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Determination of 87 types of pesticide residues in Polygoni Multiflori Radix by LC-MS/MS LIU Yuanxi, GU Donglin, WANG Qi, YAO Lingwen, WANG Ying, JIN Hongyu, MA Shuangcheng 2023, 20(6): 601-608.  DOI: 10.19803/j.1672-8629.20230085 Abstract ( 95 )   PDF (2086KB) ( 82 )   Objective To establish a liquid chromatography-tandem mass spectrometry (LC-MS / MS) method for the determination of 87 types of pesticides and their metabolites in Polygonum Multiflori Radix in order to screen pesticides in 53 batches of samples of Polygonum Multiflori Radix, provide reference for safety study of Polygoni Multiflori Radix. Methods The samples were extracted with acetonitrile via high speed homogenate, concentrated and added with analytical protective agents before being determined with LC-MS/MS. The multi reaction monitoring mode (MRM) was used to collect data, and the blank matrix matching-protective agent standard was adopted for quantitative analysis to increase the accuracy and improve the peak shape. Results The calibration curves of all the targets showed good linearity with correlation coefficients of 0.99. The average recovery of the target compounds ranged from 70.4% to 107.4% at three spike levels, with relative standard deviations less than 11.40%, which met the requirements of trace determination. Carbendazim, acetamiprid and pyrazolidate were detected in 53 batches of samples of Polygonum Multiflori Radix, and the residues were all below 0.01 mg·kg-1. Conclusion The detection indicators of this method involve the vast majority of banned pesticides detected by LC-MS / MS. This method is highly sensitive and accurate so that it can be applied to the screening and detection of pesticide residues in Polygonum Multiflori Radix, which can provide reference for the detection of pesticide residues in similar Chinese herbal medicines. References | Related Articles | Metrics

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Influences of continuous steaming with black bean decoction on contents of 24 components of Polygoni Multiflori Radix LI Yanyi, WEN Hairuo, WANG Ying, YANG Jianbo, LIU Yue, WANG Qi, ZHANG Yujie, MA Shuangcheng 2023, 20(6): 609-615.  DOI: 10.19803/j.1672-8629.20230146 Abstract ( 82 )   PDF (1947KB) ( 81 )   Objective To explore the effect of different durations of continuous steaming(0~48 h) with black bean decoction specified in “Chinese Pharmacopoeia” on the contents of main chemical components, and provide a reference for safe drug use of Polygoni Multiflori Radix(PM). Methods Pharmacopoeia-defined steamed samples were prepared before an analytical method of ultra-performance liquid chromatography with triple quadrupole mass spectrometry (UPLC-QQQ-MS/MS) was established for determination of 24 components in PM grown in Gaozhou, Guangdong Province. Results A UPLC-QQQ-MS/MS method was established for quantification of stilbene glycosides, anthraquinone, flavonoids and phenolic compounds in PM. With the extension of durations of steaming, the contents of the 24 components changed significantly. The contents of most of stilbene glycosides, anthraquinones and flavonoids decreased while those of phenolic components increased. Conclusion This method is simple, accurate and repeatable, which can be used for quantitative detection and analysis of the 24 chemical components in PM. There are strong correlations between the contents of the 24 components in PM and the durations of steaming in that the contents of stilbene glycosides, anthraquinones, flavonoids and phenols change regularly, which impact the side effects and tonic effects of PM. References | Related Articles | Metrics

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Cytotoxicity of HK-2 induced by anthraquinones components of Polygonum multiflorum LAN Jie, WEN Hairuo, HUANG Zhiying, WANG Qi, MA Shuangcheng 2023, 20(6): 616-622.  DOI: 10.19803/j.1672-8629.20230138 Abstract ( 78 )   PDF (3821KB) ( 108 )   Objective To determine the correlation between nephrotoxicity and five components of Polygonum multiflorum. Methods After HK-2 cells were treated with 2.5, 10, 20, 40, 80, 120, 160 μmol·L-1 emodin, aloe-emodin, rhein and 3.125, 12.5, 25, 50, 100, 150, 200 μmol·L-1 physcion and chrysophanol for 24 and 48 hours, the effects of these monomers on viability of HK-2 cells were determined with the cell counting kit. After HK-2 cells were treated with 6.25, 12.5, 25, 50 and 100 μmol·L-1 emodin, aloe-emodin, rhein, physcion and chrysophanol for 24 and 48 hours, the cell culture medium was collected to detect the release level of lactate dehydrogenase(LDH). The expression level of Kim-1 protein was detected via Elisa assay, the changes of the mitochondrial membrane potential (MMP) were detected by the JC-10 fluorescence probe, and the effects of the five anthraquinones components on apoptosis were measured by flow cytometry. Results The viability of HK-2 cells decreased with the increased concentration and administration time of emodin, aloe-emodin, rhein and chrysophanol significantly (P<0.05), but remained more than 75% after administration of 200 μmol·L-1 physcion and chrysophanol for 48 hours. 48 hours after administration of 100 μmol·L-1 emodin, aloe-emodin and physcion, the release level of LDH was significantly higher than in the control group (P<0.01). After administration of the five anthraquinone monomers in Polygonum multiflorum, the level of Kim-1 in the HK-2 cell supernatant didn't increase with the concentration, but increased significantly compared with the control group after 100 μmol·L-1 administration (P<0.05). The mitochondrial membrane potential of HK-2 cells decreased with the concentration of treatment and duration of administration after the administration of the five anthraquinone components in Polygonum multiflorum. Conclusion Emodin, aloe-emodin and rhein are considered the potential anthraquinone components that causes nephrotoxicity in Polygonum multiflorum, and the nephrotoxicity risk of other components in Polygonum multiflorum needs to be studied. References | Related Articles | Metrics

