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10 November 2011, Volume 8 Issue 11 Previous Issue    Next Issue

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Study of Acute and Long-term Toxicity of Chansha Capsules LIU Hai-xia, ZHAO Jian, XU Ling-chuan, LI Zi-fa 2011, 8(11): 641-644.  Abstract ( 204 )   PDF (294KB) ( 136 )   Objective To observe acute toxicity in mice and long-term toxicity in rat of Chansha Capsules. Methods Given the extract of Chansha Capsules 10.8g/kg to the rats for 14 days, and calculated the maximum administration dosage. In the long-term toxicity test, rats were continuously fed with Chansha capsule at 19.98g/kg,9,99g/kg and 2.00g/kg a day for 180 days, and 30 days of stopping treatment, observe the male and female rats weight and appetite and feces, general clinical signs, the indication of hematology and blood biochemical analysis, organs coefficient, and the major organs and tissues observed the pathology. Results The maximum administration dosage of Chansha Capsules by ig administration was 45.8g/L in mice(equal to 92.3 times of clinical dose). In the chronic toxicity tests, blood biochemical analysis, organs weight absolute value and coefficient of organs in high-dose group exist significant differences, meanwhile, the indication of hematology significantly differ in both medium and high dose groups. The changes of weight, food intake, activities, the indication of hematology and blood biochemical analysis, organs coefficient and histopathology could completely recover in 30 days after stopping the drug. Conclusion Chansha Capsules administration by long-period might slightly injure the renal and liver function of rats, but the injury was reversible. It is safe to administer the prescribed dose of Chansha Capsules. References | Related Articles | Metrics

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Experimental Study on the Pathology of Hepatotoxicity Induced by Saikosaponins in Rats LI Xiao-yu, SUN Rong, LV Li-li, HUANG Wei, QIAN Xiao lu, LI Su-jun, LU Yong-hui, ZHAI Li-ping 2011, 8(11): 645-647.  Abstract ( 245 )   PDF (424KB) ( 248 )   Objective The hepatotoxicity induced was studied after given multiple administration of Saikosaponins to mice. Methods The rats were divided into different groups of high, medium and low dose. besides the normal conditions were observed, the heart、 liver、 spleen、 lung、 kidney weigh and volume ratio were calculated, the changes of liver morphology was observed after administration. Results The liver weight and volume ratio was increased, while the rat's weight were decreased. Pathological examination showed different degree of liver pathology tissue damage, and the damage of liver in rats show an obvious dosage relationship. Conclusion the damage of liver show a relationship with the dose of Bupleurum chinense. Saikosaponins is the toxicity site, and this show a organic disease of liver after given Saikosaponins 15 days, the damage and necrosis were the main pathological changes. References | Related Articles | Metrics

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Clinical Observision of Intrapericardial Drug through Intraducing the Intrapericardial Indwelling Tube in Patients with Malignant Pericardial Effusion RUAN Xin-jian, LIU Chang 2011, 8(11): 648-650.  Abstract ( 239 )   PDF (331KB) ( 191 )   Objective To evaluate the clinical efficacy and side effects of intrapericardial drug in the patients with malignant pericardial effusion. Methods 46 patients with malignant pericardial effusion were treated by intraducing the intra pericardial indwelling tube and drawing out the pericardial effusion and then washing the pericardial cavity with 100ml physiological saline and instillation of 20mL physiological saline, cisplatine 40mg, interleukin-2 200 MIU and dexamethasone 5mg. The tube was removed when the pericardial fluid was less than 30mL and proved by type B ultrasonic. Hydration and antiemesis should be processed during treatment. Results 15 patients achieeved complete response, 24 achieved partial response,6 patients achieved no change and 1 patients achived progressive disease. The overal response rate was 84.78 percent. The KPS score elevated 10 to 40.The main side effects were I-II grade gastrointestinal reaction, bone marrow depression and fever. No patient died of intraducing the intra pericardial indwellingtube. Conclusion Intrapericardial drug through intraducing indwelling tube maybe a safe, effective and convenient way to control the malignant pericardial sffusion. References | Related Articles | Metrics

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The Discussion and Practice of Quality Control for Medical Device Adverse Event Reports TIAN Yue-jie, LI Pan-hai, XIE Yan-jun, HUANG Lin 2011, 8(11): 651-654.  Abstract ( 183 )   PDF (456KB) ( 349 )   The safety evaluation of post-marketing medical devices based on high-quality medical device adverse event(MDAE) reports. Establishment of scientific and standardized control mechanism is an effective guarantee for the quality of reports. Through the practices at the level of macro-management and micro-control, we discussed the mode of MDAE reports quality control to provide references for the improvement of MDAE reports quality. References | Related Articles | Metrics

