing radiation exposure. However, it may be influenced by factors such as obesity, which poses certain limitations.
Humans
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Imaging, Three-Dimensional
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Lumbar Vertebrae/surgery*
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Minimally Invasive Surgical Procedures
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Pedicle Screws
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Retrospective Studies
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Spinal Fusion
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Surgery, Computer-Assisted
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Tomography, X-Ray Computed
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Treatment Outcome