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Giant progress in small molecule antiviral drugs for SARS-CoV-2 ZHAO Zhe, ZHANG Qing, GE Ziruo, ZHANG Wei, CHEN Zhihai 2022, 19(1): 1-6.  DOI: 10.19803/j.1672-8629.2022.01.01 Abstract ( 487 )   PDF (1220KB) ( 251 )   Objective To study anti-SARS-CoV-2 drugs of protease inhibitors and RNA-dependent RNA polymerase inhibitors. Methods The mechanism of action, pharmacokinetics and clinical trials of two kind of drugs are reviewed. Results Small molecule drugs have the advantages of easy absorption, small molecular volume, ability to penetrate cell membrane, and easy large-scale industrial production, which are the focus of drug research and development. In the small-molecule drugs for SARS-CoV-2, breakthroughs have been made in protease inhibitors (such as Paxlovid) that target the viral protein splicing step and RNA-dependent RNA polymerase inhibitors (such as molnupiravir). Conclusion It is expected that these drugs can be widely used in early treatment in the future to reduce the rate of severe illness and mortality. References | Related Articles | Metrics

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Expert consensus on design and statistical analysis to evaluate drug safety using routinely collected health data WANG Wen, LIU Mei, HE Qiao, TIAN Chunhua, SONG Haibo, WANG Tao, TAN Jing, REN Yan, GAO Pei, PENG Xiaoxia, WEN Zehuai, SHU Xiaochen, ZOU Kang, SHEN Chuanyong, SUN Xin 2022, 19(1): 7-12.  DOI: 10.19803/j.1672-8629.2022.01.02 Abstract ( 277 )   PDF (1409KB) ( 368 )   As an important source for real world data, routinely collected health data (RCD) have been widely used for drug safety evaluation. However, the production of trustworthy evidence informing drug safety regulatory decision still have substantial challenges, such as inadequate research capacity in design and analysis. In this expert consensus, we introduced the concept and applications of RCD in drug safety evaluation; summarize the issues and proposed recommendations for study design and analysis. We hope this paper may improve the quality of production and use of evidence generating from RCD. References | Related Articles | Metrics

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Expert consensus on post-marketing risk monitoring technology for high-risk implantable passive medical devices based on real world data TAN Jing, LIU Chunrong, HUANG Shiyao, GAO Pei, WANG Yang, LI Chen, HE Yong, YUAN Hong, WANG Wen, LI Ling, XIONG Yiquan, REN Yan, YAO Minghong, ZHAO Yan, DONG Fang, SHEN Chuanyong, SUN Xin 2022, 19(1): 13-17.  DOI: 10.19803/j.1672-8629.2022.01.03 Abstract ( 225 )   PDF (1755KB) ( 192 )   Post-market surveillance of high-risk implantable passive medical devices is one of key aspects in the risk management of medical device. It is the common responsibility of medical device industry, operations, user institutions and regulatory departments to control the potential risks of medical devices to the maximum extent, and ensure the safe and effective use of medical devices and avoid mass serious consequences, which can be achieved by post-market surveillance and evaluation management of safety signals of high-risk medical devices. In order to promote and assist the post-market surveillance of high-risk implantable passive medical devices, by systematic literature review, focus group discussion and expert consultation, this expert consensus systematically reviewed the status quo of post-market surveillance of risk among medical devices home and board, further constructed the mode of risk monitoring of high-risk implantable passive medical device and key technologies which could be suitable for China's national conditions. References | Related Articles | Metrics

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Developing a safety assessment model for Chinese patent medicines based on real-world data LI Ling, LIU Yanmei, TAN Jing, WANG Wen, YAO Minghong, MA Yu, LUO Xiaochao, LIAO Xing, LIU Yan, SONG Haibo, WEN Zehuai, SUN Xin 2022, 19(1): 18-22.  DOI: 10.19803/j.1672-8629.2022.01.04 Abstract ( 235 )   PDF (1637KB) ( 495 )   Objective To develop a safety assessment model for Chinese patent medicines based on real-word data, so as to provide reference for researchers and decision makers to scientifically and rationally produce and use real-world-data-based safety assessment evidence of Chinese patent medicines. Methods We summarized the role of real-world data in the safety assessment of Chinese patent medicines by referring to domestic and foreign literatures, explored and developed the safety assessment model of Chinese patent medicines based on real-world data. Results We proposed, from the perspective of drug regulation, a safety assessment research model for Chinese patent medicines based on routinely collected and actively collected real-world data, and its application was illustrated with an example. Conclusion Real-world data plays an important role in the safety assessment of Chinese patent medicines, but there are still some limitations. There is an urgent need to introduce new study design and statistical analysis methods in this field. References | Related Articles | Metrics

