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Significance of Good Pharmacovigilance Practice in the Construction of China Pharmacovigilance System WANG Dan, REN Jingtian, WU Guizhi, XIONG Weiyi, TANG Ren, PANG Yu, FAN Rong, YANG Le 2021, 18(6): 501-503.  DOI: 10.19803/j.1672-8629.2021.06.01 Abstract ( 1142 )   PDF (1089KB) ( 1094 )   Objective To explore the significance of Good Pharmacovigilance Pracetice (GVP)in constructing the Pharmacovigilance System of China. Methods review the background of GVP, study its status in the field of drug safety supervision, summarize its core and gist, discuss its role in the Pharmacovigilance System, and analyze the significance of its introduction. Results and Conclusion the promulgation and implementation of GVP is the first step in the construction of China Pharmacovigilance System, which has great significance and far-reaching influence. References | Related Articles | Metrics

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Thoughts on the Establishment of Pharmacovigilance Systems in Pharmaceutical Group Companies under Pharmacovigilance Systems JIANG Danna, LAI Wenjian, ZHAO Xiping, LIU Ying, XU Yan 2021, 18(6): 504-506.  DOI: 10.19803/j.1672-8629.2021.06.02 Abstract ( 714 )   PDF (1154KB) ( 910 )   Objective To provide a reference for pharmaceutical groups to build a group pharmacovigilance system through reflecting on the key issues in building a group pharmacovigilance system. Methods Based on the good pharmacovigilance practices (GVP) and the experience of marketing authorization holders in establishing pharmacovigilance systems, the advantages, conditions and possible problems of a group pharmacovigilance system were discussed and suggestions on how to build a group pharmacovigilance system were made. Results The construction of a group pharmacovigilance system is conducive to maximizing resource utilization and improving the professional level of the group pharmacovigilance. Conclusion To meet the challenges brought by the implementation of GVP, pharmaceutical groups may consider establishing a group pharmacovigilance system based on their own situation. References | Related Articles | Metrics

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Thoughts on How to Implement Good Pharmacovigilance Practices in China from a Global Pharmaceutical Industry Perspective ZHANG Yijing 2021, 18(6): 507-509.  DOI: 10.19803/j.1672-8629.2021.06.03 Abstract ( 385 )   PDF (428KB) ( 528 )   Objective To explore the approaches to perform life-cycle pharmacovigilance and to implement Good Pharmacovigilance Practices (GVP) in order to fulfil the regulatory requirements in China from an industry perspective. Methods Based on the empirical data from global pharmaceutical companies, a systematic approach was taken to assess the current status of implementing GVP and make practical recommendations to the key steps of implementation of the regulation. Results and Conclusion The implementation of GVP is critical and essential to enhance pharmacovigilance system in pharmaceutical industry. References | Related Articles | Metrics

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Brief Introduction on the Guideline for the Pharmacovigilance Delegation Agreement (Pilot Version) YANG Le, TIAN Chunhua, XIA Dongsheng, WANG Dan, LIU Cuili, TANG Ren, YU Hongli PENG Lili, WANG Gang 2021, 18(6): 510-513.  DOI: 10.19803/j.1672-8629.2021.06.04 Abstract ( 665 )   PDF (1105KB) ( 2210 )   Objective To provide an important reference for drug marketing authorization holders and consignee to carry out pharmacovigilance commission. Methods From the perspective of drafters, the regulation is related with the drafting background, the status of post marketing pharmacovigilance Commission, guidelines and key points were introduced. Results and Conclusion The guidelines for the Pharmacovigilance delegation agreement (pilot version) has been officially released on June 4, 2020. As the first normative documentation on how to carry out pharmacovigilance delegation for drug marketing authorization holders in China in the new era, it aims to provide guide and enlightenment for relevant parties, and will be continuously adjusted and improved in practice. References | Related Articles | Metrics

