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Evidenced based and practical guidelines have important role in the decrease of mobility and mortality of the patients with major haemorrhage. Recently, British Society for Haematology updated a guideline on haematological management of major haemorrhage, which provides the recommendations in general and on alternatives to transfusion, obstetric haemorrhage, gastrointestinal haemorrhage, trauma and surgery, and the good practice statements for laboratory/organisational support. The comprehensive and instructive recommendations presented in the guideline will be good references for and assist in the education and development of the guidelines or protocols for the management of the patient with major haemorrhage in China.
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U.S. Food and Drug Administration recently issued a guidance on alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical. It was allowed to use platelets stored at 1 ℃ to 6 ℃, with a storage period of up to 14 days from the date of collection.The validation and quality monitoring of platelet manufacture retained pH items testing at the end of the storage, and platelet count and actual plasma volume testing items were not required. The guidance provided the recommendations and considerations for the manufacture, labeling, storage, transportation, bacterial contamination control, process validation, and quality monitoring sampling of cold-stored platelets, as well as the further research needs for its efficacy, particularly when conventional platelets are available and their use is practical. The scientific and regulatory considerations on cold-stored platelets in the guidance would be informative and instructive to the development of blood regulation and standards related with urgent transfusion in China.
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Serious hazards of transfusion(SHOT)in the United Kingdom has been received reporting of the adverse events of delayed transfusion for more than ten years. Hemovigilance Module Surveillance Protocol in Biovigilance Component in National Healthcare Safety Network in the United States updated the incident codes to include under-transfusion with the creation of a new process code: no blood (NB) and four incident codes in October 2022. This review introduces the monitoring practice of delayed transfusion/under-transfusion in the UK and the USA, makes a suggestion to incorporate delayed transfusion/under-transfusion due to blood shortage into the national health standard on the classification of transfusion reactions and haemovigilance protocol in China, and to do a national survey as well, therefore the real world data and evidences would be obtained and used for further policy making.
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Objective:To investigate the clinical efficacy and safety of transarterial chemoembolization (TACE) combined with lenvatinib plus PD-1 inhibitor (TACE+Len+PD-1) versus TACE combined with lenvatinib (TACE+Len) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).Methods:The data of 94 patients with intermediate-advanced HCC who received TACE+Len+PD-1 (One week after TACE, the patient were treated with lenvatinib and PD-1 inhibitor. lenvatinib, 8 or 12 mg/d, orally; PD-1 inhibitor, 200 mg/3 weeks, iv) or TACE+Len (One week after TACE, the patient were treated with lenvatinib.lenvatinib, 8 or 12 mg/d, orally) in the Second Affiliated Hospital of Guangzhou Medical University from June 2019 to February 2021 were collected and retrospectively analyzed. Among these patients, 44 were in the TACE+Len+PD-1 group and 50 were in the TACE+Len group. Tumor responses were evaluated according to modified response evaluation criteria in solid tumors. Objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and adverse events (AEs) were compared between the two groups. The potential prognostic factors for PFS and OS were determined.Results:The ORR of TACE+Len+PD-1 group and TACE+Len group was 72.8% (32/44) and 52.0% (26/50) (χ2=4.25, P=0.039), respectively. The DCR of TACE+Len+PD-1 group and TACE+Len group was 86.4% (38/44) and 62.0% (31/50) (χ2=7.12, P=0.008), respectively. The median PFS and median OS in TACE+Len+PD-1 group were significantly longer than those in TACE+Len group (PFS, 7.9 vs. 5.6 months, χ2=7.91, P=0.005; OS, 18.5 vs. 13.6 months, χ2=4.40, P=0.036). Multivariate Cox regression analyses showed that TACE+Len (HR=2.184,95%CI 1.366-3.493), incomplete tumor capsule (HR=2.002,95%CI 1.294-3.209) and extrahepatic metastasis (HR=1.765,95%CI 1.095-2.844) were the independent risk factors for PFS, while TACE+Len (HR=2.081,95%CI 1.097-3.948) and BCLC stage C (HR=7.325,95%CI 2.260-23.746) were the independent risk factors for OS. The incidence of ≥grade 3 AEs in TACE+Len+PD-1 group was similar to that in TACE+Len group (χ2=0.45, P=0.501). Conclusion:Compared with TACE+Len, TACE+Len+PD-1 resulted in a better tumor response and a longer PFS and OS in patients with intermediate-advanced HCC.
