Myelodysplastic syndromes (MDS) is a highly heterogeneous group of clonal disease,which is derived from hematopoietic.stem cells.Anemia is the main manifestation of most MDS patients and transfusion is required in about 90 ％ patients.Long-term blood transfusions can lead to iron overload (IOL).IOL can damage the iron balance,and excess free iron can deposite in the heart,liver and other vital organs,resulting in structural damage and organ dysfunction,which can deteriorate the prognosis,accelerate the transformation into acute myeloid leukemia,and increase the mortality.Iron chelation can improve the prognosis of patients with IOL,and prolong the overall survival and leukemia-free survival.

With the development of antibody manufacturing technology and improvement of new drug research in domestic industry, more innovative monoclonal antibody products submitted investigational new drug (IND) application. At the same time, monoclonal antibody products from abroad which have been approved marketing authorization and/or conducted clinical trials submitted IND applications in China. The National Medical Products Administration (NMPA) issued the "Guideline of Investigational New Drug Application" (No. 16, 2018) which emphasized the chemical, manufacturing, and control (CMC) regulatory, and dossier requirements in IND application, greatly promoted the application quality of innovative biological products. However, compared to the Food and Drug Administration (FDA) and European Medicines Agency (EMA), our particular guidelines are insufficient, such as guideline on virus safety evaluation of biotechnological investigational medicinal products. This review investigated the questions raised by sponsors from 2018 to 2020, including the end of production cell (EOPC) and/or unprocessed bulk (UPB) testing and virus removal or inactivation validation. Meanwhile, sponsors submitted different dossiers due to differences in understanding of stage requirements of guidelines from domestic and abroad. Based on the guidelines of virus safety from NMPA, FDA, and EMA, and the technical considerations, this review puts forward personal suggestions on the adventitious agents testing and virus removal or inactivation validation in manufacturing process, aim to ensure virus safety of innovative monoclonal antibody products in clinical trials.

After the types and characteristics of medical and health information websites in China were described , the problems existed on these websites and the reasons why they occurred were analyzed with some suggestions pro-posed for the development of medical and health information websites in China , such as controlling them by national policies and regulations, working out quality control standards, encouraging and supporting high level websites, es-tablishing needs-based medical and health resources database .

Objective:To study protective effect of nitrates pharmacological postconditioning (PI‐PostC) on ischemia‐reperfusion (I/R) injured myocardium in rats .Methods :A total of 32 Wistar rats were randomly and equally divided into sham operation group ,I/R group ,ischemia postconditioning group (IPostC group) and PI‐PostC group .Myo‐cardial ischemic area ,infract size ,plasma level of cardiac troponin I (cTnI) and cell apoptotic index were measured and compared among all groups .Results:Compare with sham operation group ,there was significant rise in plasma cTnI level [ (6.39 ± 2.35)μg/L vs .(70.33 ± 6.94)μg/L vs .(41.19 ± 4.50)μg/L ,(37.47 ± 4.20)μg/L ,P<0.01 all] in I/R group ,IPostC group and PI‐PostC group ,and those of IPostC group and PI‐PostC group were significant‐ly lower than that of I/R group , P<0.01 both .Compared with I/R group ,there were significant reductions in my‐ocardial ischemic area [ (53.31 ± 3.87)% vs .(46.46 ± 2.13)% vs .(42.08 ± 4.84)% ] ,infarct size [ (52.19 ± 3.44)% vs .(41.02 ± 2.93 )% , (38.13 ± 2.05 )% ] and cell apoptotic index [ (26.92 ± 1.91 )% vs . (20.54 ± 3.05)% ,(19.49 ± 2.41)% ] in IPostC group and PI‐PostC group ,P<0.01 all .Compared with IPostC group ,ische‐mic area significantly reduced (P<0.05) in IP‐PostC group ,but there were no significant changes in infarct size , cTnI level and cell apoptotic index between IPostC group and IP‐PostC group , P>0.05. Conclusion:Nitrates phar‐macological postconditioning possesses the same protective effect on myocardial I/R injury as ischemia postcondition‐ing ,and it can reduce myocardial ischemic area more effectively .

