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20 November 2019, Volume 16 Issue 11 Previous Issue    Next Issue

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Network Pharmacological Study on Guizhi Fuling Pills in the Treatment of Mammary Gland Hyperplasia SHI Wei, LV Zhongmin, ZHANG Haiming, NIE Yinglan, SUN Jian 2019, 16(11): 641-648.  DOI: 10.19803/j.1672-8629.2019.11.01 Abstract ( 784 )   PDF (6731KB) ( 205 )   Objective To study the mechanism of Guizhi Fuling pills against mammary glandhyperplasia using network pharmacological methods. Methods TCMSP, Drugbank and TTD databases were searched for the target proteins of mammary gland hyperplasia. The Uniprot database was used to query the corresponding gene names of target proteins and select human proteins to obtain the target proteins of mammary gland hyperplasia regulated by Guizhi Fuling pills. TCMSP software was used to search the target proteins of breast hyperplasia. The active ingredients of Guizhi Fuling pills and their corresponding targets were obtained. Cytoscape 3.2.1 software was used to construct the target network of active ingredients of Guizhi Fuling pills and conduct topological analysis of the network. Gene ontology (GO) enrichment analysis and genome encyclopedia (Kyoto Encyclopedia of Genes and Genomes, KEGG) pathway analysis of key targets were carried out using the STRING database and DAVID database. Results Network pharmacological studies suggested that Guizhi Fuling pills might inhibit breast hyperplasia through inflammatory signaling pathways and hormonal signaling pathways. Guizhi Fuling pills had the multi-component and multi-target advantages in the treatment of mammary gland hyperplasia. Conclusion The active ingredients and mechanism of Guizhi Fuling pills in the treatment of mammary gland hyperplasia have been studied with network pharmacologicalMethods, which can help find out more about its mechanism. References | Related Articles | Metrics

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Problems and Solutions to Implementation of Direct Reporting of Adverse Reaction System by MAHs YANG Yue 2019, 16(11): 649-653.  DOI: 10.19803/j.1672-8629.2019.11.02 Abstract ( 1116 )   PDF (5340KB) ( 626 )   This paper reviewed the progress in the implementation of the system of direct reporting of adverse reactions by drug marketing authorization holders(MAHs), and analyzed the challenges facing MAHs, including the low report rate of ADRs from enterprises, communication barriers encountered by MAHs, pressure and concerns of medical institutions, and duplicate reporting. This study gave some tips on how to learn from foreign countries, address concerns over reporting on the part of all reporting parties, actively strengthen the reporting obligations of MAHs, open reporting channels and prevent duplicate reporting from the perspective of system implementation and practice. References | Related Articles | Metrics

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Investigation of Pharmaceutical Manufacturers’ Ability of Direct Reporting of Drug Adverse Reactions WANG Dan, LI Xinling, DONG Duo, XIONG Weiyi, LIU Cuili, ZHU Lan, GENG Fengying, LIAO Jianbo, YANG Yueming, LAN Shan, LV Xiaoqin, WANG Tongchun, ZHAO Xia, WANG Wen 2019, 16(11): 654-661.  DOI: 10.19803/j.1672-8629.2019.11.03 Abstract ( 777 )   PDF (13214KB) ( 641 )   Objective To investigate the status quo of and existing problems with ADR monitoring in the pharmaceutical industry in China, so as to propose measures to improve the ADR reporting ability of manufacturers.Methods Personnel interviews and questionnaires were used. Personnel interviews were conducted in the form of symposiums and on-the-spot investigation, using qualitative analysis Method. Questionnaire surveys were conducted among more than 1 000 manufacturers in 16 provinces, using qualitative analysis Method.Results There were many problems with the construction of ADR monitoring systems as well as with the collection, reporting, analysis and evaluation, and control of ADRs by drug manufacturers. Technical supervision and administrative supervision needed to be improved.Conclusion Drug manufacturers, ADR monitoring centers and drug regulatory authorities should implement the Notice of the NMPA on Direct Reporting Adverse Reactions by MAHs to the letter so as to improve the awareness of safety and the level of ADR monitoring in the pharmaceutical industry as a whole. References | Related Articles | Metrics

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Direct Reporting System for Adverse Drug Reactions Strengthens Fulfillment of Responsibilities of Marketing Authorization Holders HOU Yongfang, LIU Hongliang, Zheng Mingjie 2019, 16(11): 662-665.  DOI: 10.19803/j.1672-8629.2019.11.04 Abstract ( 915 )   PDF (4012KB) ( 409 )   Objective To introduce the direct reporting system for adverse drug reactions by the marketing authorization holder (MAH), in terms of the policy background and specific functions. Methods The direct reporting system for adverse reactions by MAHs in China was illustrated by introducing such functions of the system as direct reporting of adverse drug reactions, risk data feedback, and product information maintenance. Results & Conclusion Since the direct reporting system for adverse reactions by MAHs in China was established, the regulators have been able to collect drug safety data of better quality from MAHs and promptly feedback the risk information to MAHs. The system can help MAHs to fulfill the main responsibilities. However, the application of E2B (R3)in the direct reporting system will face enormous challenges. References | Related Articles | Metrics

