Chinese Journal of Pharmacovigilance

Drug resistance mechanism of pemetrexed in non-small cell lung cancer

LIN Qiqi, LI Xinyang, MENG Fanhao

2023, 20(11): 1201-1208.
DOI: 10.19803/j.1672-8629.20230430

Abstract ( 142 )

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Objective To investigate the resistance mechanism of pemetrexed in non-small cell lung cancer (NSCLC). Methods The possible mechanism of pemetrexed resistance in non-small cell lung cancer was described in terms of oncogenes, DNA synthesis and repair, and biological behavior. Results Gene mutations and related molecular changes (including EGFR, ALK, ROS1, KRAS, and NRAS, TTF-1, HDAC), changes in pemetrexed target enzymes (TS, DHFR, and GARFT and RRM1, and MTHFR), high status of DNA repair systems (including BER, NER, and CHK1, MSH2, and Ku proteins), changes in tumor migration and metastatic processes (activation of EMT, cancer cell stem cells and biomarkers) could possibly be factors contributing to the reduced sensitivity of NSCLC cells to pemetrexed. Conclusion The mechanisms of pemetrexed resistance are diverse, and treatment regimens can be selected according to the specific genotypes of NSCLC patients to improve the progression-free survival and survival rate.

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Research progress in quantitative analysis methods for chemical reference substances

TAN Liyuan, CAI Tong, WANG Yan

2023, 20(11): 1209-1216.
DOI: 10.19803/j.1672-8629.20230407

Abstract ( 109 )

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Objective To study the quantitative analysis methods for chemical reference substances, so as to offer evidence and suggestions for drug quality regulation, drug safety evaluation and drug testing and research institutes that performing the establishment of reference substances. Methods The basic principles, scope, and influencing factors of the cutting-edge quantitative analysis methods of chemical drug standard substances were introduced. The pros and cons between different methods were compared and stated. Results and Conclusion Pharmaceutical Reference substances are the material basis for drug development, quality control testing, safety monitoring and etc., which are crucial to the insurance of the drug quality and the implementation of pharmaceutical specifications. The largest category among Pharmaceutical Reference standards are chemical drug reference substances, which makes the accuracy of their value are of vital importance. The applicability of each method should be fully considered in order to choose the most appropriate method in quantitative analysis of the chemical reference substances.

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Establishment and application of the first batch of national standards for bacterial endotoxin for monocyte activation reaction tests

PEI Yusheng, CHEN Chen, NING Xiao, CAI Tong

2023, 20(11): 1217-1220.
DOI: 10.19803/j.1672-8629.20230410

Abstract ( 65 )

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Objective To establish a specific national standard for bacterial endotoxins for 9301 monocyte activation reaction tests specified in the Chinese Pharmacopoeia, and to ensure the quality and safety of injections. Methods The first batch of national standards for bacterial endotoxins (for monocyte activation reaction tests) was established through production preparation, collaborative calibration, uniformity inspection and other studies. Results Five institutes of drug control were invited to use three methods for collaborative calibration. The calibration results showed no significant difference as evidenced by analysis of variance. The weighted average of the candidate products was 152.0 EU per vial, with a 95% confidence interval of 136.2~169.5.0 EU per vial, and the confidence limit rate was 10.96%. The result of uniformity study met the requirements. The average value of the test result of the candidate using the monocyte activation reaction test method was 144.6 EU per vial. Finally, the candidate was determined to be the national standard for bacterial endotoxin (for monocyte activation reaction tests), and the potency was 150 EU per vial. Conclusion The first batch of national standard for bacterial endotoxin (for monocyte activation reaction tests) has been established (batch number: 150608-202101).

