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20 September 2017, Volume 14 Issue 9 Previous Issue    Next Issue

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Parkinsonian Lesion in Rat Induced by Rotenone and its Possible Mechanism ZHANG Qiu-shuang, CHEN Ying, CHEN Nai-hong, YUAN Yu-he 2017, 14(9): 513-517.  Abstract ( 390 )   PDF (586KB) ( 304 )   Objective To estimate the behavioral defects, pathological abnormalities, and biochemical changes after rotenone injection in rats, and study the associated mechanisms of Parkinson's disease (PD). Methods To induce the Parkinsonian lesions, rats got a stereotaxic injection of rotenone into the substantia nigra pars compacta. Behavioral performances were estimated by rotarod test and apomorphine induced rotation; pathological abnormalities were examined by immunohistochemistry; biochemical changes were detected by western blot. Results Unilateral stereotaxic infusion of rotenone led to behavioral defects of rats and resulted in rotations after rats treated by apomorphine. The pathological and biochemical results showed that rotenone had caused loss of dopaminergic neurons, phosphorylation of α-synuclein, activation of microglia, and increased protein content of tumor necrosis factor (TNF-α) and cyclooxygenase-2 (COX-2). Conclusion Rotenone may initiate and promote the neurodegeneration of PD by destroying dopaminergic neurons, inducing α-synuclein phosphorylation, activating microglia, and increasing the protein content of TNF-α and COX-2. References | Related Articles | Metrics

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Effect of Compound Compatibility of Processed Sanhuangxiexin Decoction with Activating Blood and Resolving Stasis on Atherosclerosis in Rats YIN Xiao-jie, MAO Xiao-jing, WANG Lan, GONG Lei-lei, LI li, XIAO Yong-qing, LIANG Ri-xin 2017, 14(9): 518-522.  Abstract ( 338 )   PDF (547KB) ( 236 )   Objective To investigate effect of compound compatibility of processed Sanhuangxiexin decoction with activating blood and resolving stasis on atherosclerosis in rats. Methods The rat atherosclerosis model was established by a feeding of high-fat diet combined with injection of vitamin D3 and ovalbumn. The rats were randomly divided into 6 groups, normal group, model group, model plus positive medicine group (simvastatin 0.01g·kg-1 ) group, model plus compound compatibility groups at the dose of 1.00 g·kg-1、0.50 g·kg-1、0.25 g·kg-1, respectively. After 8 weeks of modeling, the rats were administrated corresponding drugs for 4 weeks. At the end of 12 th week, blood was collected from the abdominal aorta to determine levels of following indicators: TC, TG, HDL, LDL, SOD, MDA, NO, CRP, TNF-α, IL-1, IL-6, IL-8, IL-18. RIA was used to determine content of 6-keto-PGF1α, ET, and TXB2. Then, the aorta was harvested and HE staining was used to observe pathological changes of blood vessels. Results The compound compatibility of processed Sanhuangxiexin decoction can reduce the content of TC, TG and LDL levels with increased HDL content. Meanwhile, SOD activity was increased, and MDA was reduced. The depressed contents of CRP, TNF-α, IL-1β, IL-6, IL-8, IL-18 were found. NO and 6-keto-PGF1α contents were increased, and ET and TXB2 were decreased. The pathological observation on the morphology and structure of vascular indicated that it could attenuate lipid deposition, cholesterol crystallization and calcification. Conclusion The compound compatibility of processed Sanhuangxiexin decoction may play an important role in the protection of AS rats, which may be related with regulating blood lipid levels, antioxidant and anti-inflammatory reaction, and improving endothelial functions. References | Related Articles | Metrics

