Chinese Journal of Pharmacovigilance

Effect of Reyanning Heji on animal models of respiratory infectious inflammation

BAO Lei, GENG Zihan, GUO Shanshan, YAO Rongmei, SUN Jing, CUI Xiaolan

2023, 20(3): 241-247.
DOI: 10.19803/j.1672-8629.20220290

Abstract ( 239 )

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Objective To evaluate the pharmacological effects of Reyanning Heji on mouse animal of respiratory infections caused by the influenza virus, Streptococcus pneumoniae and hemolytic streptococcus. Methods Reyanning Heji (5, 10, 20 mL·kg^-1 for mice, 2.5,5,10 mL·kg^-1 for rats, which were half, equivalent to and double the clinical dose for humans) was used to treat the mouse models of pneumonia caused by influenza virus H1N1 / FM1, Streptococcus pneumoniae and hemolytic streptococcus. The lung index, death rate, death protection rate, life extension rate and pharyngeal pathology of the rats in each group were recorded. Results Reyanning Heji could significantly reduce the lung index of mice with viral pneumonia caused by influenza virus H1N1 / FM1. The inhibition rate of the lung index by Reyanning Heji in the medium dose group was 61.98%. Reyanning Heji could reduce the mortality of mice. The high and medium doses of Reyanning Heji could significantly reduce the lung index of mice with bacterial pneumonia caused by Streptococcus pneumoniae. Reyanning Heji could reduce the mortality of mice with bacterial respiratory infections caused by hemolytic streptococcus. The survival of mice in the medium and low dose groups was prolonged. In the low dose group, the pharyngeal lesions of rats were significantly improved while the pharyngeal lesion score was reduced. Conclusion Reyanning Heji has significant therapeutic effects against the mouse models of respiratory infections caused by the influenza virus, streptococcus pneumoniae, and hemolytic streptococcus. The therapeutic effect is equivalent to that of oseltamivir and amoxicillin at the clinical dosage.

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Effect of Jinzhen oral liquid on the model of human coronavirus pneumonia and fever epidemic immature adult mice

ZHAO Ronghua, SUN Jing, BAO Lei, GENG Zihan, Li Guiping, WANG Daohan, LI Shuran, ZHANG Jingsheng, PANG Bo, XU Yingli, ZHOU Lirun, BAO Yanyan, CHEN Mengping, GUO Shanshan, CUI Xiaolan

2023, 20(3): 248-252.
DOI: 10.19803/j.1672-8629.20220371

Abstract ( 152 )

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Objective To study the therapeutic effect of Jinzhen oral liquid against a human coronavirus pneumonia and fever epidemic immature adult mouse model. Methods ICR mice were divided into the blank group, HCoV-229E infection group, TCM heat syndrome group, human coronavirus pneumonia and fever epidemic mouse model group, chloroquine phosphate group, Lianhua Qingwen group and Jinzhen oral liquid high-dose, medium-dose and low-dose groups (30 mL·kg^-1·d^-1, 15 mL·kg^-1·d^-1, 7.5 mL·kg^-1·d^-1), with 10 mice in each. HCoV-229E infection was used for modeling and administration. Lung indexes and inhibition rates of mice were observed. The nucleic acid of lungs was detected by ELISA. IL-1β, while MDA and hypothalamus factors PGE2 and CAMP by flow cytometry. Results The lung index of model mice in the Jinzhen oral liquid medium dose group was significantly reduced (P<0.01), and the inhibition rate of the lung index was 43.93%. The viral load and IL-1β in lung tissues of model mice were significantly reduced in the Jinzhen oral liquid high-dose and medium-dose groups (P<0.05, P<0.01). MDA in lung tissues of model mice was significantly reduced in the medium-dose group (P<0.01). The production of PGE2 and CAMP in the hypothalamus of model mice was significantly inhibited in the Jinzhen oral liquid group (P<0.05, P<0.01). The percentage of peripheral blood immune cells was not significantly affected. Conclusion Jinzhen oral liquid can significantly improve the immunity of the coronavirus pneumonia and fever epidemic mouse model by inhibiting the inflammatory cytokine expression in lung tissues, mitigating lung inflammatory injury, reducing significantly the lung index and viral load, and lowering the expression of temperature-regulating central factors.

