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15 April 2020, Volume 17 Issue 4 Previous Issue    Next Issue

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Thoughts on Drug Regulatory Science in the New Era MAO Zhenbin, WANG Ying, WANG Siming 2020, 17(4): 193-197.  DOI: 10.19803/j.1672-8629.2020.04.01 Abstract ( 1708 )   PDF (1048KB) ( 1313 )   This paper describes the course of development and significance of regulatory science, and attempts in-depth thinking about the application of drug regulatory science in China in the new era. We discussed the birth and beginning of regulatory science, the development and achievement of drug regulatory science, the essence and characteristic of regulatory science, the effect and duty of regulatory science. Through the study of the strategies and implementation method path, this paper specifies the direction in which the regulatory science systems for Traditional Chinese medicine and modern pharmaceuticals of the world level are to be established. References | Related Articles | Metrics

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Risks Posed by Anti-novel Coronavirus Pneumonia Drug-arbidol WANG Tao, SONG Haibo, TIAN Chunhua 2020, 17(4): 198-201.  DOI: 10.19803/j.1672-8629.2020.04.02 Abstract ( 1231 )   PDF (497KB) ( 998 )   Objective To analyze the risks posed by arbidol in China in order to provide reference for clinical rational drug use. Methods Individual cases of adverse drug reactions retrieved from the WHO Vigilyze, China adverse drug reaction database, domestic and foreign literature were analyzed. Results The risks of gastrointestinal disorders, general disorders and cutaneous damage should be our concerns. Conclusion We should reinforce the safety monitoring of arbidol, update the drug labeling without delay and promote the rational application of medicines. References | Related Articles | Metrics

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Literature Analysis of Common Adverse Drug Reactions due to Short-term Use of Chloroquine/Hydroxychloroquine and Recommendations WEI Hongtao, SHEN Su, DI Xuan, CUI Can LIAO Yin, SONG Yao 2020, 17(4): 202-207.  DOI: 10.19803/j.1672-8629.2020.04.03 Abstract ( 898 )   PDF (1148KB) ( 317 )   Objective To analyze the possible adverse drug reactions (ADRs) caused by chloroquine/hydroxychloroquine (CQ/HCQ) and identify related influencing factors so as to provide reference for clinical rational application. Methods PubMed, CNKI and Wanfang databases were searched, while literature on possible adverse drug reactions caused by CQ/HCQ and the related factors that were likely to induce adverse drug reactions were analyzed. Results A total of 1 280 articles were retrieved, and 42 of them were included finally. There were 7 articles on heart-related ADRs involving 10 patients with arrhythmia, including 4 cases of atrioventricular block, 4 cases of prolonged Q-T interval and 3 cases of death. Seven cases recovered after drug withdrawal, and a daily dose>1 g was more likely to cause cardiotoxicity. There were 4 vision-related articles on ADRs involving 5 cases, one of whom was treated with CQ, 4 treated with HCQ. Macular lesions occurred in one case, blurred vision in one case, and conjunctival hyperemia in two cases. Neither blurred vision nor macular lesions recovered after drug withdrawal. Skin ADRs were mentioned in 21 articles, including 2 cases of Stevens Johnson Syndrome and 10 cases of acute or generalized pustulosis. There were 10 other articles related to serious ADRs that were mainly manifested in the neuropsychological system and mental symptoms. Conclusion CQ/HCQ can cause serious ADRs. Patients with preexisting heart disease and interactions between drugs should be closely monitored. A proper dosage should be determined for novel coronavirus pneumonia. The disease severity, liver and kidney function of patients should also be considered, and different drugs and administration methods should be selected. References | Related Articles | Metrics

