Archive

15 October 2023, Volume 20 Issue 10 Previous Issue    Next Issue

---

For Selected:

Download Citations EndNote Ris BibTeX

Toggle Thumbnails

Select

Suitability assessment of real-world data in active post-marketing surveillance of vaccine safety WU Yunxiao, YU Yuelin, WANG Shengfeng, SUN Feng, MENG Ruogu, ZHAN Siyan 2023, 20(10): 1081-1089.  DOI: 10.19803/j.1672-8629.20230308 Abstract ( 176 )   PDF (1020KB) ( 236 )   Objective To sort out the suitability assessment content and methods of real-world data(RWD) in active post-marketing surveillance of vaccine safety, and preliminarily build a suitability assessment framework that meets the characteristics of RWD in China. Methods The scoping review was used to retrieve and screen studies and guideline documents related to the suitability assessment of RWD in active post-marketing surveillance of vaccine safety, extract and map suitability assessment indicators and content, and combine the framework synthesis to preliminarily determine the hierarchical suitability assessment structure. Results 51 articles were included, including 8(15.7%) in China. 229 assessment indicators were extracted to form a framework for suitability assessment of RWD in active post-marketing surveillance of vaccine safety, including 3 primary indicators(data traceability, data reliability, and data relevance), 8 second-level indicators (basic characteristics of data sources, data collection, data governance, completeness, accuracy, data content, data coverage, and data characteristics), and 31 third-level indicators. Accuracy of key variables(60.8%), population coverage(45.1%), timeliness(39.2%), and completeness of key variables(35.3%) were the third-level indicators with the highest frequency in the included articles. The distribution of the third-level indicators varied according to the type of RWD, vaccine, and health system. Conclusion There is still a lack of standardized RWD suitability assessment dimensions and methods in the active surveillance of vaccine safety. The suitability assessment framework summarized in this study provides a reference for relevant studies, but expert validation is still needed in the future to ensure the scientific nature of the indicator system and thus promotes the construction of the active surveillance system of vaccine safety in China. References | Related Articles | Metrics

Select

Evaluation index system of MAH pharmacovigilance work JIA Jinsheng, WANG Qing, LIU Hongliang, HOU Yongfang 2023, 20(10): 1090-1094.  DOI: 10.19803/j.1672-8629.20230508 Abstract ( 495 )   PDF (2882KB) ( 614 )   Objective To explore methods to quantitatively evaluate the pharmacovigilance evaluation work of marketing authorization holder(MAH) and support the development of scientific supervision work based on big data. Methods The analytic hierarchy process(AHP) method was used to decompose and detail ADR/ADE monitoring and reporting, risk identification and evaluation, post-market safety research, drug safety risk control and other related aspects, forming the MAH pharmacovigilance work evaluation index system. A data analysis information platform based on this index system was designed. Results 6 indicators of the criterion layer, 25 indicators of the sub-criterion layer and 85 indicators of the lowest layer are selected, and the weight values of each indicator of the evaluation system are determined. Based on the actual business situation and real world data, an information platform for MAH pharmacovigilance work evaluation was explored and designed. Conclusion The evaluation index system and information platform of holder pharmacovigilance laid the foundation for the intelligent evaluation of MAH pharmacovigilance work. References | Related Articles | Metrics

Select

Design and implementation of polypharmacy risk data management platform for common diseases of the elderly based on real world data LIU Hongliang, WANG Qing, HOU Yongfang 2023, 20(10): 1095-1098.  DOI: 10.19803/j.1672-8629.20230505 Abstract ( 119 )   PDF (1515KB) ( 139 )   Objective To design and implement a database management platform for polypharmacy risk in common geriatric diseases based on real-world data, and to provide systematic support and reference for the risk monitoring and control of multiple drug use for common elderly diseases in China. Methods Based on the monitoring data standard of polypharmacy risk for common elderly diseases for medical institutions, a distributed data management platform was developed and established with the idea of building retrospective database and prospective database management platform. Results and Conclusion It is deployed in relevant medical institutions or regional medical information platforms to achieve data collection, data extraction and transformation, data query, analysis, statistics and other functions of data providing partners as a basic analysis environment. And it receives the analysis program of polypharmacy use for common diseases of the elderly, completes the polypharmacy analysis task of common diseases of the elderly in a single center in the local, and provides the query and submission function of the analysis structure. Through the construction of the data management platform, it could provide a basic data analysis environment for polypharmacy tasks for common geriatric diseases References | Related Articles | Metrics

