Archive

15 September 2023, Volume 20 Issue 9 Previous Issue    Next Issue

---

For Selected:

Download Citations EndNote Ris BibTeX

Toggle Thumbnails

Select

The latest progress of small molecule anti-SARS-CoV-2 drugs MA Ruize, CHEN Zhihai 2023, 20(9): 961-966.  DOI: 10.19803/j.1672-8629.20230357 Abstract ( 155 )   PDF (1375KB) ( 189 )   Objective To study the main small molecule anti-SARS-CoV-2 drugs. Methods Aiming at the molecular structure and infection mechanism of SARS-CoV-2, we discussed and summarized the small molecule drugs from the aspects of blocking virus mechanism and clinical effect. Results According to the characteristics of the current variants of SARS-CoV-2, small molecule drugs were showing great potential with their unique advantages. Focusing on protease inhibitors and RNA-dependent RNA polymerase inhibitors, significant progress has been made in the research and development of new and old anti-SARS-CoV-2 small molecule drugs. Conclusions mall molecule anti-SARS-CoV-2 drugs can be used as a powerful weapon to fight the COVID-19 epidemic, and the early application of small molecule drugs can effectively improve clinical symptoms, reduce severe disease, hospitalization and mortality rate. References | Related Articles | Metrics

Select

Processes of remote inspection of pharmacovigilance for marketing authorization holders XIA Xudong, LI Meixia, SUN Yang, YANG Shengya 2023, 20(9): 967-970.  DOI: 10.19803/j.1672-8629.20220582 Abstract ( 424 )   PDF (1241KB) ( 486 )   Objective To explore the normal processes of and considerations for remote inspection of pharmacovigilance for marketing authorization holders licensed by China's drug regulatory authorities. Methods The application of information tools and instruments in a particular part of remote inspection was discussed according to the on-site inspection workflow. Results and Conclusion Based on current information network technology, remote inspection of pharmacovigilance can achieve its purpose and help to improve efficiency, save time and costs, and identify and address drug safety issues earlier. References | Related Articles | Metrics

Select

Key points of investigation and report of suspected death of adverse drug reaction LIU Saiyue, LYU Xiaoqin, ZHOU Yun 2023, 20(9): 971-974.  DOI: 10.19803/j.1672-8629.20230307 Abstract ( 513 )   PDF (1263KB) ( 617 )   Objective To guide the drug marketing authorization holder (MAH) to standardize the investigation and report of death cases, so as to provide a basis for in-depth evaluation of drug safety. Methods This paper refers to the requirements of domestic and foreign regulatory guidelines, elaborated the key points of field investigation and internal investigation of suspected death cases of adverse drug reactions known to MAH, as well as the comprehensive analysis of death cases. Results Field investigation includes basic information of cases, drug use, adverse reactions, diagnosis and treatment of patients, and medical institutions. Internal investigation and evaluation can be carried out from the whole process of production and quality control. In addition to the investigation and disposal, the investigation report can provide comprehensive analysis and evaluation combined with the previous safety analysis of the variety. Within the prescribed time limit, the investigation content should be summarized and analyzed to form the investigation report, and submitted as required. Conclusion To standardize the investigation and report of death cases, MAH needs to improve the pharmacovigilance system, and multi-department interaction and efficient disposal, so as to provide reliable basis for risk assessment and risk control, and better guide clinical safe drug use. References | Related Articles | Metrics

Select

Management of individual adverse drug reaction reports LI Xiaozhu, WANG Qiang, PANG Yu, ZHANG Yijing 2023, 20(9): 975-977.  DOI: 10.19803/j.1672-8629.20230264 Abstract ( 562 )   PDF (1185KB) ( 675 )   Objective To summarize and analyze the key points of ways in which individual case safety reports (ICSRs) are managed by referring to domestic and overseas laws and regulations in order to assist marketing authorization holders (MAHs) in handling ICSRs. Methods Based on a review of related literature and regulations at home and abroad, the whole process of ICSR management was introduced. Speaking from experience, we discussed the problems that were worthy of attention in the course of ICSR management. Results and Conclusion ICSRs underline pharmacovigilance by MAHs, who should collect, process, and submit ICSRs in accordance with related laws and regulations. References | Related Articles | Metrics