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Spectrum-fect relationship of Ginseng Radix et Rhizoma Rubra and Polygonum Multiflorum Radix Preparata medicinal pair in protection of nerve cells LIU Jingjing, DAI Zhong, YANG Jianbo, WANG Ying, XU Beilei, LIU Yue, WANG Qi, MA Shuangcheng 2023, 20(6): 623-628.  DOI: 10.19803/j.1672-8629.20230110 Abstract ( 44 )   PDF (1735KB) ( 55 )   Objective To establish ultrahigh performance liquid chromatography (UHPLC) fingerprints of Ginseng Radix et Rhizoma Rubra(GR) and Polygonum Multiflorum Radix Preparata (PMRP) for different extraction processes, and to study the spectrum-effect relationship with the protective effect against Aβ1-42 induced HT-22 cell injury. Methods 30% ethanol reflux extracts, 30% ethanol percolation extracts, 70% ethanol reflux extracts, 70% ethanol percolation extracts and water extracts from GR and PMRP were prepared. UHPLC fingerprints for different extraction processes were established using the UHPLC method combined with the Similarity Evaluation System of TCM Chromatogramtic Fingerprint (2012A) before the common peaks were identified. Aβ1-42 was used to induce HT22 cells of hippocampal neurons. The protective effect of extracts using different processes on the model was evaluated with the MTT method. Using the protective effect against Aβ1-42 induced HT-22 cell injury as indexes, the properties of extracts using different processes were investigated. The correlations between the common peaks of UHPLC fingerprints and the indexes of analgesic and protective effect were analyzed via grey correlation analysis and the partial least square（PLS）method. Results There were 19 common peaks for different extraction processes of GR and PMRP, and 13 components were identified by reference comparison. Grey correlation analysis found that the degree of correlation between the 14 common peaks and neural cell protection exceeded 0.6, suggesting good correlations. PLS analysis indicated that peaks 6, 7, 8, 9, 10, 12, 13, 14, 17 and 18 had a greater impact on the protection of nerve cells. Conclusion UHPLC fingerprints for different extraction processes of GR and PMRP are established and 19 common peak components are identified. Emodin-8-O-β-D-glucoside, emodin methyl ether-8-O-β-D-glucoside, emodin, emodin methyl ether, 20(S)-ginsenoside Rg2, ginsenoside Ro, ginsenoside Rd and peaks 14, 17 and 18 may be the effective substances of neuroprotection. References | Related Articles | Metrics

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HT22 Cell and Caenorhabditis elegans models of the anti-aging effect of Ginseng Radix et Rhizoma Rubra and Polygonum Multiflorum Radix preparata medicinal pair LIU Jingjing, XU Beilei, YANG Jianbo, WANG Ying, LIU Yue, WANG Qi, MA Shuangcheng 2023, 20(6): 629-633.  DOI: 10.19803/j.1672-8629.20230111 Abstract ( 50 )   PDF (2124KB) ( 62 )   Objective To preliminarily discuss the anti-aging effect of Ginseng Radix et Rhizoma Rubra(GR) and Polygoni Multiflori Radix Preparata (PMRP) on nerve cells under different extraction processes, and provide data support for the application of GR and PMRP in anti-aging and anti-Alzheimer's disease (AD). Methods GR and PMRP medicinal pair extracts of 30% ethanol reflux, 30% ethanol percolation, 70% ethanol reflux, 70% ethanol percolation and water extract were prepared. The effects of different extracts on β-Galactosidase content in HT22 cells were detected by flow cytometry, and the extracts with the best anti-aging effect on nerve cells were initially screened. The anti-aging effect of the extracts on nerve cells was directly analyzed by β-galactosidase staining, and the anti-aging and anti-AD effects were verified by nematode life test and paralysis experiment. Results The different extraction processes of GR and PMRP showed significant anti-aging effects on HT22 cells, and 70% ethanol percolation extract had the best effect. Multi-concentration validation showed that it had a dose-dependent protective effect. The 70% ethanol percolation extract at 0.2 mg•mL-1 could significantly prolong the life of Caenorhabditis elegans, and the 70% ethanol percolate extract at 0.008 mg•mL-1 showed a tendency to relieve paralysis. Conclusion The 70% ethanol percolation extract of GR and PMRP has obvious anti-aging effect on nerve cells, has the potential of anti-aging and prolonging life and treating AD, which should be further studied. References | Related Articles | Metrics