Select

The mechanism of “reducing toxicity and preserving effect” of curcumin - arecoline interaction based on weak bond chemistry LIN Xiaoyu, XIANG Jiawei, YAO Shuchang, TAN Senli, WEI Jichang, CHEN Ziyu, CHEN Siyu, LEI Haimin, WANG Penglong 2023, 20(10): 1099-1107.  DOI: 10.19803/j.1672-8629.20230194 Abstract ( 43 )   PDF (5005KB) ( 56 )   Objective The interaction between curcumin and arecoline and the formation of aggregates were observed on the basis of the commonly used matching drug pairs of traditional Chinese medicine, so as to explore the mechanism of “attenuating toxicity and preserving effect” during the matching process of traditional Chinese medicine and provide references for the safe use of arecoline compound preparations in clinical practice. Methods UV-vis, IR, 1H-NMR, PXRD, ITC and conductance titration were used to analyze the formation process of the aggregation and characterize its structure. Acute toxicity test in mice and HepG2 cell model were used to observe the changes of toxicity and effect of the aggregation before and after formation. Results The results showed that arecoline and curcumin could form aggregation in 1:1 ratio by weak bond force in aqueous solution. This aggregate can significantly alleviate the stimulative effect of high-dose arecoline hydrobromide while maintaining the original anti-HepG2 proliferation activity of curcumin. Conclusion Based on the theory of TCM compatibility and the experience and practice of TCM clinical medication, this experiment provided a new idea for the study of “reducing toxicity and preserving effect” of TCM compatibility. References | Related Articles | Metrics

Select

Non-carcinogenic and carcinogenic risk assessment of toxic elements in Panax quinquefolium L. based on multi-element semi-quantitative screening ZUO Tiantian, WANG Zhao, GUO Yuansheng, WEI Feng, JIN Hongyu, MA Shuangcheng 2023, 20(10): 1108-1112.  DOI: 10.19803/j.1672-8629.20230235 Abstract ( 59 )   PDF (4738KB) ( 72 )   Objective To semi-quantitative rapid screen and assess the risk of toxic elements in Panax quinquefolium L. by inductively coupled plasma mass spectrometry (ICP-MS). Methods After microwave digestion of Panax quinquefolium L., ICP-MS was used for semi-quantitative determination of heavy metals and toxic elements. According to the basic steps of risk assessment, the risks of Al, As, Cu, Pb, Mn, Ni and Cd were evaluated. Results The contents of Pb, Cd, As, Hg and Cu in Panax quinquefolium L. were lower than the limits of current Pharmacopoeia. The results of multi-elements showed that the contents of Fe and Mn were the highest (29.27~140.17 mg·kg-1 and 33.01~87.46 mg·kg-1）. The content of Zn was in the range of 8.27 to 22.72 mg·kg-1. The contents of Se were≤0.43 mg·kg-1. The content of Sn were 0.01~0.18 mg·kg-1. The results of risk assessment showed that the daily exposure of heavy metals and toxic elements in Panax quinquefolium L. was in the order: Mn > Al > Cu > Ni > Cd > Pb > As. The non-carcinogenic risk of Al, As, Cu, Pb, Mn, Ni and Cd can be accepted, and the carcinogenic risk of As and Pb can also be accepted. Conclusion The combination of semi-quantitative analysis method and risk assessment technology can quickly determine the concentration range and risk status of harmful target elements in Panax quinquefolium L., and provide scientific and technical support for effective response to accidents caused by TCMs. References | Related Articles | Metrics

