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Post-marketing Surveillance and Evaluation of Chinese Drugs in the New Era SHEN Chuanyong, WU Tingting, LIU Wei, ZHENG Mingjie, FAN Rong, DONG Duo 2020, 17(10): 649-652.  DOI: 10.19803/j.1672-8629.2020.10.01 Abstract ( 803 )   PDF (1232KB) ( 656 )   Based on new missions, new ideas, new regulatory systems, and new situation regarding drug supervision, this article analyzes the opportunities and challenges facing post-marketing surveillance and evaluation of drugs in China. In view of the status quo in China and development worldwide, recommendations are offered as to how to improve the regulatory system quickly, continue to enhance the capabilities of monitoring and evaluation, work hard to prevent drug safety risks, research new post-marketing surveillance and evaluation methods, and establish highly efficient information systems. References | Related Articles | Metrics

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Study on 6-month Repeated Dose Toxicity of Sanqi Yaojiu via Oral Administration in Rats XIA Lijuan, YIN Xiaohong, ZHANG Chengda, YANG Qian, HUANG Mincong, XIE Fang, CHEN Yunxiang, CHEN Peng, ZHENG Gaoli, ZHANG Lijiang 2020, 17(10): 653-658.  DOI: 10.19803/j.1672-8629.2020.10.02 Abstract ( 324 )   PDF (1356KB) ( 215 )   Objective To observe the repeat-dose toxicity of Sanqi Yaojiu in rats．Methods Totally 200 SD rats (males and females)were randomly divided into 5 groups, namely blank control group (purified water),vehicle control groups (basic liquor 3, 9 mL/kg) and Sanqi Yaojiu group (3, 9 mL/kg), 40 in each group, half male and half female. All rats were administered intragastrically once a day for 6 months with 4-weeks recovery phase. Test indicators included general clinical observation, feeding, weight, ophthalmology and urine examination, hematology, biochemical examination, major organ weighing and organ coefficient, and histopathological examination. Animal necropsy was scheduled at 13 weeks, 26 weeks after administered and the end of the recovery period, respectively. Results After each administration, rats of Sanqi Yaojiu groups showed decreased activity, prone position, weakness (only 9 mL/kg) and salivation (only 9 mL/kg). As the time of administration was prolonged, the period of occurrence and recovery of the above abnormal reactions were gradually shortened, and the above abnormal reactions were recovered after withdrawal. For 9 mL/kg dose of Sanqi Yaojiu or basic liquor, the weight and food intake of male rats were decreased, the neutrophil and monocytes were increased and lymphocyte were decreased in male rats. T.P, ALB, GLO were decreased in male and female rats, and GLU was decreased in female rats. The liver coefficient increased in female rats. Histopathological examination showed that the toxic target organs of rats in the 9 mL/kg dose of Sanqi Yaojiu or basic liquor were liver and stomach, which were basically consistent with the dose of 9 mL/kg of liquor. Rats at 3 mL/kg dose did not show significant toxic target organs. The above abnormal indicators had a certain dose-related and gender differences, and recovered after 4 weeks of withdrawal. Conclusion Intragastric administration of Sanqi Yaojiu for 26 weeks at 9 mL/kg dose can induce reversible damage to liver and stomach in rats. Compared with the same dose of basic liquor, Sanqi Yaojiu did not show new, more serious toxic reactions and toxic target organs. References | Related Articles | Metrics

