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Application and Evaluation of Arbidol in Treating Viral Diseases PANG Wenyuan, WANG Qiaoyu, ZHAO Zhigang 2020, 17(6): 321-325.  DOI: 10.19803/j.1672-8629.2020.06.01 Abstract ( 548 )   PDF (1016KB) ( 777 )   Since the outbreak of SARS-CoV-2, research on antiviral drugs has continued. Arbidol is a broad-spectrum antiviral drug mainly used for anti-influenza. The success of the vitro cell test on SARS-CoV-2 attracted clinical attention and arbidol began to be used in the treatment of COVID-19. However, because of our limited knowledge of the pharmacological mechanism, clinical application evaluation and pharmaceutical care of arbidol, its clinical use was limited. Based on the relevant literature and reference at home and abroad, this paper summarizes the basic information of arbidol, the pharmacological basis of treating viral diseases with arbidol, the application and evaluation of arbidol against viral diseases in order to provide reference for the safe and effective use of arbidol in the treatment of COVID-19. References | Related Articles | Metrics

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Safe Use of Lopinavir/Ritonavir for COVID-19 Based on Literature Analysis of Adverse Reactions CAI Jun, LI Huixin, LIU Mengying, YAO Yao, GE Weihong 2020, 17(6): 326-331.  DOI: 10.19803/j.1672-8629.2020.06.02 Abstract ( 426 )   PDF (1054KB) ( 250 )   Objective To explore the clinical characteristics of adverse reactions induced by lopinavir/ritonavir so as to provide reference for its safe use in COVID-19 patients. Methods Literature related to adverse reactions induced by lopinavir/ritonavir published as of February 15, 2020 was retrieved from CNKI, VIP Chinese full-text database, Wanfang database, Pubmed and Embase, and analyzed statistically in terms of the basic information of patients, use of medicines, systems or organs involved, clinical symptoms, drug-drug interactions, treatment and outcomes. Results A total of 99 papers involving 120 cases were enrolled with an average age of (39.6±14.8) years, including 81 males and 39 females. 110 of these cases were AIDS patients and 10 were cases of post-exposure prophylaxis. The median onset time of adverse reactions was 1.0 (0.3 to 5.0) month, with 40 cases within 10 days of administration. Adverse reactions related to systems or organs at any time point occurred mainly in the form of damage to the endocrine and metabolic system, skin and its accessories, cardiovascular system and the digestive system. However, within 10 days of administration, adverse reactions were mostly manifested as damage to the cardiovascular system, blood system, skin and its accessories, digestive system, and urinary system. Acute renal injury, leucopenia, complete atrioventricular block, thrombocytopenia, arrhythmia, rash and pruritus were common. Of the 120 cases of adverse reactions, 48 were due to drug-drug interactions involving fluticasone, triamcinolone, vinblastine, tacrolimus, warfarin, levothyroxine, docetaxel, and ergotamine. After treatment, symptoms improved in 111 patients , but worsened in 4 patients and 5 patients died. Conclusion We should be alert to the adverse reactions induced by lopinavir/ritonavir in the early stage of medication in order to prevent drug-drug interactions and to ensure the safety of medication. References | Related Articles | Metrics

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Risk Management of Adverse Drug Reactions/Events Induced by Chloroquine Phosphate in COVID-19 Patients ZUO Li, XING Weiqing, WU Bin, WANG Qian, TANG Biyu 2020, 17(6): 332-337.  DOI: 10.19803/j.1672-8629.2020.06.03 Abstract ( 477 )   PDF (1255KB) ( 296 )   Objective To analyze adverse drug reactions/events caused by chloroquine phosphate in COVID-19 patients in order to provide reference for safe use of drugs for COVID-19. Methods Case reports of ADR/AE caused by chloroquine phosphate in COVID-19 patients in Shenzhen between January 1, 2020 and March 6, 2020 were analyzed. Results The incidence of ADR/AE induced by chloroquine phosphate was 65.62%. Totally 21 cases were included. The male/female ratio was 1：1.1. Patients aged 30 to 39 and 50 to 59 were the most susceptible to ADR/AE, and the percentage was 38.10% and 23.81% respectively. Thirty-two COVID-19 patients were treated with chloroquine phosphate. ADR/AE were more likely to occur in the digestive system, circulatory system (including heart), neuromuscular system and eyes. Arrhythmia caused by chloroquine phosphate was deadly. The duration of liver injury was relatively short, 3.5 days on average. The risk of liver damage could be increased when chloroquine phosphate was combined with traditional Chinese medicine decoctions. ADR/AE could occur the day chloroquine phosphate was taken or as late as 9 days later, most of which occurred in 2 to 7 days after treatment. Conclusion In the process of treating COVID-19 with phosphate chloroquine, we should avoid using contraindicated drugs, minimize the combination of drugs, and closely observe adverse reactions/events that have to be dealt with without delay so as to ensure the safety of patients. References | Related Articles | Metrics

