1.Clinical Investigation on the Effect of INF on Mumps Encephalitis in Children
Chinese Journal of Pharmacoepidemiology 2001;10(1):10-
To evaluate the therapeutic effect of INF on mumps encephalitis in children, 86 eases of mumps encephalitis wererandomly divided into two groups in order to compare the effects of INF and that of rihavirin. The recovery time of fever was 2.1± 0.52 days. The recovery time of parotid gland enlargement was 3.5±0.82 days. The recovery time of nervous system symptoms was 1.62±0.75 days. The comparison showed that the therapeutic effects of IFN was superior to that of ribavirin(P<0.05).
2.Clinical effect of low-frequency electrical pulse therapy combined with α-lipoic acid on diabetic gastroparesis in elderly patients with type 2 diabetes
Dandan ZHANG ; Xiaoyan LUO ; Hui FANG ; Yazhong ZHANG ; Jinli TIAN
Chinese Journal of Geriatrics 2016;35(6):604-607
Objective To investigate the clinical effect of low frequency electrical pulse therapy combined with α-lipoic acid on diabetic gastroparesis in elderly patients with type 2 diabetes.Methods A total of 65 patients diagnosed as diabetic gastroparesis were selected from our hospital and divided into three groups according to random number table:the control group(n =23,the α-lipoic acid treatment),the conventional treatment group (n =16),and the experimental group (n =26,treating with α-lipoic acid combined with low-frequency electrical pulse therapy).All patients received the conventional diabetic therapy.Clinical effects,gastric emptying rate and serum gastrin(GAS) and fasting blood glucose levels were compared before versus after treatment among the three groups.Results The cure and total effective rates were higher in the experimental group than in the control group [46.15% (12 cases) vs.30.43% (7 cases),80.76% (20 cases) vs.65.21% (15 cases),x2 =0.867,P<0.05].There were significant differences in gastric emptying rate,serum gastrin and fasting plasma glucose levels among the 3 treatment groups before versus after treatment.And the gastric emptying rate and serum gastrin level were better improved in the experimental groups compared with the conventional treatment and control groups.Conclusions The low-frequency electrical pulse therapy combined with α-lipoic acid has a significant clinical efficacy,which can improve clinical effects,promote gastric emptying,decrease fasting plasma glucose levels in elderly patients with type 2 diabetes.
3.Antioxidative capability of renal tissues of hypothyroid rats is decreased by iodine deficiency
Jing XU ; Yunfen ZHANG ; Yazhong ZHANG ; Yumei PEI ; Hui FANG
Basic & Clinical Medicine 2010;30(4):374-377
Objective To observe the antioxidative capability and the mRNA expression of sodium pump αl-subunit in kidney of hypothyroid rats by iodine deficiency and illuminate the pathogenesis of kidney damage.Methods Wistar rats were randomly divided into two groups as control group (NT) and hypothyroid group (HT).The rats were all fed with low-iodine diet derived from an endemic goiter area and drank deionized water containing different potassium iodide to duplicate hypothyriod animal models.We determined the morphometric parameters of kidney by routine histology method.The contents of malondialdehyde and free radical scavengers (GSH-PX and SOD) in kid-ney,as well as the activity of Na~+-K~+ ATPase were measured in two groups.The mRNA expression of sodium pump α1 subunit was determined by reverse transcription-polymerase chain reaction.Results Compared with that in the control group,in hypothyroid group (1) serum free T3,free T4,total T3 and total T4 were markedly lower.(2) mean glomerular area and volum diminished markedly.(3)the content of MDA and activity of PGx increased markedly,but the activity of SOD decreased significantly,as well as the one of Na~+-K~+-ATPase.(4)the mRNA expression level of sodium pump α1 subunit was lower.Conclusion In a hypothyroid state,the decrease of antiox-idative capability of kidney resulted in lipid peroxidative damage,atrophy of kidney,decreased activity of Na~+-K~+ -ATPase and degression of sodium pump α1 subunit mRNA expression.
4.Determination of terpenelactones in Yinxingye Soft Capsule by HPLC-ELSD
Yazhong ZHANG ; Yaqiu ZHOU ; Juan WANG ; Jianshen TAO
Chinese Traditional Patent Medicine 1992;0(01):-
AIM: To determine the content of terpenelactones in Yinxingye Soft Capsule(Folium Ginkgo). METHODS: HPLC with Evaporative Light Scattering Detector (ELSD) was established to determine the content of terpenelactones in Yinxingye Soft Capsule. The analysis was carried out on C 18 column. The mobile phase was 1-propanol-THF-water(1∶15∶84). The operating conditions of the ELSD were a nebulizer nitrogen flow-rate of 3.5L?min -1 and an evaporator tube temperature of 115℃. RESULTS: No interference was found in the terpenelactones peak position. The method was simple, with a good linear relationship. The relative standard deviation of reproducibility was 1.04% and the average recovery was 97.1%. CONCLUSION: The method can be used for quality control.