Select

Chemical composition of Huatie compound and prediction of potential mechanism for prevention and treatment of hyperplasia of mammary glands CAO Lin, RAN Zheng, HOU Qiang, QIU Zuocheng, YANG Jianhua 2023, 20(10): 1113-1120.  DOI: 10.19803/j.1672-8629.20230215 Abstract ( 40 )   PDF (2578KB) ( 54 )   Objective To qualitatively analyze the chemical compositions of Huatie compound and predict the potential mechanism of Huatie compound in the prevention and treatment of breast hyperplasia, so as to lay a foundation for further revealing the pharmacodynamic material basis of Huatie compound and its potential molecular mechanism in the prevention and treatment of breast hyperplasia. Methods UPLC-Orbitrap Exploris-MS technology was used to perform full scan detection in positive and negative ion modes. The chemical compositions of Huatie compound extract (80 % methanol as solvent) were analyzed by CNKI, SciFinder, PubChem, TCMSP and other databases. The network pharmacology method was used to screen the active ingredients through drug-likeness and oral bioavailability, and the SwissTargetPrediction database was used to predict the target of the compound components, and the OMIM database was used to obtain the target of breast hyperplasia. String online database was used to construct protein-protein interaction (PPI) network diagram. Gene ontology (GO) enrichment analysis and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway analysis were performed through DAVID database, and Cytoscape 3.8.0 software was used to construct a network diagram of ‘Chinese medicine-active ingredient-target-signal pathway. Results 101 compounds were identified from Huatie compound, including 22 terpenoids, 22 flavonoids, 14 phenylpropanoids, 10 phenols, 9 alkaloids, 9 amino acids, 4 esters, 4 fatty acids, 4 fatty acids, 2 xanthones and 1 organic acid. Twenty-four active components were selected according to drug-like properties (DL≥0.18) and oral bioavailability (OB≥30%), and 2 003 breast hyperplasia-related target genes were retrieved through the OMIM database, and 250 breast hyperplasia targets of Huatie compound were obtained by intersection. PPI network analysis showed that 9 core network proteins included TNF, VEGFA, PI3KCA, PI3KR1, MAPK1, EGFR, AKT1, SRC and HSP90AA1. Conclusion The results of network analysis showed that the treatment of hyperplasia of mammary glands with Huatie compound was related to biological processes such as protein phosphorylation, signal transduction, and protein autophosphorylation. Abundant chemical components in Huatie compound may play a role in preventing and treating hyperplasia of mammary glands by regulating MAPK, Ras and other signaling pathways. References | Related Articles | Metrics

Select

Mechanisms of Piper longum for treating gastric cancer based on network pharmacology and molecular docking WANG Rumeng, GUO Ziqi, YANG Hongxin, YANG Yong 2023, 20(10): 1121-1128.  DOI: 10.19803/j.1672-8629.20220655 Abstract ( 64 )   PDF (3665KB) ( 72 )   Objective To explore the mechanism of Piper longum for the treatment of gastric cancer via network pharmacology and molecular docking technology. Methods The components and active components of Piper longum were searched for in TCMSP. GeneCards database was used to search for targets and common genes related to gastric cancer. A PPI network diagram was drawn, and GO and KEGG enrichment analysis was performed respectively. AutoDock Tools1.5.6 software was used for molecular docking of core components and targets. MTT and flow cytometry were used to detect the effects of different concentrations of piperine on the inhibition and apoptosis of SGC-7901 cells. The expression levels of related proteins were detected by Western blotting. Results A total of 15 active components were identified. There were 15 common targets of Piper longum-gastric cancer. GO functional enrichment analysis was associated with 19 gene biological processes, 12 cell components and 4 molecular functions. KEGG pathway enrichment analysis mainly involved the TNF signaling pathway. Molecular docking results of piperine, sesamin and other core targets were good. The results of MTT assay and flow cytometry showed that compared with the control group, the inhibition rate of SGC-7901 cells in the piperine group was increased ( P < 0.01 ), so was the apoptosis rate ( P < 0.01 ). Western blotting results showed that compared with the control group; the expressions of TNF-α, Caspase-3 and Caspase-8 protein in SGC-7901 cells in the piperine group increased (P < 0.05). Conclusion Piper longum and piperine have multi-target and multi-pathway properties in the treatment of gastric cancer, which can provide reference for subsequent experimental research and clinical application. References | Related Articles | Metrics

