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    10 October 2011, Volume 8 Issue 10 Previous Issue    Next Issue

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    Research of Hepatotoxic Damage Caused by Different Components of Radix et Rhizoma Sophorae Tonkinensise
    LI Su-jun, QIAN Xiao-lu, LI Xiao-yu, HUANG Wei, SUN Rong
    2011, 8(10): 577-580. 
    Abstract ( 186 )   PDF (371KB) ( 201 )  
    Objective To investigate the hepatotoxic effect induced by different components of Radix et Rhizoma Sophorae Tonkinensise(RRST) in mice. Methods Mice are divided into different groups such as normal, water extract and alcohol extract group to observe the normal conditions after seven days administration. The activity of ALT、AST、AKP、TBI、ALB in serum, the liver weight and volume ratio, the changes of liver morphology were observed on the 7th day after administration. Results The mice’s body weight was effected after given water extract and alcohol extract of RRST, both the ALT、AST、AKP and TBI were increased, while the ALB was decreased, the liver weight and volume ratio were increased and the liver pathology was changed, the water extract group has more obvious influence. Conclusion Multiple intragastric administrations of water extract and alcohol extract of RRST with certain dosage may induce acute hepatotoxic injury in mice especially the water extract, it causes not only the changes of liver function index, but also the structural pathological changes of hepatic cell.
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    Study on the Release Rate of Niacin in Different Media for the Compound Niacin Extended-release and Simvastatin Tablets
    WANG Shu-guang, WANG lin, SHAO Zhen-zhong, LU Xiao-ping, HANG Xia-qing
    2011, 8(10): 581-584. 
    Abstract ( 200 )   PDF (376KB) ( 286 )  
    Objective To study the release rate of niacin for Niacin extended-release and Simvastatin tablets in different media, and analyze their release behavior in vitro. Methods The release of Niacin for self-prepared and imported compound preparation in four different media were determined by UV, the kinetics model and similarity factor(f2 value) were compared. Results Self-made and imported sustained-release tablets in vitro release of nicotinic acid were complied with the Ritger-Peppas equation, the n values of the equation in the four media were from 0.45 to 0.89, indicating that the drug release was caused by the interaction of the skeleton of drug diffusion and dissolution. Comparing with the value of the reference formulation, the f2 value of the self extended-release tablets which were in water, 0.1mol/L HCl, pH 4.5 acetate buffer and pH 6.8 phosphate buffer release medium were 67.59, 80.24, 67.27 and 65.57 respectively, which were greater than 50. Conclusion Niacin release behavior of self-prepared was consistent with the imported extended-release tablets in vitro.
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    Determination of the Contents of Anemonin in Clematis mandshurica Rupr by HPLC
    ZHANG Hai-feng, SUN Jian, TENG Kun
    2011, 8(10): 585-586. 
    Abstract ( 190 )   PDF (392KB) ( 276 )  
    Objective To establish a HPLC method for the determination of anemonin in Clematis mandshurica Rupr. Methods Agilent XDB C18(4.6 mm×250 mm, 5μm) column was applied,using. methanol-water(40:60) as mobile phase with the rate of 0.8mL·min-1. The column temperature was room temperature and the detective wavelength was 220 nm. Results A good linearity was obtained over the range of 5.45~109μg·mL-1 for anemonin (r=0.9993). The average recovery(n=6) was 102.41%(RSD=2.78%). Conclusion The method is simple, sensitive,good reproducibility and used as the determination of Anemonin in Clematis mandshurica Rupr.
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    The Evaluation of Diagnoses and Management in Cesarean Scar Pregnancy with Color Doppler Ultrasound
    ZHANG Xiao-ying, PENG Yan-li, CHEN Tao, ZHU Ya-li, WEI Jin-ming, WANG Yan, JIA Juan
    2011, 8(10): 587-589. 
