Drug safety has always been a global focus. Discovery and accurate information acquisition of adverse drug reaction have been the most crucial concern. Terminology of adverse drug reaction makes adverse reaction medical report meaningful, standardized and accurate. This paper discussed the domestic use of the terminology WHOART and MedDRA in terms of content, structure, and application situation. It also analysed the differences between the two terminologies and discusses the future trend of application in our country
Dictionaries, Medical ; Drug-Related Side Effects and Adverse Reactions ; Terminology as Topic ; World Health Organization

BACKGROUND: Proliferation and differentiation of mesenchymal stem cells (MSCs) is associated with platelet concentration in platelet-rich plasma (PRP). Low enrich multiple cannot reach proper effects, but high level had inhibitory effects on osteoanagenesis.OBJECTIVE: To observe the effect of different volume fraction of PRP on dog BMSC proliferation.DESIGN: A cytological in vitro study.MATERIALS: Healthy 12-month male Beagle dogs were supplied by the Experimental Animal Center, Xiangya Medical College,Central South University.METHODS: Dog BMSCs of 5 passage were adjusted to 3×10~8/L, and incubated in a 96-well plate at 200 μL per well. Following 24 hours of routine culture, primary medium and non-adherent cells were discarded. Prepared PRP gel was mixed with serum-free low-glucose DMEM containing penicillin and streptomycin, and then diluted into 5%, 6.25%, 7.5%, 8.75%, 10% volume fraction. 200 μL above-described liquid was added into the 96-well plate, which was subsequently placed in a incubator.We set up a blank control.MAIN OUTCOME MEASURES: MTT was used to investigate effect of different volume fraction of PRP on dog BMSC proliferation.RESULTS: Compared with the blank control group, various volume fraction of PLP could promote dog BMSC proliferation in early stage. With prolonged time, proliferation speed began to increase at day 6 in the 8.75% and 10% PRP groups, entering platform stage. BMSC number was increased rapidly in the 5% and 6.25% PRP groups, especially in the 6.25% PRP group.CONCLUSION: PRP gel could promote BMSC proliferation markedly and proliferation strength of BMSCs was correlated to the density of PRP. BMSC proliferation would be accelerated by the low density of PRP.

BACKGROUND: Platelet-rich plasma (PRP) contains abundant growth factors that were needed for osteanagenesis. Moreover,the proportion of each growth factor formed by an organism, with good synergism.OBJECTIVE: To explore the influence of PRP on osteogenetic activity of canine bone marrow mesenchymal stem cells (BMSCs) after induction in vitro.DESIGN, TIME AND SETTING: The in vitro cytological experiment was performed at the Central Laboratory of Xiangya Hospital of Central South University from June 2007 to February 2008.MATERIALS: Healthy 12-month male Beagle dogs were supplied by the Experimental Animal Center, Xiangya Medical College,Central South University.METHODS: The 3~(rd) generation BMSCs were collected and divided into 4 groups. BMSCs in the control group were incubated in standard medium. BMSCs in the osteogenetic induction medium group were incubated in high-glucose DMEM containing fetal calf serum, dexamethasone, beta-sodium glycerophosphate and vitamin C. BMSCs in the PRP group were incubated in low-glucose DMEM containing 6.25% PRP. BMSCs in the combination group were incubated in high-glucose DMEM containing 6.25% PRP, dexamethasone, beta-sodium glycerophosphate, and vitamin C.MAIN OUTCOME MEASURES: Alkaline phosphatase activities were measured. Expression of collagen type I was examined by immunocytochemical staining. Calcium tuberoses were labeled using modified Von Kossa staining. Expression of osteocalcin mRNA was examined by RT-PCR.RESULTS: Levels of alkaline phosphates of all groups became increased along with time. The alkaline phosphates level of combination group was strongest (P < 0.05). Following 7 and 14 days of induction, type I collagen expressed positively in the osteogenetic induction medium and combination groups, but negatively in the PRP and control groups. Following 14 days,formation of calcium nodules were found in the osteogenetic induction medium and combination groups. Following 7 and 14 days,expression of osteocalcin mRNA were similar between the control and PRP groups (P > 0.05), which was significantly lower than the osteogenetic induction medium and combination groups (P < 0.05). Expression of osteocalcin mRNA was significantly lower in the osteogenetic induction medium group compared with the combination group (P < 0.05).CONCLUSION: PRP gel can effectively promote osteoblastic effect of BMSCs after induction in vitro following induction in osteogenetic medium.

