Objective To evaluate the feasibility of process scale-up for the production of human prothrombin complex concentrate(PCC) by comparing the quality parameters of PCC samples obtained at different stages of process scale-up.Methods The PCC production process was scaled up sequentially through bench scale, pilot scale and production scale.Samples were collected at critical process control points across the three scales for comparative quality analysis. The final PCC products from each scale were tested in accordance with the Chinese Pharmacopoeia(VolumeⅢ, 2020 edition) to assess process stability and regulatory compliance during scale-up.Results After the first ultrafiltration step, no statistically significant differences were observed in the potency of human coagulation factor Ⅸ(FⅨ) or protein content among samples from the three scales(F = 1. 066 and 0. 590, respectively, each P > 0. 05). The FⅨ recovery rates were(69. 3 ± 10. 3)%,(73. 9 ±11. 1)%, and(69. 8 ± 7. 3)%, respectively, with no significant difference( F = 0. 330, P > 0. 05). Following solvent/detergent(S/D) treatment, the pH remained stable, and no significant differences were observed in FⅨ potency or protein content(F =1. 414 and 0. 542, respectively, each P > 0. 05). After the secondary ion-exchange chromatography step, no significant differences were found in FⅨ potency or specific activity(F = 0. 437 and 0. 201, respectively, each P > 0. 05), with FⅨ recovery rates of(90. 6 ± 6. 7)%,(82. 6 ± 4. 6)% and(87. 2 ± 6. 1)%, respectively, with no significant difference(F = 2. 513, P > 0. 05).At the bulk solution stage, no significant differences were observed in FⅨ potency or specific activity(F = 0. 187 and 0. 135,respectively, each P > 0. 05) with stable pH, and FⅨ recovery rates were(90. 6 ± 7. 5)%,(97. 2 ± 8. 3)%, and(92. 2 ± 6. 4)%,respectively, with no significant difference(F = 1. 016, P > 0. 05). After dry-heat virus inactivation, no significant differences were noted in the potency of factorsⅡ, Ⅶ, Ⅸ, and Ⅹ(F = 0. 11, 0. 473, 0. 818, and 0. 244, respectively, each P > 0. 05).The critical quality attributes of final PCC products from all three scales were consistent and complied with the requirements of Chinese Pharmacopoeia(Volume Ⅲ, 2020 edition).Conclusion The established PCC production process is stable, reliable, and reproducible, demonstrating the feasibility of process scale-up.

Immune response is one of the main reasons causing neurological deficits in the patients with cere -brovascular diseases , which activates microglia , induces inflammatory reaction and finally results in serious neuronal and endothelial injury .MicroRNAs take part in the regulation of immunoreaction , and simultaneously regulates many target genes and induces faster post-transcriptional regulation to its target genes compared with the traditional transcriptional regu -lation.For providing a basis for the clinical use of microRNAs and applying new therapy , this review mainly focuses on the function and mechanism of microRNAs in the regulation of the immunoreaction caused by cerebrovascular diseases .

ObjectiveTo summarize the application of pressure support ventilation (PSV) on cervical spinal cord injured patients with respiratory dysfunction.MethodSixteen patients were studied.Respiratory rate (RR),tidal volume (VT), minute ventilation (VE),peak inspiration pressure (PIP), dynamic lung conpliance (Cdyn), blood pH value, PaO2 and PaCO2 were measured under the different pressure levels of PSV. ResultAll parameters correlated with the level of PSV. Conclusion Appropriate PSV levels can make the respiratory parameters close to the reasonable level and respiratory functional status for the cervical cord injured patients with respiratory dysfunction.

ObjectiveTo observe the difference between pressure support ventilation(PSV) and synchronized intermittent mandatory ventilation(SIMV) in cervical spinal cord injury patients with respiratory failure.MethodsThe blood gas analysis,respiratory rate,heart rate,blood pressure and subjective feelings were observed in the same patient under different ventilation(PSV or SIMV).ResultsThere was no significant difference in blood pressure when patients underwent PSV and SIMV.Otherwise,There was significant difference in respiratory rate,heart rate,pH,PaO2,PaCO2 and subjective feelings when patients underwent PSV and SIMV,which showed that of PSV were better.ConclusionThe effect of PSV was better than that of SIMV on respiratory failure after cervical spinal cord injury.

地震造成大规模人群的复杂创伤,病情进一步发展,常导致多脏器功能障碍(MODS)。本文总结了地震伤后MODS的发病机制、预防、早期诊断以及治疗措施。

ObjectiveTo identify the status of quality of life in breast cancer patients and explore the impact of environmental factors on quality of life in breast cancer patients receiving chemotherapy. MethodsTotally 201 primary breast cancer patients undergoing chemotherapy after surgery were investigated.Self-developed demographic and clinical character investigation questionnaire,WHO Disability Assessment Schedule Ⅱ(WHODAS Ⅱ),and environmental factors in International Classification of Functioning Disability and Health(ICF)core sets for breast cancer patients were adopted to collect relevant data. ResultsBreast cancer patients had different levels of difficulties on each domain of WHODAS Ⅱ.Multiple stepwise regression analysis demonstrated that“material and emotional support and interrelationship with friends”, “social security service,system and policies” and“social norms,practices and ideologies” were factors influencing quality of life of breast cancer patients. ConclusionsIn addition to the strengthen of rehabilitation exercise training,nurses should advocate more services from society through policy making,prompt public awareness and scientific cognition,as well as construct effective nursing interventions to help enlarge social support resources and improve social support level.

Pancreatic encephalopathy (PE)is one of the severe complications of severe acute pancreatitis (SAP).Early diagnosis mostly depends on the history of disease as well as clinical symptoms and signs.PE progresses rapidly and is often complicated by multiple organ dysfunction,and it may finally develop into multiple organ failure with a high fatality rate if not treated in time.It is currently known that de-myelination is one of the important pathological features of this disease,with fat -soluble demyelination of cerebral gray matter and white matter,as well as inflammatory changes such as hemorrhage and edema.The target antigen of demyelinating lesions,however,is myelin basic protein (MBP).This paper reviews the changes in MBP levels in the demyelinating lesions of the central nervous system among PE pa-tients,with the purpose of providing clues for the early diagnosis and prognostic study of demyelinating lesions in PE.

A member of miR-16 family, miR-424 has been found to be closely related with tumorigenesis, tumor progrssion, prognosis and therapy.This article reviews the expression changes, roles and possible regulating mechanisms of miR-424 in leukemia and various tumors such as breast, cervical, lung, liver and colorectal cancers.Recent studies have demonstrated that the expression of miR-424 is affected by many factors, and miR-424 could be a biomarker of diagnosis, staging and prognosis in cancers,to identify the area of tumor, and be a target of therapy.

MicroRNA-494 (miR-494) is one of the microRNAs from 14q32.31 miR-gene cluster.Recently, miR-494 was found to closely relate with tumors and other diseases .This article reviews the expression changes , roles and possible regulatory mechanisms of miR-494 in multiple tumors and other hypoxia/ischemia diseases .Recent studies demon-strate that the expression of miR-494 is affected by many factors , and miR-494 could be a biomarker of diagnosis , staging and prognosis in tumors and other diseases , and a target of therapy in future .

MiRs display an important role in a variety of biological, physiological and pathological processes, including cell proliferation, differentiation, apoptosis, individual development, occurrence and progress of diseases. Recent studies have discovered that miR?424 is the significant regulatory factor of angiogenesis, and is involved in many diseases such as infectious diseases, vascular diseases, central nervous system diseases and genital system disease. This article reviews the expression, effect and possible mechanisms of miR?424 in non?tumorous diseases.