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Near-infrared spectroscopic and statistical process control methods for the quantitative control of the moisture content of calcium folinate drug reference substance

GENG Ying, LIU Yi, WANG Xuelei, TAN Dejiang, ZHU Rongdie, GUO Xianhui, CHEN Hua, ZHENG Li’e

2023, 20(11): 1221-1227.
DOI: 10.19803/j.1672-8629.20230432

Abstract ( 75 )

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Objective To study quantitative model and quality control method for the determination of moisture content for chemical drug reference substances using near-infrared spectroscopy. To establish quality control chart combining statistical inference and multivariate calibration for the quality monitoring of moisture content for chemical drug reference substances. Methods Near-infrared spectroscopy quantitative model for the determination of moisture content of the reference substance was determined using calcium folinate reference substance after sub-packaging as the research object. Karl Fischer titration data was used as reference data. Statistical control chart was established, and the upper and lower limits of moisture determination values of calcium folinate chemical reference were determined. Non-destructive determination and quality control of moisture content by near-infrared spectroscopy were realized. Results The quantitative model of near-infrared moisture content determination established in this paper was robust and accurate, which can achieve the non-destructive determination of moisture content of calcium folinate reference substance, and the quality control of uniformity and stability of chemical reference substance during sub-packaging. Conclusion Near-infrared spectroscopic method combined with statistical quality control technic can be used as a new method for moisture content determination and to achieve online and non-destructive quality control of moisture content for chemical drug reference substances.

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Transfer behavior and risk assessment of pesticide residue during the processing of Chrysanthemum morifolium

LI Hailiang, LIU Yuanxi, WANG Zhao, ZAN Ke, WANG Ying, JIN Hongyu, MA Shuangcheng

2023, 20(11): 1228-1233.
DOI: 10.19803/j.1672-8629.20230266

Abstract ( 98 )

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Objective To investigate the transfer behavior of pesticide residues in chrysanthemum morifolium under different processing, explore the effects of processing conditions and physicochemical properties of pesticides on the transfer rate, and conduct risk assessment based on the transfer situation of pesticide residues, so as to provide reference for the limit standard of pesticide residues in Chrysanthemum morifolium and the potential risks in the process of using Chrysanthemum morifolium. Methods Through the screening and detection of pesticide residues in chrysanthemum samples, the samples containing high detected pesticide residues were selected as the research objects, and the processing conditions such as water temperature, water boiling and ethanol reflux extraction were systematically studied. The pesticides in the processed samples were determined using liquid chromatography-tandem mass spectrometry (LC-MS/MS), and point assessment method was used to assess the risk of contaminated chrysanthemum and processed products. Results The transfer rate of 15 pesticide residues with high detection rates in chrysanthemum were all transferred to varying degrees during processing, the transfer rates of pesticides during water immersion and boiling were positively correlated with temperature and time, but decreased with increasing processing times; The transfer rate of residual pesticides during ethanol extraction was above 50%; The acute risk quotients of pesticide residues in processed samples were all lower than 5%, indicating a low potential risk. Conclusion The study on the transfer behavior of pesticide residues during the processing of chrysanthemum provides a certain scientific basis for the formulation of the maximum residue standard and residue risk assessment of pesticide in chrysanthemum morifolium.

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Heavy metal residual and related elemental species in Polygonum cillinerve (Nakai) Ohwl

LI Yaolei, WANG Zhao, LI Hailiang, ZAN Ke, JIN Hongyu, MA Shuangcheng

2023, 20(11): 1234-1237.
DOI: 10.19803/j.1672-8629.20230345

Abstract ( 69 )

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Objective To explore the residual levels of heavy metals in Polygonum cillinerve (Nakai) Ohwl and the existing arsenic species. Methods Using microwave digestion method combined with inductively coupled plasma mass spectrometry (ICP-MS) method, Pb (lead), Cd (cadmium), As (arsenic), Hg (mercury), Cu (copper) five heavy metals and related elements in Polygonum cillinerve (Nakai) Ohwl Measure were detected, and the content levels were analyzed; in addition, using high performance liquid phase coupled with inductively coupled plasma mass spectrometry (HPLC-ICP-MS), monomethyl arsenic (MMA), dimethyl arsenic (DMA), and arsenous acid (AsIII), arsenic acid (AsV), arsenic betaine (AsB), arsenic choline (AsC) and other six known arsenic species were studied. Results The results of the study showed that according to the 2020 edition of the Chinese Pharmacopoeia for botanical limits, except one batch of Cd in 10 batches of Polygonum cillinerve (Nakai) Ohwl, and other elements did not exceed the limit, and the overall pass rate was high. The HPLC-ICP-MS research results showed that, except for the trace amount of AsV detected in the first batch of Polygonum cillinerve (Nakai) Ohwl, the inorganic arsenic and organic arsenic in the other batches of Polygonum cillinerve (Nakai) Ohwl were not detected. Conclusion This study showed the safety risks of heavy metals and related elements in Polygonum cillinerve (Nakai) Ohwl are low. This research provides data support for the formulation of the limit standards for Polygonum cillinerve (Nakai) Ohwl heavy metals and related elements. At the same time, the determination of element species will help to accurately evaluate the safety risks brought by related elements in the future.

