Chinese Journal of Pharmacovigilance

Research progress in pharmacogenic cardiotoxicity

ZHANG Bing, SA Rina, ZHANG Xiaomeng, ZHANG Dan, LIN Zhijian, WANG Yu

2023, 20(8): 841-847.
DOI: 10.19803/j.1672-8629.20230293

Abstract ( 387 )

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Pharmacogenic cardiotoxicity is one of the severe adverse reactions triggered by drugs, the severity of which ranges from mild electrocardiographic changes to fatal arrhythmias. Pharmacogenic cardiotoxicity is characterized by multiple sources, high incidence, insidiousness, susceptibility to special populations, diversity of clinical manifestations, and complexity of mechanisms. In recent years, research on pharmacogenic cardiotoxicity has received much attention. This paper reviews the research progress in pharmacogenic cardiotoxicity in terms of its clinical manifestations, mechanisms of occurrence and preventive measures to provide reference for clinical prevention of pharmacogenic cardiotoxicity.

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Therapeutic effect of saffron against arrhythmia induced by doxorubicin in rats

SA Rina, ZHANG Bing, LIN Zhijian, ZHANG Xiaomeng, WANG Yu

2023, 20(8): 848-857.
DOI: 10.19803/j.1672-8629.20230004

Abstract ( 111 )

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Objective To observe the therapeutic effect of saffron against DOX-induced arrhythmias and provide data for clinical application of saffron against DOX cardiotoxicity. Methods An arrhythmia model was induced with adriamycin. The experimental rats were randomly divided into the control (CONT), model (DOX), positive drug (BFT), and saffron (T-SE) groups. The therapeutic effects of saffron against DOX-induced arrhythmia in rats were investigated in terms of general performance (status and body weight), biological indicators of cardiac injury (CK-MB, BNP, NT-ProBNP and cTni), cardiac functional indicators (cardiac ultrasound and ECG), and cardiac pathological indicators. Results One week after treatment with saffron in DOX arrhythmia model rats, ECG showed that the QTC interval was shortened, ST segment period was reduced, and Q wave amplitude was reduced in the T-SE group rats compared with the DOX group. Echocardiography suggested that left ventricular ejection fraction (LVEF), left ventricular fraction shortening (LVFS), and LV mass were significantly increased (P < 0.05), so were left ventricular anterior wall thickness at end-systole (LVAW;s), left ventricular posterior wall thickness at end-diastole (LVPW;d), left ventricular posterior wall thickness at end-systole (LVPW;s), interventricular septal thickness at end-diastole (IVS;d), and interventricular septal thickness end diastole (IVS;s) (P < 0.05), but left ventricular end-systolic dimension (LVEDD) and left ventricular end-systole volume (LVESV) were significantly decreased (P < 0.05) in the T-SE group compared with the DOX group. Cardiac damage biomarkers showed that creatine kinase MB(CK-MB), troponin I (cTnI), brain natriuretic peptide(BNP), and N-terminal pro-B-type natriuretic peptide (NT-proBNP) were significantly lower in the T-SE group than in the DOX group (P < 0.001). Conclusion Saffron is effective in alleviating DOX-induced arrhythmias.

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Mining and validation of anti-adriamycin cardiotoxic effect of chicory extract

YIN Yuling, HU Chujuan, ZHANG Xiaomeng, WANG Yu, ZHANG Bing, LIN Zhijian

2023, 20(8): 858-865.
DOI: 10.19803/j.1672-8629.20230118

Abstract ( 70 )

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Objective To explore and validate the potential role of chicory extract against adriamycin cardiotoxicity. Methods Related literature was reviewed to sum up advances in research on protective effects of chicory against myocardial injury. Based on network pharmacology, the mechanism of chicory against myocardial injury was explored, and its coincidence with the cardiotoxicity mechanism of adriamycin was analyzed. A mouse model of cardiotoxicity was established using a single intraperitoneal injection of 15 mg·kg^-1 adriamycin, and low, medium and high doses of chicory water extract (3.8, 19, 38 g·kg^-1) were administered for 8 d to verify the potential effects of chicory against adriamycin cardiotoxicity. Results There were 13 articles on the effect of chicory against myocardial injury, all of which were concerned with basic research, involving chicory alcohol extract, chicory acid, chicory polysaccharide, andanimal models of myocardial injury caused by nano-lead and sepsis. The protective mechanism of chicory heart was mainly anti-inflammation and anti-oxidation stress, involving such signal pathways as ErbB, MAPK and PI3K-Akt as well as TP53, Src, STAT3, AKT1 and other core targets, which overlapped with the pathogenesis of adriamycin cardiotoxicity to a great extent. Chicory water extract could significantly increase the cardiac coefficient and terminal body weight of model mice, reduce the mouse levels of NT-ProBNP, CK-MB, LDH, and AST in the cardiac tissue homogenate and serum, and improve their disorder of cardiac tissue fiber arrangement and nuclear pyknosis. Conclusion Chicory has the potential effect of anti-adriamycin cardiotoxicity, which is worthy of more exploration and research to guide the rational clinical use of adriamycin and chicory.

