OBJECTIVE:To establish a rapid method for the concentration determination of lamotrigine (LTG) in human se-rum. METHODS:HPLC was adopted after serum samples treated with methanol. The column was Hypersil BDS C18(200 mm×4.6 mm,5μm)with the mobile phase of methanol-KH2PO4(45∶55,V/V)at the flow rate of 1 ml/min,the detection wavelength was 250 nm,and the temperature was 35℃. RESULTS:The linear range of LTG was 0.5-30.0 μg/ml(r=0.999 9). The RSDs of intra-day and inter-day were all less than 5% and the recovery was 101.96%-102.74%. CONCLUSIONS:The method is simple,accurate and fast,and suitable for the monitoring of LTG serum concentration.

Guangdong province assumes the task of pilot exploration and demonstration for building the preventive health service system of Chinese medicine. In the pilot process of preventive treatment of disease, a health pro-ject of Chinese medicine, sectoral agreements and policy studies are focusing issues. This paper explores the pre-ventive health service system building of Chinese medicine in G uangdong province , from following aspects such as access policy of service agencies, access policy of professional service staff, evaluation mechanism and verify sys-tem, the revision of existing medical subjects of medical institutions, health insurance policies and compensation policies, price policies, proactive technology policies and fiscal policies, incentive policies for the introduction of private capital .

Objective To evaluate the clinical significance of antiplatelet antibody in patients with systemic lupus erythematosus complicated with thrombocytopenia.Methods Antiplatelet antibody (anti-GP Ⅱb/Ⅲa antibody, anti-GP Ⅰb/Ⅸ antibody, anti-GP Ⅰa/Ⅱ a antibody, anti-GP Ⅳ antibody) were detected by modified antigen capture ELISA. The positive rate of antiplatelet antibody between SLE complicated with thrombocytopenia group and without thrombocytopenia group before therapy were compared,and the positive rate of antiplatelet antibody before therapy and after therapy in SLE complicated with thrombocytopenia were compared,and the relevance between antiplatelet antibody and conditions in SLE complicated with thrombocytopenia were analyzed. Rank test and Chi square test were used for statistical analysis. Results The positive rate of anti-GP Ⅱb/Ⅲa antibody and anti-GP Ⅰb/Ⅸ antibody in SLE complicated with thrombocytopenia group before therapy was 50% and 67% respectively, however,the positive rate in SLE without thrombocytopenia group before therapy was 11% and 28% respectively,there was significant difference between the two groups (P＜0.05) and the positive rate of anti-GP Ⅱb/Ⅲa antibody and anti-GP Ⅰb/Ⅸ antibody in SLE complicated with thrombocytopenia group after therapy was 6% and 28% respectively, which was significantly lower than those before therapy (P＜0.05). In SLE complicated with thrombocytopenia group before therapy, there was significant relevance between anti-GP Ⅱb/Ⅲ a antibody and anti-GP[b/Ⅸ antibody, and there was significant relevance between these two antibodies and SLEDAI score,but no significant relevance between these two antibodies and ANA,dsDNA, ANCA. Neither anti-GPⅣ antibody nor anti-GP Ⅰ a/Ⅱ a antibody was detected in patients of this study. Conclusion The positive rate of antiplatelet antibody (anti-GP Ⅱb/Ⅲ a antibody, anti-GP Ⅰb/Ⅸ antibody) is significantly higher in patients with active systemic lupus erythematosus complicated with thrombocytopenia,and these two antibodies are significantly associated with clinical outcomes.

ObjectiveTo investigate the gene expression profiling of articular chondrocyte and the function and pathway of the differentially expressed genes in patients with osteoarthritis (OA) by using gene microarray technique.MethodsThree patients with OA,three patients with rheumatoid arthritis(RA) and three traumatic controls without arthritis were selected and were divided into OA versus RA and OA versus the traumatic control groups,and their articular cartilage cells were cultivated.The gene expression profiling was performed by human genome oligonucleotide microarray technique.The differences of gene expression of the articular chondrocyte in OA versus RA group and OA versus the traumatic control group were compared respectively by two class unpaired test using significant analysis of microarray software.The function and pathway of these differentially expressed genes were analyzed by using the database of Molecule Annotation System.ResultsThe number of differentially expressed genes was 145 when OA compared with the traumatic control,in which 70 were up-regulated and 75 were down-regulated; and the number was 281 when OA were compared with RA,in which 94 were up-regnlated and 187 were down-regulated.The Gene Onto-logy (GO) functions of the differentially expressed genes of OA in each group were related to pathological and immune courses including cellular process,physiological process,cell division,biological regulation and cell signal transduction.The statistically significant pathways of these genes in each group included apoptosis pathway,cell cycle pathway,P53 signaling pathway,Fas signaling pathway,NO pathway,apeptotic cascade pathway,focal adhesion pathway, ECM-receptor interaction pathway, tight junction pathway, adhesive bonding pathway,actin cytoskeleton regulation pathway,bone remodeling pathway,chondroitin sulfate biosynthesis pathway,Jak-STAT signaling pathway,Wnt signaling pathway,Toll recepor signaling pathway,cell adhesion molecules pathway,T cell receptor signaling pathway,and s o on (P＜0.05).They displayed not only marked dif-ferences in GO function and gene pathway of differentially expressed genes between OA versus RA group and OA versus the traumatic control group,but also displayed the significant overlapping of the differentially expressed genes and pathways between the two groups.ConclusionThe differentially expressed genes and pathways of articular chondrocytes involve apoptosis,extracellular matrix and cytokines in OA,which contri-bute to further study of early warning genes of OA.

