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Preliminary Thinking on the Establishment of Pharmacovigilance System in China YUAN Lin, GAOYan, LU Changfei 2020, 17(11): 749-752.  DOI: 10.19803/j.1672-8629.2020.11.01 Abstract ( 1024 )   PDF (1208KB) ( 1224 )   The new Drug Administration Law required the establishment of pharmacovigilance system in China. In this paper, the origin and development of pharmacovigilance concept were reviewed, the pharmacovigilance system and its applicability were discussed from the perspective of drug regulatory concept reform, and the concerned problems in the establishment of pharmacovigilance system were put forward. References | Related Articles | Metrics

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Effects of Bibenzyl Compound (20C) from Gastrodia elata on MPTP/p-induced Mice and Mechanism ZHOU Tiantian, ZHANG Qiushuang, CHEN Ying, ZHU Chenggen, SHI Jiangong, CHEN Naihong, YUAN Yuhe 2020, 17(11): 753-757.  DOI: 10.19803/j.1672-8629.2020.11.02 Abstract ( 248 )   PDF (1431KB) ( 299 )   Objective To study the pathological and biochemical effect of bibenzyl compound 20C on the mouse model of MPTP/p (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine, MPTP/probenecid) and explore the mechanism. Methods A mouse model of MPTP/p was established. Mice received an intraperitoneal injection of MPTP and subcutaneous injection of probenecid. Pathological changes were examined by HE staining and immunohistochemistry while biochemical changes were detected by Western blot. Results Pathological and biochemical results showed that 20C could reduce expressions of MPTP/p-induced nitrated-α-synuclein in the stomach. The results of Western blot suggested that 20C reduced the level of Toll-like receptors 4 (TLR4) in the MPTP/p model, decreased phosphorylated nuclear factor-κB (NF-κB) p65 (p-p65), inhibited interleukin-1β (IL-1β) generation, and ameliorated inflammation. Conclusion 20C can reduce the formation of α-synuclein aggregation and nitrated-α-synuclein, inhibit TLR4-NF-κB p65 pathway, prevent p65 from aetivation, decrease IL-1β, inhibit inflammation and protect mice from MPTP toxicity. References | Related Articles | Metrics

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Mechanisms of Genistein for Promoting Bhas42 Cell Proliferation and Transformation WANG Qi, QI Naisong, LIU Qian, SONG Jie, AO Rui, MA Shuangcheng, WEN Hairuo 2020, 17(11): 758-765.  DOI: 10.19803/j.1672-8629.2020.11.03 Abstract ( 190 )   PDF (1865KB) ( 115 )   Objective To investigate the potential mechanism by which GI promotes cell proliferation and transformation. Methods Bhas42 cells were used to determine the effects of GI at concentrations that could lead to cell transformation (0.1、0.5 and 1μg/mL) on cell cycle, apoptosis, and cytotoxicities (ROS, endoplasmic reticulum function, lipid accumulation, mitochondrial membrane potential, intracellular calcium ion concentration), oxidative stress related indicators (SOD, MDA, GSH, 8-HdG and ODC), expression levels of GJIC related mRNAs (PKC, Cx26, Cx32 and Cx43 ) and expression levels of tumor-related cytokines (1L-6, KC/CXCL1, MCP-1, VEGF-A, VEGF-C, TNF-α, 1L-1β, L-17A, VEGF-D). Results GI could intervene in cell cycle regulation, promote cell proliferation and transformation, and disrupt the function of GJIC. However, oxidative stress is not an important mechanism by which GI causes the proliferation or transformation of Bhas42 cells. Conclusion This study indicates that the cell cycle regulation pathway and GJIC could be the main mechanisms by which GI promotes cell proliferation and transformation. References | Related Articles | Metrics

