Archive

20 January 2019, Volume 16 Issue 1 Previous Issue    Next Issue

---

For Selected:

Download Citations EndNote Ris BibTeX

Toggle Thumbnails

Select

Repeated Dose Toxicity Study of Antexiao Capsules in Beagle Dogs for 39 Weeks DU Xiao, WANG Jiannong, HAN Lin, SUN Caixia, CAO Xiaoqiang, SUN Jian 2019, 16(1): 1-5.  Abstract ( 409 )   PDF (892KB) ( 186 )   Objective To examine the repeated dose toxicity of Antexiao capsule in Beagle dogs. Methods 48 Beagle dogs were divided into four groups: 120, 320, 800 mg·kg-1 dose of Antexiao capsule groups and solvent control group. The dogs were orally treated with Antexiao capsule for 39 weeks. Clinical observation, body weight, electrocardiogram, hematology, blood biochemistry, organ weights, and histopathological findings were examined. Results Antexiao capsule could induce vomiting, salivation and liquid stools in healthy dogs. The body weight of dogs in 800 mg·kg-1 group decreased significantly (P <0.05). The levels of serum TP, ALB and GLOB changed in dogs treated with 320 and 800 mg·kg-1 Antexiao capsule. No significant drug-related pathological changes were found. Conclusion Antexiao capsule (320 and 800 mg·kg-1) administered intragastrically can induce significant gastrointestinal toxicity in Beagle dogs. References | Related Articles | Metrics

Select

Single and Repeated Dose Toxicity Study of Recombinant Human Factor VIII for Injection in Macaca Fascicularis FAN Xiaoyu, WANG Yinuo, HUA Manman, LU Xiaochen, WANG Jiangxue, SHAN Yongchao, WEI Jinfeng, JIN Hongtao 2019, 16(1): 6-12.  Abstract ( 642 )   PDF (1182KB) ( 184 )   Objective In the experiment, recombinant human coagulation factor VIII is administered intravenously to Macaca fascicularis in a single and 30-day period to observe the potential toxicity and extent of the toxicity, and also the development and recovery of toxicity, so as to provide reference information for the clinical dose design and clinical adverse drug reactions monitoring. Methods The acute toxicity test was performed by lethal dose method. After single intravenous administration, the acute toxicity in Macaca fascicularis was observed. In the 30 days' repeated-dose toxicity experiment, 1 time/day administration was carried out for 30 days, and the recovery period was four weeks. Changes in various indexes of the Macaca fascicularis were observed. Results In the acute toxicity test, only the 61 250 IU·kg-1 group animals were observed lactate dehydrogenase (LDH) increased compared with self-controls before drug given. In the 30-day administration experiment, clinical symptoms associated with factor VIII antibodies and inhibitors, such as prolongation of APTT, hemorrhage, A/G reduction were found, and there were no toxic pathological changes clearly associated with administration. Also, no delayed or accumulation toxicity were observed. Conclusion The maximum tolerated dose of recombinant human factor VIII for single intravenous injection to Macaca fascicularis is greater than 61 250 IU·kg-1. No observed adverse effect level (NOAEL) of recombinant human factor VIII is 250 IU·kg-1 for the 30 days of repeated administration. References | Related Articles | Metrics

