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08 February 2013, Volume 10 Issue 2 Previous Issue    Next Issue

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The Effects of Compound Danshen Dripping Pills on the Pharmacodynamics and Pharmacokinetics of Warfarin in Humans YI Dan, LUO Xiao -bo ,LU Xiang -hong, LUO Sheng -ping, ZHOU Yu -lu 2013, 10(2): 65-67.  Abstract ( 342 )   PDF (285KB) ( 359 )   Objective To study the effect of Danshen Dripping Pills on the pharmacokinetics and pharmacodynamics of warfarin, and to assess whether or not Danshen Dripping Pills alone has any anticoagulant activity. Methods A randomized, double-blind, placebo-controlled, two-way cross-over trial was designed.Twelve male healthy volunteers (6 person/group) were randomized to receive either Danshen Dripping Pills in the first treatment period and placebo in the second treatment period, or vice versa. In addition to their randomized trentment, all volunteers received a single dose of 5 mg warfarin ond 29 of each treatment period. Blood samples for assessment were taken at frequent intervals during each treatment period. Results Administration of Danshen Dripping Pills significantly increasedcmax、AUC0~144、AUC0~∞、t1/2 and significantly decreased CL/F of warfarin compared with placebo.In addition, Danshen Dripping Pills had clinically significant effect on the pharmacodynamic effects of warfarin, as assessed 144h after warfarin dosing by measurement of prothrombin time, activated partial thromboplastin time. Danshen Dripping Pills alone had significant effect on these indicators of the clotting process. Conclusion Usual doses of Danshen Dripping Pills seem to have significant effects on the pharmacokinetics and pharmacodynamics of single dose warfarin in healthy subjects. References | Related Articles | Metrics

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Protection of Bicyclol on Hepatic Injury Induced by the Combination Therapy of Oxaliplatin and 5-Fluorouracil in Tumor-bearing Mice YU Ling-hong, WEI Huai-ling, BAO Xiu-qi, CHEN Xiao-guang, ZHANG Dan, SUN Hua 2013, 10(2): 68-70.  Abstract ( 248 )   PDF (509KB) ( 164 )   Objective To determine the effect of bicyclol against oxaliplatin/5 -fluorouracil -induced hepatotoxicity and the influence on the antitumor capacity of oxaliplatin/5 -fluorouracil in tumour -bearing mice. Methods C57/ BL mice implanted with Lewis lung tumors for6 days were treated with oxaliplatin(6mg·kg-1×1) and 5-fluorouracil (25mg·kg-1×5) to establish the liver damage model. Bicyclol(150,300mg·kg-1) was pretreated 2hr before the injection of oxaliplatin/5-fluorouracil. All animals were killed on the eighth day after oxaliplatin/5-fluorouracil treatment and tumor weight of each animal was measured. The activities of ALT and AST were meseared by automatic chemistry analyzer(TBA-40FR). Liver histopathological changes were examined by H.E. and light microscopy. Results The combination therapy of oxaliplatin and 5-fluorouracil significantly inhibited the growth of Lewis lung tumor and the inhibiton rate is 72.7% . At the same time, the obvious toxic reaction emerged expressed as 26.7% mice were death, the pathology of liver tissue was damaged and the serum aminotransferases were elevated. Bicyclol showeda significant protection as evidenced by the improvement of histotpathological injury and the decrease of elevated serum amino-transferases induced by oxaliplatin/5-fluorouracil. The administration of bicyclol could also reduce the mortality and increase slightly the anti-tumor activity of oxaliplatin/5-fluorouracil. Conclusion Bicyclol showed potent protective activity against oxaliplatin/5-fluorouracil-induced liver damage and decreased the death by the high-dose chemotherapy without affecting the associated inhibition of tumor growth. This maybe provide a new approach for preventing the hepatotoxicity induced by oxaliplatin/5-fluorouracil in the clinic. References | Related Articles | Metrics

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Research on the Antiallergenic Activity of the Different Ingredients from SUN Rong ,QIAN Xiao-lu, LV Li-li 2013, 10(2): 71-73.  Abstract ( 204 )   PDF (557KB) ( 256 )   Objective The effective ingredients of for anti-anaphylaxis were preliminarily confirmed by compare with the different components' antiallergic effects, in order to provide references and research ideas for innovative drugs. Methods The mice's anti-permeability strengthening of allergenic capillary vessels and passive anaphylaxis of the skin to select the effective ingredients of for anti-anaphylaxis were preliminarily observed after given alcohol extract、water extract and volatile oil components to compare with the different components' antiallergic effects.Results The antiallergenic effect of alcohol extract was the most effective, and the water extract and volatile oilcomponents were inferior which had no obvious difference between the latter two groups, and there were obviousdifferences of the antiallergenic effect between the alcohol extract and water extract or volatile oil components by compareing the antiallergenic effect of different extract of Flos Magnolia. Conclusion The antiallergenic activity ofthe different ingredients from Flos Magnolia were alcohol extract >water extract>volatile oil components, and under the guidance of antiallergenic activity, the effective ingredients of was the alcohol extract. But as the Flos Magnolia complex of pharmacodynamics characteristics of TCM and the interaction between the components and molecular mechanisms of Flos Magnolia were not very clear, so it is necessary to take more research of the multi-components between the pharmacological and molecular mechanisms, in order to provide references and research ideas for inno-vative drugs. References | Related Articles | Metrics