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Adverse reactions of immune checkpoint inhibitor myocarditis based on active monitoring system ZHENG Yi, LUO Xiao, ZHANG Pengpeng, LIU Yongmei, YE Xiaofei, GUO Xiaojing, CHEN Xia, HE Jia 2023, 20(6): 634-638.  DOI: 10.19803/j.1672-8629.20230106 Abstract ( 158 )   PDF (1657KB) ( 137 )   Objective To explore the feasibility of active surveillance of adverse drug reactions based on the China Hospital Pharmacovigilance System, taking adverse reactions to immune checkpoint inhibitors in myocarditis as an example, and to provide a corresponding basis for related studies. Methods Based on data from the China Hospital Pharmacovigilance System at a sentinel hospital in Chongqing between June 1, 2018 to June 1, 2022, information on tumor patients who had applied immune checkpoint inhibitors and tumor patients who had not used immune checkpoint inhibitors were extracted as controls, and the observed confounding factors between the two groups were controlled by using propensity score matching 1 : 4. Predictive models for myocarditis were constructed based on several commonly used machine learning algorithms and logistic regression, and the model with the best predictive efficacy was selected as the predictive model for myocarditis to identify whether patients had myocarditis, and the two groups were subsequently compared to explore whether immune checkpoint inhibitors increase the risk of myocarditis. Results A total of 15 589 patients were included in this study, including 3 496 in the immune checkpoint inhibitor group and 12 083 in the control group. The best predictive efficacy of random forest (AUC=0.948, ACC=0.988, precision=1.000, recall=0.545, F1 score=0.706) was used as a predictive model for myocarditis. Based on this model to identify whether myocarditis occurred in the patients included in the study, 64 (1.83%) of the immune checkpoint inhibitor group had myocarditis and 160 (1.32%) of the control group, the difference in incidence between the two groups was P<0.05, and the difference in incidence between the two groups was statistically significant. Conclusion The application of immune checkpoint inhibitors increases the risk of myocarditis, and clinicians should pay attention to the occurrence of myocarditis when applying immune checkpoint inhibitors to patients to ensure the safety of patients' medication. References | Related Articles | Metrics

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Machine learning method in the detection of adverse drug reaction signals of brigatinib based on FAERS database CHEN Xiao, GUO Xiaojing, XU Jinfang, WEI Lianhui, CHEN Chenxin, LIANG Jizhou, ZHENG Yi, YE Xiaofei 2023, 20(6): 639-645.  DOI: 10.19803/j.1672-8629.20220645 Abstract ( 158 )   PDF (2272KB) ( 176 )   Objective To evaluate the performance of machine learning algorithms in detecting signals of adverse drug reactions (ADR) of brigatinib. Methods Data on signals of adverse drug reaction of brigatinib retrieved from the FDA FAERS from April 1, 2017 to Match 31, 2022 was used. An input dataset was constructed for the drug to be studied, including known ADR listed in drug labels and unknown ADR. For the known ADR, four machine learning algorithms (Random Forest, XGBoost, Logistic Regression, and kNN) were trained and evaluated by the area under the curve (AUC) to compare the machine learning algorithms with traditional disproportionality analysis method involving the reporting odds ratio (ROR) and information component (IC) . Results Among these methods, the kNN algorithm had the largest AUC with an average value of 0.875, followed by Logistic regression (0.852), XGBoost (0.722), random forest (0.662) and DPA (0.548). In the unknown ADR datasets, the machine learning model established by the kNN algorithm detected 6 additional signals (15.8%), compared with 4 additional signals (10.5%) by the DPA method. Conclusion The machine learning model established by the kNN algorithm has better performance than the traditional DPA method in detecting ADR signals. References | Related Articles | Metrics

