1.Nebulization Characteristics Study of Human Interferon α1b for Injection Based on ELISA
Miao LI ; Jinqiu HUANG ; Peng SHEN ; Zhenyu ZHONG ; Xiaogang JIANG ; Jialu HOU ; Ning HE ; Guang FENG ; Jiangtao BAI
Herald of Medicine 2025;44(11):1821-1829
Objective To investigate the nebulization characteristics of human interferon α1b for injection.To characterize and compare the delivery rate,total drug substance and the aerodynamic characteristics between the two types of nebulizer.Methods Connect two types of nebulizers with a breathing simulator,respectively,and simulate the breathing patterns of an infant and child.Measure the delivery rate,total delivered dose,and delivery uniformity.The aerodynamic properties of human interferon α1b for injection were evaluated by the next generation impactor(NGI).The content of human interferon α1b was quantified by double antibody sandwich ELISA.Results In the three batches of samples in infant mode,the delivery rate and total delivered dose determind by A nebulizer were 0.45,0.49,0.44 μg·min-1,3.06,3.21,3.81 μg,respectcively;and 0.12,0.14,0.16 μg·min-1,0.73,0.73,0.75 μg,respectcively by B nebulizer.In child mode,the delivery rate and total delivered doses determined by A nebulizer were 1.36,1.49,1.20 μg·min-1,7.44,7.17,and 6.54 μg,respectcively;and 0.37,0.36,0.43 μg·min-1,1.66,1.59,and 1.41 μg,respectcively by B nebulizer.In child and infant mode,the ten results of the total drug substance delivered determined by nebulizer A were both between 65%to 135%of the average.The FPD,FPF,MMAD,and GSD determined by A neublizer of three batch samples were 2.48,2.92,2.35 μg,59.0%,57.4%,59.1%,4.18,4.34,4.15 μm,1.94,1.98,2.01,respectively.The FPD,FPF,MMAD and GSD determined by B neublizer of three batches samples were 2.70,3.38,3.06 μg,67.6%,66.4%,66.3%,3.55,3.65,3.68 μm,2.03,2.04,2.06,respectively.Conclusions The data obtained in this research characterized the in vitro nebulization characteristics of human interferon α1b for injection and provided a theoretical basis and reference for in vitro study and clinical practice.The influence of different types of nebulizers on nebulization characteristics was evaluated as well.It is suggested that the quality standard of nebulizers be strictly formulated and the use of nebulizers be standardized.
2.Nebulization Characteristics Study of Human Interferon α1b for Injection Based on ELISA
Miao LI ; Jinqiu HUANG ; Peng SHEN ; Zhenyu ZHONG ; Xiaogang JIANG ; Jialu HOU ; Ning HE ; Guang FENG ; Jiangtao BAI
Herald of Medicine 2025;44(11):1821-1829
Objective To investigate the nebulization characteristics of human interferon α1b for injection.To characterize and compare the delivery rate,total drug substance and the aerodynamic characteristics between the two types of nebulizer.Methods Connect two types of nebulizers with a breathing simulator,respectively,and simulate the breathing patterns of an infant and child.Measure the delivery rate,total delivered dose,and delivery uniformity.The aerodynamic properties of human interferon α1b for injection were evaluated by the next generation impactor(NGI).The content of human interferon α1b was quantified by double antibody sandwich ELISA.Results In the three batches of samples in infant mode,the delivery rate and total delivered dose determind by A nebulizer were 0.45,0.49,0.44 μg·min-1,3.06,3.21,3.81 μg,respectcively;and 0.12,0.14,0.16 μg·min-1,0.73,0.73,0.75 μg,respectcively by B nebulizer.In child mode,the delivery rate and total delivered doses determined by A nebulizer were 1.36,1.49,1.20 μg·min-1,7.44,7.17,and 6.54 μg,respectcively;and 0.37,0.36,0.43 μg·min-1,1.66,1.59,and 1.41 μg,respectcively by B nebulizer.In child and infant mode,the ten results of the total drug substance delivered determined by nebulizer A were both between 65%to 135%of the average.The FPD,FPF,MMAD,and GSD determined by A neublizer of three batch samples were 2.48,2.92,2.35 μg,59.0%,57.4%,59.1%,4.18,4.34,4.15 μm,1.94,1.98,2.01,respectively.The FPD,FPF,MMAD and GSD determined by B neublizer of three batches samples were 2.70,3.38,3.06 μg,67.6%,66.4%,66.3%,3.55,3.65,3.68 μm,2.03,2.04,2.06,respectively.Conclusions The data obtained in this research characterized the in vitro nebulization characteristics of human interferon α1b for injection and provided a theoretical basis and reference for in vitro study and clinical practice.The influence of different types of nebulizers on nebulization characteristics was evaluated as well.It is suggested that the quality standard of nebulizers be strictly formulated and the use of nebulizers be standardized.