ObjectiveTo explore the prevalence and clinical features of hyperuricemia and its influencing factors in elderly male people aged 90 years and above. MethodsOne hundred elderly male people aged 90 years and above who underwent routine health examination in our hospital in 2007 were selected in the study. Serum uric acid level was examined by uricase-peroxidase method, and all patients were divided into hyperuricemia group and control group according to the serum uric acid level. Clinical and biochemical indications were compared between the two groups, and logistic regression was used to analyze the influencing factors of hyperuricemia in elderly people. ResultsThe serum uric acid level was increased in 20% of the elderly people, and the prevalence of gouty arthritis was 1%. The levels of blood urea nitrogen and serum creatinine were higher in hyperuricemia group than in control group[(10. 98±4.29) mmol/L vs. (6. 87± 1.86) mmol/L, (125.2±25.9)μmol/L vs. (93. 4±19. 8)μmol/L;both P<0.05)3. The patients in hyperuricemia group had a higher prevalence of hypertension and hypertriglyceridemia, and a higher proportion of diuretic application than patients in control group(P<0. 05). Logistic regression analysis showed that serum uric acid level had the most remarkable correlation with serum creatinine(OR= 1. 969), followed by fasting blood glucose (OR= 1. 310)and blood urea nitrogen(OR = 1.161). There was negative correlation between serum uric acid level and plasma cholesterol level(OR = 0. 802). ConclusionsThe prevalence of hyperuricemia is high in elderly people aged 90 years and above, while the incidence of gouty arthritis is low. Renal function impairment, metabolic syndrome and thiazide diuretic are the major factors for hyperuricemia.

BACKGROUND: Dysfunction of endothelial cells is independently associated with coronary atherosclerotic heart disease. Correlation of dysfunction of endothelial cells to restenosis after stent implantation is not yet clearly determined.OBJECTIVE: To evaluate the correlation of vascular endothelial dysfunction to restenosis after stent implantation. DESIGN, TIME AND SETTING: A case control study was performed at the Department of Cardiology and Department of Heart Ultrasound, Sichuan People's Hospital from March 2005 to January 2007.PARTICIPANTS: After review, coronary angiography showed that 11 patients who occurred restenosis at the lesion region after stent implantation were included in a restenosis group, and an additional 15 patients who did not develop in-stent restenosis were included in a control group. Patients in the following conditions were excluded: over 70 years old, histories of long-term smoking, diabetes mellitus, multivessel disease, long coronary lesion and chronic total occlusion, heart failure (Killip's class Ⅲ or above), severe hepatic and/or renal insufficiency.METHODS: High-resolution ultrasound was used to assess the percentage of flow-mediated dilatation of brachial artery. Differences in endothelial function were compared between both groups.MAIN OUTCOME MEASURES: Ultrasound parameter of the brachial artery in both groups; Partial correlation analysis on control variable including sex, age, blood lipid level, diseased region and stent type.RESULTS: No significant difference was found in basic diameter of brachial artery in both groups. During reactive hyperemia, inner diameter and its absolute variation of brachial artery were smaller in the restenosis group than in the control group (P<0.01). The percentage of brachial artery flow-mediated dilatation was lower in the restenosis group compared with the control group (P=0.013). The partial correlation coefficient between the percentage of flow-mediated dilatation of brachial artery and in-stent restenosis was 0.47 (P=0.04).CONCLUSION: The endothelial dysfunction significantly decreases in patients with restenosis compared with controls following stent implantation. There is a correlation between endothelial dysfunction and restenosis.