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Determination of contents of erythromycin cyclocarbonate tablets using HPLC method

HOU Jinfeng, LI Min, HUANG Xiaochun, KOU Jinping, CHE Baoquan, LIU Haitao, YAO Shangchen

2023, 20(11): 1238-1242.
DOI: 10.19803/j.1672-8629.20230129

Abstract ( 72 )

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Objective To establish an HPLC method for determination of the content of erythromycin cyclocarbonate (EMC) tablets. Methods EMC tablets were grinded and extracted with acetonitrile. The chromatographic separation was performed on a Waters Xbridge C₁₈ column (250 mm×4.6 mm, 5μm) with an isocratic elution system composed of 0.02 mol·L^-1 potassium hydrogen phosphate solution (adjust pH to 11.4 with 5 mol·L^-1 potassium hydroxide solution)-acetonitrile (35 : 65) at a flow rate of 1.0 mL·min^-1. The elutes were detected at the wavelength of 204 nm. Results A good linearity (r=0.9999) was observed within the range of 0.51 to 1.52 mg·mL^-1. The recovery was between 99.0% and 100.5% (RSD=0.5%, n=9), the repeatability was 0.8% (n=6), and the intermediate precision was 0.9% (n=12). The test and standard sample solution remained stable for 10 hours at 5℃, and the method showed good durability. The contents of the three batches of EMC tablets were 102.3%, 102.0% and 103.5% respectively, which were within the current standard limit range of 93.0% to 107.0%. Conclusion This method is simple, rapid, accurate and specific, and is workable for the content determination of EMC tablets. A reference method has become available for the in-depth study of EMC and for the analysis of compounds with tautomeric structure by liquid chromatography.

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Quality evaluation of Chaihu Shugan granules ria multi-component quantification combined with GRA and EW-TOPSIS method

LIU Kecheng, WEI Tanjun, CHEN Fei, XIAO Cheng, ZHANG Yinsu

2023, 20(11): 1243-1248.
DOI: 10.19803/j.1672-8629.20230173

Abstract ( 49 )

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Objective To establish a multi-component quantification combined with GRA and EW-TOPSIS method to evaluate the quality of Chaihu Shugan granules. Methods The determination was performed on a Shimadzu C₁₈ column with the mobile phase composed of acetonitrile-0.1% phosphoric acid. The contents of albiflorin, paeoniflorin, cyperenone, nootkatone, α-cyperone, saikosaponin A, saikosaponin D, naringin, hesperidin, neohesperidin, senkyunolide A, neocnidilide and ligustilide in Chaihu Shugan granules were calculated using the QAMS method. The models for quality evaluation of GRA and EW-TOPSIS in 18 batches of samples were constructed respectively, and the results of analysis were compared. Results The 13 components of Chaihu Shugan granules showed good linear relationships within their respective ranges (r≥0.999), and the average recoveries (n=9) ranged from 96.91% to 100.07%(RSD<2.0%). There was no obvious difference between QAMS and ESM(P>0.05). The relative correlation degree with the GRA method was 0.321 6-0.604 9, and the relative proximity with the EW-TOPSIS analysis method was 0.244 9-0.664 5. The overall results of evaluation by GRA and EW-TOPSIS models were basically the same. Conclusion This method can be used for quantitative control and quality evaluation of multi-components in Chaihu Shugan granules.