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How to Strengthen China's Pharmacovigilance for SARS-CoV-2 Vaccines in Post-marketing Phase ZUO Shuyan 2020, 17(11): 766-772.  DOI: 10.19803/j.1672-8629.2020.11.04 Abstract ( 565 )   PDF (1497KB) ( 439 )   Objective To explore how timely find out the adverse events of specific interest following immunization, comprehensively evaluate the safety profile of vaccines and ensure the safety to recipients when SARS-CoV-2 vaccines are approved for marketing and inoculation to populations in the future. Methods Suggestions on strengthening pharmacovigilance are provided by review of World Health Organization's recommendations for pharmacovigilance preparedness for the launch of the COVID-19 vaccines, the standards and tools developed by the Brighton Collaboration through Safety Platform for Emergency vACcines and the analysis of China's pharmacovigilance surveillance systems. Results In view of unusual pathophysiology of COVID-19, innovative technology platform to accelerate development of SARS-CoV-2 vaccine candidates, and limited number of subject exposed, heterogeneity of population studies, and limited period of follow up during pre-licensure trials, it is critical to continue monitoring the safety of vaccine at the time of deployment to further characterize and quantify clinically relevant risks and to identify new reactions. Conclusion sIt is suggested that China urgently needs to develop a post-marketing monitoring plan for SARS-CoV-2 vaccines, layout resource to carry out active surveillance for vaccine safety and enhance passive surveillance for adverse events following immunization and adverse events of specific interests, strengthen authorities'information communication at all levels to reduce public hesitancy to vaccine. References | Related Articles | Metrics

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Pharmacovigilance Subcontracted by Foreign Marketing Authorization Holders LIU Lili 2020, 17(11): 773-776.  DOI: 10.19803/j.1672-8629.2020.11.05 Abstract ( 490 )   PDF (1204KB) ( 560 )   Objective To explore modes and management methods of pharmacovigilance subcontracted by marketing authorization holders in China based on system requirements for marketing authorization holders stipulated by the Drug Administration Law and the Measures for the Supervision over and Administration of Pharmaceutical Production. Methods The laws and regulations enacted by drug regulatory authorities concerning pharmacovigilance subcontracted by marketing authorization holders in the United States, Europe, and the United Kingdom were studied and compared with those of China. Combined with the guidelines for pharmacovigilance entrustment agreements in China, opinions or suggestions on the development of pharmacovigilance commission activities were presented. Results & Conclusion To clarify the responsibilities and obligations of the holder and the trustee is the basis of pharmacovigilance commission. Holders should evaluate pharmacovigilance practices of trustees. Pharmacovigilance inspection by drug regulatory agencies should cover the inspection of trustees and focus on the inspection of compliance and management of drug safety data. References | Related Articles | Metrics

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Course of Development and Status quo of Drug Abuse Monitoring in China BAN bingkun, REN pengyu, WEI jingtu, CAO zijing 2020, 17(11): 777-779.  DOI: 10.19803/j.1672-8629.2020.11.06 Abstract ( 477 )   PDF (1010KB) ( 282 )   Objective To investigate the history of and problems with drug abuse monitoring in China in order to offer new ideas for future work. Methods By reading literature, the course of development of drug abuse monitoring in China was reviewed, achievements summarized, while related difficulties, problems and countermeasures were presented. Results Drug abuse monitoring in China was still in infancy, without a complete legal and regulatory system, clear organizational framework and responsibilities, feasible inter-departmental coordination mechanism, professional talent team or perfect drug abuse monitoring information system. Conclusion It's urgent to establish and improve the related legal system, specify the organization and responsibilities, perfect the mode of monitoring, provide the personnel and expenses needed, establish a long-acting mechanism of communication and cooperation, improve the drug abuse monitoring information system, enhance publicity, and create an atmosphere of social co-governance. References | Related Articles | Metrics

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How to Develop a Post-marketing Risk Management Plan for New Drug Applications in Line with E2E Guidelines ZOU Limin, QI Yueli, TANG Ling, DU Yu, YANG Zhimin 2020, 17(11): 780-784.  DOI: 10.19803/j.1672-8629.2020.11.07 Abstract ( 1160 )   PDF (1104KB) ( 657 )   Objective To give applicants specific advice on how to develop a post-marketing risk management plan for new drug applications in line with the E2E guidelines and the updated Drug Administration Law. Methods Based on the ICH E2E guidelines for pharmacovigilance planning, this article was intended to elaborate on the template for risk management plans(RMP) specified by the Requirements on Format and Content of the Risk Management Plan for Anti-tumor Drugs Application published by the Center for Drug Evaluation (CDE) of NMPA. Considerations about risk assessment during the clinical review of new drug applications were also mentioned. Results The CDE RMP template covered all key points stated by E2E guidelines. By using the framework of this template, this article gave specific instructions on how to identify important risks of a new drug and to develop appropriate pharmacovigilance plans and risk minimization measures that match the safety profile. Conclusion A qualified RMP can present the critical information on drug risks for the benefit-risk assessment, and persuasively demonstrate the confidence and ability of the applicants to manage risks. It can also facilitate the review process and improve the availability of valuable drugs. It is a promising tool for the control of full life cycle risks of a new drug. References | Related Articles | Metrics