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Biological Evaluation for Quality Control of Water Soluble Extracts of Radix Glycyrrhizae Based on Macrophage Phagocytosis Model ZHANG Qiongling, XIAO Suping, LIU Lei, ZHANG Quan, DING Shilan, YAN Huijie, WANG Jiyong, YOU Yun 2020, 17(10): 659-664.  DOI: 10.19803/j.1672-8629.2020.10.03 Abstract ( 280 )   PDF (1253KB) ( 163 )   Objective To establish a method for evaluating the biological activity of water soluble extracts of Radix Glycyrrhizae based on a macrophage phagocytosis model. Methods Aquatic extracts of Radix Glycyrrhizae were provided by China National Traditional Chinese Medicine Co., Ltd. with the batch numbers of GCGSQ, GCGSC, GCNMG and GCXJ, and GSGSC is used as a verification batch. The optimized experimental conditions were investigated. The seeding density of cells, LPS concentration, action duration, drug concentration-response curves were determined by CCK-8 assay. The phagocytosis indexes of RAW 264.7 macrophages were determined by neutral red uptake assay and repeated at least 5 times to set the dose limit. Results The optimum cell density was chosen to be 3.0×105/mL and 100μL was seeded in 96-well plates, the drug action time was 24h and LPS concentration was 0.25μg/mL, which obtained more stable effects. The aquatic extracts of Radix Glycyrrhizae stimulated proliferation and phagocytic activity in RAW264.7 in a concentration-dependent manner when the concentrations ranged from 125 to 500μg/mL. At the concentration of 125μg/mL, better activity with good precision (RSD=0.9%) and repeatability (RSD=2.15%) was observed in the extracts of bathes of GCGSQ, GCGSC, GCXJ. Under this experimental condition, the concentration of 125 μg/mL was selected as the dose limit, and the phagocytosis indexes of macrophages that ranged from 115% to 129% were set as the bioassay quality control supplement. Conclusion Combined with clinical indications, the effects of Radix Glycyrrhizae on phagocytic activity in RAW264.7 macrophages might be used as an indicator for bioassay as the supplementary quality control. References | Related Articles | Metrics

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Analysis of the Association of AOX1 and MOCOS Polymorphisms with Azathioprine-induced Adverse Drug Reaction QIAN Jiajian, CHEN Chao, WANG Zhenjiang, HUANG Zaiwei, ZHANG Xiaomin, AI Xinbo 2020, 17(10): 665-671.  DOI: 10.19803/j.1672-8629.2020.10.04 Abstract ( 273 )   PDF (1156KB) ( 229 )   Objective To investigate the association of Aldehyde oxidase 1 (AOX1) rs55754655 and Molybdenum cofactor sulfurase (MOCOS) rs594445 polymorphisms on adverse reactions induced by azathioprine (AZA). Nucleoside diphosphate-linked moiety X-type motif 15(NUDT15) rs116855232 was been as a control site. Methods Patients who had received or were taking azathioprine were recruited to collect venous blood. Direct sequencing was used to determine the genotypes of these sites. High performance liquid chromatography was used to detect serum concentrations of AZA active metabolite 6-thioguanine nucleotide (6-TGN) in erythrocytes. Adverse drug reactions(ADRs) of these patients were monitored. Results In 80 patients, there were 2 mutant heterozygotes(AG) and no homozygous mutations with AOX1. There were 24 mutant heterozygotes(CA) and 4 homozygous mutations(AA) with MOCOS. There were 16 mutant heterozygotes(CT) and no homozygous mutations with NUDT15. Logistic regression analysis showed that the MOCOS mutation was protective for AZA-induced myelosuppression (P=0.012), and it was associated with AZA-induced flu-like symptoms and alopecia (P=0.043, 0.030). There was a significantly correlation between NUDT15 mutation and AZA-induced myelosuppression (P=0.012). There were no correlation between other ADRs and these genes mutations. There was no significant difference between wild type and mutant type of these genes in 6-TGN blood concentration(P>0.05). NUDT15 rs116855232 combined with MOCOS rs594445 analysis, patients with MOCOS wild-type and NUDT15 mutant had a higher risk of myelosuppression (OR=18.40, P=0.001). Conclusion It was suggested that MOCOS rs594445 and NUDT15 rs116855232 polymorphism should be detected bofore the first time use of AZA. It could improve the safety for using AZA. References | Related Articles | Metrics

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Research on Adverse Drug Reaction Monitoring Based on Chinese Hospital Pharmacovigilance System MO Kai, NONG Li, CAO Wen, ZHONG Hui, WANG Yanning, LAN Xiaobu 2020, 17(10): 672-675.  DOI: 10.19803/j.1672-8629.2020.10.05 Abstract ( 511 )   PDF (1097KB) ( 322 )   Objective To analyze the effect of adverse drug reactions (ADRs) monitoring by Chinese Hospital Pharmacovigilance System (CHPS), so as to provide reference for ADRs monitoring in Chinese medical institutions. Methods The ADR reports reported one year before and after the application of CHPS in our hospital were selected, and the report situation and the quality of report form in the two periods were statistically analyzed, to evaluate the application effect of CHPS. Results After the application of CHPS, the total number of reports increased from 60 to 174, and the total number of active monitoring reports by pharmacists increased from 25 to 99. The average time for each report was shortened from 35.39mins to 15.77mins, and the rate of unqualified reports decreased from 40.63% to 3.23%. Conclusion The establishment and application of CHPS has effectively improved the level of ADR monitoring and management in hospitals, which is of great significance for further strengthening the pharmacovigilance in Chinese hospitals. References | Related Articles | Metrics