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Overlap weighting in detection of adverse drug reaction signals: a simulated study WEI Lianhui, ZHANG Pengpeng, LIU Yongmei, GUO Xiaojing, XU Jinfang, CHEN Xiao, CHEN Chenxin, YE Xiaofei 2023, 20(6): 646-650.  DOI: 10.19803/j.1672-8629.20230113 Abstract ( 155 )   PDF (1927KB) ( 207 )   Objective To explore the effect of overlap weighting in equalizing confounding factors during detection of adverse drug reaction signals via a simulated study. Methods Point estimates, standard errors, bias, mean square errors, and 95% confidence interval coverage rate were used to evaluate the accuracy and stability of effect estimation of four methods (propensity score stratification, propensity score matching, inverse probability weighting, and overlap weighting) at four different levels of overlap between groups. Results In the simulated scenario of this study, overlap weighting yielded the most accurate and stable results of effect estimation, while the accuracy and stability of the other three methods became progressively worse as the degree of overlap decreased, and the inverse probability weighting led to the most significant difference. Conclusion Overlap weighting can be an option for equalizing confounding factors during detection of signals of adverse drug reactions. References | Related Articles | Metrics

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Combination of zero-inflated model and Dirichlet process in detection of adverse reaction signals during post-marketing surveillance CHEN Chenxin, ZHANG Pengpeng, LIU Yongmei, YE Xiaofei, HE Jia 2023, 20(6): 651-654.  DOI: 10.19803/j.1672-8629.20230109 Abstract ( 90 )   PDF (1626KB) ( 126 )   Objective To explore the possibility of the zero-inflated model being combined with Dirichlet process in optimizing the results of post-marketing safety signal detection of drugs. Methods By retrieving related literature, the principles of the zero-inflated model and Dirichlet process were reviewed. The current research on and strengths of the two methods were summarized. Thus, the combination of these two methods to extend technologies of signal detection was proposed. Results The zero-inflated model could minimize “excess zeros” and reduce the bias of signal detection results, while Dirichlet process could curb the false positive rate by enriching the selection of prior distribution of reporting rates of drug-adverse event pairs. Conclusion It is possible to combining the zero-inflated model with Dirichlet process to extend methods of Bayesian signal detection, and this approach deserves more study. References | Related Articles | Metrics

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Comparison of likelihood ratio tests in post-marketing safety surveillance PAN Zhemin, XU Sheng, ZHENG Yi, CHEN Chenxin, LIU Yongmei, ZHANG Pengpeng, YE Xiaofei, HE Jia 2023, 20(6): 655-660.  DOI: 10.19803/j.1672-8629.20230132 Abstract ( 206 )   PDF (2059KB) ( 222 )   Objective To survey and compare likelihood ratio test (LRT) approaches to post-marketing safety surveillance. Methods The fundamentals of likelihood ratio tests as well as the advantages and disadvantages of each method were summarized. Meanwhile, priorities of research in the future were predicted. Results Existing evidence suggested that LRT methods could better control type I errors than the reporting odds ratio and information component methods. Besides, LRT approaches employed a class of precise statistical tools which enabled objective evaluation under various scenarios. Conclusion LRT methods are feasible for post-marketing safety surveillance, especially when rigorous control of the false discovery rate is required or when a trade-off between the false discovery rate/type I error incidence and sensitivity/power is needed. However, there are still some problems that remain unsettled. References | Related Articles | Metrics