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Study of Single-dose Toxicity of Dexrabeprazole Sodium in Beagle Dogs LIU Cui-ling, DAI Xiao-li, MA Yu-kui, SUN Rong 2017, 14(9): 523-526.  Abstract ( 396 )   PDF (452KB) ( 280 )   Objective To study the single-dose toxicity of dexrabeprazole sodium in Beagle dogs and compare the toxicity of dexrabeprazole sodium with rabeprazole sodium. Methods Approximate lethal dose methods were adopted to evaluate the single-dose toxicity of dexrabeprazole sodium in Beagle dogs. Animals were divided into different groups and were administered with different dose for one time. The general symptoms were observed and body weight, hematology, blood biochemistry and histopathology were detected after administration. The animals were autopsied and lesion of main organs were observed after continuous observation for 14 days. Results The approximate lethal doses of dexrabeprazole sodium and rabeprazole sodium in Beagle dog are 192.2~288.3 mg·kg-1 and 128.1~192.2 mg·kg-1 respectively. The main acute toxicity symptoms of dead dogs are salivation, vomiting, weakness of limbs, tremble, tachypnea, prone position, convulsion, somatic rigidity, and eventually to death. Conclusion The toxic reactions of dexrabeprazole sodium in Beagle dogs are similar to that of rabeprazole sodium, but the toxicity level is higher than that of rabeprazole sodium . References | Related Articles | Metrics

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Enlightenment of Japanese Drug Post-marketing Evaluation System to China TIAN Chun-hua, LI Xin-ling, ZHOU Ran, XUE Bin, YANG Wei 2017, 14(9): 527-529.  Abstract ( 629 )   PDF (582KB) ( 464 )   Objective To provide a reference for the establishment of post-marketing evaluation system in China by summarizing the experience of post-marketing evaluation in Japan. Methods The similarities and differences between drug post-marketing evaluation in China and in Japan were compared by academic exchanges and the literature. Results Japanese post-marketing evaluation is mainly composed of two systems, which were reevaluation and reexamination. The reevaluation system is for solving the "old medicine" defects, and the reexamination system is for promoting the "new drug" monitoring and research. These systems effectively cover all of Japanese medicines. Conclusion Japanese post-marketing evaluation system is very unique, suitable for reference to the construction of Chinese drug post-marketing evaluation system. References | Related Articles | Metrics

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Introduction of Drug Reevaluation in United Kingdom and Germany and Enlightenment to China GAO Jian-chao 2017, 14(9): 530-533.  Abstract ( 354 )   PDF (384KB) ( 365 )   Objective To put forward enlightenment for the drug reevaluation act in China through comparing the reevaluation of marketed old drugs in the United Kingdom and Germany. Methods The reevaluation causes, methods, problems encountered during the evaluation process and the reevaluation results in the United Kingdom and Germany were reviewed. Results The marketed drug reevaluation in both countries was conducted under the mandatory requirements of the European community, the two countries adopted similar but not identical evaluation methods.The evaluation process lasted for more than 20 years in Germany, while the reevaluation project was generally completed in the United Kingdom within the time limit stipulated by the European community through many adjustments to the evaluation methods. Conclusion A feasible reevaluation strategy should be developed for the reevaluation of marketed old drugs, the quality and pace of evaluation should be balanced, and it is necessary to design a scientific policy for the reevaluation process to avoid regulatory conflicts or legal disputes. References | Related Articles | Metrics

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Analysis and Consideration on the Reproduction Toxicity Risk of Mycophenolate Mofetil or Mycophenolic Acid FENG Hong-yun, FAN Yan, WU Gui-zhi, DONG Duo 2017, 14(9): 534-537.  Abstract ( 318 )   PDF (509KB) ( 183 )   Objective To investigate the perception ability and management ability of reproduction toxicity risk of mycophenolate mofetil or mycophenolic acid in China, and to provide support to treat and prevent reproduction toxicity risk reasonably. Methods The literatures in domestic bibliographic databases, the individual adverse drug reaction cases in Vigibase, China adverse drug reaction database, and the risk management measures in domestic and overseas were analyzed. Results The reproduction toxicity risk of mycophenolate mofetil or mycophenolic acid has been identified. But in our country, the monitoring and perception of the reproduction toxicity risk is insufficient. Conclusion The reproduction toxicity risk of mycophenolate mofetil or mycophenolic acid will be existing for a long time, while the monitoring ability in our country legs behind other countries. In order to improve the monitoring and risk management ability on the reproduction toxicity risk of mycophenolate mofetil or mycophenolic acid, several departments, such as manufacturers, health professionals and regulators need do more efforts and communication. References | Related Articles | Metrics