3.Expert consensus on evaluation index system construction for new traditional Chinese medicine(TCM) from TCM clinical practice in medical institutions.
Li LIU ; Lei ZHANG ; Wei-An YUAN ; Zhong-Qi YANG ; Jun-Hua ZHANG ; Bao-He WANG ; Si-Yuan HU ; Zu-Guang YE ; Ling HAN ; Yue-Hua ZHOU ; Zi-Feng YANG ; Rui GAO ; Ming YANG ; Ting WANG ; Jie-Lai XIA ; Shi-Shan YU ; Xiao-Hui FAN ; Hua HUA ; Jia HE ; Yin LU ; Zhong WANG ; Jin-Hui DOU ; Geng LI ; Yu DONG ; Hao YU ; Li-Ping QU ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2025;50(12):3474-3482
Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards*
;
Humans
;
Consensus
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Drugs, Chinese Herbal/therapeutic use*
;
Surveys and Questionnaires
4.Predictive value of serum TRIB3 and STOX1 levels for prognosis in patients with coronary heart disease after PCI
Lin ZHANG ; Qing-song CHEN ; Guang-hong FENG ; Zhong-hua ZHU ; Mao-hai ZHANG
Chinese Journal of cardiovascular Rehabilitation Medicine 2024;33(6):683-687
Objective:To investigate the predictive value of serum levels of tribbles pseudokinase 3(TRIB3)and storkhead box 1(STOX1)for prognosis in patients with coronary heart disease(CHD)after percutaneous coronary intervention(PCI).Methods:A total of 116 CHD patients undergoing PCI in Daye People's Hospital between May 2019 and August 2022 were enrolled as CHD group,another 95 healthy volunteers undergoing physical examination in our hospital simultaneously were selected as control group.According to presence of major adverse cardiovascular events(MACE)within 3 months after PCI,CHD group was divided into MACE group(n=21)and no MACE group(n=95).Enzyme-linked immunosorbent assay(ELISA)was used to measure serum TRIB3 and STOX1 levels;multivariate Logistic regression was used to analyze influencing factors of poor prognosis in CHD patients after PCI;receiver operating characteristic(ROC)curve was used to analyze predictive value of serum TRIB3 and STOX1 for poor prognosis in CHD patients after PCI.Results:Compared with participants in control group,those in CHD group had significant higher serum TRIB3 and STOX1 levels(P<0.001 all).Compared with participants in no MACE group,those in MACE group had significant higher serum levels of TRIB3[(9.65±1.27)ng/ml vs.(12.04±1.64)ng/ml]and STOX1[(16.06±1.54)ng/ml vs.(18.21±1.78)ng/ml](P<0.001 all).Multivariate Lo-gistic regression showed that serum TRIB3 and STOX1 levels were independent risk factors for MACE in CHD pa-tients after PCI(OR=3.859,2.159,P<0.001 both).ROC analysis indicated that combined detection of serum TRIB3 and STOX1(area under the curve(AUC)=0.916)had higher predictive value for poor prognosis in CHD patients after PCI compared to those of single detection(AUC=0.837,0.776).Conclusion:Serum levels of TRIB3 and STOX1 significantly increase in CHD patients after PCI suffering from MACE,and the combination of both can better predict the prognosis of these patients.
