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08 July 2014, Volume 11 Issue 7 Previous Issue    Next Issue

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The Pharmacodynamics Research on Preventive and Therapeutic Effects of Compound Yizhihao Granules on Hand-foot-mouth Disease GUO Shan-shan, MA Xue-ping, PAN Xin, GAO Ying-jie, CUI Xiao-lan 2014, 11(7): 385-389.  Abstract ( 374 )   PDF (542KB) ( 397 )   Objective To evaluate the preventive and therapeutic effects of Compound yizhihao granules on hand-foot-mouth disease by observing the death protective effect of Compound yizhihao granules on suckling Balb/c mice infected by enterovirus 71 in vivo and the inhibition effect on enteric viruses in vitro. Methods Prophylactic admi-nistration and therapeutic administration of Compound yizhihao granules were applied to EV71 H strain infection suckling Balb/c mice at 2、1 and 1/2 times clinical equivalent dose of 3-year-old children respectively, we observed degree of infection, death number and calculated the death rates, death protection rates and life extension rates. In vitro, the effect of Compound yizhihao granules at four non-toxic dosages anti EV71 H strain, EV71 BrCr strain, CoxB3 strain, CoxB4 strain and CoxB5 strain was determined by CPE method on Vero cells. Furthermore virus proliferation in RD cells was determined by real time PCR. Results Compound yizhihao granules decreased degree of infection and death rates, simultaneously increased death protection rates and life extension rates significantly. Compound yizhihao granules showed significant therapeutic effects on suckling Balb/c mice infected by enterovirus 71 H strain. At no-toxic dosages, Compound yizhihao granules inhibited cytopathic effect induced by EV71 H strain, and EV71 BrCr strain visibly and virus proliferation of EV71 BrCr strain was inhibited by Compound yizhihao granules significantly. Conclusion Compound yizhihao granules showed notable therapeutic effects on hand-foot-mouth disease in vivo and in vitro, the mechanism maybe related to the inhibition of virus proliferation in cells. References | Related Articles | Metrics

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Safety and Short-term Efficacy of Ticagrelor in Patients with Acute Coronary Syndromes in Chinese YANG Yu-hui, ZHENG Wei-xing, HUANG Ming-fang, CAO Xiao-zhi, ZHANG Wen-li LIU Dong-lin, LUO Zhu-rong 2014, 11(7): 390-393.  Abstract ( 241 )   PDF (351KB) ( 252 )   ObjectiveTo discuss the safety and short-term efficacy of ticagrelor in patients with acute coronary syndromes in Chinese． MethodsA total of 199 acute coronary syndromes patients were enrolled．96 of them were given ticagrelor and the other 103 were given clopidogrel． We observed the adverse events in 10 days, 30 days and 90 days, and compared ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) and clopidogrel (300 to 600 mg loading dose, 75 mg daily thereafter) for the prevention of cardiovascular events and bleeding in 90 days． ResultsThere was no significant difference in basic clinical data and related routine examination results between two groups (P >0.05). Patients receiving ticagrelor had lower ratio in cardiovascular death (1% vs. 1.9%), myocardial infarction (0% vs. 1%), stroke (0% vs. 1.9%), stent thrombosis (0% vs. 1%) and recurrent ischemia (2.1% vs. 4.9%) and higher ratio in dyspnea (2.1% vs. 0%), minor bleeding (3.1% vs. 1.0%) and minimal bleeding (5.2% vs. 2.9%) than those receiving clopidogrel with no significant difference(P>0.05). There was no major bleeding in both groups. The ratio of major adverse cardiovascular events was much lower in patients receiving ticagrelor than those receiving clopidogrel (3.1% vs. 10.7%; P =0.037)． The total ratio of minor bleeding and minimal bleeding was higher in those receiving ticagrelor with no significant difference (8.3%, vs. 3.9% with clopidogrel; P =0.188). ConclusionThe safety and short-term efficacy of ticagrelor in patients with acute coronary syndromes in Chinese were in accordance with PLATO． References | Related Articles | Metrics

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Full-factorial Design for Optimizing Formulation of Metformin Hydrochloride Extended-release Tablets and Investigation of Release Mechanism in Vitro CHEN Ye-ming, ZHOU Zhi-liang, ZHANG Xue-nong, LI Xian-jun 2014, 11(7): 394-397.  Abstract ( 238 )   PDF (406KB) ( 432 )   ObjectiveTo obtain an optimized formulation of metformin hydrochloride extended-release tablets, and investigate the release mechanism of the optimized formulation. MethodsMetformin hydrochloride extended-release tablets were prepared by high shear wet granulation route. The formulation was optimized using full-factorial design by Design Expert software. Responses were measured in this study, including the f2 factor of drug release profiles in vitro and the cumulative release percentages of 10 hours(Q10). The release mechanism of optimized formulation was investigated. ResultsOptimal prescription contained metformin hydrochloride 100 g, chitosan 2.5 g, HPMC(K100 M)47.5 g, magnesium stearate 1.5 g. The predicted value of deviation was less than 4%. The drug release followed the first-order kinetics, via mechanism of Fickian diffusion. ConclusionFull-factorial design by Design Expert software is an effective and feasible method for screening metformin hydrochloride extended-release tablets formulation. The drug release follows the mechanism of Fickian diffusion. References | Related Articles | Metrics