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Misuse Risk Analysis of Methotrexate and Enlightenment to Pharmacovigilance LI Lan, XIA Dong-sheng, TIAN Chun-hua 2017, 14(9): 538-540.  Abstract ( 411 )   PDF (504KB) ( 399 )   Objective To analyze the misuse risk of methotrexate and the enlightenment for pharmacovigilance. Methods This article summarized the basic situation of methotrexate, domestic and foreign literature about medication error of methotrexate and domestic and foreign regulatory measures. Results Both domestic and foreign literatures were reported about medication error of methotrexate. The foreign drug regulatory authorities issued a number of warnings. CFDA also issued Chinese Adverse Drug Reaction Information Bulletin (No.75). It is the first time to remind the problem of drug misuse in Bulletin. Conclusion Medical personnel should be aware of the misuse risk of methotrexate and give medication guidance for patients. Chinese Adverse Drug Reaction Information Bulletin could be an important management measure for pharmacovigilance. References | Related Articles | Metrics

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The Automatic Surveillance of Cutaneous Allergy Reaction and Anaphylactoid Reaction Induced by Cinepazide Maleate HU Peng-zhou, GUO Dai-hong, WANG Xiao-yu, KOU Wei, JIA Wang-ping, PANG Ning 2017, 14(9): 541-544.  Abstract ( 316 )   PDF (586KB) ( 191 )   Objective To study the reliable incidence and occurrence characteristics of the cutaneous adverse reaction and anaphylactic reaction and anaphylactic shock caused by cinepazide maleate, so as to provide reference information for clinic. Methods The adverse drug events' active surveillance and assessment system, on cutaneous allergy reaction module and anaphylactic shock module, was used to automatic surveillance for the hospitalized patients in General Hospital of PLA who received cinepazide maleate between January 2015 and December 2016. Suspected cases submitted by system were evaluated by professionals to obtain the incidence and occurrence characteristics. The risk factors were analysed by nested case-control study. Results A total of 11 052 patients using cinepazide maleate were retrospectively surveilled, 15 cases of cutaneous adverse reaction and its incidence was 0.14%, while 2 cases of anaphylactic reaction and its incidence was 0.018%, no severe cutaneous adverse reaction or anaphylactic shock was surveilled. Risk factor analysis indicated there was no significant statistical difference in age, gender, BMI, allergic history and severe diseases between positive group and matched group. Conclusion The incidence of cutaneous adverse reaction and anaphylactic reaction induced by cinepazide maleate were in occasional and rare ranges, respectively, and the symptoms are mild. The application of special software greatly improves the efficiency of text information research. References | Related Articles | Metrics

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Construction of Drug Safety Index Based on Multi-index Comprehensive Evaluation WEI Fen-fang, FENG Xiao-chan, ZHONG Ling, MAO Qiu-rong, CHENG Bin, XIAO Xiao, WANG Qian, YANG Yue 2017, 14(9): 545-550.  Abstract ( 414 )   PDF (727KB) ( 418 )   Objective To establish a drug safety assessment indicator system and build a drug safety index. Methods The sources of drug safety risks were identified and monitored by means of literature research and field research, and drug safety indicator system and indexes were established. Results The drug safety index provided a comprehensive assessment of multiple safety indicators related to drug safety in multiple regions over the same time period. Conclusion Based on the comprehensive evaluation Results, the countermeasures and opinions on the strengthening of drug safety risk management were put forward, which provided decision support and reference for government and drug regulatory agencies. References | Related Articles | Metrics

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Literature Review on 92 Cases of Adverse Reactions Induced by Octreotide XIE Wen-jing 2017, 14(9): 551-554.  Abstract ( 332 )   PDF (643KB) ( 224 )   Objective Through investigating the characteristics and mechanism of adverse reactions induced by octreotide, to find its risk factors and provide technical support for safe and rational use of drugs in clinic. Methods Using "octreotide", "Sandostain", "Shanning", "adverse reaction"and "to"as key words to search and retrieve articles in the CNKI database, VIP Chinese full-text database and Wanfang database. 34 references which met the inclusion criteria were extracted and analyzed. Results Most of the reactions occurred in young and middle-aged patients. The major illness was pancreatitis. ADRs occurred more frequently within 24 h. Systems and organs mainly involved in adverse reactions were cardiovascular system damage, systemic lesion, etc. Arrhythmia and palpitation are the most commonly reported adverse reactions. Conclusion It is important to pay attention to the adverse reactions caused by octreotide, strengthen clinical rational use of drugs, in order to ensure the safe drug use in clinic. References | Related Articles | Metrics

