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08 June 2013, Volume 10 Issue 6 Previous Issue    Next Issue

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The Identified Study on Adverse Reactions of Ginkgolide Injection LIU Yu-jie ,XIAO Wei ,WANG Zhen-zhong ,ZHAO Bin-jiang ,TIAN Heng-yong ,HUANG Yu-hong ,GUO Jia-kui ,WENG Wei-liang 2013, 10(6): 321-323.  Abstract ( 385 )   PDF (413KB) ( 127 )   Objective To explore whether the adverse events of one subject who was allergic to ginkgolide injection was related to the drug allergy and to clarify the correlation with drug. Methods Under the adequate and effective risk prevention, an exploratory was carried out to find the relation between adverse events and drug using allergen skin prick test methods. Results Research showed the participant had a normal immune system function and no allergic diathesis, there was no allergic reactions on ginkgolide. Conclusion It is an useful attempt to monitor allergic reactions of traditional Chinese medicine injection by prick allergen test and skin allergy test. It will become one of the Methods which warn the relationships between highly sensitized traditional Chinese medicine injection and clinical adverse reactions of drugs. References | Related Articles | Metrics

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Study on the Long Term Toxicity of Ganoderma Lucidum Granule to Rats GAO Jian-bo, HAN Jing 2013, 10(6): 324-327.  Abstract ( 266 )   PDF (506KB) ( 131 )   Objective To observe the long term toxicity reaction of rats given Ganoderma Lucidum granule continuously. Methods The rats were randomly assigned to the control and three experimental groups, n =14 per group, equal number of male and female. Rats of three experimental groups were given Ganoderma Lucidum granule(ig) at dose of 1.5g·kg-1, 3.0g·kg-1, 6.0g·kg-1 for 26 weeks. The body weight, urine, hematology, plasma prothrombin time, blood biochemistry and ratio of viscera to body were measured at the end of experiment. At the same time, the major organs were examined by pathology. Results The Results showed that the abnormity induced by Ganoderma Lucidum granule were not found in all experimental groups, and the development of rats were normal. Compared with the control group, the urine, hematology, plasma prothrombin time, blood biochemistry and ratio of viscera to body of drug taking groups showed no significant toxicological difference. The pathological examination discovered no obvious pathological changes relating to drug toxicity. Conclusion Our study shows that there is not toxicity of Ganoderma Lucidum granule given to rats for long term, and it is safe to administrate Ganoderma Lucidum granule continuously. References | Related Articles | Metrics

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Study on Irritation of Rabbit Skin Caused by Multi-dose Huangzhu Xiaozhong Lotion WAN Hong 2013, 10(6): 328-329.  Abstract ( 271 )   PDF (393KB) ( 233 )   Objective To probe into irritation of rabbit skin induced by Huangzhu Xiaozhong Lotion so that evidence could be provided for clinical application of Huangzhu Xiaozhong Lotion. Methods Acute skin irritation,scraped skin irritation and dermal sensitivity test were performed on the healthy rabbits in order to observe the irritation on complete and scraped skin of rabbit. Results Huangzhu Xiaozhong Lotion showed no irritation to complete and scraped skin of rabbit. Conclusion Huangzhu Xiaozhong Lotion demonstrated no skin toxic reaction to rabbit and could be widely used in clinic. References | Related Articles | Metrics

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Long-term Toxicity of Brucea Jananica Oil Injection in Rats MA Hai-ping ,DAI Xue-dong ,DAI Xiao-li ,MA Yu-kui 2013, 10(6): 330-333.  Abstract ( 288 )   PDF (523KB) ( 207 )   Objective To observe the long-term toxicity of the Brucea Jananica Oil Injection by repeated intravenous injection. Methods Daily doses of Brucea Jananica Oil Injection(content of acid by means of olegic acid) at 1000 mg ·kg-1·d-1, 330mg·kg-1·d-1 and 100mg·kg-1·d-1 for 26 week were used for high, mid and low dose group, respectively. Examinations including haematological indexes, biochemical indexes and histopathology were performed on the 13th week, on the 26th week during the administration, and on the 6th week after the withdrawal, respectively. Results The rats in high dose group appeared diarrhea, depressed and the fur lacked luster during the administration. Three animals died and appeared face lying, breathlessness, blood excretion at the angulus oris in extremis. The mortality was 7.5% in high dose group. The high and mid doses inhibited the animals'body weight growth. The levels of ALT, AST, BUN and CR in blood serum in high dose group were significantly higher than those in control group on the 26th weeks after administration(P<0.05 ). Those changed indexes of hematology and blood biochemistery regained normal on the 6th weeks after withdrawal. The lung of dead rats in high dose group appeared pathological changes, micrangium in alveolar wall displayed distension and congestion, and there was considerable erythroic fluid in alveolar space.Conclusion Repeated administration of the Brucea Jananica Oil Injection at high dose could lead to damage to liver and kidney function and acute pulmonary edema. The no observed adversed effect level (NOAEL) of the Brucea Jananica Oil Injection on rats was 100mg·kg-1·d-1. References | Related Articles | Metrics