Objective To evaluate the preliminary outcome of postoperative three-dimensional conformal radiation therapy(3DCRT)as compared with conventional radiation therapy(CRT)in stageⅢA non-small cell lung cancer(NSCLC).Methods From December 1994 to February 2002,114 such patients received postoperative radiotherapy in M.D.Anderson Cancer Center,with 63 patients in CRT group and 51 in 3DCRT group.The median radiation dose was 53.5 Gy/27f/5-6w and 52.8 Gy/26f/5-6w in CRT and 3DCRT group, respectively.Results The median follow-up time was 28 and 13 months in CRT and 3DCRT group.The 1-,2- year overaLl survival were 80%,62% and 93%,70%.The 1-,2-year disease free survival was 62%,44% and 58%,32% in CRT group and in 3DCRT group,respectively.There was no significant difference between CRT group and 3DCRT group in terms of overall survival,disease-free survival,local-regional control,distant metastasis-free survival or treatment-related complication.There was significant difference in the death cause between two group,with 4 patients having died of cardiac complication in the CRT group and none in the 3DCRT group.Conclusions Postoperative three-dimensional conformal radiotherapy can reach the same immediate results of conventional radiotherapy in stageⅢA NSCLC,with a lower incidence of cardiac complication. However,the long-term results need further follow-up.

Aim To investigate whether D-galactose cause osteoporosis and the difference compared with the osteoporosis induced by ovariectomy, and to deter-mine whether ovariectomy coupled with D-galactose ac-celerated the progress of osteoporosis and whether es-trogen had a preventive effect on these osteoporosis models. Methods Sixty SPF mice were randomly divided into six groups , namely sham-operated group, D-galactose group, OVX group, OVX + D-galactose group, OVX + D-galactose + diethylstilbestrol group and D-galactose + diethylstilbestrol group. Seventy days later, the right tibia was processed with undecal-cified sections for bone histomorphometric analysis. Results Compared with the sham-operated group, %Tb. Ar, Tb. Th and Tb. N decrease by 50. 4%, 25. 4%, 50. 9% ( P <0.01 ) respectively, Tb. Sp in-creased by 169. 4% (P <0.05), Oc. pm, Oc. No. ,%Oc. S, Oc. N/mm which reflected bone absorption significantly increased ( P < 0.01 ) , and % L. Pm, MAR, BFR/TV, BFR/BV, BFR/BS which reflected bone formation significantly decreased ( P <0.01 ) in OVX group. %Tb. Ar decreased by 30. 4% in D-ga-lactose group, but there was no statistically significant difference. However, the four parameters reflected the bone absorption in D-galactose group increased signifi-cantly ( P<0.05 ) , while the four parameters reflected bone formation decreased significantly ( P < 0.05 ) . OVX+D-galactose group has obvious performance of osteoporosis, but there was no significant difference compared to OVX group, nor to D-galactose group. Estrogen had significant preventive effect on related pa-rameters of osteoporosis induced by D-galactose and o-variectomy coupled with D-galactose. ConclusionsOsteoporosis model of mice can be established by OVX, D-galactose and OVX +D-galactose. Estrogen can effectively prevent bone loss induced by D-galac-tose and OVX+ D-galactose.

OBJECTIVETo adapt the candidate strains of hemorrhagic fever with renal syndrome (HFRS) purified vaccine to Vero cells and to study their antigenicity and immunogenicity.

