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08 March 2013, Volume 10 Issue 3 Previous Issue    Next Issue

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Study on Analgetic Effect Mechanism and Accompanying Toxicity and Side Effects Mechanism of Water Extraction Components of Evodia Fructus HUANG Wei ,YAN Jun, SUN Rong 2013, 10(3): 129-131.  Abstract ( 263 )   PDF (323KB) ( 173 )   Objective To make the preliminary study on analgetic effect mechanism of water extraction components of Evodia Fructus, and to discuss the relevance between the accompanying hepatotoxicity and oxidative damage mechanism. Methods Mice were randomly divided into 5 groups according to weight, namely normal group, diclofanac sodium sustained release tablets group, high, middle and low dose group of water extraction components of Evodia Fructus. Mice were continuously administrated for7 days, and the level of PGE2, MDA、SOD、NO、NOS、GSH、 GSH-Px in serum were detected. Results The water extraction components of Evodia Fructus could cause the level of PGE2 in serum decreased, the activity of MDA in serum increased, and the activity of SOD decreased. The level of NO and NOS were increased, and the activity of GSH and GSH-Px were decreased. All the changes were aggravated in accordance with the dosages, and there was sijnificant difference compared with distilled water control group and there was certain dose -dependence relationship. Conclusion The analgetic effect mechanism of water extraction components of Evodia Fructus was mainly related with the reduction of the content of PGE2 in serum, and the approach of accompanying hepatotoxicity damage was related with the peroxidative damage mechanism. References | Related Articles | Metrics

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Effect of Ginsenoside Rd on Chromosome Aberration in Chinese Hamster Lung Cells GAO Mei ,CAO Chong, ZHU Chun-hua, QU Bao-en 2013, 10(3): 133-135.  Abstract ( 226 )   PDF (343KB) ( 297 )   Objective To explore the effect of ginsenoside Rd on chromosome aberration in Chinese hamster lung cells(CHL). Methods We used the method of cell counting to determine the IC50 of ginsenoside Rd on CHL cells, then to establish the range of doses according to the IC50 and to do the cell chromosome aberration experiment. When the CHL cells were exposured to ginsenoside Rd at 6h and 24h and plusedS9 mixture at 6h respectively, we observed the changes of chromosome number and structure, then to judge the chromosome aberration Results . Results Negative response was found at 6h and 24h after the treatment with ginsenoside Rd and at 6h after the addition of S9 mixture. Conclusion Under the condition of this experiment, ginsenoside Rd does not induce chromosome aberration in CHL cells. References | Related Articles | Metrics

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Impact on QTc Interval and Safety Evaluation of Amiodarone Injection for Inpatients ZHANG Xiao -xing, ZHANG Li -ming ,ZHENG Qing -min, JI Li-wei ,DING Qing -ming, LIU Yu -qing ,LOU Ying ,LI Yi-shi 2013, 10(3): 136-139.  Abstract ( 245 )   PDF (387KB) ( 179 )   Objective To evaluate the impact on QTc interval and relevant adverse drug reaction of amiodarone injeon for inpatients. Methods 1 111 inpatients from 4 upper first class hospitals in Beijing were enrolled from May 2011 to July 2012, the QTc intervals were measured to evaluate whether there would be change before and after amiodarone injection within 24 hours, and suspected proarrhythmia adverse effects due to study drug were monitored during the entire period of administration. Results The average heart rate was slowed(87.4±21.2bpm vs 99.6±27.9bpm, P<0.001) and QT interval was prolonged(388.5±55.9ms vs 366.0±55.9ms, <0.001) significantly after amiodarone administration as compared with the baseline, but QTc interval was not changed with statistical significance(456.8±51.0ms vs 457.8±50.2ms, P=0.554). One patient with atrial tachycardia experienced TdP after 54 hours amiodarone injection concomitant with oral amiodarone showed a prolonged QTc interval up to 756ms previously,TdP didn't occur again after amiodarone discontinuation and appropriate treatment. Conclusion Amiodarone injection within 24 hours does not impact on QTc interval with statistical significance in inpatients. Electrocardiograph should be monitored in a continuous amiodarone injection to avoid the relevant adverse drug reaction, especially when using oral amiodarone concomitantly. References | Related Articles | Metrics

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FDA's Risk Evaluation and Mitigation Strategy and the Inspirations to Our Country ZHAO Pin ,BIAN Lei ,YANG Yue 2013, 10(3): 140-134.  Abstract ( 236 )   PDF (463KB) ( 266 )   This article makes an introduction of the FDA's Risk Evaluation and Mitigation Strategy and analyses the background, legal framework, content, regulations and implementation process. It emphasizes the problems encountered in the implementation and relevant solutions and actions. It reflects thoughts and characteristics of FDA's policy-making to provide suggestions and references for domestic pharmacovigilance. References | Related Articles | Metrics