5.Predictive value of serum TRIB3 and STOX1 levels for prognosis in patients with coronary heart disease after PCI
Lin ZHANG ; Qing-song CHEN ; Guang-hong FENG ; Zhong-hua ZHU ; Mao-hai ZHANG
Chinese Journal of cardiovascular Rehabilitation Medicine 2024;33(6):683-687
Objective:To investigate the predictive value of serum levels of tribbles pseudokinase 3(TRIB3)and storkhead box 1(STOX1)for prognosis in patients with coronary heart disease(CHD)after percutaneous coronary intervention(PCI).Methods:A total of 116 CHD patients undergoing PCI in Daye People's Hospital between May 2019 and August 2022 were enrolled as CHD group,another 95 healthy volunteers undergoing physical examination in our hospital simultaneously were selected as control group.According to presence of major adverse cardiovascular events(MACE)within 3 months after PCI,CHD group was divided into MACE group(n=21)and no MACE group(n=95).Enzyme-linked immunosorbent assay(ELISA)was used to measure serum TRIB3 and STOX1 levels;multivariate Logistic regression was used to analyze influencing factors of poor prognosis in CHD patients after PCI;receiver operating characteristic(ROC)curve was used to analyze predictive value of serum TRIB3 and STOX1 for poor prognosis in CHD patients after PCI.Results:Compared with participants in control group,those in CHD group had significant higher serum TRIB3 and STOX1 levels(P<0.001 all).Compared with participants in no MACE group,those in MACE group had significant higher serum levels of TRIB3[(9.65±1.27)ng/ml vs.(12.04±1.64)ng/ml]and STOX1[(16.06±1.54)ng/ml vs.(18.21±1.78)ng/ml](P<0.001 all).Multivariate Lo-gistic regression showed that serum TRIB3 and STOX1 levels were independent risk factors for MACE in CHD pa-tients after PCI(OR=3.859,2.159,P<0.001 both).ROC analysis indicated that combined detection of serum TRIB3 and STOX1(area under the curve(AUC)=0.916)had higher predictive value for poor prognosis in CHD patients after PCI compared to those of single detection(AUC=0.837,0.776).Conclusion:Serum levels of TRIB3 and STOX1 significantly increase in CHD patients after PCI suffering from MACE,and the combination of both can better predict the prognosis of these patients.
6.3D-printed vertebral body in anterior spinal reconstruction after total spondylectomy for patients with cervical chordoma.
Hua ZHOU ; Ren Ji WANG ; Zhong Jun LIU ; Xiao Guang LIU ; Feng Liang WU ; Lei DANG ; Feng WEI
Journal of Peking University(Health Sciences) 2023;55(1):144-148
OBJECTIVE:
To investigate whether 3D-printed artificial vertebral body can reduce prosthesis subsidence rate for patients with cervical chordomas, through comparing the rates of prosthesis subsidence between 3D printing artificial vertebral body and titanium mesh for anterior spinal reconstruction after total spondylectomy.
METHODS:
This was a retrospective analysis of patients who underwent surgical treatment for cervical chordoma at our hospital from March 2005 to September 2019. There were nine patients in the group of 3D artificial vertebral body (3D group), and 15 patients in the group of titanium mesh cage (Mesh group). The patients' characteristics and treatment data were extracted from the medical records, including age, gender, CT hounsfield unit of cervical vertebra and surgical information, such as the surgical segments, time and blood loss of surgery, frequency and degree of prosthesis subsidence after surgery. Radiographic observations of prosthesis subsidence during the follow-up, including X-rays, CT, and magnetic resonance imaging were also collected. SPSS 22.0 was used to analysis the data.