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Mechanisms of Qingkailing soft capsules against coronavirus pneumonia based on network pharmacology and experimental verification

CHEN Mengping, WANG Yaxin, YAO Rongmei, BAO Lei, ZHAO Ronghua, SUN Jing, GENG Zihan, BAO Yanyan, DAI Min, GUO Shanshan, CUI Xiaolan

2023, 20(3): 253-257.
DOI: 10.19803/j.1672-8629.20220367

Abstract ( 126 )

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Objective To study the targets and signal pathways of Qingkailing soft capsules in the treatment of coronavirus pneumonia based on network pharmacology. Methods The main chemical ingredients of Qingkailing soft capsules were obtained by searching the TCMSP database for related literature that was published between inception and June 28, 2022. The potential targets of Qingkailing soft capsules in the treatment of coronavirus pneumonia were obtained from Swiss Target Prediction and GeneCards database. A PPI interaction network and “drug-component-target” network were constructed before the potential targets were analyzed via KEGG pathway enrichment. The effect of Qingkailing soft capsules on lung indexes was detected, and the contents of IL-6, SOD in lung tissues and those of PGE2 and CAMP in the hypothalamus were detected by Elisa. Results The “drug-component-target” network consisted of 296 edges, 7 drug nodes, 33 compound nodes and 112 target nodes. Compared with the model group, the lung indexes of the Qingkailing soft capsule group decreased significantly（P＜0.01）, so did the contents of IL-6 in lung tissues and PGE2 in the hypothalamus（P＜0.01）. Conclusion Qingkailing soft capsules may play a role in the treatment of coronavirus pneumonia by regulating inflammatory mediators and febrile mediators.

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Research progress in correlations between herpes simplex virus-1 and Alzheimer's disease and in the prevention and treatment of herpes simplex virus-1 with traditional Chinese medicine

LI Shuran, GUO Shanshan, CUI Xiaolan

2023, 20(3): 258-261.
DOI: 10.19803/j.1672-8629.20220363

Abstract ( 114 )

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Objective To review the pathological association between herpes simplex virus type I (HSV-1) and Alzheimer’s disease (AD), the possible mechanism and the role of traditional Chinese medicines in anti-HSV-1 infection. Methods CNKI and PubMed databases were searched for reports on the relationships between HSV-1 and Alzheimer’s disease and on the prevention and treatment of HSV-1 with traditional Chinese medicines and Western medicine that were published between January 1, 1990 and May 30, 2022. Results It was found that repeated HSV-1 infections induced the accumulation of β amyloid (Aβ) and the increase of p-Tau expressions. ApoE? gene facilitated the entry of HSV-1 into the brain and increased the risk of AD induced by HSV-1. Aβ might be an antimicrobial peptide that trapped HSV-1. Many of the monomers or compounds of traditional Chinese medicines had good anti-HSV-1 effect. Conclusion HSV-1 infection maybe one of the factors for the development of Alzheimer’s disease, and the mechanism may be related to the trapping of HSV-1 virus by Aβ. ApoE? gene increases the risk of HSV-1 induced Alzheimer’s disease. Some progress has been made in the study on anti-HSV-1 infection by traditional Chinese medicines, which provides strong support for screening new drugs against HSV-1 from traditional Chinese medicines.

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Toxic effect of Shujin Dingtong tablets on embryonic development of zebrafish

LIU Jing, WANG Feng, ZHANG Jingpu, MENG Jie, DAI Zhong, MA Shuangcheng

2023, 20(3): 262-265.
DOI: 10.19803/j.1672-8629.20210529

Abstract ( 94 )

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Objective To study the toxic effect of Shujin Dingtong tablets on embryonic development of zebrafish. Methods Zebrafish embryos were treated with multiple groups of samples while the wild type was used as the negative control. Embryonic development was observed at different time points. Results The four groups of Shujin Dingtong tablets showed obvious effects on the embryonic development of zebrafish at different concentrations. At a high concentration, embryonic toxicity was mainly manifested in developmental stagnation while at a medium concentration, developmental retardation and malformation of the main organs including the heart, brain and trunk were observed. At a low concentration, most of the embryos were close to normal, and a small number of embryos showed mild developmental delay. Conclusion The main manifestations of the effect of Shujin Dingtong tablets on zebrafish are embryonic development stagnation and lag at high and medium concentrations. Additionally, the toxicity of samples from the same manufacturer has a dose-dependent positive relationship with the amount of borax contained.