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Evaluation and Monitoring the Medication of Critically Ill Patients with COVID-19 and Cerebral Hemorrhage during Convalescence WANG Ying, ZHU Kun 2020, 17(4): 208-213.  DOI: 10.19803/j.1672-8629.2020.04.04 Abstract ( 771 )   PDF (1026KB) ( 462 )   Objective To evaluate and monitor the medication of one critically ill patient with cerebral hemorrhage during convalescence complicated with COVID-19, so as to privide reference for clinical drug safety. Methods The medication of one patient was analyzed in terms of pharmacodynamics, clinical pharmacology, monitoring and evaluation of adverse reactions, and the drug monitoring strategy was put forward. Results The medication of this patient was basically in line with the diagnosis and treatment of COVID-19. Conclusion The clinical manifestations of critically ill patients with COVID-19 and cerebral hemorrhage during convalescence are complex, so treatment plans should also take into consideration the convalescence related complications of intracerebral hemorrhage. References | Related Articles | Metrics

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Network Pharmacology Study of Chinese Medicine Guizhifuling Formulae YANG Shubin, PEI Chenchen, SHI Wei, WANG Xin, LI Na, CAO Guangshang, ZHANG Haiming, NIE Yinglan, SUN Jian 2020, 17(4): 214-220.  DOI: 10.19803/j.1672-8629.2020.04.05 Abstract ( 771 )   PDF (2079KB) ( 359 )   Objective To study the main active ingredients and potential targets of Guizhifuling formulae for treatment diseases based on network pharmacology. Methods The chemical constituents of ramulus cinnamom poria, tree peony bark, radix paeoniae alba and peach seed were extracted from the BATMAN-TCM database. The active ingredients and target targets were screened with scores ≥48 and P≤0.05, and the signal pathways and diseases of target enrichment were analyzed to establish a medicinal material-target-pathway network and analyze the pharmacological action mechanism of Guizhifuling formulae for treating diseases. Results Core targets such as ADORA1, ADORA2A, HTR1B, CHRM2, CHRM4 and other active ingredients such as Cordycepin, Styrene, Pachymic acid, Cinnamaldehyde, trans-Cinnamic acid were obtained. Mainly treats three types of diseases including nervous system, cardiovascular system and reproductive system, including pain, migraine, hypertension, heart failure, arrhythmia, benign prostatic hyperplasia, erectile dysfunction, endometrial cancer, endometriosis et al. In addition, this formulae was found to have potential therapeutic effects in the treatment of depression, schizophrenia, alcohol dependence, Alzheimer's disease and drug dependence. Conclusion Studying multi-component, multi-target pharmacological mechanism of Guizhifuling formulae through the network pharmacology method provides new ideas for clinical application and development of this prescriptions. References | Related Articles | Metrics

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Analysis of Adverse Drug Reactions Induced by Human Papillomavirus Vaccination MU Yibing, WU Yinglan, CHEN Xia 2020, 17(4): 221-226.  DOI: 10.19803/j.1672-8629.2020.04.06 Abstract ( 761 )   PDF (1173KB) ( 549 )   Objective To explore the characteristics and profiles of adverse drug reactions (ADRs) caused by HPV vaccination, in order to provide reference basis for the safety use promotion of HPV vaccines. Methods From January 2018 to December 2018, bivalent or quadrivalence human papillomavirus (HPV) vaccines were administered to eligible women. Local and systemic reactions that occurred within fifteen days of half a month after vaccination were recorded. Results Most of the 732 recipients of HPV vaccination were recipients, married women and urban women were the main ones. Women aged 30 to 39 accounted for a large proportion. In the previous year, less than 50% of married women completed cervical cancer screening or and human papillomavirus screening. Local adverse reactions were dominating the main, followed by dizziness, headache, digestive tract symptoms and fever. No serious adverse reactions were found. Conclusion The clinical safety of HPV vaccination is safe clinically better. In view of the adverse reactions induced by of vaccines, corresponding precautions should be taken preventive measures should be for mulated to reduce the occurrence of adverse reactions. At the same time, we should strengthen the propaganda and education of cervical cancer knowledge for rural women and unmarried women should be better informed of, so that they can fully understand References | Related Articles | Metrics