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Common problems related to P-value in observational pharmacoepidemiological studies LI Guowei, LI Likang, LIU Yingxin, WANG Ruoting, WU Darong 2022, 19(1): 23-26.  DOI: 10.19803/j.1672-8629.2022.01.05 Abstract ( 147 )   PDF (1427KB) ( 170 )   Objective To explore the common problems related to P-value in observational pharmacoe-pidemiological studies. Methods A combination of literature research and expert opinions was used for this review. Results The common problems related to P-value in observational pharmacoepidemiological studies included myths, misuse, manipulation and dichotomization of P-value. These problems could compromise the validity and reproducibility of findings and conclusions in pharmacoepidemiological studies. Conclusion Problems related to P-value often occur in observational pharmacoepidemiological studies. An integrated approach that involves advancing researchers' understanding of P-value, enhancing the quality and integrity of research and clinical practices, and ensuring proper use of P-value in the research community will help minimize the misuse of P-value in pharmacoepidemiological studies. References | Related Articles | Metrics

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Statistical considerations for real world studies supporting new drug registrations HUANG Lihong, CHEN Feng 2022, 19(1): 27-31.  DOI: 10.19803/j.1672-8629.2022.01.06 Abstract ( 133 )   PDF (1768KB) ( 142 )   Objective To review statistics-related problems in the process of obtaining real world evidence (RWE) from real world research (RWS). Methods In regard to real world data (RWD), causal inference methods for RWS and approaches to RWE evaluation were reviewed while the existing problems were analyzed and discussed. Results Obtaining reliable RWE that could be used to support regulatory decisions about medical products was an important goal of RWS. An appropriate standard for RWD data was a prerequisite for quality evaluation of the data. A standardized process of data governance and a perfect system for data quality evaluation underlay high-quality RWS. Standardized implementation of causal inference analytical methods could ensure the quality of RWE. Clinically explicable and innovative conclusions were critical to RWE. Objectivecriteria for evaluation of RWE were also needed in practice. The verifiability of results of RWS was the most important feature of RWE. Conclusion A single clinical trial is often unable to meet the criteria for determining causality. Instead, multiple studies are required to verify causality from different perspectives. Therefore, the combination of randomized controlled trials (RCT) and RWS is a good approach during drug development. References | Related Articles | Metrics

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Ways 2247 elderly patients use Lianhua Qingwen capsules in the real world SUN Linxi, XIE Yanming, LI Yuanyuan, SUN Menghua, LI Xiangjie 2022, 19(1): 32-35.  DOI: 10.19803/j.1672-8629.2022.01.07 Abstract ( 285 )   PDF (1451KB) ( 264 )   Objective To explore the characteristics and dosing patterns of elderly patients who take Lianhua Qingwen capsules, and to provide data for drug monitoring or epidemiological studies on elderly patients. Methods The medical data on elderly patients who used Lianhua Qingwen capsules between September 30, 2004 and December 31, 2015 was retrieved from the information systems of 18 hospitals across China before being standardized and modeled with the Apriori algorithm. Clementine 18.0 software was used for association rule analysis. Results The age of the 2 247 patients mostly ranged from 65 to 70 (44.19%). There were slightly more males than females. The first diagnosis of these patients upon admission was mainly pulmonary infections (10.01%). These elders became more vulnerable around October 8 every year(7.43%). Oral medication was dominating (91.86%), and a single dose was equal or lesser than 3 g(70.05%). The duration of treatment was mostly between 15 and 28 d (41.88%). The commonly used western drugs included acetylsalicylic acid (3.65%), amiloride (2.47%), and levofloxacin (1.92%). And traditional Chinese medicines that were often used in combination with western drugs were danhong injection (3.68%) and Tanreqing injection (2.53%). Conclusion Elderly patients who use Lianhua Qingwen capsules are likely to have developed pulmonary infections, and the comorbidities are mostly cardiovascular and cerebrovascular diseases. Single-dose drug specifications need to be standardized while combined medication should comply with the guidelines. References | Related Articles | Metrics