Select

Current applications of artificial intelligence in pharmacovigilance in the USA and implications WANG Tao, ZHENG Mingjie, LIU Hongliang, WANG Qing, SHEN Chuanyong 2023, 20(10): 1129-1133.  DOI: 10.19803/j.1672-8629.20230224 Abstract ( 262 )   PDF (1536KB) ( 324 )   Objective To study the current applications of artificial intelligence in pharmacovigilance in the United States in order to provide reference for the supervision of China's postmarketing drugs. Methods Based on literature review, from the perspective of drug regulation, this article outlined the concepts and performance indicators related to artificial intelligence, the background of application, FDA's experience and challenges to pharmacovigilance from the perspective of monitoring of postmarketing drugs. Results In the past decade, FDA was extensively exploring the applications of artificial intelligence in pharmacovigilance. Currently, FDA focused on the applications of artificial intelligence in handling and evaluating individual safety reports submitted to the FDA adverse event reporting system, and major progress had been made in the retrieval and analysis of key information about ICSRs, as well as in causality assessment for ICSRs. Conclusion Based on the experience of FDA, it is recommended that we accelerate the introduction of artificial intelligence technologies, strengthen training of professionals, establish a social technology and management system for artificial intelligence and promote international exchanges and cooperation in this field. References | Related Articles | Metrics

Select

Immunerelated adverse events and risk factors of carrelizumab in 528 cases of cancer patients YU Min, LI Xin 2023, 20(10): 1134-1140.  DOI: 10.19803/j.1672-8629.20230011 Abstract ( 161 )   PDF (1804KB) ( 178 )   Objective To retrospectively analyze immunerelated adverse events and risk factors of carrelizumab among cancer patients, and provide reference for its clinical applications. Methods The clinical data of patients treated with carrilizumab was collected from Jiangsu Province Hospital between July 1, 2021 and June 30, 2022. The safety of clinical medication was assessed by analyzing the clinical pathological features and the incidence of immune-related adverse events (irAEs) among patients with carrilizumab administration. The correlations between irAEs and clinical pathological features were explored. Results Oner hundred and eighty-four out of a total of 528 patients (34.85%) experienced irAEs involving dysfunction of 10 organ systems. The most common adverse reactions were observed in the endocrine system and the skin and soft tissue system. No fatal adverse events were observed. Most of the irAEs were G1~G2 grade, including 117 cases (53.67%) of G1 grade, 86 cases (39.45%) of G2 grade, 12 cases (5.50%) of G3 grade and 3 cases (1.37%) of other grades. The risk factors for irAEs of carrelizumab were identified as hepatitis B infection, tumor type, treatment schemes and the courses of treatment with immune checkpoint inhibitors ICIs (P<0.05). Multivariate analysis suggested that significant factors related to irAEs were the treatment schemes and coursed of treatment (P<0.05). In addition, reactive cutaneous capillary endothelial proliferation RCCEP related to incarrellizumab administration was statistically related to the co-administration of antiangiogenic drugs by multivariate analysis (P<0.05). Conclusion The symptoms of irAEs related to carrilizumab administration are moderate despite the high incidence. Early detection and interventions are of great importance for these patients. References | Related Articles | Metrics

Select

Adverse events associated with the three US licensed COVID-19 vaccines based on VAERS database YANG Qiuyue, SU Jun, ZHANG Xue, XIE Jiangan 2023, 20(10): 1141-1147.  DOI: 10.19803/j.1672-8629.20230100 Abstract ( 89 )   PDF (2014KB) ( 146 )   Objective To analyze and compare adverse events (AE) associated with three emergency licensed COVID-19 vaccines (i.e., Pfizer, Moderna, and Janssen) based on data from the Vaccine Adverse Event Reporting System (VAERS). Methods Data on AE associated with Pfizer, Moderna, and Janssen collected from the days the three vaccines were approved until June 30, 2022 was retrieved from VAERS database respectively. The combinatorial biomedical statistical methods were used to identify statistically significant AE. The profiles of AE were classified and represented by the Ontology of Adverse Events (OAE) for further analysis. In addition, statistical analysis based on detailed information in case reports of death was conducted to identify the major variables that might affect the occurrence of death. Results Eighty-one statistically significant AE were identified, including 67 related to Pfizer, 9 related to Moderna, and 11 related to Janssen. These AE mostly involved the cardiovascular system and behavioral and neurological conditions. Statistical analysis of case reports of death showed that the age, gender, and medical history of the vaccinated individuals had some specific effects on the occurrence of death. Conclusion The three COVID-19 vaccines have a wide safety profile with only minor and self-limiting AE. The causal association between COVID-19 vaccines and consequent AE (especially serious AE) deserves more study. References | Related Articles | Metrics