RESULTS:
There was no significant difference between the two groups in gender, age, CT hounsfield unit, surgical segments, time of surgery, blood loss of posterior surgery and total blood loss. Blood loss of anterior surgery was 700 (300, 825) mL in 3D group and 1 500 (750, 2 800) mL in Mesh group (P < 0.05). The prosthesis subsidence during the follow-up, 3 months after surgery, there was significant difference between the two groups in mild prosthesis subsidence (P < 0.05). The vertebral height of the 3D group decreased less than 1 mm in eight cases (no prosthesis subsidence) and more than 1 mm in one case (mild prosthesis subsidence). The vertebral height of the Mesh group decreased less than 1 mm in five cases (no prosthesis subsidence), and more than 1 mm in eight cases (mild prosthesis subsidence). Two patients did not have X-rays in 3 months after surgery. There was a statistically significant difference between the two groups in the prosthesis subsidence rate at the end of 12 months (P < 0.01). The vertebral height of eight cases in the 3D group decreased less than 1 mm (no prosthesis subsidence) and one case more than 3 mm (severe prosthesis subsidence). Four of the 15 cases in the Mesh group decreased less than 1 mm (no prosthesis subsidence), two cases more than 1 mm (mild prosthesis subsidence), and nine cases more than 3 mm (severe prosthesis subsidence). There was a statistically significant difference between the two groups in the prosthesis subsidence rate at the end of 24 months (P < 0.01). The vertebral height of seven cases in the 3D group decreased less than 1 mm (no prosthesis subsidence), one case more than 3 mm (severe prosthesis subsidence), and one case died with tumor. One case in the Mesh group decreased less than 1 mm (no prosthesis subsidence), one case more than 1 mm (mild prosthesis subsidence), 11 case more than 3 mm (severe prosthesis subsidence), one case died with tumor and one lost the follow-up. Moreover, at the end of 12 months and 24 months, there was significant difference between the two groups in severe prosthesis subsidence rate (P < 0.01).
CONCLUSION
3D-printed artificial vertebral body for anterior spinal reconstruction after total spondylectomy for patients with cervical chordoma can provide reliable spinal stability, and reduce the incidence of prosthesis subsidence after 2-year follow-up.
Humans
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Chordoma/surgery*
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Retrospective Studies
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Vertebral Body
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Titanium
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Cervical Vertebrae/surgery*
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Printing, Three-Dimensional
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Spinal Fusion/methods*
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Treatment Outcome
7.The risk surveillance of schistosomiasis in Yunnan, 2021
SHEN Mei-fen ; DU Chun-hong ; SONG Jing ; WANG Li-fang ; SUN Jia-yu ; CHEN Chun-qiong ; FENG Xi-guang ; ZHANG Zhong-ya ; JIANG Hua ; ZHOU Ji-hua ; DONG Yi
China Tropical Medicine 2023;23(2):157-
Abstract: Objective To evaluate the potential transmission risk of schistosomiasis in Yunnan Province, and to provide strategic basis for the prevention and control. Methods Based on the prevalence of schistosomiasis, the social and environmental factors that may lead to the epidemic, 1-3 villages from 3 provincial-level and 15 county-level counties (cities and districts) were selected as the evaluated villages in 2021. The risk of schistosomiasis spread was analyzed comprehensively by consulting, reviewing and collecting routine surveillance data of schistosomiasis in the villages, combined with snail and wild feces survey. The risk level was evaluated for the positive snails, positive wild feces, resident infection, average density of live snails and snail frame occurrence rate. Results Totally 7 snail counties schistosomiasis transmission was blocked of 18 epidemic counties and the rest were eliminated counties. A total of 152 447 snail frames were investigated and 3 043 frames with snails, 15 895 snails were captured and included 15 727 live snails in the 32 evaluated villages. The total area of snail was 58.87 hm2 and the area of reoccurrence was 34.19 hm2 with snail frame occurrence rate of 2.00% and average density of live snails 0.103 2/0.11 m2, and no positive snails were found by loop-mediated isothermal amplification (LAMP) assay. A total of 1 374 wild feces were collected in 27 evaluated villages of 14 epidemic counties, mainly from cattle, dogs, sheep, equine animals, pigs and so on, all of which were negative. According to the risk assessment of epidemic spread, Yongle Village and Yongsheng Village in Eryuan County, Zhiming Village in Chuxiong City were Ⅱ risk, and the rest were Ⅲ risk. Conclusions Although the risk of transmission is low in Yunnan Province, the risk of transmission and spread still exists. It is necessary to strengthen the risk monitoring, control of snail and effective management of livestock to prevent the rebound of the epidemic.
8.Development and global validation of a 1-week-old piglet head finite element model for impact simulations.