    Abstract ( 131 )   PDF (390KB) ( 244 )  
    Objective To evaluate our experience and diagnosis of cesarean scar pregnancy(CSP) with color doppler ultrasound. Methods From March 2006 to June 2010, 3 cases of cesarean scar pregnancy were diagnosed using color doppler sonography and treated conservatively to preserve fertility. Gastational age, sonographic findings, β-human chorionic gonadotropin(β-hCG) levels, flow profiles of transvaginal color Doppler ultrasound, and trasabdominal sonography during treatment were recorded. Results The gastational sac(GS) ages were diagnosed for about 6 weeks. The time interval from the Cesarean section to the diagnosis of Cesarean scar pregnancy was from 9 months to 126 months. Embryonic period diagnosed by color doppler sonography were as follow: the sizes of GS ranged from 0.8cm×0.4cm×0.5cm to 2.2cm×2.1cm×1.0cm, all with cardiac activity, the crown-rump length ranged from 0.3cm to 0.7cm, the anterior myometrial thickness to the csp were measured 0.5cm with rich color flow show. The patients were treated as follow: ultrasound-guided dilation and curettage under hysteroscopy within 24 hours following uterine artery embolization(n=2), the failure of uterine artery embolization and systemic methotrexate(MTX) injection, the vial GS validated by transvaginal ultrasound, then getting out and dilation and curettage of the csp under hysteroscopy by following-up(n=1). Conclusion Transvaginal ultrasound plays an important and useful role in the early diagnosis of the CSP. During operation under the abdominal ultrasound online screening, it is obvious for the shorteness of opareative time, the decrease of operator's blindness and the safeguard of operative security to dilate and currette.
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    Preliminary Safety Evaluation of Breviscapine Injection in Its Clinical Application
    YE Yun, ZHANG Shi-yong, CHENG Jun, WANG Gang-bin, HAN Yi-xuan
    2011, 8(10): 590-591. 
    Abstract ( 196 )   PDF (394KB) ( 151 )  
    Objective To generally evaluate the clinical safety of the Breviscapine injection. Methods Collect and research on the cases of Breviscapine injection in my hospital during the period of April and September 2010. Results Based on the 765 inpatient cases which involved 9 department and 19-odd diseases,whilst ADR occurred in 8 cases(1.05% among the total). The rate of drug adverse reaction was reduced when the applications followed the drug instructions. Conclusion The safety of clinical application would be enhanced by accurate operations that are strictly in line with the instructions of treatment.
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    Analysis of Clinical Use and Safety for large samples of Shuxuetong Injection
    LI Bai-qang, LU Zhong-ping, FANG Hong-zhuang, SU Rui, SUN Chang-hai
    2011, 8(10): 592-595. 
    Abstract ( 170 )   PDF (429KB) ( 337 )  
    Objective To understand the clinical use of Shuxuetong injection and its safety. Methods The 9 897 Prospective monitoring data of Shuxuetong injection comeing from 29 hospitals in Heilonjiang province was analyzed by statistical analysis software SPSS13.0. Results The number of Patients with the drugs more concentrated on above 40 years old, closed to the total 97%, and the men were more than women. Combined use of drugs was involving 16 categories, Shuxuetong injection used alone was only 9.3%. The rate of adverse reaction of the incidence is 0.9%, related with only a factor of drug allergy history. Conclusion The involved sample data analysis showed Shuxuetong injection had a lower rate of adverse reaction.
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    Analysis on Collecting Information for Adverse Drug Reaction and Ways to Report Through Spontaneous Reporting System in China
    WU Gui-zhi, WANG Chun-ting, ZHANG Li
    2011, 8(10): 596-599. 
    Abstract ( 266 )   PDF (515KB) ( 440 )  
    Collecting information for adverse drug reactions and ways to collect are two determined factors to fast and effectively collect adverse drug reactions through the spontaneous reporting system. This information usually is represented in a drug adverse reaction reporting form and its instructions. The instructions usually include principle for reporting, what to report, how to report and confidentiality. This article compared the drug adverse reaction reporting form and instructions from United Kingdom, United States, Australia and Canada with the reporting from our country. Some suggestions on how to optimize the collecting information for adverse drug reaction and ways to report in our country were also discussed.