Select

Clinical Analysis of Adverse Drug Reactions of High-dose Methotrexate in Children with Acute Lymphoblastic Leukemia JIANG Zhiping, PENG Qian, HE Limei, ZHU Wenbing, WU Pan 2019, 16(1): 13-17.  Abstract ( 470 )   PDF (735KB) ( 317 )   Objective To explore the clinical safety of high-dose methotrexate (HD-MTX) by analyzing its adverse drug reactions (ADRs) in the treatment of childhood acute lymphoblastic leukemia (ALL), and discuss the Methods to prevent those ADRs. Methods Retrospective research was performed in 67 cases of ALL children diagnosed and treated in certain hospital. ADRs were recorded during the treatment. data analysis was conducted in patients concerning the blood concentration of MTX before and after the rescue of formyl tetrahydrofolate (CF). Results A total of 264 chemotherapy sessions with HD-MTX were performed in 67 children with ALL. Adverse reactions mainly included bone marrow suppression, gastrointestinal reactions, mucosal damage, liver toxicity, cardiotoxicity, renal toxicity, etc. No children experienced adverse events such as severe emesis or diarrhea, severe mucosal damage, severe cardiotoxicity, severe infection (level IV) or death (level V) during the treatment period. After HD-MTX treatment, statistic significance (P <0.05) for the incidence of emesis and mucosal damage were detected among patients grouped by different hazard level. But there was no such significant difference (P >0.05) for the incidence of blood plasma concentration of methotrexate> 1.0 μmol·L-1 after HD-MTX treatment for 44 hours or blood plasma concentration of methotrexate> 0.3 μmol·L-1 after HD-MTX treatment for 68 hours. Apart from the thrombocytopenia and myocardial enzyme elevation (P >0.05), there is statistic significance for the incidence of other 7 types of ADRs between delayed excretion group and normal excretion group (P <0.05). Conclusion The incidence of adverse reactions could be reduced within a certain range by the use of standardized HD-MTX treatment of children with ALL, CF rescue for MTX-intoxicated children in reference to MTX serum concentration, and effective measures to prevent and diminish adverse reactions, which could improve the life quality of those children. References | Related Articles | Metrics

Select

Study on the Single Dose Toxicity and Local Toxicity of Technetium [99mTc] Pentetate Acid Injection GAO Jie, ZHANG Wei, LI Mei, SUN Ge, HU Bo, WANG Ruoqi, JIN Hongtao, LI Jianguo 2019, 16(1): 18-22.  Abstract ( 421 )   PDF (1044KB) ( 154 )   Objective To study the preclinical safety of technetium[99mTc] pentetate acid injection, so as to provide a reference for the safety study of radiopharmaceuticals. Methods ICR mice, New Zealand rabbits and guinea pigs were used respectively to carry out the single dose toxicity test of tail intravenous injection (control group, 5 550 MBq·kg-1 group and 925 MBq·kg-1 group), vein irritating test, muscle irritating test and active systemic anaphylaxis test. The general symptoms were observed, while the weight changes of the animals and the feed consumption were determined during tests. Histopathological examination was performed, in which hematological indexes were detected by single dose toxicity, gross anatomy examination was performed on dead animals and animals still alive after the end of observation period, thymus, spleen, kidney and testicles were extracted for weighing, and viscera coefficients were calculated. Results All the mice in the 5 550 MBq·kg-1 group had drooping eyelids and little movement after administration, and one male animal died about 10 min after administration. No obvious abnormality was found in animals in the 925 MBq·kg-1 group. Vein irritating, muscle irritating and active systemic anaphylaxis group showed no obvious abnormalities. Conclusion No obvious toxic reaction related to the drug was found under the conditions of this experiment, suggesting that it provides reference information for its clinical safe application. References | Related Articles | Metrics

Select

Evaluation of Vascular Irritation of a Radiocontrast Medium and Practice of Radiation Protection for Personnel SUN Ge, XU Wenli, HUANG Liqun, GAO Jie, YIN Jingjing, ZHANG Yajuan, QIN Xiujun, ZHANG Wei, LI Jianguo, AN Quan 2019, 16(1): 23-26.  Abstract ( 328 )   PDF (797KB) ( 141 )   Objective To evaluate the vascular irritation of a 99mTc labeled radiocontrast medium, so as to make suggestions on radioprotection for personnel in the preclinical toxicological study of radiopharmaceuticals. Methods Six New Zealand rabbits were injected with technetium pentetate injection. The specific activity and radiochemical purity of the samples at the start and end of the test were analyzed, and the vascular irritation to the vein was evaluated. Dose monitoring and surface contamination monitoring were carried out during the main processes of the test. Results The maximum concentration of 555 MBq·mL-1 and the dose of 194 MBq·kg-1 (21 times of the maximum clinical dose) were intravenously administered through the ear-vein of rabbits. There wasn't drug-related vascular stimulation reactions observed in the test. The detection Results of samples' specific activity and radiochemical purity both met the test requirements. The individual highest radiation effective dose of single test of all operators was 0.01 mSv. The estimated annual total radiation effective dose is not more than 1 mSv, which is less than the limit of occupational personnel radiation effective dose (20 mSv). What's more, there was no radioactive contamination detected on surface of operators and equipments. Conclusion During the non-clinical toxicological study of radiopharmaceuticals, rational dose design and protective measures should be carried out according to the nature of nuclides and labelled substrates. It could ensure the safety and efficiency of the experimental Results. And at the same time, individual dose monitoring and pollution monitoring should be strictly carried out to ensure the radiation safety of operators. References | Related Articles | Metrics