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Selection and Switch-to-OTC of Chinese Patent Medicines in China ZHU Lan, Shao Bo, XIA Dongsheng 2020, 17(11): 785-789.  DOI: 10.19803/j.1672-8629.2020.11.08 Abstract ( 296 )   PDF (1254KB) ( 201 )   Objective To review some of the Chinese patent medicines that have been selected or switched to over-the-counter (OTC) products in China so as to provide reference for the switch of prescription drugs to OTC (Rx-to-OTC) drugs in China. Methods Regulations on classification management of prescription and nonprescription drugs and the history of Rx-to-OTC switch were reviewed. Chinese patent medicines which were selected as and switched to OTC drugs were analyzed separately. Results On the basis of the list of generic drugs,there were more than 3 900 OTC Chinese patent medicines,including 3 406 medicines that had been selected as OTC drugs between 1999 and 2004,535 ones that had been switched to OTC,and 25 OTC Chinese patent medicines switched to prescription drugs in the same period. Conclusion The application materials should meet the requirements of regulations on Rx-to-OTC switch applications, After switch to OTC drugs,marketing authorization holders (MAHs) should ensure the safety of these drugs, find effective ways to collect adverse reaction(ADR)reports that should be analyzed to improve the safety instructions of the OTC label. MAHs should be responsible for drug safety for the sake of patients. References | Related Articles | Metrics

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Processes and Requirements of Peer Review of Toxicological Pathology Based on GLP LI Jian Hua, ZHAO Liang You, LIU Shu Min 2020, 17(11): 790-793.  DOI: 10.19803/j.1672-8629.2020.11.09 Abstract ( 196 )   PDF (1286KB) ( 99 )   Objective To explore the processes and requirements of peer review of toxicological pathology in order to ensure more effective peer review in China. Methods With "toxicological pathology" "peer review process" "peer review requirements" and "pathologist" as key words, the China HowNet、Wanfang、CNKI and Pubmed databases from December 1998 to December 2018 were searched to retrieve articles related to peer review processes and requirements of toxicological pathology before the content of these articles was analyzed and summarized. Results and Conclusion A total of 12,657 pieces of related literature were retrieved and 22 of them were screened out. Through literature review, it was concluded that the processes and requirements of peer review in the field of toxicological pathology were generally similar between China and other countries. However, in China's codes regarding peer review of toxicological pathology, only regulations are available, without any interpretations of these regulations. Peer review of toxicological pathology has been implemented abroad, and many regulations have been updated. References | Related Articles | Metrics

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Analysis of One Case of Anaphylactic Shock Induced by Lidocaine Hydrochloride Injection LIU Shaohua, LAN Yan, WANG Yulai, LU Zhen 2020, 17(11): 794-797.  DOI: 10.19803/j.1672-8629.2020.11.10 Abstract ( 347 )   PDF (1076KB) ( 201 )   Objective To explore and analyze the correlations and characteristics of anaphylactic shock induced by lidocaine hydrochloride injection for dental use so as to promote clinical rational drug use. Methods One case of lidocaine-induced anaphylactic shock in the Department of Stomatology of Huangshi Central Hospital was analyzed. The correlations between shock and drug use were assessed in combination with the clinical characteristics and domestic and foreign literature. Results This case of anaphylactic shock might have been induced by lidocaine hydrochloride injection. Conclusion Lidocaine may cause anaphylactic shock, so we should monitor the use of lidocaine to ensure drug safety. References | Related Articles | Metrics