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Cardiovascular risk signaling mining and mechanism of uric acid-lowering drugs

HUANG Jinjian, ZHANG Xiaomeng, ZHANG Bing, DING Xueli, YANG Ying, LIN Zhijian

2023, 20(8): 866-871.
DOI: 10.19803/j.1672-8629.20230125

Abstract ( 205 )

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Objective To provide reference for the rational clinical use of uric acid-lowering drugs given their potential cardiovascular risks using data from FAERS database. Methods The data on ADE with febuxostat, allopurinol, benzbromarone, probenecid, labrizine, and pregabalin as the main suspected drugs in FAERS database between First quarter 2004 and third quarter 2021 was extracted. The proportional reporting ratio method and Bayesian Confidence Propagation Neural Network were used for signal mining of cardiovascular risks. Univariate logistic regression was used to identify the risk factors in the process of drug administration while bioinformatics technology was used to predict potential mechanisms of cardiovascular risks. Results Febuxostat had a significant cardiovascular risk profile, mainly in the form of heart failure, ischemic heart disease and cardiac arrhythmias. Risk factor mining found that a patient's age, weight, dose administered, dosing period, and combination of drugs were all associated with cardiovascular risks of febuxostat. The potential mechanism of febuxostat cardiovascular risks involved neuroactive ligand-receptor interactions. ITGAM expression in the core target showed dose-dependent changes with febuxostat, which might be a potential target for cardiovascular risks of febuxostat. Conclusion Among the uric acid-lowering drugs, febuxostat has obvious cardiovascular risks, and the risk factors should be controlled during medication. The mechanism for cardiovascular risks may be related to the disruption of the neuroactive ligand-receptor interaction pathway of monocytes and the expression of ITGAM.

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Protective mechanism of Chinese medicine compound CB001 against low dose radiation based on network pharmacology and experimental verification

MEI Yu, ZHU Yue, ZHANG Huiting, XIAO Chengrong, GAO Yue, MA Zengchun

2023, 20(8): 872-879.
DOI: 10.19803/j.1672-8629.20230090

Abstract ( 68 )

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Objective To predict the potential mechanism by which Chinese medicine compound CB001 protects against low dose radiation (LDR) based on network pharmacology and to verify its possible mechanism of action through animal experiments. Methods Based on prediction by network pharmacology, the possible targets and pathways of protective effect of Chinese herbal compound CB001 against LDR were obtained. The mice were randomly divided into the control group, model group and low (1 g·kg^-1), medium (2 g·kg^-1) and high (4 g·kg^-1) dose groups of Chinese medicine compound CB001. The mice were exposed to low dose irradiation for 5 consecutive days. After irradiation, the mice were killed. The total number of white blood cells and lymphocytes in the peripheral blood of the mice was measured while the apoptosis of spleen cells was detected. The morphological changes of spleen tissue in each group were observed using the hematoxylin-eosin (HE) method. The expressions of AKT, p-AKT, Bax and IL-6 were detected by Western blot. Results Finally, 42 potential active components and 79 targets of Chinese medicine compound CB001 were obtained, which could affect the cell cycle, inflammatory response regulation and reactive oxygen metabolism. The results of KEGG enrichment analysis showed that the protection of Chinese herbal compound CB001 against LDR mainly involved PI3K/AKT signaling pathway. Animal experiments showed that this compound could not only increase the total number of white blood cells and lymphocytes in peripheral blood of mice, but reduce the apoptosis of mouse spleen cells and improve the pathological changes of mouse spleens. This compound could also promote the expression levels of p-AKT protein and inhibit the expression levels of Bax and IL-6 proteins in spleens of mice. Conclusion Chinese medicine compound CB001 can protect against LDR by reducing the inhibition of PI3K/AKT signaling pathway induced by LDR, inhibiting cell apoptosis and improving inflammatory response.