Select

Research Status and Prospect of Radiopharmaceuticals LI Jianguo, QIN Xiujun, HU Bo, GAO Jie, LI Mei, LIU Huan, AN Quan, JIN Hongtao 2019, 16(1): 27-31.  Abstract ( 871 )   PDF (744KB) ( 677 )   Radiopharmaceuticals refers to radionuclides for clinical diagnosis or treatment, or labeled compounds, mainly including the radiological drugs for diagnosis and radiological drugs for treatment. With the popularity of SPECT/PET/PET-CT, the research and development of diagnostic radiotherapy drugs represented by 99mTc, 18F and 68Ga have developed rapidly in recent years. In recent years, more and more attention has been paid to the research and development of therapeutic radiotherapy drugs due to their good economic benefits and research and development potential. However, there is still a big gap between China and the United States and the European Union in terms of research and development investment in radioactive drugs and relevant policies and regulations. In this paper, the present situation of radiopharmaceutical research at home and abroad and the general situation of radiopharmaceutical development in China are discussed. References | Related Articles | Metrics

Select

Inspiration of Drug Abuse Surveillance and Warning System of USA to China WU Jianru, XIAO Xiao, CHENG Bin, LIU Xiaoyu, WANG Ling, MAO Qiurong 2019, 16(1): 32-36.  Abstract ( 530 )   PDF (937KB) ( 299 )   Objective To investigate the drug abuse surveillance and warning system of USA, so as to put forward suggestions for establishing drug abuse risk warning mode in China. Methods Literature, electronic documents and guidelines in drug abuse surveillance and warning system of USA were read and analyzed. Results and Conclusion The drug abuse surveillance and warning system of USA mainly includes drug abuse warning network, national drug early warning system and national drug application and health survey. The main features are relatively complete system, large data collection scope and comprehensive intervention targets. We should strengthen construction of drug abuse surveillance and warning system from the legal construction as soon as possible, and to promote the scientific development of the use of drug abuse monitoring data in China. References | Related Articles | Metrics

Select

Investigation and Analysis of Drug Safety Knowledge and Satisfaction in Shenzhen Public WEI Fenfang, FENG Xiaochan, ZHONG Ling, CHENG Bin, XIAO Xiao, WANG Qian, MAO Qiurong, YANG Yue 2019, 16(1): 37-42.  Abstract ( 434 )   PDF (883KB) ( 176 )   Objective To investigate the public awareness and satisfaction status of drug safety in Shenzhen, and provided decision support and reference for drug safety supervision. Methods Questionnaires for public awareness and satisfaction surveys were distributed through the Internet. Databases were created using Excel and statistical analysis was performed using SPSS 22.0. Results There were 1 885 valid questionnaires with an effective rate of 88.83%. The score of this survey was 75.1±17.53 points, and the satisfaction was 76.2±17.01 points. By statistical analysis of singie factors and multi-factors, age and medical/pharmaceutics background had a significant impact on cognition, and gender, age, occupation, and region had significant effects on satisfaction. Conclusion Shenzhen public drug safety awareness and satisfaction were generally higher. Among them, it was necessary to step up efforts to raise awareness of drug safety among adolescents and the elderly, strengthen the supervision of the quality of Chinese medicine injections, and increase the crackdown on illegal advertisements. References | Related Articles | Metrics

Select

Analysis of Effects of Drug-drug Interactions on Safety and Efficacy of Atorvastatin ZHANG Hong, JIA Na, ZHANG Yatong, HU Xin 2019, 16(1): 43-46.  Abstract ( 512 )   PDF (798KB) ( 248 )   Objective To study the safety and efficacy of atorvastatin in elderly patients with CAD when combined with substrates and inhibitors of CYP3A4, so as to find out the risk factors associated with atorvastatin-induced myopathy. Methods The clinical data of elderly patients, who had received atorvastatin, were collected in one research center from March to June in 2017 and analyzed by SPSS. The associated risk factors were analyzed by multivariate linear regression analysis. Results There was no significant effect on the safety and efficacy of atorvastatin for elderly patients with CAD, combined with the inhibitors of CYP3A4. However, with the increasing number of the substrates of CYP3A4, CRE showed a rising tendency. According to the result of multivariate linear regression analysis, CK could be influenced by age, gender, dyslipidemia, and the inhibitors of CYP3A4 in elderly patients with CAD. Conclusion The safety parameters should be monitored when elderly patients received atorvastatin and in combination with CYP3A4 inhibitors and multiple CYP3A4 substrates, especially the CRE and CK. References | Related Articles | Metrics