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The Dynamic Accumulation Research on Determination of Ursolic Acid Content in the Cornel of Different Regions and Different Growth Period by RP - HPLC Method SONG Mei 2014, 11(7): 398-400.  Abstract ( 204 )   PDF (432KB) ( 94 )   ObjectiveTo evaluate the dynamic accumulation changes of ursolic acid content in the cornel of different growth period and different origin, and provide the basis for the quality evaluation of medicinal materials. MethodsThe RP-HPLC method was used to determine the content of ursolic acid in different origin and different growth period of dogwood. ResultsThe content of ursolic acid in cornel showed regular change, when the total content of ursolic acid was higher. As the dogwood fruit matured, the content of ursolic acid decreased gradually, the content of ursolic acid was lowest during fruit ripening. ConclusionThe dynamic accumulation research on ursolic acid content of dogwood in different regions and different growth phase provided the certain basis for quality evaluation of cornel medicinal materials. References | Related Articles | Metrics

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Establishment and Operation of EU Pharmacovigilance System and Its Implementation Progress SONG Yang, YANG Yue 2014, 11(7): 401-406.  Abstract ( 284 )   PDF (655KB) ( 292 )   ObjectiveAccording to the introduction of EU pharmacovigilance system and its implementation progress, suggestions were put forward to provide the example and reference for perfecting and developing pharmacovigilance system of China. MethodsLiterature study was used to analyze the foreign and domestic materials. ResultsWithin the EU pharmacovigilance system, there are complete and standard legal documents, clear obligation, simplified and reasonable procedures and public information to effectively guarantee the safety of drugs throughout the life cycle. ConclusionWe should learn from EU pharmacovigilance system to improve our ability to monitor drug safety. References | Related Articles | Metrics

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Practice and Investigation on Data Normalization of Adverse Drug Reaction Reporting WANG Ling, ZHOU Jing-xin, ZHANG Xue-ning, LIN Xu-dong 2014, 11(7): 407-412.  Abstract ( 212 )   PDF (721KB) ( 371 )   ObjectiveThe reporting data of adverse drug reaction has been increasing more and more rapidly. Whereas, the existing nonstandard data decreased the efficiency of adverse drug reaction monitoring and evaluation, and influenced the effective use of the data. By discussing the methods and applications of data normalization, to provide reference and suggestion for improving the quality of reports. MethodsOn the basis of our real working practices in data normalization, the case reports from the monitoring system were studied, non standard reports were summarized and the reasons were analyzed, the methods of data normalization and reporting quality improvement were discussed. ResultsThe standard databases and the rule databases were created, they were capable of automatic completion of the standardization work of the new cases. ConclusionThe data normalization is an effective method for improving the quality of the reports, it plays an important role in the actual work. Improving the quality of the reports is a systematic project , it needs the joint efforts of all the parties. References | Related Articles | Metrics

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Characteristics and Requirements of Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Databases ZHU Tian-tian, YE Xiao-fei, GUO Xiao-jing, ZHANG Tian-yi, WANG Jing, SHI Wen-tao, HE Jia 2014, 11(7): 413-315.  Abstract ( 211 )   PDF (493KB) ( 302 )   Pharmacoepidemiologic studies play an important role in evaluating the interrelationship between drugs and adverse events. With the development of the electronic healthcare databases, the traditional method of pharmacoepidemiologic study cannot completely meet the needs of the pharmacovigilance today. Based on the understanding of the electronic healthcare databases and of the FDA related guidelines, this paper proposes to introduce the general characteristics of pharmacoepidemiologic safety studies using electronic healthcare databases and the requirements of the data collection put forward by FDA, which aims to provide relevant technical reference to our country's pharmacoepidemiologic studies and pharmacovigilance. References | Related Articles | Metrics

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Considerations about Present Situation of Hospital ADR Mornitoring NIU Lin-lin, Li Bei, LI Xin-ling 2014, 11(7): 416-419.  Abstract ( 316 )   PDF (571KB) ( 155 )   ObjectiveTo probe into the status quo and difficulties in hospital adverse drug reaction(ADR)monitoring for improving the monitoring of ADR. MethodsThe current situation of ADR monitoring in medical institutions of Haerbin City was comprehensively analyzed. Resultsand ConclusionHospital ADR reports were imperfect in monitoring system, quality, deadline and types． It is important to enhance medical staff's ADR monitoring level, and improve the ADR monitoring system in medical institutions. References | Related Articles | Metrics

