1.Guideline for the workflow of clinical comprehensive evaluation of drugs
Zhengxiang LI ; Rong DUAN ; Luwen SHI ; Jinhui TIAN ; Xiaocong ZUO ; Yu ZHANG ; Lingli ZHANG ; Junhua ZHANG ; Hualin ZHENG ; Rongsheng ZHAO ; Wudong GUO ; Liyan MIAO ; Suodi ZHAI
China Pharmacy 2025;36(19):2353-2365
OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs, and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization (WHO), strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States, and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions; research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center, and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions, including topic selection, evaluation implementation, evidence evaluation, and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs, which can effectively guide the high-quality and high-efficient development of this work, enhance the standardized output and transformation application value of evaluation evidence, and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.
2.Failure analysis and structural optimization of water-based sliding bearings for aerospace applications
Chunmei WEI ; WangXi ; Yingbin LI ; Dewen YIN ; Zhenguo ZHANG ; Hualin SHI
Space Medicine & Medical Engineering 2025;36(3):246-249
The long service life and high reliability of SiC sliding bearings are crucial for the long-term normal operation of aerospace power equipment.In response to the fracture phenomenon observed in the sliding bearing assembly of a certain delivery pump during operation,this paper analyzes the issue from the perspectives of stress characteristics and thermal expansion effects,proposing a structural optimization design method based on temperature coefficient compensation.The research indicates that the primary cause of bearing fracture is the difference in thermal expansion coefficients between the bearing and the metal rotor under elevated temperatures,leading to axial loosening of the bearing.Additionally,the gap between the bearing and the pin,combined with unstable lubrication of the friction pair,exacerbates bearing stalling and pin impact,ultimately causing cracks and localized chipping.By optimizing the bearing structure and employing a rubber pad for torque transmission,this issue has been successfully resolved.The improved structure demonstrated high reliability and stability in bench tests,providing important theoretical and technical references for the design of bearings under similar extreme operating conditions.
3.Development of a mobile personnel radiation protection equipment
Yuan HE ; Hongchao PANG ; Yang LIU ; Jianhua WU ; Junlin WANG ; Yanan HONG ; Xubiao CHEN ; Hualin WANG ; Xiaoyu SHI ; Miao PAN ; Qiang WANG
Chinese Journal of Radiological Health 2024;33(2):158-163
Objective To design a mobile personnel radiation protection equipment for operation in environments with high radiation such as spent fuel reprocessing plants, to achieve simultaneous protection against γ radiation, neutron radiation, and radioactive aerosol, to reduce the internal and external exposure dose of radioactive workers, and to meet the requirement of operation for two hours. Methods The core parts of the mobile personnel radiation protection equipment included a shielding chamber and a respiratory maintenance system. An automated chassis was used for the movement and lifting of the shielding chamber. MCNP software was used to simulate and calculate the protective effects of shielding chamber made of different materials and material thicknesses. Experimental verification of the shielding chamber design was conducted. Mathematical models were established to describe the variations in the content of various gases in the chamber with personnel operation time. A respiratory maintenance system, a harmful gas absorption device, and an automated mobile chassis were designed. Results The shielding chamber made of polyethylene with a thickness of 80 mm achieved an 80% neutron shielding rate. The respiratory maintenance system could support workers for 2 hours of operation inside the equipment. The mobile chassis allowed operation of the equipment with one person. Conclusion This mobile personnel radiation protection equipment can solve the problem in simultaneous protection against γ radiation, neutron radiation, and radioactive aerosol. The equipment can provide radiation protection for radioactive workers, reduce exposure dose, and reduce personnel burden. This system provides technical means for the operation and maintenance of equipment in high-radiation sites such as spent fuel reprocessing plants.
4.Construction of motion sickness clinical model and diagnosis model based on blood index
Qiwei XIE ; Jiali TU ; Yaowen WANG ; Weimin ZHANG ; Hou SHI ; Yan WANG ; Hualin ZHU
Chinese Archives of Otolaryngology-Head and Neck Surgery 2024;31(7):435-439
OBJECTIVE To construct a clinical model of motion sickness(MS),provide a relatively objective diagnostic model for MS research,and provide a basis for further clinical intervention of the disease.METHODS A total of 60 subjects were included and divided into experimental group and control group according to the presence or absence of MS.The MS clinical model was established using SRM-IV rotating chair.Peripheral blood was collected before and after acceleration exposure,and the contents of adrenocorticotropic hormone(ACTH),growth hormone(GH),prolactin(PRL),follicle stimulating hormone(FSH),luteinizing hormone(LH),thyroid stimulating hormone(TRH)and gastrin-17(G-17),acetylcholine(ACH)and 5-hydroxytryptamine(5-HT)were detected,Graybiel scale was used to evaluate the severity of MS.The correlation between MS symptoms and signs and peripheral blood indexes was analyzed by multiple linear regression,and the diagnostic model was established.construct a clinical model of MS and a diagnostic model based on blood parameters,so as to provide a reliable clinical model and an objective diagnostic model for MS research,and to provide a basis for further clinical intervention of the disease.RESULTS After acceleration exposure,the Graybiel scores,ACH,5-HT,ACTH,GH and PRL levels in peripheral blood of the experimental group were higher than those before exposure,and were significantly different from those of the control group(P<0.001).There was no significant difference in FSH,LH,TRH and G-17 between the two groups before and after acceleration exposure(P>0.05).Multi-index combined diagnostic model:Graybiel scores=-9.32+0.131×ACTH+0.055×ACH+0.041×5-HT.CONCLUSION The levels of ACH,5-HT,ACTH,GH and PRL increased during the onset of MS.The multi-index combined diagnosis model can provide a certain basis for the objective diagnosis of MS in clinical practice.
