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08 December 2013, Volume 10 Issue 12 Previous Issue    Next Issue

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Protectiv e Effect of Total Glucoside of for Injection on Concanavalin A-induced Liver Injury in Mice WANG Shu-juan, JIA Zhi-dan, WEI Huai-ling, MIAO Lu -yang, ZHANG Dan ,SUN Hua 2013, 10(12): 705-708.  Abstract ( 216 )   PDF (423KB) ( 185 )   Objective To study the protective effect of total glucoside (TGP) for infection on Concanavalin A(ConA)-induced acute liver injury in ICR mice. Methods ICR mice were given intravenously TGP injection 0.5～8mg·kg-1 for five days(one time/day). After the last administration 2h, the mice were injected intravenously ConA 20mg·kg-1 to establish the immunological liver damage model. All animals were killed on 16h after ConA treatment. The activities of ALT, AST and LDH were measured by automatic chemistry analyzer(TBA-40FR). Liver histopathological changes were examined by H.E. and light microscopy. Results ConA 20mg·kg-1 could induced significant liver damage, expressed in the higher serum ALT,AST,LDH activities and the apoptosis or inflammatory cell infiltration in liver tissue. TGP injection 0.5～4mg·kg-1 showed significantly protective effect to liver damage induced by ConA, which could reduce serum transaminase activities and prevent the pathological injury. The optimum dose is 1mg·kg-1. There wasa reduced efficacy when the dose is 8mg·kg-1. While at this dose, there are no obvious toxicity. Conclusion TGP injection showed a significant protective effect on ConA-induced liver injury in mice. Its effective dose is low and the therapeutic activity will cut down when the dose is higher than 8mg·kg-1. It should be careful to the dose choice in clinical trial. References | Related Articles | Metrics

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Experimental Study of Acute Toxicity of PIKA Hepatitis B Therapeutic Vaccine(CHO Cell) and Its Component on Mice WU Xiao-fei, CAO Chun-ran ,SUN Yuan-yuan ,HU Yu-chi 2013, 10(12): 709-711.  Abstract ( 295 )   PDF (420KB) ( 206 )   Objective To compare the acute toxicity reaction of PIKA hepatitisB therapeutic vaccine(CHO cell) and its component on mice,which is PIKA adjuvant and recombinant hepatitisB vaccine(CHO cell). Methods ICR mice were randomized into solvent control group, high dose and low dose(PIKA adjuvant stoste and 2 times diluent) of PIKA adjuvant groups, recombinant hepatitis B vaccine(CHO cell) and high dose and low dose(vaccine stoste and2 times diluent ) of PIKA hepatitis B therapeutic vaccine ( CHO cell ) . Mice were administrated intramuscularly once with tested drugs(0.2 mL) and continuously observed for 14d for acute toxicity symptoms. Results All mice of every group survived and there were no toxicological changes in body weight, feed consumption, injection agents, appearance, behavioral activity, respiratory system, dejecta, organ macroscopic and pathological examination related to the tested drugs. Conclusion There is no obvious acute toxicity reaction on mice treated with PIKA hepatitis B therapeutic vaccine(CHO cell) and its component. References | Related Articles | Metrics

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Comparison of the Effect of Fascia Iliaca Compartment Block between Single and Multiple Injections CHANG Ying ,ZHANG Da -zhi ,LI Yu -jin 2013, 10(12): 712-713.  Abstract ( 237 )   PDF (492KB) ( 235 )   Objective To compare efficacy of fascia iliaca compartment block with single and multiple injections. Methods This wasa prospective, randomized, controlled study conducted on patients undergoing total hip replacement surgery. Patients were randomized to receive fascia iliaca compartment block by single injection or multiple injections using 150mg ropivacaine combined with 7.5mg dexamethasone. The total capacity of the injections is 30mL. We e valuated the onset time of sensory block and the success rate for block of the femoral nerve, the obturator nerve and the lateral femoral cutaneous nerve. Results A total of 133 patients were included in this study. The onset time of sensory block for the lateral femoral cutaneous nerve and the obturator nerve sensory were shorter in experimental group than that in control group(P <0.05), and there was no significant difference between the two groups for femoral nerve block onset time. The success rates for the lateral femoral cutaneous nerve block in control group and experimental group were 68.7% and 92.4% respectively, which was significantly different( P<0.05). In the control group and the experimental group, the success rately for obturator nerve block were 59.7% and 89.4% respectively, which was significantly different( <0.05). Conclusion Fascia iliaca compartment block using multiple injections works at higher efficiency than single injection. References | Related Articles | Metrics