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Analysis of Use of Antibacterial Drugs in 110 Discharged Patients with COVID-19 YANG Ping, AN Wei, CHEN Min, XIA Fei, XU Xin, LIAO Yaling, ZHOU Qin, LI Kuangyu, FANG Shasha, ZHANG Mingwei 2020, 17(6): 338-341.  DOI: 10.19803/j.1672-8629.2020.06.04 Abstract ( 409 )   PDF (1047KB) ( 185 )   Objective To find out about the way antibacterial drugs were used in 110 discharged patients with COVID-19 in our hospital and to explore the rational use of antibacterial drugs in patients with COVID-19. Methods The data on 110 patients with COVID-19 who were discharged between January 24, 2020 and February 17, 2020 was collected, whose usage of antibacterial drugs, admission symptoms, results of chest CT examination and clinical classification, outcomes of etiological examination, and infection indicators were retrospectively analyzed. Results Antibacterial drugs were used in all the 110 discharged patients, special-grade antibacterial drugs were used in 52.7% of them, and the percentage of patients who used a combination of antibacterial drugs was 78.2%. The count of white blood cells was normal or somewhat low in most of these patients on admission, neutrophil counts were mostly in the normal range, and lymphocyte counts were mostly reduced to different extents. During the detection after admission, 96 patients (87.3%) had normal procalcitonin (PCT) values, and 94 (85.5%) maintained normal PCT throughout the treatment. Conclusion In the early stage of the COVID-19 outbreak, the combined use of broad-spectrum antibacterial drugs and the use of special grade antibacterial drugs were quite common. With a better understanding of this disease later on, the use of antibacterial drugs was gradually standardized, while the cost and safety of antibacterial drugs were also taken into account. References | Related Articles | Metrics

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Antiplatelet Aggregation Effect of Vanillic Acid In Vitro and In Vivo KONG Linglei, WANG Haigang, LIU Chengdi, ZHANG Sen, LIU Nannan, MA Guodong, DU Guanhua 2020, 17(6): 342-347.  DOI: 10.19803/j.1672-8629.2020.06.05 Abstract ( 639 )   PDF (1359KB) ( 269 )   Objective To evaluate systematically in vivo and in vitro the anti-platelet aggregation effect of vanillic acid (VAA), which is a phenolic compound with antioxidant and anti-inflammatory properties. Methods A platelet aggregation model induced by arachidonic acid (AA), adenosine diphosphate (ADP) and thrombin (THR) was used to evaluate the antithrombotic effect of VAA in vitro and in vivo. Results In vitro, VAA significantly inhibited platelet aggregation induced by ADP and AA. And it could inhibit platelet aggregation induced by ADP in a dose-dependent manner. The results of in vivo experiments also showed that VAA (10, 30 and 100 mg/kg) decreased platelet aggregation induced by ADP and AA in a dose-dependent manner. In addition, VAA (100 mg/kg) could significantly reduce fibrinogen and increase prothrombin time, but had little effect on activated partial thromboplastin time and thrombin time. Conclusion VAA could inhibit platelet aggregation induced by ADP and AA, which provides reference for the development of new antiplatelet drugs. References | Related Articles | Metrics