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Simultaneous determination of acetaminophen and its toxicity related metabolite acetaminophen-cysteine in mouse plasma by LC-MS/MS

HE Hui, CHAI Yuanyuan, XU Yunxia, YU Qinwei, HUNAG Xin, ZHANG Luyong, JINAG Zhenzhou

2023, 20(3): 266-272.
DOI: 10.19803/j.1672-8629.20220276

Abstract ( 102 )

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Objective To establish a liquid chromatography-mass spectrometry (LC-MS/MS) method for simultaneous determination of acetaminophen (APAP) and its toxicity related metabolite acetaminophen-cysteine (APC) in mouse plasma. Methods Theophylline was taken as the internal standard (IS) while plasma samples were pretreated by volatilizing and re-dissolving the supernatant after protein precipitation. The gradient was eluted by Agilnet Zorbax SB-C₁₈ (3.0 mm×100 mm, 3.5 μm). The aqueous phase was an aqueous solution containing 0.1% formic acid while the organic phase was a methanol solution containing 0.1% formic acid. The contents of APAP and APC were detected under positive ions detection with electrospray ionization (ESI) in the selective ion monitoring (SRM) mode of m/z 152.1→110.0 and 271.0→140.0 in the triple quagdrupole tandem mass spectrometer (TSQ Quantum Ultra). Results There were good linear relationships when concentrations ranged from 60 ng·mL^-1 to 3 000 ng·mL^-1 for APAP and from 20 ng·mL^-1 to 1 000 ng·mL^-1 for APC. The selectivity, accuracy and precision, matrix effect and extraction recovery of the method met the requirements of biological sample analysis. Conclusion The LC-MS / MS method established in this study could be applied to the pharmacokinetics of APAP and APC in mice.

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Evaluation of a KKAy animal model of type 2 diabetes mellitus combined with nonalcoholic fatty liver disease

WANG Shan, HUANG Jukai, WU Honghui, WEN Yalu, ZHANG Li, WANG Jianhua, YANG Xiaohui

2023, 20(3): 273-276.
DOI: 10.19803/j.1672-8629.20220559

Abstract ( 93 )

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Objective To explore the age of onset and stability of a KKAY animal model of type 2 diabetes mellitus combined with nonalcoholic fatty liver disease. Methods Eighteen twelve-week-old C57BL/6J mice were assigned to the control group that was fed with normal diets while another 18 twelve-week-old KKAy mice served as the model group that was fed with high-fat diets. Six mice in control and model group were randomly killed at the 14,18,22 weeks of age, respectively. Blood glucose, weight, serum liver function and lipid levels were monitored and the pathological changes of hepatic tissues were observed. Results Compared with the control group, the body mass, liver mass, liver index and blood glucose level of the model group increased significantly (P< 0.05) from the 14th week. The results of serology showed that the ALT, AST, CHOL, HDL-C and LDL-C levels were significantly increased compared with the control group (P< 0.05), but no significant difference was found in TG levels between the two groups (P> 0.05). Pathological staining showed both steatosis of hepatocytes in the 14th week and inflammatory cell infiltration in the 22nd week. Conclusion The 14-week-old KKAy mice treated with high fat diets can serve as a stable mouse model of type 2 diabetes mellitus combined with nonalcoholic fatty liver disease.

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Protective effects of syringin against reproductive system injury induced by low dose radiation in mice

HU Changkun, ZHANG Xuemei, XIAO Chengrong, WANG Yuguang, MA Zengchun, GAO Yue

2023, 20(3): 277-281.
DOI: 10.19803/j.1672-8629.20220079

Abstract ( 84 )

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Objective To explore the protective effects of syringin against reproductive system injury induced by low dose radiation in mice. Methods A injury model was established after five consecutive days of low dose radiation (0.12 Gy·d^-1×5 d, cumulative 0.6 Gy). A control group (NC), radiation group (R), low dose administration group (syringin 10 mg·kg^-1), high dose administration group (syringin 20 mg·kg^-1) were established. The contents of serum cytokines (IL-1β, IL-6, IL-10, and TNF-α) and testosterone in the mice 24 h and 48 h after irradiation were determined by ELISA, and the levels of oxidative stress (MDA content, SOD activity, and GSH content) in the testis were determined by the kit. Results 24 h and 48 h after irradiation, the cytokine disorders in the testis of mice were significantly regulated, the oxidative stress level improved, and the testosterone level restored in the syringin administration group compared with the irradiation group. Conclusion Syringin can improve cytokine regulation disorders induced by low dose radiation in mice, reduce the damage to the reproductive system in mice effectively, and might be used as a potential protective drug against reproductive system damage in case of low dose radiation.