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Therapeutic effect and mechanism of Bairui granules against influenza virus-induced viral pneumonia in mice

DENG Yurong, SUN Jianhui, HAO Liyu, SHAN Zhongchao, YU Zeyue, LI Jianliang, HUO Hairu, LI Qijing, ZHANG Hongmeng, LI Hongmei

2023, 20(11): 1249-1255.
DOI: 10.19803/j.1672-8629.20230321

Abstract ( 67 )

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Objective To study the therapeutic effect and mechanism of Bairui granules against influenza virus-induced viral pneumonia in mice. Methods According to body weight, ICR mice were randomly divided into groups: the normal control group, model control group, Bairui granules 18.84、9.42、4.71 g·kg^-1 groups, and the positive control oseltamivir phosphate capsule group. Except the normal control group, all these groups of mice were intranasally infected with influenza virus to establish a mouse model of viral pneumonia. The survival and mortality of the mice were observed. Furthermore, the body weight, lung index, viral load in lung tissue, and serum levels of inflammatory factors interleukin-6 (IL-6), γ-interferon (IFN-γ), and tumor necrosis factor-α (TNF-α) at 3, 5 and 7 days post infection (dpi) were measured in the normal control group, model control group, Bairui granules 18.84 g·kg^-1 group and oseltamivir phosphate capsule group. Results Compared with the normal control group, the mice infected with influenza A virus showed a decrease in weight but an increase in the lung index, viral load in lung tissue, and the levels of serum inflammatory factors, indicating that a mouse model for influenza virus pneumonia was established. Compared with the model control group, the Bairui granules 18.84, 9.42, 4.71 g·kg^-1 groups showed a significant prolongation in survival time (P<0.01) and a significant decrease in mortality after being infected by influenza virus (P<0.01). In addition, the Bairui granules 18.84 g·kg^-1 group exhibited a significant increase in body weight (P<0.05) at 5 and 7 dpi, and a significant decrease in the lung index (P<0.05) at 3,5 and 7 dpi. Moreover, the viral load in the Bairui granules 18.84 g·kg^-1group was significantly lower than that of the model control group (P<0.01) at 5 dpi, and the serum IL-6 content in the Bairui granules 18.84 g·kg^-1 group was significantly lower than that of the model control group (P<0.01) at 7 dpi. Conclusion Bairui granules show some therapeutic effect against viral pneumonia in mice induced by influenza virus infection by increasing body weight, decreasing the lung index, prolonging survival, and reducing mortality in virus-infected mice.

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Risks to safety of vitamin B₂ injection

YANG Le, XIA Dongsheng, WANG Tao

2023, 20(11): 1256-1258.
DOI: 10.19803/j.1672-8629.20230269

Abstract ( 211 )

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Objective To analyze the safety risks posed by vitamin B₂ injection in China in order to provide reference for clinical rational drug use. Methods Individual cases of adverse drug reactions retrieved from WHO Vigilyze and China adverse drug reaction database, foreign and domestic literature were analyzed. Results The risks posed by vitamin B₂ injection, including cutaneous diseases, general disorders and gastrointestinal system damage, deserved more attention. Conclusion Drug marketing authorization holders should reinforce the safety monitoring of vitamin B₂ injection, update the drug labeling without delay and promote the rational use of medicine.

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Establishment of patient reporting scheme in the UK and its implications

PANG Yu, LIU Bo, WU Wenyu, TIAN Yuejie, WANG Tao

2023, 20(11): 1259-1263.
DOI: 10.19803/j.1672-8629.20230476

Abstract ( 139 )

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Objective To analyze the process in which the UK established the patient reporting scheme and provide reference for the start of an adverse drug reaction patient reporting scheme in China. Methods Based on literature review, the process of establishing the patient reporting scheme in the UK was analyzed. Results UK launched a nationwide pilot program to collect patients’ reports directly from patients, which greatly increased the total number of ADR reports. Subsequently, the patient reporting scheme was officially implemented. Conclusion The patient reporting scheme in the UK is a supplement to the existing yellow card scheme. Only through direct patient reporting can we get the expected results of the patient reporting scheme. It is recommended that China learn from the related experience in the UK to initiate a pilot program to start a patient reporting scheme that is workable in China.

