1.Introduction and enlightenment of the Recommendations and Expert Consensus for Plasm a and Platelet Transfusion Practice in Critically ill Children: from the Transfusion and Anemia Expertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB)
Lu LU ; Jiaohui ZENG ; Hao TANG ; Lan GU ; Junhua ZHANG ; Zhi LIN ; Dan WANG ; Mingyi ZHAO ; Minghua YANG ; Rong HUANG ; Rong GUI
Chinese Journal of Blood Transfusion 2025;38(4):585-594
To guide transfusion practice in critically ill children who often need plasma and platelet transfusions, the Transfusion and Anemia Expertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB) developed Recommendations and Expert Consensus for Plasma and Platelet Transfusion Practice in Critically Ill Children. This guideline addresses 53 recommendations related to plasma and platelet transfusion in critically ill children with 8 kinds of diseases, laboratory testing, selection/treatment of plasma and platelet components, and research priorities. This paper introduces the specific methods and results of the recommendation formation of the guideline.
2.General considerations for quality control of recombinant protein PEGylation drug production
Rong LIU ; Wu-Chao LI ; Jing-Feng HU ; Xiao-Hong LU ; Qiao-Qiao FENG
The Chinese Journal of Clinical Pharmacology 2024;40(4):629-632
Polyethylene glycosylation(PEGylation)of recombinant protein drugs are modified by PEG.To preserve the biological activity of the prototype recombinant protein,it overcomes the drawbacks of fast metabolism,poor stability,and the need for multiple doses of the prototype protein in vivo,but also has specificity.In the case of limited guidelines for quality control,discussions are conducted on the control of raw materials used in production,process control during production,quality control of intermediate and final products,stability research,and other aspects,in order to provide reference for the control and development of recombinant protein PEGylation drugs.
3.Clinical trial of recombinant human interferon-α2b combined with 5-aminolaevulinic acid photodynamic therapy in the treatment of patients with cervical intraepithelial lesions complicated with HPV infection
Ya-Nan LIU ; Yan-Yang LU ; Rong ZHANG ; Yi-Bei DU ; Yu-Jia GAO ; Ying WEI
The Chinese Journal of Clinical Pharmacology 2024;40(10):1414-1418
Objective To observe the clinical effect and safety of recombinant human interferon-α2b(rhIFN-α2b)combined with 5-aminolaevulinic acid photodynamic therapy(ALA-PDT)in the treatment of patients with cervical intraepithelial lesions and human papilloma virus(HPV)infection.Methods The clinical data of patients with cervical intraepithelial lesions and HPV infection were analyzed retrospectively.The patients were divided into control group and treatment group according to cohort method.The control group was treated with rhIFN-α2b gel at posterior fornix,qd.On this basis,the treatment group was treated with ALA-PDT,namely applying 5%ALA temperature-sensitive gel prepared by 118 mg of ketone valerate hydrochloride powder for external use on vaginal surface,combined with photodynamic therapy,once a week.The clinical efficacy,time to recovery from clinical symptoms,recurrence rate,changes in cytokines[interleukin-6(IL-6),interleukin-8(IL-8)and interferon-γ(IFN-γ)]and immune function[T cell subsets CD3+,CD4+,CD8+and CD4+/CD8+],and safety were compared between the two groups.Results There were 98 cases in treatment group and 100 cases in control group.The total effective rates in treatment group and control group were 93.88%and 83.00%,with statistically significant difference(P<0.05).The relief time of lower abdominal pain in treatment group and control group were(3.65±0.52)and(5.26±0.65)d;the time to recovery from abnormal vaginal discharge were(5.77±0.83)and(7.16±0.92)d;the time to recovery from irregular vaginal bleeding were(4.82±0.62)and(6.94±0.77)d;HPV clearance rates were 58.16%and 42.00%;IL-6 levels were(0.16±0.09)and(0.23±0.05)mg·L-1;IL-8 levels were(0.47±0.05)and(0.66±0.07)mg·L-1;IFN-γ levels were(10.07±0.98)and(7.24±0.65)ng·mL-1;CD3+were(71.06±8.29)%and(61.36±6.88)%;CD4+were(48.25±5.94)%and(42.25±5.13)%;CD8+were(20.37±2.42)%and(24.69±2.51)%;CD4+/CD8+were 2.11±0.27 and 1.36±0.16;the differences were all statistically significant(all P<0.05).Recurrence rates in treatment group and control group were 5.10%and 14.00%,with statistically significant difference(P<0.05).The total incidence of adverse drug reactions in treatment group and control group were 26.53%and 21.00%,without statistically significant difference(P>0.05).Conclusion The combined treatment of rhIFN-α2b and ALA-PDT is effective for patients with cervical intraepithelial lesions and HPV infection.It has obvious advantages in improving immunity,relieving inflammatory response and reducing recurrence rate,with good safety.