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Exploration the "Risk-Benefit Threshold" of Chinese herbs with Acrid, Hot and Toxic Properties ZHANG Xiaomeng, ZHANG Bing, ZHANG Dan, LIN Zhijian 2021, 18(6): 514-519.  DOI: 10.19803/j.1672-8629.2021.06.05 Abstract ( 133 )   PDF (1589KB) ( 712 )   Objective To study the "risk-benefit threshold" of toxic herbs and provide objective reference for their application. Method Taking Radix aconiti Sinensis and Radix aconiti Kusneziffii (Chuanwu and Caowu) with acrid, hot and toxic properties as an example, a benefit-risk assessment (BRA) model was established by integrating multi criteria decision-making, meta analysis and entropy weight method. The "threshold" exploration based on the evaluation results was carried out, and the key factors affecting the expression of efficacy and toxicity in toxicity were found and the range of interval was quantified. Result A relatively stable BRA model was established to evaluate the effect of different "threshold" conditions and intervals on the benefit risk expression of sample drugs based on the included randomized controlled trials. Conclusion "risk- benefit threshold" could provide objective basis for the rational use of toxic herbs, and also could carry out targeted early warning and prevention. References | Related Articles | Metrics

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Evaluation and Consideration of Clinical Safety of Traditional Chinese Medicine Based on Toxic Components LI Yaolei, ZHANG Bing, ZHANG Xiaomeng, LIN Zhijian 2021, 18(6): 520-524.  DOI: 10.19803/j.1672-8629.2021.06.06 Abstract ( 142 )   PDF (1195KB) ( 301 )   Objective Based on many factors in clinical application, this article aimed to analysis the clinical safety of traditional Chinese medicine (TCM), which contained toxic ingredients. And discussed the safety risk assessment model to provide technical support for clinical rational use of TCM. Methods This study described the toxicity characteristics of exogenous harmful substances and endogenous toxic ingredients in TCM, it is based on dietary risk assessment methods after combined multiple factors such as drugs, organism, and clinical medication, and assigned appropriate weights to risk factors. We established a risk evaluation model that reflected the characteristics of clinical medication. Results We tried to apply the model to analysis the safety of TCM which contained toxic and harmful ingredients. The preliminary verification had been obtained, and the foundation had been laid for the safe clinical use of drugs in the future. Conclusion This study believed that only under the control of medication frequency, course of treatment, dosage and other medication factors, can TCM contained toxic ingredients be used safely and reasonably in clinical practice. References | Related Articles | Metrics

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Benefit-Risk Assessment of Mylabris Preparations in the Treatment of Primary Hepatic Carcinoma JIANG Hao, ZHANG Zhiqi, ZHANG Bing, ZHANG Xiaomeng, GENG Kexin 2021, 18(6): 525-531.  DOI: 10.19803/j.1672-8629.2021.06.07 Abstract ( 110 )   PDF (2460KB) ( 183 )   Objective This study aims to quantitatively evaluate the benefits and risks of Mylabris Preparations (MPs) in the treatment of primary hepatic carcinoma (PHC). It can provide an intuitive basis for using MP safely and effectively in clinic. Methods This study searched for randomized controlled trials(RCTs) of MPs treatment for PHC in CNKI, Wanfang, VIP, SinoMed, Pubmed, Web of Science and other Chinese and English databases. The search time was from the establishment of the database to September 9, 2020. The multi-criteria decision-making analysis (MCDA) model for MPs treatment of PHC was established. The SWING method was used to assign weights to benefit indicators and risk indicators. Their weights were 70% and 30% respectively. With the help of Meta-analysis method to combine the RCT results, it used the MACD model to calculate the patient's benefit value, risk value and benefit-risk value. Results In total, 4 MPs were retrieved in the study, and 76 related RCTs were included. Compared with Transcatheter arterial chemoembolization(TACE), the benefit-risk value of intravenous MPs combined with TACE for PHC treatment was 59, while the benefit-risk value of oral MPs combined with TACE treatment of PHC was 55. The benefit-risk difference between the two types of MPs was 4, 95% CI [-2.4,10.4], and the probability of difference was 85.76%.The benefit-risk value of Aidi injection combined with TACE in the treatment of PHC was 63.4, and the benefit-risk value of Aiyishu injection combined with TACE in the treatment of PHC was 62.7. The benefit-risk difference of the two kinds of MPs was 0.7, 95% CI [-6.4,7.8], and the probability of difference is 54.43%. Conclusion The current evidence shows that MPs are a type of drug with better benefits and lower risks in the treatment of PHC. The benefit-risk of intravenous MPs combined with TACE in the treatment of PHC may be better than that of oral MPs, and the benefit-risk of Aidi injection combined with TACE in the treatment of PHC is equivalent to that of Aiyishu injection. References | Related Articles | Metrics

