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    10 June 2012, Volume 9 Issue 6 Previous Issue    Next Issue

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    Experimental Comparison Study on Mice's Acute Toxicity of Different Composition in Asarum
    LI Rong-rong , YANG Yong, DING Jia-xin , QIN Chao, LI Jing
    2012, 9(6): 321-324. 
    Abstract ( 255 )   PDF (394KB) ( 297 )  
    Objective To explore the acute toxicity of different components in Asarum on mice. Methods Respectively prepared Asarum volatile oil groups, supercritical fluid extraction groups and the water extraction groups. To compare the acute toxicity of different components in Asarum on mice in accordance with classical acute toxicity test methods. Results The main acute toxicity symptoms and signs are convulsions, dispirited and breathlessness. The mouse death was centralized from 12 hours after medication. 24 hours after medication, spirit and anorexia were recovered gradually in the survival mice, and had little mice died in the next 14 days. The LD50 and 95% confidence limit of volatile oil and supercritical fluid extraction in Asarum are respectively 86.9g·kg-1·d-1 (62.2~120.8g·kg-1·d-1) and 7.4g·kg-1·d-1(6.3~8.7g·kg-1·d-1); the water extraction groups are unable to make LD50, the MLD are 30g·kg-1·d-1, which are equal to 76.92 times of 70kg adult's daily dried medicinal herb expenses. Conclusion The acute toxicity of different components in Asarum on mice is as follows: supercritical fluid extraction groups > volatile oil groups > the water extraction groups,the water extraction given in higher dosage is no obvious intraocular toxic reaction and has a higher security. This study might further provide some experimental basis for the clinical application of Asarum on a high dosage in decoction.
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    Clinical Effect of Antibiotics to Treat 60 Elderly Patients with Chronic Renal Insufficiency and Bacterial Infection
    TENG Ling, TAN Jian-yang
    2012, 9(6): 325-326. 
    Abstract ( 219 )   PDF (333KB) ( 187 )  
    Objective Explore the clinical effect of antibiotics to treat 60 elderly patients with chronic renal insufficiency and bacterial infection, and influence to the renal function. MethodsChoosing 60 elderly patients with chronic renal failure and 60 elderly patients with normal renal function, all patients were suffered from lower respiratory tract infection, who were treated by Ceftazidime in our hospital from May 2008 to October 2011. Observe the difference of clinical effect and renal function change before and after treatment. ResultsThe average treatment time of observation group and control group were(10.15±3.23) d and (7.32±2.18) d (P<0.05); There were no statistical means of overall treatment effect(P>0.05), but difference of cure rate between two groups was significant(P<0.05); Besides, the difference of SCr, BUN, and CCr before and after treatment is significant(P <0.05). ConclusionUsing Antibiotics to treat bacterial infection of elderly patient with chronic renal insufficiency is harder than treating with elderly patients normal renal function. More attention need to be paid to them, and once presents renal insufficiency, the drug should be immediately discontinued, treat them with hemodialysis when necessary.
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    Retrospective Analysis on 135 Cases of Malaria in Africa
    CHEN Xiao-hong, ZHAO Zhi-gang WANG, Hui-yuan
    2012, 9(6): 327-329. 
    Abstract ( 191 )   PDF (362KB) ( 300 )  
    Objective To understand the clinical characteristics, treatment and its outcome of African malaria. MethodsClinical data of 135 malaria patients are analyzed. ResultsAmong the clinical manifestations, 135 cases(accounting for 100%) got fever, in which there are 31 patients with anemia(accounting for 22.96%), 27 patients with splenomegaly(accounting for 20.00%), 21 patients with diarrhea(accounting for 15.56%), and 19 patients with vomiting(accounting for 14.07%). All above are the most common clinical manifestations. Then there are various symptoms as cough(17 patients, accounting for 12.59%), chill(7 patients, accounting for 5.19%) and so on. 135 patients all accepted antimalarial treatment with artesunate drugs. These 135 patients were cured and no one died. ConclusionMost African malaria is malignant with a high morbility, and clinical manifestations are complicated and not typical. So early diagnosis and prompt treatment are the key to improve the disease prognosis. Artesunate drugs are safe, effective and the first choice to malaria treatment.