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Objective:To evaluate the efficacy and safety of anti-programmed cell death 1 (PD-1) receptor monoclonal antibody (MoAb) in patients with advanced hepatocellular carcinoma (HCC) after treatment of transcatheter arterial chemoembolization (TACE) combined with tyrosine kinase inhibitor (TKI).Methods:From February 2019 to February 2020, 56 HCC patients who relapsed after TACE-TKI treatment in Department of Interventional Radiology, The Second Affiliated Hospital of Guangzhou Medical University were enrolled. All patients received anti-PD-1 MoAb (sintilimab injection) and followed up every 6 weeks. According to mRECIST, the curative effect was evaluated as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD). Objective response rate (ORR) and disease control rate (DCR), progression-free survival (PFS) and treatment-related adverse events (TRAEs) were recorded. Univariate analysis by Chi-square test and binary logistic regression model was used to determine the influencing factors of DCR. The Kaplan-Meier method and Cox proportional hazard regression model were used to analyze the survival data.Results:A total of 48 patients were enrolled in this study including 42 males and 6 females, with a median age of 55 years (29-71 years). ECOG scores comprised of 0 in 24 cases, 1-2 in 24 cases. Thirty-six patients were in Child-Pugh grade A of liver function and 12 cases were grade B. The median follow-up time was 4.5 months. There were 2 patients achieved CR, 12 patients with PR and 16 with SD. ORR was 29.2%, DCR was 62.5%. The independent influencing factors of DCR was ECOG score and AFP level ( P=0.031, P=0.012). Median PFS was 4.1 months (95% CI 2.7-5.4 months), and ECOG score was the independent influencing factor of PFS ( P=0.042). Treatment-related adverse events were reported in 70.8% (34/48) patients. Incidence of grade Ⅲ-Ⅳ TRAEs was 22.9% (11/48). Conclusion:In patients with HCC who relapse from TACE and TKI treatment, anti-PD-1 monoclonal antibody is efficacious safe especially in those with ECOG 0 score.
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Objective:To study the use of radioactive I-125 seed implantation in the treatment of transarterial chemoembolization (TACE)-refractory hepatocellular carcinoma (HCC).Methods:A retrospective study was conducted on 70 patients with HCC who were initially treated with TACE between July 1, 2016 and August 31, 2019 at the Second Affiliated Hospital of Guangzhou Medical University. After these patients were found to be refractory to TACE, 29 patients were converted to radioactive I-125 seed implantation (the 125I seed group), and 41 patients were continued with TACE (the TACE group). The objective response rate, progression-free survival (PFS), overall survival (OS), total overall survival (TOS) of the two groups were compared. Results:There were 59 males and 11 females, aged (60.5±11.9 ) years in this study. At 1, 3, 6 months after treatment, the objective response rates of the 125I seed group were 20.7%, 40.7%, 34.6%, respectively, which were significantly higher than that of the TACE group of 2.6%, 3.3%, 5.0%, respectively. The PFS, OS, TOS in the 125I seed group were 7.6, 21.1, 32.1 months, respectively, which were significantly better when compared with the TACE group (3.5, 8.5, 14.8 months, respectively, all P<0.05). There was no significant difference in the embolization syndrome between the two groups [93.1%(27/29) vs 100.0%(41/41), P>0.05]. Child-Pugh B grading ( HR=0.311, 95% CI: 0.160-0.603, P=0.005) and TACE ( HR=0.308, 95% CI: 0.159-0.597, P=0.002) were independent risk prognostic factors for survival. Conclusion:This study showed better treatment efficacy and safety using radioactive I-125 seed implantation in TACE-refractory HCC and this treatment significantly improved survival of patients when compared with TACE alone.
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【Objective】 A framework to support nurses and midwives making the clinical decision and providing the written instruction for blood transfusion has been developed and implemented in the United Kingdom as a response to the changing needs of the patient and in recognition that blood transfusion services to patients could be improved by using the untapped knowledge and expertise of experienced nurses and midwives.Special education and training program for this role development are provided jointly by the national blood and nurse management authority, higher education institutions and transfusion societies.The British government has issued and implemented a compulsory professional indemnity which cover nurses and midwives as well.The development and implementation of the framework, policies and procedures for this role development is based on the regulatory compliance and the collaboration of, and beneficial to the multiple stakeholders, with the gaps left by doctors being fillled, work load of doctors reduced, nurses and midwives achieving professional development, hospitals performing more efficiently, and most importantly, the patients having a better transfusion services.At present, there is no similar policy or program for nurses and midwives in China.Therefore, this paper introduces the policy framework and implementation for this role development in UK, which would be a valuable reference for the role development and extension of nurses and the organization, education and training for transfusion professional teams as well in China in the near future.
