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20 April 2017, Volume 14 Issue 4 Previous Issue    Next Issue

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Effects of Bicyclol on α-naphthalene Isothiocyanate-induced Liver Injury in Mice LIU Ning, LIU Wei, ZHANG Dan, BAO Xiu-qi, SUN Hua* 2017, 14(4): 193-195.  Abstract ( 273 )   PDF (2198KB) ( 119 )   Objective To observe the effects of bicyclol on α-naphthalene isothiocyanate (ANIT) -induced liver injury in ICR mice. Methods ICR mice were given intragastric administration bicyclol 200 mg·kg-1 for five days continuously, oncedaily. Two hours after the third administration, the mice were treated with ANIT 110 mg·kg-1 to establish the liver damage model. All animals were killed on 2 h after the fifth bicyclol administration. The activities of ALT, AST, ALP, TBIL,DBIL and TBA in serum were measured by automatic chemistry analyzer. 10% liver homogenate were prepared to test the MDA and SOD. Results ANIT 110 mg·kg-1 could induce significant liver damage, the mortality rate of mice increased and the levels of serum ALT, AST, ALP, ALB, TBIL, DBIL and TBA were significantly increased. 200 mg·kg-1 bicyclol had no even aggravating effects on the elevated level of the blood biochemical indexes as well as MDA and SOD. Conclusion Bicyclol aggravates ANIT-induced liver injury in mice probably and this should catch our attentions. References | Related Articles | Metrics

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Repeated Subcutaneous Injection Toxicity Study of Arctigenin in Beagle Dogs LIU Dong-guang1, XU Yan1, YAO Jing-chun1, ZHANG Gui-min1, LI You2, * 2017, 14(4): 196-200.  Abstract ( 320 )   PDF (1084KB) ( 146 )   Objective To observe the toxicity of arctigenin in Beagle dogs by continuous subcutaneous injection, so as to provide reference information for the clinical research. Methods 40 healthy conventional Beagle dogs, half male and half female, were divided into 5 groups: control group, polyethylene glycol (PEG) control group and arctigenin (NBZGY) 6, 20, 60 mg·kg-1 groups, 8 dogs in each group. Dogs of each group were given 1.2 mL·kg-1 by subcutaneous injection 1 time per day for 28 days, and observed for 2 weeks after the last administration. During the experiment, the general state of animals, food consumption, body weight, hematology, blood biochemistry parameters were detected. Results The stimulus response caused by PEG had been seen in the administration location of PEG-control group and NBZGY each dose group, 60 mg·kg-1 NBZGY group could strengthen the stimulation, after the last administration, the stimulus response could be partly recovered. 20 and 60 mg·kg-1 induced injury of liver and biliary duct in contrast to the control group during the period of administration. At the end of convalescence, dogs in 20 mg·kg-1 group showed a recovery of the injury of liver and biliary duct, but the injury of liver and the biliary duct had not recovered obviously in the 60 mg·kg-1 group. There was no overt toxicity in 60 mg·kg-1 group except the stimulus response in the administration location. Conclusion Repeated subcutaneous injection of large dose of NBZGY can induce injury of liver and biliary duct and strengthen the reaction to the stimulus caused by PEG in dogs. References | Related Articles | Metrics

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Study on Developmental Toxicity of Four Chinese Patent Medicines to Zebrafish Embryos CHEN Jie-feng1, LIU Tong1, HUANG Dan-ping2, HE Qi-di1, CHEN Zuan-guang1, YAO Mei-cun1, * 2017, 14(4): 201-204.  Abstract ( 266 )   PDF (1376KB) ( 241 )   Objective To study the developmental toxicity of four pregnancy-contraindicated Chinese patent medicines (Fule granule, Fuyanjing capsule, Shenrongbaifeng pill and Rupisanjie capsule) to zebrafish embryos. Methods Powders of Chinese patent medicines were dissolved and conducted on serial dilutions with E3 medium, respectively. Zebrafish embryos were exposed to these solutions and scored for lethal or teratogenic effects using microscope at 24, 48 and 72 h post fertilization. Results All of the medicines were found to be developmentally toxic. Especially, cardiac edema or tail edema were observed in zebrafish embryos exposed to Fule granule and Fuyanjing capsule, which were proved to be potentially teratogenic. The LC50 and EC50 values for Fule granule were 0.743 mg·mL-1 and 0.484 mg·mL-1, respectively; the corresponding values for Fuyanjing capsule were 5.23 mg·mL-1 and 3.77 mg·mL-1. Conclusion Developmental toxicity of 4 Chinese patent medicines was found. It is practicable to study developmental toxicity of Chinese patent medicines using zebrafish model. References | Related Articles | Metrics