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    The Analgesic Effect Study on Margin of Safety on Different Components from Folium Artemisiae Argyi
    CHI Xue-jie, WANG Hui, HUANG Wei, BAO Zhi-ye, SUN Rong
    2012, 9(6): 330-332. 
    Abstract ( 191 )   PDF (631KB) ( 178 )  
    Objective To determine the material basis of analgesic effect and the effective dose range of Folium Artemisia Argyi, to clear the appropriate therapeutic index and safety margin, in order to provide the basis for the clinical safety. MethodsAnalgesic effect of the volatile oil and water extracts from Folium Artemisia Argyi were investigated by hot plate test and the toxicity in mice were investigated by the Bliss method to calculate the relevant indicators. ResultsThe ED50 and 95% confidence limit of water extraction components and volatile oil in Artemisia Argyi are respectively 2.0978 g·kg-1·d-1(1.5555~2.7917)g·kg-1·d-1, 0.302 mL·kg-1·d-1(0.213~0.429)mL·kg-1·d-1. TI and SF of water extraction components are respectively 38.2,10.9. TI and SF of volatile oil volatile oil in Artemisia Argyi are respectively 5.53, 1.06. ED95 and LD5 are respectively 1 086.70 and 1 151.60 amounts equivalent to the pharmacopoeia. ConclusionThe material basis of Folium Artemisia Argyi are water extraction components and volatile oil, the effective dose range are respectively(1.5555~2.7917)g·kg-1·d-1, (28.0~56.5)g ·kg-1·d-1. This study cleared water extraction components were more sensitive than volatile oil on the response to thermal stimulation in mice. The volatile oil has narrower margin of safety and low security than water extraction components.
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    The Analgesic Effect Study on Margin of Safety on Different Components from Cortex Periplocae
    ZHU Lan-lan, BAO Zhi-ye, WANG Hui, HUANG Wei, SUN Rong
    2012, 9(6): 333-334. 
    Abstract ( 204 )   PDF (459KB) ( 230 )  
    Objective To research analgesic effect of the margin of safety of Cortex Periplocae. MethodsAnalgesic effect from different components from Cortex Periplocae were investigated by hot plate test; the symptoms in mice were observed, the experimental datas of ED50, ED95, LD50 and LD5 are calculated by the Bliss method and the therapeutic index(TI), safety factor(SF) of different components from Cortex Periplocae were assured by applying some formulas. ResultsThe different components from Cortex Periplocae showed good effect of analgesia, and showed certain dose-effect relationship, ED50 of the water extracts from Cortex Periplocae is 1.5698 g·kg-1·d-1, TI is 59.611 and SF is 17.4702, ED95 is equal to 48.0 times and LD5 is equal to 839.0 times of 70kg people's daily dried medicinal herb expenses. The alcohol extracts from Cortex Periplocae of ED50 is 1.3687 g·kg-1·d-1, TI is 44.853 and SF is 14.2405, ED95 is equal to 35.7 times and LD5 is equal to 509.0 times of 70kg people's daily dried medicinal herb expenses. ConclusionThe analgesic effect of the margin of safety from water extracts is greater than the alcohol extracts from Cortex Periplocae. We should pay more attention to the occurrence of adverse reactions in the application.
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    The Margin of Safety Study on Anti-inflammatory Effect of Different Components from Rhizoma Menispermi
    ZHENG Li-na, LUO Dong, SUN Rong
    2012, 9(6): 335-337. 
