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08 August 2015, Volume 12 Issue 8 Previous Issue    Next Issue

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Evaluation on the "Efficacy-toxicity" Correlation of Radix Aconiti Lateralis Praeparata on Spleen-kidney Yang Deficiency Rat with Heart Failure LI Xiao-yu, LUAN Yong-fu, SUN Rong 2015, 12(8): 449-453.  Abstract ( 370 )   PDF (558KB) ( 225 )   Objective The efficacy and heart toxicity of Aconite's water decoction on spleen-kidney yang deficiency rat with heart failure were studied to explore "efficacy-toxicity" relationship of Aconite on animal models combined disease and syndrome. Methods Chronic heart failure rat model was established with isoprenaline by subcutaneous injection and spleen-kidney yang deficiency rat model was established with rhubarb powder suspension. Rat models were established and Aconite's water decoction was administered simultaneously for 9 consecutive days. Electrocardiogram (ECG) and hemodynamics of rats were measured. Heart, left ventricular, brain, liver, spleen and kidney were weighed and indexes of them were calculated. The activities of N-terminal pro-brain natriuretic peptide (NT-pro BNP), high sensitivity C reactive protein (hs-CRP), aspartate transaminase (AST), lactate dehydrogenase (LDH) and cardiac troponin I (cTn-I) were detected. Results The heart rate of rats dropped, the amplitude of T enlarged and QRS extended after the administration of Aconite's water decoction in the dosage range of 1.35~5.40 g·kg-1. Left ventricular pressure (LVSP) and left ventricular pressure development during isovolumetric contraction/relaxation(±dp/dtmax) elevated and the levels of serum NT-pro BNP and hs-CRP reduced. Heart index and left ventricular index increased. Conclusion Aconite's water decoction in the dosage range of 1.35~5.40 g·kg-1 has certain efficacy on spleen-kidney yang deficiency rat with heart failure, showing that the evaluation on the "efficacy-toxicity" correlation of Radix Aconiti Lateralis has important significance to ensure the safety of clinical cardiac function. References | Related Articles | Metrics

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Study on Protective Effect of Chinese Herb Serum on RGCs Purified Cultured under the Condition of Hypoxia in Vitro LI Ying, DI Hong-lian 2015, 12(8): 454-457.  Abstract ( 318 )   PDF (506KB) ( 132 )   Objective To explore the protective effect and mechanism of Bushenhuoxue(invigorating the kidney and promoting blood circulation) TCM serum on retinal ganglion cells (RGCs) purified cultured under the condition of hypoxia in vitro. Methods 30 neonatal rats 1d after birth were selected. Through the two step screening system, the RGCs of SD neonatal rats were purified cultured. 6 SD rats 7d after birth were selected and through improved enzymatic digestion technique, retinal Muller cells of neonatal SD rats were purified cultured. Then, according to the ratio of 1:25, RGCs were inoculated in the medium coated by retinal Muller cells to establish a common culture model. Glucose (50 mmol·L-1) and sodium dithionite (1.0 mmol·L-1) (high glucose hypoxia group), only glucose (50 mmol·L-1) (high glucose group) and sodium dithionite (1.0 mmol·L-1) (hypoxia group) were respectively added into the medium in vitro. Based on this, formulated Bushenhuoxue TCM serum of 20% volume fraction was respectively added for intervention. And the leakage of lactate dehydrogenase (LDH) and activity of glutamine synthetase (GS) in extracellular fluid of the model were respectively determined in 24 h, 48 h and 72 h. Results In 48 h, 72 h, the leakages of LDH in the normal control group, high glucose group and hypoxia group significantly increased, compared with that in 24 h (P <0.05). Comparing normal control group, high glucose group, hypoxia group and high glucose hypoxia group with their respectively corresponding TCM intervention in the same time, it could be found that the leakages of LDH were significantly higher than those TCM intervention groups (P <0.05). When it was 48 h and 72 h, the activity of GS in normal control group, high glucose group, hypoxia group, high glucose hypoxia group and their corresponding TCM intervention group increased significantly, compared with that in 24 h (P <0.05). With extension of time, the activity of GS in normal control group, high glucose group, hypoxia group, high glucose hypoxia group was significantly lower than that of the TCM intervention group. Conclusion High glucose or anoxic conditions can cause deviation of cell membrane stability of RGCs and retinal Muller cells and increase of permeability. Bushenhuoxue TCM can improve the stability of the cell membrane and increase GS activity, so as to protect the RGCs cells. References | Related Articles | Metrics