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Di scussion on the Relationship between National Essential Medicine System and Adverse Drug Reaction Monitoring LIU Cui-li ,HOU Yong-fang ,SONG Qiu-jie, TIAN Chun-hua 2013, 10(6): 334-336.  Abstract ( 241 )   PDF (553KB) ( 143 )   Abastract: The formally releasing of 2012 edition of National Essential Medicine List indicates that the work of Chinese national system for essential medicines into the stable development of the new period. In the implementation of essential medicine system process, adverse drug reaction(ADR) monitoring is a routine measure to ensure the smooth implementation of essential medicine system, at the same time, the essential medicine system also promotes the development of ADR monitoring work. Through introducing the relationship between the essential medicine system and the ADR monitoring in China, the relationship between them is mutual influence and promotion in the process of development. References | Related Articles | Metrics

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Dialectically Viewing the Status of Adverse Drug Reaction Monitoring and Evaluation in China LI Wen-wu 2013, 10(6): 337-340.  Abstract ( 303 )   PDF (762KB) ( 290 )   Objective To explore the status of ADR monitoring and evaluation in China, which could provide references for holding the future trend of this work scientifically. Methods The internal relation of the factors between the achievements and problems, agencies and teams, the quantity and quality of the report, the hospital reporting and the enterprise reporting, monitoring and reevaluation, sentinel surveillance and wide coverage, and all that were analyzed by using the method of dialectical analysis, which were hackled by affirming the achievements and identifying problems. Results and Conclusion It is essential to clarify the vague understanding, to clear direction, and to enhance the sense of pride, responsibility and professional self-identity for ADR monitoring. References | Related Articles | Metrics

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Thoughts on National Medical Device Evaluation Information System Construction LAN Weng-chi, XU Wei 2013, 10(6): 341-343.  Abstract ( 256 )   PDF (606KB) ( 259 )   The Medical Device Evaluation Information System refers to an application operating system which uses information technology to embed the legal procedures and process for the review of medical devices intoa computer network system, by which the review process is conducted. With the upcoming release of the new Medical Device Supervision and Administration Ordinance and its related regulations and regulatory documents, the national Medical Device Evaluation Information System will be upgraded in accordance with the new procedures and requirements. Based on such background, in this article we investigated the status of the current national Medical Device Evaluation Information System, and put forward opinions and suggestions for the next step in the construction of the information system, hoping that the amendments to the regulations bring an opportunity to further improve the evaluation information system construction and thus speed up the informationization process of the medical device evaluation in China. References | Related Articles | Metrics

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A Study o f Drug Safety Monitoring Awareness Assessment Index System for Drug-producing Enterprises Staff Based on Delphi Method GAO Jing ,TIAN Ke-ren ,YU Chao, ZHOU Juan, XU Jin ,WAN Kai-hua, LI Sui 2013, 10(6): 344-347.  Abstract ( 286 )   PDF (565KB) ( 322 )   Objective To establish an unified, standardized, and feasible drug safety monitoring awareness assessment index system for drug-producing enterprises staff. Methods On the basis of literature search, government documents review and expert interviews, we constructed the framework of drug safety monitoring awareness assessment for drug -producing enterprises. Then,a modified Delphi method was used to analyze, screen and determine indicators in the framework. Results The authoritative coefficient, determination coefficient and familiarity coefficient was 0.81, 0.75 and 0.86, respectively.于The indicator system consisted of 5 first-dimensions, 18 second-dimensions and 19 third -dimensions.The Kendall coordination coefficients of experts for two times consulting were 0.383 and 0.467, respectively, which had statisticcal significance. Conclusion The drug safety monitoring awareness assessment index system for drug-producing enterprises has higher scientificity and reliability, which can provide the scientific evidences for an assessment of the situation about drug safety monitoring among drug-producing enterprises. References | Related Articles | Metrics