Select

Exploring the significance of collecting patient reports based on international pharmacovigilance experience PANG Yu, LIU Bo, LYU Shaoli, WANG Tao, XING Ying, QIN Xingyu, TIAN Yuejie, WU Wenyu 2023, 20(9): 978-981.  DOI: 10.19803/j.1672-8629.20230247 Abstract ( 296 )   PDF (1192KB) ( 375 )   Objective To explore the significance of enterprises collecting patient reports as stated in Good Pharmacovigilance Practice (GVP). Methods Review the literature about the research findings from various nations and discuss the value of patient reports to reveal the importance of collecting patient reports. Results and Conclusion Patient reports are a beneficial supplement to doctor reports and are conducive to signal detection. Enterprises should take patient reports seriously, establish paths for collecting patient reports, and ensure the paths work efficiently. References | Related Articles | Metrics

Select

Management of adverse events during clinical trials SHEN Yanjie, WU Yiqing 2023, 20(9): 982-986.  DOI: 10.19803/j.1672-8629.20230310 Abstract ( 363 )   PDF (1248KB) ( 472 )   Objective To give advice about drug safety during clinical trials by introducing ways to manage adverse events(AE). Methods By summarizing the laws and regulations in China, reviewing the related literature, and outlining the sponsors' current practices, the time and ways to collect AE, the content to be collected, means of reporting of safety information and analysis of reports of AE were described. Results With the successive enforcement of laws and regulations in China, the collection and reporting of adverse events during clinical trials became increasingly standardized, but there was still a lack of uniform standards in some specific areas (e.g. start-end time or causality judgment). Conclusion Management of safety in clinical trials underlies the establishment of safety profiles in the product label as well as post-marketing safety surveillance. Therefore, close collaboration and active communication between health authorities, sponsors, and investigators are critical. References | Related Articles | Metrics

Select

Simultaneous determination of fifteen components in Xuanfudaizhe decoction by UPLC-MS/MS GAO Le, WANG Xiang, MA Jingmei, ZHANG Zezhao, WANG Xinguo, NIU Liying 2023, 20(9): 987-991.  DOI: 10.19803/j.1672-8629.20220735 Abstract ( 51 )   PDF (2285KB) ( 49 )   Objective To establish a method for simultaneous determination of fifteen components in Xuanfudaizhe decoction by UPLC-MS/MS. Methods The separation was performed on a Shim-pack GIST C18 column (2.1 mm × 100 mm, 2.0 μm) with acetonitrile-0.1% formic acid as the mobile phase under gradient elution at a flow rate of 0.3 mL·min-1. The column temperature was 35℃. The detection was carried out via electrospray ionization (ESI). Multiple-reaction monitoring (MRM) scanning was used for quantification in a negative ion mode. Results Liquiritin, glycyrrhizic acid, liquiritigenin, isoliquiritigeni, isoliquiritin, isoliquiritin apioside, neoliquiritin, chlorogenic acid, cryptochlorogenic acid, ferulic acid, isochlorogenic acid A, isochlorogenic acid C, ginsenoside Rb1, ginsenoside Re and 6-gingerol had good linear relationships in their respective concentration ranges (r>0.998 6). The average recovery ranged from 97.0% to 103.1%, and the precision, stability and repeatability of the method were good. Conclusion This method is simple and accurate, which can provide reference for Xuanfudaizhe decoction and its preparations. References | Related Articles | Metrics