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The Study and Development of FDA Drug Risk Management Plan in View of Specific Drug LI Shu -fang, PAN Wen -hao 2013, 10(3): 144-147.  Abstract ( 331 )   PDF (448KB) ( 371 )   Objective To research the risk intervention and management plan about ER/LA opioid analgesic which developed by the United States Food and Drug Administration(FDA), and provide suggestions to the development of risk management plan about similar drugs in our country. Methods By literature research method, the development of risk management plan about ER/LA opioids analgesics was studied. Results and Conclusion Risk management plan about ER/LA opioid analgesics in the United States has been systematized gradually. It has various kinds of risk communication Methods and pays much more attention to reduce the burden to health care system. In the light of the existing problems, we should draw lessons from American experience and perfect similar drugs risk management plan in our country. References | Related Articles | Metrics

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Analysis of the Volatile Oil Constituent of Atractylodes Coreana (Nakai)Kitam by GC-MS YAO Hui-juan,YAO Hui-min, BU Shu-hong, LU Xiao-tong, ZHANG Jian 2013, 10(3): 148-150.  Abstract ( 252 )   PDF (485KB) ( 182 )   Objective To analyze the volatile oil constituent of . Methods The volatile oil was extracted by steam distillation, analyzed by capillary GC. The relative content of chemical components was calculated by peak area normalization method, the chemical components were identified by gas chromatography mass spectrometry. Results We found that 58 components were isolated, 55 components were identified, the identified chemical components account for 79.94 % of the total volatile oil, including 1,2-Bis -[4-pyridine -N -oxide]ethane (31.1831%)、[5,6]cholestan -3 -ol,3',6 -dihydro-, (3.beta.,5.beta.,6.alpha.) -Cyclopropa (12.3086 %)、5 α-Spirostan (11.2161%)、1,2,3,5,6,7,8,8a-octahydro-1,8a-dimethyl-7-(1-methylethenyl)-,[1R-(1.alpha.,7.beta.,8a.alpha.)]Naphthalene(7.05606%)、 γ-Elemene(4.24732%)、8(14)-en-3-ol,(3.beta.)-Ergost(2.11089%)、Caryophyllene(1.44473%)、decahydro -4a -methyl -1 -methylene -7 -(1 -methylethenyl) -, [4aR -(4a.alpha.,7.alpha.,8a.beta.)] -Naphthalene (1.43541%)、9,10-dehydro-isolongifolene(1.21445%)、α-Caryophyllene(0.72132%). Conclusion We concluded that the main chemical components of . volatile oil are sesquiterpenoids. References | Related Articles | Metrics

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Determination of Aspirin and Chlorpheniramine Maleate in Suke Ganmao Tablets by HPLC ZHANG Mei ,YANG Bo, ZHANG Li 2013, 10(3): 151-154.  Abstract ( 235 )   PDF (516KB) ( 386 )   Objective To determine the content of aspirin and chlorpheniramine maleate in Suke Ganmao tablets by HPLC. Methods The quantification of aspirin and chlorpheniramine maleate was detected respectively by two different HPLC conditions. Results There are both good linear relationships within the detection range, and the average recovery is 100.3% and 100.0% respectively. Conclusion The method is accurate, and the quantification was lower than the marked amount, which suggested us pay attention to the amount of the material that administed in process of production. References | Related Articles | Metrics

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Research Development on Toxicity of Radix Aconite Lateralis Based on Efficacy and Material Basis WANG Yi ,YAN Jun ,HUANG Wei, LI Xiao -jiaoyang ,SUN Rong 2013, 10(3): 155-158.  Abstract ( 240 )   PDF (503KB) ( 305 )   Objective To provide literature basis and research idea for the toxicity research of Radix Aconite Lateralis related to the efficacy and material basis. Methods References in the last two decades at home and abroad about Radix Aconite Lateralis were collated, analyzed and summarized. Results Recently, the research on toxicity of Radix Aconite Lateralis was focused on the alkaloids material. The protein, oleic acid, polysaccharide and other substances were not further studied, and the associated study between material basis and toxicity were lacked. On the other hand,a large number of pharmacodynamics and mechanism researches on the efficacy of Radix Aconite Lateralis were studied, but the associated study between efficacy and toxicity were in the blank spaces. Conclusion Considering that the toxicity of traditional Chinese medicine was recognized gradually in the process of expressing efficacy and has close relation with material basis's varieties and contents, so the expression of efficacy and toxicity should be paid attention at the same time, and to conduct the material basis separation and control under the expression of toxicity. The similarities and differences of pharmacology character of pharmacology efficacy and toxicity and that of material basis varieties that leads to these reactions should also be noticed. Only in this way, could we raise the toxic warning schemes and the diagnosis and treatment measures of adverse reactions about the toxicity of Radix Aconite Lateralis in the actual clinical use, to insure the safe use in clinic. References | Related Articles | Metrics