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Data analysis of adverse events of clobazam among children based on foreign pharmacovigilance safety spontaneous reporting system

PENG Jing, TUO Yali, LI Qiaoling, ZHOU Rong, LI Xinlin, PENG Hui

2023, 20(11): 1264-1268.
DOI: 10.19803/j.1672-8629.20230226

Abstract ( 120 )

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Objective To analyze the occurrence of adverse drug reactions/events (ADR/ADE) in real world clinical use of clobazam among children aged 0 to 17, and to provide data for clinical use of clobazam in pediatrics. Methods The data on reports of ADR/ADE of clobazam in the population aged 0 to 17 was retrieved from the WHO global database (VigiBase) of reported potential side effects of medicinal products (from inception to November 16, 2022), FDA Adverse Event Reporting System (FAERS) database (from January 1, 2004 to November 17, 2022) and from European Union Drug Regulating Authorities Pharmacovigilance (Eudra Vigilance) database (from inception to November 13, 2022). Descriptive analysis and proportional reporting ratio (PRR) data mining algorithms were used to detect ADR/ADE signals. Results A total of 31 990 ADR/ADE reports were retrieved for clobazam, including 3 885 from Eudra Vigilance, 19 066 from FAERS, and 9 039 from VigiBase. All the three databases showed that clobazam-related reports accounted for a relatively higher proportion (13.08% ~ 14.54%) of those relating to children aged 3 to 11, and clobazam was involved in more ADR/ADE reports related to the nervous system disorders and psychiatric disorders. In the Eudra Vigilance database, the incidence of nervous system disorders, psychiatric and gastrointestinal disorders and skin & subcutaneous tissue diseases was higher in older children, while respiratory & thoracic and mediastinal disorders were more common in younger children. FAERS data mining showed that the PRR value of ADR/ADE signals of infant relaxation syndrome among children aged 0 to 2 was as high as 718.58, which was worthy of attention. Besides, the PRR values of aggressiveness and cognitive impairment were higher in children ages 3 to 11, so were the PRR values of appetite decline and aggressiveness in children ages 12 to 17. Conclusion In clinical use of clobazam in pediatrics, attention should be paid to the ADR/ADE related to the nervous system, psychiatry, skin & subcutaneous tissue and the respiratory system. Clobazam may have an effect on newborns, so it should be used with caution in children under 2 years old, and in pregnant and lactating women.

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Risk factors and precautions for adverse drug reactions caused by Digoxin

WANG Li, YU Wenwen, LI Min, GUO Ruihui, CAO Guangsheng, QI Yingmei

2023, 20(11): 1269-1272.
DOI: 10.19803/j.1672-8629.20230297

Abstract ( 179 )

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Objective To study the risk factors and precautions for adverse drug reactions(ADR) caused by digoxin so as to ensure safe and rational use of this drug. Methods Based on related literature, digoxin-related ADR, risk factors, precautions, digoxin poisoning monitoring and treatments were reviewed. Results ADR caused by digoxin were similar to the first symptoms of the disease. Age, gender, drug interactions, liver and kidney function, timing of blood collection, genetic factors, dosage, administration compliance, and other variables were among the wide range of risk factors for ADR. Toxic reactions were severe once they occurred. Conclusion The risk factors should be avoided to the great extent possible during administration. Patients should be given proper administrations in order to minimize intoxication reactions and other ADR.

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Adverse drug reactions caused by new anti-tumor drugs from 2018 to 2022 in one hospital

YAO Xin, GE Qiuge, LI Yamin, WANG Yifan, LI Yuanyuan, LIU Zhiqiang

2023, 20(11): 1273-1278.
DOI: 10.19803/j.1672-8629.20230204

Abstract ( 136 )

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Objective To provide data for the monitoring of adverse drug reactions (ADR) induced by new anti-tumor drugs and for early warning of danger signals and pharmaceutical monitoring of ADR. Methods Ninety-one reports of ADR of new anti-tumor drugs submitted to the National Adverse Drug Reaction Monitoring Center by Jiyuan People’s Hospital between 2018 and 2022 were retrospectively analyzed according to the patients’ age, gender, BMI, primary diseases, systems-organs involved, usage of drugs and outcomes. Results ADR of new anti-tumor drugs mainly affected the skin and its accessory systems in 32 cases (35.16%), and the digestive system in 20 cases (21.98%), with diarrhea (25.00%)as the most common type of ADR in the digestive system. Multiple logistic regression analysis showed that the independent risk factors for ADR of the digestive system were lower BMI and concomitant medication. Patients with ADR of the digestive system related to immune checkpoint inhibitors took a longer time to recover (2 weeks to 1 month). Conclusion Clinical pharmacists are to be alert to ADR of new anti-tumor drugs among patients under concomitant medication or with lower BMI and manage adverse reactions caused by immune checkpoint inhibitors.

