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 evaluate the self-treatment effectiveness on patients with ehwnic Keshan disease.Methods Twenty patients with chronic Keshan disease were selected from individuals with Keshan disease in Fuyu County,Heilongjiang Province.They were trained three times every three months of self management including pathogenetic condition education,general guidance,drug therapy,and they also taught how to adiust the doBe of drug according to their illness.Major symptom score,heart rate(HR),ultrasoundcardiogram (UCG)index and cardiac functional grading of these patients at basehne,after 3 months and 6 months of treatment were compared.Results The 20 patients rated their main symptoms score as(15.03 ±6.77)before self- treatrnent,and significantly decreased to(7.25±4.82)and(6.70±4.90)after 3 and 6 months treatment(P<0.01); the heart rate(HR) was (76.40±12.06) beats per minute(bpm)before self-treatment,and dramatically decreased to (69.95±12.63),(67.15±9.76)bpm after 3 and 6 months treatment(P<0.01).As for UCG detecting index,left atrial diameter(Lad)aIld left ventricular end-diastolic diameter(LVEDd)Was(37.85 ±5.23)nun and(52.49± 9.38)mm separately before self-treatment,and notablely decreased to(36.77 ±5.63),(52.15 ±9.24)mm,and (35.29±5.50),(50.81±8.88)mm respectirely after 3 and 6 months of treatment(P<0.01 or<0.05);left ventricuIar ejection fractiOII(LVEF)markedly increased(P<0.05),from(55.15±15.80)%at baseline to(57.35± 12.51)%at 3 months and(60.30±13.42)%at 6 months;there were no significant differences in mitral flow E/A ratio changes before and after treatment(P>0.05);compared with prior to the treatment.cardiac function grading was significantly better aftertreatmentfor 3 months(T=36.0,P<0.05),but not after 6 months(T=17.5,P> 0.05).Conclusions The patients'serf-treatment is effective,which we recommend to uphold and widespread.

Objective To observe the change in cardiac shape and heart function and evaluate the effect of self-treatment on patients with Keshan disease by echocardiography. Methods To check the 31 patients with Keshan disease before the self-treatment, and follow them up in the 3rd and 6th months after self-treatment by echocardiography. The left atrium diameter(LAd), left ventricular end-diastolic diameter(LVEDd), the thickness of interventricular septum in end-diastolic(IVSTd), the thickness of LV posterior wall in end-diastolic (LVPWTd), left ventricular mass(LVM), left ventricular mass index(LVMI), left ventricular ejection fraction(LVEF) and mitral valve flow E/A ratio(E/A) were measured. Results The LAd[(35.8±5.1)ram] and LVPWTd[(9.3±1.0)mm] obviously decreased in the 3rd month after serf-treatment compared with prior self-treatment [ (37.0±5.0), (9.9± 1.2)mm](P<0.05). The LAd[(34.5±5.0)mini, IVSTd[(9.5±1.3)mm], LVEDd[(50.2±7.7)mm], LVPWTd [(8.7±1.1)mm], LVM[(196.1±87.2)g] and LVMl[(126.5±56.4)g/m2] obviously decreased in the 6th month after self-treatment compared with prior self-treatment [(37.0±5.0), (10.2±1.5), (51.3±8.1), (9.9±1.2)mm, (230.4±95.5)g, (144.0±54.6)g/m2] and in the 3rd month after self-treatment [(35.8±5.1)mm, (10.2±1.4) ram, (51.1±8.1)nun, (9.3±1.0)mm, (219.4±82.5)g, (136.8±50.0)g/m2] (P<0.05). The results of the mitral valve flow E/A ratio and LVEF in the 3nt month after self-treatment [1.0±0.5, (59.4±13.3)%] were increased compared with the prior self-treatment[0.9±0.5, (58.1±15.6)%], and the results in the 6th month after self-treat- ment[ 1.0±0.4, (60.7±13.6)%] were further inereased compared with before, but there was no signifieant differ- ence(P0.05). Conclusions Self-treatment of Keshan disease patients can improve the heart function by pre- venting left ventrieular remodeling and reversing. Echocardiography can be used as an essential technique to evalu- ate the effect of self-treatment on Keshan disease patients.

Aged ; Diabetes Mellitus, Type 2 ; complications ; Humans ; Male ; Middle Aged ; Neoplasm Grading ; Prostate-Specific Antigen ; blood ; Prostatic Neoplasms ; blood ; etiology ; pathology ; Retrospective Studies

At present, the study of clinical practice guide focuses on the quality of the guide, but not enough attention to the reporting standards of the practice guide, so how to standardize the report is an urgent problem in the field of evidence-based medicine. This paper uses the latest practice guidance reporting tool RIGHT standard, analyzes the latest two sepsis practice guidelines at home and abroad, and found that there are few problems in the basic information, recommendations and other information in 7 major areas, and many deficiencies in background, evidence, review and quality assurance, funding and declaration and management of interests, in particular, domestic guidance. We hope that the researchers will use the RIGHT standard to develop new guidelines for sepsis or other areas, standardize the report of the guide, especially the writing of traditional Chinese medicine guide, should reflect the characteristics of traditional Chinese medicine.