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Summary on Adverse Reactions of Antidiabetic Drugs SHI Hong-bo, CAI Qiang 2013, 10(3): 159-162.  Abstract ( 269 )   PDF (561KB) ( 314 )   Objective To provide a basis for rational drug use in clinic by reviewing clinical adverse reactions caused by all kinds of antidiabetic drugs. Methods The related references in recent years at home and abroad about clinical adverse reactions of antidiabetic drugs were collected, summarized and analyzed. Results In the process of diabetic treatment, it could cause a lot of adverse reactions along with the drug dose increased and other factors affected, and at present the commonly clinical adverse reactions of antidiabetic drug were mainly hypoglycemia, gastrointestinal symptoms, allergy reaction, metabolism and nutrition disorder, and so on. Conclusion The adverse reactions of antidiabetic drugs involved many systems, even resulted in some serious consequences, so clinical doctors should pay more attention to the adverse reactions of antidiabetic drugs, strengthen rational drug use in clinic, enhance the treatment effect, and reduce the pain of patients. References | Related Articles | Metrics

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Analysis of 40 Cases of Adverse Drug Reactions/Event Induced by Ambroxol Hydrochloride Injection HUANG Yuan ,LI Pan-hai ,TIAN Yue-jie 2013, 10(3): 163-165.  Abstract ( 314 )   PDF (589KB) ( 587 )   Objective To probe into the status,characterstics and influencing factors of ADR/ADE cases induced by Ambroxol Hydrochloride injection. Methods We analyzed 40 ADR/ADE cases induced by ambroxol hydrochloride injection which were collected by Shandong ADR monitoring network from Jan. to Dec. of 2011. Results 95% of the patients were under 14 or more than 45 years old. The symptoms of serious ADR were mainly anaphylactoid reactions. 92.5% of ADR/ADE appeared within 30 min. Conclusion Serious ADR/ADE can be caused by a variety of factors. High attention should be paid to acute anaphylactoid reactions. Ambroxol hydrochloride injection should be used with more caution and exact monitoring. References | Related Articles | Metrics

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Literature Analysis of 44 ADR Reports Induced by 5-HT3 Receptor Antagonist LV Xin -yan ,LIANG Mao –ben 2013, 10(3): 166-167.  Abstract ( 212 )   PDF (546KB) ( 120 )   Objective To explore the features and contributing factors of adverse drug reaction(ADR) induced by receptor antagonist and aims to provide reasonable suggestions in the clinical medication. Methods A statistical analysis was conducted on 44 ADR cases induced by 5-HT3 receptor antagonist, publicly reported during the years from January 2000 to December 2011. Terms like "Ondansetron Hydrochloride", "Granisetron Hydrochloride", "Tropisetron", "Azasetron hydrochloride", "Ramostetron Hydrochloride" and "5-HT3 receptor antagonist" were searched in major domestic journals and databases, such as VIP Medical Information Resources Service System, Wanfang Data Medical Information System, Journals of Chinese Medical Association, and Chinese Hospital Digital Database. Results of all the 44 ADR patients, 20 of them are male, accounting for 45.45% and 24 of them are female, comprising 54.55%. The ADR cases induced by Granisetron Hydrochloride reach up to 30(68.18%), and ADR was chiefly observed on skin, accessories, the cardiovascular system and the respiratory system. Conclusion High attention should be paid on the ADR related to 5-HT3 receptor antagonist in clinic in order to ensure the safe medication. References | Related Articles | Metrics

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Analysis of 25 Cases of Adverse Reactions Induced by Inirotecan in Advanced Colorectal Cancer Patients ZHANG Xiao-guang, ZHANG Xia 2013, 10(3): 168-171.  Abstract ( 244 )   PDF (598KB) ( 392 )   Objective To study the relative risk factors of adverse reactions for improving the application security and expanding the range of irinotecan. Methods Patients were collected and analyzed on adverse reactions in the oncology of our hospital from December 2011 to October 2012, who are using irinotecan combination chemotherapy.Fisher accurate inspection was adopted in SPSS17.0, and analyzed the relations between different kinds of clinical parameters with adverse reactions. Results The incidence of nausea and vomiting was 64.00%. The incidence of severe nausea and vomiting (Ⅲdegrees) was 8.00%.The incidence of bone marrow suppression was 56.00%. Severe bone marrow suppression(above Ⅲdegrees) incidence was 12.00%. Delayed diarrhea incidence was 40.00%. Severe diarrhea (Ⅲdegrees) incidence was 4.00%, no more serious diarrhoea(Ⅳdegree).Acute cholinergic syndrome incidence was 16.00%. Long-term smoking and alcohol drinking history were risk factors of diarrhea. Conclusion The adverse reactions of irinotecan are more common, but severe bone marrow suppression and delayed diarrhea (Ⅲ-Ⅳdegree) with low incidence. Delayed diarrhea occurred around the time of 4～6 days after medication. The patients had delayed diarrhea occurred at higher risk with a long history of cigarette smoking and alcohol drinking. This part of patients should be reinforced of cigarette and alcohol abstinence promotion to achieve the safety. References | Related Articles | Metrics

