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08 July 2013, Volume 10 Issue 7 Previous Issue    Next Issue

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Effects of Bicyclol on the Inhibition of Gap Junctional Intercellular Communication by DDT in WB-F344 Cells SUN Hua ,YU Ling-Hong ,WEI Huai-Ling ,ZHANG Dan 2013, 10(7): 385-389.  Abstract ( 207 )   PDF (526KB) ( 162 )   Abstract : Objective To determine the effects of bicyclol on dichloro diphenyl trichloroethane ( DDT ) -induced inhibition of gap junctional intercellular communication in WB -F344 rat liver epithelial cells and the mechanisms involved in the process. Methods The scrape loading/dye transfer(SL/DT) technique was used to assay the inhibition of GJIC induced by DDT and the preventive effects of bicyclol. The expression of total -Cx43, phosphor -Cx43, E -cadherin and β-catenin were assessed by Western blot. Immunofluorescence analysis was used to determine the subcellular distribution of Cx43, E -cadherin and β-Catenin. Results Two hours treatment of DDT could inhibit GJIC of WB-F344 cells in a dose-dependent manner. The cells were pre-incubated with bicyclol for 22h and this was followed by treatment with DDT for 2h, bicyclol could prevent the inhibition of GJIC induced by DDT. The reduction of high phosphor-Cx43 expression induced by DDT and the restoration of gap junction maybe contribute to the mechanisms of bicyclol. Both DDT and bicyclol showed no significant effect on expression, activity and cellular distribution of E -cadherin and β-catenin. Conclusion Bicyclol prevented the DDT -induced GJIC inhibition via regulating the expression of phosphor-Cx43 and restoring the gap junction. The inhibition of GJIC is a known cellular event associated with tumor promotion. Previous Results showed that bicyclol could prevent the hepatocarcinogenesis induced by diethylnitrosamine/phenobarbital. This paper suggested that bicyclol maybe also have the potential prevention to DDT induced tumorgenesis, which isa pesticide and strongly persists in the environment. Key words: bicyclol; WB-F344 cell; gap junctional intercellular communication; diohloro diphenyl trichloroethane(DDT) References | Related Articles | Metrics

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Experimental Study on Mice's Acute Toxicity of Different Compositions in Inonotus Obliquus(Fr.) Pilat LIU Xiang-hui, XIE Ren-ming, CHEN Lin, LI Zhen-zhi, SUN Wen-ji, ZHAO Ye 2013, 10(7): 390-392.  Abstract ( 258 )   PDF (538KB) ( 154 )   Objective The acute toxicity of different components in Inonotus obliquus(Fr.) Pilat on mice was studied in order to provide a basis for safe and reasonable medication in clinic. Methods Using classical Methods of acute toxicity tested, the median lethal dose(LD50) of water extraction components and 70% alcohol extraction components of Inonotus obliquus(Fr.) Pilaton mice were tested besides its toxic reaction. Results The higher the dose of water extraction and 70% ethanol extraction components increased, the more obvious the acute toxicity appeared to be, the more the mice died, and the control group showed normal. As to crude drug per kilogram body weight, the LD50 of water extraction components on mice was 17.49g·kg-1, moreover the 95% confidence limit was 16.36～18.70g·kg-1; the LD50 of 70% alcohol extraction components was 61.97g·kg -1, in addition the 95% confidence limit was 53.73～71.46g·kg -1. Conclusion The water extraction components and 70% alcohol extraction components of Inonotus obliquus(Fr.) Pilat had some toxicity, but the working quantity of water extraction components's toxic effect was lower than 70% alcohol extraction components. References | Related Articles | Metrics