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    Review of Adverse Drug Reaction Reports Causality Assessment Methods
    WEI Jing, WANG Yu-xin
    2011, 8(10): 600-602. 
    Abstract ( 1414 )   PDF (470KB) ( 1585 )  
    ADR causality assessment method is an important tool in the process of pharmacovigilance. The aim of this review is to provide an overview of these methods and discuss their strengths and weaknesses. The methods were found, falling into three broad categories: expert judgement/global introspection, algorithms and probabilistic methods(Bayesian approaches). Expert judgements are individual assessments based on previous knowledge and experience in the field using no standardized tool to arrive at conclusions regarding causality. Algorithms are sets of specific questions with associated scores for calculating the likelihood of a cause-effect relationship. Bayesian approaches use specific findings in a case to transform the prior estimate of probability into a posterior estimate of probability of drug causation. The prior probability is calculated from epidemiological information and the posterior probability combines this background information with the evidence in the individual case to come up with an estimate of causation. Different causality categories are adopted in each method, and the categories are assessed using different criteria. In conclusion, there is still no method universally accepted for causality assessment of ADRs.
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    Comparison of the Drug Package Inserts of Domestic and Foreign Compound Preparations Containing Narcotic Drugs
    LIU Wei, LUAN Rong, ZHAI Suo-di
    2011, 8(10): 603-605. 
    Abstract ( 171 )   PDF (495KB) ( 1437 )  
    Objective To regulate the drug package inserts of domestic compound preparations containing narcotic drugs and improve rational use of these drugs. Methods From the safe medication's angle, choose drug abuse and dependence, contraindications, precautions and so on from the drug package inserts, and then contrastively analyse the domestic and foreign part. Results The domestic drug package inserts are lack of warnings. Both the domestic and the foreign ones are not all-inclusive about contraindications. The Chinese and English drug package inserts do not correspond. Conclusion We can reference package inserts of the narcotic drugs unilaterally preparations and foreign compound preparations containing narcotic drugs to revise domestic ones.
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    Analysis of the Irrational Clinical Application of Chinese Patent Medicine and Policy Recommendations
    DANG Hai-xia, WANG Hai-nan
    2011, 8(10): 606-607. 
    Abstract ( 176 )   PDF (575KB) ( 608 )  
    In this paper, the main causes of the irrational application of Chinese patent medicine were analyzed by consulting medical periodicals and summarizing the clinical usage of Chinese patent medicine. Moreover, we put forward some policy recommendations to avoid the irrational application of Chinese patent medicine.
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    Discussion of Quality Control Methods of Adverse Drug Reaction Reports
    LI Pan-hai, FENG Qiao-qiao
    2011, 8(10): 608-610. 
    Abstract ( 228 )   PDF (578KB) ( 198 )  
    Based on the thought and practice of quality control of adverse drug reaction reports in Shandong Province, the methods of micro-control and macro-control for the adverse drug reaction reports were proposed and analyzed in this paper, to provide valuable reference on the quality control of adverse drug reaction reports.
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    The Consequences and Causes of Traditional Chinese Medicine(TCM) Injection Overdosage
    LI Wen-jie, LI Xiao-yun, FAN Xue-liang
    2011, 8(10): 611-612. 
    Abstract ( 216 )   PDF (520KB) ( 836 )  
    Traditional Chinese Medicine(TCM) injection has been used more and more in clinic ,but overdosage is common. Using medicine beyond instruction becomes breakthrough of irrational using medicine. This paper describes present utilizations、consequences and causes of TCM injection overdosage. It is hoped to provide references for safety use of TCM in clinic, preventing medical dispute and reduction of adverse effect. Also it reminds clinicians to follow the instructions of medicine.
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    Intellectual Property Right(IPR) Protection of Chinese Traditional Medicine
    SUN Wei
    2011, 8(10): 613-614. 
