Archive

08 April 2010, Volume 7 Issue 4 Previous Issue    Next Issue

---

For Selected:

Download Citations EndNote Ris BibTeX

Toggle Thumbnails

Select

The Study On Hepatotoxicity of Mastic and Myrrha in Rats TAN Ying, XU Xin, ZHOU Kun, HE Jian, QU Cai-qin, GAO Xiu-mei 2010, 7(4): 193-195.  Abstract ( 235 )   PDF (319KB) ( 296 )   Objective To compare the mixture of Olibanum and Myrrha and their different extracts, so as to investigate the hepatotoxicity in rats. Methods Wistar rats were administered intragastrically for 12 weeks with Olibanum+ Myrrha crude powder, volatile oil, aqueous extract, volatile oil+aqueous extract(3g/kg) and distilled water(control group). After the end of last administration, rats were anesthesia by chloral hydrate after fasting for 12 hours. Blood was taken from abdominal aorta and blood biochemistry indices were determined. The Liver was weighted and liver coefficient was calculated, and Malondialchehyche(SOD) and Superoxide Dismutase(SOD) was tested in liver tissue also. The pathologically examination for the liver was performed with light microscopt. Results Total cholesterd(TC) in group of Olibanum+ Myrrha crude powder, aqueous extract, volatile oil+aqueous extract, were higher than that of the control group(P<0.01). Albumin(ALB) in group of Olibanum+ Myrrha crude powder, volatile oil+aqueous extract, were higher than that of the control group(P<0.05). Compared with the control group, Liver coefficient index in group of Olibanum+Myrrha crude powder, aqueous extract, volatile oil+ aqueous extract were increased significantly(P<0.01), while liver coefficient index in volatile oil group remained unchanged significantly. Malondial-dehyde(MDA) in liver tissue of the treatment group animals except volatile oil were higher than that of the control group(P<0.005~0.01).Liver histopathological examination showed that the rats of the treatment group except volatile oil were suffered from various degrees of vacuolar degeneration. Conclusion Rats in group of Olibanum and Myrrha, aqueous extract, volatile oil and aqueous extract were observed liver damage at various degrees which maybe concerned with higher oxidative stress, while no significant effect in group of volatile oil. References | Related Articles | Metrics

Select

Determination of Serum Methotrexate Concentration with Internal Standard Method and Its Apply in Low-dose Methotrexate Therapy LI Ming-yan, WU Hong-wen 2010, 7(4): 196-198.  Abstract ( 215 )   PDF (320KB) ( 246 )   Objective To establish a internal standard method to determine the serum concentration of Methotrexate(MTX) and apply in the low-dose MTX therapy. Methods The serum MTX concentration was determined by HPLC, with metron-idazole as internal standard. The separation was carried out using Shimadzu VP-ODS C18(250mm×4.6mm, 5μm) column with mobile phase of methanol-sodium acetate buffer(pH3.5) (10:90) at a flow rate of 1.0mL/min． The detection wavelength was 306nm and the column temperature was 25℃． And the serum concentration was examined within 1.5~2h after intravenous injection of the patients who received low-dose MTX. Then the patients were followed-up to observe the adverse reaction. Rusults The linear range was 20~1 000μg/L(r=0.9992, n=8)． The intra-day and inter-day precision were both less than 15%. The serum MTX concentration in patients with adverse reactions were significantly higher than those without them. Conclusion The method is sensitive, rapid and accurate. We demonstrated that serum MTX concentration is worthy of detection in low-dose MTX therapy. References | Related Articles | Metrics

Select

Effect of Salvia Miltorrhiza bge.f.alba on Protecion of Vascular Endothelial Cells YU Chang-kai, ZHANG Xiao-yan, GAO Yun-sheng 2010, 7(4): 199-201.  Abstract ( 231 )   PDF (475KB) ( 175 )   Objective To study the effect of Salvia miltiorrhiza bge.f.alba(SMA) on a model of injured human umbilical vascular endothelial cell(HUVEC) in vitro by hydrogen peroxide(H2O2). Methods In vitro perfusion and enzyme diges-tion method is used to culture HUVEC, and the cells are identified by morphological observation and Ⅷ immunoreactivity. Select the cells in the exponential phase of growth and treated, the cells viability is measured by morphological observation and the MTT assay. Results HUVEC are damaged obviously in H2O2 damage group, while in groups with SMA, condition of HUVEC is improved obviously, and the activity(OD value) of the cells is significantly increased. Conclusion SMA can protect HUVEC from damage by H2O2. References | Related Articles | Metrics

