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    10 February 2012, Volume 9 Issue 2 Previous Issue    Next Issue

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    Orginal Article
    Experimental Comparis on Study on Mice's Acute Toxicity of Different Composition in Herba Menthae
    LI Xiao-yu, SUN Rong
    2012, 9(2): 65-68. 
    Abstract ( 274 )   PDF (448KB) ( 308 )  
    Objective To compare the acute toxicity of different components in Herba Menthae on mice which is all components, peppermint oil, water extract, make an observation and evaluation of acute toxicity to Herba Menthae in order to provide a basis for safe and reasonable medication in clinical. MethodsRespectively prepare the all components, peppermint oil, water extract, and compare the acute toxicity of different components in Herba Menthae on mice in accordance with classical acute toxicity test methods, and the experimental datas are calculated LD50 with the Bliss method, with the continuous administration and observation for 14 days. ResultsThe LD50 of peppermint oil is 1.4895 ml·kg·d-1 and the 95%confidence interval is 1.3508-1.6407 mL·kg-1·d-1; the water extract in Herba Menthae are unable to make LD50, MTD results calculated in accordance with crude drug content were respectively 64.0g·kg-1·d-1,which is equal to 746.7 times of 70kg people's daily dried medicinal herb expenses, the MLD of all component is 24.36 g·kg-1·d-1, which is equal to 284.2 times of 70kg people's daily dried medicinal herb expenses. ConclusionThe acute toxicity of different components in Herba Menthae on mice is: peppermint oil> water extract> all components. By comparing the acute toxicity of different components in Herba Menthae on mice, it is beneficial to make an observation and evaluation of acute toxicity to Herba Menthae herbs, provide experimental basis for further toxicity-based parts and toxical substances and provide a basis for safe and reasonable medication in clinical.
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    Compatibility of Polyene Phosphatidylcholine and 10 Drugs in Common Use
    LIU Xiao-hong,ZHANG Ming-sheng
    2012, 9(2): 69-70. 
    Abstract ( 341 )   PDF (317KB) ( 465 )  
    Objective To observe the compatibility of polyene phosphatidylcholine and 10 other drugs in common usage. MethodsTo mix isopyknic polyene phosphatidylcholine glucose injection with 10 other drugs and pharmic glucose injections and observe the clarity of the mixtures and test their pH values; to directly mix isopyknic polyene phosphatidylcholine injection and 8 other injections and observe their clarity. ResultsMixtures of polyene phosphatidylcholine glucose injection with vitamin B6 ant glucose injection and aminomethyl benzoic acid and glucose injection are muddy and their PH values are lower than 6.5; Mixtures of isopyknic polyene phosphatidylcholine and ribavirin, vitamin C, metoclopramide dihydrochloride and vitamine K1 are muddy. ConclusionPolyene phosphatidylcholine is incompatible with vitamin B6, aminomethylbenzoic acid, ribavirin, vitamin C, metoclopramide dihydrochloride and vitamin K1.
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    Analysis on the Risk Factors Associated with the Development of Thrombocytopenia in Patients Who Received Linezolid Therapy
    CHEN Chao, GUO Dai-hong, CAO Xiu-tang, CAI Yun, WANG Zhi-lin, XU Yuan-jie, ZHU Man, MA Liang, ZHAO Peng-zhi
    2012, 9(2): 71-76. 