OBJECTIVE:To build the off-label drug use control system,and to realize automatic prompt for off-label drug use by system when physicians prescribed drugs. METHODS:The module and flow chart of off-label drug use control system were de-signed based on B/S structure. The drugs of the prescriptions were verified one by one in terms of drug indication,drug dosage, age and gender of patient,route of administration,etc. The system prompted automatically off-label drug use when drug use didn’t agree with preset value;at the same time,the management effect of the system was evaluated by taken the amount of attention about antibiotics medical orders as an example. RESULTS:At present,265 kinds of drugs were involved in the system designed by our hospital. Since the system was applied,the system had prompted more than 50 thousand items of off-label drug use prescrip-tions/medical orders,accounting for 0.3% of total. Among the types of off-label drug use,the most number of medical orders were over single dose(745 items),followed by extra-indication(706 items)and over daily dose(671 items). Within 3 months after sys-tem used,the attention numbers of antibiotics medical orders of over daily dose decreased month by month. CONCLUSIONS:Es-tablished off-label drug use control system of our hospital has a stable running and convenient manipulation,and contains powerful practicability. It can monitor off-label drug use of some drugs.

Objective To explore an algorithm to define the threshold value for tumor contouring on 18F-fluorodexyglucose (FDG) PET imaging. Methods A National Electrical Manufacturing Association (NEMA)NU 2 1994 PET phantom with 5 spheres of different diameters were filled with 18F-FDG. Seven different sphere-to-background ratios were obtained and the phantom was scanned by Discovery LS 4. For each sphere-to-background ratio, the maximum standardized uptake value ( SUVmax ) of each sphere, the SUV of the border of each sphere ( SUVborder ), the mean SUV of a 1 cm region of background (SUVbg) and the diameter (D) of each sphere were measured. SPSS 13.0 software was used for curve fitting and regression analysis to obtain the threshold algorithm. The calculated thresholds were applied to delineate 29 pathologically confirmed lung cancer lesions on PET images and the obtained volumes were compared with the volumes contoured on CT images in lung window. Results The algorithm for defining contour threshold is TH% = 33.1% + 46.8% SUVbg/SUVmax + 13.9%/D ( r = 0.994) by phantom studies. For 29 lung cancer lesions, the average gross tumor volumes ( GTV ) delineated on PET and CT are ( 7.36 ± 1.62 ) ml and (8.31 ±2.05) ml, respectively (t = -1.26, P＞0.05). Conclusion The proposed threshold algorithm for tumor contouring on PET image could provide comparable GTV with CT.

No abstract available.
Keloid* ; Recurrence*

No abstract available.
Enterococcus*

No abstract available.
Enterococcus*

Neoplasms presenting at birth or within the first month of life are defined as congenital tumors. The principal components of this congenital tumors are neuroblastoma, leukemia, brain tumors and sarcomas. The neuroblastoma is the most common accounting for 15~50% of all tumors in this group. It most often presents with an abdominal mass due to adrenal-retroperitoneal primary or hepatomegaly resulting from extensive metastasis. Most often the primary site is adrenal but other loci include the retroperitoneum, mediastinum, pelvis, etc. This 2-day-old female presented with hepatomegaly and a left adrenal mass at birth, first detected by ultrasonography. On the first day, she suffered from hematemesis and bradycardia. She died on the second day. Postmortem examination revealed massive metastatic tumor nodules in the liver and a well-demarcated round mass, 4 cm, in the left adrenal, with necrosis and hemorrhage. Microscopic findings revealed largely undifferentiated neuroblastoma with focal neuronal differentiation and areas of necrosis and calcification in the background of fine fibrovascular stroma. Other metastatic foci were detected in the right adrenal and pituitary gland.
Female ; Humans ; Neoplasm Metastasis ; Neuroblastoma