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Study of VigiBase Database of Uppsala Monitoring Centre ZHANG Wei, WEI Fuqian, YANG Yue 2020, 17(10): 676-680.  DOI: 10.19803/j.1672-8629.2020.10.06 Abstract ( 1875 )   PDF (1616KB) ( 1111 )   Objective To study the structure, tools and functions of VigiBase, a database managed by the Uppsala Monitoring Centre (UMC), and to provide reference for improving the database of adverse drug reactions (ADRs) in China. Methods The structure and functions of VigiBase were analyzed by consulting literature and searching VigiBase. Results VigiBase was the largest database of individual case safety reports (ICSRs) in the world. UMC evaluated the quality of ICSRs via VigiGrade, inspected the duplicate reports via VigiMatch, detected drug safety signals via VigiRank, and also provided VigiLyze, VigiFlow, VigiAccess and other tools for member states to manage ICSRs and retrieve data from VigiBase. Conclusion The assessment of report quality and drug safety signal detection need to be improved in China. References | Related Articles | Metrics

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Pharmacovigilance Duties of Marketing Authorization Holders under of New Drug Administration Law of the People's Republic of China SUN Jun, WANG Jiayu, LIU Pengcheng, YU Dandan, WANG Minjiao, SHEN Mengqiu 2020, 17(10): 681-687.  DOI: 10.19803/j.1672-8629.2020.10.07 Abstract ( 738 )   PDF (1156KB) ( 559 )   Objective To sort out pharmacovigilance duties of MAH according to the new Drug Administration Law of the People's Republic of China. Methods Use the literature induction method to sort out and summarize the relevant content of legal regulations in China. Results The main pharmacovigilance duties of MAA/MAH for applicants and holders in China are to establish and improve the pharmacovigilance system and carry out specific activities such as monitoring, identification, evaluation and control. Suggestions China should improve the legal system of pharmacovigilance, to link up different laws and regulations, provide detailed guidelines and carry out accurate guidance, urge the MAH to effectively carry out pharmacovigilance activities, and rationally design the route of supervision and control, strengthen supervision and promote the implementation of pharmacovigilance system. References | Related Articles | Metrics

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The Practice and Thinking of Pharmacovigilance at the Municipal Level under COVID-19 WU Wenyu, XIAO Xiao, WU Jianru 2020, 17(10): 688-691.  DOI: 10.19803/j.1672-8629.2020.10.08 Abstract ( 332 )   PDF (1189KB) ( 160 )   Objective To summarize the practice of pharmacovigilance in Shenzhen during the outbreak of COVID-19, and to consider the construction of pharmacovigilance system. Methods On the basis of pharmacovigilance practice in Shenzhen, literature research was conducted to analyze the theoretical connotation and system composition of pharmacovigilance. Results The development of pharmacovigilance work under public health emergencies required the establishment of a more complete risk monitoring, data sharing, and utilization mechanism. Conclusion It is necessary to incorporate the construction of the pharmacovigilance system into the overall public health technology system plan from a national perspective, and to improve the capacity of drug risk monitoring and emergency response in terms of expanding data sources, strengthening information construction, building a data sharing mechanism, and formulating effective emergency response plans. References | Related Articles | Metrics

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High-risk Medications in Elderly Patients in Our Hospital Based on List of High-risk Perioperative Medications DONG Na, HE Dan, WU Xiaoyan, ZHANG Haixia 2020, 17(10): 692-696.  DOI: 10.19803/j.1672-8629.2020.10.09 Abstract ( 232 )   PDF (1031KB) ( 151 )   Objective To evaluate high-risk medications in elderly patients in our hospital based on the list of high-risk perioperative medications in order to provide more evidence for rational medications in perioperative elderly patients. Methods A total of 230 elderly patients during the perioperative period were selected from January 2018 to December 2018. The list of high-risk perioperative medications for the elderly released in 2019 was used as the criteria to evaluate the high-risk medications detected. Results In the 230 patients, 279 medications were detected, 36.52% (84/230) of whom received high-risk medications during the perioperative period, and 29.13% (67/230) used two or more types of high-risk drugs. A total of 37 types of drugs were detected, among which dexmedetomidine, diazepam and NSAID were more frequently used, accounting for 20.43%, 14.35% and 11.30% respectively. A total of 3 patients developed adverse reactions after perioperative administration. Conclusion There are potential drug risks to perioperative elderly patients in our hospital, so we should strengthen the regulation of perioperative medications in elderly patients and improve the quality of medications. References | Related Articles | Metrics