Select

A Proposal for Safety Reporting of Drug Randomized Controlled Trials XING Jian-min, LI Xun LIU, Jian-ping 2010, 7(4): 202-205.  Abstract ( 425 )   PDF (383KB) ( 419 )   To introduce the importance of safety reporting in clinical trials from the aspect of drug clinical trial's defi-nition and classification of different stages, briefly summarize the current situation of safety reporting in drug clinical trials, and explain the reporting standards of drug clinical trials based on the recommendations of Consort extension on harm. References | Related Articles | Metrics

Select

Normative Reporting on Adverse Drug Reaction in Case Report FEI Yu-tong, YANG Hong, LIU Zhao-lan, ZHANG Hui-min, LIU Jian-ping 2010, 7(4): 206-207.  Abstract ( 439 )   PDF (368KB) ( 338 )   Case report is an important model of clinical study reports, taking obvious advantages on unusual or serious adverse drug reaction reports. This paper introduces case report from the concept, classification and criterion of case reporting. Based on methodological characteristics of adverse drug reaction case reports and reference of the standard of international case reports, we also develop and propose suggested items of case reports as a reference for clinical workers and researchers in medical field. References | Related Articles | Metrics

Select

The Evidence Summary of Drug Safety Evaluation in the Cochrane Collaboration XIA Yun, LI Xin-xue, LIU Jian-ping 2010, 7(4): 208-210.  Abstract ( 192 )   PDF (431KB) ( 271 )   Objective To summarize the evidence related to drug safety available from the Cochrane Collaboration. Methods Electronic searching on the Cochrane Library(2009 Issue 3), the searching terms included adverse drug reaction and drug safety. Results ＆Condusion Articles related to 6 aspects including Cochrane systematic review, abstracts of non-Cochrane systematic review, clinical trials, methodological study, health technology assessment and economical evaluation, respectively, were reviewed. The safety was evaluated along with efficacy or effectiveness of drugs. Currently, there has been no specific systematic review focusing on drug safety in the Cochrane Collaboration. References | Related Articles | Metrics

Select

Thingking of the Administration of Standardization Technical Committee of Medical Device DONG Fang 2010, 7(4): 211-212.  Abstract ( 231 )   PDF (458KB) ( 241 )   This essay aims to orient the obligations of Standardization Technical Committee of Medical Device(STCMD), study the scientific management which can make the best used of its capability and control medical device.Through combine the practice with the internal characters of medical device, discuss the Methods and measures which manage the technical committee for standardization of medical device and provide guidance and reference for it. References | Related Articles | Metrics

Select

The Risks and Regulation of Skin Graft Substitute XU Wei 2010, 7(4): 213-216.  Abstract ( 230 )   PDF (551KB) ( 216 )   Alloskin, heteroskin and tissue engineered skin have been extensively used in clinical. The regulation should be emphasized on the safety and effectiveness since the potential risks of virus transmission and immunological rejection. It analyzed the potential risks associated with the application of Alloskin, heteroskin and tissue engineered skin. The present situation on the regulation of these products also summarized and gives some new suggestions and comments on the regulation enhancement. References | Related Articles | Metrics

Select

Factor Analyse and Risk Vigilance Evaluate of PASS Used Monitoring Prescription GUO Dai-hong, DU Xiao-xi, CHEN Hui, ZHANG Su-min, LIU Gui-yang, ZHANG Su-qiong, CHEN Chao, DONG Fang, SHI Guo-bing, ZHANG Qin 2010, 7(4): 217-220.  Abstract ( 198 )   PDF (560KB) ( 202 )   Objective Analying of influence factor and evaluating of vigilance effection of PASS used monitoring pre-scription. Methods Using case investigating method. Screenning some inpatient prescription of three hospital during May to December in 2008 by PASS, Evaluating vigilance effection and analyse influence factor. The correlative data were deal with the SPSS software. Results There were 2 813 piece of stress vigilance information in 29 700 prescription of 4 910 cases, Concentrated in five representation-interaction, special patient, no-no mix, dosage and approach. Effective 1 161 piece by reason of personnel, and the other 1 652 piece are restricted by PASS itself. Conclusion Using PASS to monitor prescription have distinct practicality for rational drug use. Its vigilance information can remind doctor to avoid the risk about drug safety. References | Related Articles | Metrics