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Clinical Distribution, Drug Resistance Characteristics and KPC Gene Expression Analysis of Klebsiella Pneumonia GUI Hong1, MENG Fan-xiang2, HONG Yan-ying1, GAO Xiang1, CUI Xu-ran1, DING Jun-ying1, LIU Qing-quan1, * 2017, 14(4): 205-208.  Abstract ( 250 )   PDF (978KB) ( 229 )   Objective To investigate the clinical distribution and drug resistance characteristics of Klebsiella pneumonia in different hospitals, to analyze KPC gene, and to provide the basis for rational drug selection. Methods The pathogenic bacteria were isolated from clinical samples and identified by the two hospitals in 2015 respectively. The sample characteristics in clinical departments and type distribution were investigated. The results about drug resistance were verified with K-B method. All the Klebsiella pneumonia resistant to imipenem and meropenem were selected, of which the KPC genes were detected by PCR. Results The 5075 and 1694 strains bacteria were isolated from two hospitals respectively, including 524 strains Klebsiella pneumoniae and 286 strains respectively, which distributed mainly in ICU and respiratory department and from sputum, urine and blood samples. The drug resistance of Klebsiella pneumoniae in Tianjin Fourth Hospital were compound sulfamethoxazole, ampicillin, nitrofurantoin, ampicillin / sulbactam and piperacillin in order, while those in the other hospital were compound sulfamethoxazole, ampicillin, nitrofurantoin, ampicillin / sulbactam and cefazolin orderly. Some Klebsiella pneumoniae resistant to imipenem and meropenem could express the KPC gene. Conclusion The distribution characteristics and sample types of the two hospitals were similar, and the drug resistance spectrum was slightly different. These indicated that the respiratory tract infection in the respiration department and ICU should be paid attention to, and the rational drug was selected according to the drug resistance gene expression. References | Related Articles | Metrics

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Clinical Efficacy and Safety Analysis on Fufanghuashengyi Granules in Treatment of Thrombocytopenia Induced by Chemotherapy CHEN Xiang 2017, 14(4): 209-211.  Abstract ( 439 )   PDF (953KB) ( 241 )   Objective To investigate the clinical efficacy and safety of Fufanghuashengyi granules in treatment of thrombocytopenia induced by chemotherapy. Methods 80 cases of cancer patients were collected from March 2013 to March 2016 in our hospital, according to the grade of thrombocytopenia induced by chemotherapy, I and II degree patients were divided into control group (40 cases, given conventional therapy) and treatment group (40 cases, given Fufanghuashengyi granules) using random digital method, compared the clinical efficacy and safety differences of the two groups. Results Compared with the control group, the PLT, Hb count and the minimum value of PLT of treatment group both significantly increased, the time of PLT back to 50 or 100×109·L-1 significantly shortened, with statistical significance (P<0.05). Logistic multiple regression model showed that Fufanghuashengyi granules had significantly antagonistic effect to vomiting, fever, fatigue and edema (P<0.05). Conclusion Fufanghuashengyi granules in treatment of I and II degree thrombocytopenia induced by chemotherapy has good clinical effect, and safety is relatively high, it is worth to be popularized and applied. References | Related Articles | Metrics