5.Analysis on Antidepressant Mechanism of Verbascoside Based on RNA-Seq Technology
Xiaoyan XUE ; Jin PAN ; Huishan SHI ; Yong WANG ; Jiang WU ; Zhili GAO ; Qiancheng MAO ; Hualin ZHONG ; Ting MA ; Ke MA
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(14):148-157
6.Molecular diagnosis and treatment of meningiomas: an expert consensus (2022).
Jiaojiao DENG ; Lingyang HUA ; Liuguan BIAN ; Hong CHEN ; Ligang CHEN ; Hongwei CHENG ; Changwu DOU ; Dangmurenjiapu GENG ; Tao HONG ; Hongming JI ; Yugang JIANG ; Qing LAN ; Gang LI ; Zhixiong LIU ; Songtao QI ; Yan QU ; Songsheng SHI ; Xiaochuan SUN ; Haijun WANG ; Yongping YOU ; Hualin YU ; Shuyuan YUE ; Jianming ZHANG ; Xiaohua ZHANG ; Shuo WANG ; Ying MAO ; Ping ZHONG ; Ye GONG
Chinese Medical Journal 2022;135(16):1894-1912
ABSTRACT:
Meningiomas are the most common primary intracranial neoplasm with diverse pathological types and complicated clinical manifestations. The fifth edition of the WHO Classification of Tumors of the Central Nervous System (WHO CNS5), published in 2021, introduces major changes that advance the role of molecular diagnostics in meningiomas. To follow the revision of WHO CNS5, this expert consensus statement was formed jointly by the Group of Neuro-Oncology, Society of Neurosurgery, Chinese Medical Association together with neuropathologists and evidence-based experts. The consensus provides reference points to integrate key biomarkers into stratification and clinical decision making for meningioma patients.
REGISTRATION
Practice guideline REgistration for transPAREncy (PREPARE), IPGRP-2022CN234.
Humans
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Meningioma/pathology*
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Consensus
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Neurosurgical Procedures
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Meningeal Neoplasms/pathology*
7.Dry weight evaluation in hemodialysis patients
Jun WANG ; Hualin QI ; Xintian ZHANG ; Xuezhu LI ; Yuan SHI ; Shougang ZHUANG ; Haidong YAN
Chinese Journal of Nephrology 2014;30(2):104-111
Objective To estimate dry weight (DW) and prevent dialysis-related hypotension and hypertension with the on-line monitoring of relative blood volume (RBV) and other judgments.Methods One hundred and eight maintenance hemodialysis patients were assigned to three groups according to their blood pressure:normal blood pressure group (A group,n=43),hypotension group (B group,n=35) and hypertension group (C group,n=35).The level of hemoglobin,serum albumin,dialysis adequacy were determined.Systolic blood pressure,diastolic blood pressure,mean arterial pressure,heart rate,ultrafiltration volume,relative blood volume changes and the corresponding clinical symptoms were monitored during hemodialysis in all patients.Each of the patients was continuously monitored of the indicators above for 10-12 times.At the observing period,the inferior vena cava diameter (IVCD),brain natriuretic peptide (BNP) and cardiothoracic ratio(CTR) were measured.Then according to the monitoring results,appropriate clinical interventions were given under on-line blood volume monitoring guidance.Results (1)The shape of RBV curve in group A showed doubleexponential curve early,then down to the final linear decling ended during hemodialysis.(2)The RBV curve in group B was stable in the former two hours,then rapidly linear declined.RBV changes were significantly higher in group B than group A (P < 0.05),but when changes in RBV were plotted against ultrafiltration volume,there was no significant difference in the two groups.The level of RBV reduction at which symptomatic hypotension occurred showed considerable inter-individual variability (P < 0.05,coefficient of variation=0.28).(3)The RBV curve in group C slowly linear declined.At the end of dialysis,RBV changes were significantly lower in group C than group A (P < 0.05).(4)The IVCD values in three groups of patients before dialysis were greater than normal,significantly decreased after the dialysis (P < 0.05),but that in group B and group C were still greater than that in group A (P < 0.05).The BNP values were significantly greater in three groups before and after dialysis (P < 0.05),but after dialysis,the values decreased significantly than that before dialysis (P < 0.05).(5)After appropriate clinical intervention were given under on-line blood volume monitoring in hemodialysis,the patients of group B controlled weight gain,and even cut dry weight,the RBV change significantly decreased at the end of dialysis and significantly reduced the incidence of hypotension events (P < 0.05); When the patients of group C cut dry weight,increased ultrafiltration,the RBV change increased,the mean arterial pressure decreased significantly than before (P< 0.05).Conclusions (1)Hemodialysis patients with symptomatic hypotension show larger RBV decline rate in the forth hour and lager total RBV changes,which provides important information for forecasting the symptomatic hypotension in hemodialysis.(2)IVCD and CTR have certain significance to the adjustment of dry weight,but the BNP has guiding significance to volume change.(3)On-line monitoring of RBV can effectively guide the adjustment of dry weight,reduction of symptomatic hypotension occruence,and controlling of refractory hypertension in hemodialysis.

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