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Safety and Efficacy of Qiangguyin in Treatment of Osteoporosis LIU Guo-tai, LIU Jie ,ZHANG Zhi-qiang, SHI Xiao-lin 2013, 10(7): 393-395.  Abstract ( 254 )   PDF (440KB) ( 200 )   Objective To evaluate the safety and efficacy of qiangguyin in treatment of osteoporosis. Methods 116 cases with osteoporosis were reviewed. The change in bone mineral density(BMD), visual analogue scale(VAS), liver and renal function were revaluated before and after treatment for one year. Results There was significant difference before and after treatment in VAS and BMD( P<0.05). There was no significant difference before and after treatment in liver and renal function( P>0.05). Conclusion Qiangguyin can effectively enhance BMD and reduce the ache which is caused by osteoporosis, with long-term safety. It is an optional drug for osteoporosis treatment. References | Related Articles | Metrics

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Brief Introduction and its Implication of New Pharmacovigilance Legislation in EU WANG Xiao-yan, YANG Yue 2013, 10(7): 396-399.  Abstract ( 461 )   PDF (532KB) ( 416 )   Objective According to the introduction of new pharmacovigilance legislation in EU, suggestions were put forward to provide the example and reference for perfecting and developing adverse drug reation reporting and monitoring system of China. Methods Literature study was used to analyze the foreign and domestic materials. Results New pharmacovigilance legislation in EU focuses on collection of key information on medicines, better analysis and understanding of data and information, regulatory action to safeguard public health and communication with stakeholders. Conclusion We should learn from the new EU pharmacovigilance law to improve capabilities of adverse drug reaction reporting and monitoring. References | Related Articles | Metrics

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The Basic Principles of ICH PSUR and Its Implications for China REN Jing-tian, Yang Le, Guo Xiao-xin, DU Xiao-xi 2013, 10(7): 400-404.  Abstract ( 276 )   PDF (519KB) ( 314 )   The article introduced the basic principles of ICH Periodic Safety Update Reports (PSUR). The article suggested that PSUR should be promoted step by step. When the data lock point in China couldn't be synchronized with the IBD, Line-listings and Summary Tabulations, Summary Bridging Reports and Addendum Reports should be adopted depending on the circumstances. The Marketing Authorization Holder(MAH) should put emphasis on finding safety risks through PSUR, and provide clues for further investigation and risk management. References | Related Articles | Metrics

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Immunotoxicity Evaluation Research Progression of Traditional Chinese Medicine Injections LIU Han-qing, WANG Wen-gang, WANG Ai-ping 2013, 10(7): 405-407.  Abstract ( 207 )   PDF (501KB) ( 178 )   The immunotoxicity experimental researches of Traditional Chinese Medicine Injections(TCMI) were summarized in terms of immunotoxicity evaluation technology , anaphylactoid reaction , immune index of long -term toxicity evaluation to review the progress of TCMI immunotoxicity evaluation . Although some progresses were made in selection of sensitive animals, examination of allergen, application of new technology, research of cell experiment, relationship between tween-80 and anaphylactoid reaction and observation of immune index in long-term toxicity evaluation, it still need to be strengthened in consummating evaluation methodology and guidline and improving operation standardization. References | Related Articles | Metrics

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Advances of Research Methods for the Herbal Hepatotoxic and Hepatoprotective Properties GU Li –qiang, MA Bing –jie, MENG Xia, BI Kai –shun, CHEN Xiao -hui 2013, 10(7): 408-410.  Abstract ( 305 )   PDF (496KB) ( 351 )   Herbal hepatotoxicity is increasingly being understood and valued by people in recent years.The research Methods for the herbal hepatotoxic and hepatoprotective properties have been widely developed.Compared with the conventional in vivo experiment of pharmacokinetics,the effect to the cells and tissues can be derectly reflected by the Precision-Cut Liver Slices and the hepatocytes and the subcellular models.It is very meaningful that the in vivo metabolic mechanism was illustrated and the new biomarkers were found through the Methods of genomics, proteomics and metabonomics combined with mass spectrometry technology. The series of advances will help the study of the herbal hepatotoxic and hepatoprotective properties. References | Related Articles | Metrics