    Abstract ( 220 )   PDF (507KB) ( 193 )  
    Objective To research therapeutic index(TI) and the margin of safety(SF) of anti-inflammatory effect of Rhizoma Menispermi. MethodsEstablish granuloma model induced by subcutaneous injection of agar and administrate different doses of water extraction, alcohol extraction components of Rhizoma Menispermi to mice for seven days consecutively to observe anti-inflammatory effect of different components of Rhizoma Menispermi, using the Bliss method to calculate ED50 and ED95 of anti-inflammatory efficacy of the different components; According to earlier reports in our laboratory about the results of acute toxicity studies of different components of Rhizoma Menispermi, ED50, ED95, LD50 and LD5 are calculated by the Bliss method and the therapeutic index(TI), safety factor(SF) of different components from Rhizoma Menispermi were assured by applying some formulas. ResultsThe different components from Rhizoma Menispermi showed good granuloma effect, and showed certain dose-effect relationship, the anti-inflammatory effect of alcohol extraction componentis, is better than that of water extraction component. TI of the water extracts and the alcohol extracts from Rhizoma Menispermi is 57.532 and 17.4702, SF is 45.844 and 9.800 respectively. ConclusionThe anti-inflammatory effect of the alcohol extracts is greater than the water extracts from Rhizoma Menispermi, but the margin of safety from water extracts is greater than the alcohol extracts from Rhizoma Menispermi. We should pay more attention to the occurrence of adverse reactions and strengthen drug monitoring in the application.
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    People's Livelihood and Drug Safety
    LIU Jia, LI Guo-qing
    2012, 9(6): 338-339. 
    Abstract ( 221 )   PDF (499KB) ( 175 )  
    Medicine is an important tool for protecting public health.So the drug safety is always concerned with a matter of the people's livelihood. As an essential content of the basic health system, drug safety protecting is one of the primary subjects in improving people's livelihood. This article analyzes the definition of people's livelihood and drug safety, discusses the relationship between them and provides some advice and reference on drug safety administration.
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    Registration Clinical Research Technical Requirements to the Influenza Virus Nucleic Acid Detection Reagents
    LI Yao-hua
    2012, 9(6): 340-343. 
    Abstract ( 316 )   PDF (462KB) ( 144 )  
    Based on the characteristic of influenza virus prevalence trend, related regulations and assay reagents, this article illustrated the clinical trial design requirements for influenza virus nucleic acid detection reagent registration. Ethical issues, protocol design, comparative method, study site, statistical analysis and clinical trial report were all involved and provided guidelines for the specific reagent registration.
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    Preliminary Study on Unlabeled Uses of Medicines
    WU Wei, XIN Hua
    2012, 9(6): 344-346. 
    Abstract ( 236 )   PDF (526KB) ( 264 )  
    Objective This article introduces the existence situation of "unlabeled uses" and related policy at home and abroad to be able to cause community-wide concern and promote the safe use of drugs. MethodsAccess to relevant literature in recent years, thought analysis, summary and synthesis is reviewed. Resultsand ConclusionThere are no clear legislatives about "unlabeled uses" in China. medical institution and management agencies need to work hard together. Management department needs to accelerate the legislative process. Physicians and pharmacists need to strengthen self-discipline to effectively guarantee public safety.
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    The Cardiotoxicity of Terfenadine and Application Profile
    MAO Lu, WANG Nan
    2012, 9(6): 347-349. 
    Abstract ( 250 )   PDF (523KB) ( 850 )  
    Objective The cardiotoxicity of Terfenadine and its application profile in the world were reviewed in this article. The references of clinical rational and safe use of the drug were provided. MethodsWe accessed relevant literature of Terfenadine withdrawal from the market in some countries and analysed the research on the cardiac toxicity of the drug, and summarized the application and adverse reactions of this drug in China. ResultsAnalysis showed that Terfenadine has cardiac toxicity, when overdosed or increased blood concentration the adverse reaction was easy to happen. Although the drug was withdrawn or was restricted in use in the late 1990s, Terfenadine is still used in China as prescription drug, and the adverse reactions were reported in recent years. ConclusionThe clinical adverse drug reactions should be alert. The dosage and combination drugs should be specified, in order to improve the safety and effectiveness for clinical medication.
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    Analysis on the Study of Toxicity and Poisoning Prevention of Xixin
    PING Jing, WANG Jun-ning, ZHANG Cheng-bo
    2012, 9(6): 350-353. 