    Abstract ( 421 )   PDF (451KB) ( 438 )  
    Objective This study investigated risk factors associated with the development of thrombocytopenia in patients who received linezolid therapy and to clarify the reasons and incidence of this adverse reaction. MethodsThis was a restrospective study of patients treated with linezolid by the oral or parenteral route,between January 2011 and May 2011. Data were extracted from the electronic medical records obtained from hospital information system.Thrombocytopenia was defined as a final platelet count of <100×109/L. Risk factors associated with thrombocytopenia in patients who received linezolid therapy were identified via logistic regression analysis,and to predict clinical feature via ROC curves. ResultsIn total, 208 patients(129 men and 79 women; mean[SD]age, 62.67[18.66]years[range,16-98 years]) were included in the study.The mean duration of linezolid therapy was 9.68[6.07]days,with a range of 3 to 39 days.Thrombocytopenia occurred in 59 patients(28.37%), defined as a decrease in platelet count of ≥25% from the baseline occurred in 106 patients(50.96%). Among the patients, 20 patients(9.62%) developed severe thrombocytopenia, requiring platelet transfusion. In univariate analysis, age, lowered creatinine clearance,serum albumin , low baseline platelet count, total bilirubin were significant factors for thrombocytopenia associated with linezolid therapy; however, in multivariate analysis, only age ,baseline platelet count were significant risk factors for thrombocytopenia associated with linezolid therapy. Draw ROC curves maximum, the curve Youden index for 0.739, corresponding area under the sensitivity degrees for 62.71%, specific degrees for 75.84%. ConclusionBaseline platelet count≤204×109/L, age≥82 years were independent risk factors associated with thrombocytopenia in patients who received linezolid therapy and the incidence may increase. Several factors may influence the occurrence of linezolid-induced thrombocytopenia. Further studys are necessary to determine which at-risk patients are candidates for concentation adjustment of linezolid. Furthermore,we can calculate the area under ROC curves to predict these cut off values for risk factors.
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    The Exploration of Pharmacovigilance Based on the Hospital Information System
    GENG Kui-kui, LIU Sheng, SHEN Ai-zong
    2012, 9(2): 77-80. 
    Abstract ( 288 )   PDF (401KB) ( 264 )  
    Objective To introduce the pharmacovigilance system which is based on HIS system with a purpose of exploring the work mode of pharmacovigilance in medical institutions. Methods The Pharmacovigilance system within the network was established based on DTHealth system and electronic medical record system of Donghua, adopting architecture of Brower/Server, technology of web-service, Net.Framework1.1 and relational database cache, SQLserver2000, embeding the platform of pharmacovigilance into hospital HIS system, realizing the integration of functions of data collection, input, print, export and management, monitoring the whole process from drug procument to use and ADR reporting. Results The application of pharmacovigilance system significantly improve the effect of adverse drug reactions monitoring and reduce the harm caused by irrational use of drugs and the drug quality. Conclusion The medical institutions can carry out pharmacovigilance effectively based on the HIS system, playing an important role at medication safety of patient.
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    Investigation on the Establishment of Relief System of Traditional Chinese Medicine(TCM) Injection Adverse Reactions
    WANG Pan, ZHU Wen-tao
    2012, 9(2): 81-84. 
    Abstract ( 209 )   PDF (525KB) ( 168 )  
    Objective To explore the relief system of traditional Chinese medicine(TCM) injection adverse reactions. MethodsWith Introducing the foreign relief system of adverse drug reactions and contrasting our existing system, we analyze the status quo of relief system of TCM injection adverse reactions and give advice to solve the difficulty. Results& ConclusionIn order to protect the legitimate rights and interests and advance the development of TCM injection pharmaceutical business, we should establish the relief system of TCM injection adverse reactions.
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    Metrological Evaluation on the Safety of Yuxingcao Injection
    LI Man, ZHAO Zhi-heng, WANG Zhong, JING Zhi-wei, YU Jiang-yong, ZHANG Xiang-lin
    2012, 9(2): 85-88. 
    Abstract ( 230 )   PDF (516KB) ( 279 )  
    Objective In order to provide the basis for clinical drug safety, observed the adverse reaction incidences, types, proportions and risk factors of Yuxingcao injection. MethodsUising "yuxingcao", "adverse reaction", "treatment", "care reprot", ect. as the key words,original case reports were downloaded from Chinese Journal Full-text Datebase(1979~2010) in CNKI and VIP. 97 literatures were pickede up from the whole 118 results, including 54 pieces of aderves reaction incidences and 43 pieces of adverse reaction types. ResultsThe incidence of adverse events can be accumulated prompted several organ systems to skin damage, allergic reactions and gastrointestinal damage ect. Time focused on after 30 minniutes, and it based both delayed. The severe cases can cause anaphylactic shock. ConclusionBy intensively warded the suffers and perfecting the content of the drug manual and the clinican's rational drug use,to avoid occurrence of serious adverse reactions.
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    Discussion on the Safety of Traditional Chinese Medicine Injection
    BI Feng-lan, ZHANG Li
    2012, 9(2): 89-91. 