    Abstract ( 183 )   PDF (486KB) ( 321 )  
    At present, the herbal medicine industry share is very low in international market; on the other hand, the phenomenon of mutual imitation of proprietary Chinese medicines, a large number of low-level repetitive production, and duplication of the same species exist in the domestic market. Under such circumstances, the exclusive ownership of innovative behavior of traditional Chinese medicine can be defined by intellectual property protection, but the Chinese intellectual property issues involved in a wide range, including patent, trademark, trade secret protection and four main aspects of administration. In regard to Chinese herbal medicines, there are lots of contents of protections, such as pieces, prescription, extract, preparation, pharmaceutical engineering, related derivatives and other need of protection. Therefore, how to make good use of Chinese modern intellectual property system to protect the treasure of the Chinese nation becomes the problem to be solved.
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    Research Development on the Prevention of Cerebral Ischemia in Angelica sinensis Related with Efficacy and Material Basis
    SUN Rong, ZHANG Ya-nan, LV Li-li
    2011, 8(10): 615-618. 
    Abstract ( 236 )   PDF (627KB) ( 327 )  
    Objective By combing pertinent literature, and summarizing the current states of the prevention of cerebral ischemia in Angelica sinensis related with efficacy and material basis, to identify its effective composition, offer the accordance and research ideas for further research on the relationship between efficacy and chemical composition of Angelica sinensis. Methods The related references in recent 10 years both at home and abroad about Angelica sinensis were analyzed, collated and summarized. Results The Angelica sinensis has many kinds of bioactive ingredients and extensive pharmacological effects. It has been used in clinical to treat the anemic cerebrovascular disease, and obtains the good curative effect. Conclusion The research of efficacy and material basis in Angelica sinensis has limits in embarks from its effective component, the mechanisms of treating the anemic cerebrovascular disease are not definite completely. The pharmaceutical chemistry ingredient is complex, and has variously uses. It needs to be further study of the effective monomer ingredient, the target and the related protection mechanism research, to expound that its curative effect and does with the mechanism provides the theory basis, with the aim of instructing the clinical reasonable medication and the new medicine research.
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    Analysis of 91 Cases Adverse Reactions Caused by Intravenous Infusion of Clindamycin
    ZHAO Xuan1GUO Jing2ZHAO Huai-quan1
    2011, 8(10): 619-620. 
    Abstract ( 201 )   PDF (651KB) ( 354 )  
    Objective To study the characteristics of adverse drug reactions(ADR) caused by intravenous infusion of Clindamycin in our hospital and to provide reference for clinical medication. Methods 91 cases adverse reactions resulted from Clindamycin collected by Beijing ADR monitoring network from Dec, 2004 to Dec, 2010 in our hospital were analyzed statistically. Results The constant ADR induced by Clindamycin is slight. The occurrence of ADR is related to drug combination, Conclusion Clinical application of Clindamycin should be used to comply with the indication, to ask in detail about patients with a history of allergies and the stability of the medicine, to treat severe ADR occurred possibly.
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    Analysis of 226 Cases of Adverse Drug Reactions Induced by Traditional Chinese Medicine Injections
    WANG Hua, XU Jian, LIU Jing-jing
    2011, 8(10): 621-623. 
    Abstract ( 170 )   PDF (679KB) ( 199 )  
    Objective To Understand adverse drug reactions of the Traditional Chinese Medicine Injections occurred in our city and provide alerts for clinical medicine. Methods 226 serious Adverse Drug Reactions Induced by Traditional Chinese Medicine Injections collected by Chuzhou City during 2009~2010 were analyzed using retrospective study method. Results out of the 226 cases ADR reports,higher ADR occurrence is observed in elderly patient group,amount to 40.52% percent.The clinical expression of ADR is showed mostly skin and appendix harms, amount to 33.63% percent;secondly a general harm, amount to 20.80% percent. ADR involving four types traditional Chinese medicine injection, the highest incidence of activating blood flow types, amount to 51.52% percent; involving 28 species, most of which occurred Shuanghuanglian injection, amount to 12.55% percent. Conclusion Traditional Chinese Medicine Injection shoud be used reasonably and ADR Induced by Traditional Chinese Medicine Injections should be intensively monitored to avoid personal injury caused by irrational use.