5.The significance, development and prospects of healthcare data integration in new drug clinical trials.
Hongwei CAI ; Yanhong LI ; Zibao ZHANG ; Yazhong DENG
Acta Pharmaceutica Sinica 2015;50(11):1415-9
With the deployment of electronic medical records systems, more and more routine clinical data are recorded electronically, which become a potential data source for new drug clinical trials. In this paper, we summarized the opportunities, challenges, obstacles and the latest development in this field.
7.Relationship between homocysteine level and peripheral artery disease in patients with newly-diagnosed type 2 diabetes
Yumei PEI ; Hewei ZHANG ; Jing XU ; Hui FANG ; Jinli TIAN ; Yazhong ZHANG ; Weiping WU
Chinese Journal of Diabetes 2009;17(12):913-914
Objective To observe the association between homocysteine (Hcy)level and low limb vascular disease(LLVD) in newly-diagnosed type 2 diabetic patients. Methods The study subjects were divided into three groups : control group (NC), newly-diagnosed type 2 diabetes group without peripheral artery disease (T2DM) and peripheral artery disease with newly-diagnosed type 2 diabetes group (T2DM+LLVD).Both Hcy and the ankle-brachial index(ABI) were measured in three groups. Results Compared with NC group, clinical parameters of body mass index,waist-to-hip ratio,systolic blood pressure, total cholesterol(TC),triglycerides(TG),low density lipoprotein-cholesterol(LDL-C),and glycated hemoglobin A1C (HbA1c) increased markedly,and the content of high density lipoprotein-cholesterol (HDL-C) was markedly lower in both T2DM and T2DM+LLVD groups.In T2DM+LLVD group the contents of Hcy,LDL-C and HbA1c were markedly higher than in T2DM group,but the content of HDL-C decreased significantly.Hcy was independently associated with the development of peripheral artery disease in newly-diagnosed type 2 diabetic patients by logisitic regression analysis. Conclusions Increased Hcy is an independent risk factor for peripheral artery disease in newly-diagnosed type 2 diabetes.
8.Study on the antioxidative capability and Na+-K+-ATPase α1-subunit mRNA expression in myocardinm of hypothyroid rats
Hui FANG ; Yumei PEI ; Yazhong ZHANG ; Jinli TIAN ; Jingxia FANG ; Hewei ZHANG ; Jing XU ; Weiping WU
Chinese Journal of Endocrinology and Metabolism 2008;24(5):550-551
The antioxidative capability and Na+-K+-ATPase α1-subunit mRNA expression in myocardium of hypothyroid rats induced by low-iodine diet were observed. The results showed that the antioxidative capability of myocardium decreased, resulting in lipid peroxidative damage, atrophy of myocardial cells and chondrification of tunica intima, along with decreased expression of sodium pump α1 subunit mRNA in hypothyroid rats.
9.Simultaneous Determination of Liquiritin and Glycyrrhizic Acid in Erxieting Granule by HPLC
Qingxia CHU ; Haijun QIN ; Junling LIU ; Hui ZHANG ; Bo YU ; Yuhan MA ; Yazhong ZHANG
China Pharmacist 2017;20(4):743-745
Objective:To establish an HPLC method for the simultaneous determination of liquiritin and glycyrrhizic acid in Erxieting granule.Methods:A TechMate C18-ST(250 mm×4.6 mm,5 μm) column with a DAD detector was used.The mobile phase consisted of acetonitrile (A) and 0.05% phosphoric acids in water (B) with gradient elution.The flow rate was 1.0 ml·min-1 and the detection wavelength was 237 nm.The sample size was 5 μl and the column temperation was room temperatence.Results:Linear calibration curves were obtained within the range of 10.32-51.62 mg·L-1 for liquiritin and 79.40-397.00 mg·L-1for glycyrrhizic acid.The average spiked recovery of liquiritin and glycyrrhizic acid was 98.10(RSD=1.0%,n=6)and 97.15(RSD=1.8%,n=6),respectively.Conclusion:The method is accurate,reproducible and stable,and can be used for the quality control of Erxieting granule.
10.Clinical trial data management and quality metrics system.
Zhaohua CHEN ; Qin HUANG ; Yazhong DENG ; Yue ZHANG ; Yu XU ; Hao YU ; Zongfan LIU
Acta Pharmaceutica Sinica 2015;50(11):1374-9
Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.