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Clinical characteristics and combined medication of Shengmai injection in the treatment of 9215 elderly patients with cardiovascular diseases SUN Chunquan, XIE Yanming, HOU Hengyue 2022, 19(1): 36-40.  DOI: 10.19803/j.1672-8629.2022.01.08 Abstract ( 119 )   PDF (1625KB) ( 114 )   Objective To conduct a real-world study of Shengmai injection based on the hospital information system (HIS) in order to find out more about the clinical characteristics of elderly patients with cardiovascular diseases who use Shengmai injection (SMI). Methods The clinical data on 9 215 elderly patients with cardiovascular diseases treated in 29 tertiary hospitals between January 1, 2001 and December 31, 2016 was retrieved from the HIS database by R software to analyze the clinical characteristics of patients and ways in which Shengmai injection was used. Results There were 5 109 male patients and 4 035 female ones involved. The average age of these patients was (78.15±6.90) years, and their length of hospital stay averaged (25.39±19.88) days. Hypertension, respiratory tract infection and arrhythmia were the most common comorbidities. The main route of administration of SMI was intravenous drip (7 504 cases) and the average single dose was (55.79±18.06) ml. The average duration of treatment was (6.02±7.37) days. The most commonly used drug combinations included Tanreqing injection+ambroxol. Conclusion Analysis of the data on elderly patients with cardiovascular diseases has revealed some of the characteristics of these patients and ways of medication of SMI, which can help clinicians to use SMI rationally. References | Related Articles | Metrics

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A real-world study of Xiyanping injection in the treatment of upper respiratory tract infections and complications in children XIANG Hong, WANG Zhifei, XIE Yanming, LI Lixun, WEI Ruili, WANG Qi 2022, 19(1): 41-46.  DOI: 10.19803/j.1672-8629.2022.01.09 Abstract ( 133 )   PDF (2480KB) ( 126 )   Objective To analyze the preferred clinical drug combinations of Xiyanping injection in the treatment of URI in children, and explore clinically optimized schemes and routes of administration. Methods The medical data on 21 316 patients aged 0 to 14 with upper respiratory tract infection (URI) treated with Xiyanping injection between December 5, 2006 and June 20, 2016 was retrieved from the information systems of 29 tertiary hospitals across China. After standardization of the data, the Tabu search algorithm and complex network analysis were used to perform cluster module analysis. Results By dividing the clinically cured and improving population into sub-groups, the sub-groups of western medicine and traditional Chinese medicine used in the core combinations were obtained, and the relationships between the subgroups were clarified. For the treatment of URI and complications with western medicine, the obviously related sub-groups were the combination of Xiyanping with ibuprofen/acetaminophen, chlorpheniramine/loratadine, bromhexine and chlorpheniramine, or acetaminophen plus vitamin plus cimetidine plus chloral hydrate. As for TCM, the obviously related sub-groups included Xiyanping injection combined with Xiaoerchaigui antipyretic granules/Xiaochaihu granules, Xiaoerresuqing granules/Shuanghuanglian granules, Lanqin oral liquid plus stomatological spray/Kaihoujian spray, or antipyretic plus Feilike mixture. Conclusion In the real world, Xiyanping injection is usually used in combination with other drugs in the treatment of URI and its complications in children. The combined medication conforms with the guidelines. There are some regularities that facilitate clinical medication. References | Related Articles | Metrics

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Real-world study on Xiyanping injection combined in the treatment of childhood pneumonia SU Xinxin, LI Lixun, WANG Zhifei, XIE Yanming, WANG Qi 2022, 19(1): 47-51.  DOI: 10.19803/j.1672-8629.2022.01.10 Abstract ( 136 )   PDF (2098KB) ( 102 )   Objective To analyze the medication characteristics of Xiyanping injection combined in the treatment of children with pneumonia in the real world. Methods Based on HIS and LIS database of hospitalized patients from 29 hospitals in China from December 1, 2006 to June 30, 2016, the Apriori algorithm was conducted to establish the model and clementine 12.0 was conducted to analyze the characteristics and combination medication of 35 233 children who received Xiyanping injection with pneumonia. Results Children aged 0~3 years (82.83%) accounted for the largest proportion; In the real world, Xiyanping injection is mainly used for children with general conditions; The number of days in hospital was 4~14 days; For Xiyanping injection, the single intravenous dose per day was 50~100 mg; The main diagnosis of Western medicine was bronchial pneumonia, and the main diagnosis of Traditional Chinese medicine was pneumonia, asthma and cough, and the main syndromes were phlegm-heat and wind-heat; Xiyanping injection is generally combined with ambroxol (methusol) mucus dissolver, budesonide corticosteroid hormone, salbutamol selective β2-adrenergic receptor stimulant, and ipratropium bromide anticholinergic drug. Conclusion Xiyanping injection is often used in combination with mucolysis drugs, corticosteroid hormones, selective β2-adrenergic receptor promoters and anticholinergic chemicals in the treatment of children with pneumonia to provide a reference for the rational use of Xiyanping injection in clinical practice. References | Related Articles | Metrics