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The History and Expectation of Classification Management of Drugs in China LIU Chun-guang, JIN Feng ,YUAN Guo-hui 2013, 10(6): 348-351.  Abstract ( 416 )   PDF (760KB) ( 241 )   The core of drug classification management is to strengthen the management of prescription drugs, standard management of the over-the-counter drug, reduce the irrational use of drugs, and ensure the safe and effective use of the people. This paper summarizes the history of classification management of drugs in China. It introduces the situation of categorized management of drugs on the implementation process in different stages, and analyzes the problem that exists at present. It looks forward to the future of drug classification management to provide reference for the system. References | Related Articles | Metrics

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The Therapeutic Method and Theoretical Evidence of Blood-activating and Stasis-removing Therapy of Intracerebral Hemorrhage ZHANG Gen-ming, ZHOU Li ,MA Bin, CUI Fang-yuan, CHEN Ying 2013, 10(6): 352-354.  Abstract ( 254 )   PDF (603KB) ( 320 )   Blood stasis is the basis of Traditional Chinese Medicine (TCM ) pathology for intracerebral hemorrhage. The main disease mechanism includes the following three aspects: the bleeding from brain vessels leads to the blockage of brain vessels, abnormal metabolism of body fluid distribution dues to the formation of phlegm and water, and the brain injuried by toxic evil produced from pathogenic factors. The common clinical symptoms consist of blood stasis pattern with endogenous liver wind, turbid phlegm blocking collaterals and heat-toxic stagnation. In terms of the characteristics of TCM pathogenesis and the evolution law of TCM syndromes, we have formulated the blood-activating and stasis-removing therapy in order to realize the clinical transformation of TCM research achievements for intracerebral hemorrhage. References | Related Articles | Metrics

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Research Development on the Protection of the Active Constituent of Ligusticum chuanxiong Hort againstIschemic Cerebrovascular Disease CHI Xue-jie, SUN Rong 2013, 10(6): 355-357.  Abstract ( 309 )   PDF (734KB) ( 318 )   Objective By summarizing the research development on the protection of the active constituent of Ligusticum chuanxiong Hort against ischemic cerebrovascular disease and its molecule mechanism, to provide evidence and research ideas for the further study. Methods The pertinent literatures at home in recent 15 years were analyzed, collated and summarized. Results Its main active component Tetram ethylpyrazine(TMP) could stretch blood vessel, restrain the aggregation of platelet, prevent thrombopoiesis, improve brain ischemia. The phenols Fumalic acid(FA) can also restrain the aggregation of platelet and clear oxygen radicals. Its essential oil has a protective effect against ischemic brain injuries. Conclusion TMP and FA can be against ischemic cerebrovascular disease, their mechanisms of pharmacologic actions are clear. Its essential oil also has a protective effect against ischemic brain injuries. The present study is only limited to single components and essential oil. Because Traditional Chinese Medicine are multicomponent and have complex effects, the subsequent research should be combined with the pharmacodynamics and mechanisms study of Ligusticum chuanxiong Hort active ingredients, active ingredients group, effective sites, effective sites group, to provide theoretical basis for clarifying the anti-ischemic cerebrovascular disease mechanism of Ligusticum chuanxiong Hort in order to guide the clinical use of drugs and innovative drug development advisablely. References | Related Articles | Metrics

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Application of Risk Matrix in Post-marketing Drug Risk Assessment:A Case Study of Terfenadine LI Li-hua ,CHEN Yong-fa 2013, 10(6): 358-361.  Abstract ( 274 )   PDF (632KB) ( 136 )   Objective To discuss how to use risk matrix in post-marketing drug risk assessment. Methods A detailed explanation of how to use the method is introduced in the text by taking terfenadine as an example. Results The Results obtained by the method are consistent with the facts.Conclusion Risk matrix is a practical method for drug risk assessment. References | Related Articles | Metrics

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Hepatic Lesion Risk Analysis of Yangxueshengfa Capsule YANG Le ,GUO Xiao-xin ,SONG Hai-bo 2013, 10(6): 362-365.  Abstract ( 250 )   PDF (607KB) ( 469 )   By reviewing the relevant references and reports of the adverse drug reaction cases of Yangxueshengfa capsule in China, the post-marketing safety and risks(hepatic lesion) in post-marketing period of Yangxueshengfa capsule were reevaluated in this article. Risk management measures according to the characteristics of medicine were put forward. Suggestions were proposed for a safe and rational use of this medicine. References | Related Articles | Metrics