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Analysis of Pregnancy Outcome in Insulin Injection for Gestational Diabetes in Different Gestational Age TAN Bai-ju, LI Yu-mei, FENG Xiao-ping, GUO Hai-feng 2017, 14(4): 212-214.  Abstract ( 325 )   PDF (921KB) ( 131 )   Objective To observe the efficacy and safety of insulin in the treatment of gestational diabetes in different gestational age. Methods The data of 84 women with gestational diabetes were retrospectively collected, and divided into early treatment group (n=40) and late treatment group (n=44) based on first use of insulin in different gestational age. All patients received controlled diet (calorie intake no more than 35 kJ·kg-1·d-1, carbohydrate, fat and protein were distributed by 11:4:5). Insulin injection started with 4~6 units before meals and at bedtime by 4:2:3:1 depending on the levels of fast blood glucose and postprandial 2 h blood glucose, patients were divided into early treatment group (first injection before pregnant 28 week) and late treatment group (first injection group after pregnant 28 week). The data of fast blood glucose and postprandial 2 h blood glucose at the first and delivery, pregnancy outcomes and neonatal conditions were collected of 2 groups. Results During delivery, the fast blood glucose and postprandial 2 h blood glucose levels in the early treatment group were significantly lower than those in the late treatment group (P<0.05). In the early treatment group, the improvement of postprandial 2 h blood glucose level vs. fasting was significantly lower than that in the late treatment group (P<0.05). The number of cesarean section and fetal distress number between the two groups were not significantly different. The number of macrosomia of early treatment group was significantly less than the late treatment group, and the 5 min neonatal Apgar score of early treatment was significantly higher than late treatment group (P<0.05). Conclusion Treatment with insulin before pregnant 28 weeks can effectively control the blood glucose, improve the adverse uterus environment and pregnancy outcomes with safety. References | Related Articles | Metrics

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Influence of Processing on the Dissolution Rates of Flavonoids in Viticis Fructus WANG Ting, TANG Li-ying*, GUO Ri-xin, XU Meng-ying, YU Xian-kuo, WANG Zhu-ju* 2017, 14(4): 215-217.  Abstract ( 260 )   PDF (955KB) ( 179 )   Objective To investigate the influence of processing on the content and dissolution rate of flavonoids in Viticis Fructus. Methods HPLC was used to determine the contents of isoorientin and vitexicarpin in Viticis Fructus simultaneously, chromatographic conditions were listed as follows: Agilent TC-C18 column (4.6 mm × 250 mm, 5 μm), mobile phase of methanol (A) -1% acetic acid water (B) for gradient elution (0~10 min, 25%~35% A; 10~18 min, 35% A; 18~45 min, 35%~75% A), flow rate of 1 mL·min-1, detection wavelength at 254 nm, column temperature at 30 ℃. Changes between the raw and processed Viticis Fructus of these contents and dissolution rates were analyzed. Results The contents of these constituents in raw herbs were 0.035%, 0.066%, their contents were 0.033%, 0.056% after being processed. The dissolution rates of isoorientin and vitexicarpin were 40.0%, 12.1%, and they were 60.6%, 14.3% after being processed. Conclusion Processing would increase the contents and dissolution rates of isoorientin and vitexicarpin in Viticis Fructus. References | Related Articles | Metrics

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Ponatinib and Its Risk Management in United States and European Union YUE Xiao-meng1, GUO Xin-yi2, WAN Jing-yuan3, GUO Jian-fei1, * 2017, 14(4): 218-221.  Abstract ( 685 )   PDF (946KB) ( 162 )   Objective To provide suggestions to conduct risk management and risk evaluation and mitigation strategy in China by describing ponatinib risk management experience in the United States (US) and European Union (EU). Methods Using Medline and other Internet-based search engines, we systematically reviewed ponatinib withdrawal case due to serious vascular occlusion events and its reintroduction into the market under the Risk Evaluation and Mitigation Strategy (REMS) in US. We also reviewed ponatinib risk assessment in European Union. Results Ponatinib (Iclusig®), a kinase inhibitor, was approved for positive chronic myeloid leukemia and positive Philadelphia chromosome positive acute lymphoblastic leukemia. Due to the serious adverse reaction, ponatinib was withdrawn in October 2013. Due to its unique pharmacologic efficacy, it was re-introduced to the market in December 2013 under the unique REMS in US. A similar risk management plan was introduced in EU countries. Conclusion The risk management for pharmaceutical products applies to the life cycle of drug development from Investigational New Drug (IND), New Drug Application (NDA), post-marketing, and even to post-withdrawal and reintroduction. The experience of ponatinib risk management in US and EU might shed some light for the future risk management of drug safety in China. References | Related Articles | Metrics