Select

The Impact of FDA Amendment Act 2007 to US Pharmaceutical Industry in US and the Enlightenment to Drug safety Surveillance System in China BIAN Bo-yang, GUO Jian-fei 2010, 7(4): 221-223.  Abstract ( 205 )   PDF (513KB) ( 178 )   Introduce the main contents of FDA amendment act 2007(FDAAA). in this article we review the related files and documents about FDAAA and introduce about the several contents about FDAAA. FDAAA is one of the most important reforms about pharmaceutical industry laws and regulations in US in last 40 years. It touched almost every aspect of process of pharmaceutical management system in US. It is important for pharmaceutical companies to understand the implications of FDAAA. We suggested China should using some experience from FDAAA in our pharmaceutical management work, especially in the drug safety and surveillance. References | Related Articles | Metrics

Select

Analysis of Drug Risk Management Through Issuing the Information Bulletin about Cefradin WANG Chun-ting 2010, 7(4): 224-225.  Abstract ( 218 )   PDF (539KB) ( 201 )   The condition of hematuria induced by Cefradin have been introduced, the information bulletin of adverse drug reaction about Cefradin and relevant risk management measures have been reviewed in this article. On this basis, the role and effect of all processes of drug risk management have been analyzed to deepen understanding of drugs risk management and promote this work in China. References | Related Articles | Metrics

Select

Thinking of Drug Safety from Risk Society Theory Perspective SHANG Peng-hui, LIU Ji-tong, LIU Jia, LI Na, SHU Zheng, ZHANG Yao-wen, QIU Qiong, ZHAN Si-yan 2010, 7(4): 226-228.  Abstract ( 214 )   PDF (559KB) ( 236 )   The reasons of drug safety issues were analyzed deeply from perspective of risk society theory , from whichwe should keep correct view of drug safety issues, through strengthening risk education to improve awareness and ability of prevention for the whole society on risk. Elimination of unreasonable risk taking mechanism to avoid embarrassed situation of uncertain subject of responsibility, rational and scientific adjustment of medical industrial structure, improving enterprise's innovation capability and competitiveness, avoiding vicious competition homogenization and drug manufacturing defects which may be induced by this. To establish an open and transparent drug safety information release mechanism, regulate the media to popularize knowledge of drug safety to raise satisfaction about drug safety of public. References | Related Articles | Metrics

Select

Thinking on the Current Situation of Drug Risk Management in China JIN Hui, SONG Jin-bo, QU Yi, CHEN Wei-jun 2010, 7(4): 229-231.  Abstract ( 286 )   PDF (620KB) ( 364 )   Overview of the concepts and characteristics of drug risk management, analyzed the factors of drug risk management. We should strengthen the supervision and the guidance for enterprises, establish and perfect the whole monitoring system, and promote the legalization of risk management. References | Related Articles | Metrics

Select

Analysis of 305 Cases of Drug-induced Hematuria in Children on Chinese Literatures TONG Zhi-qing, ZHANG Xu 2010, 7(4): 232-233.  Abstract ( 185 )   PDF (586KB) ( 227 )   Objective To investigate disposition and general rule about the drugs which can result in drug-induced hematuria in children. Methods The documents about the drug-induced hematuria in children on internal medicine periodical from 1999 to 2009 by applying CNKI were statistically analyzed. Results 305 cases of drug-induced hematuria involves in 23 kinds of drugs.Among the total,most of the drugs were antimicrobial drugs(204cases) and NSAIDS(90cases). Conclusion Clinical worker should handle the disposition and general rule about the drug-induced hematuria in children, inorder to safely apply medicine. References | Related Articles | Metrics

Select

Analysis of 168 Adverse Drug Reaction/Event Reports WANG Hui-rong 2010, 7(4): 234-236.  Abstract ( 373 )   PDF (635KB) ( 369 )   Objective To investigate the features and general pattern of the adverse drug reaction/event(ADR/ADE), and provide references of clinical rational and safty use of drug and evaluate the quality of ADR/ADE reports. Methods A total of 168 ADR/ADE cases collected in our hospital from Jan.2007 to June 2009 were analyzed retrospectively. Results A total of 104 drugs were involved in the 168 ADR/ADE,mainly anti-infective drugs(45.2%), followed by Traditional Chinese Medicines(25.6%). The main route of administration was by intravenous drip(61.9%). The ADR/ADE were chiefly characterized by the lesions of skin and appendages(46.4%). There were four severe cases and most of ADR/ADE occurred within 24 hours after medication(112 cases); 52 cases were given symptomatic treatment and 60 cases were left untreated. The number of ADR/ADE reports was less than expected and the quality of ADR/ADE reports was poor. Conclusion ADR monitoring and reporting should be strengthened to ensure safe, effective and rational drug use in the clinic. The ADR/ADE occurred in our hospital were mainly induced by the use of anti-infectives and Chinese materia medica preparation administered by intravenous drip. Measures should be taken to tighten control on rational drug use. References | Related Articles | Metrics