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Effect of Hypoalbuminemia and Advanced Age on Hemorrhagic Events in Patients Taking Atorvastatin, Clopidogrel and Aspirin ZHOU Shuhua 2020, 17(6): 348-352.  DOI: 10.19803/j.1672-8629.2020.06.06 Abstract ( 472 )   PDF (1225KB) ( 295 )   Objective To investigate the effects of hypoalbuminemia and age on hemorrhagic events in patients taking atorvastatin, clopidogrel and aspirin simultaneously. Methods Patients with cardiovascular disease who underwent stenting for coronary artery stenosis and were treated with atorvastatin 20 mg, clopidogrel 75 mg, and aspirin 100 mg between January 2016 and May 2018 were selected as the subjects. To determine the effect of protein content, these patients were divided into two groups: the low albumin (≤35 g/L) group and normal albumin (> 35 g/L) group. The number of cases of urinary occult blood, fecal occult blood and hemoglobin was compared between the two groups and the difference was analyzed. When the influence of age was studied, the patients were divided again into two groups: those who were ≥70 years old and those who were under 70. Chi-square test was used to compare categorical variables. Bleeding was a dependent variable,while age, sex, systolic blood pressure upon admission, heart rate, hematocrit, endogenous creatinine clearance rate, serum albumin content, diabetes mellitus, peripheral vascular and cerebrovascular diseases were independent variables. Binomial logistic regression analysis was used to assess the risk of bleeding caused by hypoproteinemia or otherwise. Results There were significant differences in the number of cases in which urinary occult blood turned positive between the low albumin group and normal albumin group. There was also difference in the number of cases in which fecal occult blood turned positive after medication. Levels of hemoglobin declined more drastically after medication. There were significant differences in the number of cases in which levels of hemoglobin declined by over 10 g/L and were below normal values. There was significant difference in the number of cases in which urinary occult blood turned positive after medication between those ≥ 70 years old and those < 70 years old. Fecal occult blood turned positive after medication in more cases in the elderly group than in the younger group, but there was no significant difference. Multivariate logistic regression analysis showed that age, femininity and low albumin increased the risk of bleeding in these patients. Conclusion In patients who take atorvastatin, clopidogrel, and aspirin at the same time, low albumin and advanced age can increase the chance of bleeding. References | Related Articles | Metrics

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Research on the Evaluation Method of New Drug Technology Readiness Level in the United States ZHANG Chunpeng, FAN Yuting, DONG Hongxia 2020, 17(6): 353-356.  DOI: 10.19803/j.1672-8629.2020.06.07 Abstract ( 327 )   PDF (1109KB) ( 305 )   Objective To generate a technology readiness evaluation mechanism suitable for drug R & D and safety management in China. Methods The evaluation standards and methods of biomedical technology readiness level(BTRL) in the United States are studied and analyzed. Combined with the characteristics of drug discovery, supervision and industrialization in China, the technology readiness level and indicators in China are put forward, and an empirical analysis in the major R&D project of new drug discovery are performed. Results and Conclusion Through the research, the evaluation method of technology readiness level of chemical drugs and biological drugs in China are established. The evaluation method provides management and evaluation tools of scientific research projects, R&D and safety control in China, which also provides reference for other industries. References | Related Articles | Metrics

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Analysis of Differences between Periodic Safety Update Reports for Marketed Drugs in China and Periodic Benefit-risk Evaluation Report in ICH ZHU Qian, SHAN Qiuyue, YUAN Ye, FANG Wei, SONG Hong, LIANG Jinjin, CAO Tiejun 2020, 17(6): 357-360.  DOI: 10.19803/j.1672-8629.2020.06.08 Abstract ( 931 )   PDF (997KB) ( 1163 )   Objective To analyze the differences between periodic safety update reports for marketed drugs in China and periodic benefit-risk evaluation report in International Council for Harmonization (ICH). Methods The differences of periodic safety update reports between China and ICH is performed by comparing ICH (R1) (periodic safety update reports for marketed drugs, PSUR), ICH (R2) (periodic benefit-risk evaluation report, PBRER) and relevant laws and regulations in China. Results In terms of time requirement, the deadline for writing and submitting PSUR in China is 60 days, while the deadline for writing and submitting ICH is divided into 70 calendar days or 90 calendar days according to the characteristics of its drugs. In terms of content, China mainly collects safety-related content during the reporting period, while the ICH collects safety-related and efficacy-related content during the reporting period and accumulated content in the early stage. PBRER also includes a description of signal detection and evaluation methods. Conclusion Although there are differences between the requirements of China and ICH, China will pay more attention to the benefit-risk evaluation and the differences will gradually narrow in the future with the development of pharmacovigilance activities as well as increasing demands on marketing authorization holders. References | Related Articles | Metrics