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A national reference standard for fructosazine and deoxyfructosazine

LIU Bo, GUO Yunxiao, ZHANG Tong, HUANG Lu, HE Lanying, FAN Huihong

2023, 20(3): 282-285.
DOI: 10.19803/j.1672-8629.20220223

Abstract ( 89 )

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Objective To establish new national reference standards for fructosazine and deoxyfructosazine used for impurity determination of raw materials or preparations of glucosamine in order to ensure the quality of products of glucosamine. Methods UV, HRMS, ¹HNMR, ¹³CNMR, 2D NMR and CD were used to confirm the structure while the content of the product was calculated using the mass balance method before being verified by the QNMR method. Results The structure of this product was identified and the contents of fructosazine and deoxyfructosazine were assigned as 98.0% and 95.1% respectively. Conclusion Fructosazine and deoxyfructosazine have been established as national reference standards for the first time, which can be applied to quality control of glucosamine and related products.

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Protective effects of phenylethanol glycosides of herba cistanche on mice with cholestatic liver disease

CAO Lin, JU Bowei, RAN Zheng, YANG Jianhua, HU Junping

2023, 20(3): 286-291.
DOI: 10.19803/j.1672-8629.20220147

Abstract ( 87 )

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Objective To investigate the protective effect of phenylethanol glycosides from Cistanche deserticola against α-naphthalene isothiocyanate (ANIT)-induced cholestatic liver disease in mice. Methods C57 mice were orally administered with 125, 250, 500 mg·kg^-1 of phenylethanol glycosides from Cistanche deserticola and 100 mg·kg^-1 of diammonium glycyrrhizinate for seventeen consecutive days, once daily. 80 mg·kg^-1of ANIT was administered by a single gavage two hours after administration on the fifth day to induce a model. Blood and tissue samples of mice were collected after two days of continuous intervention. Levels of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), albumin (ALB), alkaline phosphatase (AKP), lactate dehydrogenase (LDH), total bilirubin (TBIL), bile acid (TBA), glutathione peroxidase (GSH-Px), superoxide dismutase (SOD) and malondialdehyde (MDA) were detected, while the histopathological changes of the liver were observed. Results Compared with the model group, the levels of ALT, AST, AKP, TBA, TBIL and MDA in ANIT model mice were significantly decreased in each group of phenylethanol glycosides from Cistanche deserticola (P<0.05). The activities of ALB, GSH-Px and SOD were significantly increased in the medium and high dose groups (P<0.05). Conclusion Cistanche deserticola may help protect against ANIT-induced cholestatic liver disease by improving cell membrane permeability and eliminating free radical oxidation.

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Quality analysis of Guci tablets based on national drug evaluation sampling

LIU Jing, LIU Yan, ZHENG Xiaowei, WANG Qi, HE Fengyan, WANG Feifei, WANG Yadan, HE Yi, NIE Lixing, HU Xiaoru, DAI Zhong, MA Shuangcheng

2023, 20(3): 292-295.
DOI: 10.19803/j.1672-8629.20210776

Abstract ( 104 )

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Objective To evaluate the quality of Guci tablets based on national drug evaluation sampling. Methods This quality analysis was based on inspections of standards and research. Since the prescription involved four toxic crude drugs, in-depth research on safety and effectiveness was carried out by targeting the problems found during inspections of standards. Results The qualified rate of inspections of standards was 98.1%. There were 2 batches of unqualified samples and their contents of strychnine fell short of the standard. Research indicated that arsenic and mercury exceeded standard limits in some samples. High concentrations of arsenic and mercury posed a risk to safety. In addition, some crude drugs might have been of poor quality or crude drugs were not used according to the prescriptions. Conclusion Importance should be attached to the safety and effectiveness of drugs. It is recommended that manufacturers strengthen the control over the source of drugs and production processes in order to ensure the safety and effectiveness of medicines.

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Clinical characteristics and drug combination analysis of Lianhua Qingwen capsules (granules) in the real world

DU Ying, XIE Yanming, WANG Lianxin, GENG Hongjiao, LI Xiangjie

2023, 20(3): 296-300.
DOI: 10.19803/j.1672-8629.20220069

Abstract ( 267 )

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Objective To explore the clinical characteristics and drug combination of Lianhua Qingwen capsules (granules) in the treatment of targeted populations in the real world so as to provide reference for clinical use. Methods The clinical data on 5 902 patients treated with Lianhua Qinwen capsule (granules) in 18 hospitals in China between May 20, 2002 and March 20, 2019 was analyzed based on the Hospital Information System(HIS). The clinical characteristics of the patients were identified, and association rules were used to analyze combined medications. Results The users of Lianhua Qingwen capsules (granules) were mostly male patients aged 45 to 65, and hospital stay ranged from 15 to 28 days. The most prevalent symptoms diagnosed by western medicine were pulmonary infections. Most of the patients were improved or discharged after being cured. Clinically, Lianhua Qingwen capsules (granules) were normally used in combination with such western medicines as acetylsalicylic acid, ambroxol (methamphetamine), levofloxacin and with such traditional Chinese medicines as Danhong injection, Tanreqing injection and Xiyanping injection. Conclusion The clinical use of Lianhua Qingwen capsules (granules) generally complies with drug instructions, but the single dose is greater than the dose range in the instructions. Analysis of combined medications has revealed the commonly used combined treatment schemes in clinic, which provides reference for clinical rational medications.