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Licorice and dried ginger decoction protects macrophages from cisplatin-induced cytotoxicity XIN Yumeng, LU Tiangong, SUN Zhenxiao 2023, 20(6): 661-670.  DOI: 10.19803/j.1672-8629.20220716 Abstract ( 48 )   PDF (3049KB) ( 63 )   Objective To investigate the protective effect and mechanism of licorice and dried ginger decoction (LDGD) against cisplatin-induced cytotoxicity in macrophages. Methods The effects of different concentrations of cisplatin（1、2、3、4、6 μg·mL-1）, LDGD (5、10、20 mg·mL-1), the sequential administration and coadministration of cisplatin and LDGD on the cell viability of mouse macrophage RAW264.7 cells cultured in vitro were detected by MTT assay. The apoptosis, reactive oxygen species (ROS) and mitochondrial membrane potential (MMP) of RAW264.7 cells were analyzed by flow cytometry. Twenty-four male C57/BL6J mice were randomly divided into four groups (n=6): the control group, model group, cisplatin (4 mg·kg-1) group and combination group (4 mg·kg-1+LDGD 5 g·kg-1). One day after inoculation with Lewis lung carcinoma (LLC), the mice in each group except those in the control group were given LDGD by intragastric administration for 20 days. The cisplatin group and the combination group were intraperitoneally injected with cisplatin every 3 days. The changes of tumor volume, body weight, visceral indexes, spleen T lymphocyte typing, immune factors of serum TNF-α, IL-6 and macrophage infiltration in tumor sections were determined after 21 days. Results Compared with the control group, cisplatin dose-dependently inhibited the cells' viability of RAW264.7 (P<0.01), while LDGD promoted the cell viability (P<0.01). LDGD could reduce the inhibitory effect of cisplatin on RAW264.7 cell viability (P<0.01). LDGD could reduce the apoptosis rate of RAW264.7 induced by cisplatin (P<0.01). Cisplatin induced an increase of ROS and a decrease of mitochondrial membrane potential (MMP) in RAW264.7 cells, but LDGD reversed the cisplatin - induced increase of ROS and the decrease of MMP (P<0.01). Both the cisplatin group and the combination group could significantly inhibit the growth of tumors, and cisplatin could lead to a significant increase in the liver indexes of mice, and a significant decrease in the indexes of body weight, kidneys, spleens and thymuses. Thymus indexes were restored to normal in the combination group, so were the organ indexes. LDGD could improve the levels of CD3+, CD4+ and CD8+ T lymphocytes in the spleen of mice following the use of cisplatin. LDGD increased macrophage infiltration in tumor tissues and TNF-α contents, but reduced IL-6 contents in mice serum. Conclusion LDGD inhibits cisplatin-induced apoptosis and reduces cisplatin-induced cytotoxicity in mouse macrophage RAW264.7 cells by reducing ROS production and stabilizing MMP. LDGD can mitigate the damage to the liver, kidney and immune organs caused by cisplatin, promote macrophage function, and improve the body's immunity. References | Related Articles | Metrics

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Effect of involvement of Puerariae Lobatae Radix in fermentation of Semen Sojae Praeparatum on osteoporosis in vitro ZHANG Ao, DUAN Tianhua, XU Rongrong, JIANG Xiaoya, ZHANG Zezhao, FENG Wei, NIU Liying 2023, 20(6): 671-674.  DOI: 10.19803/j.1672-8629.20220706 Abstract ( 56 )   PDF (2944KB) ( 52 )   Objective To investigate the effect of involvement of Puerariae Lobatae Radix in fermentation of Semen Sojae Praeparatum (SSP) on the anti-osteoporosis activity in vitro by adding Puerariae Lobatae Radix as an auxiliary material for fermentation of SSP. Methods The SPSS22.0 software was used to analyze the pharmacodynamic activities between the Puerariae Lobatae Radix-adding pure culture fermentation group, the pure culture fermentation without Puerariae Lobatae Radix group, the pure culture fermentation with Puerariae Lobatae Radix as the only auxiliary material group, the Pueraria lobata-involving natural fermentation group, the non-Pueraria lobata-involving natural fermentation group, and the Puerariae Lobatae Radix-involving alone natural fermentation group. At the same time, the optimum fermentation time within the first seven days was compared between pure culture fermentation groups. Results It was found that the best anti-osteoporosis condition was at the concentration of 1×10-4 g·L-1, SSP fermented with Pueraria for 4 days was the most effective in promoting osteoblast proliferation, and the proliferation rate was 45.8%. Conclusion This study has confirmed that Puerariae Lobatae Radix, when used as an auxiliary material for fermentation, can effectively improve the anti-osteoporosis activity in vitro, and provide new ideas for the fermentation of traditional Chinese medicines. References | Related Articles | Metrics

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Correlations of ABCB1 C3435T genetic polymorphism with serum concentrations and adverse reactions of high-dose methotrexate in children with mature B-cell lymphoma LUO Fangmei, WU Pan, LI Jing, WANG Ting, WANG Fangjie 2023, 20(6): 675-679.  DOI: 10.19803/j.1672-8629.20220680 Abstract ( 70 )   PDF (1804KB) ( 139 )   Objective To investigate the correlations between polymorphisms of ABCB1 C3435T genes（CC, CT and TT）, blood drug concentrations and adverse drug reactions (ADR) during high-dose methotrexate (HD-MTX) chemotherapy in children with mature B-cell lymphoma. Methods The medical data of children with mature B-cell lymphoma who had received HD-MTX chemotherapy and had had their MTX concentrations after administration determined and polymorphisms of ABCB1 C3435T detected was retrospectively collected from Oct, 2019 to Oct, 2022. The relationships between ABCB1 C3435T gene polymorphisms, MTX plasma concentrations and ADR were analyzed. Results A total of 66 patients, including 52 males and 14 females with an average age of 7.46±3.09 years (1.9~15.0 years), were enrolled. The most common ADR associated with HD-MTX were neutropenia (98.48%), anemia (89.39%), thrombocytopenia (77.27%) and mucosal injury (53.03%). The MTX 44 h blood concentration of the ABCB1 C3435T TT type was higher than that of the CC type (P<0.05). Compared with the ABCB1 C3435T CC type, CT and TT types had higher incidence of mucosal injury, vomiting and liver function damage (P<0.05). Conclusion ABCB1 C3435T gene polymorphisms may be associated with serum levels of HD-MTX and adverse reactions (mucosal injury, vomiting and liver function damage) in children with mature B-cell lymphoma. References | Related Articles | Metrics