Select

Literature Review of Adverse Drug Reactions Induced by Mylabris YU Hongli, YU Dongmei 2019, 16(1): 47-51.  Abstract ( 454 )   PDF (748KB) ( 271 )   Objective To investigate the general characteristics of adverse drug reactions (ADRs) induced by Mylabris (Banmao), so as to provide reference for safe and rational drug use. Methods The cases of ADRs induced by Mylabris were retrieved, and the characteristics of ADRs and risk factors were analyzed. Results The total of 112 cases of ADRs were included in 84 literature reports. According to the analysis, the ADRs involved multiple organs and systems. The main causes were toxicity reactions and irrational drug use. Conclusion It is necessary to strengthen regulation to guidance for the safe and rational use of Mylabris. References | Related Articles | Metrics

Select

Comparative Analysis of Adverse Drug Reactions/Adverse Events between Ticagrelor and Clopidogrel HE Guilin, ZUO Li, WANG Qian 2019, 16(1): 52-57.  Abstract ( 713 )   PDF (725KB) ( 276 )   Objective To compare the adverse drug reactions/adverse events (ADRs/AEs) caused by ticagrelor and clopidogrel, in order to provide reference for clinical safe and rational use of the antiplatelet agents. Methods ADR/AE cases caused by ticagrelor and clopidogrel were screened and analyzed statistically from ADR/AE cases reported in Shenzhen city from 2014 to 2017. Results 31 ADR/AE cases caused by ticagrelor and 43 caused by clopidogrel were screened out. All of the ADR/AE cases were mainly male, however, the ratio of ticagrelor males and females was more obvious. The onset time of most ADRs/AEs by ticagrelor was within 2 to 7 days after oral medication (35.48%), and that of clopidogrel was mostly within 1 day and 2 to 7 days (32.56%, 30.23%). The main clinical manifestations by ticagrelor were bleeding(56.46%) and dyspnea(33.33%). The involved system-organs and clinical manifestations by clopidogrel were more than that by ticagrelor. Most clinical manifestations by ticagrelor and clopidogrel were mild and had good prognosis, but the patients were more tolerant to ticagrelor compared with clopidogrel. One fatal case was reported by clopidogrel. Conclusion Clinicians and clinical pharmacists should pay more attention to monitor ADRs/AEs by tigrelor and copidogrel within one week. The bleeding and dyspnea by tigrelor should be more concerned. Clinic should strengthen medication monitoring to reduce ADRs and ensure drug safety. References | Related Articles | Metrics

Select

One Case of Acute Pancreatitis Induced by Highly Active Antiretroviral Therapy HUANG Chunmei, XU Yu, XU Shuyuan 2019, 16(1): 58-58.  Abstract ( 361 )   PDF (539KB) ( 134 )   References | Related Articles | Metrics

Select

One Case of Serious Adverse Drug Reactions Induced by Gd-DTPA FU Hong, QIU Zhaojuan, RONG Youhe 2019, 16(1): 59-60.  Abstract ( 456 )   PDF (562KB) ( 342 )   References | Related Articles | Metrics

Select

One Case of Erythroderma Induced by Teicoplanin for Injection YUAN Qianqian, TANG Kun 2019, 16(1): 61-62.  Abstract ( 429 )   PDF (560KB) ( 212 )   References | Related Articles | Metrics

Select

One Case of Fanconi Syndrome and Low Phosphorus Osteomalacia Induced by Adefovir Dipivoxil Capsules HUANG Xiaomei, NING Junkai, DAI Xubo 2019, 16(1): 63-64.  Abstract ( 391 )   PDF (557KB) ( 139 )   References | Related Articles | Metrics