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08 October 2015, Volume 12 Issue 10 Previous Issue    Next Issue

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Study on the Protective Effect of Aqueous Extracted Components of Bupleurum against Rats' Liver Fibrosis Induced by Improvement Method DOU Li-wen, SUN Xiao-qian, LI Xiao-yu, SUN Rong 2015, 12(10): 577-581.  Abstract ( 312 )   PDF (555KB) ( 139 )   Objective To study the protective effect of different doses of aqueous extracted components of Bupleurum chinense against rats' liver fibrosis induced by composite factors. Methods The model of rats' liver fibrosis was established by the composite factors of high-fat diet, alcohol stimulation and porcine serum. Rats were observed in 0, 1, 6, 11, 16, 21 d in terms of animal general, syndrome integral, body weight, daily food intake, daily water, organ index of liver and spleen, thymus, calculation, serum the alanine aminotransferase(ALT), aspartate aminotransferase (AST), laminin (LN), serum hyaluronic acid (HA), procollagen type III (PC-III), type IV collagen (IV-C), transforming growth factor beta 1 (TGF- beta 1) index level. Results The diet, drinking water and physical activities of rats were improved by aqueous extracted components of Bupleurum chinense ranged from 0.90 g·kg-1 to 3.60g·kg-1 for 21 consecutive days by gavage. The contents of ALT, AST, HA, LN, IV-C and PC III and liver index declined significantly. Conclusion Liver fibrosis in rats induced by composite factors can be protected effectively by aqueous extracted components of Bupleurum chinense and shows a good dose-effect relationship. References | Related Articles | Metrics

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Effects of Naringenin on ICAM-1 and NF-κB Activities Following Myocardial Ischemia/Reperfusion Injury QIAN Xiu-fang, LIU Dan, QIANG Lie-ying 2015, 12(10): 582-585.  Abstract ( 278 )   PDF (502KB) ( 151 )   Objective To investigate the effects of naringenin (NAR) on ICAM-1 and NF-κB activities in rats following myocardial ischemia/reperfusion(MI/R) injury. Methods Rat model of MI/R injury was established by coronary artery ligation for 30 min followed by 2-hour reperfusion. Then rats were divided randomly into 5 groups (n=10), namely sham, model and NAR groups (100, 50 and 25 mg·kg-1). NAR was administered by intraperitoneal injection once a day for 7 days pre-operation. The size of myocardial infarction was measured by NBT staining after the reperfusion. The myocardial ICAM-1 and NF-κB activities were detected by immunohistochemistry. The MPO activity in heart homogenate was detected by chromatometry to evaluate the neutrophil infiltration. Results NAR (100 mg·kg-1) reduced the size of myocardial infarction to 32.91%, showing a significant difference compared to 39.78% of model group(P<0.05). The MPO activities in NAR groups were 330.54, 322.74 and 280.64 U·g-1, respectively, which were significantly lower than 423.9 U·g-1 of model group (P<0.05 or P<0.01). NAR evidently reduced the ICAM-1 positive rates in heart to 50.12%, 44.75% and 42.05%, respectively, comparing to 65.22% of model group (P<0.01). Similarly, NAR significantly reduced the NF-κB positive rates to 32.05%, 30.22% and 29.16%, respectively, comparing to 38.41% of model group (P<0.05 or P<0.01). Conclusion The myocardial protection of NAR pretreatment in MI/R injury appears to be associated with the inhibition of neutrophil infiltration, expression of ICAM-1 and NF-κB and inflammatory response. References | Related Articles | Metrics

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Clinical Observation of Self-made Geche Decoction for Treating Infantile Rotavirus Enteritis HE Chun-lin, LIU Guo-tai, ZHANG Jian 2015, 12(10): 586-589.  Abstract ( 285 )   PDF (541KB) ( 280 )   Objective To observe the clinical effect of self-made Geche decoction for the treatment of infantile rotavirus enteritis (IRE). Methods All 90 patients are randomly divided into three groups, Routine medication group (group A), ribavirin group (group B) and Geche decoction group (group C), 30 cases in each group. Group A was given zinc gluconate tablets and oral rehydration salts Ⅲ (ORS Ⅲ) everyday. Group B was based on group A to plus ribavirin injection. Group C was based on group A to plus Geche decoction. All of the groups were given 7 days treatment. Results The total effective rate was 63.3% in group A, 60.0% in group B and 90.0% in group C, respectively, showing significant difference (P<0.05) in comparing group C with group A and B. After 6 days of treatment, the negative conversion rate of rotavirus was 43.3% in group A, 56.7% in hroup B and 83.3% in group C, respectively, which was higher in group A than group A and B(P <0.05). Conclusion Self-made Geche decoction could effectively alleviate the clinical symptoms and signs in IRE patients, accelerate the negative conversion of rotavirus. So it is an effective drug for IRE in treatment TCM. References | Related Articles | Metrics