Select

Signal mining of adverse drug events of abiraterone based on FAERS database ZHANG Xuanyi, KONG Wenqiang, ZHONG Hong, DENG Huiyuan, SHU Yunfeng 2023, 20(10): 1148-1153.  DOI: 10.19803/j.1672-8629.20230043 Abstract ( 112 )   PDF (2862KB) ( 154 )   Objective To provide data for rational drug use via the mining and analysis of adverse drug reaction signals of abiraterone. Methods Based on the adverse Event Reporting System (FAERS) of the United States Food and Drug Administration (FDA), the reporting odds ratio (ROR) and information component (IC) method were used to mine and analyze the data on AEs of abiraterone reported between the first quarter of 2011 and the fourth quarter of 2022. Statistical analysis was performed according to the preferred terms (PT) and system organ class (SOC) of the International Dictionary of Medical Terms (MedDRA). Results A total of 34 432 reports of AEs of abiraterone were retrieved, and mostly involved males (32 823 reports, 95.3%). The mean age of onset in patients with known age was 74.7. AEs were chiefly reported in the United States (24 948 cases, 72.5%). Most of the interviewees were consumers (12 237, 35.8%). Reports of AEs kept increasing since 2011 and peaked in 2019 (5 517, 16.0%). A total of 280 abiraterone AE signals were detected in 24 SOCs. Among the top 50 PTs of occurrence, 18 positive signals were not recorded in the drug package, which were concentrated in various examinations (2 cases), diseases of the nervous system (1 case), diseases of the blood and lymphatic system (1 case), diseases of the respiratory, chest and mediastinum (2 cases), infectious and invasive diseases (1 case), benign, malignant and unknown tumors (6 cases), metabolic and nutritional diseases (3 cases), musculoskeletal and connective tissue diseases (2 cases). Conclusion The results of mining of suspicious abiraterone AE signals are generally consistent with those recorded in the manual, but new signals are still found and need to be actively monitored. References | Related Articles | Metrics

Select

Signal detection and analysis of adverse events related to nirmatrelvir/ritonavir based on JADER database QIAN Peipei, CAO Kai, XU Bingxin, YING Yabin, ZHAO Ningke, ZHAO Liang 2023, 20(10): 1154-1158.  DOI: 10.19803/j.1672-8629.20230091 Abstract ( 132 )   PDF (1736KB) ( 154 )   Objective To detect and analyze the potential adverse event signals related to nirmatrelvir/ritonavir based on Japanese Adverse Drug Event Report (JADER) database in order to provide reference for safe clinical use of nirmatrelvir/ritonavir. Methods The reporting odds ratio (ROR) method and the MHRA method were used to search the JADER database (version 202212) for ADE reports related to nirmatrevir/ritonavir from pharmaceutical companies or healthcare institutions between April 2004 and August 2022. Results A total of 92 reports of ADE related to nirmatrelvir/ritonavir were retrieved. Thirty-four disproportional signals related to 11 system organs classes (SOC) were detected. ADE signals were mostly distributed in various examinations, gastrointestinal disorders, general disorders, manifestations of administration sites and renal and urinary disorders. Among them, there were 27 new ADE signals, such as renal impairment, increases of blood urea, off-label use and c-reactive protein elevation. Conclusion The new ADE signals detected in this study can add to the information about safety specified in the instructions. In the process of medication, related ADE should be monitored to ensure the safety of patients. References | Related Articles | Metrics