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Development of the first national reference substance of favipiravir as a candidate drug against COVID-19 XIONG Jing, YAN Jing, LIU Yi, LIU Yang, HE Lan 2022, 19(1): 52-56.  DOI: 10.19803/j.1672-8629.2022.01.11 Abstract ( 134 )   PDF (2314KB) ( 89 )   Objective To establish the first national reference standard for content determination of favipiravir in order to ensure the quality of favipiravir tablets. Methods MS, 1H-NMR, 13C-NMR, and FTIR were used to confirm the structure. HPLC was used to analyze the related substances, uniformity and stability of favipiravir. Other physical and chemical properties were examined by GC, water determination, dynamic vapor sorption(DVS) and residue on ignition test. The content was assigned using the mass balance method and verified by 19F-NMR, HPLC, DSC. Results The structure of the national reference substance for favipiravir was confirmed, and the content was 99.7%. Conclusion The first national reference substance for favipiravir is characterized by high purity, good accuracy and stability, which can effectively control the quality of this product. References | Related Articles | Metrics

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Developmental toxicity of zopiclone and its impurities in zebrafish embryos YIN Jie, NAN Nan, CHEN Hua 2022, 19(1): 57-61.  DOI: 10.19803/j.1672-8629.2022.01.12 Abstract ( 91 )   PDF (2007KB) ( 83 )   Objective To compare the toxicity of zopiclone and its main impurities on embryonic development of zebrafish. Methods Embryonic development of zebrafish was investigated under a stereo microscope at different concentrations of the drug. The teratogenicity and lethality of zebrafish embryos were statistically analyzed in conjunction with microscopic observation. Results Zopiclone and its impurities had a similar toxic phenotype to embryonic development of zebrafish and the toxic effects occurred during the development of embryonic organs. The results showed that both teratogenicity and the mortality rate of embryos were positively correlated with drug concentrations. The embryonic toxicity was the strongest in impurity C, followed by 2-amino-5-chloropyridine, impurity B, impurity A, and zopiclone. Conclusion Based on the impurity spectrum of zopiclone, the contents of impurities in marketed drugs and the experimental toxicity results of zopiclone and its major impurities on embryonic development, it was recommended that 2-amino-5-chloropyridine be controlled as a specified impurity with a strict limit in the quality specifications of zopiclone materials and preparations in order to ensure the safety and quality of this drug. References | Related Articles | Metrics

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Network toxicological analysis and mechanism prediction of cardiotoxicity of alkaloids in Aconiti Radix FENG Qun, YAO Jingchun, LI Xin, JING Fanbo, ZHANG Na, ZHANG Guimin 2022, 19(1): 62-68.  DOI: 10.19803/j.1672-8629.2022.01.13 Abstract ( 134 )   PDF (5491KB) ( 117 )   Objective To explore and predict cardiotoxic targets and mechanism of alkaloids in Aconiti Radix with network toxicology and molecular docking methods, and provide data for the safety of clinical application. Methods Literature related to toxicant alkaloids in Aconiti Radix was retrieved from TCMSP and CTD. SwissTargetPrediction online database was used to screen the target proteins of these ingredients while Cytoscape software was used to construct the toxicant alkaloids-target network. The target proteins of cardiotoxicity were predicted by CTD. The intersection of the two networks was considered to be the potential cardiotoxic targets of Aconiti Radix, which was analyzed to establish the protein-protein interaction (PPI) network by STRING database. The action mechanisms were predicted by Gene Ontology (GO) and the Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment with the help of Metascape database. The affinity and binding modes of the key proteins with toxic ingredients of Aconiti Radix were verified by AutoDock Vina software. Results There were 26 candidates for toxicant alkaloids, involving 33 target proteins of cardiotoxicity. The results of GO and KEGG enrichment analyses showed that the targets participated in the supply of blood to the heart and homeostasis of mall molecular substances by means of blood circulation and transmembrane transport. The influence of such targets as CHRM2, MAPK14, AGTR2 and PARP1 on many signaling pathways played an important role in the metabolism, development and form of the heart, and consequently cardiotoxicity occurred. Molecular docking results indicated that the majority of the toxicant alkaloids displayed good binding activities with the cardiotoxic targets, indicateing that hydrogen bonding, hydrophobic effect, and Pi-Pi bonding were the main forms of interactions. Conclusion Based on network pharmacology, it is proved that the interaction of alkaloids in Aconiti Radix with multiple protein targets and pathways results in cardiotoxicity, which can provide new clues to studies on cardiotoxic mechanisms of Aconiti Radix. References | Related Articles | Metrics