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Development of Alarming System to Actively Monitor and Assess the Adverse Drug Events in Hospitalized Patients CHEN Chao,GUO Dai-hong, XUE Wan-guo, LIU Dong-jie, LIU Gui-yang, ZHU Man 2013, 10(7): 411-414.  Abstract ( 325 )   PDF (731KB) ( 381 )   Objective To develop active surveillance and assessment system for the detection and prevention of ADE in hospitalized patients in order to make up for the deficiency of the voluntary reporting and improve the status of "passive surveillance" to "real-time monitoring". Methods The principles of triggers technology were applied to the development of the system. The accuracy of the system was evaluated by the Results of the verification of clinical pharmacists. Results Detection rules of drug-related thrombocytopenia, anemia, liver damage, kidney damage were designed. The key technical route of automatic monitoring, medication review, assistance evaluation, characteristics analysis, high-risk screening were established and the software was developed to dock with hospital voluntary reporting system. +PV was 69.4%. Conclusion The computerized survelliance and auxiliary evaluation of adverse drug events was developed, and the electronic platform with SRS of ADE linkage monitoring was established. The study providesa new way of thinking and practical technology tools in order to carry out the drug safety monitoring. References | Related Articles | Metrics

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Analysis of 162 Cases of Drug-induced Liver Injury ZHU Lei ,HUANG Ping ,LI Ying 2013, 10(7): 415-418.  Abstract ( 282 )   PDF (622KB) ( 358 )   Objective To investigate the clinical characteristics and laws of drug-induced liver injury so as to promote the rational use of drugs. Methods Selecting 162 cases of ADRs which induced liver injury from Anhui's 2012 ADR database, and using the retrospective study Methods to analyze these cases of ADR. Results Drug-induced liver injury incidence is the highest in elderly patients whose age are over 60 years, accounting for 35.80%. Drug-induced liver injury report involveda total of 10 categories of drugs, in which caused by western medicine cases accounting for 89.20% and oncologic drugs is the largest share, followed by antibacterial drugs, proton pump inhibitors and anti-cerebral vascular drugs. Traditional Chinese medicine injections is the most proprietary in all of the Chinese medicines, accounting for 8.92% . The most common route of administration is intravenous infusion, accounting for 71.83%. Liver damage occurred in quite different time, the fastest is 1 day and the longest is 175 days, but clinical manifestations and laboratory tests were not significantly different. Most patients recovered after discontinuation and symptomatic treatment. Conclusion Doctors should improve the understanding of drug -induced liver injury which induced by ADR and must take symptomatic treatment actively as soon as the drug -induced liver injury is diagnosed. Additionally, doctors should strengthen the monitoring of ADR and improve the level of rational use of drugs. References | Related Articles | Metrics

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Analysis of Narcotic Drug Use for Outpatients with Cancer at Our Hospital from 2011 to 2012 ZUO YONG-jun ,LI YONG-bing 2013, 10(7): 419-420.  Abstract ( 213 )   PDF (663KB) ( 232 )   Objective To evaluate the narcotic drug use in treatment of severe cancer pain at our hospital, and to provide reference for clinical rational use of drugs. Methods The information of narcotic drugs for outpatients at our hospital was collected from 2011 to 2012. The content included the amount of medication, medication days, defined daily dose (DDD), medication frequency, defined daily cost (DDC), drug utilization index (DUI). Results The first place of the amount of medication and DDDs was morphine sustained -release tablet. Drugs of DUI >1 were morphine sustained-release tablet, morphine injection, bucinnazine hydrochloride injection and pethidine hydrochloride injection.The highest DDC drug was hydroxyl oxycodone sustained -release tablet. Conclusion The use of three -step analgesic ladder for outpatients with cancer at our hospital was fundamentally rational, yet there are some problems to be solved. References | Related Articles | Metrics

