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Pharmacokinetics of Isopsoralen in Rat Model with 3 Months of Repeated Administration MEN Weijie, HUO Xiangxiang, BI Yanan, YUAN Xiaomei, ZHANG Yue, ZHOU Kun 2019, 16(10): 577-580.  DOI: 10.19803/j.1672-8629.2019.10.01 Abstract ( 591 )   PDF (3373KB) ( 141 )   Objective To study the pharmacokinetics of isopsoralen after 3 months of repeated administration in rats. Methods Thirty-six Wistar rats (half male and half female) were randomly divided into three groups. Isopsoralen (14.0, 7.0, 3.5 mg·kg-1) was given for 3 months by continuous gavage , once a day. Blood samples were taken before and after the last gavage to determine the plasma concentration of isopsoralen in rats at different time points, and the pharmacokinetic parameters were calculated with DAS3.0 program. Results The pharmacokinetic parameters of isopsoralen in rats after repeated gavage in high, medium and low dose groups were as follows: AUC was（27287.42±2680.24）,（18483.87±2455.46）and（5189.97±791.67）μg·L-1·h-1 respectively, t1/2 was (4.67±0.80）,（11.30±2.37）and（5.87±1.52）h respectively, while Cmax was（2509.26±191.78）,（2287.06±172.43）and（825.64±76.45）μg·L-1 respectively. AUC, Cmax and MRT in rats increased with the dose. Conclusion Within the dose range of this study (3.5-14.0 mg·kg-1), the pharmacokinetics of isopsoralen given by repeated gavage in rats is nonlinear. References | Related Articles | Metrics

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Protective Effect of Icariin on Oxidative Damage of HUVECs Induced by Hydrogen Peroxide ZHANG Li, HUANG Dehong, SUN Fujun, LI Guihai 2019, 16(10): 581-587.  DOI: 10.19803/j.1672-8629.2019.10.02 Abstract ( 410 )   PDF (6416KB) ( 117 )   Objective To observe the protective effect and its possible mechanism of icariin (ICA) on oxidative damage of human umbilical vein endothelial cells (HUVECs) induced by hydrogen peroxide. Methods An oxidative stress injury model of HUVECs induced by hydrogen peroxide in vitro was established, to which icariin of different concentrations of icariin（12.5 μg·mL-1, 25 μg·mL-1, 50 μg·mL-1) was added in different groups were added. Cell viability was measured by MTT colorimetry, and superoxide dismutase (SOD) activity in cells and lactate dehydrogenase (LDH) released in the supernatant were measured using the biochemical method. Furthermore, MCP-1 and ICAM-1 were detected by real-time fluorescence quantitative PCR (RT-PCR). Results Icariin of different concentrations could significantly increase the cell viability and SOD activity of the damaged cells, and reduce the release of LDH in the supernatant compared with the model group. The difference was statistically significant (P <0.01). Further analysis of the mechanism showed that the expressions of ICAM-1 and MCP-1 mRNA were down-regulated (P <0.01). Conclusion Icariin can improve the oxidation index of damaged cells, reduce the expressions of atherosclerosis-related cytokines, and improve the progression of such vascular diseases such as atherosclerosis. References | Related Articles | Metrics

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Thoughts on Implementing E2B(R3) in Individual Case Safety Reports in China HOU Yongfang, FANG Kairui, QI Yan, WANG Qing, LIU Hongliang 2019, 16(10): 588-590.  DOI: 10.19803/j.1672-8629.2019.10.03 Abstract ( 887 )   PDF (2765KB) ( 412 )   Objective To offer thoughts on implementation of E2B(R3) in individual case safety reports (ICSR)in China. Methods By interpreting the significance and ways of implementating E2B (R3), the challenges to and countermeasures for the implementation of E2B (R3) were explored. Results & Conclusion The implementation of E2B (R3) is conducive to the sharing and exchange of ICSR. There are many formidable challenges. E2B (R3) needs to be gradually implemented based on the level of development of adverse drug reaction monitoring. References | Related Articles | Metrics

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Impact of E2B(R3) Implementation on Information System Construction in Drug Safety Related Institutions in China WANG Qing, REN Wei, YANG Jijiang 2019, 16(10): 591-593.  DOI: 10.19803/j.1672-8629.2019.10.04 Abstract ( 539 )   PDF (3057KB) ( 248 )   Objective To explore the impact of implementing E2B (R3) in the field of pharmaceutical supervision on the development of information systems for pharmacovigilance and ADR monitoring by related institutions in the future. Methods The process and scope of E2B (R3) implementation were analyzed, and the possible impact of E2B (R3) implementation on China's regulatory bodies, medical institutions and related enterprises in the construction of their respective information systems was explored. Results & Conclusion The implementation of E2B (R3) is an important measure in the field of pharmaceutical supervision in China. It has posed a series of challenges to the information system construction of regulatory agencies, medical institutions and related enterprises. Those institutions need to take corresponding measures related to overall planning, system construction and standard compatibility. References | Related Articles | Metrics