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Short-term efficacy and safety evaluation of PD-1 inhibitor combined with chemotherapy as a first-line neoadjuvant therapy for locally advanced gastric adenocarcinoma

JIAO Fuzhi, CHEN Yarui, JI Wei, HAO Jianpeng, GUAN Quanlin

2023, 20(3): 301-305.
DOI: 10.19803/j.1672-8629.20220594

Abstract ( 145 )

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Objective To evaluate the short-term efficacy and safety of programmed death receptor-1 (PD-1) inhibitor combined with oxaliplatin plus S-1 (SOX) regimen in neoadjuvant therapy of locally advanced gastric adenocarcinoma. Methods The clinical data on 114 patients with locally advanced gastric adenocarcinoma admitted to the First Hospital of Lanzhou University between 2020 and 2022 was analyzed retrospectively. According to treatment regimens, these patients were divided into the PD-1 inhibitor combined with SOX group (35 cases) and SOX group (79 cases). The short-term efficacy and adverse reactions in the two groups were assessed after treatment. Results In terms of short-term efficacy, the percentages of patients evaluated as CR, MPR and pCR after treatment in the combined group and chemotherapy group were 17.14% vs 3.79% (χ²=4.247, P=0.039), 28.57% vs 12.66% (χ²=4.246, P=0.039) and 20.00% vs 6.33%(χ²=4.813,P=0.028) respectively, so the difference was statistically significant. The ORR between the two groups was 71.43% and 50.63% respectively, suggesting that the difference was of statistical significance (χ²=4.280, P=0.039). The DCR was 100% and 97.47% respectively, with no statistically significant difference. The descending rate of N stage was 91.43% and 56.96% respectively in the two groups, and the difference was also statistically significant (χ²=13.143, P<0.001). In terms of adverse reactions, there was no significant difference between the two groups. As for 1~2 grade adverse reactions, the incidence of transaminase elevation in the combination group was higher, and the difference was statistically significant. No grade 4 adverse reactions or treatment related deaths were observed in either group. Conclusion PD-1 inhibitor combined with SOX regimen showed significant efficacy and good safety in neoadjuvant therapy of locally advanced gastric adenocarcinoma, which can be used as a first-line treatment option.

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Risks of Kangfuxiaoyan suppository due to routes of administration

ZHU Lan, JIN Zhe, LIU Lihong, ZHONG Lumiao, LIUXiaojun

2023, 20(3): 306-310.
DOI: 10.19803/j.1672-8629.20220443

Abstract ( 176 )

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Objective To analyze the risk of Kangfuxiaoyan suppository related to routes of administration in order to provide reference for clinical rational drug use. Methods The cases of adverse drug reactions (ADR) reported in the national ADR monitoring system , related domestic literature, and precautions taken in China were summarized. The risks of Kangfuxiaoyan suppository due to vaginal administration were analyzed. Results A total of 1 916 cases of ADR related to Kangfuxiaoyan suppository were collected from the national adverse drug reaction monitoring system between 2004 and 2022. Kangfuxiaoyan suppository should have been administered rectally, but there were 215 cases of ADR caused by vaginal administration. The incidence of pain at the site of application, vulvovaginal pruritus, vulvovaginal discomfort, vulvovaginal burning sensation and allergic reactions was higher in these cases of ADR. Vaginal administration could affect the efficacy and cause such adverse reactions as vaginal irritation. Conclusion The drug label of Kangfuxiaoyan suppository has been upgraded under the requirement of National Medical Products Administration(NMPA). Drug marketing authorization holders should communicate more with health care providers and patients to control the safety risks related to vaginal administration of Kangfuxiaoyan suppository.

