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Clinical Research of COVID-19 Based on Good Clinical Practices for Clinical Trials of Drugs CONG Duanduan, ZHAO Fei, XUE Wei, LI Kexin, HU Xin 2021, 18(2): 101-104.  DOI: 10.19803/j.1672-8629.2021.02.01 Abstract ( 219 )   PDF (554KB) ( 152 )   Objective To review several issues arising from the current clinical trials of coronavirus disease 2019 (COVID-19) so as to promote subsequent trials and regulation. Methods In line with the new version of Good Clinical Practices for Clinical Trials of Drugs (2020 edition), the on-going COVID-19-related clinical trials were studied through an exhaustive literature search. Results The surge of COVID-19 related clinical trials had advanced our understanding of the characteristics and pathogenic mechanisms of SARS-CoV-2, and promoted the development of vaccines and drugs. However, many problems also arose, such as design flaws, waste of research resources, and regulatory difficulties. Conclusion The National Medical Products Administration (NMPA) and the National Health Commission (NHC) should draw on the experience of our own and other countries, solicit expert opinions and continue to optimize resource allocation. By promoting high-quality and high-efficiency clinical trials and nurturing professional clinical researchers, the national public health emergency management system will be improved substantially. References | Related Articles | Metrics

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Active Monitoring of Adverse Drug Reactions Caused by Lopinavir/ritonavir in Treating Coronavirus Disease 2019 WU Fei, LI Min, FANG Yuting, CHEN Yongwu, SHEN Aizong 2021, 18(2): 105-109.  DOI: 10.19803/j.1672-8629.2021.02.02 Abstract ( 194 )   PDF (1331KB) ( 164 )   Objective To investigate the safety of LPV/r in the treatment of patients with COVID-19, and to provide reference for the safe use of LPV/r. Methods Based on China Hospital Pharmacovigilance System, an LPV/r active monitoring model was established through teamwork to monitor COVID-19 patients who were using LPV/r from January 21 to February 23, 2020.The positive warning cases were reviewed manually for further study on ADRs. Results A total of 65 patients were monitored. After manual re-evaluation, the incidence of LPV/r-related hepatic dysfunction was 29.23% and severe ADRs occurred in one patient. A duration of medication of more than10 d (OR=4.511, 95% CI: 1.128~18.033) was an independent risk factor for hepatic dysfunction caused by LPV/r. Text active monitoring found 23 cases of adverse reactions, the most common one of which was nausea. Conclusion LPV/r can cause hepatic dysfunction, nausea, vomiting and other adverse reactions. During clinical medication, the laboratory indicators of patients should be closely monitored as a precaution, and symptomatic treatment should be actively conducted to prevent the occurrence of severe ADRs. References | Related Articles | Metrics

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Safety of an Anti-novel Coronavirus Pneumonia Drug：Chloroquine Phosphate LYU Qiang, YAN Jiayang, ZHANG Wangzheqi, YE Xiaofei, GUO Xiaojing 2021, 18(2): 110-114.  DOI: 10.19803/j.1672-8629.2021.02.03 Abstract ( 188 )   PDF (1191KB) ( 182 )   Objective To analyze safety signals of chloroquine phosphate based on the data of the US FAERS and Canada Vigilance in order to provide reference for safe and rational medication against novel coronavirus pneumonia. Methods The reporting odds ratio method (ROR) and the information component method (IC) were adopted to detect ADR signals of the data of the FAERS from 2015 to 2019 and of Canada Vigilance from 1965 to 2019. Results From FAERS and Canada Vigilance, a total of 126 cases and 54 cases of adverse drug reactions were obtained respectively, and a total of 58/32, 9/2 ADR signals were detected by ROR and IC from FAERS and Canada Vigilance. The SOC with the largest number of reports of ADR signals in FAERS was injury, poisoning and procedural complications (85 cases, 16.2%), while PT with the strongest signal was restrictive cardiomyopathy (n=9, ROR=18.92, IC=4.24), compared with skin and subcutaneous tissue disorders (23 cases, 18.7%) and photosensitivity reaction (n=9, ROR=17.01, IC=4.08) respectively in Canada Vigilance. Conclusion Long-term clinical use of chloroquine phosphate can cause severe ADRs, so this drug should be used with caution in patients with heart-based diseases and nervous system-based diseases. References | Related Articles | Metrics