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Experimental Study on Safety in Guinea Pig about the Different Components of Flos Magnolia Nose Drop LV Li-li, QIAN Xiao-lu ,SUN Rong 2013, 10(2): 74-76.  Abstract ( 235 )   PDF (460KB) ( 178 )   Objective To study the safety of the different components of Flos Magnolia Nose Drop in guinea pig and to provide experimental data for safe use in clinical. Methods The acute toxicity experiment: The different components of Flos Magnolia Nose Drop were administrated to guinea pig and the acute toxic symptoms were observed. The mucosal irritation experiment: The different components of Flos Magnolia Nose Drop were administrated to guinea pig' nasal cavity and the degree of nasal irritation was observed. Results We did not find the chronic toxicity and the mucosal irritation to guinea pig' nasal cavity after given Flos Magnolia Nose Drop for7 days. Conclusion The acute toxicity test and the mucosal irritation test showed that the Flos Magnolia Nose Drop was safe. References | Related Articles | Metrics

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The Study on Antiallergenic Mechanisms of Effective Parts from Flos Magnoliae QIAN Xiao -lu, SUN Rong 2013, 10(2): 77-79.  Abstract ( 234 )   PDF (526KB) ( 214 )   Objective The antiallergenic mechanisms of effective parts from Flos Magnoliae were studied, so as to provide references and research ideas for antiallergenic drugs and innovative drugs. Methods The effect of sensitized rat peritoneal mast cells(PMC) degranulation and the release of histamine about Flos Magnoliae effective parts of the freeze-dried powder of serum drug were observed through the patterns and fluorescence, the antiallergenic effects of Flos Magnoliaewas researched and the antiallergenic mechanisms was studied. Results The PMC degranulation and the release of histamine were significantly inhibited after given the preparation of freeze -dried powder of serum drug 15 and 60min, and there are some limitations relations. The antiallergenic mechanisms of Flos Magnoliae may be related to the mast cell membrane stability, inhibiting their degranulation and the release of allergic media. Conclusion The effective parts of Flos Magnoliae has an significant effect, and there are some relations about Flos Magnoliae effective antiallergenic parts and the release of allergic PMC medium-the histamine. References | Related Articles | Metrics

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The Probe into the Necessity of the Safety Monitoring of Over-the-Counter Drug in China XIA Dong-sheng ,TIAN Chun-hua ,WANG Ao, SONG Qiu-jie, LI Lan, DU Xiao-xi 2013, 10(2): 80-83.  Abstract ( 242 )   PDF (615KB) ( 213 )   Objective To probe into the necessity of the safety monitoring of OTC drug in China. Methods From the point of view of the combination of drug classification management system and adverse reaction monitoring status, discuss the main problems with the use and adverse reaction monitoring of OTC drug. Results and Conclusion It is urgent to establish a mode of drug safety monitoring which is suitable for OTC drug's characteristics and use on Chinese drug classification management system, which could lay the foundation for the further research on OTC drug safety supervision in the future. References | Related Articles | Metrics

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Ximelagatran and Its Risk Management Plan in United States GUO Jing ,GUO Jian-fei 2013, 10(2): 84-87.  Abstract ( 311 )   PDF (455KB) ( 244 )   The risk management for pharmaceutical products applies toa life cycle ofa new drug development from Investigational New Drug (IND) , New Drug Application (NDA) to post -marketing. It plays a critical role in its withdrawal from the market. In this article we reviewed the risk management events of Ximelagatran(Exanta R) which is a new generation of anti-clotting drug manufactured by AstraZeneca, from its new drug approval to its withdrawal. The experience of Ximelagatran risk management in USA might provide a clue for the future risk manage ment of drug safety in China. References | Related Articles | Metrics