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Comparative and Analytic Research on Processing Procedures of Prepared Slices of Chinese Crude Drugs of Different Provinces in China YU Jiang-yong, HUANG Qin-wei, LI Heng, HUANG Xiao-jing, FAN Bao-juan, CHEN Hao 2011, 8(11): 655-657.  Abstract ( 361 )   PDF (608KB) ( 728 )   Recently, with the compilation and revision of processing procedures of prepared slices of Chinese crude drugs of different provinces ,compilation experience of processing procedures was enriched gradually. The article can provides suggestions and reference for future compilation work on "National processing procedures of prepared slices of Chinese crude drugs" by comparative analysis and summary on processing procedures of prepared slices of Chinese crude drugs of different provinces. References | Related Articles | Metrics

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The Study on Classification of Medical Device Adverse Events Based on Epidemiological Model of Injure WEN Qiang, TANG Xiao-hong, LIU Xiao-lan, ZHU Shu-bing, XIONG Xue-cai 2011, 8(11): 658-661.  Abstract ( 194 )   PDF (443KB) ( 196 )   Nowadays, medical device adverse events(MDAE) monitoring has become the more important research direction of the post-marketing medical device risk management. The study, based on the epidemiological model of injure, analysed 4 sorts of the mechanism-related factors of MDAE and then raised the viewpoint on the classification of MDAE. References | Related Articles | Metrics

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The Necessity of Implementing Adverse Drug Reaction Monitoring and Risk Management in Accordance with the Regulations for Pharmaceutical Manufacturers LI Wen-wu 2011, 8(11): 662-663.  Abstract ( 220 )   PDF (622KB) ( 331 )   Objective To inspire pharmaceutical manufacturers to actively monitor adverse drug reaction(ADR), and to raise their awareness of risk management. Methods By analyzing the current Decree of Management of Adverse Drug Reaction Report and Monitor and the new requirements of current work, including national system of Essential Medicines, safety reevaluation of traditional Chinese medicine injections, vaccine monitoring program, etc., as well as stating the importance of ADR monitoring and risk management, to clearly illustrate the legal obligation, duty and task of the manufacturers. Results and Condusion It is important to accelerate the manufacturers upgrading ADR monitoring and risk management levels to ensure drug safety for human beings and enterprises development sustainability. References | Related Articles | Metrics

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The Primary Discuss on Risk Management of Infant Incubator ZHAO Yan, ZHENG Li-jia, DONG Fang 2011, 8(11): 664-666.  Abstract ( 188 )   PDF (524KB) ( 256 )   By introducing the working principle and announcements for safety use of infant incubator, to discuss the frequent adverse event and risk management of infant incubator. References | Related Articles | Metrics

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Reviewing of Tramadol for International Control Based on Drug Surveillance PANG Li-Yan, MA Jun-Li, ZHOU Li-Xin, Zhang Li-Ming 2011, 8(11): 667-669.  Abstract ( 189 )   PDF (558KB) ( 345 )   Objective To analyze WHO Expert Committee's report on reviewing of tramadol for International Control, find out drug surveillance's data is a key factor which determines whether or not to recommend international control of substances. Methods US FDA and WHO website were retrieved and review data sheet of tramadol conducted by WHO Expert Committee are researched. Results During 1992 and 2006, tramadol had been submitted to the Expert Committee four times to determine whether or not to recommend under international control. According to the data subjected by countries, Committee considered that, even after a recent major increase in the extent of its use because of its therapeutic usefulness, tramadol continues to show a low level of abuse. Hence, the Committee concluded that there was not sufficient evidence to recommend international control of tramadol. Conclusion Surveillance of post-marketing psychoactive substances plays role in placing the substances under control. References | Related Articles | Metrics

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Analysis of Errors in Pharmacy Intravenous Admixture Service of Our Hospital and Preventive Measures DENG Xue-e 2011, 8(11): 670-671.  Abstract ( 182 )   PDF (536KB) ( 279 )   The article collected various errors in PIVAS of Beijing Friendship Hospital from January 2011 to June 2011, and analyzed the occurrence of the errors according to drug package inserts, Chinese Pharmacopoeia, Clinical Medication Information, Pharmaceutical incompatibility in intravenous infusion and clinical drug consulting system. The external ratio of errors in PIVAS was 0.105‰, and the internal ratio of errors was 1.44‰. The errors occurred mainly were errors of making up prescriptions, dispensing errors and errors of checking finished products. Meanwhile, PIVAS adopted the targeted preventive measures according to the reasons and to cut down the mistakes in order to guarantee safe drug of patients. References | Related Articles | Metrics