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Special Safety Evaluation on Ibuprofen Injection CAO Chong, GAO Mei, YANG Lin-ke, ZHANG Ting-ting 2015, 12(8): 458-461.  Abstract ( 588 )   PDF (522KB) ( 969 )   Objective To evaluate safety of ibuprofen for injection based on the special safety experiments of ibuprofen injection, Methods Three experiments were used, including hemolysis and blood cell agglutination test in vitro and stimulation test in blood vessel, allergic test induced by ibuprofen injection in guinea pigs, to observe whether ibuprofen injection could induce hypersensitive response, vascular stimulation response, hemolytic reaction and agglutination or not. Results Ibuprofen injection caused no hemolysis and blood cell agglutination when its concentration was 4 mg·mL-1, neither vascular stimulation in rabbits nor allergic reaction in guinea pigs were observed when its concentrations were 4 mg·mL-1 and 25 mg·mL-1 respectively. Conclusion Ibuprofen injection is safe for intravenous injection. References | Related Articles | Metrics

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Study on Acute Toxicity of Arctigenin Injection in SD Rats LIU Song-jiang, LIU Song-yan 2015, 12(8): 462-463.  Abstract ( 381 )   PDF (455KB) ( 236 )   Objective To study the acute toxicity of arctigenin injection in rats by Up-and-Down Procedure(UDP). Methods The UDP test includes intravenous injection group and subcutaneous injection group, according to the AOT425 StatPgm administration. 40 healthy SD rats were divided into two groups, 20 each. Results LD50 of intravenous injection group is 8.9 mg·kg-1, the 95% confidence interval is 6.6~17.5 mg·kg-1. LD50 of subcutaneous injection group is 227.3 mg·kg-1, the 95% confidence interval is 166.3~348 mg·kg-1. Conclusion In this study, arctigenin intravenous injection has greater toxicity, subcutaneous injection is relatively safe. References | Related Articles | Metrics

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GC Determination of Fatty Acids in Polysorbate 80 for Injection REN Rui, LI Kun-li, ZHANG Lu, LI Ying, ZHANG Yuan-yuan 2015, 12(8): 464-466.  Abstract ( 384 )   PDF (578KB) ( 302 )   Objective To determine the contents of fatty acids in polysorbate 80 for injection by GC. Methods The GC system consisted of DB-WAX capillary column and the temperature was set at 250℃. The detector was FID using nitrogen as carrier gas. Results The fatty acid methyl esters (methyl myristate, methyl palmitate, methyl stearate, methyl oleate, methyl linoleate, methyl arachidate, methyl eicosenoate, methyl behenate) were separated with a good linearity in the sample size ranges. The average recoveries were 96.5%~104.2%. Conclusion This method is simple, feasible and reproducible. It can be used for the quality control of polysorbate 80 for injection. References | Related Articles | Metrics

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Sampling Results and Quality Assessment of Dieda Pills in 2012 LI Li, CHENG Chen, XIE Wen-ming 2015, 12(8): 467-470.  Abstract ( 278 )   PDF (574KB) ( 149 )   Objective To evaluate the quality status and exsisting problems of Dieda pills. Methods Using statutory testing >Methods combined with the exploratory research to examine samples, the quality status of Dieda pills was evaluated by statistical analysis of the Results. Results In 34 batches of samples, the quality of all products can meet the current standards(100%) in terms of weight variation, disintegration time, water content, microbial limit and determination of content. Conclusion At present, the preparation quality is generally good, but exploratory research shows that current standards are defective. References | Related Articles | Metrics