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Analysis of 35 Cases of Adverse Drug Reaction Induced by Intra-oral Medication REN Li-jie ,YU Ping, XU Zuo-guo 2013, 10(7): 421-423.  Abstract ( 271 )   PDF (666KB) ( 215 )   Objective To discuss the adverse drug reaction (ADR) induced by dentistry intra-oral medication, and to provide the reference for clinical medication safety. Methods ADR reports of inpatient and outpatient at our hospital were statistically analyzed since June 2009 to October 2012. Results 35 cases of intra-oral medication adverse reaction were involved in5 kinds of medicines. Articaine hydrochloride and epinephrine tartrate injection accounted for 75%. Single medication accounted for 88.75%. 85.71% adverse reactions happened in3 days. There were 18 kinds of clinical manifestations. Conclusion Intra -oral medication has limitations, small doses, and adverse reaction happened less. Despite the higher security, attention to should be paid prevent infection. References | Related Articles | Metrics

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Literature Analysis of the Low Blood Sugar Reactions Caused By Glibenclamide GUO Mei-hua QIU Xiao-hong MA Manling HU Bao-rong MA Yan-yan LIU Shi-ping 2013, 10(7): 424-426.  Abstract ( 268 )   PDF (720KB) ( 265 )   Objective To analyze the cases of low blood sugar reactions caused by glibenclamide and identify the relevant factors, provide a reference for the clinical use of drugs. Methods 742 cases of glibenclamide -induced low blood sugar reactions were statistically analyzed. Results Male to Female ratio was 1.1:1,88.0% of the cases are the elderly, 39.6% of them had non -standard situation of drug use, 14.6% of them used single drug, 43.9% of them had the combined use of drugs. Clinical types of the cases were mainly hypoglycemic coma(62.7% ), 93.5% of them were cured ,48 cases showed adverse outcome (death in 41 cases). Conclusion Glibenclamide can cause relatively severe low blood sugar reactions, and even lead to death. When use, the age, usage, dosage and other factors must be carefully considered, so as to medicate rationally and then reduce the incidence of hypoglycemia. References | Related Articles | Metrics

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Literature Analysis of 171 Cases of Severe Adverse Drug Reactions in Children XU Shun-gui ,ZHAO Shang-qing ,WANG Yong-hong 2013, 10(7): 427-431.  Abstract ( 246 )   PDF (665KB) ( 111 )   Objective To analyze the literature of adverse drug reaction(ADR) of children, to understand the regularity and features of ADR. Methods Using "pediatric drug" and "adverse reaction" as the keywords, searched the online journals of CNKI for children ADR reported in China between 2000-2013, and analyzeed the severe ADR. Results The severe ADR in children associated drug mainly involved the antimicrobial drugs, Chinese medicine preparations, antiepileptic drugs, and analgesic-antipyretic drugs. The manifestations of the severe ADR include severe systemic allergic reaction, dermatitis, skin and adnexa damage, hematuria and proteinuria of urinary system damage. Conclusion More attention shoud be paid to the management of antimicrobial drugs and Chinese medicine preparations. The hospital should collect information on medicines in children. Pay attention to the work of monitoring of ADR cases to ensure the safety of medication in children. References | Related Articles | Metrics

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Study on the Integration of Medical Device Registration Review Information Data LAN Wen-chi ,LI Dong-dong 2013, 10(7): 432-434.  Abstract ( 224 )   PDF (693KB) ( 188 )   The food and drug administration departments at all levels, as well as their technical support departments, have all established the corresponding computer business operation systems to meet their respective functions. Based on the vast amount of data produced from these business operation systems, how to manage resource integration and data sharing is one of the priorities during the medical device regulatory informationization. This article, taking the data generated from the domestic third-class and imported medical device registration review process responsible by SFDA as an example, tries to clarify the definitions of the review data and its data center, and to analyze the current status of the quality and utilization of the medical device registration review data as well as the necessity of data integration. Based on the actual registration review process, this article proposes the practical implementation strategy and procedures of the data integration, aiming to building up the basic preparation work on the national medical device registration review data integration, and further serves the construction of the state food and drug (medical device) regulatory data center. References | Related Articles | Metrics