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Mechanism of Shufeng Jiedu Capsules in Treating Coronavirus Based on Network Pharmacology and Molecular Docking LIU Xiao, XU Yinying, JIANG Sunmin, XU Yun 2021, 18(2): 115-120.  DOI: 10.19803/j.1672-8629.2021.02.04 Abstract ( 180 )   PDF (2404KB) ( 233 )   Objective To explore the possible mechanism by which Shufeng Jiedu capsules can be used for treating the coronavirus (COVID-19) by using network pharmacology. Methods Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP) was used to screen the active ingredients and to predict targets of Shufeng Jiedu capsules. The COVID-19 related genes were screened via the Online Mendelian Inheritance in Man (OMIM) and The Human Gene Database (GeneCards), and the drug-target-disease network and protein-protein interaction (PPI) network were constructed with Cytoscape software. Autodock_vina was used for molecular docking verification. GO(Gene Ontology) function and Kyoto encyclopedia of genes and genomes (KEGG) pathway enrichment were analyzed based on David database. Results The results showed that 190 kinds of active ingredients in Shufeng Jiedu capsules were screened, and 299 predicted targets were selected. There were 52 targets that were intersected with COVID-19. Through the topological analysis of the drug-target-disease network and PPI network, eight core active components including resveratrol, puerarin, and quercetin were screened out, so were four core targets such as interleukin-6 (IL-6), tumor necrosis factor (TNF), mitogen-activated protein kinase 8 (MAPK8), and mitogen-activated protein kinase 1 (MAPK1). A total of 130 GO entries with P≤0.05 and False Discovery Rate （FDR）≤0.05 were enriched, involving lipopolysaccharide-mediated signal pathways, cytokine activity, inflammatory response, and immune response. 23 KEGG pathways with P≤0.05, FDR≤0.05, were enriched to TNF signal pathway, phosphatidylinositol 3 kinase-protein kinase B (PI3K-AKT) signal pathway, nuclear factor kappa-B (NF-кB) signaling pathway, hypoxia-inducible factor-1 quotation pathway, and calcium ion signaling pathway. Molecular docking verification showed that the core active components possessed good binding activity with the receptor-binding domain of virus chimera and angiotensin-converting enzyme. Conclusion Resveratrol, puerarin, emodin and other components of Shufeng Jiedu capsules may affect the invasion of virus by acting on ACE and cell serine protease, thus having therapeutic effect against COVID-19. References | Related Articles | Metrics

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Effects of Quercetin on Rat Isoniazide Metabolism via N-acetyltransferase Evaluation RAO Zhi, ZANG Kaihong, WANG Xiaohua, QIN Hongyan 2021, 18(2): 121-125.  DOI: 10.19803/j.1672-8629.2021.02.05 Abstract ( 93 )   PDF (1594KB) ( 92 )   Objective To investigate the effect of quercetin on the metabolic properties of isoniazide (INH) in rats by evaluating N-acetyltransferase (NAT). Methods Male Wistar rats were orally administered with INH (60 mg/kg) alone or in combination with quercetin (50 mg/kg). Serum samples were collected at the designated time points after INH administration. The serum concentrations of INH and its metabolite acetylisoniazid (Ac-INH) were determined using HPLC-MS, and the pharmacokinetic parameters were calculated. After that, liver samples were collected to determine the protein expression and enzyme activity of NAT in order to explore the underlying mechanism. Results Compared to the INH treated group, quercetin and INH co-administration significantly elevated the serum concentration of INH (P<0.05)L/h/kg, accompanied by markedly reduced concentration of Ac-INH (P<0.05). The pharmacokinetic parameters of AUC0→t (60.15±9.69 vs 43.40±2.89)mg h/L and t1/2 (3.09±1.56 vs 1.07±0.13) h in quercetin pretreated rats were all significantly increased, while those of CL/F were markedly reduced (0.93±0.15 vs 1.38±0.11, P<0.05). Moreover, compared to the INH treated group, NAT activity rather than NAT expression in the quercetin and INH co-administration group was markedly reduced (P<0.05). Conclusion Quercetin can reduce the metabolism of INH and the concentration of Ac-INH by inhibiting NAT activity. This finding may provide an important clue to the prevention of INH-induced hepatotoxicity. References | Related Articles | Metrics