4.Bioequivalence study of pyrazinamide tablets in Chinese healthy subjects
Li-Bing YE ; Chong YAO ; Ying-Rong CHEN ; Lu-Yuan TONG ; Tao YANG ; Xiao LU ; Min XU ; Qiu-Yue JIN ; Shui-Xin YANG
The Chinese Journal of Clinical Pharmacology 2024;40(15):2236-2240
Objective To evaluate the bioequivalence and safety of two pyrazinamide tablets in healthy Chinese subjects.Methods An open,randomized,single-dose,two-sequence,two-cycle,double-cross trial design was used.All 48 healthy subjects(24 in fasting and 24 in fed trial)were randomized to receive a single oral dose of a 0.5 g pyrazinamide tablet(test or reference)per cycle.The plasma concentration of the drug was determined by liquid chromatography coupled to tandem mass spectrometry method.The pharmacokinetic parameters were calculated by WinNonlin v8.2,and the bioequivalence was evaluated by SAS 9.4.Results In the fasting group,the Cmax of the test and reference preparation of pyrazinamide tablets were(13.28±2.82)and(12.88±4.49)μg·mL-1,the AUC0-t were(139.17±26.58)and(138.63±28.92)h·μg·mL-1,the AUC0-∞ were(148.96±33.65)and(148.71±36.97)h·μg·mL-1 respectively.In the fed group,the Cmax of the test and reference preparation of pyrazinamide tablets were(11.89±1.96)and(11.99±1.92)μg·mL-1,the AUC0-t were(138.22±37.21)and(141.68±25.80)h·μg·mL-1,the AUC0-∞ were(152.20±32.41)and(151.04±28.05)h·μg·mL-,respectively.The 90%confidence intervals of Cmax,AUC0-t and AUC0-∞ geometric mean ratios of the test and reference preparation were all within 80.00%to 125.00%.The incidence of adverse events was 16.70%for both the test and reference preparation in the fasting group and 8.30%for both the test and reference preparation in the fed group,all of which were mild in severity.Conclusion The test and reference preparation of pyrazinamide tablets were bioequivalent,safe and well tolerated in healthy Chinese subjects under fasting and fed conditions.
5.Physicochemical Processes of Biofilm Formation on The Surface of Structures in Water
Kai SHEN ; Fei GAO ; Xu-Qiang HUANG ; Xiao-Peng LU ; Hui-Min ZHOU ; Wei-Rong LI ; Di TIE
Progress in Biochemistry and Biophysics 2024;51(1):145-157
Microorganisms can form biofilms, complex, heterogeneous, multicellular communities that adhere to surfaces. Biofilm formation on the surface of structures in water will accelerate structures’ corrosion, seriously affect their service efficiency and life, and significantly impact the growth of animals, plants, and human life. Hence, clarifying the mechanism of biofilm formation contributes to developing new strategies to control biofilm formation on surface and then reduce infections, biofouling, and contaminations. Biofilm-targeting strategies include the regulation of established biofilms or the modulation of single-cell attachment. In most studies, physicochemical mechanism is frequently applied to explain the initial bacterial adhesion phenomena but rarely to explain other stages of biofilm formation. This review presents a five-step comprehensive description of the physicochemical process from film formation to biofilm maturation: (1) period of film formation; (2) period of bacterial adhesion; (3) period of extracellular-polymeric-substances (EPSs) membrane formation; (4) period of regulating biofilm by quorum sensing (QS); (5) period of biofilm maturation. We first clarify how the film formed by compound molecules affects the surface’s physicochemical properties and initial adhesion, summarizing many factors that affect bacterial adhesion. We then review the types of EPSs and signal molecules secreted by bacteria after irreversible adhesion, as well as their role and QS mechanism in biofilm maturation. Finally, we discuss how bacteria or microcolonies separate from the mature biofilm by physicochemical action and summarize the morphology and adhesion characterization methods after the biofilm matures. This review redefines the role of physicochemical in the whole process of biofilm formation and provides a theoretical basis for the prevention, removal, and utilization of biofilm and other related research fields.