Select

Molecular mechanism of luteolin for inhibiting esophageal squamous cell carcinoma based on network pharmacology and in vitro studies YANG Zhenzhen, CHANG Cheng, GAO Na, ZHANG Xiaolin, SONG Yinsen, LIU Ying, FAN Tianli 2023, 20(9): 992-1001.  DOI: 10.19803/j.1672-8629.20220744 Abstract ( 83 )   PDF (4868KB) ( 88 )   Objective To investigate the molecular mechanism by which luteolin inhibits esophageal squamous cell carcinoma (ESCC) based on network pharmacology and in vitro studies. Methods The common targets of luteolin and ESCC were identified by constructing Venn diagrams of active ingredients and diseases. The common targets were visualized via the String database before a protein-protein interaction network (PPI) was established. The Hub genes were screened using the plug-in of Cytoscape 3.9.1. Gene Ontology (GO) enrichment analysis and KEGG pathway analysis were performed using the R programming language. The inhibitory effect of luteolin on ESCC cell lines (TE-13 and KYSE-510) was observed in vitro, and the binding activity of luteolin and Hub genes was verified by molecular docking. Results A total of 69 common targets of luteolin and ESCC were collected, and Hub target genes represented by AKT1, ESR1 and SRC were screened. The targets involved not only such biological functions as cellular oxidative stress and protein modification, but such signaling pathways as reactive oxygen species, inflammation, and extracellular matrix. The PI3K-Akt signaling was selected to verify the rationality of the results of the network pharmacology analysis. In vitro studies showed that luteolin inhibited the ability of TE-13 and KYSE-510 cells to proliferate, migrate, and invade, and reduced the expressions of phosphorylated proteins in the FAK-SRC-PI3K-Akt pathway. In addition, the results of molecular docking showed that luteolin showed good affinity for FAK, SRC and Akt. Conclusion The inhibition of ESCC by luteolin is characterized by multiple targets and multiple pathways, which may be related to the inhibition of the FAK-SRC-PI3K-Akt pathway. References | Related Articles | Metrics

Select

Status and thinking of Parmacovigilance regulatory system during clinical trials of the pediatric drug in China LIU Wendong, CUI Huanhuan, WANG Xiaohan, SU Xian, WANG Haixue 2023, 20(9): 1002-1006.  DOI: 10.19803/j.1672-8629.20220535 Abstract ( 186 )   PDF (1399KB) ( 259 )   Objective To summarize the current status of pharmacovigilance regulatory system during clinical trials of the pediatric drug in China, in order to provide reference for further improving of the pharmacovigilance regulatory capacity during the clinical trials of pediatric drug in China. Methods Theoretical analysis and comparative analysis were used to summarize the current status of pharmacovigilance regulations during clinical trials in China, compare the differences of drug safety reports review strategies between children and adults, and provide suggestions for the regulatory authority. Results Most of the current pharmacovigilance regulations during clinical trials in China are aimed at the overall population, and there are no regulations related to pediatric drug. There are significant differences of the drug safety reports review strategies between children and adults, and should be considered when developing review standards. Conclusion The pharmacovigilance regulatory system during clinical trials needs to be further refined for the pediatric drug. References | Related Articles | Metrics

Select

Conditional approval of medical devices in the United States and enlightenment ZHANG Qi, CHEN Min, ZHANG Shiqing 2023, 20(9): 1007-1010.  DOI: 10.19803/j.1672-8629.20230078 Abstract ( 92 )   PDF (1356KB) ( 96 )   Objective To provide a reference for balancing the related work of pre-marketing evidence support and post-marketing research collection of medical devices, and to improve the scientific decision-making level of pre-marketing approval of medical devices. Methods By introducing the content and approval of the U.S. Food and Drug Administration (FDA) guidelines for conditional approval of medical devices were sorted out, and the relevant policies in China were compared. The relevant recommendations for the whole life cycle management of medical devices in China were obtained. Results FDA revised the relevant guideline of medical device conditional approval, which can be referenced by China's regulatory for the requirements of post-market study. In China, the balance between the expected data collected after the approval and before the market should be fully considered for medical devices that treat diseases that are seriously life-threatening and which do not have effective treatment methods. Conclusion The specificity of the conditional approved medical device product is that the pre-market research can be balanced by the data that is expected to be collected after approval, provided that the conditions attached to it are followed up and evaluated in a timely manner and, if necessary, appropriate regulatory measures are taken. It is recommended that China's medical device regulatory authorities improve the level and capability of reviewing scientific decision-making by clarifying the specific circumstances of the project, standardising the writing of conditional approval information, accelerating the frequency of post-market surveillance and establishing a medical device full life-cycle regulatory information system. References | Related Articles | Metrics