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The Analysis and Thought of Safety Problem and Rational Application of Anthraquinones-Containing Traditional Chinese Medicine HUANG Zhengkai, ZHANG Bing, LIN Zhijian, ZHANG Xiaomeng, ZHANG Dan, YIN Yuling 2021, 18(6): 532-536.  DOI: 10.19803/j.1672-8629.2021.06.08 Abstract ( 157 )   PDF (1308KB) ( 152 )   Objective This paper aims to find out the risk-related factors and provide references for the rational use of the Chinese traditional medicine containing anthraquinones by reviewing the application situation and the characteristics of the adverse reactions. Methods This study used the methods of questionnaire survey and literature research. We conducted the questionnaire survey on the application and risk problems of anthraquinones-containing functional food in the public. On the other hand, we searched the domestic literature systematically such as CNKI, Wan Fang and VIP and collected the ADR /AE case reports caused by anthraquinones-containing traditional Chinese medicine and Chinese patent medicine comprehensively from the establishment to February 28, 2021. Then, we analyzed the adverse reactions from retrospective study and data mining. Results Total 6000 questionnaires were distributed and 5491 valid questionnaires were collected. 1140 questionnaires contained with the reports of discomfort symptoms, such as astrointestinal damage, skin and accessories damage, and urinary system dysfunction, after using the anthraquinones-containing functional food. And 234 papers contained the reports of ADR/AE induced by the anthraquinones-containing Chinese traditional medicine and Chinese patent drug, involving 276 cases, which showed damages to skin and appendages, digestive system, and other organs and systems. This research shown the influencing factors of ADR/AE were the special population and irrational drug use. Conclusion The anthraquinones-containing traditional Chinese medicine has potential risks, so it is necessary to recognize the risk factors in daily healthcare and clinical applications. This paper might ensure the safe use of the anthraquinones-containing Chinese medicine. References | Related Articles | Metrics

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Effect of Mailuoshutong Pills on Renal Function Indexes in the Real World Based on Propensity Scores CHENG Fengjingming, XIE Yanming, WANG Lianxin, MIAO Yu 2021, 18(6): 537-541.  DOI: 10.19803/j.1672-8629.2021.06.09 Abstract ( 131 )   PDF (1281KB) ( 115 )   Objective To investigate the effect of Mailuoshutong pills on renal function indexes in the real world. Methods Based on the integrated data warehouse, the data on patients who took Mailuoshutong pills and those who did not between 2006 and 2016 was retrieved from the medical electronic database of fourteen tertiary hospitals in China. With the same gender and age of ±5 years as the matching conditions, patients in the Mailuoshutong pill group and control group were matched at the ratio of 1∶1. After matching, there were 2 395 patients in either group. The effect of medication on renal function indexes (Cr, BUN) was used as the outcome evaluation index. Propensity scoring was used to control the confounders in this study, and four statistical methods were used for safety analysis. Results Eleven confounders were weighted and balanced with the propensity scoring method, and the results obtained by the four statistical methods were all P>0.05. Abnormal changes in renal function indexes were as likely in the control group as in the Mailuoshutong pill group, and the difference between the two groups was not statistically significant. In the real world, the use of Mailuoshutong pills had no direct effect on renal function indexes. Conclusion Based on the data of this study, no significant effect of MailuoShutong pills on renal function indexes is found, but this drug should be used with caution. References | Related Articles | Metrics