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Literature Review of Adverse Drug Reactions of Quinolones-induced Thrombocytopenia CHANG Xinyu, GUO Guiming 2020, 17(4): 227-230.  DOI: 10.19803/j.1672-8629.2020.04.07 Abstract ( 1091 )   PDF (1119KB) ( 383 )   Objective To analyze the clinical characteristics of thrombocytopenia caused by quinolones, levofloxacin and moxifloxacin so as to provide reference for clinical safe drug use. Methods By searching PubMed, Medline, CNKI database and VIP Chinese full-text database, case reports of adverse drug reactions of thrombocytopenia induced by levofloxacin and moxifloxacin were retrieved. The patients' gender, age, underlying diseases, combined medication, routes of administration, clinical manifestations and prognosis were also analyzed statistically. Results Totally 10 patients with thrombocytopenia induced by levofloxacin and 6 patients by moxifloxacin were collected. Statistics showed that 62.5% of these adverse reactions occurred in patients over 60 years old. 68.75% of the cases had a history of such preexisting chronic diseases as hypertension and diabetes mellitus. Except for one patient who died, the conditions of other patients improved within 5~40 days of withdrawal. The adverse reactions of this type were severe. Conclusion There are few reports of adverse drug reactions of thrombocytopenia caused by quinolones, but the consequences are serious. Clinical application should be monitored as soon as possible for the sake of symptomatic treatment. References | Related Articles | Metrics

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Current Off-label Use of Clonazepam in Department of Psychiatry ZHU Lifang, WANG Laihai, CHEN Yongxin, WANG Chuansheng, ZHANG Ruiling 2020, 17(4): 231-234.  DOI: 10.19803/j.1672-8629.2020.04.08 Abstract ( 731 )   PDF (1060KB) ( 360 )   Objective To find out about the current off-label use of clonazepam and provide data for formulating related specifications in a psychiatry department. Methods The off-label use of clonazepam was analyzed based on drug instructions, literature research as well as retrospective analysis of the outpatient prescriptions of clonazepam in our hospital from June 2017 to June 2018. Results A total of 7 200 prescriptions related to psychotropic drugs of category were retrieved, 1080 of which involved clonazepam, and in 972 of the 1 080 prescriptions off-label use of clonazepam was found. The rate of off-label usage was as high as 90.00%. Among the cases of off-label use, 95.06% were related to indications and 4.94% to the dose. The top four diseases involving off-label use of clonazepam were anxiety, sleep disorder, insomnia and depression. The rates of off-label prescriptions by doctors at all levels were basically the same, with no significant difference (χ2=0.77, 3.24, 1.33, P>0.05). Conclusion The off-label use of clonazepam in the outpatient pharmacy is relatively common in our hospital, which is sometimes acceptable and necessary clinically. Guidelines for off-label drug use are urgently needed to supervise and protect physicians and ensure patients' safety. Meanwhile, irrational use should be contained to lower drug-induced risks. References | Related Articles | Metrics

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Analysis of Adverse Reactions Induced by Iodine Contrast Media in CT Enhanced Scan WANG Guanjie, CHEN Huanlei, WANG Zhenhua 2020, 17(4): 235-238.  DOI: 10.19803/j.1672-8629.2020.04.09 Abstract ( 769 )   PDF (1050KB) ( 395 )   Objective To analyze the characteristics of adverse reactions of iodine contrast media in CT-enhanced scanning, so as to provide reference for clinical medication. Methods A retrospective analysis was performed on the data of patients with adverse reactions of iodine contrast media used in the CT Room of our hospital between January 2017 and May 2018. The gender, age, types of iodine contrast media, time of adverse reactions, systems involved and clinical manifestations of the patients were statistically analyzed. Results Among the 2 500 patients who received iodine contrast media during CT-enhanced scanning,81 (3.24%) ended up with adverse reactions, of whom 35 were males and 46 were females. The ratio of males to females was 0.76:1. Such commonly used non-ion iodinated agents as iopromide, iohexol, iodixanol and ioversol were involved, and iopromide and iohexol were responsible for most of the cases of adverse reactions. 27 cases occurred during the skin test, and 54 cases occurred after intravenous administration .The clinical manifestations of the anaphylactic reactions varied. Skin and its accessories disorders, such as rashes and pruritus, were the most common, followed by gastrointestinal disorders such as nausea and vomiting. Anaphylactic shock was the most serious but no death occurred. Conclusion Before using the media, we should pay attention to the prevention of adverse reactions and be prepared for any emergency, observe closely, identify adverse reactions and intervene early so as to improve the safety of clinical use of iodine contrast media. References | Related Articles | Metrics