METHODSThe viral strains H8207 (Hantaan virus, HTN) and Y86013 (Seoul virus, SEO) were continuously propagated in Vero cell by the terminal dilution method and studied the characteristics of virus multiplication, viral titers and the amounts of virus antigen after serial passages. Three batches of crude monovalent inactivated vaccine were developed using the different passages of these 2 viral strains.

RESULTSThe strains H8207 and Y86013 adapted to Vero cells and stably grew on the cells with high titers. Rabbits immunized with the crude vaccines of H8207 and Y86013 showed 100% sero-conversion and the neutralizing antibody titers of the rabbit immune sera reached 1?10 at 4 weeks after 2 times of immunization.

CONCLUSIONSThe results suggest that these 2 candidate strains had adapted to Vero cells, possessed high titers and good immunogenicity and be feasible to prepare the HFRS purified vaccine in Vero cells.

Animals ; Antibodies, Viral ; blood ; Cercopithecus aethiops ; Hantaan virus ; growth & development ; immunology ; Hemorrhagic Fever with Renal Syndrome ; prevention & control ; Mice ; Neutralization Tests ; Rabbits ; Seoul virus ; growth & development ; immunology ; Vaccination ; Vaccines, Inactivated ; immunology ; Vero Cells ; Viral Vaccines ; biosynthesis ; immunology

OBJECTIVETo investigate the relationship between coxsackievirus infection and type 1 diabetes mellitus (T1DM), and observe the changes of T lymphocyte subsets in the development of T1DM.

METHODSWe detected Coxsackievirus RNA by reverse transcription PCR, and measured the change in T-lymphocyte subsets by flow cytometry in 22 cases of newly diagnosed T1DM (group I), 30 patients with diabetes for some time (group II), and 30 healthy subjects (group III).

RESULTSThe positivity rate of coxsackie virus RNA in groups I, II, and III was 55.55%, 23.33%, and 6.67%, respectively, showing a significant difference among the 3 groups (P<0.01). Patients with upper respiratory tract infection had a higher positivity rate for coxsackie virus RNA than those without upper respiratory tract infection in group I (P<0.05). Compared with the control group, the percentage of CD3, CD4 and CD4/CD8 ratio decreased significantly in groups I and II (P<0.01 or P<0.05). CD3, CD4 and CD4/CD8 tended to increase in group II in comparison with group I, and there was an significant difference in CD3 and CD4 between the two groups (P<0.01 or P<0.05). Compared with the control group and CVBRNA-negative group, CVBRNA-positive group showed significantly lowered CD3, CD4, CD8 and CD4/CD8 (P<0.01 or P<0.05).

CONCLUSIONThe occurrence and development of type 1 diabetes is closely related to coxsackie virus infection, and the changes in T lymphocyte subsets serves as a probable mechanism of its pathogenicity.

Adolescent ; Adult ; CD4-CD8 Ratio ; CD4-Positive T-Lymphocytes ; immunology ; CD8-Positive T-Lymphocytes ; immunology ; Coxsackievirus Infections ; complications ; immunology ; Diabetes Mellitus, Type 1 ; complications ; virology ; Female ; Humans ; Lymphocyte Count ; Male ; T-Lymphocyte Subsets ; immunology ; Young Adult

OBJECTIVETo compare two different procedures of colostomy in the laparoscopic- assisted abdominoperineal resection(LAPR), and to reduce the related complications of colostomy.

METHODSSixty- three cases with anorectal cancer undergone LAPR from June 2001 to December 2005 were registered and followed up. Circular stapler anastomosis with sigmoid colon and abdominal skin were applied on 61 cases of the colostomy, and 2 cases were hand sutured. All patients were assigned to group A and B. Thirty- seven cases received the procedure of colostomy through the rectus abdominis peritoneally in group A,other 26 cases through extraperitoneal tunnel and the rectus abdominis in group B.