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Literation Research on the Incompatibility of Ambroxol Hydrochloride Injection JIANG La-Mei, TIAN Yue-jie 2011, 8(11): 672-674.  Abstract ( 245 )   PDF (543KB) ( 310 )   Objective To research the incompatibility of :Ambroxol Hydrochloride Injection in clinical treatments for guiding clinical rational drug use. Methods To retrieve the incompatibility of: Ambroxol Hydrochloride Injection reported in domestic journals of medicine from 2005 to 2011, to analyze and summarize by drug systematics. Results There are incompatibilities between Ambroxol Hydrochloride Injection and many kinds of drugs, especially for some respiration medication. Conclusion we should be care of the incompatibility in the usage of Ambroxol Hydrochloride Injection to avoid adverse clinical event occurred. References | Related Articles | Metrics

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Progression of Material Basis Related to Angina Pectoris of Ligusticum chuanxiong Based on Efficacy and Pharmacology GONG Yan-sheng, LI Xiao-yu, SUN Rong 2011, 8(11): 675-677.  Abstract ( 225 )   PDF (601KB) ( 307 )   Objective To summarizing the current states of material basis of Ligusticum chuanxiong, identify effective composition and its molecular mechanisms in Ligusticum chuanxiong related with angina pectoris, offer the accordance and research ideas for further research of Ligusticum chuanxiong. Methods The related references in recent 20 years about Ligusticum chuanxiong were analyzed, collated and summarized. Results The main compositions in Ligusticum chuanxiong related with angina pectoris are ligustilide, chuanxiongzine and ferulic acid. Research is almost on their pharmacological characteristics, but on molecular mechanisms is not deep enough. Conclusion Ligusticum chuanxiong has obvious therapeutic effect on angina pectoris. The effective composition and its molecular mechanisms related to angina pectoris are still at an initial stage. References | Related Articles | Metrics

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Research Summary on Neurotoxicity of Traditional Chinese Medicine XU Xin-hua, LI Wei-rong, MI Sui-qing, WANG Ning-sheng* 2011, 8(11): 678-680.  Abstract ( 243 )   PDF (626KB) ( 249 )   In recent years, the reports about adverse reactions of Traditional Chinese Medicine(TCM) increased day by day. The research of it has also become an important part of TCM study in modern times. The influence of TCM on nervous system is especially striking. Understanding the regularity and characteristics of adverse reactions on nervous system of TCM will help us improve the safety of clinical use, ensure the accuracy of drug use and master the rationality of drug compatibility. References | Related Articles | Metrics

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Domestic Literature Analysis on adverse Drug Reactions Induced by Propofol Injection GONG Shan-chu, LI Dong, XU Yu-hong, YANG Xi-ling, LI Shan-hua 2011, 8(11): 681-684.  Abstract ( 286 )   PDF (705KB) ( 498 )   Objective To find out the clinical features of adverse drug reactions(ADRs) induced by propofol injection and provide reference for its clinically safe application. Medhods The Chinese electronic databases of the Chinese National Knowledge Infrastructure and Wangfang data during 1994-2010 were searched with composite terms of propofol and adverse drug reaction or allergy, etc. All literatures associated with adverse drug reaction of propofol injection were reviewed and screened. Propofol injection-induced ADR cases were analyzed statistically in respects of demographic distribution, types of disease and allergic history, organs and systems involved in ADR, clinical manifestations and ADR outcomes, etc. Results Thirty-two of Available literatures were retrieved and total 37 adverse drug reaction cases were collected. Of all screened cases, the incidence in female patients was 2.4 times higher than that in male patients, 70.27% of those was occurred in the population of ages15-44. The lesions of adverse drug reaction involved primarily in circulation system and respiratory system, the corresponding constitutive ratio were 26.88% and 26.34%, respectively. The allergic shock happened to 16 patients(43.24%) with one death. 23(62.16%) of adverse drug reactions occurred within 30 min and the fastest adverse drug reaction case occurred about 5 seconds after injection.Conclusion The clinical manifestations of propofol induced-ADRs are complicated and diversified. The frequency of allergic shock induced by propofol injection is high and severe cases can lead to death. Clinical physicians should pay more attention to the patient and ensure patient safety after propofol injection is administered. References | Related Articles | Metrics