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Survey about Medical Staff's Knowledge of Drug Abuse Monitoring in China WANG Chenggang, HUANG Yuan, WU Shifu, WANG Ling, TIAN Yuejie, WU Chen, WANG Xiaojun 2020, 17(10): 697-702.  DOI: 10.19803/j.1672-8629.2020.10.10 Abstract ( 300 )   PDF (1396KB) ( 181 )   Objective To find out about how much health care providers know about drug abuse monitoring in order to provide basic information for drug abuse monitoring in medical institutions. Methods A random sampling method was employed to investigate the amount of knowledge of drug abuse monitoring and the status quo with drug abuse. Health care providers from comprehensive hospitals, mental hospitals and cancer hospitals in 12 provinces in China were enrolled in this survey. Results Data collected from 358 health care providers (in 61 medical institutions) was analyzed. The results showed that 84.6% of the health care providers knew something about drug abuse. 60%-67% of them had some knowledge of drug abuse monitoring, drug dependence as well as the diagnostic standards for drug abuse. However, 10% of them interpreted drug abuse and drug abuse monitoring differently from the National Medical Products Administration. Only 50% of these health care providers had a clear idea about the drugs that could cause drug dependence. The percentage of health care providers who had encountered narcotic drugs abuse, mental drug abuse and drug overdose was 18.9%, 31.9%, and 9.0%, respectively. Conclusion When medical institutions start drug abuse monitoring, it is advisable to give the personnel concerned some training regarding the related concepts, diagnostic standards and drugs which could cause dependence. The departments of emergency, oncology, psychiatry and psychology should be the focus of monitoring. References | Related Articles | Metrics

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One Case of Hepatic Injury Caused by Chemotherapy of Breast Cancer SHEN Limeng, JIANG Sunmin, YAO Ying, XU Yinying 2020, 17(10): 703-706.  DOI: 10.19803/j.1672-8629.2020.10.11 Abstract ( 339 )   PDF (997KB) ( 260 )   Objective To analyze the causes of drug-induced liver injury (DILI) in breast cancer patients during chemotherapy, in order to provide reference for workers in related fields. Methods The causes of DILI in a breast cancer patient with multiple chemotherapies were explored and the drugs that may cause liver injury were evaluated according to the guidelines for the diagnosis and treatment of drug-induced liver injury, relevant research publications and the Roussel Uclaf Causality Assessment Method(RUCAM). Results This patient's DILI could not be excluded. Considering length of drug administration and RUCAM quantitative form, the liver injury showed associations with trastuzumab, paclitaxel and cimetidine. Conclusion DILI is a dose-limiting toxicity of anti-tumor drugs. For patients with malignant tumors that require multiple cycles of chemotherapy, RUCAM quantitative form can distinguish potential DILI and improve treatment outcomes. References | Related Articles | Metrics

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Severe Adverse Drug Reaction of Acute Anaphylactic Shock Induced by Mannatide CAO Yuan, WANG Xue, SUN Tiantian, GAO Jie 2020, 17(10): 707-709.  DOI: 10.19803/j.1672-8629.2020.10.12 Abstract ( 301 )   PDF (886KB) ( 248 )   Objective To explore the methods of managing severe adverse drug reactions of acute anaphylactic shock induced by mannatide. Methods Two cases of severe adverse drug reactions of acute anaphylactic shock induced by mannatide, a drug often used for diseases caused by hypoimmunity, were analyzed. Results Both patients suffered from anaphylactic shock within about 10 minutes of intravenous drip of mannatide. The patients' symptoms were ameliorated after such symptomatic treatments as the withdrawal of mannatide, use of anti-allergic drugs and oxygen inhalation. Conclusion Clinicians are to learn about the allergic history and medical history of patients before the medication with mannatide injection. Patients should be closely monitored during medication. The skin test and use of anti-allergic drugs before administration could help prevent adverse drug reactions. References | Related Articles | Metrics