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Efficacy and safety of different analgesia drugs in the treatment of lower extremity ischemic pain LI Tan, ZHANG Yang, ZHANG Wangde, WANG Yun 2023, 20(6): 680-683.  DOI: 10.19803/j.1672-8629.20230089 Abstract ( 92 )   PDF (1675KB) ( 79 )   Objective To analyze the applicability of different analgesic schemes in patients with ischemic pain of lower limbs, and to provide reference for clinical medication. Methods Patients with ischemic pain of lower limbs treated between October 1, 2018 and October 31, 2022 were selected as the subjects. The analgesic schemes were evaluated via retrospective analysis. The basic data of patients, usage of analgesic drugs, scores of the visual analogue scale (VAS) of pain and incidence of adverse reaction were analyzed. Results The 71 patients were divided into the opioid group (30 cases), opioid plus non-steroidal anti-inflammatory drugs (NSAIDs) group (32 cases) and sciatic nerve block group (9 cases). There was no significant difference in gender, age, courses of disease, disease complications or smoking status between the three groups (P > 0.05). The VAS score decreased more significantly in the sciatic nerve block group than in the opioid group and opioid combined with NSAIDs group (6.667 ± 1.658 vs 3.567 ± 0.817, t=7. 716, P <0.001; 6.667 ± 1.658 vs 3.938 ± 0.982, t=6. 271, P < 0.001), but there was no significant difference between the opioid group and the opioid combined with NSAIDs group (P > 0.05) or between the three groups (P>0.05) in terms of adverse reactions and safety. Conclusion There are many analgesic regimens for ischemic pain in lower limbs. Compared with opioid alone or opioid combined with NSAIDs, sciatic nerve block can improve pain complaints and VAS scores more significantly and cause fewer adverse reactions, which should be made more accessible. References | Related Articles | Metrics

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Data mining and analysis of adverse drug reaction signals of fampridine sustained-release tablets based on FAERS database ZHAO Wenhua, SHU He, NI Chenming, GUO Jinmin 2023, 20(6): 684-690.  DOI: 10.19803/j.1672-8629.20220212 Abstract ( 141 )   PDF (2090KB) ( 238 )   Objective To provide reference for clinical safe drug use via data mining of adverse drug events /adverse drug reaction (ADE/ADR) caused by fampridine sustained-release tablets. Methods Based on the FDA Adverse Event Reporting System (FAERS), the ADR/ADE reports of fampridine sustained-release tablets submitted between January 2013 and June 2021 were mined by using the reporting odds ratio (ROR) method and information component (IC) method. Statistical analysis was conducted according to the preferred terms (PT) and system organ classification (SOC) in the International Dictionary of Medical Terms (MedDRA). Results A total of 141 768 ADR/ADE were reported with fampridine sustained-release tablets as the primary suspected drug, involving 47 486 patients, most of whom were females (72.39%) and aged 41 to 70 (82.83%). The United States was the leading reporting country (90.98%). There were 7 873 serious ADR/ADE (16.58%), which mostly resulted in hospitalizations or prolonged hospitalizations (12.24%). A total of 174 positive signals were detected after screening, 126 of which were not recorded in the instructions. There were 36 PT positive signals in the top 50 cases of ADR/ADE reported, and 30 PTs not recorded in the instructions. The top 50 PTs in terms of signal intensity that involved SOC included various examinations (19 cases), neurological diseases (11 cases), systemic diseases and various reactions of sites of administration (5 cases). There were 13 system and organs involved in effective signals, involving general disorders and administration site conditions (28.53%). nervous system disorders (26.03%) and psychiatric disorders (8.79%). Conclusion The real-world data analysis of ADR/ADE caused by newly-marketed fampridine sustained-release tablets suggests that clinicians should strictly follow the instructions and care about the patients' history of epilepsy and renal function. Furthermore, some new and stronger signals have been detected, such as abnormal T cells, CD4 lymphocytes and B cells. Therefore, clinicians should closely monitor the results of examinations of patients and stay alert to risks unmentioned in instructions, such as neurological diseases. References | Related Articles | Metrics