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MAHs’ Principal Responsibilities for Safety Risk during the Whole-life Cycle of Drugs ZHONG Lumiao 2019, 16(11): 666-669.  DOI: 10.19803/j.1672-8629.2019.11.05 Abstract ( 569 )   PDF (4042KB) ( 409 )   Objective To enhance MAHs’awareness of principal responsibilities for drug safety risks.Methods The causes of pre-marketing and post-marketing risks were analyzed. The strengths of regulatory models overseas were summarized.Results & Conclusion In the whole-life cycle of drugs, MAHs, as the main body of research and development, production and economic benefit, should bear the principal responsibilities for drug safety risks. References | Related Articles | Metrics

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Post-marketing Risk Management of New Drugs in China Inspired by E2E Guidelines ZOU Limin, QI Yueli, TANG Ling, YANG Zhimin 2019, 16(11): 670-674.  DOI: 10.19803/j.1672-8629.2019.11.06 Abstract ( 605 )   PDF (4641KB) ( 361 )   Objective To propose new ideas on post-marketing risk management of new drugs in China. Methods By reviewing the ICH harmonized tripartite guideline pharmacovigilance planning E2E, and drawing lessons from the practices of regulatory bodies of the European Union, Japan and USA, suggestions on post-marketing risk management of new drugs were raised in line with the regulatory environment of pharmaceuticals in China. Results To comply with E2E, China’s regulatory bodies are to require that a risk management plan composed of safety specifications and risk counter-measures should be included in the dossiers of drug marketing authorization applications, especially applications related to a new entity. Regulatory bodies assume the responsibility to offer solutions and guidance to applicants to address issues and challenges during implementation. Conclusion Regulatory bodies in China should be faithful to the ICH commitment by following the E2E guidelines to promote the post-marketing risk management of drugs, new entities in particular, which conforms to the current regulatory environment of pharmaceuticals in China and can benefit patients. References | Related Articles | Metrics

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Risks Analysis of Gastrodin Injection WANG Tao, WANG Dan 2019, 16(11): 675-677.  DOI: 10.19803/j.1672-8629.2019.11.07 Abstract ( 518 )   PDF (2925KB) ( 194 )   Objective To analyze the risk related to gastrodin injection in China in order to provide reference for clinical rational drug use. Methods The individual cases of adverse drug reactions in China Adverse Drug Reaction Database and domestic and foreign literature, as well as risk management measures taken in China were analyzed. Results When gastrodin injection was used clinically, there were risks associated with pediatric use and severe allergic reactions. Conclusion We should strengthen the clinical application monitoring of gastrodin injection, update the drug labeling without delay and promote the rational use of medicines. References | Related Articles | Metrics

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Stability and Variation of Plasma Concentrations of Isoniazid, Rifampicin and Pyrazinamide ZHOU Jun, LIU Yuan, LV Xiaohui, ZHAO Yuan, XIONG Chaogang, LEI Qian, WANG Hao 2019, 16(11): 678-682.  DOI: 10.19803/j.1672-8629.2019.11.08 Abstract ( 578 )   PDF (4832KB) ( 132 )   Objective To investigate the stability, regularity and variation of plasma drug concentration of three commonly used first-line anti-tubercular drugs, and to assess and improve the value of therapeutic drug monitoring (TDM) in guiding individualized applications of clinical anti-tubercular drugs. Methods By comparing the deviations of plasma concentrations between two times of testing, we analyzed the stability of plasma concentrations of three of three anti-tubercular drugs - isoniazid, rifampicin and pyrazinamide. Moreover, the extent to which isoniazid, rifampicin and pyrazinamide varied was compared by uniforming and analyzing the data by dividing the deviations of the Results of two-time tests by the average of the paired Results. Results It was found that each drug had a concentration disparity between the two-time testing. However, there was no significant differences between the two lines of data in paired t-test (isoniazid: t=0.924, P=0.363; rifampicin: t=0.054, P=0.957; pyrazinamide: t=1.027, P=0.323). Further analysis revealed that the variation of isoniazid and rifampicin was larger than that of pyrazinamide. Conclusion During individualized treatment based on TDM monitoring, drugs which have large fluctuation in metabolic changes and intracorporal exposure levels, such as isoniazid and rifampicin, need to be detected more than once as actually required. References | Related Articles | Metrics