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The research development of inoculation safety associated with licensed HPV vaccines in China

ZI Wenrui, YANG Qiuyue, SU Jun, XIE Jiang'an

2023, 20(3): 311-316.
DOI: 10.19803/j.1672-8629.20211075

Abstract ( 220 )

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Objective To review the inoculation information of licensed human papilloma virus (HPV) vaccines in China, so as to provide reference for the safety of HPV vaccine inoculation. Methods We did a systemic discussion based on the types of vaccine, the status quo of inoculation, and the safety studies of the licensed vaccines in China. Focus on the development of surveillance and research for the safety of vaccination, and then put forward targeted opinions and suggestions for future HPV prevention. Results Four HPV vaccines (i.e., Cervarix, Gardasil, Gardasil 9, and Cecolin) have been licensed in China, and their vaccination coverage rates are increasing year by year. The feedback of vaccination safety was mainly from three measures: active surveillance, passive surveillance, and observational studies. Conclusion The safety evaluation for licensed HPV vaccines has great significance to improve inoculation safety and increase vaccination coverage rate. The existing safety studies are still stay in data statistical processing, more in-depth analytical methods and researches need to be implemented.

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Comparison and interpretation of guidelines for the application of bacterial endotoxin tests in Chinese and American Pharmacopoeia

PEI Yusheng, CHEN Chen, CAI Tong, ZHAO Xiaoyan, GAO Hua

2023, 20(3): 317-320.
DOI: 10.19803/j.1672-8629.20211190

Abstract ( 582 )

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Objective To provide reference for the detection, research and pharmacovigilance related to bacterial endotoxin in China. Methods USP 1085 and Chinese Pharmacopoeia 9251 were studied, and the similarities and differences in endotoxin reference material management, quality management and sections prone to misinterpretation in the guidelines were introduced and interpreted. Results USP 1085 and Chinese Pharmacopoeia 9251 were included in 2020 for the first time. Practitioners were given detailed guidance and descriptions on the background, testing, working standard calibration, quality management, limit calculation, and alternative methods. Conclusion USP 1085 and Chinese Pharmacopoeia 9251, as an authoritative guideline for bacterial endotoxin detection, is quite helpful for personnel engaged in endotoxin testing and for revision of Chinese Pharmacopoeia. It will be constantly revised and improved in the process of practice.

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Safety of sugammadex for reversal of neuromuscular block based on FAERS database

YE Pei, ZHANG Hewei, LYU Qiang, YE Xiaofei, XU Jinfang, GUO Xiaojing

2023, 20(3): 321-325.
DOI: 10.19803/j.1672-8629.20220415

Abstract ( 117 )

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Objective To retrieve the signals of suspected adverse events caused by sugammadex based on the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database so as to provide reference for clinical rational drug use. Methods The signals were detected using the ROR method in the disproportionality assay analysis of FAERS data collected from January 1, 2012 to March 31, 2022. Results A total of 1 379 records of adverse events associated with sugammadex were detected, and a total of 130 suspected adverse event signals were detected based on the ROR method. Recurrence of neuromuscular blockade (n=58,ROR₀₂₅: 79.67), bronchospasm (n=123,ROR₀₂₅: 71.47), anaphylactic reactions (n=192,ROR₀₂₅: 44.47), bradycardia (n=177,ROR₀₂₅: 38.32) and anaphylactic shock (n=85,ROR₀₂₅: 35.48) had higher signal intensities. The common adverse events following the use of sugammadex in patients of different age groups varied, and the overall intensity of adverse event signals was lower in the group aged 0 to 17. Conclusion Adverse events related to sugammadex mainly involve respiratory, cardiovascular and immune systems. Among other things, allergic events and arrhythmia are strongly associated with sugammadex. Anesthesiologists should routinely monitor neuromuscular function, ECG and hemodynamics when using sugammadex.

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Risks to storage of nitroglycerin after unsealing and ways of prevention

DING Qian, LI Boyu, ZHANG Qingxia

2023, 20(3): 326-330.
DOI: 10.19803/j.1672-8629.20211216

Abstract ( 114 )