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Research Development on Toxicity of Tripterygium silfordii Related to Efficacy and Chemical Material Basis FENG Qun ,LUAN Yong-fu ,SUN Rong 2013, 10(2): 88-91.  Abstract ( 273 )   PDF (546KB) ( 256 )   Objective To provide literature evidences and research ideas of efficacy and toxicity of the chemical composition of guided separation, control and efficacy, and the research on the "dose-effect relationship" and "dosetoxicity relationship" about the toxical components. Methods References in old days and in the last decades both at home and abroad about Tripterygium silfordii were collated, analyzed and summarized. Results and Conclusion The research on Tripterygium silfordii about the toxicity and margin of safety control based on the chemical separation and quality control about the effective material basis combined with the process of the effectiveness of expression, so as to provide consummating safety standards and putting forward early-warning scheme of adverse reaction, the early diagnosis and treatment measures that can be referred to clinical usage. Tripterygium silfordii will be ensured to use safely asa clinical drug. References | Related Articles | Metrics

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Clinical Adverse Reactions of Quinolone Antibacterial Drugs TAN Li-li 2013, 10(2): 92-95.  Abstract ( 375 )   PDF (534KB) ( 687 )   Objective By reviewing clinical adverse reactions of quinolone antibacterial drugs, to provide warning for the clinical rational use of antimicrobial drugs, and to prevent the adverse reactions happening of this kind of drug. Methods The related references about clinical adverse reactions of quinolone antibacterial drugs at home and abroad in recent years were collected, summarized and analyzed. Results The main clinical adverse reactions of quinolone drugs were the digestive system reaction, allergic reaction, photosensitized reaction, central nervous system reaction, cardiovascular system reaction, liver and kidney function damage, the blood system reaction, cartilage toxicity, tendon injuries and the influence on blood glucose, etc. Conclusion The symptomsf adverse reactions caused by the quinolone antibacterial drugs were numerous, involving many systems with some serious serious consequences in some cases, so clinical doctors should strictly master indications, reasonably choose medicine, attache great importance to adverse reactions monitoring, immediately take effective measures once the adverse reactions occur, so as to improve the safety of drugs. References | Related Articles | Metrics

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Analysis of 190 Reports of Adverse Drug Reaction Induced by Statins ZENG Ting-ting 2013, 10(2): 96-100.  Abstract ( 260 )   PDF (710KB) ( 275 )   Objective To investigate the characteristics and influence factors of adverse drug reactions (ADR) induced by statins. Methods 190 reports of adverse drug reactions induced by statins, collected from Sichuan ADR Monitoring Center via National ADR Monitoring System from Jan. 2004 to Jun. 2012 were analyzed. Results Skin le sions, muscle lesions, gastrointestinal system and liver function failure were the most common adverse reaction of statins, some nervous system and blood system abnormals followed. The serious adverse reactions frequently involved liver dysfunction. Conclusion Lipid -lowering drugs should be strictly regulated by dose and time -limit, to avoid any overtime or overdose medication. To emphasize the return consultation and follow-ups of out-patients may reduce the incidence of adverse reaction in statins. References | Related Articles | Metrics

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Analysis of Clomipramine Adverse Reaction/ Event WEI Xiu –feng, XU Zuo -guo, SUI Zhong –qing 2013, 10(2): 101-102.  Abstract ( 254 )   PDF (579KB) ( 256 )   Objective To investigate adverse reactions of clomipramine provide a reference for clinical safety of drugs. Methods To analyze the case reports of adverse reactions of clomipramine published by mental journals and pharmaceutical journals in the past 15 years, and several cases collected at our hospital. Results Clomipramine adverse reactions involve 9 major categories including 25 kinds of clinical manifestations, most of them are seizures, leukopenia, liver damage and mental disorders. Newly discovered adverse reactions are mental disorders, extrapyramidal reactions, allergies, leukopenia, fever, dependence, etc. 62.75% adverse reaction occurred within 15 days. Conclusion Adverse reactions of clomipramine are more serious, should pay. attention to prevention. References | Related Articles | Metrics

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Literature Analysis of 174 Cases of Lactic Acidosis Caused by Phenformin ZHANG Xin-jian, GUO Mei-hua, YANG Li-jie,LIU Shi-ping ,HU Bao-rong 2013, 10(2): 103-106.  Abstract ( 236 )   PDF (646KB) ( 247 )   Objective To provide a rational pharmacotherapy of phenformin by investigating the lactic acidosis induced by phenformin. Methods 174 lactic acidosis cases of phenformin were statistically analyzed. Results Male female ratio was 1.4:1, 76.8% of the patients were over 60 years old. For 75.3% of the cases, the dosage of the drug daily was more than 75 mg. For 70.3% of the patients, drug use time was more than halfa year, 92.0% of cases had the induced factors, 63.2% of the patients were cured or improved, 64patients died(36.8%). Conclusion Phenformin can cause lactic acidosis, severe cases can lead to organ failure, and even death. When using this drug should consider carefully the age, usage and dosage, course of treatment and other related factors, ensure rational drug use so as to reduce the incidence of adverse drug reactions. References | Related Articles | Metrics

