1.Analysis of Impurities in Peptide Drug Bivalirudin Based on Three Kinds of Separation Principle Technology
Jing YIN ; Wanting WANG ; Yihong LU ; Shuqiang ZHAO ; Haiwei SHI ; Bin DI ; Minhua XUE ; Ling CAO
Chinese Journal of Modern Applied Pharmacy 2024;41(5):626-635
OBJECTIVE
To establish HPLC methods with different separation principles to analyze the relevant impurities in the APIs of bivalirudin from seven enterprises, to provide a basis for the comprehensive control of related substances of bivalirudin.
METHODS
Reversed-phase high performance liquid chromatography(RP-HPLC) was used to separate and analyze 11 kinds of impurities. Hydrophilic chromatography(HILIC)-HPLC was used to control four process impurities. Polymers were determined by size exclusion chromatography(SEC)-HPLC.
RESULTS
The established RP-HPLC could effectively separate the principal component and 11 impurities, the correction factors of 11 impurities were between 0.8−1.2, the detection concentration of bivalirudin was 0.1 μg·mL−1, and the detection limit was 0.004%. The established HILIC-HPLC could effectively separate the principal components and four process impurities, and the detection concentration of bivalirudin was 0.3 μg·mL−1, and the detection limit was 0.01%. Under SEC-HPLC conditions, the polymer and bivalirudin peaked sequentially, the resolution of the two was 2.9, the detection concentration of bivalirudin was 6 ng·mL−1, and the detection limit was 0.000 6%. Fifteen kinds of known impurities and polymers in 15 batches of samples from 7 enterprises were calculated by the self-control method of principal components, and the impurity contents from different enterprises had a certain correlation with their production processes.
CONCLUSION
The three different principles of the method have good specificity, high sensitivity, good durability, and reliable results, and can be used for quality control of substances related to bivalirudin.
2.Preliminary experience of endoscopic bilateral thyroid surgery through gasless axillary approach
Dongning LU ; Jiajie XU ; Haiwei GUO ; Chuanming ZHENG ; Minghua GE
Chinese Journal of Endocrine Surgery 2022;16(4):401-405
Objective:To investigate the feasibility and safety of endoscopic thyroidectomy by gasless unilateral axillary approach.Methods:A matching study was conducted to analyze 21 patients with etgua of Zhejiang Provincial People’s Hospital from Mar. 2019 to Sep. 2021, including 8 cases of bilateral radical thyroidectomy and 13 cases of unilateral radical thyroidectomy + contralateral lobectomy (benign) . At the same time, 23 patients who underwent conventional thyroidectomy were matched as controls, including 8 cases of bilateral radical thyroidectomy and 15 cases of unilateral radical thyroidectomy + contralateral lobectomy (benign) . The operation process was recorded, and the differences in operation safety, postoperative recovery and incision satisfaction between endoscopic group and open group were compared.Results:The operation time in the endoscopy group was longer than that in the open group. The postoperative drainage volume in the endoscopy group was larger than that in the open group. There was no significant difference in the amount of intraoperative bleeding, postoperative stay in hospital or the incidence of complications. The neck pain scores in the endoscopic group were lowter than those in the open group. In terms of postoperative cosmetic satisfaction, the endoscopic group was higher than the open group.Conclusion:Endoscopic bilateral thyroidectomy by gasless unilateral axillary approach is a safe and effective surgical method, and has high cosmetic satisfaction.