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Improvement and Discussion of Review Model for New Drugs in America GAO Jing, YANG Yue 2015, 12(8): 471-475.  Abstract ( 352 )   PDF (812KB) ( 330 )   Objective To provide references for Chinese review model for new drugs. Methods Improved review model for NMENDAs and Original BLAs in PDUFAV was briefly introduced, assessed and analyzed. We explored the way of enhancing communication, review transparency and first-cycle approval rate and some revelations were put forward. Results The new review model adjusts PDUFA review timelimit and gives applicants and review teams enough time to improve and review applications respectively. Milestone meetings offer two-way communication opportunities for them. The third-party assessment shows that new review model promoted review process, improved review transparency and first-cycle approval rates and the review process is more predictable, especially for applications with special designations, such as Breakthrough Therapy and Fast Track. Conclusion When considering new drug review model, we should guarantee adequate review resources, control key review steps and enhance communication between applications and reviewers to improve the efficiency and effectiveness of first-cycle review. References | Related Articles | Metrics

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Current Status of Surveillance for Medical Product Defects in Taiwan Area of China CHEN Zhi-dong 2015, 12(8): 476-478.  Abstract ( 330 )   PDF (723KB) ( 330 )   Objective To introduce surveillance for medical product defects (MPD) in Taiwan area of China, and to offer references for drug safety surveillance in Mainland China. Methods Based on the related data with the author's learning experience in Taiwan area of China, MPD related issues such as the concept, risk categories, operating procedure, and surveillance Results were all introduced. Results The number of MPD reports continues to grow, the annual average number is more than 500 from 2004 to 2013 in Taiwan area of China, and the major defects of MPD are abnormal drug packaging and appearance. Conclusion Now MPD surveillance is an important part of drug safety surveillance, which plays more and more role in ensuring the safety of drug use as well as improving the quality of drug in Taiwan area of China. References | Related Articles | Metrics

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Discussion on Quality and Improvement of Medical Device Adverse Event Monitoring Reports ZHANG Xue-ning, WANG Ling, WANG Gang, LIN Xu-dong, DU Hong-yang 2015, 12(8): 479-482.  Abstract ( 553 )   PDF (697KB) ( 574 )   Objective To explore the impact of all aspects of medical device adverse event(MDAE) monitoring and evaluation on the quality of MDAE reports, so as to provide references for upgrading the reporting quality and further improving the MDAE monitoring and evaluation. Methods Based on real working practices in MDAE data normalization, the quality of MDAE reports was analyzed by studying the data from national MDAE monitoring information system. Compared with related researches home and abroad, the factors influencing the reporting quality were summarized. Results and Conclusion The reporting quality is the foundation of the MDAE monitoring and evaluation, It can be improved at source by innovating reporting method and monitoring mode. Meanwhile, strengthening the construction and improvement of related regulations and technical standards, implementing the review and evaluation effectively by monitoring technology institutions, establishing data sharing and risk communication mechanism within relevant institutions might be powerful approaches to upgrade the reporting quality. References | Related Articles | Metrics

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Research and Its Revelations on the EU Cosmetic Adverse Reaction Monitoring System SUN Bo, SHEN Lu, GENG Li, WANG Yan, ZHU Wen-ling, JIN Xin, HAN Xu, YAO Xiao-yuan 2015, 12(8): 483-486.  Abstract ( 414 )   PDF (667KB) ( 270 )   Objective To understand the content and characteristics of the EU cosmetic undesirable effect monitoring system and to provide reference for cosmetic adverse reaction monitoring work in china. Methods The background, progress and characteristics of the EU cosmetic undesirable effect monitoring system were studied, the differences and relations were also analyzed. Results and Conclusion The EU system offers clear definitions of cosmetic undesirable effect and detailed provision on communication and countermeasures of serious undesirable effect with an advanced causality assessment standard, the related information is kept confidential. All mentioned above are of certain reference value to cosmetic adverse reaction monitoring work in china. References | Related Articles | Metrics