Zhong-Qing SU ; Da-Peng LI ; Rui LI ; Guang-Liang WANG ; Lang LIU ; Ya-Feng WANG ; Ya-Zhou GUO ; Zhi-Gang LI
Chinese Journal of Traumatology 2023;26(3):147-154
PURPOSE:
Child head injury under impact scenarios (e.g. falls, vehicle crashes, etc.) is an important topic in the field of injury biomechanics. The head of piglet was commonly used as the surrogate to investigate the biomechanical response and mechanisms of pediatric head injuries because of the similar cellular structures and material properties. However, up to date, piglet head models with accurate geometry and material properties, which have been validated by impact experiments, are seldom. We aim to develop such a model for future research.
METHODS:
In this study, first, the detailed anatomical structures of the piglet head, including the skull, suture, brain, pia mater, dura mater, cerebrospinal fluid, scalp and soft tissue, were constructed based on CT scans. Then, a structured butterfly method was adopted to mesh the complex geometries of the piglet head to generate high-quality elements and each component was assigned corresponding constitutive material models. Finally, the guided drop tower tests were conducted and the force-time histories were ectracted to validate the piglet head finite element model.
RESULTS:
Simulations were conducted on the developed finite element model under impact conditions and the simulation results were compared with the experimental data from the guided drop tower tests and the published literature. The average peak force and duration of the guide drop tower test were similar to that of the simulation, with an error below 10%. The inaccuracy was below 20%. The average peak force and duration reported in the literature were comparable to those of the simulation, with the exception of the duration for an impact energy of 11 J. The results showed that the model was capable to capture the response of the pig head.
CONCLUSION
This study can provide an effective tool for investigating child head injury mechanisms and protection strategies under impact loading conditions.
Animals
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Swine
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Finite Element Analysis
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Skull/injuries*
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Craniocerebral Trauma/diagnostic imaging*
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Brain
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Biomechanical Phenomena
;
Scalp
9.Chinese expert consensus on the diagnosis and treatment of traumatic cerebrospinal fluid leakage in adults (version 2023)
Fan FAN ; Junfeng FENG ; Xin CHEN ; Kaiwei HAN ; Xianjian HUANG ; Chuntao LI ; Ziyuan LIU ; Chunlong ZHONG ; Ligang CHEN ; Wenjin CHEN ; Bin DONG ; Jixin DUAN ; Wenhua FANG ; Guang FENG ; Guoyi GAO ; Liang GAO ; Chunhua HANG ; Lijin HE ; Lijun HOU ; Qibing HUANG ; Jiyao JIANG ; Rongcai JIANG ; Shengyong LAN ; Lihong LI ; Jinfang LIU ; Zhixiong LIU ; Zhengxiang LUO ; Rongjun QIAN ; Binghui QIU ; Hongtao QU ; Guangzhi SHI ; Kai SHU ; Haiying SUN ; Xiaoou SUN ; Ning WANG ; Qinghua WANG ; Yuhai WANG ; Junji WEI ; Xiangpin WEI ; Lixin XU ; Chaohua YANG ; Hua YANG ; Likun YANG ; Xiaofeng YANG ; Renhe YU ; Yongming ZHANG ; Weiping ZHAO
Chinese Journal of Trauma 2023;39(9):769-779
Traumatic cerebrospinal fluid leakage commonly presents in traumatic brain injury patients, and it may lead to complications such as meningitis, ventriculitis, brain abscess, subdural hematoma or tension pneumocephalus. When misdiagnosed or inappropriately treated, traumatic cerebrospinal fluid leakage may result in severe complications and may be life-threatening. Some traumatic cerebrospinal fluid leakage has concealed manifestations and is prone to misdiagnosis. Due to different sites and mechanisms of trauma and degree of cerebrospinal fluid leak, treatments for traumatic cerebrospinal fluid leakage varies greatly. Hence, the Craniocerebral Trauma Professional Group of Neurosurgery Branch of Chinese Medical Association and the Neurological Injury Professional Group of Trauma Branch of Chinese Medical Association organized relevant experts to formulate the " Chinese expert consensus on the diagnosis and treatment of traumatic cerebrospinal fluid leakage in adults ( version 2023)" based on existing clinical evidence and experience. The consensus consisted of 16 recommendations, covering the leakage diagnosis, localization, treatments, and intracranial infection prevention, so as to standardize the diagnosis and treatment of traumatic cerebrospinal fluid leakage and improve the overall prognosis of the patients.

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