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Clinical Analysis and Countermeasures of Oxaliplatin-induced Allergic in Our Hospital XUE Jing, GAO Min, PAN Ying, LI Xiaoyan 2020, 17(6): 361-365.  DOI: 10.19803/j.1672-8629.2020.06.09 Abstract ( 445 )   PDF (629KB) ( 468 )   Objective To identify the patterns and characteristics of allergic reactions induced by oxaliplatin, and to explore prevention and treatment strategies in order to provide reference for clinical treatment. Methods The clinical data on forty-nine cases of allergic reactions induced by oxaliplatin was collected between January 2013 and December 2018.The general conditions of the patients, medication and the occurrence of allergic reactions were analyzed. Other cases of oxaliplatin-induced allergic reactions reported in literature were also reviewed. Results Allergic reactions induced by oxaliplatin can occur at any age and the median age was 52 years old. Males were more susceptible and the onset mostly occurred within 30 minutes. Most of the cases were of levels I-II. The median cumulative course of treatment was five,while the median cumulative dose was 636 mg. Thirty-one cases of oxaliplatin-induced allergic reactions were retrieved from literature. The most common symptom was hypotension, and there were even two unique cases of hypertensive crisis. Conclusion Hypertension crisis may be one of the oxaliplatin-induced allergic reactions that can be mitigated by reducing the rate of administration. In case of allergic reactions that cannot be avoided by reducing the rate of administration, changing the treatment regimen may be a better choice. Pretreatment may be an effective preventive measure. Allergic reactions caused by other chemotherapeutic drugs as well as infusion reactions should be distinguished from those induced by oxaliplatin. References | Related Articles | Metrics

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Pareto Chart Analysis of Irrational Drug Use in Outpatient of A Large Tertiary Hospital HU Tingting, XU Ting 2020, 17(6): 366-369.  DOI: 10.19803/j.1672-8629.2020.06.10 Abstract ( 444 )   PDF (1161KB) ( 310 )   Objective To analyze the rationality of outpatient prescriptions in a large tertiary hospital (this hospital) so as to provide reference for clinically proper use of drugs. Methods The rationality of prescriptions for outpatients in this hospital between June 2018 and May 2019 was evaluated by manual review. The primary, secondary and common causes of irrational prescriptions for outpatients were analyzed with the Pareto diagram. Results A total of 23 658 prescriptions were evaluated, including 1022 irrational prescriptions that accounted for 4.32%. The leading cause was indication mismatch and incomplete writing of clinical diagnosis. The secondary cause was improper usage or dosage. The common causes included sub-standard clinical diagnosis, inappropriate combinations of drugs, improper formulations or routes of administration, poor selection of drugs, repeated administration and contraindications. Conclusion The Pareto diagram can help identify problems with prescriptions and improve the level of rational clinical use of drugs in hospitals. References | Related Articles | Metrics

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Analysis of Diarrhea Induced by Baixuan Xiatare Capsule in Our Hospital SI Ke, LI Na, LIAO Yufang, YUE Jiannong 2020, 17(6): 370-372.  DOI: 10.19803/j.1672-8629.2020.06.11 Abstract ( 409 )   PDF (441KB) ( 340 )   Objective To investigate the characteristics and mechanism of diarrhea caused by oral Baixuan Xiatare Capsule. Methods Retrospectively analyzed 58 cases of diarrhea adverse reactions caused by Baixuan Xiata Re Capsule reported in our hospital from 2016 to 2018, Explored the main causes of diarrhea in patients. Results The cause of diarrhea in the patients was the composition of the scavengers and aloe-emodin in the acacia and the aloe. Conclusion The use of Baixuan Xiatare Capsule should follow the syndrome differentiation and strengthen the pharmaceutical care of key populations such as children and old people, and should not be combined with other laxatives and long-term use. References | Related Articles | Metrics