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Literature analysis of Oxaliplatin Allergic Reactions in Chinese patients LI Min, ZHONG Qiaoni, ZHAO Li, LAN Lulu, LIU Dong, ZHANG Chengliang 2020, 17(11): 798-802.  DOI: 10.19803/j.1672-8629.2020.11.11 Abstract ( 301 )   PDF (1299KB) ( 226 )   Objective To collect case reports on oxaliplatin (OXA)-induced allergic reactions in Chinese patients, summarize their characteristics and regularities, and improve the safety of OXA in clinical application. Methods Chinese literature databases including Wanfang and CNKI etc from January 1999 fo May 2019. were searched for case reports of OXA-induced allergic reactions. Data on gender, age, chemotherapy cycles, the time allergic reactions occurred, dosage, clinical manifestations, severity and outcomes of the patients was statistically analyzed. Results A total of 102 OXA allergic reactions were reported. The average age of patients was 53 years old and the male-female ratio was 1.04:1. OXA-induced allergic reactions can occur in any cycle of medication, mostly within 30min, which can involve multiple systems such as digestive, cardiovascular and respiratory systems. Most of these allergic reactions are grade III, and all of these cases have improved after drug withdrawal or treatment. Conclusion Allergic reactions are common with OXA, which can lead to the interruption of chemotherapy. Severe allergy even poses a threat to patients' safety. The clinical medical staff should be alert to the allergic reactions of OXA, strengthen monitoring and prevention, and improve the safety of medication for patients. References | Related Articles | Metrics

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Analysis of 182 Case of Serious Adverse Drug Reactions/events Reports in a Hospital WU Wenli, JING Jing, LU Zhaogang, ZANG Guixiang, WANG Jian, WANG Xiaoxu, WANG Jiyun 2020, 17(11): 803-807.  DOI: 10.19803/j.1672-8629.2020.11.12 Abstract ( 405 )   PDF (1458KB) ( 344 )   Objective To analyze the characteristics of serious adverse drug reactions/events (ADR/AE) reported in one hospital so as to provide reference for rational drug use in clinical practice. Methods One hundred and eighty-two reports of serious ADR/AE in one hospital were retrospectively analyzed, while drug categories, routes of administration, prognosis, systems or organs involved and clinical manifestations were studied. Results Among the 182 cases, 90 were males and 92 were females, and the group aged 15 to 44 accounted for 35.71%. According to categories, antimicrobial drugs ranked first (28.04%), followed by Chinese patent medicines and central nervous system drugs. Hepatobiliary disorders, general disorders, skin and appendages disorders were the most common involved systems organ classes(SOCs). The main clinical manifestations were abnormal hepatic function, increased hepatic enzymes, and anaphylactic shock. Conclusion Antimicrobial drugs and Chinese patent medicines remain the focus of monitoring of serious ADR/AE. Patients over 45 years old who have taken more than one drug for a long time should be monitored for liver and kidney function to ensure medication safety． References | Related Articles | Metrics

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Literature Analysis of Dapagliflozin-induced Euglycemic Diabetic Ketoacidosis CAI Jun, LIU Simin, LI Huixin, NIE Li, HAN Dan, ZHANG Jinping 2020, 17(11): 808-812.  DOI: 10.19803/j.1672-8629.2020.11.13 Abstract ( 480 )   PDF (1350KB) ( 678 )   Objective To investigate the characteristics of dapagliflozin-induced euglycemic diabetic ketoacidosis so as to provide reference for clinical safe and rational use of dapagliflozin. Methods Literature about euglycemic diabetic ketoacidosis induced by dapagliflozin published as of June 2019 was retrieved from CNKI, VIP Chinese full-text database, Wanfang database, Pubmed and Embase. The basic information, drug use, treatment, risk factors, outcomes and relevance evaluation of the cases were statistically analyzed. Results A total of 29 papers involving 41 cases were included. There were 13 males and 28 females with an average age of (52.15±15.32) years old. 50.00% of the adverse reactions occurred within one month after medication. The most common clinical symptoms were vomiting, nausea, abdominal pain, dyspnea and weakness. At the time of diagnosis, blood glucose averaged 10.13 mmol/L, pH 7.15, blood bicarbonate 8.65 mmol/L, anion gap 25.05 mmol/L, and β-hydroxybutyrate 5.85 mmol/L. The most common risk factors included surgery, low-carbohydrate diets, infections, and insulin reduction or discontinuation. Forty patients recovered after treatment, but one patient died. The results of relevance evaluation were all "very likely". Conclusion We should be alert to the risk of euglycemic diabetic ketoacidosis induced by dapagliflozin, and strengthen the follow-up for high-risk patients in the initial stage of dapagliflozin medication so as to treat patients with symptoms of ketoacidosis as early as possible and ensure the safety of drug use. References | Related Articles | Metrics