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Adverse Events Induced by Immunization of Concomitant Inoculation of Freeze-dried Hepatitis A (Live) Vaccine with Vaccines for National Immunization Program from Surveillance Data JIANG RuiJu, YIN QiongZhou, XU MingJue, ZHAO ZhiMei, DENG Yan, NING Ruotong, CHE YanChun 2020, 17(10): 710-714.  DOI: 10.19803/j.1672-8629.2020.10.13 Abstract ( 239 )   PDF (1027KB) ( 97 )   Objective To analyze the characteristics of adverse events following immunization (AEFI) after concomitant inoculation of freeze-dried Hepatitis A Attenuated Live Vaccine (HepA-L) with other national immunization program (NIP) vaccines so as to tentatively evaluate the safety of concomitant inoculation and to provide reference for daily concomitant inoculation. Methods Descriptive epidemiology were adopted to analyze AEFI case data of concomitant inoculation of HepA-L with other NIP vaccines between 2013 and 2018, which was collected from the China Information Management System for Immunization Programming. Results A total of 482 AEFI cases were reported due to the concomitant inoculation of HepA-L with other NIP vaccines. Children aged 1 to 2 were the main population. Boys outnumbered girls in these reported cases. A total of ten vaccines were involved in the concomitant inoculation. The top three vaccines that resulted in AEFI cases were MMR, DTaP and JEV-L. When HepA-L was co-inoculated with one of the three vaccines respectively, general reactions accounted for 86.11%-88.69% and abnormal reactions 10.24%~13.89%. A total of 98.21% AEFIs occurred within 3 days of concomitant inoculation, but all the symptoms were improved and no death occurred. Compared with the national AEFI monitoring data on inoculation with NIP vaccine alone, no new abnormal reactions occurred in concomitant inoculation and the risk of inoculation was not increased. Conclusion A recipient who is healthy and has no contraindication to vaccination can be co-inoculated with HepA-L in conjunction with other NIP vaccines. However, the occurrence of rare and severe abnormal reactions should be a focus of attention. References | Related Articles | Metrics

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201 Cases of Drug-induced Liver Injury in Children ZHANG Houli, XU Lili, XIE Yanjun, GENG Tao, SU Fengyun 2020, 17(10): 715-719.  DOI: 10.19803/j.1672-8629.2020.10.14 Abstract ( 366 )   PDF (1127KB) ( 261 )   Objective To investigate the clinical characteristics and patterns of drug-induced liver injury (DILI) in children so as to promote appropriate medication. Methods A total of 201 cases of DILI in children aged 18 or above were collected between January 2013 and December 2017 from the database of Shandong ADR Monitoring Center and analyzed retrospectively. Results Statistical data showed that the incidence of drug-induced liver injury in children aged 13 or above was the highest, accounting for 61.70%. The three dominating types of drugs were anti-infective agents, nervous system drugs, and anti-tumor drugs. The top three drugs that were likely to cause DILI were methotrexate, rifampicin and olanzapine. Most of the cases of DILI occurred within 2 weeks of administration(155 cases, 54.20%), and the median time of DILI occurrence was different between oral administration and intravenous infusion. Most of these patients recovered after discontinuation of drugs and symptomatic treatment. Conclusion Clinicians should learn more about drug-induced liver injury and strengthen the monitoring of anti-infective agents, nervous system drugs, and anti-tumor drugs to ensure the safety of drug use. References | Related Articles | Metrics

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Analysis of Clinical Application of Cefenime Sodium in Pediatric Inpatients ZHANG Lei 2020, 17(10): 720-723.  DOI: 10.19803/j.1672-8629.2020.10.15 Abstract ( 262 )   PDF (1058KB) ( 275 )   Objective To assess clinical use of Cefonicid sodium in pediatric inpatients, in order to provide the basis for a normative and optimized medication. Methods Clinical data of Cefonicid sodium in pediatric inpatients in our hospital from January 2016 to December 2017 were recorded and analyzed, which included fundamental state, medical information and adverse reactions occurred. Results A total of 1 438 inpatients were collected in the study. In practice, the main patients (accounted for 46.48%) are pre-school age. It was reasonable for routes of administration and choices of vehicle. Of all drug use,86.69% satisfied medication purpose,32.68％showed too long medication. In terms of body mass conversion, most of the children took too much medicine. Conclusion Clinical use is generally standardized of Cefonicid sodium in pediatrics department and relative safety. For the irrational use of drugs, evaluation of effectiveness and safety should be strengthened, it is necessary to ensure medication safety in children. References | Related Articles | Metrics