3.Changes of regional saturation of cerebral oxygenation and neuron specific enolase in patients after cardiopulmonary resuscitation
Haiwei SUN ; Jianjun ZHU ; Limei MA ; Juan LU ; Lijun LIU ; Baochun ZHOU
Chinese Critical Care Medicine 2021;33(9):1094-1098
Objective:To observe the changes of regional saturation of cerebral oxygenation (rScO 2) and blood neuron specific enolase (NSE) in patients after cardiopulmonary resuscitation (CPR), and to explore its value in evaluating the prognosis of patients' neurological function. Methods:From January 2012 to December 2020, 97 patients with return of spontaneous circulation (ROSC) after cardiac arrest (CA) treated in the intensive care unit (ICU) of the Second Affiliated Hospital of Soochow University were selected. According to the prognosis, the patients were divided into two groups: good neurological function group [Glasgow-Pittsburgh Cerebral Performance Categories (CPC) 1-2, 20 cases] and neurological dysfunction group (CPC classification 3-5, 77 cases). The clinical data of gender, age, the number of patients with defibrillable rhythm, time of ROSC, the number of CA patients outside the hospital, acute physiology and chronic health evaluationⅡ(APACHEⅡ), Glasgow coma scale (GCS), global non-response scale (FOUR), body temperature, mean arterial pressure (MAP), blood lactic acid (Lac) and GCS at discharge, as well as the length of ICU stay, rScO 2 and blood NSE were collected. The differences of rScO 2 and NSE between the two groups were compared; and the receiver operator characteristic curve (ROC curve) was drawn to evaluate the value of rScO 2 and NSE alone or in combination in predicting the prognosis of patients with ROSC after CA. Results:The rScO 2 of good neurological function group was significantly higher than that of neurological dysfunction group at 1, 3, 6, 12, 24 and 48 hours (all P < 0.05). At 24 hours after admission, the rScO 2 on the left and right sides of good neurological function group was significantly higher than that in neurological dysfunction group [left: 0.65 (0.59, 0.76) vs. 0.55 (0.44, 0.67), right: 0.62 (0.61, 0.73) vs. 0.50 (0.30, 0.69), both P < 0.05], and NSE was significantly lower than that in the neurological dysfunction group [ng/L: 21.42 (15.38, 29.69) vs. 45.82 (24.05, 291.26), P < 0.05]. ROC curve analysis showed that both rScO 2 and NSE alone and combined detection had a certain value in predicting the prognosis of neurological function in patients with ROSC after CA, and the area under the ROC curve (AUC) detected by the combination was the largest, which was higher than the AUC predicted by rScO 2 or NSE (0.904 vs. 0.884, 0.792). When the cut-off value of combination was 0.83, the sensitivity and specificity were 75.7% and 100% respectively. Conclusion:Monitoring rScO 2 and NSE can predict the prognosis of neurological function after CPR, especially the combined evaluation of the two indexes, which can greatly improve the accuracy of diagnosis.
4.Clinicopathological features of diffuse leptomeningeal glioneuronal tumor
Jinhua TU ; Leiming WANG ; Li LIU ; Haiwei HAN ; Yongjuan FU ; Yueshan PIAO ; Dehong LU ; Lianghong TENG
Chinese Journal of Pathology 2021;50(8):876-881
Objective:To investigate the clinicopathological features, diagnosis and prognosis of diffuse leptomeningeal glioneuronal tumor (DLGNT).Methods:Five cases of DLGNT diagnosed from January 2016 to January 2020 were collected from Xuanwu Hospital, Capital Medical University. The clinical features, histopathologic characteristics, immunohistochemical and molecular genetic findings and prognosis were analyzed and the relevant literature was reviewed.Results:The five patients (two males and three females) were aged 2 to 52 years (median 11 years), and had history of increased intracranial pressure (headache and vomiting) or limb weakness. Three of them were younger than 16 years of age. The imaging studies showed diffuse intracranial and intraspinal nodular leptomeningeal thickening and enhancement, with or without parenchymal involvement. At times there were associated small cyst-like lesions. Imaging interpretations were inflammatory lesions in three cases and space occupying lesions in two. Microscopically, in three cases the tumors showed low to moderate cellularity, consisting of relatively monomorphous oligodendrocyte-like cells arranged in small nests or diffusely distribution. No mitosis and necrosis were observed. In two cases there were increased cellularity with a diffuse honeycomb pattern. The tumor showed mild to moderate polymorphism with hyperchromatic nuclei. Mitosis, endothelial vascular proliferation and glomeruloid vessels were seen. Necrosis was absent. The tumor cells in all five cases were positive for synaptophysin,Olig2 and negative for IDH1 and H3 K27M. GFAP was focally positive in four cases and only one case expressed NeuN partly. The Ki-67 labeling index was 1%-35%. BRAF fusion was detected in four cases. Genetic analysis showed solitary 1p deletion in two cases (2/5), while all cases were negative for 1p/19q co-deletion (0/5). The five patients were followed up for 13 to 28 months (median 15 month). One patient died after 27 months. There was no evidence of tumor progression in the remaining four patients.Conclusions:DLGNT is rare and easily confused with other central nervous system tumors and inflammatory lesions. Therefore, the diagnosis of DLGNT should be made based on comprehensive information including imaging, morphologic and corresponding immunohistochemical examinations and molecular genetics to avoid misdiagnosis and delay in management.