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Foreign Pharmaceautical Enterprises' Pharmacovigilance Databases Overview and Enlightenments ZHANG Yuan, YE Xiao-fei, ZHANG Tian-yi, ZHU Tian-tian, SHI Wen-tao, HE Jia 2015, 12(10): 590-592.  Abstract ( 953 )   PDF (1034KB) ( 471 )   Some foreign pharmaceautical enterprises have owned mature pharmacovigilance databases.This article mainly introduced the sources of data, the process of data collection, the algorithm of signal detection about these databases and found out their advantages. Furthermore,this article proposed recommendations on the development of pharmacovigilance database of pharmaceautical enterprises in our country based on the experience of foreign pharmaceutical enterprises and the actual situation of China's domestic pharmaceutical enterprises. References | Related Articles | Metrics

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Implication of EU Pharmacovigilance System to China ZHANG Gui-ju, CHU Xiao-yi, TIAN Yue-jie, HUANG Lin, LI Yu-ji 2015, 12(10): 593-596.  Abstract ( 1208 )   PDF (568KB) ( 47746 )   Objective To draw experience from pharmacovigilance system construction in EU, provide reference for pharmacovigilance system in China. Methods Introduce the organization structure and pharmacovigilance processes of EU pharmacovigilance system, compare the differences in regulations, directives and pharmacovigilance processes between China and EU, and provide advice on the improvement of drug adverse reaction monitoring and reporting in China. Results and Conclusion There are many differences between the drug adverse reaction monitoring and reporting system in China and EU pharmacovigilance system, such as the basement of regulation, the system design and the working mechanism. It is helpful for us to reform the drug adverse reaction monitoring and reporting in China borrowing the EU pharmacovigilance and enhance the interaction between drug administration and drug safety monitoring after drug approval. It would encourage the pharmaceutical enterprises taking responsibility of drug safety, promote the policy coordination of drug regulation, and improve the administration efficiency. References | Related Articles | Metrics

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Processes for PSUR Assessment in the European Union Network LI Ke-nan, ZHEN Zhi-qin, DU Xiao-lei, FENG Ya-nan 2015, 12(10): 597-599.  Abstract ( 828 )   PDF (597KB) ( 908 )   Objective To provide reference for facilitating and optimizing China's periodic safety update report (PSUR) assessment according to the introduction of PSUR assessment process of European Union(EU) guideline on good pharmacovigilance practices(GVP). Methods Literature study was used to analyze the European Medicines Agency(EMA) and China Food and Drug Administration(CFDA) website information about PSUR assesment process. Results By optimizing the allocation of resources, the EU has adopted different PSUR assessment procedures for different medicinal products. This initiative aims to harmonize and strengthen the safety and benefit-risk review of medicines across the European Economic Area. Conclusion We should learn from EU processes for PSUR assessment to improve our ability to monitor drug safety． References | Related Articles | Metrics

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Active Surveillance of Adverse Drug Reaction and Its Development Trend WANG Dan 2015, 12(10): 600-602.  Abstract ( 1234 )   PDF (1205KB) ( 986 )   Active surveillance of adverse drug reaction(ADR) is an important supplement to passive ADR monitoring. In this article, we aim to make clear the difference between active and passive monitoring, explore the development process and trend of active surveillance, discuss the pros and cons of active surveillance under the background of big data, and provide ideas and direction for its practice in China. References | Related Articles | Metrics

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Study on the ADR Monitoring of Medical Institutions of 6 Provinces in China ZHANG Xue-mei, GUO Jia-dong, FENG Bian-ling*, YANG Shi-min 2015, 12(10): 603-606.  Abstract ( 358 )   PDF (592KB) ( 243 )   Objective To investigate the present situation of ADR monitoring of the medical institutions and analyze the existing problems and provide practical recommendations. Methods The method of cluster sampling was adopted and the questionnaires were administered to the medical institutions in Jiangsu, Guangdong, Henan, Hebei, Shanxi and Sichuan province. Descriptive Statistics and Chi-square test are used to analyze the returned questionnaires with SPSS 18.0. Results 199 effective questionnaires were received. the ADR staff are part-timers in most medical institutions. The funds and resources need to be strengthened. The communication, propaganda and training of ADR work of various regions are different. The ADR report is good. The job satisfaction is middling at best. Conclusion The part-timers' amount of work, working hours and payments should be determined rationally. Medical institutions should make use of their own advantages to raise money. Medical institutions in western regions can take some measures, such as organization intervention, to ensure that ADR works are carried out smoothly. References | Related Articles | Metrics