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Acute toxicity of anti-gastric cancer active ingredients of Ferula ferulaeoides

YANG Minghan, QIAO Meiling, LUO Jiaoyang, YANG Meihua, SHENG Ping

2023, 20(8): 880-884.
DOI: 10.19803/j.1672-8629.20230136

Abstract ( 53 )

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Objective To study the acute toxicity and safety of anti-gastric cancer active ingredients of Ferula ferulaeoides so as to provide reference for the research and development of anti-gastric cancer drugs and clinical medications. Methods The mixed suspension of anti-gastric cancer active ingredients of Ferula ferulaeoides was administered intragastrically to mice at the maximum dose. The mice were weighed before and 14 days after administration. The health and death of mice were observed for 14 consecutive days. On the 14th day after administration, serum was collected, and the white blood cell count (WBC), red blood cell count (RBC), hemoglobin concentration (HGB), platelet count (PLT) and lymphocyte percentage (LYM) of mice were determined. The indexes of the liver, spleen and kidney were calculated by dissecting mice. The pathological sections of the liver, spleen, kidney and stomach were prepared to observe the pathological injury to the organs. Results The maximum dosage of anti-gastric cancer active ingredients of Ferula ferulaeoides for mice was 5.00 g·kg^-1. During administration, the mice in the group of anti-gastric cancer active ingredients of Ferula ferulaeoides appeared listless, tired, with erection and dark blood color of hair and sticky feces. Compared with blank control group, there was no significant difference in body weight before and 14 d after administration (P > 0.05), or in white blood cell count (WBC), red blood cell count (RBC), hemoglobin concentration (HGB), platelet count (PLT) and lymphocyte percentage (LYM) (P > 0.05), or in the indexes of the liver, spleen and kidney (P > 0.05). Histopathological results showed no significant pathological changes in the liver, spleen, kidney or stomach. Conclusion The anti-gastric cancer active ingredients of Ferula ferulaeoides cause no serious toxic reactions within 14 days, without any significant effect on the weight and diet of mice or on the liver, spleen, kidney and stomach of mice, but irritative reactions may occur within 2h of administration. This may be caused by nerve irritation or gastrointestinal irritation of the anti-gastric cancer active ingredients of Ferula ferulaeoides.

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Determination of 135 pesticide residues in Farfarae Flos by UPLC-MS/MS and risk assessment

ZAN Ke, ZHAO Lei, JIANG Dacheng, WANG Ying, JIN Hongyu, MA Yu, MA Shuangcheng

2023, 20(8): 885-890.
DOI: 10.19803/j.1672-8629.20220641

Abstract ( 54 )

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Objective To establish an ultra-high performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for screening 135 pesticide residues in Farfarae Flos. Methods Acetonitrile was used as the extraction solvent, and high speed homogenate was used for extraction. The chromatographic column was CORTECS^TM UPLC (C₁₈, 1.6 μm,2.1 mm×150 mm). The mobile phase was composed of 0.1% formic acid (containing 5mmol·L^-1 ammonium formate) solution as the aqueous phase, and 95% acetonitrile solution (containing 5 mmol·L^-1 ammonium formate and 0.1% formic acid) as the organic phase under gradient elution. The flow rate was 0.3 mL·min^-1, column temperature was 40℃, and injection volume was 2 μL. The electrospray ion source was used in the multi-reaction monitoring mode. The contents were calculated with the standard curve method. The chronic hazard quotient (HQ_c) was calculated via chronic exposure assessment. Results The recoveries of the 135 pesticides ranged from 70.30% to 118.45%, and the relative standard deviation was less than 9.1%. The measured components showed a good linear relationship (r ≥ 0.99) in the range of 1~100 ng·mL^-1. Seven batches of chlorpyrifos, one batch of nitridazole and one batch of carbaryl were screened out from 27 batches of samples. The HQ_c of all the batches was far less than 1, and the risk of pesticide residues of Farfarae Flos was low. Conclusion This method is multi-functional, accurate and fast, which is suitable for the high throughput determination and risk assessment of 135 pesticide residues in Farfarae Flos, and is of referential value for the detection of pesticide residues in other Chinese medicinal materials.

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Quantitative transfer relationships of Rubia yunnanensis Diels formula granules based on standard decoctions

WANG Xiang, SUN Shuai, WANG Xinguo, NIU Liying

2023, 20(8): 891-898.
DOI: 10.19803/j.1672-8629.20220721

Abstract ( 52 )