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One Case Analysis of Antibacterial Agents Interaction with Warfarin after Transcatheter Aortic Valve Implantation LUO Min, XU Ting 2017, 14(9): 555-558.  Abstract ( 300 )   PDF (737KB) ( 340 )   Objective To learn the antithrombosis management strategy after transcatheter aortic valve implantation (TAVI) and the drug-drug interactions between warfarin and antimicrobial agents based on the real case, and provide a reference for optimizing therapeutic options. Methods We described and analysised a case, and reviewed the relevant literature. Results By reviewing the relevant literatures, combined with clinical experience, warfarin was chosen as the postoperative antithrombotic drug of a patient who accepted TAVI. When warfarin was used in combination with antimicrobials (moxifloxacin, levofloxacin, piperacillin tazobactam, fluconazole), the patient's international normalized ratio (INR) increased to 5.53, which was consistent with conclusions of the literatures. According to the INR values, we timely adjusted the dose of warfarin, and avoided the occurrence of bleeding events. In addition, we educated the patient, once she stopped taking the fluconazole, she needed increasing the dose of warfarin and the frequency of INR monitoring. Conclusion The antithrombosis management strategy after TAVI requires individualization. The effect of the interactions between warfarin and antibacterial agents can be very obvious. Thus, individuals receiving interacting medications are likely to require increased INR monitoring, so as to achieve the best anticoagulant effect and reduce the incidence of adverse reactions. References | Related Articles | Metrics

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Analysis of 350 Cases of Antimicrobial Agents Clinical Use in Pediatric Inpatients ZHANG Lin, YANG Bo, WANG Lai-cheng 2017, 14(9): 559-561.  Abstract ( 468 )   PDF (666KB) ( 274 )   Objective To investigate the application of antibacterial agents in pediatric inpatients in our hospital and evaluate the rationality to provide references for clinic. Methods 350 outpatients' medical records were selected randomly by HIS from January to June in 2016. The indexes in terms of antibacterial selection, frequency of medication, combination therapy and pathogenic examination were analyzed. Results 128 cases were treated with one kind of antibiotics and the ratio was 36.57%. 222 cases were treated with combination use of antibiotics and the ratio was 63.43%. The inspection ratio of pathogenic bacteria was 33.14%. Penicillins, cephalosporins, and macrolides ranked top 3 in terms of use frequency. Conclusion Clinical management of the use of antibacterials is mainly rational, but the irrational administration of antibiotics in pediatric outpatients is still present in terms of drug selection, combination therapy, frequency of medication and improper drug selection. The supervision of using antibiotics should be highlighted to enhance the clinical management of rational use of antibacterials. References | Related Articles | Metrics

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Survey on Off-label Drug Use in Pediatric Outpatients in a Hospital ZHANG Xia-lan, SHEN Xi-kun, MIAO Jie 2017, 14(9): 562-565.  Abstract ( 352 )   PDF (643KB) ( 345 )   Objective To understand the off-label drug use in pediatric outpatients of our hospital,and provide basic data for safe and rational use of drugs. Methods A retrospective survey of 100 pediatric prescriptions in outpatient department every month had done from Sep. 2015 to Aug. 2016. The information of weight, gender, age, diagnosis and drugs were collected and analyzed. Results All the 1 200 prescriptions with 2 836 medical records were extracted which contained 594 off-label drug prescriptions of 874 records. The incidence rate of off-label drug use was 49.50% and 30.81% for prescriptions and records respectively. The most common type of off-label drug use was absence of information about child medication, accounting for 79.17%. The rate of wrong dosage was 10.18%, and the rate of frequency of administration was 8.24%. Conclusion We should pay attention to the safety of children's medication. We aim to call on the state to introduce relevant laws to regulate off-label drug use prescriptions in pediatric outpatients References | Related Articles | Metrics