    Abstract ( 282 )   PDF (564KB) ( 428 )  
    This paper summarizes the correlational research on toxicity of Xixin from toxicol,clinical manifestation,poisoning reason and poisoning prevention. We draw the conclusion that the poisoning reason is relating to overdosage, being dealt with deficient time,confusion variety and different part of Xixin. The effect of toxicity mainly damages nervous system, circulatory system and respiratory system. Respiratory paralysis is the cause of death. We should pay attention to the poisoning prevention in terms of dosage, administration, compatibility and individual difference.
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    The Medical Device Adverse Events Monitoring and Primary Analysis on Corneal Contact Lens
    ZHAO Yan, ZHENG Li-jia, DONG Fang
    2012, 9(6): 354-356. 
    Abstract ( 282 )   PDF (617KB) ( 301 )  
    By introducing the classification, material properties, common use, suspected medical device adverse event(MDR) and analysis of the MDR causes of corneal contact len, to analyze the risk factor of corneal contact lens. The analysis of the risk factor is based on three aspects, they are material factor, patients factor and use factor. By giving some advices on the risk control, so as to strengthen the monitoring of this product, and then to ensure the correct and safe use of corneal contact lens.
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    Analysis on the Adverse Reaction/ Event Reports of Benzhexol Hydrochloride
    DONG Wen-tao, LIU Xiao-ling, XU Zuo-guo
    2012, 9(6): 357-359. 
    Abstract ( 197 )   PDF (655KB) ( 715 )  
    Objective To discuss the adverse reaction of Benzhexol Hydrochloride and provide reference for drug safety in clinical practice. MethodsStatistically analyse the adverse reaction cases reported by 9 psychiatry journals over the past 15 years and the clinical data collected by author. ResultsBenzhexol Hydrochloride adverse reactions/events involved 8 major systems and 23 kinds of clinical manifestation, mostly with mental disorders(61.22%), 67.53% of which appeared within 5 days. ConclusionMental disorders account for the most Benzhexol Hydrochloride adverse effects/events, withdrawal reaction followed can not be ignored. To avoid the confusion with the original mental symptoms, the joint or regular application of Benzhexol Hydrochloride is not appropriate.
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    Safety Evaluation of 700 cases of Danhong Injection in Its Clinical Application by Active Centralized Monitoring
    KANG A-long, ZHANG Xian, HUANG Li-ming, SUN Cheng-rong, MAI Jin-qiang
    2012, 9(6): 360-362. 
    Abstract ( 216 )   PDF (580KB) ( 235 )  
    Objective To evaluate the clinical safety of the Danhong injection. MethodsMedication and Patient data and ADR of 700 cases of Danhong Injection in our hospital were collected by active centralized minitoring during the period of January and October 2011. ResultsBased on the 700 inpatient cases which involved 8 departments and 16 rinds of diseases, whilst ADR occurred in 3 cases(0.43% of the total). 73.71% of the injection-takers were old patierits, 105 cases of the medication is unreasonable, accounting for 15.00%. Condusion A low incidence of ADR for the Danhong injection in its clinical application was found. Irrational drug use can increase safety risk. We should strengthen the supervision of clinical rational use of traditional Chinese medicine injections.
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    The Clinical Safety Comparison Between Sirolimus-eluting Stent and Other Coronal Stents in Treating Coronary Artery Disease
    LIU Wei
    2012, 9(6): 363-366. 
    Abstract ( 216 )   PDF (615KB) ( 175 )  
    Objective To compare the clinical safety of sirolimus-eluting stent(SES) and other coronary stents in treating coronary artery disease. MethodsAll comparision study relating to the endpoints of SES in treating coronary artery disease published in the last five years, including major adverse cardiac events(MACE), target vessel revascularization(TVR), target lesion revascularization(TLR), are retrieved by indexing pubmed, OVID medline,sciencedirect, CNKI and Wanfang Data. ResultsCompared to bare-metal stent(BMS), the MACE of SES decreased obviously, at the same time TVR and TLR of SES dropped in significantly too. Contrasting to other drug-eluting stents, the clinical safety of SES was equal to PES, and better than ZES in some patients who had complications of diabetes mellitus or coronary bifurcation lesions. For patients with renal inadequacy, the clinical safety of SES was better than BMS and equal to PES. Perhaps C-reactive protein had a predictive value of the MACE incidence after SES implantation. ConclusionCompared to BMS, SES preferred to show a significantly higher safety which equals to PES.