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Objective To study the quantitative transfer relationships of Rubia yunnanensis Diels granules based on extraction rates, contents of Rubinaphthin A and characteristic chromatograms of standard decoctions. Methods The standard decoction samples of Rubia yunnanensis Diels were prepared before a method for determination of contents and characteristic chromatograms was established. The quantitative transfer relationships between herb-herbal pieces, standard decoctions, and formula granules were studied. Results The results of study on 15 batches of standard decoctions showed that the extraction rates ranged from 15.3% to 28.4%, the content of Rubinaphthin A in Rubia yunnanensis Diels ranged from 15.83 mg·g^-1 to 29.39 mg·g^-1 and the transfer rate ranged from 21.79% to 40.47%. A total of six characteristic chromatogram were identified, with two characteristic peaks identified for peak 1 of Rubinaphthin A and peak 4 of Rubinaphthin A. Fifteen batches of Rubia yunnanensis Diels herbs and herbal pieces and three batches of pilot formula granules from different sources were collected. The content of Rubinaphthin A in Rubia yunnanensis Diels herbs ranged from 14.32 mg·g^-1 to 19.79 mg·g^-1, from 12.71 mg·g^-1 to 18.81 mg·g^-1 in herbal pieces, and from 18.71 mg·g^-1 to 19.80 mg·g^-1 in formula granules. The transfer rate of herbal pieces to herbs ranged from 64.41% to 119.62%, that of standard decoction to herbal pieces from 21.79% to 40.47%, and that of herbal pieces to formula granules from 26.10% to 28.73%. Six characteristic peaks were detected in Rubia yunnanensis Diels herbs, herbal pieces and formula granules, and the relative retention time was within the specified range. Conclusion The quantitative transfer relationships between herb-herbal pieces, standard decoctions, and formula granules of Rubia yunnanensis Diels are stable and within the range of standard decoctions, indicating that the quality of Rubia yunnanensis Diels formula granules is stable and equivalent to standard decoctions.

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Whole process management of narcotic drugs and psychotropic drugs based on intelligent information management system

SHI Xiangfen, SUN Zhiyong, ZHANG Xufeng, LU Xiaojing, DU Shuzhang, ZHANG Xiaojian

2023, 20(8): 899-903.
DOI: 10.19803/j.1672-8629.20220176

Abstract ( 111 )

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Objective To standardize the prescription review and dispensing process of outpatient anesthetics based on the clinical rational drug use management system and hospital information system. Methods The FOCUS-PDCA method was used to identify problems, analyze the causes, formulate and implement interventions. The management system for clinical rational drug use was used to set up detailed audit rules for the indications, usage and dosage and courses of treatment. Pharmacists established medical records of outpatients with cancer pain via the electronic medical record system in the hospital information system (HIS). They also adjusted prescriptions after finding out whether an outpatient was hospitalized and when previous drugs were dispensed with. Results According to drug instructions and related laws and regulations, detailed audit rules were formulated for 8 categories of narcotic drugs and class I psychotropic drugs and for 7 categories of class II psychotropic drugs. Electronic medical records of outpatients were established for cancer patients. The refund rate of outpatient prescriptions for narcotic drugs and class I psychotropic drugs decreased from 11.41% to 2.32%, and the rate of standard use of class II psychotropic drugs increased from 86.81% to 97.83%. Conclusion The whole process management of narcotic drugs and psychotropic drugs for outpatients can improve the rate of standard prescriptions, and ensure the rationality and safety of patients' medication.

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Comparison standard terminology for pharmaceutical dose forms

ZHANG Yuqi, XU Xinyi, ZHU Lan, ZHU Yan

2023, 20(8): 904-910.
DOI: 10.19803/j.1672-8629.20220444

Abstract ( 151 )

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Objective To provide reference for standardization and internationalization of pharmaceutical dose forms of pharmacovigilance in China. Methods The conceptual model, classification system, characteristics of terms, and expanded applications of pharmaceutical dose forms in European Directorate for the Quality of Medicines (EDQM) standard terms were analyzed and compared with dosage forms in the Chinese Pharmacopoeia 2020 Edition. Based on the current applications of terms of dose forms in China, proposals were raised. Results Pharmaceutical dose forms are part of EDQM standard terms, which are an online semi-structured database maintained by European Directorate for the Quality of Medicines. Pharmaceutical dose forms in EDQM are accepted as preferred terms by ICH, and recognized worldwide. China National Medical Products Administration has supported their use in individual case safety reports as well. EDQM terminologies for dose forms are constructed on the basis of IDMP developed by ISO, especially the core conceptual model. There is a unique code, a definition, and 4 characteristics for each term, so that its meaning remains the same across languages and regions. Using taxonomy terms, a 3-level classification system and several auxiliary classifications are constructed, where terminologies for dose forms are at the third level. Dosage forms also play a role in complex concept modeling, such as combined pharmaceutical dose forms. Another reference for pharmaceutical dose forms of pharmacovigilance is Chinese Pharmacopoeia(CP) in China. It constructs a 3-level classification system for dose forms as well, but without taxonomy terms. Terminologies in it can be partially mapped to EDQM. There are differences in applications, accreditation criteria, and coverage between dose forms from Chinese Pharmacopoeia and EDQM. Inaccurate labelling of dose forms, and variations in terminologies, codes and classifications exist in the applications of dose forms of CP. Conclusion There is a need to improve Chinese translation of EDQM pharmaceutical dose forms so as to use them in combination with CP. China could consider completing terminologies for dose forms in CP, promoting standardization, and including new dose forms with reference to EDQM's experience.