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A Real World Study on the Effect of Cervus and Cucumis Polypeptide Injection on Liver Function in Fractured Patients CHEN Fan, LI Yuanyuan, ZHANG Qing, XIE Yanming, GAO Minghui 2021, 18(6): 542-546.  DOI: 10.19803/j.1672-8629.2021.06.10 Abstract ( 143 )   PDF (1473KB) ( 92 )   Objective To study the effect of cervus and cucumis polypeptide injection on liver function in fractured patients based on real-world medical electronic data. Methods The information about 12 847 fractured patients who received cervus and cucumis polypeptide injection (experimental group) and 12 619 fractured patients who did not between July 1, 2003 and December 31, 2014 (control group) was retrieved from the database of the hospital information system (HIS) and laboratory information management system (LIS) of 26 tertiary hospitals in China. Propensity score weighting using the generalized boosted model (GBM) was employed to control confounders, while Logistic regression was used to analyze whether there were statistically significant differences in liver function abnormalities between the two groups in the real world. Results The changes of liver function (ALT and AST) in the two groups were analyzed using Logistic regression following propensity score weighting. P values were all greater than 0.05, and the difference was not statistically significant. Conclusion Based on the available data and this analysis, cervus and cucumis polypeptide injection may not affect the liver function of patients with fractures. References | Related Articles | Metrics

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Complex Network Analysis of Danshen Chuanxiongqin Injection in the Treatment of Renal Insufficiency in the Real World CHEN Haoran, ZHANG Lidan, XIE Yanming, GAO Yang, LIU Hao, YANG Yunyun 2021, 18(6): 547-551.  DOI: 10.19803/j.1672-8629.2021.06.11 Abstract ( 187 )   PDF (1690KB) ( 91 )   Objective To study the characteristics and regularities of combined use of Danshen Chuanxiongqin injection in the treatment of renal insufficiency in the real world. Methods The clinical data on diagnosis and treatment of patients with renal insufficiency treated with Danshen Chuanxiongqin injection between 2010 and 2019 was retrieved from the database of information systems of 18 hospitals nationwide before the tabu search algorithm was used to establish models. Community graphs or matrix methods were used to show the relationship between different self-networks in order to analyze the correlations. The core prescriptions for renal insufficiency and the correlations between multiple drugs were studied. Results The treatments of renal insufficiency with Danshen Chuanxiongqin injection included Danshen Chuanxiongqin injection combined with telmisartan to strengthen renal function, Danshen Chuanxiongqin injection combined with furosemide and spironolactone against heart failure, and Danshen Chuanxiongqin injection combined with cefodizime against infections. Conclusion Because of the complicated etiology and pathogenesis of renal insufficiency caused by various chronic diseases and improper medication, the combination with traditional Chinese medicine on the basis of conventional symptomatic treatment has a significant effect. The combined medication with Danshen Chuanxiongqin injection conforms to the guidelines for diagnosis and treatment of renal insufficiency, which provides more effective reference for individualized clinical treatment. References | Related Articles | Metrics

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Pharmacovigilance of Chinese Medicine in Medical Institutions GENG Hongjiao, WANG Lianxin, XIE Yanming 2021, 18(6): 552-555.  DOI: 10.19803/j.1672-8629.2021.06.12 Abstract ( 230 )   PDF (535KB) ( 229 )   Objective To explore theories of pharmacovigilance of traditional Chinese medicine (TCM) in medical institutions in order to provide reference for related pharmacovigilance. Methods The definitions and evolution of pharmacovigilance of TCM were summarized. Traditional theories of pharmacovigilance and the realities in medical institutions in China were taken into consideration. The priorities of TCM pharmacovigilance were outlined. Results Medical institutions should not only supervise the quality and safety of traditional Chinese medicine during pharmacovigilance, but also promote clinical pharmacy services related to TCM. Standard methods should be employed to assess the safety of TCM while therapeutic drugs of TCM should be constantly monitored to create an atmosphere for pharmacovigilance. Conclusion Medical institutions cannot keep improving pharmacovigilance of TCM unless the safety of TCM takes center stage. References | Related Articles | Metrics