RESULTSDescending colon, sigmoid colon and rectum were dissected using laparoscopic instruments in 63 cases. No conversion to open procedure and no operative death occurred in two groups of patients. There was no significant difference between two groups in mean operation time, but significant differences were found in the time of return of bowl function[A group (2.4 +/- 1.1)d vs B group (1.9 +/- 0.8)d,P < 0.05], duration of postoperative hospital stay [A group (19.9 +/- 7.8)d vs B group (14.5 +/- 3.9)d,P < 0.01] and stoma related complications(A group 29.4% vs B group 4.0%,P < 0.05). Postoperative hospital stay were shorter, and less colostomy related complications were found in group B.

CONCLUSIONColostomy through extraperitoneal tunnel and the rectus abdominis is a better procedure in LAPR, which can reduce the related complications of colostomy and shorten postoperative hospital stay.

Abdominal Cavity ; surgery ; Adult ; Aged ; Aged, 80 and over ; Anal Canal ; surgery ; Colostomy ; methods ; Female ; Humans ; Laparoscopy ; Male ; Middle Aged ; Neoplasm Staging ; Peritoneum ; surgery ; Rectal Neoplasms ; pathology ; surgery

Based on the deletion information of high virulent PRRSV genome, 3 oligonucleotide primer were designed and synthesized. Specific and sensitive reverse transcription-PCR (RT-PCR) assays were de-veloped for the detection of high virulent PRRSV. The sensitivity and specificity of RT-PCR assays were evaluated, the results showing that the detection limit of the assay was found to be 0.265 pg of tissue total RNA, and the protocol have no cross-reaction with classical swine fever virus, porcine circovirus type 2,pseudorabies virus, streptococcus, haemophilus parasuis and Escherichia coli. Then 36 cell cultures, two PRRSV live vaccine strains and 184 clinical specimens from 52 farms were tested. Five PRRSV field iso-lates were the high virulent PRRSV; two PRRSV live vaccine strains from normal PRRSV, and 123 speci-mens from 42 farmer were positive (only 1 specimen was normal PRRSV). This RT-PCR method proved to be accurate differential diagnosis of the high virulent PRRSV and normal PRRSV with the characteristics of rapidity, sensitivity and specificity, and has a strong clinical relevance.

Objective To evaluate the effect of PTH gene polymorphisms on bone mineral density (BMD) at multiple skeletal sites in normal females.Methods PTH gene phenotype was determined by PCR-RFLP of restriction enzyme Bst BⅠin 596 females aged (46.3?13.7) years (20-80 years),and PCR products with or without enzymolytic site were considered as genotype B or genotype b respectively.BMDs of the anteropesterior spine (AP) and supine lateral spine (Lat) of lumbar vertebrae (L_1-L_4),femoral neck (FN),total hip (T-hip), Ward's triangle (Ward),Trochanter (Troch),forearm [radius+ulna ultradistal (RUUD) and total area of radius + ulna (RUT) ] were measured by DEXA (QDR4500A).Results (1) Hardy-Weinberg equilibrium was evident for PTH polymorphisms.The frequencies of genotype were BB 0.784,Bb 0.208,bb 0.008 and frequencies of alleles B,b were 0.888 and 0.112 respectively in 596 normal females.Frequencies of BB,Bb,bb genotypes were 0.781,0.210,and 0.009 respectively in 347 postmenopausal women and their frequencies of alleles B,b were 0.886,0.114.No significant difference was found between post- and premenopausal women in genotype frequen- cy.(2) Comparing their BMDs of AP,Lat,FN,T-hip,Ward,Troch,RUUD and RUT,there was no significant difference between BB and Bb genotypes of pre- and postmenopansal women groups.(3) Logistic regression analysis failed to show any statistical difference between normal and osteoporosis women with regard to PTH phenotype.Conclusion PTH gene polymorphism has little effect on BMD in normal females.