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Rational Use of Pregnancy Termination Drugs in a Maternal and Child Health Care Hospital WANG Haiqing, WANG Xiaoli, CHEN Xiaohong, CHEN Lin 2020, 17(11): 813-817.  DOI: 10.19803/j.1672-8629.2020.11.14 Abstract ( 620 )   PDF (1503KB) ( 375 )   Objective To analyze the usage of pregnancy termination drugs in a Maternal and Child Health Hospital, and probe its rationality so as to provide data for clinical rational drug application. Methods The prescription automatic screening system (PASS) and HIS system were used to retrieve data from medical records, involving 100 records of outpatients and emergency patients and 50 hospitalizations in 2017 and 2018. The clinical diagnosis, usage and dosage, combined use and improper use of drugs for termination of pregnancy were analyzed after the data of eight quarters was summarized. Results The average age of 1,200 randomly selected patients who used drugs for terminating pregnancy was (29.0±5.24)y. In addition to early induced abortion and middle//late pregnancy induced labor, other diagnoses involving drug pregnancy termination accounted for 29.25%, such as missed abortion, postoperative and ectopic pregnancy. Common drugs used in combination with pregnancy termination drugs included Chinese patent medicines, antimicrobial agents, estrogen and progesterone drugs (contraceptives), intraoperative medications and drugs for the prevention/treatment of postpartum bleeding. The irrational usage of drugs for termination of pregnancy mainly involved inappropriate drug usage and dosage, accounting for 48.5%. Conclusion From 2017 to 2018, the percentage of rational use of pregnancy termination drugs in our hospital gradually increased from 80.67% to 97.33%, but there are still cases of irrational use, which should be improved continuously. References | Related Articles | Metrics

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Analysis of 129 Cases of Adverse Reactions and Clinical Application of Plasma Concentration Monitoring of Olanzapine ZENG Huansi, ZHONG Caini, ZHONG Yilin, PENG Chenchen, ZHANG Xuan 2020, 17(11): 818-822.  DOI: 10.19803/j.1672-8629.2020.11.15 Abstract ( 451 )   PDF (1412KB) ( 543 )   Objective To analyze the adverse drug reactions (ADR) and plasma concentration monitoring of olanzapine so as to provide reference for clinical rational use of drugs. Methods A retrospective analysis of 129 cases of ADR by Shenzhen Kangning Hospital from January 2017 to June 2019 induced by olanzapine was conducted to explore the relationships between the patients' gender, age, dosage, drug combination, plasma concentration and concentration-dosage ratio (C/D) and ADR of olanzapine. Results ADR mainly damaged the neuropsychiatric system, hepatobiliary system and cardiovascular system. The most common clinical manifestations were abnormal liver function, extrapyramidal diseases and akathisia. Most of the patients were aged 19 to 40. ADR reports involved more females than males, but in reports of serious ADR, males outnumbered females(P <0.05). There was no significant difference in the incidence of serious ADR between combined medication and single medication(P>0.05). 72.87% of the patients had their plasma concentrations monitored during the occurrence of ADR. There was no significant difference in the plasma concentration or C/D value between ADR and serious ADR(P>0.05). Conclusion When olanzapine is used in clinic, clinicians should strengthen the monitoring of ADR and therapeutic drugs, reduce drug combination, and ensure the safety of clinical drug use. References | Related Articles | Metrics

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Epidemic Characteristics of First-time Drug Abuse and Influencing Factors of Synthetic Drug Abuse among Adolescents in Shenzhen WU Jianru, XIAO Xiao, LIU Xiaoyu, WANG Shu 2020, 17(11): 823-827.  DOI: 10.19803/j.1672-8629.2020.11.16 Abstract ( 196 )   PDF (1484KB) ( 223 )   Objective To investigate the causes and influencing factors of first-time drug abuse among adolescents in Shenzhen, and to provide reference for establishing a first-level intervention model for drug abuse among adolescents in Shenzhen. Methods A cross-sectional survey was carried out through the "Shenzhen Youth Drug Abuse Survey Form". Descriptive analysis, Chi-square test and logistic regression were used to describe and compare drug abuse characteristics of drug-abusers of different genders and occupations. Results A total of 1,506 drug abusers under 35 years old were included in the survey, 69.8% of whom were holders of junior high school diplomas or worse. Most of them were unemployed. The influencing factors for synthetic drug abuse were age, gender, and family incomes. Synthetic drugs were obtained mainly online. Conclusion There are different causes of synthetic drug abuse among adolescents, including personal understanding of drugs, mental state, family, and society. Adolescents should be better informed of the harm of drug abuse and control of drug abuse among young people should be tightened. References | Related Articles | Metrics