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Literature Analysis of 242 Cases of Allergic Reactions Caused by Insulin MA Man-ling, GUO Mei-hua, YANG Li-jie, HU Bao-rong, WANG Jin-hua 2013, 10(3): 172-174.  Abstract ( 248 )   PDF (670KB) ( 163 )   Objective To understand the cases of allergic response caused by insulin, analyze the relevant factors, and providea reference for the clinical use of drugs. Methods 242 cases of insulin-induced allergic reactions were statistically analyzed. Results Male to Female ratio was 1.1:1, 61.1% of the cases involved the elderly, 15.7% of the patients had allergy history, 91.3% of the allergies were due to subcutaneous injection, 50.0% of the patients administered premixed insulin, 80.2% of the cases occurred aftera few or many times administration. The main allergic reactions were local reactions(57.0%), and could be cured or improved mostly. Conclusion Insulin may cause serious allergic reactions and even shock. When we use this drug, we must carefully consider the age, usage, dosage and other relevant factors, then make rational use of drugs to reduce the incidence of allergic reactions. References | Related Articles | Metrics

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Literature Analysis of 21 Cases of Adverse Drug Reactions Induced by Extraction of Bone-melon YI Dan ,LUO Xiao-bo, LU Xiang-hong 2013, 10(3): 175-177.  Abstract ( 245 )   PDF (653KB) ( 166 )   Objective To explore the characteristics and related factors of adverse drug reactions (ADR) induced by extraction of bone-melon so as to provide references for rational clinical drug use. Methods ADR cases induced by extraction of bone -melon reported in domestic medical journals during 1994～2012 were collected and analyzed statistically. Restuls ADR induced by Extraction of Bone-melon often occurred in aged group. The onset of ADR was usually within 30min after injection. ADR could involve multiple organs and systems, and clinical manifestations were various, mainly allergic reactions. Severe allergic reactions could manifest dyspneic respiration and anaphylactic shock. Conclusion Clinical physicians and pharmacist should pay attention to the ADR induced by extraction of bone-melon and persist in rational drug use. References | Related Articles | Metrics

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Analysis on Off-Label Use at Outpatient and Emergency Department LIU Liao ,JIANG Dan ,JIA Ping ,XU Wen -fang 2013, 10(3): 178-180.  Abstract ( 528 )   PDF (683KB) ( 449 )   Objective To analyze the situation of off-label use at outpatient and emergency department in our hospital for references of rational drug use in the clinic. Methods The prescriptions of outpatient and emergency department from June 2012 to Nov. 2012 were selected in our hospital. The off-label use was analyzed according to the package inserts. Results Of the total 600 prescriptions, 63 ones involved off -label use. The problems were mainly over dosage(33.3%), beyond indication(23.8%), route of medication(20.6%) etc. Examples of off-label use mainly included nifedipine for the treatment of preterm labor, ambroxol hydrochloride injection nebulized for the treatment of respiratory tract infections, maxingganshi decoction for the treatment of respiratory tract infections in children etc. Conclusion The off -label use is widespreaded at outpatient and emergency department. Risks exist during the health care process. It is sensible for our hospital to pay great attention on off-label use to establish corresponding control system and procedure, so as to ensure safe use of drug in patients. References | Related Articles | Metrics

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Analysis of Common Potential Errors in Hospital Pharmacy and Countermeasures ZHANG Ya-nan, CHEN Ning 2013, 10(3): 181-183.  Abstract ( 333 )   PDF (673KB) ( 575 )   Objective To reduce pharmacy potential medication errors to ensure patient safety and improve the quality of service. Methods Analysing 465 cases of errors by statistical errors types, find out the cause of the errors, and put forward the corresponding countermeasures. Results There are 283 cases of errors, accounting for 61.5% , ranking the first place of error occurred. The main reasons that caused the errors include similar name of the drug, prescription identification error, similar drug packaging, and adjacent medicines etc. Conclusion Causes of medication potential errors are various. Based on the realities of pharmacy, the corresponding countermeasures should be put forward to ensure maximum safety of patients. References | Related Articles | Metrics