Select

Analysis of 117 Cases of Adverse Drug Reaction/Event Induced by Traditional Chinese Medicine ZHANG Yan, XIE Yu-tao, CHEN Jin-xin, LI Lin 2010, 7(4): 237-239.  Abstract ( 221 )   PDF (682KB) ( 367 )   Objective To understand the characteristics of the adverse drug reaction/event(ADR/ADE) of Eraditional chinese Medicine to promote clinical rational drug use. Methods 117 ADR/ADE reports of Traditional Chinese Medicine were analyzed retrospectively. Results 59 cases of Traditional Chinese Medicine injections accounted for 49.6%; 31 cases of Quyu agent involved in 24.8 percent accounted for 15 Varieties of drugs. Conclusion Dialectical view of adverse reactions and the monitoring of adverse reactions to Traditional Chinese Medicine, should be strengthened to reduce the ADR/ADE incidence. References | Related Articles | Metrics

Select

Analysis of 105 Reports of New Adverse Reactions Caused by Injection JING Yun-yun, MENG Qing-yi, ZHAO Yun 2010, 7(4): 240-242.  Abstract ( 193 )   PDF (663KB) ( 260 )   Objective To analyze the 105 reports of new adverse reactions caused by injection, provide reference for clinical application and quality control. Methods 105 ADR reports collected by Linyi County for ADR Monitoring were analyzed using retrospective study method from January to December 2009. Results High ADR occurrence was also observed in the old patients. Most of ADR were antimicrobial drugs. 17 organs systems were involved. It involved 35 kinds of national essential drugs. Conclusion ADR caused by injection should be monitored so as to reduce or avoid severe ADR. References | Related Articles | Metrics

Select

Literature Review and Cause Analysis of Adverse Reactions Caused by Asarone Injection MA Wei-cong, ZHANG Qing, LI Hui, CHU Ting, SHI Hua-yue, MAO Sheng-jun 2010, 7(4): 243-245.  Abstract ( 207 )   PDF (627KB) ( 182 )   Objective This article reviews adverse reactions caused by asarone injection in the past 5 years and analyzes the type, characteristics and tendency. Methods One hundred and twenty-eight cases of adverse reaction reports Cansed by asarone injection were collected by searching for CNKI and VIP journals database, and as well as google and baidu search engines. Results It was found that the chief adverse reaction was systemic anaphylaxis in total case, come to 66 cases including 34 cases of serious anaphylactic shock. Skin and its accessories damage accounted for 26 cases, digestive system damage took place 27 cases and other adverse reactions contributed 9 cases. Most adverse effect cases are related to infant patient, approaching to 87.5% in all cases. We investigated anaphylaxis factor in the formula of asarone injection and detected that tween-80 is principal factor causing the adverse reactions. Conclusion We must attach great im-portance to the adverse reactions and improve medication safety of the high risk asarone injection as soon as possible. References | Related Articles | Metrics

Select

Analysis of 46 Cases of Allergic Shock Induced by Cefoperazone /Sulbactam TIAN Yan-ping, ZHU Yan, YIN Hong, GUAN Ying-zhuo, ZHAO Zhi-gang, CUI Xiang-li 2010, 7(4): 246-248.  Abstract ( 201 )   PDF (638KB) ( 293 )   Objective To summarize allergic shock of cefoperazone/sulbactam for injection, prove information for rational use of it in clinic. Methods 46 cases of allergic Shock caused by cefoperazone/sulbactam for injection ranging from January 2003 to June 2009 were collected by statistically classified and analyzed. Results Elderly patients occurred allergic shock with a higher proportion during the 46 cases;there were 42 patients who Started anaphylactic shock in 30 minutes after the infusion started,then they received emergency resuscitation, but 9 patients died at last. Conclusion Attention should be paid to adverse drug reaction(ADR) of cefoperazone/sulbactam for injection. References | Related Articles | Metrics