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Analysis on Adverse Drug Reactions of Fluoxetine DONG Wen-tao, XU Zuo-guo 2011, 8(11): 685-686.  Abstract ( 208 )   PDF (596KB) ( 670 )   Objective The purpose of this study was to explore the adverse drug reaction seldomly of fluoxetine. Methods Analysis the adverse drug reactionS of Fluoxetine that come from six kinds journal of Psychiatry and collecting case by authors in near ten years. Results It was found that the side-effect of fluxeline related to eight system and eighteen kinds of diseases. The new side-effect was found. The extramidol nervous system, epilepsy and mental disorder was more common. About percent eighty adverse drug reactions was happened in fifteen days. Conclusion The adverse drug reactions of fluoxetine were more then another and it must be careful in treating. References | Related Articles | Metrics

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The Analysis and Evaluation of 262 Cases of Adverse Drug Reactions in Children DONG Yi-zhen, ZHANG Sheng-an, LIU Xin-ning, HU Xiao-hong, ZHANG Wei 2011, 8(11): 687-689.  Abstract ( 246 )   PDF (714KB) ( 221 )   Objective To realize the incidence and damage of the adverse drug reactions(ADRs) in children and promote rational use of drugs in pediatric clinical practice. Methods We collected 262 cases of ADRs in our hospital from 2006 to 2010, and retrospectively analyzed and evaluated them. Results In the 262 cases, most of the ADRs occurred in the infants from 1 months to 3 years, accounting for 58.77%(154 cases)of the total number. Introvenous injection was with the highest incidence of ADRs, 97.3%(255 cases) of the total number. Among the used drugs, antibiotics had the highest incidence of ADRs, 55.34%(145 cases) of the total number. Most of the clinical symptoms were allergic reactions, skin and accessories injury. Conclusion ADRs can easily happen in infants. Antibiotics or intravenous injection is prone to causing ADRs. We should further strengthen the monitoring of ADRs in children so as to reduce or avoid the occurence of it. References | Related Articles | Metrics

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Analysis of 73 Adverse Drug Reaction/Event Reports on Liver Damage Induced by Anticancer Drugs GAN Ge, GU Cheng-jie 2011, 8(11): 690-693.  Abstract ( 187 )   PDF (664KB) ( 454 )   Objective To investigate the epidemiological characteristics of liver damage induced by anticancer drugs. Methods With retrospective case study, analyzed 73 liver damage ADR/ADE reports induced by anticancer drugs in Jiangsu province from 2004 to June 2010. Results 73 ADR/ADE reports included 44 anticancer drugs, and the incidences of liver damage by Cisplatin、Gemcitabine and Vidarabine occupied the front 3 places in sequence. The drugs for intravenous administration resulted in the highest rate(86.3%), and most of the patients have ADR/ADE in 1~2 weeks. The clinical manifestations were jaundice, fatigue, fever, abdominal distension, abdominal pain, dark urine, nausea, edema, chest tightness, rash, itching, anorexia. Liver function examination showed that alanine amino transferase was in 48~2 610 U/L, and total bilirubin was in 6.7~260.1μmol/L in average. Conclusion It should be strengthening the observation and evaluation of liver damage induced by anticancer drugs. References | Related Articles | Metrics

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Analysis of Water-sodium Retention Adverse Reactions of Infant Induced by Licorzinc JIANG Peng-yu, ZHANG Jun-li, ZHANG Ke-min, YU Hong-yun, JIN Chun-hua 2011, 8(11): 694-695.  Abstract ( 206 )   PDF (621KB) ( 383 )   Objective To investigate the mechanism and the prognosis after water-sodium retention adverse reactions of infant induced by Licorzinc. Methods Combination of literature review and retrospective analysis 8 infant cases in our hospital induced water-sodium retention adverse reactions by Licorzinc. Results and conclusion Licorzinc induced infant water-sodium retention adverse reactions is due to direct or indirect aldosterone sample function, after withdrawal symptoms may itself disappear, Licorzinc not as infant the first-line use zinc patching. References | Related Articles | Metrics

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Analysis of 93 Cases of Severe Adverse Drug Reactions Caused by Moxifloxacin ZHOU Bing, ZHANG Jun, ZHANG Li-ming 2011, 8(11): 696-697.  Abstract ( 231 )   PDF (703KB) ( 396 )   Objective To probe into the general pattern and characteristics of severs ADRs indused by moxifloxacin so as to procide references for clinic retional use of moxifloxacin. Methods A total of 93 cases indused by moxifloxacin received from 2004 to 2009 in Beijing were analyzed statistically. Results The clinical use of moxifloxacin most can defer to the drugs instruction, the minority exists the irreasonabl phenomenon. Conclusion The use of moxifloxacin should strictly accord to the drugs instruction, enhance medication monitoring process, reduce the injury which the drugs bring. References | Related Articles | Metrics