Select

Active monitoring of adverse reactions related to haemocoagulase agkistrodon for injection in children TAI Jun, YU Miao, ZHANG Lin, LEI Yi, LIU Junting, LI Tao, HUANG Guimin, CHENG Yijing, NIE Xiaolu, WANG Qing 2023, 20(9): 1011-1016.  DOI: 10.19803/j.1672-8629.20220736 Abstract ( 89 )   PDF (1583KB) ( 118 )   Objective To explore methods of active monitoring of adverse reactions related to haemocoagulase agkistrodon for injection in children so as to contribute to revelation and mining of the adverse reactions. Methods Using entity recognition technology, adverse reactions in children who used haemocoagulase agkistrodo and were hospitalized at the Capital Institute of Pediatrics between February 25, 2014 and January 8, 2021 were monitored actively and retrospectively. The results of experiments were assessed using three indicators: Precision (P), Recall (R) and F1 value. Results After three rounds of analysis, all the three indicators achieved 100%. Conclusion The application of natural language processing technology can be used to monitor adverse reactions related to haemocoagulase agkistrodon for injection in children. References | Related Articles | Metrics

Select

Clinical characteristics of Xiyanping injection in 3846 patients with bacterial intestinal infection in the real world SHI Bowen, LI Lixun, XIE Yanming, WANG Zhifei, WANG Qi 2023, 20(9): 1017-1021.  DOI: 10.19803/j.1672-8629.20220061 Abstract ( 87 )   PDF (1645KB) ( 94 )   Objective To find out about the clinical characteristics of Xiyanping injection in the treatment of bacterial intestinal infections in order to provide reference for its clinical use. Methods A total of 3 846 patients with bacterial intestinal infections treated with Xiyanping injection were selected from clinical information systems of 14 big hospitals in China between July 26, 2011 and June 1, 2019. The records of clinical medications, diagnostic protocols, basic data on treatment and combined medications were analyzed using frequency statistics and association rules. Results Most of the patients were aged 1 to 3 (2 378 cases). Male patients outnumbered female ones. The top three comorbidities included other forms of heart disease, acute upper respiratory tract infections and metabolic disease. In terms of drug combinations, the main Western drugs were those for other forms of heart disease, heparin drugs, third-generation cephalosporins, mucolytic drugs and H2-receptor antagonists. Drug combinations with traditional Chinese medicine were dominated by heat-clearing agents. The third-generation cephalosporin and penicillin were the most common Western drugs combined with antibiotics. Conclusion Patients with bacterial intestinal infections may also be complicated with or vulnerable to secondary cardiac diseases and acute upper respiratory tract infections. It is critical to find out whether patients have such diseases. At the same time, clinicians should be alert to adverse reactions caused by Xiyanping injection when used in combination with other drugs. References | Related Articles | Metrics

Select

Evaluation of the rationality of proton pump inhibitors in preventing perioperative stress related mucosal disease in biliary and pancreatic surgery LI Xingren, SHEN Aizong, SU Dan 2023, 20(9): 1022-1026.  DOI: 10.19803/j.1672-8629.20220741 Abstract ( 86 )   PDF (1342KB) ( 116 )   Objective To evaluate the rationality of proton pump inhibitors (PPIs) in the prevention of stress ulcer（SU） during perioperative period of biliary and pancreatic surgery, and to provide reference for the rational use of PPIs. Methods A retrospective survey was conducted to collect information on 478 patients who used PPIs during the perioperative period in the Department of Biliary and Pancreatic Surgery of a certain hospital from June to August 2020. The usage rate and medication indications of PPIs were statistically analyzed. Subsequently, drug selection, medication timing, usage and dosage of cases with medication indications were evaluated. Results Among 623 surgeries, PPIs were used for prevention in 530 cases, accounting for 85.07% of the cases. Among them, 268 cases (50.57%) had no indication of PPIs medication. The cases with medication indications, were mainly due to inappropriate drug selection, inappropriate timing of administration, inappropriate frequency of administration, and overly long treatment periods. The majority of patients exhibited multiple inappropriate medication situations, with only 11 cases (2.08%) being relatively rational. Conclusion The unreasonable phenomenon of using PPIs to prevent stress ulcer in the perioperative period of biliary and pancreatic surgery in the hospital is significant. Physicians should strictly control medication indications, and pharmacists should strengthen pre prescription review to jointly promote rational drug use. References | Related Articles | Metrics