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Risk of Narcotics and Psychotropic Substances Abuse among Drug Abusers LIU Bin, LV Jialin, YIN Ruoyun, ZHOU Juan, HUANG Helang, WU Lei 2020, 17(11): 828-832.  DOI: 10.19803/j.1672-8629.2020.11.17 Abstract ( 249 )   PDF (1384KB) ( 257 )   Objective To obtain the prevalence of narcotics and psychotropic substances used by drug addicts for non-medical purposes. To find the factors changing its trend for some suggestions on improving medical drug supervision and preventing drug abuse. Methods Form January to December 2017, 2 025 drug addicts were newly admitted to six judicial enforcement agencies in Jiangxi province, who were investigated and interviewed for information to analyze the current situation and influencing factors of drug abuse. Results Among the 2 025 subjects, 141 cases had abused ephedrine drugs, accounting for 6.96%. In addition to methadone, tramadol (21.99%), federal cough syrup (18.44%), diazepam (17.73%) and morphine (11.35%) were used. Most of the patients who abused medical drugs except methadone were 20 to 40 years old (62.41%), most of them were male (90.07%), and many persons had been addicted for more than 5 years (60.99%). The access to narcotic drugs, class I and II psychotropic drugs mainly came from hospitals, accounting for 56.41% and 43.10%, respectively, while non-listed drugs were mainly purchased from pharmacies (45.45%), and most of the medical drugs were consumed in their own places (79.43%). Conclusion The supervision of hospitals and pharmacies should strengthen management in some drug, which are tramadol, federal cough syrup, diazepam, morphine and more. It would be good for improving medical drug supervision and preventing drug abuse. References | Related Articles | Metrics

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One Case of Hyponatremia Complicated with Hyperkalemia Induced by Compound Sulfamethoxazole PENG Xiaoye 2020, 17(11): 833-834.  DOI: 10.19803/j.1672-8629.2020.11.18 Abstract ( 573 )   PDF (357KB) ( 297 )   Objective To explore the cause of hyponatremia and hyperkalemia induced by combined medication of Trimethoprim-sulfamethoxazole(SMZ co) and follow-up treatment. Methods An old female patient with long-term spironolactone use took SMZ co for urinary tract infection and then developed hyponatremia and hyperkalemia. The process of diagnosis and treatment was analyzed based on literature retrieval. Results The patient presented with nausea and dyspnea, accompanied hyponatremia, hyperkalemia and renal deterioration after initiating SMZ co for 6 days. Symptomatic and supportive treatment were implemented immediately including withdrawal of spironolactone, reducing dosage of SMZ co, diuresis, electrolyte correction, urine alkalinization etc. Furthermore Blood potassium and sodium gradually returned to normal, creatinine level decreased. Conclusion High basal creatinine levels combined with potassium-preserving diuretics are risk factors for adverse drug reactions. Attention should be paid to the influence of drug interaction, especially in patients with renal dysfunction. It is recommended to closely monitor electrolytes and renal function, reduce or stop medicaition if necessary. Baseline high serum creatinine, and co-administration of spironolacone may contribute to these ADR. References | Related Articles | Metrics

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One Case of Lamotrigine-induced Severe Erythema Multiforme Drug Eruption WANG Xiao, WU Lingdi, WANG Jun, WEI Wei, WANG Weibo, WANG Haiying 2020, 17(11): 835-837.  DOI: 10.19803/j.1672-8629.2020.11.19 Abstract ( 230 )   PDF (996KB) ( 123 )   Objective To explore ways to treat Stevens Johnson syndrome induced by lamotrigine. Methods The diagnosis and treatment of one case of Stevens Johnson syndrome induced by lamotrigine was analyzed. The mechanism by which lamotrigine induced Stevens Johnson syndrome was discussed in combination with literature. Results The patient was diagnosed with Stevens Johnson syndrome on the 55th day he took lamotrigine. The drug was stopped immediately. His condition gradually improved after the treatment with intravenous methylprednisolone sodium succinate. Skin rash was significantly improved, and itching disappeared on the 19th day of withdrawal. Conclusion The use of lamotrigine should be stopped immediately should Stevens Johnson syndrome occur. Glucocorticoid and other drugs should be given as symptomatic treatment. References | Related Articles | Metrics