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Bibliometrics Research and Visualization Analysis on Foreign Literature of Adverse Drug Reaction XUE Jing ,WEI Jian-xiang, ZHU Yun-xia, XU Hou-Ming 2013, 10(2): 107-110.  Abstract ( 237 )   PDF (600KB) ( 280 )   In order to understand the foreign research situation of adverse drug reaction, academic literatures of WOS about ADR from 1993 to 2011 were analyzed by using bibliometric method and information visualization tools. Firstly, in this paper we madea quantitative analysis about literature number, region distribution, research institute, main publication, correlative discipline and so on. Then, visualization analysis by using CiteSpace tool was made on two knowledge maps about hot topics time-zone and keywords clustering. References | Related Articles | Metrics

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Analysis of Shenmai Injection Application and Adverse Reaction at Our Hospital ZHU Ling-qi, ZHOU Xin ,Du Lei ,Wang Hong-min, Jin Hui-lin, XU Li-wen 2013, 10(2): 111-113.  Abstract ( 275 )   PDF (593KB) ( 345 )   Objective To analyze the clinical application and adverse reaction of Shenmai injection at our hospital, and provide reference for medical staff and regulators. Methods By the method of hospital intensive monitoring, we reviewed the medical records of all patients who ever used Shenmai injection from January to October 2011 at our hospital, and statistically analyzed the ADR of Shenmai injection. Results We collected 468 cases, 85.5% patients are over 50 years old. In most cases, indications, dosage and duration of treatment of Shenmai injection are consistent with the drug instruction. The incidence of ADR is 1.7%, belonging toa common category.The symptoms of adverse reactions are relatively light and transient, such as dizziness, fatigue, chest pain and discomfort. Conclusion Hospital intensive monitoring method isa good supplement of spontaneous reporting system, which can get a referential incidence rate of ADR, but multicenter studies are needed to make the data more representative. References | Related Articles | Metrics

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Analysis of Domestic Literature on Adverse Reactions Induced by Rabies Vaccine CAI Wei ,FENG Qiao-qiao ,LIAN Ya-ling ,DONG Duo 2013, 10(2): 114-116.  Abstract ( 289 )   PDF (593KB) ( 352 )   Objective The characteristics of adverse reactions induced by rabies vaccine were analyzed to provide reference for the clinical use. Methods 72 adverse reaction cases induced by rabies vaccine were analyzed retrospectively. Results There is no significant difference between the proportion of female and male patients. The proportion of patients under 15 years old is higher than that of other age groups. The skin and accessories damage is the most common. The serious adverse reaction is anaphylactic shock. Conclusion In order to ensure the safe and effective medication in the clinic, the adverse reaction monitoring of rabies vaccine and the awareness of drug safety should be strengthened. References | Related Articles | Metrics

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Antibacterials Use Density at Our Hospital in 2011 ZHANG Shi-yang, CHENG Jun ,ZHANG Shi-yong 2013, 10(2): 117-118.  Abstract ( 365 )   PDF (639KB) ( 171 )   Objective To evaluate application of antibacterials in our hospital inpatients. Methods By retrospective study, the data of drug used in 2011 were collected and analyzed. Taking defined daily dose(DDD) as the unit, antibacterials use density(AUD) was calculated and analyzed. Results The mean value of AUD was 61.49 The third generation cephalosporins, the second generation cephalosporins and quinolones were in the top 3 places respectively .The top three drugs of AUD were cefoperazone/sulbactum, cefepime and cefuroxime.Conclusion There are such problems as over medication and use of high-class antibacterials at our hospital. Thus, the management of antibacterials should be strengthened. References | Related Articles | Metrics

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Pharmaceutical Care of One Patient with Suspected Secondary Hypertension ZHONG Xue, ZHANG Ya-tong, HU Xin ,CHENG Gang 2013, 10(2): 119-121.  Abstract ( 274 )   PDF (600KB) ( 152 )   Hypertension isa common cardiovascular disease and may induce many complications which are the major causes of human's death. It is essential to select the correct and reasonable therapeutic regimens for the prognosis of patients. A young patient suffering hypertensive crisis of unknown origin were given pharmaceutical cares and educations by clinical pharmacists. Monitoring points of pharmaceutical care included tracking the treatment process; monitoring the adverse drug reactions; selecting the reasonable diagnostic method and therapeutic regimen before evaluating the value of aldosterone to rennin ratio (ARR). Clinical pharmacists provided medication education and clinical follow-up for the patient according to the monitoring Results . With the efforts of clinical pharmacists, medication compliance of this patient was improved and safety and efficiency of drugs use was ensured. In the treatment process, clinical pharmacists were playing the unique role. References | Related Articles | Metrics