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Chemical Constituents of Psoralea corylifolia L. GAO Hutongyue, GAO Panpan, ZANG Yingda, MA Jie, YANG Jingzhi, YE Fei, LI Chuangjun, ZHANG Dongming 2021, 18(6): 556-561.  DOI: 10.19803/j.1672-8629.2021.06.13 Abstract ( 197 )   PDF (1162KB) ( 105 )   Objective To analyze the chemical constituents of the fruit of Psoralea corylifolia L.. Methods 95% ethanol extract of Psoralea corylifolia L. was studied with silica gel, MCI, ODS column chromatography and high performance liquid chromatography. The structure was elucidated with MS and NMR. Results Ten compounds were isolated from 95% ethanol extract of Psoralea corylifolia L.. They were seputhecarpan A (1), bakuchiol (2), 13-hydroxyisobakuchiol (3), 12-hydroxyisobakuchiol (4), bisbakuchiol A (5), bisbakuchiol B (6), bisbakuchiol C (7), 4, 2'-dihydroxy-4'-methoxy-5′-(3'', 3''-dimethylallyl)-chalkone (8), isobavachromene (9) and 4-hydroxyisolonchocarpin (10). Conclusion Compound 1 was isolated from this plant for the first time. The results of evaluation of PTP1B inhibitory activities showed that compounds 2 and 7 displayed significant PTP1B inhibitory activities. References | Related Articles | Metrics

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Effect of Gefitinib Combined with Paclitaxel on Quality of Life and Survival in Patients with NSCLC CAO Hongli, YU Panpan, YANG Jing, XI Jianing 2021, 18(6): 562-565.  DOI: 10.19803/j.1672-8629.2021.06.14 Abstract ( 173 )   PDF (1154KB) ( 79 )   Objective To investigate the effect of gefitinib combined with paclitaxel on the quality of life and survival of patients with advanced non-small cell lung cancer (NSCLC), and analyze its clinical value. Methods Ninety patients with advanced NSCLC admitted to our hospital were randomly divided into the observation group and control group. The control group was treated with albumin binding paclitaxel and cisplatin, while the observation group was additionally given gefitinib. The clinical efficacy, adverse reactions, quality of life and changes of cancer markers were compared between the two groups. Results After 3 months of treatment, the effective rate and disease control rate of the observation group were 55.56% and 84.44% respectively, which were higher than 22.22% and 60.00% of the control group (P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P<0.05). After 6 months of treatment, the quality of life in the two groups was improved, and the scores of SF-36 in each field in the observation group were higher than those of the control group (P<0.05) in the same period. After 3 months of treatment, levels of CEA, CA50 and CA125 in the two groups decreased. After 6 months of treatment, the above indexes in the observation group were lower than those of the control group (P<0.05). The progression free survival time and 3-year survival rate of the observation group were (5.97±0.88) months and 42.22% respectively, which were higher than (3.62±0.74) months and 24.44% in the control group (P<0.05). Conclusion Combined with albumin binding paclitaxel and cisplatin chemotherapy, gefitinib can significantly improve the quality of life, prolong the survival of patients with advanced NSCLC, and achieve a better clinical effect while ensuring the safety of treatment. References | Related Articles | Metrics

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Medical Device Vigilance Systems in European Union ZHAO Yan, ZHAO Yifei△, ZHENG Lijia, DONG Fang 2021, 18(6): 566-569.  DOI: 10.19803/j.1672-8629.2021.06.15 Abstract ( 350 )   PDF (1123KB) ( 303 )   Objective To provide reference for the establishment of medical device vigilance systems in China by analyzing the responsibilities and requirements of the medical vigilance system in the amendments to European Union(EU) medical device regulations. Methods The advantages of the EU medical device vigilance system were analyzed and compared with the monitoring of medical device adverse events in China. Results The medical device vigilance system was critical to risk management of the whole life cycle of medical devices and to the safety of the public. Conclusion Ways to improve medical device vigilance in China are suggested by learning from the experience of European Union and based on the current monitoring practices of medical device adverse events in China References | Related Articles | Metrics