    Abstract ( 317 )   PDF (518KB) ( 608 )  
    Traditional Chinese Medicine Injection(TCMI) is widely used in China at present. With the improvement of the drug supervision and administration and the adverse drug reaction surveillance system in China, the number of ADR reports is increasing steadily. The author put forward to related risk factors and risk control measurements after analyzing the characteristics of the traditional Chinese medicine injection and current status of the development, to offer information on the technical supports for improvement of the safety of TCMI.
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    Current Situation Analysis on Adverse Drug Reaction Reporting and Monitoring in Our Country
    HU Wen-jun, CAI Ji-fen
    2012, 9(2): 92-94. 
    Abstract ( 260 )   PDF (570KB) ( 489 )  
    Through the analysis on china's current adverse drug reaction(ADR) reporting and monitoring ,this paper is aimed to find out the existing problems in ADR reporting and monitoring and put forward some specific measures for improvement in the hope of providing reference for the ongoing work of the ADR reporting and monitoring in our country.
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    Experience and Practice of Clinical Pharmaceutical Care
    Wang Fen
    2012, 9(2): 95-95. 
    Abstract ( 256 )   PDF (470KB) ( 244 )  
    To Introduce in our hospital clinical pharmacists in clinical pharmacy service work contents and effect. Explore clinical pharmaceutical care in promoting rational drug use and development of hospital pharmacy on important role.
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    Introduction to TCMI Enterprises on How to Establish Risk Management System
    SUN Qiu-ying, YE Zheng-liang, LIANG Yi
    2012, 9(2): 96-99. 
    Abstract ( 225 )   PDF (908KB) ( 148 )  
    With the increasing adverse events of traditional Chinese medicine injection, its safety problem arouses the social's concern, therefore it's necessary for traditional Chinese medicine injection(TCMI) enterprises to perform quality risk management. This article took the experience of an enterprise as example, introduced to TCMI enterprises how to establish risk management system under the recommendation procedure in ICH Guideline Q9, to achieve the purposes of minimizing risks and ensuring quality and safety of drugs.
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    Research Development on Pharmacological of Paeoniflorin
    ZHENG Shi-cun, LI Xiao-yu, OU Yang-bing, SUN Rong
    2012, 9(2): 100-103. 
    Abstract ( 467 )   PDF (527KB) ( 578 )  
    Objective To offer the accordance and research ideas for further research of paeoniflorin, by summarizing the current states of paeoniflorin. MethodsThe related literatures in the recent 10 years of paeoniflorin were collated, analyzed and summarized. Resultsand ConclusionPaeoniflorin has wilderness biological activity and sure pharmacological function on thecardiovascular, central nervous system, immune and smooth muscle. Modern pharmacology studies provide a new theoretical basis and develop a more extensive clinical application for the clinical curative effect of paeoniflorin.
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    Causation and Treatment Of Orthopedic Implants Adverse Events Systematic Review
    TAO Qing-mei, SUN Feng, YU Kai, ZHAI Wei, ZHAN Si-yan
    2012, 9(2): 104-109. 
    Abstract ( 298 )   PDF (626KB) ( 360 )  
    Objective To study the causation and treatment of orthopedic implants adverse events in China. MethodsArticles about orthopedic implants adverse events published by Nov. 2010 in China were searched. The causes and treatment of the adverse events were analyzed. ResultsAccording to our searching strategy and including criteria, 45 studies were included. The overall adverse events were caused by medical techniques, patient factors, medical implants and the comprehensive factors, the medical techniques covered 46.8%, was the main cause, and the comprehensive factors covered 31.8% among these four factors, different kinds of orthopedic implants showed the same way. The main treatment was operation which may be suitable to different cases. ConclusionThe main causes of orthopedic implants adverse events in China were medical techniques and the comprehensive factors, operation was most likely to apply when the adverse events happened, relative measures to control the main causes and researches to make sure the causes of the adverse events are needed to reduce the orthopedic implants adverse events incidence.
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    Literature Analysis of the Hypoglycemia Deaths Caused By Glibenclamide
    MA Man-ling, GUO Mei-hua, YANG Li-jie
    2012, 9(2): 110-113. 