Select

Analysis of 327 reports of new adverse drug reactions ZHANG Luxin, MENG Lu, ZHANG Hong 2023, 20(10): 1159-1162.  DOI: 10.19803/j.1672-8629.20230062 Abstract ( 499 )   PDF (1600KB) ( 508 )   Objective To study the characteristics of new adverse drug reactions so as to provide reference for effective prevention of new adverse drug reactions. Methods Three hundred and twenty-seven reports of new adverse drug reactions were screened from 856 reports submitted by a hospital between 2019 and 2022. Results Among the 327 new ADR, 245 cases (74.92%) involved people aged 41 or older. In terms of types of drugs, 241 cases (73.70%) were associated with Western drugs and 86 cases (26.30%) with proprietary Chinese medicines. The top three drugs responsible for new ADR were Ginkgo Biloba injection, compound thromboxane tablets, and levofloxacin hydrochloride injection. There were twenty-one drug dosage forms involved, and the top three were injection, powder injection and tablets. Thirteen routes of administration were involved, including 195 cases of intravenous injection (59.63%) and 90 cases of oral administration (27.52%). The systems-organs involved were mainly skin and its accessory injury, followed by injuries to the digestive system and nervous system. Conclusion New adverse drug reactions have their own patterns of occurrence, and targeted monitoring of new adverse drug reactions can improve the level of rational clinical use of drugs and effectively avoid the risk that arises from drug use. References | Related Articles | Metrics

Select

Analysis of 136 reports of adverse reactions related to small molecule kinase inhibitors JIA Bei, WANG Weihua, YANG Liang, DAI Yuanyuan 2023, 20(10): 1163-1167.  DOI: 10.19803/j.1672-8629.20230148 Abstract ( 80 )   PDF (1619KB) ( 110 )   Objective To analyze the characteristics of adverse drug reactions (ADR) of small molecule kinase inhibitors (SMKI), and provide reference for rational use of drugs in clinic. Methods The data on 136 cases of SMKI-related ADR monitored in our hospital between 2011 and 2022 was analyzed while the characteristics and risks of ADR caused by SMKI were studied in terms of patients, drug use, and occurrence of ADR. Results One hundred and thirty-six cases of ADR involved 21 types of SMKI. The average age of the patients was 57.75±12.74, and patients with lung cancer accounted for 54.41%. There were 34 cases of off-label use of drugs. The systems-organs implicated in ADR were mainly the gastrointestinal system, followed by the skin and subcutaneous tissue. 54.41% of the patients with ADR did not have the dosage of SMKI adjusted, 16.91% were severe ADR cases, and 56.62% improved after treatment. Conclusion SMKI-related ADR are tolerable for most of the patients. Some patients require dose reduction and symptomatic treatment. ADR can implicate multiple systems-organs. Patients should be assisted in targeted ADR monitoring and management to improve the safety and compliance of medication. References | Related Articles | Metrics

Select

Balanced decision between anti-infective and antitumor therapies and pharmaceutical care for a malignant tumor patient WANG Yanting, ZHANG Yuanyuan, CHEN Yiran, SUN Jie, ZHU Yu, YANG Liyan, WU Zhigui, SHEN Lijun, CHENG Min, LI Guohui 2023, 20(10): 1168-1172.  DOI: 10.19803/j.1672-8629.20230200 Abstract ( 87 )   PDF (696KB) ( 114 )   Objective To explore the balance between the anti-infective therapy and anti-tumor therapy and pharmaceutical care delivered to a malignant tumor patient by doctors and clinical pharmacists. Methods The roles of clinical pharmacists in the treatment of a case of advanced ovarian cancer were reported. Optimization of treatment focused on the differentiation of infectious fever from neoplastic fever, the selection of anti-microbial drugs, and the pharmaceutical care related to the anti-tumor therapy. Results Clinicians and pharmacists differed considerably in the differential diagnosis of infection and tumor fever for this patient. After multidisciplinary weighing, the anti-tumor therapy was selected and given with priority. Clinical pharmacists gave advice about the diagnosis of infection, risk analysis of the anti-tumor therapy and pharmaceutical care for the anti-tumor therapy so as to ensure the safety and efficacy of the treatment. Conclusion For patients diagnosed with advanced malignant tumor with high infection-related indicators but different diagnosis of infections, the anti-tumor therapy can be the first option, but the risks and benefits should be weighed and the patient should be monitored closely. Clinical pharmacists and doctors can help improve the safety and efficacy of pharmacotherapy by giving full play to their expertise. References | Related Articles | Metrics