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Objective To find out how nitroglycerin is currently stored after unsealing, analyze the risks to the storage, and recommend countermeasures so as to ensure the clinical efficacy of nitroglycerin. Methods The way in which nitroglycerin was stored after unsealing was investigated through a site survey of nitroglycerin-related drugs of the basic amount in the wards of our hospital on June 1, 2021, a telephone questionnaire survey of outpatients using nitroglycerin in our hospital in August 2021, and a nationwide Wenjuanxing questionnaire survey of health care providers from June 23 to September 30, 2021. Results There were thirty-two wards in our hospital that stored a basic amount of nitroglycerin, in four of which nitroglycerin was stored in oral sub-packaged plastic bags as well as the shelf life in twenty-nine of these wards was marked as thirty-six months (as in the instructions), which were incorrect. There were sixty-seven patients surveyed via the questionnaire, including forty-three males and twenty-four females whose average age was 65 (37 to 90) years. There were fifty-one people aged 60 and over. Sixty-one of these people did not use nitroglycerin for the first time. Patients who carried nitroglycerin in their pockets accounted for 75.76%. Patients who were not informed of nitroglycerin medications accounted for 88.06%. There were 4 365 questionnaires collected from health care givers from 931 hospitals and institutions in 31 provinces, including 1 580 nurses, 1 232 pharmacists, 1 005 doctors, 413 medical technicians and 135 administrative personnel respectively. The number of people whose shelf life of nitroglycerin exceeded three months after unsealing accounted for 65.41% in wards, 49.59% in pharmacies and 59.89% at home or on a trip respectively. The patients who carried nitroglycerin accounted for 34.30%. Conclusion Medical staff and patients are not well-informed about the storage of nitroglycerin after unsealing. It is recommended that people learn more about the storage container, expiration date and ways to carry this drug after unsealing so as to ensure the safe and effective use of nitroglycerin in patients.

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107 cases of liver injury caused by traditional Chinese medicines

WANG Guanjie, DU Shifang, LIU Baosheng, HAN Jiayan, WANG Zhenhua, LU Changfei

2023, 20(3): 331-333.
DOI: 10.19803/j.1672-8629.20220330

Abstract ( 417 )

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Objective To analyze the characteristics of liver injury caused by traditional Chinese medicines in order to provide data for clinical medication. Methods The Pareto diagram was used to analyze 107 cases of liver injury caused by traditional Chinese medicines, which were recorded by Shandong Adverse Drug Reaction Monitoring System between 2018 and 2020. Results Among the 107 cases reported, males accounted for 57.94%. People aged 51 to 60 made up 29.91%. There were 11 types of traditional Chinese medicines that were found to cause liver injury. Desiccating formulas (34.59%) accounted for the largest proportion, followed by blood-regulating agents (25.24%) and heat-clearing agents (14.96%). Elevated levels of alanine aminotransferase and aspartate aminotransferase were the most common clinical symptoms. The shortest duration of medication was only one day (2 cases), and the longest was 2 years. The overall prognosis of liver injury was good, and no permanent liver injury or death was found in these reports. Conclusion Such ADR as liver injury induced by traditional Chinese medicines should be subject to more vigorous monitoring in order to reduce the incidence of liver injury and ensure the safety of medications.

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Eighty-four cases of adverse drug reactions caused by novel anti-tumor drugs

YANG Yan, ZHOU Dexi, WU Xinli, XUE Shuya, DING Haihua, ZHANG Quan, ZHANG Yunling

2023, 20(3): 334-338.
DOI: 10.19803/j.1672-8629.20220188

Abstract ( 246 )

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Objective To analyze the characteristics and regularity of adverse drug reactions (ADR) caused by novel anti-tumor drugs in Anhui Chest Hospital so as to provide reference for rational use of drugs. Methods A total of 84 cases of ADR of novel anti-tumor drugs reported by our hospital to the national ADR Monitoring System from January 1, 2020 to December 31, 2021 were collected. These ADR were analyzed in terms of types, age and diseases of patients, types of drugs used, organs and/or systems involved, main drugs and clinical manifestations of severe ADR. Results Most of these patients were middle-aged and elderly ones (≥45 years old). The organs and/or systems at the highest risk of ADR were the digestive system and the skin and its accessory system. 34.52% of the cases were serious ADR and there were 9 cases of off-label drug use. Conclusion Clinicians and pharmacists should be alert to ADR caused by novel anti-tumor drugs, and the course of medication should be rigorously monitored so as to provide data for clinical drug safety and re-evaluation of drugs after marketing.

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Pharmaceutical care for a case of severe myelosuppression induced by meropenem injection combined with vancomycin injection

LIU Baohua, SHEN Aizong, SU Dan

2023, 20(3): 339-342.
DOI: 10.19803/j.1672-8629.20220160

Abstract ( 606 )

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Objective To remind clinicians of possible adverse reactions of granulocytic myelosuppression induced by meropenem and vancomycin injections in clinical use. Methods One case of severe granulocytic myelosuppression was reported in a patient after cerebral hemorrhage surgery. Correlation analysis of the adverse reactions was conducted to identify the possible drug responsible for the occurrence of granulocytic myelosuppression in the patient. Results The severity of the adverse reactions was grade IV myelosuppression. The patient's condition and concomitant medication were excluded before the cause of severe myelosuppression was determined to be the combined use of antibacterial meropenem and vancomycin injections. The relevance of adverse reactions was evaluated as “probable”. The drug was immediately discontinued and the patient was improved after symptomatic treatment. Conclusion Adverse reactions of grade IV myelosuppression induced by the combined use of antibacterial meropenem and vancomycin injections are rarely reported and should be identified during clinical drug treatment.