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Effects of Polypharmacy on Long-term Prognosis of Elderly Patients with Coronary Heart Disease and Atrial Fibrillation DONG Min, ZOU Tong, XU Lei, HE Qinghua, PEI Zuowei, WANG Fang 2021, 18(2): 126-132.  DOI: 10.19803/j.1672-8629.2021.02.06 Abstract ( 138 )   PDF (1126KB) ( 122 )   Objective To explore the effect of polypharmacy on the long-term prognosis of elderly patients with coronary heart disease and atrial fibrillation. Methods Patients aged over 65 years with coronary heart disease and atrial fibrillation were studied and followed up for a minimum of 5 years via the telephone, outpatient and inpatient case inquiry. The difference in liver and kidney function,adverse drug reactions (ADR) and major adverse cardiovascular and cerebrovascular events (MACCE) in patients using different types of drugs was studied. Results A total of 295 patients were included in the study, with an average age of （79.2±5.9） years. In addition, 141 (47.8%) of these patients were over 80 years old. Each of them was afflicted with (6.5±1.9) kinds of diseases and used (8.3±3.2) types of dispensed drugs on average. 267 of these patients (90.5%) were treated with more than 5 types of dispensed drugs, 223 (75.6%) with antiplatelet therapy and 63 (21.4%) with anticoagulation. In different age groups, patients were divided into polypharmacy group A (dispensed drugs≥8) and polypharmacy group B (dispensed drugs<8) according to the types of medication. In the younger group（aged<80 years）, the proportion of old myocardial infarction and heart failure in group A was higher than that in group B (36.0% vs 21.5%, 52.0% vs 31.6%, respectively, P<0.05). In the older group（aged≥80 years）, NYHA heart function grade in group A was worse than that of group B (2.2±0.9 vs 2.1±1.0, P<0.05). During the follow-up of at least 5 years, the incidence of MACCE and heart failure in group A was significantly higher than that in group B in both age groups (P<0.05), and the incidence of bleeding was slightly higher in group A (P> 0.05), but there was no significant difference between the two groups in the changes of ALT, AST, GFR, ADR or death rate (P>0.05). Conclusion Polypharmacy is not uncommon in elderly patients with coronary heart disease and atrial fibrillation, especially in patients with old myocardial infarction and heart failure. During the follow-up, no deterioration of liver and kidney function, ADR or increased mortality have been found except for the slightly higher risk of bleeding. Therefore, the diagnosis and treatment of this cardiovascular high-risk population requires a comprehensive and optimized drug treatment scheme that can be simplified as long as the curative effect can be ensured to achieve the best possible prognosis References | Related Articles | Metrics