Select

Pharmaceutical care of one case of luminous phenomena induced by high-dose amiodarone ZHAO Rui, YU Xiaojia, AN Zhuoling 2023, 20(10): 1173-1175.  DOI: 10.19803/j.1672-8629.20220442 Abstract ( 64 )   PDF (3302KB) ( 96 )   Objective To analyze the causes of luminous phenomena in a patient under combined medication, recommend therapies, and make physicians and pharmacists better aware of the luminous phenomena and drug interactions. Methods One patient with acute myocardial infarction developed sinus tachycardia and ventricular arrhythmia. During the treatment with a variety of antiarrhythmic drugs, luminous phenomena occurred for a short time. The pharmacist assisted the clinician in analyzing the causes of adverse reactions and recommended treatments. Results The clinical pharmacist clarified the mechanism by which luminous phenomena was caused by irvabradine. The occurrence of luminous phenomena was attributed to drug interactions. The drug dose was adjusted and the patient was soothed at the same time. Conclusion Active participation of clinical pharmacists in pharmaceutical care will help to detect adverse drug reactions as soon as possible so as to prevent irrational use of drugs. References | Related Articles | Metrics

Select

Pharmaceutical care of a patient with grade Ⅳ myelosuppression induced by olapalil WANG Qiru, ZUO Li, DU Qiong, YE Ling, RUAN Cong, ZHAI Qing, XU Rui 2023, 20(10): 1176-1180.  DOI: 10.19803/j.1672-8629.20230166 Abstract ( 87 )   PDF (1710KB) ( 112 )   Objective To investigate the pharmaceutical interventions in one case olapari-induced grade Ⅳ myelopathic depression by clinical pharmacists, and to provide reference for clinical safe and rational drug use. Methods Clinical pharmacists participated in the pharmaceutical care and adverse reaction management of one case of olapari-induced grade Ⅳ myeliopathic depression, regularly monitored and assessed adverse reaction symptoms, biochemical indexes and coagulation function of the patient, initiated immediate symptomatic treatment, and recommended individualized medication by referring to domestic and foreign literature and the consensus on guidelines for management of adverse reactions caused by PARP inhibitors. Results Clinical pharmacists worked in close collaboration with physicians to administer olaparil to this ovarian cancer patient to manage her adverse reactions, and assisted physicians in optimizing and restarting the treatment plan. Pharmacists followed up this patient for more than 8 months, during which time her blood biochemistry was within the reference range, tumor condition was stable, and no obvious grade Ⅱ or above myelopathic suppression occurred again. Conclusion The involvement of clinical pharmacists in drug monitoring and adverse reaction management during olaparil maintenance therapy of ovarian cancer patients, and in adjusting individualized medication plans can promote rational, safe and effective drug use for patients. References | Related Articles | Metrics

Select

One case of addiction induced by dezocine injection in a patient with HIV SHEN Qian, ZHANG Lei 2023, 20(10): 1181-1183.  DOI: 10.19803/j.1672-8629.20230048 Abstract ( 78 )   PDF (1534KB) ( 109 )   Objective To explore the adverse reactions to addiction caused by dezocine injection in an HIV patient and analyze the influencing factors so as to provide reference for clinical safety. Methods The clinical data of an HIV patient with dezocine injection addiction treated in our hospital was analyzed while the mechanism and influencing factors of dezocine injection addiction were discussed based on literature review. Results The mechanism of addiction to dezocine injection was related to partial activation of μ receptors, inhibition of serotonin reabsorption and norepinephrine reuptake, and κ receptor activation. This patient had been using dizocine injection for more than forty consecutive days. Too long a course of treatment and too high a dose could significantly increase the risk of addiction to dezocine. Conclusion In clinical application of dezocine injection, the indications should be strictly controlled to prevent abuse and avoid long-term use. References | Related Articles | Metrics