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Improper Prescriptions for Antitumor Drugs in Pharmacy Intravenous Admixture Services BAI Shunmin, FAN Zhe 2020, 17(4): 239-244.  DOI: 10.19803/j.1672-8629.2020.04.10 Abstract ( 724 )   PDF (1238KB) ( 426 )   Objective To analyze improper prescriptions for antitumor drugs in Pharmacy Intravenous Admixture Service (PIVAS) in our hospital, so as to provide reference for clinical rational use of drugs. Methods A total of 211 improper prescriptions for antitumor drugs found in Pharmacy Intravenous Admixture Service (PIVAS) of our hospital between January 2016 and December 2017 were statistically and retrospectively analyzed．Results The improper prescriptions for antitumor drugs were concentrated in the selection of wrong solvents(61.61％), incorrect solvent dosage(17.54％), unsound dosage of administration(6.16％), and the wrong order in which drugs were used(5.69％). Conclusion The review of anti-tumor drug prescriptions should be strengthened,Intervention skills of prescription-checking pharmacists should be improved. Doctors and nurses should also increase their knowledge of drug instructions in order to improve the accuracy of prescriptions and guarantee the safety of antitumor drug use. References | Related Articles | Metrics

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Analysis of One Case of 木 Toxic Epidermal Necrolysis Induced by Aspirin DU Xiu1, CAO Yun 2020, 17(4): 245-248.  DOI: 10.19803/j.1672-8629.2020.04.11 Abstract ( 845 )   PDF (464KB) ( 244 )   Objective To probe the experience learned from the treatment of toxic epidermal necrolysis (TEN) induced by aspirin. Methods The possible causes of TEN and treatment protocols were studied and summarized by analyzing the medical records of a patient in June 2019. Results The patient needed oral anticoagulation because of percutaneous coronary intervention (PCI) two years ago. On the second day after taking oral aspirin, the patient developed red rash before some of the maculae were gradually fused into a large area. Over the next few days, blisters appeared and were ulcerated, and epidermis was exfoliated. TEN induced by aspirin was considered and aspirin was immediately stopped so that the symptoms on the patient's skin were relieved gradually via anti-allergic therapy and symptomatic supportive treatment. Conclusion TEN may be induced by aspirin. Early identification, suspension of suspected medicine and effective treatment are the key to cure of drug-induced TEN. References | Related Articles | Metrics

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Drug Use and Transfusion Safety of Blood Donors SHEN Jun, WU Qiuhui, CHEN Yanhua, PENG Jie 2020, 17(4): 249-252.  DOI: 10.19803/j.1672-8629.2020.04.12 Abstract ( 556 )   PDF (1108KB) ( 313 )   Objective To improve the safety of blood products, set the delay period and formulate management measures for blood donors who have received medication in order to provide reference for blood transfusion safety. Methods According to the pharmacodynamics and pharmacokinetics of drugs and the literature at home and abroad, the delay period and management measures for blood donors who have taken drugs were proposed. Results & ConclusionIt is recommended that special blood products be developed for children under 12 years old. After the drug delay period of peak time and 5 plasma elimination half-lives (Tmax+5 t1/2), the drug content in the donor’s plasma will be less than 3% of the treatment concentration. Donors who use teratogenic drugs, genotoxic drugs and drugs that affect platelet function have to be observed and asked to wait for a long time. Serious interviews and information collection of blood donors are an important part of health check-up. It is recommended that a network system be used to keep patients’ medication records. References | Related Articles | Metrics