Objective: To investigate the epidemiological characteristics of varicella outbreaks in primary and middle schools, and to establish a risk predictive model, so as to provide scientific guidance for the prevention of varicella outbreaks in schools. Methods: Based on a nested case-control study, primary and middle schools in 4 districts of Shanghai (Yangpu District and Jingan District) and Hangzhou (Xiaoshan District and Linping District) from January to December 2023 were selected to observe the status of varicella outbreaks. Associated factors of varicella outbreaks were investigated and used for establishing the predictive model, which was evaluated by the Hosmer-Lemeshow(H-L) goodness of fit test, receiver operating characteristic (ROC) curve, Calibration curve, decision curve analysis (DCA). Results: A total of 98 varicella outbreaks were included, with 195 schools without varicella outbreaks during the same period as controls. Eight factors, including the availability of warm water in restroom, availability of hand soap in restroom, average class size, duration of student attendance at school per day, presence of a fulltime school doctor, hesitancy of the school principal towards varicella vaccination, and rates of first and second doses of varicella vaccination, were identified as potential factors for school varicella outbreaks, with statistically significant differences (χ2/Z=10.01, 20.49, 17.43, 9.74, 32.17, 6.60, 2.20, 3.39, P<0.05). The 8 variables above were employed to construct a risk predictive model, and Hosmer-Lemeshow goodness of fit test yielded a χ2 value of 5.863 (P>0.05); the area under the ROC curve (AUC) was 0.846 (95%CI=0.799-0.893); Calibration curve analysis indicated good consistency between predicted and actual values of the model. DCA demonstrated favorable predictive performance of the model over a wide range. Conclusions The predictive model for school varicella outbreaks demonstrates satisfactory accuracy and efficacy. It suggested to make good use of this prediction model and take relevant measures to reduce the risk of varicella transmission in schools.

Objective To study the clinical events and risk factors of in stent restenosis (ISR) during the ＞1 year follow-up period after vertebral artery stenting.Methods Forty-six patients with 48 stents implanted from the Shaoxing No.2 Hospital between January 2010 and October 2016were divided into ISR group (n=8) and ISR-free group (n=38) or clinical events group (n=8)and clinical events-free group (n=38).The influencing factors for their long-term clinical outcome were analyzed after vertebral artery stenting.Results The mean stenosis length was (7.7 ± 4.6mm,the stenosis severity was 80.7％±14.2％,and the residual stenosis was 3.0％±8.4％ before stenting.The mean angiographic follow-up time was 31.6±20.8 months,during which ISR occurred in 8 patients (17.4％).The mean clinical follow-up time was 53.8±27.0 months,during which clinical events occurred in 8 patients (17.4％).Survival analysis showed that ISR usually occurred in the first 20 months and no clinical events occurred in 23 patiemts (50.0％) after vertebral artery stenting.The stenosis was significantly longer in ISR group than in ISR-free group (6.00±2.00 mm vs 2.76±4.14 mm,P=0.003).The diameter of stents was significantly shorter in clinical events group than in clinical events-free group (3.53±0.93 mm vs 4.18±0.67 mm,P=0.024).Conclusion The long-term clinical follow-up outcome is associated with the length and diameter of stents in patients after vertebral artery stenting.

Objective:To understand the current situation and problems of pediatric drug clinical trials in China, and provide reference for the healthy development of pediatric drug clinical trials.Methods:Such keywords as " pediatrics" " children" " annual reports" " children′s drug research and development" " policies" were used, to search for information on China′s pediatric drug research and development policies and regulations, pediatric drug clinical trial institutions and pediatric drug clinical trial professional registration status, as well as pediatric drug clinical trial project registration status as of October 2023 on the drug clinical trial institution registration management information platforms and relevant government department websites. Then descriptive analysis was made on the collected information.Results:China has released 9 policies and regulations on pediatric drug research and development, supporting the development of new varieties, dosage forms, and specifications of pediatric drugs that meet the physiological characteristics of children, and giving priority review and approval to pediatric drugs. 477 drug technology guiding principles have been released, but only 14 of them were specifically designed for pediatric populations. As of March 20, 2023, there were a total of 272 registered pediatric drug clinical trial institutions, accounting for 20.72% of the total number of registered institutions. The top 5 provinces for their number of registered institutions were Guangdong province (34), Henan province (21), Zhejiang province (20), Beijing (20), and Jiangsu province (18); A total of 26 clinical trial specialties for pediatric drugs have been registered, with the largest number of registrations being pediatric respiratory (143), pediatric hematology (72), pediatrics other (71), pediatric endocrinology (68), and pediatric neurology (64). From 2020 to 2022, the proportion of pediatric drug clinical trial registration projects in newly registered drug clinical trials was 8.8% (129/1 473), 8.3% (168/2 033), and 8.3% (164/1 974), respectively, while clinical trials conducted only in the pediatric population accounted for 2.2% (33/1 473), 3.0% (61/2 033), and 3.2% (64/1 974), respectively.Conclusions:The policies and regulations on pediatric drug research and development in China still need further improvement. The number of registered pediatric drug clinical trial institutions and pediatric specialties is lower than that of adults and distributed unevenly. Clinical trial registration projects for pediatric drugs, especially those conducted in the pediatric population, account for a relatively small proportion. It is recommended to further improve the policy system for drug research and development in the pediatric population, optimize the layout of pediatric drug clinical trial institutions and specialties in the country.