Select

Research progress in error sources and control methods of mycotoxin detection in traditional Chinese medicine LI Hailiang, LI Yaolei, WANG Zhao, ZAN Ke, LIU Lina, JIN Hongyu, MA Shuangcheng 2023, 20(10): 1184-1188.  DOI: 10.19803/j.1672-8629.20230267 Abstract ( 52 )   PDF (1696KB) ( 85 )   Objective To study the current mycotoxin contamination in traditional Chinese medicine, analyze the error sources and control methods of mycotoxin detection, and provide reference for reliable detection of mycotoxin in traditional Chinese medicine. Methods Theoretical research and literature review were used to summarize the sources of errors in the detection of mycotoxin, a traditional Chinese medicine. Recommendations were offered about the methods of error control. Results Sampling, as the first step of mycotoxin detection, was directly related to the accuracy of detection results, but was the biggest source of errors. Sample preparation was directly correlated with results of analysis and served as an important guarantee of the accuracy of test results. In order to ensure the accuracy of results of mycotoxin detection, a well-designed sampling scheme, appropriate sample preparation methods and sensitive and accurate analysis techniques should be used. Conclusion This paper has explored the sources of errors and control methods of mycotoxin detection in terms of sampling, sample preparation, analysis and detection so as to provide reference for improving the quality of analysis and reducing the analysis risk of mycotoxin detection in traditional Chinese medicine. References | Related Articles | Metrics

Select

Evaluation of animal models of high altitude qi deficiency and blood stasis syndrome and research progress in therapeutic drugs GAO Jing, ZHANG Zhuo, YAN Jiayi, GE Yunxuan, MA Zengchun, GAO Yue 2023, 20(10): 1189-1194.  DOI: 10.19803/j.1672-8629.20230120 Abstract ( 47 )   PDF (1786KB) ( 59 )   Objective To summarize the ways animal models of high altitude qi deficiency and blood stasis syndrome have been established in recent years and different studies on related therapeutic drugs so as to provide reference for standardization of studies on animal models of high altitude qi deficiency and blood stasis syndrome and the research and development of therapeutic drugs. Methods Literature on establishment of animal models and therapeutic drugs of high altitude qi deficiency and blood stasis syndrome published in CNKI, Wanfang and VIP database in the past 20 years was searched for and summarized. Results The animal models of high altitude qi deficiency and blood stasis syndrome were mostly prepared via the combination of low pressure, low oxygen and cold, which left much to be desired. For example, the methods for establishing these models using modern medicine and pathology did not conform to TCM theories on etiology and pathogenesis, lacked objective, quantitative and standardized evaluation indexes of TCM for macro symptoms, and failed to reflect the combined use of the four diagnostic methods of TCM. The related treatment plans mostly worked by referring to the prescriptions for treating qi deficiency and blood stasis syndrome, or by revising classic well-known prescriptions to treat qi deficiency and blood stasis at a high altitude, without enough counter-evidence prescriptions. Conclusion There are relatively few studies on high altitude qi deficiency and blood stasis syndrome, so there is the need to make uniform methods for establishing the animal models, improve the diagnosis and evaluation system, and develop counter-evidence prescriptions. At the same time, it is hoped that the development of altitude disease and the research and development of drugs can be promoted based on the syndrome of altitude qi deficiency and blood stasis. References | Related Articles | Metrics

Select

Research progress in key technologies for quality control of snake venom hemocoagulase drugs LIU Bo, GUO Yunxiao, LIU Lisha, FAN Huihong 2023, 20(10): 1195-1200.  DOI: 10.19803/j.1672-8629.20230228 Abstract ( 72 )   PDF (1854KB) ( 61 )   With the wide application of snake venom hemocoagulase in clinical practice in recent years, better quality of its products is required. However, constrained by the complexity of the products and related technologies, it becomes increasingly difficult for the key quality control technologies, especially quality control projects such as structural characterization, purity analysis and potency, to meet the requirements of increasingly stringent quality control. By referring to domestic and foreign pharmacopoeias and the latest research progress in other proteinic drugs, this article summarizes the structural characteristics, purity and potency determination methods of snake venom hemocoagulase drugs before future developments are predicted. It is hoped that this article can be of referential value for the improvement of levels of quality control of hemocoagulase drugs. References | Related Articles | Metrics