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Features and Requirements of Non-clinical Toxic Evaluation of Inhalable Drugs ZHANG Haifei, YU Shanshan, CAO Jin, ZHANG Tianzhu, WU Dongkai, NI Yike, ZUO Conglin, HU Xiaomin 2021, 18(6): 570-574.  DOI: 10.19803/j.1672-8629.2021.06.16 Abstract ( 210 )   PDF (1107KB) ( 186 )   Objective To analyze the features and requirements of non-clinical evaluation of inhalable drugs in order to provide reference for development of new inhalable drugs. Methods The characteristics of inhalable drugs were analyzed, such as generation of aerosols, dosimetry, reliability of the inhalation system, and interpretation of results. Factors that affected the non-clinical evaluation of inhalable drugs were identified so as to help design, conduct and analyze non-clinical experiments. Results The delivered dose of inhalable drugs was calculated, on the basis of which the deposited dose was estimated. During inhalation, the environmental parameters had to be monitored intensively. Inflammation in the upper airway was frequently noted due to the physiological and anatomical features of rodents. Aggregations of macrophages in the lung required cautious analysis. For inhalable biological drugs, the most common adverse reaction was inflammation. Conclusion The pharmaceutical properties of inhalable drugs place special demands on non-clinical evaluation. References | Related Articles | Metrics

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Potential Risks of Salviae Miltiorrhizae and Ligustrazine Injection XU Xianxing, YANG Jingwen, MIAO Huiqing 2021, 18(6): 575-578.  DOI: 10.19803/j.1672-8629.2021.06.17 Abstract ( 161 )   PDF (1145KB) ( 121 )   Objective To investigate the potential risks of Salviae Miltiorrhizae and Ligustrazine injection so as to promote rational use in clinical practice. Methods The valid data of Salviae Miltiorrhizae and Ligustrazine injection was retrieved from the database of National Center for Adverse Drug Reaction Monitoring and literature. The clinical applications and potential risks of this injection were analyzed. Results Salviae Miltiorrhizae and Ligustrazine injection was widely used in clinic. Both the number of adverse reactions reported and the proportion of serious reports were trending up. Additionally, off-label use and overdose were common, which might increase the incidence of adverse reactions in patients. Conclusion Salviae Miltiorrhizae and Ligustrazine injection should be used in accordance with indications. Meanwhile,close attention should be paid to the risk of serious allergic reactions, especially anaphylactic shock. References | Related Articles | Metrics

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A Risk Prediction Model for Tacrolimus in Children with Nephrotic Syndrome ZHU Lili, GENG Wei, YUAN Yuan, AN Xiaojie, YUAN Shuangli, LI Yukun, CHEN Bosong, ZHAO Jun 2021, 18(6): 579-583.  DOI: 10.19803/j.1672-8629.2021.06.18 Abstract ( 119 )   PDF (1219KB) ( 117 )   Objective To explore the factors that affecting the blood concentration of tacrolimus in children with nephrotic syndrome and to establish a risk prediction model. Methods Information was collected retrospectively on 90 children diagnosed with NS and meeting inclusion/exclusion criteria from January 2017 to October 2019, including demographic information, laboratory test indicators, combined medication, and tacrolimus steady-state trough concentration and dose. Univariate analysis was used to screen for factors affecting low and high exposure to tacrolimus concentration, Then a risk prediction model was established by multivariate Logistic regression method. Results Univariate analysis result showed that dose, azithromycin and red blood cell volume were the significant factors affecting low and high exposures of tacrolimus steady-state trough concentration (P<0.05). The low exposure risk model established by multivariate Logistic regression was Logit(P)=2.521-1.419(dose)-2.401(with azithromycin)+0.964(serum cystatin C)-1.93 6 erythrocyte volume (<35%) and with a better accuracy, specificity and sensitivity. Conclusion In children with nephrotic syndrome, the effects of dose, combined azithromycin and erythrocyte volume on tacrolimus steady-state trough concentration should be considered. The low exposure risk model can be used to predict the probability of low blood concentration exposure in children to avoid the occurrence of tacrolimus adverse reactions and improve the therapeutic effect. References | Related Articles | Metrics