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Analysis on 61 Cases of Perineal Pruritus Induced by Dexamethasone Injection ZHENG Heng-bin, LI Hua-bin, DONG Fang 2014, 11(7): 420-422.  Abstract ( 267 )   PDF (589KB) ( 515 )   ObjectiveTo investigate the occurring regularity and influencing factors of the adverse reactions of dexamethasone injection causing perineal pruritus, and provide reference for clinical rational drug use and revising medicine instructions. MethodsAdopting a retrospective research way makes a statistical analysis of the adverse reactions of dexamethasone injection causing perineal pruritus in 61 cases reported. ResultsDexamethasone injection as a kind of common anti-allergic medicine, also causing the reaction of allergy, the cases of the adverse reactions of skin and its appendages lesions are the most common, the majority was associated with itching in perineal. ConclusionThe clinical professionals can choose glucose injection as menstruum, and adopt the measures of little amount in many times, reducing the rate of dosage, avoid or reduce the incidence of the adverse reactions. References | Related Articles | Metrics

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Comparison of Domestic and Foreign Adverse Drug Reaction Monitoring Based on Bibliometric Analysis WANG Shu-bin, HUANG Rui, YANG Li-juan, SUI Xin 2014, 11(7): 423-428.  Abstract ( 222 )   PDF (598KB) ( 237 )   ObjectiveFrom the perspective of bibliometrics, comparing the Chinese and foreign research situation in the field of adverse drug reaction(ADR) monitoring, provide reference for the research in this field in China. MethodsThrough the web of Science core collection and CNKI database, retrieving the nearly 10 years of related literature at home and abroad, using literature metrological visualization software CiteSpace 3.8R1 to make keywords co-occurrence analysis of literature, annual number analysis and highly cited literature analysis. ResultsThe number of the literature about ADR monitoring at home and abroad rised overall. After the peak in 2009 in China, the number of the literature began to slow down, reflecting the ADR monitoring in China into the stable development from the rapid development stage. Children's medication safety, adverse reaction of antibiotics, drug risk management and drug monitoring were commonly concerned at home and abroad, the foreign also focused on adverse drug reactions in the elderly, pharmacovigilance, anti-rheumatoid and antiepileptic drug adverse reactions. In our country, we focused on the theme of Chinese traditional medicine adverse reaction monitoring. ConclusionADR monitoring field at home and abroad had a lot in common, and each had its own characteristics. Our country should draw lessons from foreign advanced experience in the field, and ADR monitoring system will be prefected gradually. References | Related Articles | Metrics

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Risk Analysis and Measures of Fetal Skeletal Abnormalities Caused by Magnesium Sulfate Injection WANG Chun-ting, ZHENG Ming-jie 2014, 11(7): 429-431.  Abstract ( 247 )   PDF (595KB) ( 307 )   According to the situation of magnesium sulfate injection risk control measures at home and abroad, the background and basis of its safety warnings are further analyzed so as to explore the correlation between magnesium sulfate injection and fetal skeletal abnormalities. The newly exposed risk and the magnesium sulfate injection, which leads to change the balance of risk/benefit, need each side to give more attention and take corresponding measures. References | Related Articles | Metrics

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Literature Study of Drug Combination Type and Incompatibility of Traditional Chinese Medicine Injections LI Jian-ping, GUO Jian-ming, DUAN Jin-ao, FAN Xin-sheng, DU Xiao-xi, SUN Jun 2014, 11(7): 432-438.  Abstract ( 536 )   PDF (685KB) ( 351 )   ObjectiveTo explore the specificity and regularity of incompatibility during drug combination of traditional Chinese medicine injections(TCMI) by literature study, to provide reference for the research of incompatibility, and guidance for the drug combination in clinic. MethodsTCMI were classified into five types based on their function and efficacy: antitumor, activating blood circulation to dissipate blood stasis, heat-clearing and detoxifying, emergency and others. Different types of drug combination of TCMI were summarized and the incompatibility of 36 kinds of TCMI was analyzed. ResultsAntitumor injections were mostly used in combination with basic chemotherapy medicines; the literature study of incompatibility of antitumor injections is less than other injections. Activating blood circulation to dissipate blood stasis injections were mostly used in combination with circulatory system medicines and antibiotics. Heat-clearing and detoxifying injections were mostly used in combination with antibiotics; the insoluble particles and precipitation will occur when heat-clearing and detoxifying injections are mixed with antibiotics. ConclusionThere is some specificity and regularity in the incompatibility of TCMI, but the research of incompatibility of TCMI is simple, and the level is uneven. References | Related Articles | Metrics

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Patient Safety Objective and Construction of Medicine Risk Management System in Medical Institutions ZHAO Huai-quan 2014, 11(7): 439-442.  Abstract ( 220 )   PDF (751KB) ( 223 )   Objective To explore the construction of medicine risk management system in medical institutions, based on patient safety objective. Methods The effect of medicine management policies, clinical application management practices, and patient safety objective, such as patient identity recognition, the use of high risk drugs or similar medicine, the report of drug safety event(adverse event), the effective communication among medical staff, and patient's participation in medical safety activities were analyzed. Results and Conclusion The construction of medicine risk management system in medical institutions is an important part of medical quality management, and is a basic requirement to achieve the objectives of patient safety and rational drug use. Key words: patient safety objective; medical institutions; risk management References | Related Articles | Metrics