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Analysis of the Case Study on the Economic Cost of Adverse Drug Events GAO Jian-chao, LI Lan, XIA Dong-sheng, TIAN Chun-hua 2015, 12(10): 607-610.  Abstract ( 417 )   PDF (618KB) ( 271 )   Adverse drug events injure the health of patients and impose heavy economic burden on patients and society. The study on the economic cost of adverse drug events not only reduces the economic burden on patients and the national medical care system, but also provides scientific basis for rational drug use and developing optimal disease control measures. We introduced the classification of drug adverse event and the composition of its economic cost, summarized different economic cost research methods by analyzing the case studies of economic cost, and finally proposed advices for reducing the economic costs of adverse drug events. References | Related Articles | Metrics

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Correlation Analysis of Furfural, 5-hydroxymethylfurfural Content and pH Value of Dextran 40 and Glucose Injection GUO Huan-ying, GENG Qing-guang, WANG Chang-he 2015, 12(10): 611-613.  Abstract ( 313 )   PDF (704KB) ( 271 )   Objective To analyze the correlation of furfural, 5-hydroxymethylfurfural (5-HMF) content and pH value of dextran 40 and glucose injection, and to provide reasonable suggestions for the production, transportation and use. Methods High performance liquid chromatography method was used to determine the content of 5- HMF and furfural of 90 batches of dextran 40 and glucose Injection. The pH value of the solution was determined by acidometer. Correlation of furfural, 5-HMF content and pH value was analyzed by SPASS 17.0. The destructive tests were carried out to verify the conclusion. Results There is a negative correlation between the value of pH and content of 5- HMF, and the content of furfural was positively correlated with 5- HMF. Destructive test results show that, the decrease of pH value will lead to the generation of 5- HMF and furfural. Conclusion Through the strict control of pH value, the stability of dextran 40 and glucose injection can be increased. And the increase 5- HMF and furfural content of the preparation could be suppressed too. References | Related Articles | Metrics

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Determination of 20 Heavy Metals and Trace Elements in Lonicera Japonica and Lonicera Hypoglauca by ICP-MS XU Shun-gui, LIU Chun-guang 2015, 12(10): 614-617.  Abstract ( 281 )   PDF (672KB) ( 136 )   Objective To develop a method for the determination of a total of 20 elements such as plumbum (Pb), copper (Cu), arsenic (As), cadmium (Cd), mercury (Hg), manganese (Mn), nickel (Ni), thalliu (Tl) in Lonicera japonica and Lonicera hypoglauca. Methods The samples were digested by microwave-assisted method and then chose appropriate determination parameters of ICP-MS, using Ge and In as the internal standard. Results All the correlation coefficients exceeded 0.9993, showing good linearities over the concentration range. The lower limit of detection of the assay ranged from 0.004 to 0.071 μg·L-1. The method exhibited good precision and accuracy, while the recoveries ranged from 80% to 100%. Conclusion The method is simple, accurate and highly sensitive, successfully applied to rapid monitoring the multi-elements in Lonicera japonica and Lonicera hypoglauca for the quality control and identification. References | Related Articles | Metrics

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Problem Analysis and Suggestion on Application Materials of OTC Switch ZHENG Ming-jie, XIA Dong-sheng 2015, 12(10): 618-622.  Abstract ( 398 )   PDF (729KB) ( 144 )   Objective To promote enterprises' comprehension and data preparation to OTC switch application, and to promote the work of OTC switch smoothly. Methods According to the policy requirements of OTC switch, 111 "No Filing Notices" that CDR sent to enterprises about OTC switch application materials were analyzed, to identify the main problems on the OTC switch application materials, and propose recommendations for improvement. Results Various problems are involved in 111 "No Filing Notices", including the materials absence, incomplete or incompatible with the relevant requirements. From the statistics results, the problems of review data and pharmacy data are as outstanding as safety studies data. "Other item" is mainly related that the electronic document data is not submitted. Specific outstanding problems are as follows: adverse reaction information, drug quality data, the smallest sales unit sample, proposed OTC instructions, electronic documents, etc. Conclusion The problems of materials absence, incomplete or incompatible with the relevant requirements are common in enterprises, because the enterprises are not aware of relevant policies, or not fully understand policies, lack practical experience, pay inadequate attention, sloppy and so on. So we suggest the enterprises to pay more attention to the preparation of OTC switch application, be careless, and to conscientiously study, accumulate experience and gradually improve. References | Related Articles | Metrics