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Discussion of Risk Evaluation and Mitigation Strategy of Rosiglitazone in America XU Rong-qin, XU Mei-ting ,YANG Yue 2013, 10(12): 714-718.  Abstract ( 176 )   PDF (545KB) ( 172 )   Objective To analyze post -marketing risk management of rosiglitazone in America, in order to provide references for risk management of post -marketing drugs in China. Methods By searching medical literature from the FDA and CFDA website, and collecting rosiglitazone related information, it introduced the risk evaluation and mitigation strategy(REMS) on rosiglitazone in America. It analyzed post -marketing supervision of rosiglitazone in China and compared the risk intervention measures of China with America's. Results and Conclusion The American rosiglitazone REMS is an important measure in post-marketing supervision and it strictly limited the use of rosiglitazone. It has significant meaning to guide our drugs post-marketing risk management. References | Related Articles | Metrics

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Systematic Review of Oral Ketoconazole Adverse Reactions and Hepatotoxicity Incidence TAO Qing-mei, NIE Xiao-lu ,CHENG Gang, WANG Dan, WU Gui-zhi, ZHAN Si-yan 2012, 9(12): 719-722.  Abstract ( 232 )   PDF (559KB) ( 202 )   Objective To study the oral ketoconazole adverse reactions in the world, especially the hepatotoxicity. Methods Searching articles using relative terms about ketoconazole, oral administration published on PUBMED, MED LINE, CBM, CNKI, VIP, WANFANG and many other databases by Nov. 2011. Picking up the basic information, method features, interventions and adverse reactions when the studies were included, fixed models were used for the final Results ' Meta-analysis. Results The number of included studies was 195. The top three adverse reactions were intestinal adverse reactions(44.5%), neurological and psychiatric adverse reactions(13.8%), hepatotoxicity(11.0%). The hepatotoxicity incidence proportion was 3.1% ~4.1%. Conclusion Many kinds of oral ketoconazole adverse reactions were observed, relating to all systems, the hepatotoxicity proportion was high(3.1%~4.1%). Because elevated liver enzymes were the most common reporting markers, severe liver injure proportion couldn't be measured. When generalizing the Results one should consider the study qualities and publication bias. References | Related Articles | Metrics

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A Systematic Review of Efficacy of Trimetazidine for Stable Angina Pectoris in Chinese People ZHANG Jin -li ,YANG Xue ,ZHANG Hui -xia, LU Jie, WANG Li ,CHENG Gang 2013, 10(12): 723-729.  Abstract ( 241 )   PDF (885KB) ( 173 )   Objective To evaluate the efficacy of trimetazidine(TMZ) in the treatment of stable angina pectoris(SAP). Methods All literatures related to trimetazidine were retrieved in the following databases as PubMed, EMbase, Cochrane Central Database, CBM, CNKI, VIP and WanFang Data. The literatures which met the inclusion and exclusion criteria were selected, data were extracted, the quality was evaluated, and then statistical Methods such as Meta-analysis were performed. Results A total of 13 RCTs involving 869 patients were included. The Meta -analysis showed that, compared with the control group, TMZ was significantly superior in the following5 aspects: total efficiency, weekly mean number of angina attacks, weekly nitroglycerin consumption, the time to 1 mm drop of ST segment and angina pectoris threshold. But TMZ has no significant difference in duration of doing exercise compared with the control group. Conclusion Based on current studies, TMZ is superior to other medicines in the control group for SAP at present. However, due to defect of the data analysis method, this Conclusion needs to be confirmed by more high quality, large sample, multi-center, double blind RCTs. References | Related Articles | Metrics