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Blood Concentration Monitoring of Vancomycin in One Patient with Peritoneal Dialysis-related Peritonitis YANG Qing, CAI Ning, YUAN Ling, SUN Bin, JIN Xin 2019, 16(11): 683-687.  DOI: 10.19803/j.1672-8629.2019.11.09 Abstract ( 332 )   PDF (4646KB) ( 101 )   Objective To provide reference for clinical pharmacists when participating in anti-infection therapy and individualized pharmaceutical care for patients with peritoneal dialysis-related peritonitis. Methods Clinical pharmacists participated in the pharmaceutical treatment of a patient with peritonitis in our hospital by consulting relevant information on diagnosis and treatment of peritonitis and monitoring blood drug concentration, and gave recommendations on the vancomycin medication regimen to assist clinicians in formulating an individualized regimen. Results After anti-infection therapy, the peritonitis of the patient was effectively controlled and no adverse drug reactions occurred. Conclusion Using blood concentration monitoring technology and relevant professional knowledge, clinical pharmacists can play an important role in the treatment of peritonitis patients by assisting clinicians in the preparation and modification of medication regimens, and by providing individualized pharmaceutical care for patients.Keywords: peritonitis; peritoneal dialysis; vancomycin; blood concentration monitoring References | Related Articles | Metrics

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Research Progress in Mechanisms of Drug-induced Kidney Injury QIU Caixia, YANG Cuiping, JIN Hongtao 2019, 16(11): 688-694.  DOI: 10.19803/j.1672-8629.2019.11.10 Abstract ( 470 )   PDF (6650KB) ( 243 )   Objective To help gain keen insights into drug-induced kidney injury and prevent such injury by analyzing the mechanism of this disease Methods By searching PubMed, ScienceDirect and other authoritative databases, the latest literature was summarized on the pathogenesis, mechanism, typical diseases and drug safety evaluation Methods of drug-induced kidney injury. Results The clinical phenotypes of drug-induced kidney injury could be divided into four categories: acute renal injury, glomerular injury, renal tubule injury and renal calculus. The mechanisms of drug-induced kidney injury could be divided into six categories: direct action, oxidative stress, immune inflammation, acid-base balance disorder, drug effect on transporters. Typical drug-induced kidney injury included thrombotic microangiopathy, aristolochic acid nephropathy and Fanconi syndrome. More sensitive Methods for safety evaluation of drug-induced kidney injury were needed. Conclusion We should improve our understanding of the clinical phenotypes, pathogenesis and typical diseases of drug-induced kidney injury and try to establish comprehensive and reliable drug safety evaluation Methods so as to update our knowledge of drug-induced kidney injury while enhancing prevention and control of this disease. References | Related Articles | Metrics

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One Case of Systemic Urticaria Complicated with Dyspnea Induced by Moxifloxacin Hydrochloride Injection LIU Xiaoli, LIU Yajuan, CAO Yidan, SONG Yanqing, WANG Xiangfeng 2019, 16(11): 695-696.  DOI: 10.19803/j.1672-8629.2019.11.11 Abstract ( 494 )   PDF (2054KB) ( 232 )   References | Related Articles | Metrics

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One Case of Erythrodermic Drug Eruption Induced by Meropenem for Injection ZHAO Na, LIU Wei, BAI Xiafeng 2019, 16(11): 697-698.  DOI: 10.19803/j.1672-8629.2019.11.12 Abstract ( 426 )   PDF (1959KB) ( 178 )   References | Related Articles | Metrics

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One Case of New Adverse Drug Reaction Induced by Compound Dilong Capsules TANG Man, CHEN Xintong 2019, 16(11): 699-700.  DOI: 10.19803/j.1672-8629.2019.11.13 Abstract ( 374 )   PDF (1873KB) ( 222 )   References | Related Articles | Metrics

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One Case of Anaphylactic Shock Induced by Thromboplastin for Injection ZHAO Pei, MI Cuilan, GONG Kaimin, LIU Jun 2019, 16(11): 701-702.  DOI: 10.19803/j.1672-8629.2019.11.14 Abstract ( 400 )   PDF (1920KB) ( 187 )   References | Related Articles | Metrics

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One Case of Severe Allergic Reaction Induced by Diclofenac Sodium Lidocaine Injection YUWEN Lixia, KONG Yingli, YUAN Yaohui, WANG Lihua 2019, 16(11): 703-704.  DOI: 10.19803/j.1672-8629.2019.11.15 Abstract ( 473 )   PDF (56318KB) ( 203 )   References | Related Articles | Metrics