6.Effect of USP9X on Akt phosphorylation and platelet function
Xuemei JIA ; Shujun SHAO ; Lujie ZHOU ; Danxin DU ; Huangying LU ; Cheng CHEN ; Rong XIA
Chinese Journal of Blood Transfusion 2024;37(4):377-384
【Objective】 To explore the expression of USP9X in platelets and its effect on platelet function. 【Methods】 The expression of USP9X in human and mouse was evaluated by PCR and Western blot. Platelets from young and old mice were separated and prepared, and the expression of USP9X was detected. USP9X inhibitos were used to assess the regulation of USP9X in platelet function, including aggregation, ATP release and spreading. Platelet lysates were collected in different time points to evaluate the change of phosphorylation of Akt in USP9X inhibitors treated platelets. 【Results】 Both human and mouse platelets expressed USP9X. Compared to the young mice, the old mice showed significantly enhanced expression of USP9X(P<0.05). To assess the effect of USP9X on platelet function, USP9X inhibitor was used to pre-incubate platelets for 30 min and platelet function were examined later. Results showed that USP9X inhibitor significantly decreased platelet activation including aggregation, ATP release and spreading(P<0.05). Compared to the control group, the inhibitor treated group showed a significant decrease in the spreading area after 45 minutes. The Western blot results showed a significant decrease in Akt phosphorylation levels of platelets in the USP9X inhibitor treated group. 【Conclusion】 Both human and mouse platelet express USP9X, and inhibition of USP9X decreased platelet function including aggregation, ATP release and spreading. USP9X can also influence the phosphorylation of Akt. The inhibitor of USP9X may become a potential therapeutic target for thrombosis intervention.
7.Review and prospects of international clinical research in critical care medicine in 2023
Ziqi RONG ; Pengyu LU ; Wei HUANG
Chinese Critical Care Medicine 2024;36(2):113-117
The main clinical research advances of critical care in 2023 includes: new trials of Chinese herbal medicine, hydroxocobalamin (vitamin B12), methylene blue as well glucocorticoids have shown the potential to improve outcomes of patients with sepsis and septic shock; international committees launched new global definition and managing recommendations for acute respiratory distress syndrome (ARDS). Besides, a cluster of new evidences has emerged in many aspects as following: fluid control strategy in sepsis (restrictive/liberative), antibiotic infusion strategy (continuous/intermittent), oxygen-saturation targets for mechanical ventilation (conservative/liberative), blood pressure targets after resuscitation from out-of-hospital cardiac arrest (hypotension/hypertension), blood pressure targets after successful stroke thrombectomy (intensive/conventional), and nutritional support strategies (low protein-calories/conventional protein-calories, fasting/persistent feeding before extubation). Thus, given above progress, carrying out high -quality domestic multi-center clinical registration researches, constructing shareable standardized databases, as well raising public awareness of sepsis, should be the essential steps to improve our level of intensive care medicine.
8.Negative pressure wound therapy promotes autologous skin transplantation by alleviating inflammatory reaction in pa-tients with chronic venous leg ulcer
Xu-Song YUAN ; Jian ZHANG ; Lu XU ; Jin-Rong LIN
Chinese Journal of Current Advances in General Surgery 2024;27(2):134-138
Objective:To investigate the mechanism of inhibiting inflammatory response by negative pressure wound therapy in the chronic venous leg ulcer.Method:The clinical data of 29 patients with chronic VLU treated in Hechuan-Rhine Traditional Chinese Medicine Hospital of Shanghai from June 2018 to December 2021 were collected.According to different treatment meth-ods,the patients were divided into the control group(n=13)and the observation group(n=16).The control group adopted routine varicose vein operations and debridement,routine dressing change was performed on the VLU wound every other day after operation.The observation group adopted debridement and then NPWT on the basis of routine varicose vein operations,the VLU wound was continuously drained with negative pressure for 1 week after operation.IL-1β and IL-18 levels were measured with ELISA.ASC、NLRP3 and Caspase-1 levels were detected with Western blot-ting.The autologous skin transplantation time of the two groups were calculated by survival curve analysis.Results:The inflammatory response was milder in the observation group than in the con-trol group 7 days after operation.The results of ELISA showed that the levels of IL-1 p and IL-18 in the observation group were lower than those in the control group.The results of Western blotting showed that the relative expression levels of ASC、NLRP3 and Caspase-1 in the observation group were lower than those in the control group.The survival curve analysis showed that the autologous skin transplantation time of the observation group was less than the control group.Conclusion:The inflammatory response can be distinctly alleviated by NPWT in the VLU,leading to better condi-tions for autologous skin transplantation within a short period.