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Determination of clindamycin in drainage fluid of bone marrow infection by HPLC WANG Peixu, XU Lingxiao, LIU Shuhua 2022, 19(1): 69-71.  DOI: 10.19803/j.1672-8629.2022.01.14 Abstract ( 65 )   PDF (1544KB) ( 63 )   Objective To establish an HPLC method for determining clindamycin in drainage fluid and explore the clinical applicability of clindamycin hemihydrate calcium sulfate bone cement in the local antibacterial drug delivery system. Methods Agilent ZORBAX Extend-C18 (150 mm×4.6 mm, 5 µm) was used as the column. Phosphate buffer (6.8 mg·mL-1 KH2PO4, pH adjusted to 7.5 with 25% KOH) and acetonitrile (55∶45) served as the mobile phase. The detection wavelength was 210 nm and the flow rate was 1.0 mL·min-1. Results Clindamycin presented a good linear range of 1.48 to 88.90 μg·mL-1 (r=0.999 7). The average recoveries were 92.90%, 98.03% and 97.13% respectively. The RSD values were less than 2.0% and 3.5%. Conclusion The reversed-phase high performance liquid chromatography method for the determination of concentrations of clindamycin in drainage fluid is simple, sensitive and accurate, which is of referential value for clinical applications of clindamycin semi-water calcium sulfate bone cement. References | Related Articles | Metrics

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Efficacy of chemotherapy combined with anlotinib against advanced pancreatic cancer XU Baoyu, SHEN Hua, LI Xin, HAN Feng 2022, 19(1): 72-73.  DOI: 10.19803/j.1672-8629.2022.01.15 Abstract ( 220 )   PDF (1332KB) ( 123 )   Objective To investigate the efficacy of chemotherapy combined with anlotinib in treating advanced pancreatic cancer. Methods The clinical data on 60 patients with advanced pancreatic cancer was retrospectively analyzed who had been treated at Yifu Hospital and Hai'an People's Hospital between October 31, 2019 and February 28, 2021. The patients were divided into a control group and a test group using the random number table method, with 30 in each group. Patients in the control group were treated with single-agent gemcitabine while those in the experimental group were treated with albumin-bound paclitaxel and gemcitabine as the main chemotherapy combined with anlotinib. The overall survival and incidence of adverse reactions were observed. Results Chemotherapy combined with anlotinib prolonged the survival of patients with advanced pancreatic cancer. Conclusion Chemotherapy combined with anlotinib can improve the therapeutic effect against advanced pancreatic cancer. References | Related Articles | Metrics

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An introduction to the Medical Dictionary for Regulatory Activities and its use Anna C Zhao-Wong, ZHU Lilin 2022, 19(1): 74-78.  DOI: 10.19803/j.1672-8629.2022.01.16 Abstract ( 935 )   PDF (1733KB) ( 1511 )   Objective To introduce the Medical Dictionary for Regulatory Activities (MedDRA) Terminology, a medical terminology developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the use of MedDRA in the regulatory area. Methods The need for an international standard terminology in the 1990s was traced, the structure and maintenance of MedDRA were illustrated, the milestones of MedDRA's growth and development were listed, including its recent actions to meet the challenges of the COVID-19 pandemic, and the future developments of MedDRA were outlined. Results and Conclusion MedDRA by ICH resulted from the need for an international standard terminology that could meet the regulatory needs in pharmaceutical research and development. MedDRA has been used in the registration, documentation, safety monitoring and oversight of medicinal products through each phase of the pipeline, from clinical trials to post-marketing surveillance. The structure and maintenance model of MedDRA can facilitate its use. Since its inception as a user-driven terminology, MedDRA has grown in volume and expanded in scope under the care of the Maintenance and Support Services Organization (MSSO) to meet the needs of users and of evolving regulatory reporting and to keep up with the advances of medicine. References | Related Articles | Metrics