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Pharmaceutical care of one case of malignant arrhythmia induced by multidrug combination

ZHENG Jinfeng, WANG Jinghong

2023, 20(11): 1279-1281.
DOI: 10.19803/j.1672-8629.20230216

Abstract ( 156 )

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Objective To explore the entry point of clinical pharmacists to carry out pharmaceutical care for critically ill patients and prevent serious adverse reactions through the introduction of a case of a patient with heart failure complicated with pulmonary infection induced by multi-drug tip torsion ventricular tachycardia. Methods Clinical pharmacists participated in the treatment of a case of malignant arrhythmia caused by multi-drug combination, assisted doctors in identifying suspicious drugs, dealing with drug-induced TdP and implementing pharmaceutical care. Results Clinical pharmacists assisted physicians to adjust the medication regimen and take effective measures for serious adverse reactions, which achieved good results. Conclusion Clinical pharmacists can effectively ensure the safety of medication by participating in the treatment team, taking pharmacy as the breakthrough point and acting as the assistant of doctors.

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Pharmaceutical care of a patient with indapamide-induced agranulocytosis

SU Su, WU Shiqi, ZHANG Qingxia, YAN Suying

2023, 20(11): 1282-1285.
DOI: 10.19803/j.1672-8629.20230178

Abstract ( 129 )

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Objective To explore the role of a clinical pharmacist in the treatment of a patient with agranulocytosis induced by indapamide via etiological analysis and pharmacological care. Methods One clinical pharmacist participated in the treatment of a patient with agranulocytosis. By analyzing medications used and using the Chinese Adverse Reaction Association Evaluation Methodand the Naranjo’s assessment scale, the pharmacist screened out indapamide as a possible drug that caused agranulocytosis from nine medications used. The pharmacist suggested withdrawing indapamide. The antihypertensive regimen was also optimized to switch to amlodipine and telmisartan. Results After withdrawal of indapamide, the patient’s neutrophil count returned to normal. Blood routine was monitored after discharge and no abnormality was found. The antihypertensive regimen was also improved by recommending a switch to amlodipine, and the patient was given medication instructions to avoid reuse of indapamide and reminded of the need for regular blood monitoring. Conclusion The clinical pharmacist played an important role in the clinical treatment by offering pharmaceutical care of a patient with agranulocytosis caused by indapamide, finding suspicious drugs in time, optimizing the treatment plan, and implementing individualized pharmaceutical care.

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Two cases of fetal malformation after exposure to low dose warfarin sodium tablets in early pregnancy

YANG Caihua, YANG Longna, LI Xiaobo

2023, 20(11): 1286-1289.
DOI: 10.19803/j.1672-8629.20230074

Abstract ( 95 )

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Objective To investigate the influencing factors and pharmacogenetic effects of fetal malformation caused by maternal exposure to low-dose warfarin sodium tablets during early pregnancy. Methods Two cases of fetal cleft lips and palates as well as short nasal bone development due to exposure to low-dose warfarin sodium tablets(<5 mg·d^-1) during early pregnancy for anticoagulation after mechanical valve replacement were reported. The possible drug correlations and teratogenic molecular mechanism between fetal malformation and low-dose warfarin were discussed based on related literature. Results and Conclusion In Chinese populations, low-dose warfarin exposure(<5 mg·d^-1) in early pregnancy can increase the risk of fetal oral-facial malformation, and its teratogenic mechanism may be correlated with the maternal warfarin dose, exposure time window and individual differences. Literature suggests that inter-individual CYP2C9, VKORC1 gene polymorphisms and AYL Sulfatase E gene mutations may also play a key role, which deserves clinical attention.