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Overview of Implementation of E2B (R3) Guidelines by ICH Founding Regulatory Members LIU Hongliang, ZHENG Mingjie, LI Xinling, WANG Qing, HOU Yongfang 2019, 16(10): 594-596.  DOI: 10.19803/j.1672-8629.2019.10.05 Abstract ( 638 )   PDF (2861KB) ( 290 )   Objective To introduce the implementation of E2B（R3） guidelines by regulatory agencies in Europe, the United States, Japan and other countries in order to provide reference for the implementation of E2B（R3） in China. Methods The current implementation of E2B in ICH founding regulatory agency member states was outlined by analying adverse reaction databases, guidelines and report submission methods in Europe, the United States, Japan and other countries. Results & Conclusion Developed countries, such as Europe, the United States and Japan, have accumulated much experience after many years of implementation, which can facilitate the implementation of E2B（R3） in China. References | Related Articles | Metrics

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Data Quality of Individual Case Safety Reports Based on ICH E2B (R3) Implementation Guidelines WAN Bangxi, YU Lina, XU Juping 2019, 16(10): 597-601.  DOI: 10.19803/j.1672-8629.2019.10.06 Abstract ( 638 )   PDF (4031KB) ( 300 )   Objective To analyze specifications related to quality in ICH E2B (R3) guidelines and to find out about the data quality requirements of individual case safety reports. Methods Data elements in the ICH E2B (R3) guidelines were associated with human cognition. The whole process from data, information, knowledge and finally to wisdom was analyzed and demonstrated before factors and visual dimensions that affected data quality were determined. Results Data quality was embodied in data integrity (data dimension) and data accuracy (granularity). The requirements on data relationships and data elements in E2B (R3) guidelines could effectively guarantee the quality of individual case safety reports. Relevant design based on E2B (R3) guidelines could deliver high-quality data on drug safety. Conclusion When designing the safety information collection form, the marketing license applicant and MAH need to ensure data quality from the perspective of accuracy and integrity according to the ICH E2B (R3) implementation guidelines. High-quality data can be accumulated in the safety database to discover potential drug safety signals. References | Related Articles | Metrics

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Implication of Drug Abuse Monitoring and Early Warning of New Psychoactive Substances in EU LIU Chunguang, LIU Chenqi 2019, 16(10): 602-607.  DOI: 10.19803/j.1672-8629.2019.10.07 Abstract ( 498 )   PDF (6273KB) ( 176 )   Objective To find out about the mechanism and model of drug abuse monitoring in the EU so as to provide reference for improvement of the system and model for monitoring drug abuse in China. Methods By searching the official website of the EU and related literature at home and abroad, the current regulations on monitoring of drug abuse, technical means and developments in the EU were explored. Results Along with the emergence of new psychoactive substances, the EU has attempted to strengthen active monitoring, establish an early warning system for the use of new psychoactive substances, and facilitate information exchange and risk assessment to control the abuse of new psychoactive substances. Conclusion China should improve the construction of drug abuse monitoring systems, expand the scope of monitoring, establish scientific monitoring methods, and improve the capability of monitoring and early warning. References | Related Articles | Metrics

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Application of Electronic Information-and-network-based Technology in Clinical Trial Management FAN Yi 2019, 16(10): 608-613.  DOI: 10.19803/j.1672-8629.2019.10.08 Abstract ( 359 )   PDF (5866KB) ( 304 )   Objective To improve the efficiency and quality of clinical trial research and to provide reference for more effective information supervision of drug life cycles. Methods By focusing on the construction of information systems for clinical trial research management, CNKI and official websites of drug regulatory agencies in various countries were searched to collect papers, literature and guidelines.The advantages, characteristics, functions and processes of commonly-used clinical trial research management information systems were analyzed comprehensively in combination with our actual work. Results & Conclusion The advantages of clinical trial research management systems over the original methods or modes of management have been illuminated, the possible impact of popularization of electronic information technology discussed, and solutions to problems to be solved offered. References | Related Articles | Metrics

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Risk Signals of Innovative Antineoplastic Drug Chidamide Tablets WANG Tao, DONG Duo, XIONG Weiyi, TIAN Chunhua, LIU Hongliang 2019, 16(10): 614-616.  DOI: 10.19803/j.1672-8629.2019.10.09 Abstract ( 503 )   PDF (3039KB) ( 255 )   Objective To analyze the risk signals of chidamide tablets in China in order to provide reference for clinical rational use of this drug. Methods By using two signal detection methods- PRR and BCPNN, data mining of chidamide tablets was carried out in China adverse drug reaction database between 2014 and 2018. In addition, individual cases of adverse drug reactions documented in China adverse drug reaction database, domestic and foreign literature, and risk management measures in China were analyzed. Results After manual determination and screening, two valuable signals related to chidamide were discovered, namely heart failure and interstitial pneumonia. Conclusion Monitoring of clinical application of chidamide tablets should be enhanced, drug labeling updated without delay and rational application of medicine promoted. References | Related Articles | Metrics