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Objective To preliminarily explore the early process of hepatitis B virus (HBV) infection in HepG2 cells induced by dimethyl sulfoxide(DMSO) ,and provide cytological bases for mechanism study of HBV infection in vitro .Methods HepG cells were divided into the DMSO inducing group and control group ,and were cultured 4 days by DMEM containing 1 .5% DMSO and normal DMEM respectively ;changes of cellular morphology were observed .In addition ,selected ECV304 cells as the negative con‐trol group and treated with DMSO .Cells in the three groups were incubated 2 hours with HBV positive serum after culturing 24 hours ,then trypsin digestive solution ,HepG2 cells and ECV304 cells were collected and polymerase chain reaction (PCR) was used for the determination of HBV DNA .Simultaneously ,the blank control group was set ,and the position of HBsAg on HepG2 cells were detected by using indirect immunofluorescence .Results HepG2 cell volume in the DMSO inducing group was obviously in‐creased .HBV DNA was found in HepG2 cells both in DMSO inducing group and control group ,and DMSO inducing group ex‐pressed much stronger .The results of IIF shown that green fluorescent signals of cell membrane and cytoplasm of HepG 2 cells in the DMSO inducing group were increased obviously ,while the results of HBV DNA and IIF both were negative in the negative con‐trol group .Conclusion DMSO could facilitate adsorption of HBsAg in some extent ,which are benefit for completing the process of early infection .
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Objective To investigate the clinical outcome and treatment of portal vein thrombosis (PVT) following partial splenic embolization (PSE).Methods From April 2006 to April 2010,105patients with hypersplenism caused by cirrhotic portal hypertension were treated with PSE.Contrastenhanced abdominal computed tomography or magnetic resonance imaging was performed routinely in 60patients before PSE and 1 -3 months after PSE.PVT was detected in 10 patients on images after the procedures.After PVT was diagnosed,4 patients received anticoagulant therapy immediately,and the other 6 patients did not receive therapy.Clinical data of these 10 PVT patients were analyzed retrospectively.Results 3 of 4 patients who received anticoagulant therapy had complete or partial resolution of the thrombus,and one developed mild ascites without thrombosis progression.Of the 6 patients who did not receive anticoagulant therapy,follow-up studies (6- 48 months,mean 16.9 months) demonstrated partial clot calcification in one,thrombosis progression in 5.Among those 5 patients with thrombosis progression,two experienced hematemesis due to variceal rupture and underwent transjugular intrahepatic portosystemic shunt,2 developed cavernous transformation,extensive collateral circulation,ascites and variceal progression,and one had variceal progression with melena during the follow-up period.Conclusions PVT is a severe complication of PSE.Early diagnosis and prompt anticoagulant therapy is effective in preventing PVT.
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Objective To survey the frequency of H deficient phenotype in blood donor population and analyze the serological and genetic characteristics of these individuals.Methods The H deficient phenotype was screened with anti-H monoclonal antibody.The ABO type was screened with serological method and with sequence specific primer polymerase chain reaction(PCR-SSP).FUT1 and FUT2 gene sequences were analyzed with direct sequencing of PCR products and gene cloning products.Result Of 85 390 blood donors,ten individuals were identified to be para-Bombay phenotype.Four h alleles were found in 14 para-Bombay phenotype individuals,h1(nt547-552?ag),h2(nt880-882?tt),h3(nt658c→t),and h_(new-2)(nt328g→a).The FUT1 genotypes of these para-Bombay individuals were h1/h1(6 individuals),h1/h2(7 individuals) and h3/h_(new2)(1 individual),and the frequency of 4 allele were 67.85%(h1),25%(h2),3.57%(h3),and 3.57%(h_(new-2)),respectively.FUT2 gene was analyzed in 12 para-Bombay phenotype individuals,and a mutation of nt357c→t was detected in all FUT2 gene,another mutation of nt716g→a were heterozygous in 5 individuals with h1/h2 genotype.No null FUT2 gene was detected.In serological analysis,all atypical anti-A or anti-B antibody of 14 para-Bombay individuals were inactive at 37℃,7 individuals had active anti-H antibody at 37℃.Conclusion The frequency of H deficient phenotype in Fujian population is about 1:8 500.The h1 and h2 alleles are predominant in Fujian H deficient individuals on h1-Se~(357) and h2-Se~(357,716) haplotype background.