Select

Safety-related risk factors in clinical management of narcotics and psychotropic substances via failure mode and effect analysis YUAN Sisi, WANG Guangyan, LI Yifan, LI Ruilian, DU Boran, FENG Xin 2023, 20(9): 1027-1030.  DOI: 10.19803/j.1672-8629.20220637 Abstract ( 74 )   PDF (1376KB) ( 89 )   Objective To investigate the safety-related risk factors in clinical management of narcotics and psychotropic substances by means of failure mode and effect analysis (FMEA). Methods A research group on the management of narcotics and psychotropic substances and on prevention strategies for medication errors was established at Beijing Obstetrics and Gynecology Hospital. The failure modes and risk factors were collected via literature retrieval, questionnaire surveys and field investigation. FMEA was used to score the severity (S), frequency of occurrence (O) and discovery index (D) and determine risk priority numbers (RPNs). Management and prevention strategies were formulated for high-risk factors with RPN scores > 100. Results Based on results of FMEA, there were ten high-risk factors (23 in total) with RPN>100 in the whole life cycle of narcotics and psychotropic substances, four of which were found in patient medications, two in drug production, and one in the management system, information system, drug management and drug use respectively. Conclusion The application of FMEA can effectively identify medication error-related risk factors for narcotics and psychotropic substances in clinical practice. By improving management systems, rules and regulations, and quality targets, the prevention and management strategies in medical institutions can be continuously optimized to ensure the medication safety of narcotics and psychotropic substances, thereby reducing negative social impacts. References | Related Articles | Metrics

Select

Principles and measures of medication risk management in the elderly ZHU Yuanchao, ZHANG Yatong, HU Xin 2023, 20(9): 1031-1034.  DOI: 10.19803/j.1672-8629.20220585 Abstract ( 262 )   PDF (1250KB) ( 339 )   Objective To study the causes of medication risks in the elderly and recommend measures of management. Methods The risk factors for medication in the elderly were analyzed in terms of pharmacokinetics, pharmacodynamics, polypharmacy and poor medication compliance. The principles of risk management and control for the elderly were explained to ensure the medication safety. Results According to the principles of medication risk management for the elderly, a multidisciplinary geriatric work team was established for geriatric assessment. Active management and control strategies for drug risks among the elderly were formulated. Conclusion Active exploration of management and control measures against medication risks based on medication principles of the elderly is an effective solution to polypharmacy in the elderly. References | Related Articles | Metrics

Select

Surveillance data on adverse reactions associated with real-world immune checkpoint inhibitors ZHANG Li, WANG Yujia, ZHANG Lingling, CHEN Jiaxin, LIN Minhua, LIN Xiaohui, NIE Xuekun 2023, 20(9): 1035-1038.  DOI: 10.19803/j.1672-8629.20220640 Abstract ( 102 )   PDF (1228KB) ( 133 )   Objective To analyze the incidence of immune-related adverse reactions (irAEs) caused by immune checkpoint inhibitors (ICIs) in our hospital. Methods The clinical data of patients treated with ICIs in our hospital in 2021 was investigated via the hospital information system. The monitoring and occurrence of irAEs were analyzed. Results A total of 80 patients treated with ICIs were included, including 7 cases (8.75%) of injuries to immune-related thyroid function, 4 cases (5.00%) of checkpoint inhibitor pneumonitis (CIP), and 3 cases (3.75%) of immune-related cutaneous adverse events (ircAEs). Only 67.50% of the patients regularly had their thyroid function evaluated, 47.50% regularly had their adrenal cortical function assessed and 50.00% regularly had their heart function evaluated. Adverse reactions were poorly monitored or left unmonitored. Conclusion The incidence of irAEs that require clinical treatment in our hospital is consistent with what has been reported, and the treatment of patients with adverse reactions is generally acceptable. Oncology pharmacists can promote the standardized clinical use of ICIs by enhancing the monitoring and analysis of irAEs in hospitals. References | Related Articles | Metrics