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Sampling Investigation of Current Situalion of Pharmacovigilance in Pharmaceutical Manufacturers in Jiangsu Province SHEN Mengqiu, LI Ming, WANG Jiayu, GAN Ge, LIU Pengcheng, SUN Jun 2021, 18(2): 133-137.  DOI: 10.19803/j.1672-8629.2021.02.07 Abstract ( 313 )   PDF (1169KB) ( 336 )   Objective To investigate the status quo of pharmacovigilance by drug manufacturers in Jiangsu Province, and to offer recommendations on how to improve pharmacovigilance by manufacturers amid the transition from monitoring of adverse drug reactions to pharmacovigilance. Methods After representatives of drug manufacturers in Jiangsu Province were selected, a questionnaire survey was conducted regarding the pharmacovigilance system, drug safety monitoring and risk management. SPSS 22.0 software was used for data entry and statistics. Results The survey covered 108 drug manufacturers of different types. The results indicated that most of the enterprises had established basic pharmacovigilance systems. Although the input into and effectiveness of ADR monitoring systems are increasing among those manufacturers, the level of risk management is relatively low. Conclusion It is recommended that manufacturers improve their awareness of drug safety, strengthen their pharmacovigilance systems, overcome their weaknesses, and that regulatory authorities and agencies provide related support in a timely manner. References | Related Articles | Metrics

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Influence of Chinese Hospital Pharmacovigilance System on Quality of ADR Reports in 2 Hospitals YUAN Xingdong, XU Yuming, ZHOU Juan, XU Jin, ZHONG Changming, LIU Zhijun, ZHANG Wei 2021, 18(2): 138-140.  DOI: 10.19803/j.1672-8629.2021.02.08 Abstract ( 252 )   PDF (1099KB) ( 188 )   Objective To explore the influence of Chinese Hospital Pharmacovigilance System(CHPS) on the quality of ADR reports. Methods The ADR reports submitted by two hospitals before the installation of CHPS and one year later were divided into the control group and study group. The indexes of the reports were scored in accordance with the "Guidelines for Quality Evaluation of ADR Reports (Tentative)". The difference in the number of ADR reports, quality of individual reports, overall quality of the reports and the total scores of the reports was compared between the two groups. Results The total number of ADR reports in the study group was 41.80% larger than that in the control group, and the number of serious ADR reports was 173.81% larger. The difference in the integrity and standardization of the reports between the two groups was statistically significant. The overall quality score and the total score of the reports in the study group were 34.28% and 21.41% higher than those in the control group, respectively. Conclusion CHPS is able to detect ADRs quickly, easily and accurately, which can significantly improve the quantity and quality of ADR reports in hospitals. References | Related Articles | Metrics

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Survey of the Regulation System of OTC Drugs in the United States XU Shungui, LIU Chunguang 2021, 18(2): 141-144.  DOI: 10.19803/j.1672-8629.2021.02.09 Abstract ( 231 )   PDF (1141KB) ( 216 )   Objective To provide reference for the improvement of regulation of OTC drugs in China by analyzing the related laws and regulations concerning OTC drugs in the United States. Methods By consulting the official website and literature of the US drug regulatory departments, the author analyzed the progress in the US OTC drug marketing system and procedures, prescription drug conversion, OTC drug labeling and supervision of advertisements. Ways to promote the supervision of China' s OTC drugs were also recommended. Results OTC monograph path saves review resources, improves regulatory efficiency, and speeds up the listing of OTC drugs.in the USA. At the same time, it actively modifies the monograph process to deal with the backlog of monographs and inefficient review. Conclusion It is recommended that marketing methods of OTC drugs be diversified in China by learning from the United States. We should innovate the post marketing supervision of OTC drugs, bring into full play the role of industry associations, tighten the control over OTC advertising, and help consumers learn more about drug use. References | Related Articles | Metrics