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Advances in Prevention and Treatment of Drug-induced Deafness SI Ji-gang 2013, 10(12): 730-733.  Abstract ( 265 )   PDF (558KB) ( 712 )   In order to further understand the types of ototoxic drugs and the mechanism of deafness, and to explore the prevention and treatment strategies of drug -induced deafness, literatures about drug -induced deafness at home and abroad in recent years were collected, summarized and analyzed. The ototoxicity of drugs is related not only with hereditary, dose, length of time and administration route, but also with age and physical condition. The ototoxic drugs involve many kinds of chemicals and they will cause unimaginably serious consequence. More attention should be paid in clinical practice,clinical rational drug use should be strengthened. Prevention first and appropriate treatment as early as possible are the therapeutic strategies of the drug-induced deafness. References | Related Articles | Metrics

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A 5-year Analysis on Iodine Contrast Induced Anaphylactic Reaction Occurred During Percutaneous Coronary Intervention ZHUANG Wei, LIU Yu-qing ,LI Yi-shi ZHANG Er-li ,SONG Guang-yuan, ZHAO Jie ,WU Yong-jian 2013, 10(12): 734-736.  Abstract ( 288 )   PDF (551KB) ( 263 )   Objective To analyze the characteristics of iodine contrast induced anaphylactic reaction occurred during percutaneous coronary intervention( PCI) , so as to provide a reference to reduce the risk of its use. Methods By searching the clinical database of Beijing Fuwai Cardiovascular Hospital, we retrospectively investigated the incidence of iodine contrast induced anaphylactic reaction during PCI, including coronary angiography, in recent 5 years. We described the relationships between the use of the agent and gender, age, clinical manifestation, and the type of the agent, respectively. Results In all of the 79 102 patients who received PCI , 48 patients ( 0.061 % ) ended up with anaphylactic reaction. Among them, 44(0.056% ) patients were males and 4(0.02% ) patients were females. The ratio between male and female was 11:1. Some commonly used non -ion iodinated agents including iohexol, ioversol, iopamidol, iodixanol and iopromide were involved, iopromide and iodixanol induced most of the anaphylactic reaction. The clinical manifestation of the anaphylactic reaction varied broadly, in which rash was the most commonly observed and shock was the severest drug adverse reaction. Two patients eventually died of severe anaphylactic reaction. Conclusion In general, non-ion iodinated contrast is safe to use in PCI. However, it is still necessary to carefully monitor the occurrence of its anaphylactic reaction. Early recognition and intervention of its manifestation is very critical to improve the safety of both drug use and PCI. References | Related Articles | Metrics

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Analysis of 157 Reports of ADR/ADE Induced by Magnesium Sulfate Injection LI Wen-wu 2013, 10(12): 737-739.  Abstract ( 302 )   PDF (729KB) ( 468 )   Objective To study the general pattern and characteristics of adverse drug reaction(ADR) induced by magnesium sulfate injection to provide references for clinical rational use of the drugs. Methods 157 cases of ADR/ADE related to the magnesium sulfate injection from January 2010 to June 2013 in Henan province were analyzed using retrospective study method. Results Most of the patients taking the drug were female whose age was 20~39(69.43%). The cases occurred within 30 minutes accounted for 68.79% of the total. The main ADR/ADE damages were systemic damage ( 36. 36 % ) and gastrointestinal system damage ( 25. 17 % ) . The ADR manifestations mainly covered nausea, vomiting, flushing, dizziness and palpitation, etc. Conclusion The ADR/ADE induced by magnesium sulfate injection had been recorded in Henan ADR monitoring database. It is suggested that we should strengthen the ADR monitoring of magnesium sulfate injection, and improve the drug instruction, in order to reduce the incidence of severe ADR/ADE. References | Related Articles | Metrics

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Literature Analysis of 65 Cases of Adverse Drug Reaction Induced by Amikacin Injection FAN Yan 2013, 10(12): 740-743.  Abstract ( 232 )   PDF (688KB) ( 407 )   Objective To analyze the general characteristics of adverse drug reaction induced by amikacin, provide reference for rational drug use in clinic. Methods Used "amikacin" and "adverse reaction" as the keyword, search the cases of the adverse drug reaction induced by amikacin that reported from Jan 1980 to Jan 2013. Data should be analyzed through occurrence time, the original disease, clinical manifestation, prognosis, et al. Results There were 52 publications including 65 cases. Central& peripheral nervous system disorders were the highest incidence, followed by the respiratory system disorders and cardiovascular disorders. The main clinical manifestation were allergic shock, expiratory dyspnea, hypotension, cyanosis, weak pulse, et al. The most adverse drug reactions got right after drug withdrawal and symptomatic treatment, but serious adverse reaction may cause death. Conclusion The clinical manifestations of adverse drug reaction induced by amikacin were complex and diversity. The prognosis was preferable, but serious adverse reaction can cause death. So attention should be paid to the adverse drug reactions induced by amikacin in clinic, and the monitoring of medication should also be strengthened to ensurea safe medication. Key words: amikacin; adverse drug reaction; literature analysis References | Related Articles | Metrics