Select

Jinghuaweikang capsules combined with quadruple therapy in the treatment of Helicobacter pylori associated gastritis: a systematic evaluation and meta-analysis LIU Qian, HU Jing, LI Bo, YANG Xiaojing 2023, 20(9): 1039-1045.  DOI: 10.19803/j.1672-8629.20230153 Abstract ( 99 )   PDF (1523KB) ( 86 )   Objective To explore the efficacy and safety of Jinhuaweikang capsules combined with quadruple therapy in the treatment of patients with Helicobacter pylori (Hp) associated gastritis. Methods Cochrane Library, EMBASE, PubMed, Sinomed, CNKI, Wanfang data and VIP databases were searched for articles published between inception and May 19, 2022 about Hp associated gastritis patients treated with Jinhuaweikang capsules combined with quadruple therapy. The therapeutic effect was compared with those treated with quadruple therapy alone. The data was retrieved and integrated with the clinical effective rate (markedly effective and effective) and Hp eradication rate as the main indicators of outcomes and with the improvement of digestive tract-related symptoms, inflammatory factor (IL-6,CRP and TNF-α) and adverse reactions were secondary indicators of outcomes. The bias risk assessment tool of the Cochrane collaborative network was used to evaluate the quality of an individual study,the grade evidence quality grading system was adopted to evaluate the quality of an individual index of outcomes, and Revman 5.4.1 software was used to analyze data and test heterogeneity. Results Ten RCTs and 1 181 patients were included. Meta analysis results showed that when Jinhuaweikang capsules were combined with quadruple therapy to treat Hp associated gastritis patients, the clinical effective rate was (RR=1.20, 95%CI 1.12-1.30, P<0.000 01), Hp eradication rate was (RR=1.16, 95%CI 1.10-1.23, P<0.000 01), the improvement of digestive tract-related symptoms was (SMD=-1.74, 95%CI -2.85--0.62, P=0.002), IL-6 was (SMD=-3.68, 95%CI -5.72--1.64, P=0.000 4), CRP was (SMD=-2.09, 95%CI -2.44--1.73, P<0.000 01), TNF-α was (SMD=-2.58, 95%CI -3.11--2.06, P<0.000 01) and rate of adverse reactions was (RR=0.89, 95%CI 0.60-1.32, P=0.55). Conclusion In the treatment of Hp associated gastritis, the combination of Jinhuaweikang capsules with quadruple therapy is more effective than quadruple therapy alone in terms of the Hp eradication rate, the improvement of digestive tract-related symptoms and inflammatory factors. Due to the low quality of clinical studies, more high-quality clinical studies are needed to verify the above conclusions. References | Related Articles | Metrics

Select

Risks of safety Qingkailing oral preparation YU Hongli, YU Dongmei, XIAO Aili, ZHU Lan, SONG Haibo 2023, 20(9): 1046-1048.  DOI: 10.19803/j.1672-8629.20220676 Abstract ( 175 )   PDF (687KB) ( 187 )   Objective To analyze the risk of Qingkailing oral preparation in order to provide reference for rational clinical use. Methods Cases of adverse reactions related to Qingkailing oral preparation that were retrieved from National ADR Monitoring System and literature , and the relevant control measures issued by regulatory agencies were analyzed. Results From 2015 to 2021, the National ADR Monitoring System has received 7 185 ADR/ADE reports involving Qingkailing oral preparations, which involved gastrointestinal, skin, nervous and other systems and organs. The systems and organs literature reports involved in ADR/ADE of Qingkailing oral preparations were basically consistent with the reports in National ADR Monitoring System. Conclusion Adverse drug reaction associated with oral preparations of Qingkailing involve multiple systems-organs, and clinical attention should be paid to the adverse reactions associated with oral preparations of Qingkailing to promote the safe and rational use of drugs. References | Related Articles | Metrics