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    Analysis of 89 Severe Adverse Drug Reaction/ Event Reports
    FAN Ping-ping
    2011, 8(10): 624-626. 
    Abstract ( 233 )   PDF (673KB) ( 243 )  
    Objective To investigate the features, general pattern and preventive measures of the severe adverse drug reaction/event(ADR/ADE), and provide references of clinical rational and safe use of drug. Methods 89 ADR/ADE cases collected in Dalian Medicine Adverse Reaction Monitoring Center from Jan. 2008 to Apr. 2010 were analyzed retrospectively. Results The females and aged patients have a higher incidence of severe ADR/ADE; most cases were induced by intravenous drip; and more cases were caused by antimicrobial agents and Chinese medicine. Conclusion Medical workers should pay more attention to females and aged patients; intravenous drip and drug combination should be avoided if it is not necessary; Preventive action could be taken before using sensitizing drugs.
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    Literature Analysis of Adverse Drug Reactions Induced by Bisoprolol
    CHEN Chong-Ze, JIANG Xiu-Yan
    2011, 8(10): 627-628. 
    Abstract ( 197 )   PDF (616KB) ( 281 )  
    Objective To investigate the adverse effects of bisoprolol induced the general rules and characteristics. Methods We searched the "China Journal Full-text Database"and"Chinese Scientific and Technial Periodicals Database" in 1994 and 2009 due to adverse drug reactions bisoprolol, and statistical analysis. Results Bisoprolol caused a total of 13 cases of adverse reactions, more men than women. Adverse reactions due to a maximum of sinoatrial, atrioventricular block in 5 patients(38.46%), followed by secondary amenorrhea in 2 cases(15.38%), urinary system diseases in 2 cases(18.36%), respiratory disorder in 2 cases(18.36 %), neurological problems and 1(7.70%). Conclusion The clinical application should strengthen monitoring of bisoprolol in order to reduce the incidence of adverse reactions.
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    Analysis of 56 Cases of the Orthopedic Implants Suspicious Adverse Events
    SHUAI-Jun, SU Qi, ZHOU Yu-gang
    2011, 8(10): 629-631. 
    Abstract ( 191 )   PDF (638KB) ( 359 )  
    Objective To analyze the causes of the orthopedic implants suspicious adverse events and to study the preventive measures of it. Methods From Jaunary 2009 to Jaunary 2010, 56 patients with orthopedic implants suspicious adverse events were reviewed. Results The quantity of the plates was the most among the events incidence, the incidence of the Kirschner wire was the most among the events incidence. The fracture, the loosen were the most familiar manifestation. Conclusion The causes of the orthopedic implants suspicious adverse events are composed of following factors: factor of patients, the level of medical operations and implants. Adverse events can be prevented if strengthen orthopedic implants adverse event monitoring, improve surgical skills and enhance patients'consciousness of self-protecting.
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    Pharmaceutical Care on a Patient with Atrial Fibrillation for Anticoagulation Therapy Using Warfarin
    ZHAO Yu-qin, GAO Jie, XIE Cheng
    2011, 8(10): 632-633. 
    Abstract ( 154 )   PDF (613KB) ( 242 )  
    A 86-year-old male patient with atrial fibrillation was given warfarin for anticoagulation therapy in hospital. The international normalized ratio(INR) of the patient fluctuated during the period of therapy. Clinical pharmacists analysed disease,drug-drug interactions and other influence factors,combined with the characters of pharmacokinetics and pharmacodynamics to provide physicians with some reasonable advices. Clinical pharmacists also provided medication education to the patient, and played an important role in the safety of drug use.
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