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Serious Delayed Diarrhea Induced by IRIS Regimen in an UGT1A1-wild-genotype Patient MEI Dan, LU Junguo, GU Haijuan, NI Meixin 2020, 17(6): 373-376.  DOI: 10.19803/j.1672-8629.2020.06.12 Abstract ( 343 )   PDF (904KB) ( 195 )   Objective To report and analyze one case of serious delayed diarrhea induced by chemotherapy of irinotecan combined with S-1 (IRIS regimen) in an uridine-diphosphoglucuronosyl transferase 1A1 (UGT1A1)-wild-genotype patient with metastatic recal cancer. Methods The diagnosis and treatment process of the case of delayed diarrhea after IRIS regimen chemotherapy was analyzed and related literature was reviewed. Results The serious delayed diarrhea was possibly induced by IRIS regimen chemotherapy, which might be related to the gene polymorphisms of irinotecan transporters and the combination with S-1. Conclusion We should be alert to the occurrence of serious delayed diarrhea when IRIS regimen chemotherapy is used for UGT1A1-wild-genotype patients. References | Related Articles | Metrics

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Multiple Organ Dysfunction in Children Induced by Delayed Elimination of High-dose Methotrexate Injection LI Shan, YAN Haihong, ZHANG Ping, LIAO Yingxi, WANG Xiaodan, TIAN Jixin 2020, 17(6): 377-380.  DOI: 10.19803/j.1672-8629.2020.06.13 Abstract ( 290 )   PDF (900KB) ( 206 )   ：Objective To investigate ways of prevention and treatment of multi-organ damage in children with acute lymphocyte leukemia (ALL), which is induced by high-dose methotrexate (HD-MTX). Methods The treatment plan of multi-organ damage in an 11-year-old boy with acute lymphocyte leukemia was summarized, who was treated with HD-MTX (6.6 g, 5 g/m2) in our pediatric department in April 2018. Results On the next day after the first intravenous infusion of MTX, the child manifested various symptoms of adverse reactions, such as vomiting, changes in stool characteristics, fever and decreased urine outputs. The blood concentration of MTX at 42 h was 218 μmol/L. On the 4th day, the levels of phosphokinase and inosine were elevated to 173.2 U/L and 382.7 μmol/L, respectively. It was suspected that the multiple-organ damage was induced by MTX excretion delay. Intravenous injection of calcium folinate was administrated at a dose of 100 mg every 6 h. Meanwhile, such symptomatic treatment as hydration alkalization, hemodialysis, anti-infection, antiemetic medication and liver protection was carried out. Subsequently, the patient completely recovered without further complications. Conclusion HD-MTX can cause delayed excretion and induce multi-organ damage. It is recommended that dynamic monitoring of the level of MTX in blood be implemented and immediate measures be taken, including sufficient hydration and alkalization, to reduce the occurrence of adverse reactions and ensure the safety of patients. References | Related Articles | Metrics

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Asthma Induced by Tramadol Hydrochloride Injection WANG Kangtao, CHEN Jianghui, TIAN Ying, YE Chunyan, PEI Haiping 2020, 17(6): 381-383.  DOI: 10.19803/j.1672-8629.2020.06.14 Abstract ( 592 )   PDF (896KB) ( 524 )   ：Objective To analyze rare allergic reactions caused by tramadol hydrochloride injection. Methods One case of allergic reactions (asthma) after tramadol hydrochloride injection in our Department of Anesthesiology in February 2019 was reported. Related literature was searched for retrospective analysis. Results A patient with chills after operation and anesthesia was twice treated with tramadol injection, resulting in asthma, faster heart rate and lower blood pressure. After emergency treatment, the patient returned to normal. Seven papers from databases were included and analyzed. Conclusion Tramadol should be used with caution. In case of such adverse reactions as shortness of breath or tachycardia, tramadol injection should be stopped immediately, while respiratory support should be provided and bronchodilators and antiallergic drugs should be given. References | Related Articles | Metrics