Select

Adverse reactions in patients with COVID-19 after using tocilizumab LI Jing, XU Ye, LIU Ranjia, PAN Chen, CUI Xiangli 2023, 20(9): 1049-1053.  DOI: 10.19803/j.1672-8629.20230214 Abstract ( 94 )   PDF (1323KB) ( 86 )   Objective To study the adverse drug reactions (ADR) caused by tocilizumab in patients with Corona Virus Disease 2019 (COVID-19) and to provide clinical reference. Methods Cases of adverse drug reactions caused by tocilizumab between December 1, 2022 and January 31, 2023 in our hospital were retrospectively analyzed to summarize the characteristics of ADR associated with tocilizumab. Domestic and overseas databases were searched to collect the cases of ADR due to tocilizumab reported as of January 31, 2023. The included patients were analyzed in terms of age, gender, weight, high-risk factors, types of COVID-19, time for administration of tocilizumab, regimens and durations, other drugs for COVID-19, onset time of adverse reactions, length of hospital stay and clinical outcomes. Results A total of 48 patients with COVID-19 were administered with tocilizumab, seven of whom experienced ADR within about 5 [(inter quartile range (IQR) 1-7] days of dosing, including 6 cases of (85.74%) thrombocytopenia, 3 cases of (42.86%) infections, and 1 case of (14.29%) liver function abnormalities. The median length of hospitalization was 19 (IQR 16-41) days, and 4 (57.14%) patients died during hospitalization. The literature search retrieved 14 case reports with a total of 30 COVID-19 patients with ADR induced by tocilizumab. ADR occurred about 11 (IQR 4-14.5) days after the first dose of tocilizumab and included 16 cases of (53.33%) infections, 9 cases of (30%) liver damage, 5 cases of (16.67%) intestinal ulcers/enteric perforation, and 3 cases of (10%) thrombocytopenia. The median length of hospitalization of patients was 29 (IQR 19-50) days and 9 (30%) patients died during hospitalization. Conclusion Patients with COVID-19 should be alerted to ADR such as infections, liver damage, and thrombocytopenia during the use of tocilizumab. References | Related Articles | Metrics

Select

Adverse reactions caused by levetiracetam LIANG Dong, LUO Li, CHENG Junxiang 2023, 20(9): 1054-1059.  DOI: 10.19803/j.1672-8629.20220719 Abstract ( 160 )   PDF (1494KB) ( 194 )   Objective To analyze the occurrence and clinical characteristics of adverse drug reactions (ADR) induced by levetiracetam and to promote rational clinical drug use. Methods Case reports about ADR induced by levetiracetam in Chinese and English databases between January 1, 1999 and November 1, 2022 were collected and analyzed. Results A total of 77 articles about ADR caused by levetiracetam were retrieved and 85 patients (37 men and 48 women) were included. ADR mainly occurred within 30 days (63.53%) of therapy. The top three adverse drug reactions were respectively mental disorders (28.42%), skin and its appendage damage (17.89%) and blood and lymphatic system abnormalities (13.68%). Conclusion Levetiracetam can cause some new and serious ADR. It is necessary to raise the awareness of ADR caused by levetiracetam while medication should be monitored more rigorously to ensure the safety and efficacy of drug use. References | Related Articles | Metrics

Select

Psoriasis aggravated by labetalol during pregnancy: a case report ZHANG Qing, ZHU Lei, LIN Cunlian, XIE Peitao, YANG Junli, SU Changhai 2023, 20(9): 1060-1063.  DOI: 10.19803/j.1672-8629.20220642 Abstract ( 93 )   PDF (1307KB) ( 97 )   Objective To study the applicability of labetalol hydrochloride tablets in the treatment of gestational hypertension with psoriasis so as to provide reference for safe clinical use of the drug. Methods One case of gestational hypertension with psoriasis aggravated by labetalol hydrochloride tablets in our hospital was analyzed. The mechanism of action and characteristics of skin rash caused by labetalol hydrochloride tablets were explored by referring to literature. Results Labetalol hydrochloride tablets aggravated psoriasis in this patient with hypertension during pregnancy. Conclusion Clinical pharmacists should be sensitive to the adverse drug reactions in the treatment of psoriasis in special populations. Beta-blockers should be used with caution in patients with hypertension complicated with psoriasis during pregnancy. References | Related Articles | Metrics