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One Case of Severe Serum Transaminase Elevation with Acute Cholecystitis Induced by Gefitinib Tablets LIAO Yufang, YUE Jiannong, SI Ke 2021, 18(6): 584-587.  DOI: 10.19803/j.1672-8629.2021.06.19 Abstract ( 158 )   PDF (1054KB) ( 152 )   Objective To investigate the mechanism and treatments of severe serum transaminase elevation complicated with acute cholecystitis induced by gefitinib. Methods The clinical pharmacist analyzed one case of severe serum transaminase elevation complicated with acute cholecystitis after receiving long-term oral gefitinib. The related literature was reviewed, while the pathogenesis and treatments of gefitinib-induced liver injury with cholecystitis were explored. Results Gefitinib-caused severe elevation of serum transaminase with acute cholecystitis was a rare serious adverse reaction. After gefitinib was discontinued and active hepatoprotective treatment was adopted, the patient’s liver and gallbladder condition was significantly improved. Conclusion This case is a rare adverse reaction of gefitinib, and new priorities of pharmaceutical care have been proposed in clinical application, which can contribute to ensuring the safety of patients' medication. References | Related Articles | Metrics

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Adverse Reactions of Visual Disturbances and Hallucinations Induced by Voriconazole Tablets in Two Cases and Related Literature Review ZHANG Xiaojuan, YANG Hongxin, GUO Xiaobin, JIE Peitao 2021, 18(6): 588-591.  DOI: 10.19803/j.1672-8629.2021.06.20 Abstract ( 277 )   PDF (1132KB) ( 120 )   Objective To summarize the regularity of such adverse reactions as visual disturbances and hallucination caused by voriconazole, and to provide reference for the safe and rational use of medicine by health care givers. Methods Two cases of visual disturbances and hallucinations caused by voriconazole in our hospital were reviewed. The chance, onset time, mechanism, correlations with blood concentration and outcomes of adverse reactions caused by voriconazole were studied. Results Voriconazole was more likely to cause visual toxicity and neurotoxic side effects than other antifungal drugs. Adverse reactions occurred mainly within the first five days of administration. There was a significant correlation between neurotoxicity and concentrations, but there was no significant correlation between visual toxicity and concentrations. Immediate discontinuation of the drug after the occurrence of adverse reactions could lead to good prognosis. Conclusion The adverse reactions to voriconazole mostly occur in the first five days of administration, and the prognosis is better if the drug is discontinued quickly. References | Related Articles | Metrics

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Research Progress on Prevention and Treatment of Respiratory Virus Infectious Diseases with Traditional Chinese Medicine WANG Yaxin, CUI Xiaolan, GUO Shanshan 2021, 18(6): 592-596.  DOI: 10.19803/j.1672-8629.2021.06.21 Abstract ( 137 )   PDF (1087KB) ( 117 )   In recent years, a number of pandemics caused by respiratory viruses have killed tens of thousands of people.The outbreak of the novel coronavirus (Covid-19, 2019) has posed a serious threat to human health due to its long period of incubation and high contagiousness. So far, no safe and effective specific drugs have been developed at home and abroad.Traditional Chinese medicine (TCM) has become a hot spot of research due to its rich experience, extensive drug sources and unique treatment. This paper summarized some of the intensively-studied fields related to prevention and treatment of respiratory virus infectious diseases with traditional Chinese medicine from the perspective of monomer components, single Chinese medicine and compound preparations in order to advance our understanding of the research of Chinese medicine against viruses. References | Related Articles | Metrics

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Pre-Clinical Evaluation of Oncolytic Virus Drugs WANG Xin, MIAO Yufa, HUO Yan, WANG Sanlong, ZHOU Xiaobing, GENG Xingchao 2021, 18(6): 597-600.  DOI: 10.19803/j.1672-8629.2021.06.22 Abstract ( 270 )   PDF (473KB) ( 149 )   Oncolytic viruses (OVs) are a new antitumor biological product. They are constructed based upon structurally modified viral vectors, infect tumor cells preferentially and reproduce themselves in tumors without damaging normal tissues. They enjoy some advantages in that they have diverse vectors, carry a wide range of foreign fragments, exert significant antitumor effects and can be combined with multiple drugs when used in clinic. Oncolytic virus drugs have the characteristics of both gene therapies and biotechnological drugs. During preclinical safety assessment, we should comply with the general principles of toxicological research of drugs and design special experiments in line with the properties of these drugs. The related research should focus on general toxicity, safety pharmacology, immunotoxicity and immunogenicity, biodistribution, shedding and other related studies. This article is intended to elaborate on the priorities of research and experimental methods concerning OVs. References | Related Articles | Metrics