5. Minimal invasive subcutaneous internal fixator in treatment of anterior pelvic ring instability-analysis of effects and complications
Haiwei YAN ; Juzheng HU ; Ying YANG ; You XIE ; Zhanzhu HUANG ; Xiaosong CHENG ; Lu WEI ; Yansong FENG ; Boyu LIU ; Zhanying SHI
Chinese Journal of Orthopaedics 2019;39(13):826-832
Objective:
To investigate the incidence of complications following minimal invasive subcutaneous internal fixator (INFIX) for the treatment of anterior pelvic ring instability, and to analyze control measures.
Methods:
Data of 42 patients with anterior pelvic ring instability who were treated by anterior subcutaneous internal fixation in our hospital from January 2016 to December 2017 were retrospectively analyzed. There were 15 females and 27 males with an average age of 45.4 years (range, 18-67 years). There were 26 traffic injuries, 10 falling injuries, 3 crush injuries and 3 low energy injuries. According to Tile classification, 24 cases of B2 type, 16 cases of B3 type, 1 case of C1 type and 1 case of C2 type. According to Young-Burgess classification, there were 20 cases of LCI, 18 cases of LCII, 1 case of LCIII, 1 case of APCI, 1 case of APCII, and 1 case of VS. Fourteen cases were combined with limb fractures, and 11 cases were combined with thoracic or abdominal injuries requiring surgical treatment, while 16 cases were with brain injuries. For type APC2, LC1, and some LC2 fractures, fixation for the anterior pelvic ring is enough with INFIX technique alone. For some LC2, LC3, or VS fractures, the anterior and posterior ring were both fixed. Postoperative reduction was evaluated by Matta radiological criteria. Lateral thigh numbness and pain, quadriceps muscle power were recorded during follow-up, and clinical efficacy was evaluated by Majeed score at 6 months after operation.
Results:
All the 42 patients were followed up for 6 to 12 months, with an average of 9.3 months. Matta standard evaluation for fracture reduction showed that 28 cases were excellent, 14 cases good, and the excellent and good rate was 100%. The early complication rate (within 3 month after operation) was 23.8% (10/42) including 6 cases of lateral femoral cutaneous nerve injury and 2 cases of femoral nerve injury. The symptoms were obviously relieved after the treatment of nutrient nerve and hyperbaric oxygen; 1 case had incision infection which was healed after anti-infection therapy and internal plant removal; 1 case suffered from superior gluteal artery injury which was controlled by pressure hemostasis. Six months after surgery, no case had lost reduction. At 6 months follow-up, the Majeed score was 72-96, with an average of 84.96, of which 32 were excellent and 10 were good, thus the excellent and good rate was 100% (42/42).
Conclusion
INFIX is an effective internal fixation method for the treatment of unstable anterior pelvic ring injury. However, it has a high rate of early complications, among which nerve injury has the highest incidence.
6.Study on the Structure and Function of Repetition in Doctor-patient Outpatient Conversation Based on Corpus
Chinese Medical Ethics 2016;29(5):767-770,797
This paper explored the methods of corpus linguistics application based on the corpus of doctor-pa-tient outpatient conversation, which was built by the project team members. Under the framework of the theory of conversation analysis, it discussed the inductive characteristics of subjective and functional repetition, and com-pared the similarities and differences of the repetition strategy use between patients and doctors. This study con-cludes a new OIR mode, enriching the theory of conversation analysis. The corresponding countermeasures of the repetition strategy use that put forward in this article provided a reference to strengthen the doctor-patient commu-nication, enhance the communication effect, and establish the interacted, cooperated and equal doctor-patient re-lationship. Meanwhile, it offered a new viewpoint to the study of doctor-patient communication.
7.Case of intractable scalp pain.
Chinese Acupuncture & Moxibustion 2015;35(12):1220-1220
Acupuncture Points
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Acupuncture Therapy
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Adult
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Headache
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therapy
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Humans
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Male
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Pain, Intractable
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therapy
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Scalp
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Treatment Outcome
8.Application of virtual reality technology in oral and maxillofacial anatomy and three-dimensional digital model construction
Lu GAO ; Xiaohong ZHANG ; Haiwei JIN ; Wei CONG ; Fu WANG
Chinese Journal of Tissue Engineering Research 2015;(46):7492-7497
BACKGROUND:With the rapid development of medical technology, computer image technology and the urgent needs of computer-aided clinical teaching, the application of virtual reality technology in oral and maxilofacial anatomy has become an issue of concern. OBJECTIVE:To summarize the application of virtual reality technology in oral and maxilofacial anatomy, thereby providing the better methods for clinical and basic research of oral medicine, laying the foundation for building the digital repository, and realizing the informatization and networking construction. METHODS:A computer-based retrieval was performed by the first author in the CNKI and PubMed databases to search papers related on the virtual reality technology applied in oral and maxilofacial anatomy published between January 2004 and December 2014, using the key words of “tissue engineering, virtual reality, oral and maxilofacial anatomy, digital, 3D reconstruction, multimedia, teeth, skul” in Chinese and English, respectively. According to inclusion and exclusion criteria, 52 papers were included in the final analysis. RESULTS AND CONCLUSION:The application of virtual reality technology in oral and maxilofacial anatomy mainly includes 3D digital model and virtual digital database of human body. 3D medical reconstruction software includes 3D-Doctor and Minics that support the original data sources including continuous fault anatomical images, varieties of image data and 3D scanning data. A variety of virtual reality technologies can successfuly reproduce the tooth, dentition and oral and maxilofacial anatomy, laying the foundation for building the virtual reality platform in oral clinical application and teaching.