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Analysis of Mental Abnormality Induced by Flurbiprofen Axetil Injection YI Qin, TAN Qiuhong, LUO Shengping 2020, 17(10): 724-725.  DOI: 10.19803/j.1672-8629.2020.10.16 Abstract ( 367 )   PDF (785KB) ( 228 )   Objective To remind the medical staff to pay close attention to medication safety of flurbiprofen axetil injection. Methods A case of right leg pain with limited movement after traffic accident was retrospectively analyzed, which became mental abnormality caused by postoperative analgesia with flurbiprofen axetil injection. Results Flurbiprofen axetil injection may be the cause of mental abnormality such as delirium, gibberish, agitation, etc. After timely withdrawal of the drug, the family members of the patient complained that there were no previous symptoms, and the patient had no neurological sequelae. Conclusion Flurbiprofen axetil injection caused by low incidence of mental abnormality, timely withdrawal of the drug has a good prognosis, but it is easy to cover up the disease, which deserves attention. References | Related Articles | Metrics

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Efficacy and Safety of Oral Anticoagulants in Non-valvular Atrial Fibrillation Therapy: A Bayesian Network Meta-analysis ZHU Mingjing, ZHANG Dandan, YANG Ying, YANG Yue 2020, 17(10): 726-731.  DOI: 10.19803/j.1672-8629.2020.10.17 Abstract ( 214 )   PDF (1206KB) ( 116 )   Objective To evaluate the safety and efficacy of oral anticoagulants in the prevention of stroke/systemic embolism in patients with non-valvular atrial fibrillation using Bayesian network meta-analysis. Economy was compared between different oral anticoagulants for Chinese patients. Methods Such databases as the Cochrane Library, PubMed, and Embase were searched for randomized controlled trials of oral anticoagulants in treating patients with non-valvular atrial fibrillation published by May 1, 2019. Indexes for outcomes included stroke/systemic embolism and major bleeding. A Markov model was established to evaluate the cost-effectiveness of regimens that were more effective than warfarin. Results A total of 12 randomized controlled trials involving 78 067 patients were included. Network meta-analysis results: rivaroxaban 15 or 20 mg qd had the best chance of being the most effective in the prevention of stroke/systemic embolism, followed by dabigatran 150 mg bid. The risk of major bleeding caused by the same drug was does-dependent. Edoxaban 30 mg qd was most likely to be the safest treatment, followed by apixaban 5 mg bid, dabigatran 110 mg bid, and rivaroxaban 15 or 20 mg qd. Results of cost-effectiveness analysis: according to per capita GDP in 2018, edoxaban 60 mg qd had advantages over rivaroxaban 15 or 20 mg qd and dabigatran 150 mg bid. Conclusion Rivaroxaban 15 or 20mg qd is more effective than other oral anticoagulants in the prevention of stroke/systemic embolism, but edoxaban 60 mg qd is more economical. As for patients at high risk of bleeding, appropriate anticoagulant regimens should be selected according to the patients' own condition. There is evidence that the risk of bleeding related to edoxaban 30 mg qd is lower than that of other anticoagulant regimens. References | Related Articles | Metrics

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Water Retention and Neuropsychiatric Symptoms Induced by SAN AO PIAN CAO Jianying, WANG Xiao, SONG Yuhuan, FENG Zhanqin, QU Xiujun 2020, 17(10): 732-734.  DOI: 10.19803/j.1672-8629.2020.10.18 Abstract ( 367 )   PDF (916KB) ( 350 )   Objective To analyze the safety risk of water retention and neuropsychiatric symptoms induced by SAN AO PIAN (tablets). Methods The risk signals of one case of adverse reactions induced by SAN AO PIAN were reported while the causes were analyzed. Related databases were searched to mine ADR data about ephedra and ephedra-containing drugs that was published between January 2000 and July 2019. Results The adverse reactions induced by SAN AO PIAN were related to ephedra it contained and contraindications. Ephedrine, the main component of ephedra, can excite the central and sympathetic nerves, cause bladder sphincter contraction and detrusor relaxation, and induce neuropsychiatric symptoms and dysuria. Conclusion Clinicians should be alert to the adverse drug reactions caused by SAN AO PIAN, especially in patients with ephedra allergies. Clinical treatment should be provided in conjunction with syndrome differentiation to promote safe and rational use of drugs. References | Related Articles | Metrics