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One case of extremely abnormal coagulation caused by warfarin combined with compound paracetamol and amantadine hydrochloride tablets

ZHANG Wenwen, NIE Xiting, XU Huiru, RAN Ye, TIAN Chenglin, YU Shengyuan

2023, 20(11): 1290-1292.
DOI: 10.19803/j.1672-8629.20220492

Abstract ( 146 )

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Objective To explore the possible adverse drug interactions between warfarin and compound paracetamol and amantadine hydrochloride tablets. Methods A patient who had been taking warfarin for a long time for venous sinus thrombosis was reported to have sustained extremely abnormal coagulation function after intermittent administration of compound paracetamol and amantadine hydrochloride tablets. Results The coagulation function of the patient recovered gradually after discontinuation of warfarin and supplementation of vitamin K and coagulation factors. Conclusion Compound paracetamol and amantadine hydrochloride tablets may significantly enhance the anticoagulant effect of warfarin, leading to an extremely high risk of bleeding. Clinicians should be alert to the interactions between the two drugs. Warfarin and cold medicine must be cautiously combined in clinical treatment, and bleeding and clotting function should be closely monitored.

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One case of scleroderma-like skin in bilateral calves induced by pemetrexed disodium for injection

LIANG Yan, YAN Jiaqing, YANG Jun

2023, 20(11): 1293-1295.
DOI: 10.19803/j.1672-8629.20230157

Abstract ( 75 )

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Objective To explore the clinical characteristics and treatment of adverse reactions in the skin of lower limbs caused by pemetrexed. Methods One case of rare skin toxicity in the lower leg caused by pemetrexed disodium for injection in a patient with non-small cell lung cancer was analyzed. The clinical manifestations and appropriate treatments of such rare skin toxicity were summarized based on literature review. Results The clinical manifestations of this patient, including swelling, erythema multiforme, itching, pigmentation, pain, sclerosis, and fever, were similar to those of pemetrexed related sclerodermic changes reported abroad, and the use of antibacterial drugs had no significant effect. After the dose of pemetrexed chemotherapy was reduced and hormone and antihistamine drugs for symptomatic treatment were used, the symptoms were significantly alleviated. Conclusion The sclerodermic changes related to pemetrexed are not included in the known adverse reactions of pemetrexed and are often misdiagnosed as cellulitis or erysipelas, which can seriously affect the quality of life of patients and deserves attention.

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One case of deep coma and severe drug-induced liver injury caused by sulfatinib and oxycodone hydrochloride prolonged-release tablets

CHEN Gang, LI Yan, JIANG Caihong, XIE Peitao, SU Changhai

2023, 20(11): 1296-1298.
DOI: 10.19803/j.1672-8629.20220575

Abstract ( 63 )

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Objective To analyze one case of deep coma and severe liver injury induced by sulfatinib and oxycodone sustained-release tablets so as to provide reference for safe use. Methods The clinical data of one patient with deep coma and severe liver injury caused by sulfatinib and oxycodone sustained-release tablets was described, the treatment process was reported, and the related literature was reviewed. Results This male patient with small cell lung cancer regularly took oxycodone sustained-release tablets chronically due to bone metastasis. After 4 days of oral treatment with sulfatinib, the patient developed deep coma, which was considered to be oxycodone poisoning. His symptoms were improved after naloxone was administered. His liver function index was checked soon. It was found that the level of transaminase had increased more than five times the upper limit. Drug-induced liver injury was regarded as likely so that sulfatinib was immediately discontinued, followed by symptomatic hepatoprotective treatment, and transaminase returned to normal one week later. Sulfatinib was used a second time in combination with oxycodone sustained-release tablets before transaminases and bilirubin increased again. The Naranjo score for sulfatinib and oxycodone-induced deep coma was 7 (most likely). The interactions between the two drugs were little reported. Conclusion Physicians and pharmacists should pay attention to drug interactions during medication, especially interactions between the liver, drug and enzyme system. For opioid tolerant patients with cancer pain, vigilance and monitoring must be strengthened when potentially interacting drugs are used in combination.

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One case of spontaneous hemorrhage of iliopsoas and gluteal muscles induced by drugss

XIE Jing, GUAN Fei

2023, 20(11): 1299-1302.
DOI: 10.19803/j.1672-8629.20220460

Abstract ( 119 )

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Objective To review the process of treating one case of the iliopsoas and gluteal muscle hemorrhage caused by nadroparin,aspirin, efoperazone sodium and sulbactam sodium for injection so as to provide reference for clinical treatment. Methods The diagnosis and treatment of a patient with spontaneous iliopsoas and gluteal muscle hemorrhage and treated with the combination of nadroparin, aspirin, cefoperazone sodium and sulbactam sodium for injection was retrospectively analyzed. Results After conventional treatment, the hemorrhage of the iliopsoas and gluteal muscle improved, but hematoma was formed in psoas muscles. Conclusion Treatment with nadroparin, aspirin, cefoperazone sodium and sulbactam sodium for injection can possibly induce a rare deep muscle hemorrhage, which deserves attention clinically.