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    Thoughts and Suggestions on Unreasonable Prescription Criteria for Prescription Comment
    ZHAO Huai-quan, LIN Ping
    2012, 9(6): 367-368. 
    Abstract ( 266 )   PDF (680KB) ( 328 )  
    Via analyzing and considering the unreasonable prescription criteria in Management Practices of Hospital Prescription Comment(Trial), some problems about its related items are discussed in this study. These problems, which include superposition of content's subordination, confusion of cause and result, similarity or repetition of content, are easy to cause confusion, misjudgment or repetition in prescription comment results. As a result, some suggestions, including adjusting the unreasonable prescription criteria related items, defining and explaining the places easy to misunderstand or confuse, are raised to enhance its practicability, to advance the effect of prescription comment on the continuous quality improvement of prescription, and to improve the rational drug application in clinic.
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    Analysis of Antibacterial Drugs Used in 216 Patients on Orthopaedic Surgery
    LIU Yao-hua
    2012, 9(6): 369-371. 
    Abstract ( 186 )   PDF (635KB) ( 215 )  
    Objective To understand the antimicrobial drug use on orthopedic surgery patients in our hospital and guide clinical use of antimicrobial drugs. MethodsAccording to pre-designed questionnaire, 216 archived surgical records of the fourth quarter of 2010 were retrospectively analysed. ResultsThe antibiotics use rate was 100%, prophylactic use accounted for 93.5%; aztreonam was most frequently used, followed by cephalosporin and penicillin. ConclusionThere are many irrational use of antimicrobial drugs in orthopedic surgery. It's necessary to strengthen the rational use of prophylactic antibiotics.
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    Medication Analysis on Pediatric Outpatient Prepscriptions at Our Hospital
    ZHANG Xiao-hong
    2012, 9(6): 372-373. 
    Abstract ( 226 )   PDF (651KB) ( 308 )  
    Objective Understand the medication and existing problems at pediatric outpatient department, promote the rational drug use. MethodsWe randomly selected 1 200 prescriptions from January to December in 2010, calculated out the number of species of drugs, the use rate of essential medicines, the percentage of prescriptions containing injections, the percentage of prescriptions containing antibiotics, the percentage of prescriptions containing antibiotics combined with traditional Chinese medicine injections, then we discussed and analysed them on the basis of the relevant provisions. ResultsIn per prescription, the percentage of injection used is 45.0%, the average kind of drugs used is 3.12, the use rate of antimicrobial drugs is 55.0%, antibiotics combined with traditional Chinese medicine injections used is 23.0%, and the essential medicines use rate is 36.5%. Conclution We should develop interventions to strengthen the policy advocacy, and make sure the clinical treatment safe, effective and economical.
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    Analysis of Irrational Outpatient Prescriptions and Measure for Improvement
    WEI Ran
    2012, 9(6): 374-376. 
    Abstract ( 238 )   PDF (593KB) ( 215 )  
    Objective To investigate the situation of drug use in the outpatient prescription,so as to provide reference for rational use of drug. Methods 300 outpatient prescription from January to March in 2011 in our hospital were collected and evaluated in accordance with Hospital Prescription Evaluation Management Norms(Trial) and Prescription Management Norms. Results In 300 outpatient prescription, the irrational prescriptions accounted for 26% and involved in nonstandard handwriting, drugs inappropriate indication, use of irrational dosage, incorrrect combined use and repeated use, ETC. Conclusion The outpatient prescriptions of our hospital were basically rational, but the guality should be improved. Aimed at the above situation, we need to seek reason and estabish correspond measure in order to ensure the safety, effective ness, and economic use of drugs.
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