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Methods for risk trend analysis of EU post-marketing surveillance for medical devices ZHENG Chao, WU Yan, ZHANG Lan, HU Kai, ZENG Ye, WANG Wen, WANG Ling 2022, 19(1): 79-82.  DOI: 10.19803/j.1672-8629.2022.01.17 Abstract ( 220 )   PDF (1751KB) ( 255 )   Objective To improve the level of risk management based on a study of statistical methods for post-marketing risk assessment of medical devices. Methods The applications of trend analysis methods for post-marketing risk assessment of medical devices were explored by reference to the trend reporting requirements in the new EU medical device regulations. The process of determining the control limits and continuous trend monitoring via historical data was analyzed by examples, and related problems were discussed. Results Trend analysis was one of the methods for scientifically evaluating the risks of post-marketing medical devices, and it could be implemented in China. Conclusion Manufacturers can use real-world risk data to carry out trend analysis and improve the ability to warn against post-marketing risks. References | Related Articles | Metrics

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Observation of 110 cases of adverse drug reactions induced by iodixanol ZHANG Dan, LI Li, XU Hengwei, ZHU Yaning, ZHANG Peng, ZHOU Nan 2022, 19(1): 83-86.  DOI: 10.19803/j.1672-8629.2022.01.18 Abstract ( 241 )   PDF (1612KB) ( 177 )   Objective To analyze the characteristics and patterns of adverse drug reactions (ADR) caused by iodixanol during angiography, and to provide reference for control of risks of clinical medications. Methods A clinical pharmacist performed pharmacy monitoring of 415 patients who used iodixanol between July 1, 2018 and May 31, 2019 in the Cardiology Department of Shaanxi Provincial People's Hospital. Patients were asked while the time ADR occurred, symptoms and severity of ADR after using iodixanol were recorded. Other information including gender, age, weight, and levels of creatinine was retrieved with the HIS. Results Among the 415 patients, 359 entered valid information of ADR, A total of 110 patients developed ADR. The overall rate was 30.64%, compared with 14.55% for immediate reactions, 85.45% for delayed reactions, 73.64% for mild reactions, 25.45% for moderate reactions, and 0.91% for severe reaction. According to the statistics, there were a total of 181 cases of ADR involving systems and organs. Damage to the skin and its accessories accounted for 25.41%, 27.62% for the digestive system, 24.31% for the nervous system, 3.87% for the cardiovascular system, 9.39 % for the respiratory system, and 1.10% for the urinary system. Systemic adverse reactions made up 8.29%. One patient had anaphylactic shock, and two suffered from contrast-induced acute kidney injury (CI-AKI). Conclusion The incidence of adverse drug reactions associated with iodixanol is higher than was previously reported. Preoperative preventive evaluation and measures should be enhanced to reduce the incidence of adverse reactions and improve the safety of medications. References | Related Articles | Metrics

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Influencing factors of coagulation abnormalities induced by cefoperazone sodium and sulbactam sodium in patients with ischemic cerebrovascular disease LIANG He, MENG Guangyi, ZHONG Liqiu, ZHOU Lijuan, PANG Jiarong 2022, 19(1): 87-90.  DOI: 10.19803/j.1672-8629.2022.01.19 Abstract ( 146 )   PDF (1651KB) ( 134 )   Objective To investigate the influencing factors of coagulation abnormalities induced by cefoperazone sodium and sulbactam sodium in patients with ischemic cerebrovascular disease. Methods The clinical data on 102 patients with ischemic cerebrovascular disease treated with cefoperazone sodium and sulbactam sodium in our hospital between January 1, 2015 and September 30, 2019 was retrospectively analyzed. The basic information, medications, liver and kidney function parameters, serum albumin levels and coagulation function parameters were recorded and analyzed using binary logistic regression analysis. Results The incidence of coagulation abnormalities was 42.16% (43/102). Logistic analysis showed that the number of days cefoperazone sodium and sulbactam sodium were used and serum levels of creatinine and albumin were independent risk factors for coagulation abnormalities in patients with ischemic cerebrovascular disease (P<0.05). Conclusion Ischemic cerebrovascular disease complicated with renal insufficiency and hypoalbuminemia could increase the risk of coagulation abnormalities induced by cefoperazone sodium and sulbactam sodium. The incidence of coagulation abnormalities increases with the number of days cefoperazone sodium and sulbactam sodium are used. Therefore, coagulation function should be monitored. References | Related Articles | Metrics