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104 Cases of New and Serious Adverse Drug Reactions Induced by Creatine Phosphate Sodium for Injection SUN Chunxiao, TIAN Yuejie, XIE Yanjun, XU Lili, CHANG Hong, HUO Yanfei, WU Shifu 2021, 18(2): 145-149.  DOI: 10.19803/j.1672-8629.2021.02.10 Abstract ( 185 )   PDF (1193KB) ( 268 )   Objective To analyze the factors related to new and serious adverse drug reactions (ADRs) induced by creatine phosphate sodium for injection, and provide reference for clinical medication safety. Methods As was reported by Shandong Province to the national ADR monitoring system between January 2008 and December 2018,104 cases of new and serious ADRs of creatine phosphate sodium for injection were retrieved for analysis. The information about these cases of ADRs, such as patients' age and gender,preexisting diseases,allergy,methods of administration,combined therapy,the onset time and results of ADRs, was analyzed statistically．Results Of the 104 reports about new and serious ADRs of creatine phosphate sodium for injection, 71 cases (68.27%) were new ADRs, and 33 cases (31.73%) were severe ones. There were 61 males and 43 females involved, and the ratio of males to females was 1.42∶1. Most of them were aged 61-70 years or less than 10 years old, accounting for 57.69% of the total. There had been 5 cases of adverse drug reactions/incidents before. Most of these ADRs occurred within one day of treatment. The systems involved were mainly gastrointestinal damage, systemic damage, damage to the skin and its attachments, damage to central and peripheral nervous systems, and damage to the respiratory system. The main manifestations included nausea, vomiting, chills, high fever, rash, itching, dizziness, and chest tightness. Conclusion The drug instructions for creatine phosphate sodium for injection are not specific enough. The prevention of ADRs and standard clinical application should become a priority, and drug use has to be monitored to ensure safe and effective drug use. References | Related Articles | Metrics

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Safety of High-dose Canagliflozin for Type 2 Diabetes Mellitus: A Meta Analysis CHEN Qiying, HUANG Dandan, CHEN Tianyu 2021, 18(2): 150-154.  DOI: 10.19803/j.1672-8629.2021.02.11 Abstract ( 127 )   PDF (1418KB) ( 121 )   Objective To evaluate the safety of high-dose canagliflozin(CANA) in the treatment of type 2 diabetes mellitus(T2DM). Methods PubMed, Medline, Cochrane Library, Embase, CNKI, Wanfang Database, VIP and CBM were searched for randomized controlled trials (RCTs) published from the inception of the database to September 2019. Data on randomized controlled trials related to canagliflozin at a low dose of 100 mg/d and at a high dose of 300 mg/d used for treating type 2 diabetes mellitus was collected and analyzed using the RevMan5.3 software. Results A total of 14 RCTs and 6, 233 cases of patients were included. Meta analysis results showed that high doses of calpagliflozin were more likely to cause male genital fungal infections, and the difference was statistically significant [RR=1.38,95％CI(1.06,1.79),P=0.02]. The risk was also higher for volume depletion-related AEs and the difference was statistically significant[RR=1.44,95％CI(1.05,1.98),P=0.03]. LDL-C levels increased more significantly, and the difference was statistically significant [MD=0.05,95％CI(0.00,0.10),P=0.04]. The occurrence of ther difference was basically similar to that of low dose. Conclusion High-dose canaglif102in can in rease the risk of male genital fungal infections, volume depletion-related AEs. and elevated the LDL-C levels There is no significant difference in the occurrence of other adverse reactions. However, this conclusion needs to be verified by long-term RCTs. References | Related Articles | Metrics

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112 Cases of Hypersensitivity Induced by Methylprednisolone Sodium Succinate CHEN Huanlei, LI Ning, ZHENG Xueling 2021, 18(2): 155-159.  DOI: 10.19803/j.1672-8629.2021.02.12 Abstract ( 205 )   PDF (1099KB) ( 319 )   Objective To investigate the characteristics and regularity of hypersensitivity caused by methylprednisolone sodium succinate in order to provide reference for rational clinical use of drugs. Methods The data on 112 cases of ADRs induced by methylprednisolone sodium succinate that was collected by Weifang Center for ADR Monitoring between January 2013 and October 2019 was analyzed. Results Among the 112 patients, the ratio of males to females was 1.6:1, and 66.07% of them were 0-3 years old. The preexisting diseases mostly involved the respiratory system, accounting for 67.87% of the total. The most common manifestations of hypersensitivity were the damage to the skin and its accessories (74.63%). Meanwhile, 96.43% of the ADRs occurred on the day of administration, and 71.43% within 30 minutes. In the end, 110 patients were improved/cured after symptomatic treatment. Conclusion The hypersensitivity induced by methylprednisolone sodium succinate deserves more attention. Administration should be discontinued soon after ADRs occur and symptomatic treatment should start without delay. References | Related Articles | Metrics