    Abstract ( 214 )   PDF (647KB) ( 274 )  
    Objective To survey the cases of hypoglycemia deaths caused by glibenclamide and analyze the relevant factors, provide a reference for the clinical use of drugs. Methods37 cases of glibenclamide-induced hypoglycemia deaths were statistically analyzed. ResultsMale to female ratio was 1.6:1,87.8% of cases for the elderly(>60), 86.5% of the patients had non-standard situation of drug use, 8.1% single drug, 75.7% of cases combined use of drugs, 100% of the cases are different degrees of clinical symptoms of low blood sugar coma, 54.1% of the cases were not discovered in time, misdiagnosed or missed. There are many reasons of death, 56.8% of death cases are caused by prolonged hypoglycemic coma with multiple organ failure or respiratory, circulatory failure. ConclusionHypoglycemic coma caused by glibenclamide can cause great harm. Hypoglycemic drugs should pay attention to safety. 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 low blood sugar reactions.
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    Analysis of Reports on Adverse Events of Surgical Suture Devices
    CHEN Xi, LONG Li-ping*
    2012, 9(2): 114-116. 
    Abstract ( 341 )   PDF (647KB) ( 1541 )  
    Objective By analyzing the reports on adverse events of surgical suture devices in Hunan province in 2010, provide technical support for the monitoring work of medical device adverse events. MethodsWith the description method, statistically analyze 409 reports collected in 2010 with the help of Microsoft Excel, primarily discuss the existing problems and present corresponding measures. ResultsThese surgical suture adverse events in Hunan province largely occurred in the patients between 20-30 years old. The reports mainly came from medical facility, and most events happened in November, in which the majority was absorbable surgical suture adverse events. The clinical manifestations of adverse events focused on suture reaction and poor wound healing, 80.20% of all the adverse events needed internal and surgical treatment to avoid the permanent injury. ConclusionWe should strengthen the training of surgical suture adverse event monitoring, promote the quality of reports to make them become effective information available for the safe use of medical devices.
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    Retrospective Analysis of 38 Granulocytopenia Cases Induced by Vancomycin
    LIU Li-ying, LI Yong, GU Shu-yi
    2012, 9(2): 117-118. 
    Abstract ( 325 )   PDF (1001KB) ( 651 )  
    Objective To study the clinical traits of granulocytopenia induced by vancomycin. MethodsClinical information of 38 granulocytopenia cases at our hospital from jaunary to june in 2006 was collected, and age, gender, medication, clinical manifestation of granulocytopenia and prognosis were analyzed. Results26 patients (68.42%) were male in 38 cases and 12 were female(31.58%). The average age was 39.66±9.86 years old. The course of treatment by vancomycin was 7~27 days. The minimum of leucocytes count was 0.49×109/L. Vancomycin withdrawal was adopted in all patients, among whom 6 patients received drugs to elevate leucocytes and 32 patients not received any special treatments. All patients' leucocytes and neutrophils returned to normal ranges after 2~7 days. ConclusionGranulocytopenia induced by vancomycin is reversible, whereas the risk of concurrent infection is increased, which should be paid much attention to.
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    Literature Analysis on the Adverse Reactions of Cephalosporins
    FAN Ming
    2012, 9(2): 119-122. 
    Abstract ( 331 )   PDF (669KB) ( 451 )  
    Objective To explore the situation and rules of adverse drug reactions(ADRs) of cephalosporins. MethodsThe ADRs of 29 kinds cephalosporins from 1169 cases,reported in WANFANG date base during 1998 to 2010, were collected and analysis. ResultsThe first 3 place on the 29 kinds of ADRs induced by cephalosporins were ceftriaxone(19.16%)、cefoperazone(16.60%) and cefradin(11.29%). ADRs of cephalosporins often occurred in pediatric and teenagers under 10 years(16.08%). The main administration routes were through intravenous injection(88.37%).The adverse effects involved 16 organs/systems, with the most frequent in systemicr eactions(35.67%), followed by CNS and PNS(19.76%)、blood occurred occasionaly(13.94). The clinical manifestation of ADRs were anaphylactic shock(28.14%)、disulfiram like reactions (12.74%) and screening(8.04%). The onset of ADRs was usually within 30 min after administration(37.30%).The onset of anaphylatic shock was usually within 10 mins after administration(60.79%). 53 cases(4.76%) died. ConclusionWe should pay more attention to the ADRs of cephalosporins, such as anaphylactic shock.Test of cephalosporins was necessity and importance.
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