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Analysis of Adverse Events of Tracheostomy Tube and Imported Products Recall LUO Qing-feng ,YE Cheng-hong, DENG Jie 2013, 10(7): 435-437.  Abstract ( 237 )   PDF (643KB) ( 173 )   The adverse events of tracheostomy tube will seriously affect the clinical rescue and treatment. This paper describes product structure and common adverse events, reviews the recall action of imported product and corrective measures of enterprises. This paper also briefly analyzes the possible causes leading to product recalls, advances the measure to reduce the risk of tracheostomy tube, then makes recommendations to the enterprises, health care workers, regulatory authorities, proposes the specific requirements of the product registration documentation. This article intends to provide reference for personnel engaged in production, and technical review, and so on. References | Related Articles | Metrics

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Survey and Analysis on the Awareness Rate of Medication with Caution for Allergy to Sulfanilamide in Clinical Staffs ZHOU Le-xing 2013, 10(7): 438-439.  Abstract ( 232 )   PDF (709KB) ( 217 )   Objective To provide evidence for training and regularizing the behavior of clinical staffs'safe medication for those who are allergic to sulfanilamide. Methods We investigated the awareness of medication in clinical staffs. The questionnaires were designed by our own, and 52 clinical staffs were investigated randomly in our hospital, the statistical analysis was made in the end. Results All the investigated personnel had low awareness rate about the safe medication of allergy to sulfanilamide. There was significant difference between the different seniorities and different educational background. Conclusion Clinical staffs must enhance the knowledge about safe medication of allergy to sulfanilamide. References | Related Articles | Metrics

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Analysis of Blood Concentration Monitoring of Vancomycin in the Hospital from 2010 to 2012 ZHONG Xue, YANG Li-ping ,HU Xin, CHENG Gang 2013, 10(7): 440-443.  Abstract ( 237 )   PDF (601KB) ( 203 )   Objective To analyze the monitoring Results of drug concentration in serum of vancomycin in Beijing Hospital and promote the individual administration of vancomycin. Methods The valid data of vancomycin in the hospital from 2010 to 2012 were retrieved, and a retrospective analysis was made on the distribution of blood concentration.Results There were 652 cases of 314 patients who were monitored vancomycin serum concentrations from 2010 to 2012. In the 652 cases of vancomycin surveyed, there were 154(23.62%) cases were monitored 2 hours peak concentration.Among them there were 81(52.60%) cases lower 25μ g·mL-1 and 54(35.06%) cases of 25～40 μg·mL-1 and 19(12.34%) cases over 40 μg·mL-1. In the 652 cases of vancomycin surveyed, there were 498(76.38%) cases were monitored trough concentration. According to the standard of Geraci (therapeutic window of vancomycin: 5～10μ g·mL-1), there were 66(13.25%) cases lower 5 g·mL-1 and 153(30.72%) cases of 5～10μ g·mL-1 and 279(56.02%)cases over 10μ g·mL-1.According to the standard of vancomycin therapeutic guidelines(therapeutic window of vancomycin:15～20μ g·mL-1), there were 366(73.49%) cases lower 15μ g·mL-1 and 64(12.85%) cases of 15～20 μg·mL-1 and 68(13.65%) cases over 20ug·mL-1. Conclusion The intensity of vancomycin serum concentration monitoring was insufficient in Beijing Hospital. We should take action to strengthen publicity and encourage clinicians to raise awareness of detection.Secondly, another goal is to improve communications between clinicians and pharmacists. The vancomycin serum concentration monitoring should be closely combined with clinical practice and a further study should be conducted to investigate the therapeutic window of vancomycin for the Chinese population. References | Related Articles | Metrics