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Literature Analysis of 59 Anaphylaxis Cases Induced by Compound Danshen Injection KANG Jian 2013, 10(12): 744-748.  Abstract ( 220 )   PDF (844KB) ( 307 )   Objective Through analysing 59 anaphylaxis cases by Compound Danshen Injection to explore the mechanism and characteristics, provide a reference for clinical rational use of drugs. Methods By searching literature in Chinese journal full -text database from 1994 to 2013, 59 anaphylaxis literatures of Compound Danshen Injection involving 59 cases, were statistically analyzed. Results In the 59 anaphylaxis cases by Compound Danshen Injection, it had no selection to sex, and anaphylaxis often occurred in aged group. The shortest time was 2 min after administration and the longest time was 16d, and the most was found in 30 minutes after administration; the major clinical manifestations of anaphylaxis involved many systems and organs, and were complex and varied, and the cardiovascular system was the first, followed by respiratory system, gastrointestinal system, systemic damage, nervous system; all cases were found timely, made an immediate withdrawal and symptomatic treatment to get satisfactory outcome, and no cases of death were reported. Conclusion The doctors and pharmacists should pay attention to the anaphylaxis caused by Compound Danshen Injection, and the clinical monitoring should be strengthened to prevent the occurrence of adverse reactions. References | Related Articles | Metrics

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Literature Analysis on the Adverse Drug Reactions of Gd-DTPA WANG Yu, CHEN Wei ,YANG Jun 2013, 10(12): 749-751.  Abstract ( 279 )   PDF (653KB) ( 665 )   Objective To explore the situation and rules of adverse drug reactions of Gd -DTPA injection, in order to provide reference for the rational use of drugs in clinic. Methods We collected the literatures related to the adverse reactions of Gd -DTPA injection in WANFANG Database from 2002 to 2012, and conducteda statistical analysis. Results The Results showed that the ratio of male to female was 1:1.2. Most adverse reactions occurred whthin 30 minutes after medication. There were 59 cases(44%) of non-allergic reactions, 47 cases(35%) of mild allergic reactions, 10 cases(8 % ) of moderate allergic reactions ,18 cases( 13% ) of severe allergic reactions ,of which 6 cases ( 4% ) died. Conclusion In spite of Gd-DTPA injection with low incidence of adverse reaction, it can still cause severe allergic reactions and even death. Pharmacists should strengthen the monitoring because of its use in imaging diagnosis without clinical care. References | Related Articles | Metrics

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Analysis for Inherent Risk of Metallic Bone Plate GUAN Wei, ZHAI Wei, LIU Bin ,ZHAO Yan 2013, 10(12): 752-754.  Abstract ( 226 )   PDF (635KB) ( 223 )   Objective To understand the inherent risk of metallic bone plate in clinic use, analyze its possible reasons and suggest corrective actions, so as to improve the safety and effectiveness of metallic bone plate. Methods Collecting the representative medical device adverse event of metallic bone plates. Related articles were also collected, analysed and concluded. Results and Conclusion There isa balance between profit and risk in any kind of post-marketed medical device. The inherent risk of metallic bone plates will cause different kinds of adverse events. So none but avoiding such risks and taking control measures can improve the safety and effectiveness of metallic bone plates. References | Related Articles | Metrics