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Analysis of 160 Cases of Adverse Drug Reaction Characteristics and Risk Factors of Osteomalacia Induced by Adefovir XU Li-li, TIAN Yue-jie, XIE Yan-jun, CUI Xiao-kang, ZHAI Shu-yue 2015, 12(8): 487-490.  Abstract ( 334 )   PDF (734KB) ( 213 )   Objective To probe into the general rules, characteristics and risk factors of the ADR induced by adefovir so as to provide references for clinical safe medication. Methods We retrospectively analyzed 160 ADR cases induced by adefovir which were collected by Shandong adverse drug reaction database, discussed the time distribution of the ADRs, and emphatically analyzed the ADRs of the skeletal muscle system lesions and hypophosphatemia. Results The ADRs induced by adefovir mainly involved in stomach intestinal system lesions and skin and local lesions. The serious ADRs by adefovir mainly involved in skeletal muscle system lesions and urinary system lesions, and usually appeared after a long-term administration. Stomach intestinal system lesions and skin and local lesions usually appeared within half a year, abnormal liver and renal function and hypophosphatemia usually appeared after half a year, skeletal muscle system lesions usually appeared after one year, osteomalacia usually appeared after four years. Conclusion The ADRs induced by adefovir were related to administration time, and would lead to nephrotoxicity, hypophosphatemic and osteomalacia after long-term administration of adefovir. The serious ADRs by adefovir were easy to appeare in the patients with liver cirrhosis or who were elderly. The regular monitoring of liver and renal function and serum phosphorus should be strengthened with correct diagnosis and timely treatment. References | Related Articles | Metrics

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Analysis of 208 Cases of Serious Adverse Drug Reactions Induced by Gugua Extracts Injection SHEN Xiao-hua, LUO Ling-feng, HUANG Yi-bin 2015, 12(8): 491-493.  Abstract ( 262 )   PDF (661KB) ( 235 )   Objective To explore the characters of the serious adverse reactions caused by Gugua extracts injection. Methods 208 reports of the serious adverse reactions caused by Gugua extracts injection were analyzed via retrospective study. Results Gugua extracts injection may lead to serious adverse reactions such as anaphylactic shock, anaphylactoid reaction,rigors,dyspnea,fever, etc. The serious adverse reactions occurred within 30 min, and anaphylactic shock occurred within 15 min. Conclusion It is necessary to re-evaluate the risk of serious adverse reactions caused by Gugua extracts injection and modify the drug instructions on this basis. References | Related Articles | Metrics

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Literature Analysis of 56 Cases of Adverse Reactions Induced by Montelukast XIA Hui-hong 2015, 12(8): 494-496.  Abstract ( 344 )   PDF (771KB) ( 157 )   Objective Through investigating the characteristics and mechanism of adverse reactions induced by montelukast, to find its risk factors and provide technical support for safe and rational use of drugs in clinic. Methods Using 'montelukast', 'adverse reaction'and 'caused by', as key words to search and retrieve articles in the CNKI and VIP database. Thirty-two references which met the inclusion and exclusion criteria were extracted and analyzed. Results Children and old patients appear to have higher ADR occurrence rate by using montelukast. Systems and Organs mainly involved in adverse reactions are nervous system, skin and its appendages, urinary system, gastrointestinal system, blood system, liver and skeletal system damage, etc. Conclusion It is important to pay attention to the adverse reactions caused by montelukast, as well as the clinical use beyond indications, specially to strengthen post-marketing surveillance in old patients and children, in order to prevent adverse drug reactions and ensure the safe drug use in clinic. References | Related Articles | Metrics