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Analysis of One Case of Skin Pigmentation Caused by Polymyxin B for Injection SHI Yun, XI Na, CHEN Zhe, ZHAO GuanRen 2020, 17(11): 838-840.  DOI: 10.19803/j.1672-8629.2020.11.20 Abstract ( 849 )   PDF (1165KB) ( 264 )   Objective To investigate the role of a clinical pharmacist in the diagnosis and treatment of skin pigmentation induced by polymyxin B. Methods A clinical pharmacist participated in the diagnosis and treatment of a patient with pigmentation. According to the changes of the patient's condition, the clinical pharmacist and the clinician consulted each other, analyzed the causes of the adverse reactions, raised pharmaceutical suggestions, and worked out an appropriate treatment plan. After discharge, the patient was followed up by the clinical pharmacist to track the prognosis. Results In the course of diagnosis and treatment, doctors adopted the advice of the clinical pharmacist that skin pigmentation was caused by polymyxin B. The symptoms did not aggravate after discontinuation, but the skin color base line remained unchanged. Conclusion When polymyxin B is used, the patient can take into account the adverse reactions caused by this drug, and the clinical physician and the clinical pharmacist need to weigh the advantages and disadvantages of using the polymyxin B to balance the efficacy and adverse events. At the same time, careful consideration should be given to the combination of other drugs that may lead to skin-like symptoms. Clinical pharmacists are expected to combine their expertise with clinical practice, improve the diagnosis of disease and the level of medication in order to ensure the safety of patients.. References | Related Articles | Metrics

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One Case of Nervous System Toxicity Induced by Amphotericin B Liposomes via Intrathecal for Injection YANG Min, YANG Yong, ZHOU Jie 2020, 17(11): 841-844.  DOI: 10.19803/j.1672-8629.2020.11.21 Abstract ( 251 )   PDF (1202KB) ( 159 )   Objective To analyze the nervous system toxicity induced by amphotericin B liposomes delivered by intrathecal injection in a patient with pediatric cryptococcal meningitis in order to help reduce adverse reactions in pediatrics. Methods Data on the patient's process of hospitalization, therapeutic regimen, time of occurrence and prognosis of adverse reactions was collected. The related literature and diagnosis and treatment guidelines were reviewed, possible causes of adverse reactions were analyzed and corresponding treatment measures were recommended. Results It was likely that the adverse reactions were caused by the intrathecal injection of amphotericin B liposomes. After discontinuation of intrathecal injection and psychological counseling, the adverse reactions were relieved. Conclusion There is a high risk of neurotoxic reactions when amphotericin B is administrated by intrathecal injection, so intrathecal injection should not be routinely recommended for cases of non-refractory cryptococcal meningitis. Amphotericin B liposomes should be avoided when intrathecal injection is needed. Given the weak psychological capacity of pediatric patients, appropriate psychological counseling could optimize the treatment response. References | Related Articles | Metrics

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Analysis of One Case of Severe Pneumonia in The Elderly Complicated with Drug Fever Induced by Vancomycin GONG Yu, ZHENG Zhixin, JING Tianchuang, SU Dan 2020, 17(11): 845-847.  DOI: 10.19803/j.1672-8629.2020.11.22 Abstract ( 233 )   PDF (1174KB) ( 269 )   Objective To explore the methods of drug fever induced by Vancocin. Methods Clinical pharmacists participated in the treatment of severe pneumonia and explored the characteristics, diagnosis and solutions of drug fever induced by Vancocin in elder patients with severe pneumonia. Results Vancocin, which induced adverse reaction of drug fever, was stopped in time under the intervention of clinical pharmacists and the patient's temperature returned to normal. Conclusion The clinical pharmacists should pay attention to the adverse reactions in the treatment of severe pneumonia by Vancocin and improve the safety and efficacy of Vancocin treatment. References | Related Articles | Metrics