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229 cases of adverse drug reactions caused by Keke tablets QIAO Weilin, LI Haiyan 2022, 19(1): 91-94.  DOI: 10.19803/j.1672-8629.2022.01.20 Abstract ( 155 )   PDF (1613KB) ( 138 )   Objective To analyze the characteristics of 229 cases of adverse drug reactions (ADR) induced by Keke tablets, and provide reference for rational use of drugs in clinic. Methods The clinical data of ADR caused by Keke tablets between January 1, 2017 and December 31, 2018 was retrospectively analyzed. Results Among the 229 cases of ADR, there were 123 males and 106 females (1.16∶1). Most of the patients were 15 to 44 years old (54.15%). Common ADR (n=162) were the most prevalent, accounting for 70.74% of the total, followed by new common ADR (n=65) that accounted for 28.38%. Most of the ADR occurred in the skin system. The main symptoms were rash (44.59%) and by pruritus (19.75%). Conclusion The characteristics of ADR induced by Keke tablets have been confirmed in this analysis, which can help standardize the clinical use of Keke tablets and revise the drug instructions so as to reduce or prevent serious ADR and to ensure safe and rational drug use. References | Related Articles | Metrics

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Literature analysis of adverse drug reactions induced by posterior pituitary injection XIE Xiaoyan, XIA Xudong, YANG Xue, LI Qingfang, LIU Cuili, CHEN Shiwei 2022, 19(1): 95-99.  DOI: 10.19803/j.1672-8629.2022.01.21 Abstract ( 127 )   PDF (1753KB) ( 141 )   Objective To study the pattern, characteristics and influencing factors of adverse reactions induced by posterior pituitary injection so as to provide reference for clinical safe medication. Methods Based on such key words as“pituitrin injection”and“adverse reactions”, literature was searched for that was related to the adverse reactions caused by pituitrin injection reported in CNKI, VIP and Wanfang databases between inception and April 30, 2019. According to the inclusion and exclusion criteria, 159 articles were included for data retrieval and statistical analysis. Results The adverse reactions involved multiple organs and systems. The most common reactions were hyponatremia and gastrointestinal tract damage. In severe cases, hyponatremia encephalopathy and cardiac arrest were likely. Conclusion The adverse reactions caused by posterior pituitary injection deserve attention, and efforts have to be made to guard against the occurrence of adverse reactions to ensure the safety of clinical medication. References | Related Articles | Metrics

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Management and working modes of outpatient pharmacies amid routine COVID-19 epidemic prevention ZHAO Xuan, GUO Jing, REN Shuang, ZHEN Jiancun 2022, 19(1): 100-102.  DOI: 10.19803/j.1672-8629.2022.01.22 Abstract ( 110 )   PDF (692KB) ( 105 )   Objective To explore the ways in which outpatient pharmacies of hospitals work in order to finish the daily work and ensure the safety of drugs amid the COVID-19 pandemic Methods By reference to the related guidelines and literature and based on the actualities in our hospital, important measures for prevention and control of the pandemic in the daily work of the outpatient pharmacy were clarified. Meanwhile, efforts were made to change the working mode in the outpatient pharmacy. Results In the outpatient pharmacy, some prevention measures were formulated while the working mode was changed accordingly. Conclusion Amid the routine epidemic prevention of COVID-19, the measures that have been taken and changes that have been brought into the working mode in the outpatient pharmacy can ensure the safety of patients and pharmacists. Pharmaceutical care in the outpatient pharmacy has been improved. References | Related Articles | Metrics