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Analysis of Adverse Events and Related Factors of Implantable Cardiac Pacemaker YU Wen-wen, ZHAO Yan ,QING Shan 2013, 10(6): 366-368.  Abstract ( 303 )   PDF (707KB) ( 540 )   Objective To explore the risk point of implantable cardiac pacemaker and offer the risk control measures respectively. Methods With retrospective case study, adverse events of implantable cardiac pacemaker were collected from the domestic literature and analyzed retrospectively. According to the reason of adverse events, the events caused by the operation or quality of the instrument itself were excluded. Results A total of 258 cases of adverse events were collected. The common complications were electrode dislocation, pacemaker syndrome, capsular infection and capsular rupture. Conclusion The control measures should be taken to decrease the risk of adverse events of implantable cardiac pacemaker. More attention should be paid on pre -operative prevention, operative manipulation and postoperative guidance. Early finding, diagnosis and therapy were effective Methods for preventing adverse events to raise the safety for clinical use. References | Related Articles | Metrics

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Analysis of 94 Cases of Drug-induced Liver Injury WANG Ji -mei, ZHANG Cui -fang ,ZHAO Shou -mei 2013, 10(6): 369-372.  Abstract ( 288 )   PDF (674KB) ( 155 )   Objective To analyze clinical features and causative agents of drug-induced liver injury and provide reference for clinical use accordingly. Methods Ninety -four cases of drug -induced liver injury from clinical reports in our hospital from Jan 2010 to Dec 2012 were collected and analyzed retrospectively. Results The average age was 49.82±16.32 years old(from 2 to 86y) in the 94 patients including male 56 and female 36 cases. In their previous histories, there were drug allergies in 24 cases(25.53%) and liver diseases in 8 cases(8.51%). Fifty-five kinds of drugs were involved in the 94 drug-induced liver injury cases in which lipid-lowering drugs ranked first(31.92%), antibiotics ranked second (20.21%) and antipyretic analgesics and nervous system drugs ranked third(9.57%). The clinical types of drug-induced liver injury in these cases included liver cell type in 61 cases(64.89%), cholestasis type in 19 cases(21.27%) and mixed type in 14 cases(14.89%). More common in varying degrees of clinical manifestations were fatigue, anorexia, nausea, vomiting and other gastrointestinal reactions. The latent period was1～4 weeks. Conclusion The types of drug-induced liver injury drugs are diversed. During the course of medication, regularly checking liver function and discontinuing medication are the main measures to reduce drug-induced liver injury. References | Related Articles | Metrics

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Pharmaceutical Care for a Patient with Allergic Rhinitis and Cold by Clinical Pharmacists YU Hui-bin ,WANG Kui ,XIONG Hui 2013, 10(6): 373-374.  Abstract ( 283 )   PDF (728KB) ( 161 )   Objective To discuss the approaches for clinical pharmacists to carry out pharmaceutical care. Methods Combining the disease characteristics of the patient and medication history, clinical pharmacist provided the patient with individualized pharmaceutical care. Results The treatment-related problems in time were identified and resolved by clinical pharmacists, and the pharmacotherapy was effective and rational. Conclusion Clinical pharmacists can provide pharmaceutical services to ensure the safety and effectiveness of drug use. References | Related Articles | Metrics

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Pharmaceutical Care for a Patient with BRIC Type2 QIN Li ,WU Rong-rong ,LIU Miao, LIU Feng-qun ,CAO Ming-xue ,HAN Jin 2013, 10(6): 375-377.  Abstract ( 263 )   PDF (686KB) ( 150 )   Objective To introduce the experience of the diagnosis and treatment ofa patient with BRIC2 type involved in our hospital, and provide reference and guidance for better clinical pharmaceutical service to that kind of patients. Methods Analyzed and summarized by the content of pharmaceutical care in the patient's service to solve the practical problems encountered in the clinical. Results To discuss treatment options with the clinician, the patient discharged with symptoms comprehensive mitigation. Conclusion Pharmacists and physicians, according to their respective professional advantage, can further optimize the treatment regimens and enhance clinical drug safety, effectiveness and economy effectively. References | Related Articles | Metrics

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Experience of ADR Reporting by Clinical Pharmacist CHEN Qing 2013, 10(6): 378-379.  Abstract ( 277 )   PDF (783KB) ( 240 )   This paper introduces the experience that quantity and quality of ADR reports were improved obviously after clinical pharmacists' publicizing and reporting ADR actively. It advises that clinical pharmacists undertake the ADR reporting initiatively and give full play to their professional advantages, and establisha pharmacist-led hospital pharmacovigilance system. References | Related Articles | Metrics