Select

Research progress in methods for toxicity-decreasing processing of toxic herbal traditional Chinese medicines HE Jia, JIN Yan, ZHAO Yuyang, ZHOU Junhui, LI Xiaolin, YUAN Yuan, FU Lu 2023, 20(9): 1064-1070.  DOI: 10.19803/j.1672-8629.20220624 Abstract ( 92 )   PDF (1386KB) ( 120 )   Objective To summarize the current studies on processing methods to decrease toxicity of toxic herbal TCM in China so as to provide reference for subsequent studies. Methods Toxicity-decreasing processing methods and similarities and differences between these methods when used in a variety of medicinal parts were analyzed via literature review. Results The commonly used processing methods for toxic Chinese herbal medicines included JingZhiFa, ChaoZhiFa, FuLiaoGongZhiFa, QuYouZhiShuangFa. Medicinal parts could be divided into three parts: root and rhizome drugs, fruit and seed drugs and resin drugs. Processing methods varied depending on the medicinal parts. For example, steaming and boiling were used for root and rhizome drugs, while oil removal was employed to reduce toxicity in fruit and seed drugs rich in oil. Conclusion The main objective of processing for toxicity reduction is to remove toxic components and reduce adverse reactions of drugs. However, the toxicity and active components of most of the toxic Chinese herbal medicines are not clear, throwing doubt on the feasibility of these processing methods. The mechanism by which toxicity is minimized should be clarified, processing conditions should be optimized, and the relationships between toxicity and efficacy should be balanced. References | Related Articles | Metrics

Select

Research progress on targeting CD47 in treatment of lymphoma HE Huizhen, GUO Yixian, SUN Wanling 2023, 20(9): 1071-1077.  DOI: 10.19803/j.1672-8629.20230332 Abstract ( 71 )   PDF (1452KB) ( 65 )   CD47 is one of the emerging immune checkpoints in the treatment of lymphoma in recent years. The most important role of CD47 is to interact with the macrophage receptor SIRP α under the regulation of various pathways, thereby inhibiting the immune attacks of macrophages and enabling tumor cells to achieve immune escape. There are various of CD47 blocking molecules at present, among which CD47 monoclonal antibody is the first to be applied in clinical practice. In order to reduce the prominent adverse reactions of the blood system, new drugs such as selective SIRP α antibody and double clonal antibody and combined therapy have been further developed. This article mainly reviews the clinical research progress on the regulatory mechanism, adverse reactions and related CD47 blockades in the treatment of lymphoma, so as to further improve clinical development through the innovation and combination of CD47 blockers References | Related Articles | Metrics

Select

Differentiation of vancomycin induced anaphylactoid and anaphylactic reactions ZANG Tianying, LIU Bingyang, TANG Xiaojun 2023, 20(9): 1078-1080.  DOI: 10.19803/j.1672-8629.20220630 Abstract ( 99 )   PDF (1199KB) ( 110 )   Vancomycin is a glycopeptide antibiotic, which is widely used in clinic. It is one of the most effective antibiotics for drug-resistant gram-positive bacterial infections. It can control refractory infections, but may also induce a variety of side effects. For example, the incidence of anaphylactoid reactions represented by Red Man Syndrome (RMS) and Ig-E mediated hypersensitivity reactions is high, and the clinical consequences are serious. Moreover, the clinical manifestations and diagnostic methods of the two are similar, which requires quick identification and intervention. However, the treatment methods following the two types of reactions vary and whether vancomycin can continue to be used depends on the conditions of patients, so the prevention, diagnosis and differential diagnosis of the two types of side effects are very important. With regard to the similarities and differences between RMS and Ig-E mediated hypersensitivity, this article reviews the related literature and outlines the clinical manifestations, differential diagnosis, identification of high-risk populations, prevention methods, and treatments. References | Related Articles | Metrics