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Research on the Management of Waste Drugs Based on Extended Producer Responsibility HAO Li-pan, WANG Shu-ling* 2017, 14(4): 222-225.  Abstract ( 282 )   PDF (1115KB) ( 100 )   Objective To plan the path to apply reverse logistics of waste drugs (RLWD) and finally provide references for management of waste drugs by analyzing the present situation of RLWD in China. Methods Literature and questionnaire method were used for analysis. Results and Conclusion The analysis showed that the negative external problems of waste drugs were prominent, so that it is necessary to determine how to share the responsibility of RLWD. Therefore, Producer Responsibility Extension Theory should be considered when making design RLWD, which can help define responsibilities among governments, producers and consumers and finally promote the management of waste drugs. References | Related Articles | Metrics

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Literature Analysis of 71 Cases of Adverse Drug Reactions Induced by Hydroxyurea DAI Ting, QIAN Xi-fen 2017, 14(4): 226-229.  Abstract ( 258 )   PDF (940KB) ( 215 )   Objective Through investigating the characteristics and mechanism of adverse drug reactions (ADRs) induced by carbamazepine, to find its risk factors and provide technical support for safe and rational use of drugs in clinic. Methods Using “Hydroxyurea”, “adverse reaction” and “to” as key words to search and retrieve articles in the CNKI,VIP and WanFang Data. According to inclusion and exclusion criteria to analyze the literature. Results A total of 44 papers, 71 cases, 79 series of ADR were included. Systems and organs mainly involved in ADRs were skin and its appendages, systemic damage and digestive system damage. The skin and appendages damage was the most commonly reported ADRs, and refractory skin ulcer accounted for the most. Conclusion It is important to pay attention to the ADR, caused by hydroxyurea, strengthen clinical rational use of drugs, in order to prevent ADR and ensure the safe drug use in clinic. References | Related Articles | Metrics

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Literature Analysis of 146 Cases of Adverse Drug Reactions Induced by Carbamazepine PAN-Li, LI Su-hua, ZHANG Xiao-le 2017, 14(4): 230-234.  Abstract ( 292 )   PDF (922KB) ( 243 )   Objective Through investigating the characteristics and mechanism of adverse drug reactions (ADRs) induced by carbamazepine, to find its risk factors and provide technical support for safe and rational use of drugs in clinic. Methods Using “carbamazepine”, “adverse reaction” and “to” as key words to search and retrieve articles in the CNKI database. According to inclusion and exclusion criteria to analyze the literature. Results A total of 52 papers, 146 cases, 194 series of ADR were included. Systems and organs mainly involved in ADRs were skin and its appendages, neurological and psychiatric system damage, cardiovascular system damage, blood system damage, etc. The skin and appendages damage was the most common reported ADRs, including bullous epidermal necrolysis, exfoliative dermatitis, etc. It causes severe organ failure and even death. Conclusion It is important to pay attention to the ADR caused by carbamazepine, strengthen clinical rational use of drugs, in order to prevent ADR and ensure the safe drug use in clinic. References | Related Articles | Metrics

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Literature Analysis of 578 Cases of Adverse Drug Reactions Induced by Sophora tonkinensis Gagnep YANG Xue1, XIA Dong-sheng2, *, GAO Jian-chao2, TIAN Chun-hua2, LI Lan2 2017, 14(4): 235-241.  Abstract ( 281 )   PDF (966KB) ( 253 )   Objective To explore the clinical toxicity characteristics and risk factors of Sophora tonkinensis Gagnep, in order to offer literature basis for clinical safety medication. Methods The adverse reactions of Sophora tonkinensis Gagnep on literatures from January 1st, 1953 to April 1st, 2016 were summarized, and the toxicity characteristics and risk factors for clinical use were analyzed. Results Oral use of Sophora tonkinensis Gagnep causes multiple organ damage, the main damages are nervous system damage and digestive damage. And other damages are dysmetabolism, hepatobiliory system damage, visual impairment, respiratory system injury, disorder of motor nerve. The main risk factors of adverse reactions of Sophora tonkinensis Gagnep are toxicity, drug overdose, misuse of different varieties, improper compatibility, using out of the direction of doctor and preventing disease. Conclusion Toxicity of Sophora tonkinensis Gagnep should be paid attention to in the clinical use, so as to control the risk factors and prevent the happening of the adverse drug reaction. References | Related Articles | Metrics