OBJECTIVE: Plant-derived cytotoxic transgene expression, such as trichosanthin (tcs), regulated by recombinant adeno-associated virus (rAAV) vector is a promising cancer gene therapy. However, the cytotoxic transgene can hamper the vector production in the rAAV producer cell line, human embryonic kidney (HEK293) cells. Here, we explored microRNA-122 (miR122) and its target sequence to limit the expression of the cytotoxic gene in the rAAV producer cells. METHODS: A miR122 target (122T) sequence was incorporated into the 3' untranslated region of the tcs cDNA sequence. The firefly luciferase (fluc) transgene was used as an appropriate control. Cell line HEK293-mir122 was generated by the lentiviral vector-mediated genome integration of the mir122 gene in parental HEK293 cells. The effects of miR122 overexpression on cell growth, transgene expression, and rAAV production were determined. RESULTS: The presence of 122T sequence significantly reduced transgene expression in the miR122-enriched Huh7 cell line (in vitro), fresh human hepatocytes (ex vivo), and mouse liver (in vivo). Also, the normal liver physiology was unaffected by delivery of 122T sequence by rAAV vectors. Compared with the parental cells, the miR122-overexpressing HEK293-mir122 cell line showed similar cell growth rate and expression of transgene without 122T, as well as the ability to produce liver-targeting rAAV vectors. Fascinatingly, the yield of rAAV vectors carrying the tcs-122T gene was increased by 77.7-fold in HEK293-mir122 cells. Moreover, the tcs-122T-containing rAAV vectors significantly reduced the proliferation of hepatocellular carcinoma cells without affecting the normal liver cells. CONCLUSION HEK293-mir122 cells along with the 122T sequence provide a potential tool to attenuate the cytotoxic transgene expression, such as tcs, during rAAV vector production.
Animals ; Dependovirus/genetics* ; Genetic Therapy ; Genetic Vectors/genetics* ; HEK293 Cells ; Humans ; Mice ; MicroRNAs/genetics* ; Trichosanthin

OBJECTIVE: To assess the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids, SZ-A) for treatment of type 2 diabetes in a randomized, double-blind, placebo-controlled multicenter clinical trial. METHODS: A total of 200 patients were randomized to receive SZ-A (n=100) or placebo (n=100) for 16 weeks. The data analysis system for electronic data capture clinical trial central randomization system was used for randomization and dispensing of drugs. The primary outcome was the change in glycosylated hemoglobin (HbA1c) level. The secondary outcome included the proportions of cases with HbA1c <7.0% and HbA1c <6.5%, fasting blood glucose (FBG), postprandial blood glucose (PBG), area under curve for the PBG (AUC_0-2h), body weight, and body mass index (BMI). Adverse events (AEs), severe adverse events (SAEs), treatment-related adverse events (TAEs), gastrointestinal disorders (GDs), blood pressure, routine blood tests, and liver and kidney function were monitored. RESULTS: Compared with baseline, the change of HbA1c at week 16 was -0.80% (95% CI: -0.98% to -0.62%) and -0.09% (95% CI: -0.27% to 0.09%) in SZ-A group and placebo group, respectively. The proportion of patients with HbA1c <7% and <6.5% was higher in the SZ-A group than in the placebo group (46.8% vs. 21.6% and 29.9% vs. 10.8%). The observed values and changes in FBG, 1 h-PBG, 2 h-PBG, and AUC_0-2h differed significantly between groups (P<0.001), but differences were not significant in body weight and BMI (P>0.05). The incidence rates of AEs, TAEs, and GDs differed significantly between groups (P=0.010, P=0.005, and P=0.006, respectively), whereas the incidence rates of SAEs showed no significant differences between groups (P=1.000). CONCLUSION SZ-A are effective and safe for treatment of type 2 diabetes. The protocol was registered in http://www.chictr.org.cn/showproj.aspx?proj=60117 (ChiCTR2000038550).
Alkaloids ; Blood Glucose ; Diabetes Mellitus, Type 2/drug therapy* ; Double-Blind Method ; Glycated Hemoglobin A ; Humans ; Hypoglycemic Agents/therapeutic use* ; Morus ; Tablets/therapeutic use* ; Treatment Outcome