9.Expert opinions on operation rules of Morita therapy outpatient service
Jiangbo LI ; Zucheng WANG ; Yuhua CUI ; Yingzhi LU ; Weijie QU ; Haiyin ZHANG ; Fuqiang MAO ; Fengqing QIE ; Wanghong SHI ; Qinfeng ZHANG ; Lingyi PAN ; Ling ZHANG ; Jianzhong LI ; Guangcheng CUI ; Tongxian CHEN ; Xiuqing MA ; Wei RONG ; Jianjun ZHANG ; Qingfang ZHONG ; Yanchi ZHANG ; Boquan ZHANG ; Xinrui WANG ; Wenyou MA ; Qingtao REN ; Yongfa JING ; Huanzhong LIU ; Zhenjian YU ; Laitian ZHAO ; Tianming HAN ; Xue HAN
Chinese Mental Health Journal 2024;38(1):68-72
Morita therapy has been bom for more than 100 years.Inpatient Morita therapy is highly oper-able and easy to master.It can improve many refractory neuroses through four-stage treatment.But more neuroses are treated in outpatient clinics,and Morita therapy cannot be used in hospitalized patients.Therefore,the formula-tion of expert opinions on outpatient operations is particularly important.This paper is based on domestic and for-eign references,and after many discussions by domestic Morita therapy experts,and then drew up the first version of the expert opinions on operation of outpatient Morita therapy.Meanwhile the operation rule of Morita therapy in three stages of outpatient treatment was formulated:in the etiological analysis stage,under the theoretical guidance of Morita therapy,analyze the pathogenic factors,to improve treatment compliance and reduce resistance;during the operating stage,guide patients to engage in constructive and meaningful actions,realizing the achievement of letting nature take its course principle;in the cultivating character and enriching life stage,pay attention to positive infor-mation,expanding the scope and content of actions,improving the ability to adapt to complex life,and preventing recurrence caused by insufficient abilities.It will lay a foundation for the promotion of Morita therapy in domestic outpatient clinics,so that more patients with neurosis and other psychological diseases could receive characteristic Morita therapy treatment in outpatient clinics.
10.Short-term results of sleeve wrapping technique using remnant aortic wall in modified Bentall procedure
MENG Maolong ; Yao WANG ; Pingfan LU ; Huapeng LI ; Rong REN ; Wen ZHANG ; Fengjie CHEN ; Xianmian ZHUANG ; Xiang WANG ; Gang LI ; Hongwei GUO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(02):283-287
Objective To evaluate the short-term results of sleeve wrapping technique using remnant aortic wall in modified Bentall procedure. Methods The patients undergoing modified Bentall procedure with the remnant aortic wall as a sleeve to cover the sewing area of composite valved graft and the aortic annulus for proximal hemostasis between March 2021 and March 2022 in Shenzhen Fuwai Hospital were enrolled. Short-term results were assessed by cardiopulmonary bypass time, aortic clamping time, mechanical ventilation time, ICU stay, postoperative hospital stay, effusion drainage on the first postoperative day, left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDD), and follow-up results. Results A total of 14 patients were collected, including 12 males and 2 females, with a mean age of 55.33±10.57 years. There was no postoperative or follow-up death. Cardiopulmonary bypass time was 147.90±21.29 min, aortic clamping time was 115.70±15.23 min, mechanical ventilation time was 19.42±8.98 h, ICU stay was 99.08±49.42 h, and postoperative hospital stay was 16.33±2.74 d. Thoracic drainage volume was 333.33±91.98 mL on the first postoperative day. Only 2 patients required blood transfusion (4.5 U and 2 U, respectively). During the follow-up of 6.17±3.69 months, there was no death, no aortic or valve-related complications. There was statistical difference in the LVEDD between preoperation and before discharge after surgery (P<0.001), and between half a year after surgery and before discharge after surgery (P<0.001). There was a little decrease of LVEF before discharge after surgery compared with preoperative LVEF, but there was no statistical difference (P=0.219). There was no statistical difference in the LVEF half a year after operation compared with that before operation (P=1.000). Conclusion Sleeve wrapping technique using remnant aortic wall in modified Bentall procedure has good short-term results. This modification may be a simple, effective way in controlling proximal bleeding.

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