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Analysis of External Quality Assessment Results for Therapeutic Drug Monitoring from 2010 to 2012 YAN Ying ,ZHANG Shun -li ,ZHONG Kun ,REN Si -mei ,MA Rong ,WANG Dong -huan ,ZHANG Chuan-bao 2011, 8(12): 755-759.  Abstract ( 204 )   PDF (781KB) ( 115 )   Objective To analyze the external quality assessment(EQA) program Results for therapeutic drug monitoring (TDM) from 2010 to 2012 in China, and to provide the reference for improving the TDM determination quality .Methods Three times of blood TDM EQA Results and6 times of serum TDM EQA Results from 2010 to 2012 were collected and analyzed statistically by National Center for Clinical Laboratories(NCCL). Results From 2010 to 2011, the number of blood TDM EQA participants increased from 88 to 102, the serum TDM EQA participants increased from 119 to 136. In blood TDM EQA, the average qualified rate of cyclosporine A, tacrolimus, sirolimus in 3 years were 94.2%, 83.4% and 89.1%, respectively. In serum TDM, the average qualified rate of theophylline, digoxin, phenytoin, valproic acid, carbamazepine in3 year were 94.3%, 81.9%, 95.4%, 96.7% and 95.9%, respectively. In all the participated laboratories, the number of fluorescence polarization immunoassay(FPIA) decreased, the number of acridinium direct chemiluminescence and enzyme-multiplied immunoassay technique(EMIT) increased every year. Approximately 92.3% of the 195 lots of EQA, the coefficient of variation of the Methods were less than 20%, 7.2% of the lots, the coefficient of variation of Methods were between 20%～30%, and 0.5% of the lots, the coefficient of variation of Methods were more than 30%. Conclusion The determination accuracy and comparability for TDM should be improved by strengthening quality control management and standardization, and it will provide the credible diagnostic reference for the clinical application. References | Related Articles | Metrics

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Analysis of Prescriptions of Antimicrobial Drugs in Pediatric Outpatient Department ZHANG Lei 2013, 10(12): 760-761.  Abstract ( 389 )   PDF (697KB) ( 271 )   Objective To understand the use of antibiotics in pediatric outpatients in our hospital so as to provide reference for rational drug use.Methods A total of 1000 prescriptions for pediatric outpatients were sampled randomly from our hospital for statistical analysis in respect of the number of drug categories, infusion use frequency and combination of drug uses etc. Results Cephalosporins, macrolides, penicillins took the lead in the total antibacterials used in our hospital. The rate of antibiotics combination was 24.3% in the statistical prescriptions of antibiotics. The average number of drugs prescribed in one prescription was about 4.46. Conclusion The application of antibiotics in different categories is on the high side and antibiotics are combined with Chinese medicine injection or even hormone, which should be paid attention to. References | Related Articles | Metrics

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Analysis of Irrational Medical Order in Pharmacy Intravenous Admixture Service of Our Hospital DENG Xue-e ,SHEN Su 2013, 10(12): 762-763.  Abstract ( 209 )   PDF (606KB) ( 263 )   Objective To summarize the irrational medical orders in pharmacy intravenous admixture services (PIVAS) in our hospital, so as to improve the quality of drug dispensing and the rational drug use in clinic. Methods The irrational medical orders of PIVAS in our hospital from January to July in 2012 were analyzed statistically in the article. Results Among 237 150 medical orders, 915 irrational medical orders accounted for 0.38%, including irrational administration, improper solvent selection and incompatibility, etc. Conclusion PIVAS pharmacists can improve rational use of drug by correcting irrational medical order. References | Related Articles | Metrics

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Effect of Iron Chelation Therapy on Hematologic Response in an Aplastic Anemia Patient SUN Wan-ling ,ZHAO Hong JI ,Bing-xin, WAN Sui-gui ,SU Li 2013, 10(12): 764-766.  Abstract ( 228 )   PDF (617KB) ( 428 )   Objective To evaluate the effect of iron chelation therapy on hematologic response in a patient with severe aplastic anemia. Methods A patient diagnosed as severe aplastic anemia was treated with immunosuppressive therapy. Eleven months later, no improvement on peripheral blood cell count was available and transfusion -related iron overload was confirmed. Therefore, regular iron chelation therapy with deferoxamine was administrated. Results The patient became platelet transfusion-independent in5 months from the beginning of iron chelation therapy, red blood cell transfusion-independent in 7 months, and the iron chelation therapy lasted 9 months. A complete remission was achieved in 13 months from the beginning of iron chelation therapy, and no adverse effect happened. Conclusion Monitoring serum ferritin is necessary to transfusion -denpendent patients with bone marrow failure, and timely iron chelation therapy is helpful to achieve hematologic response for iron overload patients. References | Related Articles | Metrics