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Safety of four phosphodiesterase 5 inhibitors based on the FAERS database CHEN Yakun, MEN Peng, WANG Pan 2023, 20(6): 691-696.  DOI: 10.19803/j.1672-8629.20230073 Abstract ( 107 )   PDF (1969KB) ( 118 )   Objective To mine real-world adverse event report data and analyze the post-marketing safety characteristics of four phosphodiesterase 5 (PDE5) inhibitors. Methods By searching the FDA Adverse Event Reporting System (FAERS), data on adverse drug event (ADE) reports of sildenafil, tadalafil, vardenafil, and avanafil as first suspected drugs were collected from the second quarter of 2012 to the third quarter of 2022, respectively, and standardized map analysis of systematic organ classification (SOC) and preferred term (PT) was performed. Valid disproportional measures signals of adverse drug reaction (ADR) were screened according to report-odds ratio (ROR) and information component (IC), and high-intensity ADR signals were analyzed. Results A total of 27 695 cases of sildenafil ADE, 16 683 cases of tadalafil, 718 cases of vardenafil and 222 cases of avanafil were found and included. The major types of SOC reported on the 4 drugs were similar. In terms of high-intensity ADR signals, the overall signal intensity (of ROR value) from largest to smallest was sildenafil, tadalafil, vardenafil, while no valid signal of avanafil was detected. The ADR signals of sildenafil were mainly concentrated in the reproductive system with multiple malignant skin tumor related ADR signals. The signal intensity of ADR related to malignant skin tumors of tadalafil was significantly higher than that of other drugs, and most of its high-intensity signals were not yet included in the specification. Vardenafil was mainly represented by diseases of reproductive system and eye organs. Conclusion The ADR signal strength of the four PDE5 inhibitors showed a decreasing trend with the time of marketing, but there were considerable differences in the specific characteristics. Targeted attention should be paid to the clinical application, and it is recommended to timely supplement and update the ADR information in the instructions of vardenafil and sildenafil. References | Related Articles | Metrics

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Characterization of adverse reactions associated with drug-induced liver injury in 448 inpatients CHEN Chongze, LI Jie, KUANG Lian, TAN Xuewen, LIU Minhui, LIU Xi, ZHENG Yanchai, JIN Hongtao 2023, 20(6): 697-704.  DOI: 10.19803/j.1672-8629.20220648 Abstract ( 549 )   PDF (2556KB) ( 259 )   Objective To investigate the occurrence and outcomes of drug-induced liver injury in hospitalized patients and provide evidence for rational drug use in the clinic. Methods Drug-induced liver injury (DILI) reported between January 1, 2014 and July 31, 2022 was analyzed retrospectively. Cases of DILI adverse reactions were screened by setting inclusion and exclusion criteria before they were analyzed in terms of age, gender, clinical typing, RUCAM scores severity, regression, and drugs involved. Results A total of 201 268 hospitalizations were collected, and 448 inpatients with DILI adverse reactions were screened. The incidence of DILI adverse reactions was 0.22%. The male-to-female ratio was 1: 0.56. The mean age was (59.24±18.22) years old, and there was a significant difference between males and females in age (P< 0.05). The diseases were mostly infectious diseases (28.35%) and cerebrovascular diseases (27.46%), and the clinical manifestations were primarily non-specific. As for clinical types, the dominating type was hepatocyte injury (218 cases, 48.46%), followed by the mixed type (161 cases, 35.93%), and the cholestasis type (69 cases,15.40%). The RUCAM scale score averaged above 3 points, with 264 cases (58.93%) ≥6 points. There were significant differences in RUCAM scores and severity between the three clinical types. The levels of ALT, AST, ALP, GGT, TBIL and ALB were also significantly different between. The top three suspected types of drugs were cardio-cerebrovascular and lipid-regulating drugs, antibiotics and antipyretic analgesics. The top three suspected drugs were atorvastatin, rosuvastatin and moxifloxacin. There were 387 cases (86.38%) of mild liver injury according to the grading of severity. There were of 36 cases of moderate liver injury (8.04%), compared with 25 cases of severe liver injury (5.58%). The clinical outcomes were generally good after drug withdrawal/reduction and liver-protecting and symptomatic treatment. Conclusion Male, middle-aged and elderly patients are prone to DILI adverse reactions, especially mild to moderate liver injury. Clinical use of cardio-cerebrovascular and lipid-regulating drugs, antibiotics, antipyretic analgesics requires alertness to DILI adverse reactions. References | Related Articles | Metrics

