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

Objective To value the clinical application of diffusion tensor imaging (DTI) in cerebral diseases. Methods Six volunteers and 6 patients (including 3 patients with ischemic stroke and 3 patients with glioma) were examined by DTI and T1weighted, T2weighted MR scan. All data were processed with DtiStudio software to show the white matter fiber tracts. The fractional anisotropy (FA) of the diffusion tensor were measured between the affected and the unaffected side. Results The white matter fiber tract could be observed clearly on the FA map. The pyramidal tract with different degree disruption could be showed in 3 patients with ischemic stroke. Compression, displacement, infiltration or destruction of pyramidal tract, corpus callosum or internal capsule and external capsule could be seen in 3 patients with glioma, and FA was significantly reduced on the affected side as compared to the unaffected side. Conclusion Diffusion tensor imaging is useful in observing the damage and displacement of the white matter fiber tracts in vivo, beneficial to the surgical plan for patients and prognosing recovery of function.

Objective To investigate the prevalence of subclinical hypothyroidism and its relation to serum total cholesterol (TC),triglyceride (TG) levels and non-alcoholic fatty liver.Methods Serum levels of TC,TG, TSH,TT_3 and TT_4 were determined in 1 602 subjects which were divided into groups by sex and age (20-39,40- 59 and≥60 years).Fatty liver was diagnosed by type B ultrasonography.Restults ( 1 ) Prevalence of subclinical hypothyroidism was 6.6% in this population.(2) The mean levels of serum TC and TG in subclinical hypothyroidism group and normal group showed no significant difference ( both P＞0.05 ).(3) On the whole,the prevalences of subclinical hypothyroidism in hypercholesterolemia group and normal cholesterolemia group showed significant difference (P＜0.01 ).(4) In the three age groups of male and few.ale examinees,the prevalences of subclinical hypothyroidism in hypercholesterulemla group and normal cholesterolemia group showed no significant difference ( all P＞0.05 ).In the multiple regression analysis,TSH level was not related with raised TC level.(5) In the three age groups of male,there was no significant difference between the prevalences of subclinical hypothyroidism in hypertriglyceridemla group and normal triglyceridemia group ( all P＞0.05 ).In female,expect for the elderly group (＞60 years old ),the prevalence of subclinical hypothyroidism was higher in hypertriglyceridemia group than that in normal triglyceridemia.However,in the multiple regression analysis, increased TSH level was positively associated with increased serum TG level ( OR = 1.072,P=0.013 and OR = 1.102,P = 0.03 ).(6) The prevalence of subclinical hypothyroidism in non-alcobolic fatty liver group and normal group showed no significant difference ( P＞0.05 ).In the multiple regression analysis,TSH level was not the independent risk factor of non-alcoholic fatty liver (P＞0.05 ).Conclusion Subclinical hypothyroidism is not asseciated with serum TC level but positively associated with serum TG level.Subclinical hypothyroidism does not apparently increase the prevalence of non-alcoholic fatty liver.

AIM:To evaluate 23G vitrectomy for macular edema in eyes with retinal vein occlusion (RVO) combined with vitreoretinal traction (VMT) or epiretinal membrane (ERM).METHODS:Totally 22 patients (22 eyes) diagnosed with macular edema of RVO combined with VMT or ERM were retrospectively analyzed.Twelve cases performed with 23G vitrectomy together with peeling of inner limiting membrane (ILM) and/or ERM were considered as the observation group or intervention group.Ten cases without vitrectomy were recruited as control group.The best corrected visual acuity (BCVA) and central retinal thickness (CRT) at baseline, 1, 3 and 6mo were recorded and compared.RESULTS:At baseline, the difference of BCVA and CRT between observation group and control group was not statistically significant (P=0.645, 0.206).After vitrectomy, the BCVA and CRT of RVO patients in observation group were significantly improved compared with baseline at each follow-up (F=2.895, P=0.048;F=16.431, P<0.01).However, the BCVA and CRT in control group remained the same as baseline at every follow-up.Moreover, the BCVA and CRT in observation group were much better than that in control group at both 3 and 6mo after vitrectomy.However, the BCVA and CRT between two groups were not significantly different at 1mo postoperatively.CONCLUSION:The 23G vitrectomy could markedly improve BCVA and reduce CRT in RVO patients with macular edema combined with VMT and/or ERM.