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Chinese and western medicine pharmaceutical care for one diabetic foot patient with multiple complications ZHUANG Hongyan, LIU Shanshan, GUO Wei, XUE Chunmiao, HE Yue, ZHAO Yan 2022, 19(1): 103-106.  DOI: 10.19803/j.1672-8629.2022.01.23 Abstract ( 133 )   PDF (746KB) ( 134 )   Objective To explore the methods and effects of participating in the treatment of diabetic foot complicated with multiple diseases by clinical pharmacists. Methods Clinical pharmacists participated in treating limb infections of a diabetic foot patient with a variety of complications, provided data for clinical medication, analyzed the efficacy, monitored medication safety and gave tips to the patient according to the effect of medication. Results This case is diabetic foot with multiple complications receiving multi drug treatment. The diabetic foot ulcers are mainly treated with Chinese herbal decoction, local dressing of ulcerated surface is used as an auxiliary method. The symptoms are well controlled. Conclusion Chinese pharmaceutical care and pharmaceutical care in clinical practice are conducive to safe and effective use of drugs, which can improve the level of clinical treatment and promote the rational use of drugs in clinical practice. References | Related Articles | Metrics

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One case of primary adrenal insufficiency induced by pembrolizumab MENG Dehui, WANG Weilan 2022, 19(1): 107-110.  DOI: 10.19803/j.1672-8629.2021.12.24 Abstract ( 243 )   PDF (1621KB) ( 144 )   Objective To investigate the pathogenesis and management of primary adrenal insufficiency caused by pembrolizumab. Methods The diagnosis and treatment process of one case with primary adrenal insufficiency caused by pembrolizumab was analyzed. Based on literature analysis, the causal relationships between pembrolizumab and primary adrenal insufficiency, incidence, pathogenesis and treatments were explored. Results After 6 months of intravenous administration of pembrolizumab, the patient showed obvious symptoms of fatigue, poor physical strength, poor appetite and blackened skin. The patient was hospitalized for laboratory examination of 8AM serum ACTH 16.7 pmol·L-1 and 8AM serum cortisol < 25.7 nmol·L-1. Primary adrenal insufficiency caused by pembrolizumab was suspected. It was recommended that pembrolizumab be suspended, and that oral prednisone (5 mg·time-1, bid) was used as an alternative therapy with steroid hormone. The patient's symptoms improved after one week and he was discharged. The dosage of prednisone was gradually reduced to 5 mg·d-1. Conclusion Primary adrenal insufficiency caused by pembrolizumab should be treated according to the classification standards for adverse reactions. References | Related Articles | Metrics

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Telbivudine induced vomiting with elevated creatine kinase and lactic acid: a case report LIANG Kai, LAI Mingyu 2022, 19(1): 111-112.  DOI: 10.19803/j.1672-8629.2021.12.25 Abstract ( 96 )   PDF (1305KB) ( 86 )   Objective To analyze a case of vomiting with elevated creatine kinase and lactic acid caused by tibivudine, so as to provide reference for clinical safe drug use. Methods The process of treating one case of vomiting with elevated creatine kinase and lactic acid caused by tibivudine was analyzed based on literature retrieval. Results The patient appeared recurrent vomiting, creatine kinase 1 559 U·L-1 and blood lactic acid 8.930 mmol·L-1 after using tibivudine about 5 months. Stopped using tibivudine immediately and changed to entecavir. The patient was getting better. 2 weeks after withdrawal, there were no vomiting symptoms, creatine kinase and blood lactic acid basically returned to normal. Conclusion We should pay close attention to the occurrence of adverse reactions when using tibivudine. Once vomiting, elevated creatine kinase and lactate increase occur, the drug should be stopped in time and changed the treatment plan. References | Related Articles | Metrics

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Research progress in dependence potential evaluation of antidepressants of biogenic amines CHEN Ying, LI Liang, JI Wenyue, Wu Chunqi, Dong Yansheng 2022, 19(1): 113-116.  DOI: 10.19803/j.1672-8629.2022.01.26 Abstract ( 142 )   PDF (1568KB) ( 107 )   Antidepressants of biogenic amines promised good economic benefits and prospects of development. In recent years, the research and development of antidepressants targeting the reuptake inhibitory effect of the 5-HT/NE/DA triple targets has been accelerated. However, abuse and addiction as possible side effects have become a public health concern globally. Drug dependence evaluation guidelines issued by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and China's National Medical Products Administration (NMPA) all require non-clinical dependence potential evaluation of such drugs for the purpose of evaluating the dependence potential of these drugs effectively and guide clinical use. Through literature research, the status quo, existing problems and prospects of research on antidepressants of biogenic amines and evaluation of their dependence potential were studied. It is recommended that China learn from the experience of FDA and EMA to step up investment in the non-clinical dependence evaluation platform of antidepressants of biogenic amines and update related policies and regulations. References | Related Articles | Metrics