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One case of nephrotic syndrome caused by rabies vaccine in a 5-year-old child

ZHAO Huanhuan, SONG Jiawei, LIU Jinguang, HUANG Minghui

2023, 20(11): 1303-1305.
DOI: 10.19803/j.1672-8629.20220722

Abstract ( 107 )

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Objective To study the adverse events of rabies vaccine and explore the adverse reactions among children with nephrotic syndrome. Methods By analyzing one case of nephrotic syndrome in children caused by rabies vaccine (Vero cells) (PVRV), the correlations with adverse drug reactions and the causal association of vaccine adverse events were discussed. Results Binocular eyelid edema appeared on the 4th day after the first dose, abdominal pain and vomiting on the 5th day, edema affected the face on the 8th day, and nephrotic syndrome was diagnosed on the 10th day. A third injection was not given, and the nephrotic syndrome was treated. After 3 days of medication with glucocorticoid, edema was mitigated and urine protein became negative. Conclusion A causal association between PVRV and nephrotic syndrome is possible and should be of concern to clinicians and pharmacists. Rabies vaccine (human diploid cells) is recommended for children with allergies.

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One case of gynecomastia induced by efavirenz tablets

TANG Jiong, LIU Ying

2023, 20(11): 1306-1308.
DOI: 10.19803/j.1672-8629.20230041

Abstract ( 81 )

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Objective To explore one case of gynecomastia induced by efavirenz, and to provide reference for clinical prevention and treatment of the adverse reactions. Methods The process of treating one patient who had developed gynecomastia after taking efavirenz was analyzed in order to investigate the mechanism by which efavirenz caused gynecomastia and to rule out the possibility of other drugs. Results The patient developed unilateral gynecomastia after taking efaveranz. The breast discomfort was alleviated 2 months after withdrawal of efaveran and surgical treatment. Conclusion Gynecomastia caused by efavirenz may be related to the effect of estrogen/androgen. During medication, breasts should be examined regularly for the sake of early identification and treatment.

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Research progress on detection and risk assessment of exogenous heavy metals and related elements in Codonopsis Radix

ZHONG Yingying, WANG Zhao, ZUO Tiantian, LI Yaolei, LI Hailiang, MA Shuangcheng

2023, 20(11): 1309-1315.
DOI: 10.19803/j.1672-8629.20230370

Abstract ( 78 )

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Codonopsis Radix is widely used in traditional medicine, and its safety is the prerequisite for its effective role, while exogenous heavy metals and related elements are one of the main factors affecting its quality and application. Through risk assessment, the residual risk of exogenous heavy metals and related elements in Codonopsis Radix can be controlled. This study reviewed the research progress on the detection technology, residual situation and standard limits of exogenous heavy metals and related elements in Codonopsis Radix in recent years, and focused on the progress of risk assessment, in order to provide reference for the formulation of the limit standard, and also for the quality and safety evaluation.

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Research progress in the role of NLRP3 inflammasome in neurodegenerative diseases and in treat-ments

MA Yidan, SHEN Xin, YANG Jun, YAN Jiaqing

2023, 20(11): 1316-1320.
DOI: 10.19803/j.1672-8629.20230154

Abstract ( 67 )

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Neurodegenerative diseases are serious health issues facing the world’s aging population, which are usually manifested as cognitive decline, loss of motor function and dementia. The pathogenesis of neurodegenerative diseases is complex, and current treatments for these diseases can do nothing more than control their symptoms. NLRP3 inflammasome, as the most studied inflammasome, is widely involved in neurodegenerative diseases. This article reviews the structure and function of NLRP3 inflammasome and its involvement in different neurodegenerative diseases before the progress in drug research related NLRP3 inflammasome in the treatment of neurodegenerative diseases is summarized.

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