A new wood-degrading fungus Monodictys asperospera(Cooke & Massee) Ellis with a high level of laccase production was chosen to study.This laccase was purified by ammonium sulfate precipitation,DEAE-cellulose and sephacryl S-300.Purification of about 8.1 fold was achieved with an overall yield of 5.7%.Its molecular weight was estimated to be about 77 kD.The optimum temperature and pH of the lac-case activity were 55?C and 6.0,respectively.Kinetic studies of the laccase showed that the Km and the Vmax for using syringaldazine as substrate was 0.163 mmol/L and 0.194 mmol/(L.min),respectively.The carbo-hydrate content was 18.14%.In addition,it was found that laccase activity was significantly inhibited by Cu2+.

Objective To study the expression of MCP-1 and its correlation with SSc.Methods Twenty-seven patients with SSe and 21 healthy control subjects were examined for MCP-1 expressions by ELISA.mRNA and protein of MCP-1 in fibroblast cells from 5 SSc patients and 3 healthy subjects were also measured by RT-PCR and immunohistochemistry.At the same time,the correlation between the expression levels of MCP-1 and SSc was analyzed.Results The plasma level of MCP-1 was significantly higher in pa- tients with SSc than in healthy control subjects(787?393)pg/ml versus(426?266)pg/ml,P

Objective To establish and evaluate a gene microarray for determination katG mutations of Mycobacterium tuberculosis isolates associated with resistance to isoniazid(INH).Methods A panel of probes were designed and gene chips were prepared by dotting.Mycobacterium tuberculosis isolates resistance to 5 drugs was determined by proportional dilution methods.Amplicons of Mycobacterium tuberculosis isolates were detected by our chip and sequenced.Results The drug resistance rate of the isolates to at least one of the anti-tuberculosis drugs was 70.8%(97/137).45 strains out 137 Mycobacterium tuberculosis isolates was resistant to INH(32.8%).katG was successfully amplified from 100% of the susceptible strains and 88.9%(40/45)resistant strains.4 of 45 INH resistant isolates' katG were deleted.27 of 40(67.5%) katG has been detected to have katG 315 codon mutations.The mutations were 315 AAC(Asn,13/40), ACC(Thr,6/40),ACA(Thr,4/40),ATC(Ile,2/40),AGC(Arg,2/40).The mutation rate of katG analyzed by gene chips we prepared were identical to katG sequencing.Conclusion The gene microarray techniques we developed for determination of Mycobacterium tuberculosis resistance to INH are specific, sensitive and may be used as an alternative in clinical laboratory.

Apoptosis ; drug effects ; Cell Division ; drug effects ; Esophageal Neoplasms ; pathology ; Humans ; Selenomethionine ; pharmacology ; Tumor Cells, Cultured

International clinical trials register is one of the global measures to realize transparency in clinical trials and also one of a powerful measure to improve the quality of clinical trials. Many scholars studying the quality of TCM clinical trials find that they are poor in quality and lack transparency. Furthermore, they find that TCM clinical trial registry has many problems. We must base on the successful experiences of WHO and international clinical trial registry to establish technical specifications for registry of traditional Chinese medicine clinical study of their own. Then, it can effectively improve the overall level of TCM clinical studies. We have suggested some concrete and feasible measures to establish technical specifications for registry of traditional Chinese medicine clinical study of their own based on the problems of TCM clinical trial registry.
Biomedical Research ; Humans ; Medicine, Chinese Traditional ; standards ; Registries

In recent 10 years, clinical trials of Chinese medicine and pharmacy (cMP) at clinicalTrials.gov.(USA) are gradually increasing. In order to analyze features of CMP clinical register, ClinicalTrials.gov register database were comprehensively retrieved in this study. Included clinical trials were input one item after another using EXCEL. A final of 348 CMP clinical trials were included. Results showed that China occupied the first place in CMP clinical register, followed by USA. CMP clinical trials, sponsored mainly by colleges/universities and hospitals, mostly covered interventional studies on evaluating safety/effectiveness of CMP. The proportions of studies, sponsored by mainland China and companies, recruitment trials and multi-center clinical trials in interventional trials were increasing. The proportions of studies sponsored by Hong Kong and Taiwan, research completed trials, unclear research status, phase III clinical trials, and published research trials in interventional trials were decreasing. Published ratios of CMP clinical trials were quite low. There were more missing types and higher proportions in trial register information.
Biomedical Research ; China ; Clinical Trials as Topic ; Databases, Factual ; Humans ; Medicine, Chinese Traditional ; United States