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Analysis of 907 Cases of Adverse Drug Reactions Induced by Antineoplastic Drugs WEI Ling-yu, QIU Xiao-chun*, ZHOU Yan-lai, WANG Zuo-rong 2017, 14(4): 242-245.  Abstract ( 380 )   PDF (943KB) ( 272 )   Objective To study the characteristics and regularities of adverse drug reactions (ADR) induced by antineoplastic drugs and provide references for the clinical rational use of antineoplastic drugs. Methads 907 reports of ADR induced by antineoplastic drugs from 2011 to 2016 in our hospital were retrospectively analyzed in terms of patient’s general information, drug varieties, routes of administration, occurrence time, involved organs-systems, clinical manifestations, treatments and outcomes. Results There is no difference between male and female. ADR of antineoplastic drugs mainly (74.42%) occurred in patients aged 40 years above. Most (82.58%) cases happened in 0~7 days after medication. 8 classes of antineoplastic drugs were involved, among which cisplatin occupied the top. Drug combinations were the main use of anti-tumor drugs (90.86%). Cisplatin for injection, dorsey injection, paclitaxel injection were the top three of combinations. Intravenous dripping was the main route of administration (74.54%). The blood system was the most involving system, followed by the digestive system, skin and its accessories. Most patients were improved or cured after given the appropriate treatment (87.10%). Conclusion Intensive cares should be adopted to reduce the occurrence of ADR when antineoplastic drugs were applied. Processing of ADR timely could reduce the harm and improve the safety of drug use. References | Related Articles | Metrics

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Analysis of Medication Rationality in Children of Ophthalmology WANG Li, GONG Rui-zhong, WANG Chen 2017, 14(4): 246-248.  Abstract ( 390 )   PDF (942KB) ( 91 )   Objective To investigate the rationality of medication for children in our hospital so as to promote rational use of drugs in ophthalmology. Methods We retrospectively analyzed a total of 400 outpatient prescriptions and 400 medical records collected from Shanxi eye hospital to analyze the medication situation of children in ophthalmology. Results There are 25 unreasonable situations in 400 outpatient prescriptions with irrationality ratio of 6.25%, including 6 cases of non-indicated use of drugs (accounting for 1.5%), 6 cases of inappropriate administration (accounting for 1.5%),9 cases of inappropriate choice of drugs (accounting for 2.25%) and 4 cases of off-label usage (accounting for 1.00%). 20 unreasonable situations were analyzed in 400 medical records with irrationality ratio of 5%,which were mainly composed of repeated-use of medication (2.75%) and irrational use of antibacterial drugs (1.25%). Conclusion In order to improve the irrational situation of medication for children existed in our hospital, it is recommended to the overall implementation of electronic prescription, intervention of pre-prescription review, compliance of drug instructions and timely attention to updated information of drug instruction. References | Related Articles | Metrics

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Application of Intensive Hospital Monitoring in Adverse Drug Reaction Supervision of Inpatients Admitted to Respiratory Department LIN Zhi-qiang, WANG Da-xuan, ZHANG Bao-yan 2017, 14(4): 249-253.  Abstract ( 301 )   PDF (926KB) ( 164 )   Objective To investigate the role of intensive hospital monitoring in the adverse drug reactions (ADR) supervising among inpatients in respiratory department. Methods All in-hospital patients admitted to the two treatment groups of respiratory department from January to June in 2016 were selected as observation subjects. Two clinical pharmacists were dispatched to the two treatment groups to participate in the daily ward-rounds. Each patient’s basic information, primary disease, drug use and ADR occurrence were recorded detailedly, and the incidence of ADR among different age groups as well as ADR occurrence in those patients who use different kinds of drugs were analyzed and compared, according to the requirements of the intensive hospital monitoring method. Results A total of 1, 003 patients were enrolled in the study, of which 138 cases presented ADR, with an incidence of ADR 13.76%. The incidence of ADR (31.43 %, 11/35) in group over 80-year-old was significantly higher than that in other age groups (average P < 0.05). Twenty-seven drugs were associated with ADRs, and the top three categories were antibacterial drugs (8 species), anti-tumor drugs (6 species) and anti-tuberculosis drugs (4 species), accounting for 66.67 % of all ADRs. Conclusion By applying intensive hospital monitoring method in respiratory department, the incidence and clinical manifestations of ADR have been revealed in different diseases, different ages and different drug use. Thus, patients can receive targeted pharmaceutical care, so as to ensure the safety of medication. References | Related Articles | Metrics