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Analysis of 76 Reports of Adverse Drug Reaction Induced by Cefoperazone/Tazobactam ZHONG Xun-long, FENG Xia, DUAN Lian, YE Li-ka, WANG Ruo-lun 2015, 12(10): 623-626.  Abstract ( 314 )   PDF (1174KB) ( 298 )   Objective To summarize the characteristics and rules of adverse drug reactions (ADRs) induced by cefoperazone/tazobactam and provide prevention countermeasures for clinical safe, effective and rational use of antimicrobials by analysis of antibacterial-related ADR reports. Methods 76 ADR reports were statistically analyzed from Jan, 2005 to May, 2015 in our hospital to ADR monitoring center. The patient's age, gender, diseases, usage and dosage, ADR occurrence time and clinical manifestations were analyzed retrospectively. Results Among the 76 cases of ADR, the difference in gender aspect was not significant (P ＞0.05). There were statistically significant differences of the age, kinds of diseases(P ＜0.01). Less than 30 minutes after administration were ADR high-incidence period (59.21%). The main side effects were injuries of skin and its appendages (55.22%), and followed by systemic damage and hematological system damage, etc. 76 cases of ADR including 7 reports of serious adverse reactions, allergic shock and hematological system were involved in the most of cases. Conclusion The indication and dosage of cefoperazone/tazobactam should be strictly mastered by clinicians, and the pharmaceutical care of cefoperazone/tazobactam should be strengthened. The medical staff should tell patients potential ADR and prepare the emergency treatment measures for incidentally critical ADR. References | Related Articles | Metrics

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Analysis of 501 Cases of Drug-induced Kidney Injury ZHAO Liang, GUO Dai-hong*, ZhU Man, XU Yuan-jie, MA Liang, ZHAO Peng-zhi, CAI Le, ZHAO Su-yu, WANG Zhong-qiang 2015, 12(10): 627-631.  Abstract ( 245 )   PDF (664KB) ( 217 )   Objective To analyze the regular pattern and characteristics of drug-induced kidney injury and provide reference for the use of clinical drug. Methods 501 drug-induced kidney injury cases from 2009 to 2014 were collected from the database of PLA ADR monitoring center. Age and gender of patients, categories of suspected drugs, route of administration, occurrence time, clinical feature and prognosis were statistically analyzed. Results The 501 cases were composed of 175 female patients (34.93%) and 326 male patients (65.07%). The average age of the patients was (53.48±21.99) years. The adverse drug reactions were caused by 197 kinds of drugs, among which the anti-infective drugs ranked first, with 221 related cases. Intravenous infusion was the primary administration route and the occurrence time of ADRs was mainly within one week. Most cases had good prognosis, with 356 cases (71.06%) cured or improved. Conclusion A wide category of drugs may cause drug-induced kidney injury. Therefore, much more attention should be paid on the high-risk drugs and high-risk groups. References | Related Articles | Metrics

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Pharmaceutical Care of One Patient with Acute B Lymphocytic Leukemia and Pulmonary Infection YANG Bo, ZHANG Lei, ZHU Tie-liang 2015, 12(10): 632-652.  Abstract ( 309 )   PDF (632KB) ( 212 )   Objective To study the significance and effectiveness of clinical pharmacist's participation in clinical practice. Methods The clinical pharmacists participated in the whole treatment of the patient's acute B-lymphoblastic leukemia combined with the lung infection, by participating in formulating and adjusting the treatment plan of the anti-infectious drugs, monitoring and dealing with the adverse drug reactions, providing pharmaceutical care, playing the role of clinical pharmacists and then promoting the rational drug use. Results Through the participation of the clinical pharmacists, the anti-infection therapeutic regimen for the patient is reasonable and effective. The disposition of adverse drug reaction is rational, and the patient was discharged with the better health. Conclusion The clinical pharmacists should participate in the clinical practice actively, give full play to the medicine knowledge, reflect the value of the clinical pharmacists, and promote the rational medication. References | Related Articles | Metrics