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Analysis of Irrational Medical Advices in Pharmacy Intravenous Admixture Service in A Hospital LIU Jian, LI Yonghui, LU Ming, ZHANG Yuan 2020, 17(10): 735-739.  DOI: 10.19803/j.1672-8629.2020.10.19 Abstract ( 279 )   PDF (1129KB) ( 316 )   Objective To statistically analyze the improper prescriptions detected by the pharmacy intravenous admixture service of the Second Hospital of Hebei Medical University between 2017 and 2018 so as to provide reference for the rationality, safety and effectiveness of clinical medication. Methods The data on 667705 medical prescriptions were classified and collected from the pharmacy intravenous admixture service of The Second Hospital of Hebei Medical University from 2017 to 2018. To sum up, sort out and analyze the irrational medical advice. Results There were 16 180 irrational medical advices, accounting for 2.42% of the total medical advices. The irrational factors included wrong Format of Doctor's Order, improper selection of solvent varieties, inappropriate dosage of drugs, TPN inappropriate formula, improper dosage of solvent, nappropriate compatibility of drugs, improper frequency of drug use, incompatibility of drugs in a prescription, repeated medication, incorrect use of drugs. Conclusion Irrational medical prescriptions can be found and intervened in time by examination of prescriptions of pharmacists, which not only can reduce the incidence of intravenous administration clinical adverse reactions, but also ensure the rationality and safety of patient's medication, promoting the specialization of patient drug use. References | Related Articles | Metrics

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Usage of Sustained and Controlled Release Preparations in A Hospital SHENG Xiangling, SONG Xuemin, PENG Jie 2020, 17(10): 740-744.  DOI: 10.19803/j.1672-8629.2020.10.20 Abstract ( 223 )   PDF (1082KB) ( 148 )   Objective To find out how sustained and controlled release preparations are used in the Affiliated Drum Tower Hospital of Medical School, Nanjing University, so as to provide reference for clinical rational use of drugs. Methods All the prescriptions related to sustained and controlled release preparations for inpatients in April 2019 were collected, and the rationality with which these sustained and controlled release preparations were used was analyzed retrospectively. Results There were something irrational about the use of sustained and controlled release preparations, such as incorrect dose segmentation, improper routes of medication, excessive frequency of administration, and repeated use of medicines. Conclusion It is suggested that prescriptions be reviewed by pharmacists in a standardized way and clinicians receive better training to improve the rationality of sustained and controlled release preparations, promote the rational use of clinical medicines and to ensure the safety of patients References | Related Articles | Metrics

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Analysis of 1073 Cases of Clinical Use of Reduning Injection by Pareto Chart and Fishbone Diagram LYU Tianyi, KUANG Li, CHEN Mingying 2020, 17(10): 745-748.  DOI: 10.19803/j.1672-8629.2020.10.21 Abstract ( 363 )   PDF (1155KB) ( 212 )   Objective To analyze the rationality of clinical use of Reduning injection and consequent adverse drug reactions in our hospital in order to provide reference for the rational use of Reduning injection in children. Methods Data on all the cases of children who received Reduning injection in our hospital between December 2017 and November 2018 was retrieved, and a total of 1073 cases were selected. Adverse drug reactions were analyzed using Pareto charts and fishbone diagrams. Results Improper medication was found in 532 (49.58 %) of the 1073 cases who used Reduning injection. of which off-labeled use (56.58 %) and over-course of treatment (24.25 %) were the leading factors. The secondary factor was undifferentiated medication(12.22 %). ADR occurred in 22 of the 1 073 cases, accounting for 2.05 % and related to off-labeled use, beyond-the-course medication , intravenous drug concentration and drip rate, and patients themselves. 59.09 % of the adverse reactions were caused by off-labeled use and 31.82 % by beyond-the-course treatment. Conclusion There is something irrational about the way Reduning injection is used in our hospital. The hospital can strengthen the real-time monitoring and intervention of the use of TCM injections with the risk factors in mind. References | Related Articles | Metrics