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Analysis of 100 Cases of Adverse Drug Reactions Induced by Alprostadil SHEN Ying, WU Po 2015, 12(8): 497-499.  Abstract ( 326 )   PDF (668KB) ( 318 )   Objective To provide references for clinical prevention and treatment by analyzing the clinical features and related factors of adverse drug reactions due to alprostadil. Methods The incidences of ADRs caused by alprostadil reported in the hospital from 2010 to 2014 were analyzed in terms of gender, age, primary disease, specification and dosage, the method of administration, clinical manifestation, relevance evaluation, treatment and prognosis. Results Totally, 100 cases of ADR caused by alprostadil were reported. In 100 patients, 56 cases were male, average age was (65.5+1.7) years old, while 44 cases was female, average age was (52.5 + 26.5) years old. Mainly primary disease were fracture (20 cases), nephropathy (19 cases), varicose vein (13 cases). Alprostadil doses were 10 μg·d-1 (2 cases) and 20 μg·d-1 (27 cases). 96 patients were treated with intravenous infusion, 4 cases with intravenous injection. Medication time was 2 d (2.9 + 2.8) d. Clinical manifestations of adverse reactions were mainly cardiac vascular system damage, accounting for 62.4%. In all 100 cases of ADR, 2 cases were "must", 47 cases "very likely", 51 cases "possible". Treatment Methods of adverse reaction were withdrawal, external application, oxygen inhalation, intravenous injection of glucocorticoid. Among the outcomes, 17 cases were cured, 83 cases improved. Conclusion Adverse reactions of alprostadil have occurred from time to time, clinical attention should be paid to the proper preservation and use of alprostadil and alprostadil adverse reactions monitoring. References | Related Articles | Metrics

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Narcotic Drugs and Psychotropic Drugs of Category 1 Management Research Based on the PDCA Cycle WEI Ning, PAN Hong-mei, LIAO Yi 2015, 12(8): 500-502.  Abstract ( 380 )   PDF (619KB) ( 235 )   Objective To regulate the management of narcotic drugs and psychotropic drugs of category 1, improve the management level by using the PDCA cycle method. Methods The existing problems in narcotic drugs and psychotropic drugs of category 1 management among medical staff in clinical departments of hospital were statistically analyzed. Management was conducted through planning, implementation, examination and handling. Results Effective management system must be established and perfected, and feasible rules and management quality goals must be made so as to achieve standardized management and use of narcotic drugs and psychotropic drugs in hospital ward. It's an important link to strengthen the training and education for the improvement of management consciousness in medical staff. Careful supervision, inspection and assessment is an important means. Conclusion The PDCA cycle method has played a very good role in promoting the management standardization of narcotic drugs and psychotropic drugs of category 1. References | Related Articles | Metrics

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Anaylysis of Rational Medication to Two Patients with Essential Thrombocythemia during Gestation Period SUN Wan-ling, SU Li, ZHOU Qi 2015, 12(8): 503-505.  Abstract ( 326 )   PDF (629KB) ( 258 )   Objective To present the treatment of two essential thrombocythemia (ET) patients during gestation period and perinatal period, and analyze the rational medication. Methods Evaluated two ET patients, and individualized therapies were given during the gestation period and perinatal period according to the risk stratification. Results To the high risk patient, low molecular weight heparin (LMWH) and interferon α-2 b were applied during the whole gestation period; to the low risk patient, aspirin and interferon α-2 b were applied during the whole gestation period. Both patients delivered the fetus successfully, and LMWH was used from 12 hours to 6 weeks after delivery. Conclusion ET patients during gestation period and perinatal period are at high risk of complications. Evaluation of the prognosis, individualized treatment and rational drug use is required, by the cooperation of hematologists and obstetrists. References | Related Articles | Metrics

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One Case of Pure Red Cell Aplastic Anemia Induced by Isoniazid Combined with Rifapentine PAN Kun-ming, LIANG Yan, ZHOU Ying, et al 2015, 12(8): 506-507.  Abstract ( 303 )   PDF (609KB) ( 344 )   References | Related Articles | Metrics

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One Case of Oral Ulcer Induced by Nicorandil SHI Qi, GUO Ting-ting 2015, 12(8): 508-508.  Abstract ( 314 )   PDF (523KB) ( 334 )   References | Related Articles | Metrics

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One Case of Anaphylactic Shock Induced by Shenmai Injection YIN Wen-jie, WANG Dong-xue, SUN Lu 2015, 12(8): 509-510.  Abstract ( 358 )   PDF (578KB) ( 127 )   References | Related Articles | Metrics

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Pharmacovigilance Newsletter National Center for Adverse Drug Reaction Monitoring China 2015, 12(8): 511-512.  Abstract ( 478 )   PDF (619KB) ( 140 )   Related Articles | Metrics