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Literature Analysis of Adverse Drug Reactions Induced by Articaine as Stomatological Medicine XIA Lin, YANG Hongwen, WANG Fang 2021, 18(2): 160-163.  DOI: 10.19803/j.1672-8629.2021.02.13 Abstract ( 190 )   PDF (1108KB) ( 640 )   Objective To analyze the characteristics and regularity of adverse reactions induced by articaine as a stomatological medicine so as to provide reference for the prevention of adverse reactions and rational clinical use. Methods Using“articaine”“primacaine”“to”“allergy”and“adverse reactions”as the key words, the articles in the CNKI and Wanfang detabase published from January 2005 to December 2018 were searched for and retrieved. The literature was analyzed according to the inclusion and exclusion criteria. Results A total of 27 papers (29 cases) were included. Systems and organs involved in ADRs were mostly central and peripheral nervous systems, the cardiovascular system and respiratory system. ADRs occurred most frequently within 30 min of medication. Conclusion More attention should be paid to articaine-caused adverse reactions in stomatology. Precautions should be taken to prevent adverse reactions, especially common allergic reactions so as to reduce the damage of adverse reactions to patients. References | Related Articles | Metrics

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Countermeasures Against Risk of Neonatal Off-label Drug Use JIANG Yongxian, PU Xinyu, CHEN Wenwen, TAO Wanjun, CHEN Juan, LI Gen 2021, 18(2): 164-169.  DOI: 10.19803/j.1672-8629.2021.02.14 Abstract ( 189 )   PDF (1288KB) ( 182 )   Objective To retrospectively analyze off-label medications among neonatal inpatients in our hospital in 2018, and to identify the risk factors for drug use so as to provide data for reducing the risk of drug use and optimizing off-label drug use policies in our hospital. Methods Neonatological cases and related doctors' instructions in 2018 were randomly chosen using the method of equal number distribution. The basic information of the patients, incidence of off-label instructions, types of drugs used, and the incidence of adverse events were statistically analyzed. Results Based on the number of children and the number of medication orders, the incidence of off-label drug use was 98.13% and 65.48% respectively. The average number of off-label drugs used per child was 11.9±1.5. The most common drugs that were used off-label were contrast agents (100.00%), followed by hematopoietic drugs (96.03%), and respiratory drugs (95.38%). Off-label use of drugs often involved drugs whose usage for newborns was not mentioned (61.89%), over-indication drugs (15.83%) and over-dose drugs (8.66%). The proportion of adverse events caused by off-label drug use was 55.56%. Conclusion The incidence of off-label drug use among newborns in our hospital is high, involving a wide range of varieties, Therefore, hospitals should improve the documentation of off-label drug use, ensure informed consent of patients, and work out emergency measures and monitor the risk of off-label drug use daily. References | Related Articles | Metrics

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Neuropsychiatric Symptoms Induced by Oxytocin Injection BAI Junsong, CAO Jianying, Li Jia 2021, 18(2): 170-173.  DOI: 10.19803/j.1672-8629.2021.02.15 Abstract ( 210 )   PDF (1150KB) ( 381 )   Objective To analyze the risk of neuropsychiatric symptoms induced by oxytocin injection. Methods A total of 481 cases of suspected ADRs caused by oxytocin injection collected by the ADR monitoring database of Shandong Province between 2018 and 2019 and by Weifang between 2013 and 2017 were analyzed. Results Monitoring data, domestic and foreign literature showed that neuropsychiatric symptoms were a new risk of serious adverse reactions induced by oxytocin injection. Conclusion The safety monitoring and risk control of oxytocin injection should be strengthened, and the product specifications should be updated quickly to promote the safe and rational use of drugs in clinical practice. References | Related Articles | Metrics