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Analysis of 481 Reports of Adverse Drug Reactions Induced by Quinolone Drugs LIN Xin, LI Jin, REN Huiling 2019, 16(10): 617-624.  DOI: 10.19803/j.1672-8629.2019.10.10 Abstract ( 769 )   PDF (6087KB) ( 347 )   Objective To analyze the occurrence of adverse drug reactions (ADRs) induced by quinolone drugs in China. Methods Based on the National Science Data Sharing Platform for Population and Health, 481 case reports of quinolone drugs-induced ADRs were collected. The fields in each case report were standardized, and the ADR symptoms were extracted and standardized by using Jieba word segmentation module and WHO adverse reaction terminology. In addition, gender, age, routes of administration and organs/systems involved in ADRs were retrospectively analyzed. Results In these reports, male patients slightly outnumbered female ones and the proportion of patients aged 20 to 59 was higher. ADRs induced by intravenous drip were the most common and tended to occur within 10 minutes of administration. The ADRs recorded in most of these case reports were relatively mild. The most common serious ADRs were life-threatening, and levofloxacin caused most of the serious adverse reactions. Quinolone drugs were involved in a total of 184 adverse drug reactions, the dominating ones of which were chest pain and palpitation. The main organ system involved was the skin and its appendages, with such clinical manifestations as pruritus and rash. Conclusion This study has effectively analyzed ADRs caused by quinolone drugs by extracting the adverse reaction symptoms from case reports and standardizing the terms, providing a novel approach to retrospective analysis of adverse reactions. Health care workers should pay close attention to adverse reactions that may occur along with the use of quinolone drugs to ensure safe and rational clinical use. References | Related Articles | Metrics

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Antibiotic Application of Myasthenia Gravis Complicated with Infection PAN Weirong, SHEN Xian, SUN Sixian, ZHU Xuying 2019, 16(10): 625-631.  DOI: 10.19803/j.1672-8629.2019.10.11 Abstract ( 415 )   PDF (5485KB) ( 130 )   Myasthenia gravis( MG ) is an acquired autoimmune disease that primarily affects the postsynaptic membrane acetylcholine receptors of neuromuscular junctions. Infection is one of the most common complications in the development of MG. However, some antibacterial drugs interfere with the movement of nerve-muscle joints, which may aggravate the symptoms of MG and even induce myasthenic crisis. Therefore, cautious selection of antibacterial drugs is particularly important for MG patients. This paper summarizes the antibacterial drugs that affect the symptoms of MG, and raise recommendations for the selection of antibacterial drugs in order to provide reference for clinicians to use antibacterial drugs and for new drug research and development. References | Related Articles | Metrics

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Nephrotoxicity of Immune Checkpoint Inhibitors FAN Qianqian, ZHANG Bo, ZHAO Bin, LI Qiuyue, LIU Fang, MA Jie 2019, 16(10): 632-638.  DOI: 10.19803/j.1672-8629.2019.10.12 Abstract ( 385 )   PDF (5803KB) ( 146 )   The development of immune checkpoint inhibitors (ICIs) has revolutionized the field of cancer therapy. Despite the benefits, the use of ICIs is also accompanied by a unique spectrum of side effects, referred to as immune-related adverse events. Among them, ICIs-related kidney injury has been reported worldwide these years. Although uncommon, such injury may pose a threat to patients' drug treatment, quality of life and even life. So far, such adverse drug reactions have rarely been reported in China. In this paper, the characteristics, monitoring and treatment of ICIs-related kidney injury are summarized based on literature review in order to provide evidence for ICIs-related decision-making and adverse reaction management. Current clinical data suggests that the occurrence of acute kidney injury is relatively more common than other renal complications associated with ICIs use. There are also reports of ICIs-related nephrotic syndrome and kidney transplantation rejection. Glucocorticoid is the mainstay of current treatment. In addition, close monitoring of renal function during ICI treatment, early detection and intervention of kidney injury are critical to the outcome. References | Related Articles | Metrics

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One Case of Unconsciousness Induced by Oral Sustained-release Tramadol CHEN Zihua, XIE Yanbing 2019, 16(10): 639-640.  DOI: 10.19803/j.1672-8629.2019.10.13 Abstract ( 526 )   PDF (1912KB) ( 219 )   References | Related Articles | Metrics