9.Changes in pain threshold and glial cell line-derived neurotrophic factor in rat model of trigeminal neuralgia.
Sijia QIN ; Xiaohong ZHANG ; Haiwei JIN ; Lu GAO ; Fu WANG
West China Journal of Stomatology 2015;33(1):16-20
OBJECTIVEThis research aims to study the changes in pain threshold and glial cell line-derived neurotrophic factor (GDNF) in a Sprague Dawley (SD) rat model oftrigeminal neuralgia.
METHODSA total of 36 male SD rats were randomly divided into three groups: operative, sham-operative, and control. In the operative group, a chronic constriction injury (CCI) was caused by placing loose chromic gut ligatures around the right infraorbital nerve (ION). In the sham-operative group, the right ION was subjected to the same procedure, but without ligation. In the control group, the right ION was not subjected to any treatment. The pain thresholds of the three groups were recorded at different times after the operation. The GDNF expression in each group was analyzed via immunohistochemical staining.
RESULTSAn allodynia to mechanical stimulation in the region of the ligated ION was observed starting on the 2nd week after operation. Pain thresholds started to increase gradually from the 6th week and returned to the original level at the 10th to 12th week after operation. Cells that expressed the GDNF markedly increased in number in the operative group with changes observed at different times.
CONCLUSIONWe use chronic constriction injury to the infraorbital nerve (CCI-ION) to establish a trigeminal neuralgia-like animal model in SD rats. GDNF may play a role in regulating pain by promoting the restoration and regeneration of nerve fibers.
Animals ; Constriction ; Disease Models, Animal ; Glial Cell Line-Derived Neurotrophic Factor ; Glial Cell Line-Derived Neurotrophic Factors ; Hyperalgesia ; Male ; Pain Threshold ; Rats ; Rats, Sprague-Dawley ; Trigeminal Neuralgia
10.Reconstruction and application of three-dimensional digital visual model of tooth and skull
Lu GAO ; Xiaohong ZHANG ; Haiwei JIN ; Wei CONG ; Fu WANG
Chinese Journal of Tissue Engineering Research 2015;(5):727-732
BACKGROUND:Because the content of oral and maxil ofacial anatomy is various and complex, only the traditional way of multimedia cannot display the anatomical structures from multi-angle and al-round. The development of virtual reality technology in oral and maxil ofacial anatomy of three-dimensional reconstruction research is rapid, causes the attention of many scholars, and has become a hot spot. OBJECTIVE:To develop a three-dimensional digital model of tooth, dentition and skul , and establish a multimedia database of oral and maxil ofacial anatomy to facilitate network sharing and information dissemination so as to provide new method for teaching of basic and clinical oral medicine. METHODS:Extracted teeth with intact crown and root, dentition and skul were chosen. Each specimen was taken at horizontal and vertical direction by the camera in the center of turntable. Al the images obtained were treated using Photoshop CS5 for dressing and compression. The image data were input into The VR Worx system, fol owed by parameters and hotspots setting and the compression. Final y, the three-dimensional digital models were reconstructed and output with QuickTime VR format into disk. RESULTS AND CONCLUSION:Three-dimensional digital models of tooth and skul were constructed with photography and the VR Worx 2.6 software, which could faithful y reproduce the anatomical characteristics of teeth, dentition and skul s, and facilitate researchers to rotate and scale for observation. Also, it was easy for hotspot-marking. On the platform of digital photography and The VR Worx software, it is feasible to establish the three-dimensional digital model of tooth and skul . This approach is the entity reconstruction, and the reconstructed model appears clear, vivid, and is easy to be saved and promoted.


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