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Analysis and Consideration on Risk of Sodium Aescinate for Injection YU Yi, WANG Hui, LIU Hongliang, WANG Chunting 2021, 18(2): 174-177.  DOI: 10.19803/j.1672-8629.2021.02.16 Abstract ( 208 )   PDF (1363KB) ( 284 )   Objective To analyze the risk of Sodium Aescinate for injection, so as to provide reference for clinical use safety. Methods The individual ADR (adverse drug reaction) cases in China adverse drug reaction database, domestic literatures, and the risk management measures by NMPA were analyzed. Results Data analysis showed that, the ADR of the Rash, pruritus, phlebitis, anaphylactic shock, liver damage et al. induced by Sodium Aescinate for injection and the risk of medication for children and the elderly should be concerned in clinical use and take relevant prevention and control measures. Conclusion Marketing authorization holders should take risk control measures such as revising the drug instructions for the identified risks and actively carry out post market study; hospitals should strengthen the rational use of drugs to avoid the occurrence of adverse reactions; institutions of monitoring and evaluation of adverse drug reactions should continuously strengthen the monitoring of adverse reactions to ensure the safety of drug users. References | Related Articles | Metrics

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Efficacy and Safety of Osimertinib in the Treatment of EGFR-mutated Advanced Non-small Cell Lung Cancer：A Meta-analysis ZHANG Conghui, XIE Yanjun, PENG Tingting, LU Yan, GUO Linlin, LIU Jian 2021, 18(2): 178-183.  DOI: 10.19803/j.1672-8629.2021.02.17 Abstract ( 219 )   PDF (1224KB) ( 159 )   Objective To evaluate the efficacy and safety of osimertinib in the treatment of non-small cell lung cancer (NSCLC). Methods RCTs related to osimertinib used for treating NSCLC were collected by searching PubMed, EMbase, the Cochrane Library, CNKI, VIP and Wanfang database from the beginning to December 31, 2019. After quality evaluation and information retrieval,a meta-analysis was conducted using Stata 12.0 software. Results A total of 8 studies and 1 795 patients were included. Meta analysis results showed that the progression-free survival (PFS), Objective response rate (ORR), and disease control rate (DCR) of the osimertinib group were better than those of the control group, and their differences were statistically significant (all P<0.05). In the subgroup analysis, for patients with Ex19del / L858R mutations, the PFS, ORR and DCR achieved with osimertinib as a first-line therapy were better than those of the first-generation EGFR-TKIs (gefitinib/erlotinib), and their differences were statistically significant. except for ORR (all P<0.05). For patients with T790M mutations, PFS, ORR, and DCR achieved with osimertinib as a second-line treatment were better than those of chemotherapy, and their difference were also statistically significant (all P<0.05). As for safety, the incidence of adverse drug reactions (ADRs) and grade≥3 ADRs in the osimertinib group was lower than that of the control group, but there was no significant difference in the incidence of ADRs (P>0.05). In addition, the incidence of diarrhea, interstitial lung disease, prolonged QT interval, and rash/acne was significantly. whether it is first-line medication or second-line and above medication after T790M mutation. higher in the osimertinib group than in the control group. Conclusion For patients with EGFR-mutant NSCLC, whether it is first-line medicaation or second-line and above medication after T 790M mutation osimertinib is more effective and can reduce the incidence of grade ≥3 ADRs, but there is safety risk. References | Related Articles | Metrics