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Pharmaceutical care for a case of Parkinson's syndrome caused by trimetazidine hydrochloride tablets in an elderly patient with renal insufficiency

ZHANG Yuan, HE Mei

2023, 20(3): 343-345.
DOI: 10.19803/j.1672-8629.20220211

Abstract ( 145 )

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Objective To investigate the causes and mechanisms of parkinsonism induced by trimetazidine hydrochloride tablets in elderly patients with renal insufficiency, and to provide reference for rational clinical use of trimetazidine hydrochloride tablets. Methods The course of treatment of one patient after taking trimetazidine hydrochloride tablets was analyzed while related literature was reviewed. Results Parkinsonism occurred one day after treatment with trimetazidine hydrochloride tablets, but disappeared when these tablets were discontinued. Conclusion Trimetazidine hydrochloride tablets may increase the risk of parkinsonism in elderly patients with renal insufficiency and should be monitored during clinical use.

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One case of breast hyperplasia caused by digoxin tablets

OUYANG Ying, ZHONG Changxin, XIA Chunhua, NIE Jungang, ZHOU Ying

2023, 20(3): 346-347.
DOI: 10.19803/j.1672-8629.20210979

Abstract ( 234 )

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Objective To study one case of breast hyperplasia induced by digoxin tablets in order to provide reference for clinical prevention and treatment of related adverse reactions. Methods The process of treating one patient who had developed breast hyperplasia after taking digoxin tablets was analyzed. The mechanism by which digoxin tablets caused breast hyperplasia was investigated and the possibility of involvement of other drugs was ruled out. Results The patient had bilateral breast hyperplasia after taking digoxin. After the drug was discontinued and other medications were used for one month, breast discomfort decreased. Conclusion Breast hyperplasia caused by digoxin tablets may be related to the estrogen-like effect of digitalis drugs, so regular breast examination is required during medication. It is also important to guard against other serious adverse reactions caused by digoxin tablets.

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Research progress in Yi medicine Valeriana jatamans and predictive analysis of related quality markers

CAI Yuluo, GUO Jiahui, Wang Xinguo, TIAN Yilong, WANG Meng, NIU Liying, LI Junshan

2023, 20(3): 348-352.
DOI: 10.19803/j.1672-8629.20210520

Abstract ( 79 )

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The Yi medicine Valeriana jatamansi contains many chemical components, such as iridoids, volatile oils, lignans and flavonoids. According to modern pharmaceutical research, Valeriana jatamansi delivers a range of pharmacological effects, such as central inhibition, antibacterial and antiviral effects, cytotoxicity and anti-tumor effect. Based on the concept of Q-markers, this article predicted and analyzed the Q-marker components of Valeriana jatamansi in terms of specificity, traditional medicinal effects, traditional medicinal properties, and measurability of chemical constituents in the hopes of providing reference for quality control and rational use of Valeriana jatamansi.

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Advances in multi-target intervention in vascular endothelial injury in metabolic syndrome by traditional Chinese medicine

XU Shuai, ZHANG Ling, ZHAO Yuqing, YANG Yidian, BIAN Haoyu, ZHANG Liping

2023, 20(3): 353-359.
DOI: 10.19803/j.1672-8629.20220256

Abstract ( 124 )

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Metabolic syndrome（MS）is a cluster of clinical syndromes of multiple metabolic disorders with complex pathogenesis. It can develop into atherosclerosis and serious cardio-cerebrovascular diseases if quick intervention is impossible. Vascular endothelial injury is an early predictor and the main pathological basis of MS. Western medicine focuses on hypoglycemic, lipid-lowering and hypotensive treatments, so many of these drugs have obvious contraindications, and drug interactions occur in combined medications, which is likely to aggravate adverse drug reactions. Under the guidance of holistic concepts and treatments based on syndrome differentiation theories, traditional Chinese medicine is characterized by multi-component and multiple-target properties, long-lasting efficacy and smaller side effects in the intervention of vascular endothelial injury of MS. This article summarizes the research progress in Chinese herbs in the treatment of vascular endothelial injury in order to provide data for the prevention and treatment of MS-related vascular endothelial injury by TCM.

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