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Discuss the safety management of medical toxic drugs in medical institutions ZHAO Xuan, GUO Jing, CHEN Ning, MEI Long, ZHENG Tingting, ZHANG Lifang, ZHANG Wei 2023, 20(6): 705-708.  DOI: 10.19803/j.1672-8629.20230114 Abstract ( 102 )   PDF (1733KB) ( 128 )   Objective To explore and promote the safe management of toxic drugs, the usage of type A botulinum toxin in medical institutions will be analyzed. Methods The national documents on toxic drug management were consulted. The relevant guidelines and literature were searched. At last, The usage of medical toxic drugs based on the actual working conditions were analyzed. Results The toxic drug-related laws and regulations released by relevant national departments were mostly outdated. Related guidelines from foreign countries provided opinions, literature reviews and case reports on the reception, storage, preparation, transportation, management or disposal of these drugs. Our hospital revised the management system for the circulation of toxic drugs in various links referring to the relevant laws and regulations, domestic and foreign guidelines, literature, and considering about the problems encountered in actual work. However, in our hospital the clinical medical staff did not give enough emphasis on the use of toxic drugs. Actual drug usage did not match the prescribed dosage and the drug utilization index was low. Conclusion We call on updating and revising the laws and regulations related to toxic drugs to the relevant national departments. Medical institutions should increase their attention to toxic drugs and give the supervision continuously, and develop relevant systems in conjunction with actual work situations to promote the safe management of toxic drugs collectively. References | Related Articles | Metrics

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One case of hyponatremia encephalopathy caused by compound polyethylene glycol electrolyte powder (Ⅱ) XIE Anjie, WANG Changde, CHEN Hui, ZHANG Shiqiang 2023, 20(6): 709-711.  DOI: 10.19803/j.1672-8629.20220225 Abstract ( 108 )   PDF (1526KB) ( 130 )   Objective To explore the clinical characteristics, diagnosis and treatment of hyponatremia caused by compound polyethylene glycol electrolyte powder (Ⅱ) . Methods One case of hyponatremia caused by compound polyethylene glycol electrolyte powder (Ⅱ) was analyzed, and the related literature was summarized. Results A 62-year-old lady was hospitalized for colonoscopy due to “colonic polyps”. She drank 4 bags (68.56 g/bag) of compound polyethylene glycol electrolyte powder (Ⅱ) dissolved in 4 000 mL of warm water. Eighteen hours after treatment, the patient lost consciousness and developed convulsion of the right lower limb and urinary incontinence. Quick examination showed that blood sodium was 114 mmol·L-1. Plain CT scan of the head revealed global brain edema so that the patient was diagnosed with hyponatremia encephalopathy. After 5 hours of symptomatic treatment, the patient opened her eyes without speaking. On the third day, the patient regained consciousness, blood electrolytes returned to normal, and there were no more limb convulsions. Conclusion After polyethylene glycol powder is prescribed, clinicians should pay attention to the changes of electrolytes and other clinical complications. References | Related Articles | Metrics

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Annual report of national adverse drug reaction monitoring (2022) 2023, 20(6): 712-719.  DOI: 10.19803/j.1672-8629.20230168 Abstract ( 1657 )   PDF (3455KB) ( 1266 )   Objective To analyze the amount of monitoring of adverse drug reactions/events(ADR/AE) in depth in China in 2022, and to remind the public of the need to use drugs safely and properly. Methods Work related to nation-wide monitoring of adverse drug reactions in 2022 was summarized. Reports of ADRs/AEs received by the National Adverse Drug Reaction Monitoring System in 2022 were statistically analyzed and interpreted. Results A total of 2.023 million reports of ADR/AE were received in 2022, 642 000 of which were new and serious reports. 2.185 million reports involved suspected drugs, 82.3% of which were chemical drugs, 2.6% were biological products, and 12.8% were Chinese medicines. There were 942 000 reports of ADR/AE that involved essential drugs. The risks of adverse reactions of anti-infective drugs, cardiovascular system drugs, anti-metabolic drugs, and drugs for children were given much attention. Conclusion Adverse drug reaction monitoring should continue to be strengthened to ensure safe use of drugs and offer better protection for the public. Related Articles | Metrics

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Pharmacovigilance Newsletter 2023, 20(6): 720-720.  Abstract ( 482 )   PDF (700KB) ( 555 )   Related Articles | Metrics