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Early Warning of Risks of Statins in Atherosclerosis Therapy Based on Bioinformatics ZOU Lina, LIN Zhijian, ZHANG Xiaomeng, ZHANG Bing, HUANG Zhengkai 2021, 18(2): 184-189.  DOI: 10.19803/j.1672-8629.2021.02.18 Abstract ( 125 )   PDF (2231KB) ( 130 )   Objective To explore the potential safety risks of statins in the treatment of atherosclerosis based by bioinformatics. Methods The gene chip data GSE32547 in GEO database was retrieved by bioinformation technology. GO annotation, KEGG pathway analysis and protein interaction network analysis were conducted of the genes differentially expressed in HUVECs cells by statins to identify the safety risk of statins in the treatment of atherosclerosis. Results The results showed that the treatment of atherosclerosis with statins could be accompanied by skeletal muscle injuries and abnormalities in neurochemical conduction, thyroid metabolism, the respiratory system and fertility. Conclusion Statins can cause potential adverse reactions when used in the prevention and treatment of atherosclerosis. When statins are used for treating atherosclerosis, the condition of a patient's skeletal muscle deserves attention. When patients with skeletal muscle disease take statins, the risk/benefit to patients should be evaluated. Clinicians should be alert to safety risks to the nervous system, endocrine system, respiratory system and reproductive system. References | Related Articles | Metrics

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Evaluation Outpatient Prescriptions of Local Anesthetics in Stomatological Hospital YU Jiaoling 2021, 18(2): 190-193.  DOI: 10.19803/j.1672-8629.2021.02.19 Abstract ( 433 )   PDF (1007KB) ( 537 )   Objective To evaluate the prescriptions of local anesthetics in a stomatological hospital, and promote the rational use of the drug. Methods A total of 113 590 prescriptions of local anesthetics from the outpatient department of a hospital in 2019 were selected. According to the Prescription Administrative Policy and Management Practices of Hospital Prescription Comment (on trial), drug instructions, relevant guidelines and expert consensus, special comments were made on local anesthetics, while the way these drugs were used and causes of irrational use were analyzed. Results There were 1 811 imperfect prescriptions of local anesthetics, accounting for 1.59% and involving sub-standard medication, inappropriate selection of drugs, inappropriate usage and dosage, incompatibility or adverse interactions. Conclusion The clinical use of local anesthetics in this hospital is basically proper, but there are still some problems. We should continue to strengthen the management, constantly improve the level of rational drug use, and ensure the safety of drug use for patients. References | Related Articles | Metrics

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Case Analysis of Drug-induced Microscopic Colitis due to Long-term Use of Proton Pump Inhibitor KONG Bin, LIN Rongfang, LIU Xiaoxia 2021, 18(2): 194-195.  DOI: 10.19803/j.1672-8629.2021.02.20 Abstract ( 191 )   PDF (804KB) ( 92 )   Objective To analyze the process of diagnosing and treating a rare case of microscopic colitis detected during histopathological examination of a patient with chronic diarrhea, who had long been taking a proton pump inhibitor (PPI). Methods Related literature was reviewed while the characteristics of drug-induced microscopic colitis and the mechanism of PPI-induced microscopic colitis were analyzed to determine the adverse drug reactions in this case. Results Irregular and long-term use of a PPI was likely to lead to drug-induced microscopic colitis. Conclusion Clinical pharmacists ought to use their knowledge of pharmacy to quickly discover the adverse reactions caused by drugs in clinical diagnosis and treatment, which can provide reference for the rational use of PPIs in clinical practice. References | Related Articles | Metrics

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Cace Analysis of General Numbness and Dyspnea Caused by Foscarnet Sodium for Injection LIU Yang, MA Chunhua, LIANG Lianchun 2021, 18(2): 196-198.  DOI: 10.19803/j.1672-8629.2021.02.21 Abstract ( 238 )   PDF (784KB) ( 245 )   Objective To explore the mechanism of foscarnet sodium causing general numbness and dyspnea and to analyze the related literature. Methods A case of liver failure with cytomegalovirus infection was diagnosed and treated in our hospital. The symptoms of numbness and dyspnea occurred during the application of foscarnet sodium. Through literature analysis, the mechanism of the occurrence of foscarnet sodium related adverse reactions was discussed. Results Foscarnet sodium could cause general numbness and dyspnea, which might be related to hypocalcemia. Conclusion During the application of foscarnet sodium, the patients should be closely monitored, and adverse reactions should be found and treated in time. References | Related Articles | Metrics