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Analysis of the association of adverse reactions with relative dose of melphalan and body weight in POEMS syndrome patients undergoing melphalan-based ASCT

ZOU Dongmei, FANG Fang, GUO Yixian, NI Jing, ZHAO Hong, HU Ronghua, SUN Wanling

2023, 20(8): 911-914.
DOI: 10.19803/j.1672-8629.20230292

Abstract ( 49 )

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Objective To analyze the association of adverse reactions and the dose per actual body weight（ABW）of melphalan hydrochloride for injection in POEMS patients undergoing melphalan-based autologous stem cell transplantation (ASCT) and provide reference for clinical drug dose adjustment. Methods The clinical data of five patients with POEMS syndrome undergoing melphalan-based ASCT in the Department of Hematology of Xuanwu Hospital was analyzed retrospectively, to summary the adverse reactions and explore the association of those with relative dose of melphalan. Results One low-body-weight patient was given melphalan calculated based on BSA, with relative melphalan dose of 5.45 mg·kg^-1, had normal renal function, grade one oral mucositis(OM) and grade three drug-induced intestinal disaese(DID). Neutrophil engraftment occured on day +10, platelet on day +11. Three normal-body-weight patients were given melphalan calculated based on ABW, with relative melphalan dose of 4.44~5.41 mg·kg^-1, had normal renal function, no( two patients) and grade two (one patient) OM, grade one, two and three DID, respectively. Neutrophil engraftment occured on day +11~+13, platelets on day +11~+13. One overweight patient with ABW of 130% ideal body weight(IBW), was given melphalan calculated based on IBW, with relative melphalan dose of 4.22 mg·kg^-1, had renal insufficiency because of stem cell mixed with much lysed erythrocyte, grade three OM and grade two DID. Neutrophil engraftment occured on day +11, platelet on day +12. Conclusion In POEMS patients undergoing melphalan-based ASCT, high relative dose of melphalan and renal insufficiency may increase the grade of OM and DID, and may not affect neutrophil and platelet engraftment. Whether body weight based dose adjustment of melphalan is necessary with adequate precautions in overweight patients still need more clinical data to be verified.

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Adverse events caused by HER2 conjugated antibodies via FAERS

HE Xiong, MA Junlong, YANG Guoping

2023, 20(8): 915-920.
DOI: 10.19803/j.1672-8629.20220658

Abstract ( 119 )

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Objective To provide reference for clinical drug safety by mining and analyzing adverse drug reaction/event (ADR/ADE) signals of T-DM1 and T-DXd which are antibody-conjugated drugs targeting HER2. Methods ADR/ADE reports submitted between January 1, 2020 and June 30, 2022 were retrieved from the Adverse Event Reporting System of the United States Food and Drug Administration (FAERS) before signals were screened and analyzed after removal of duplicate reports. Results A total of 2 806 ADR/ADE reports were collected with T-DM1 or T-DXd as the primary suspected drug, and 3 979 ADR/ADE signals were obtained after screening. The classification of ADR/ADE signals found that the signals of the two drugs were of a similar system organ class (SOC). However, T-DM1 was additionally involved in the reproductive system and breast disorders and vascular disorders. Furthermore, ADR/ADE signal intensities associated with T-DM1 were higher for hepatopulmonary syndrome, sideroblastic nevus and nodular aplastic hyperplasia, while T-DXd was more significantly correlated with elevated kL-6, carcinomatous lymphadenopathy and interstitial lung diseases. Among the top 20 ADR/ADE in terms of signal intensities, spider naevus, hyperalgesia and sensory abnormality were not mentioned in the instructions of T-DM1, while keratitis and femoral neck fracture were not mentioned in T-DXd instructions. Conclusion The real-world ADR/ADE mined conform with those specified in drug instructions. New ADR/ADE are also reported that can provide reference for clinical use of T-DM1 and T-DXd.

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535 reports of new and serious adverse drug reactions caused by preparations of lappaconitine hydrobromide

HUO Yanfei, TIAN Yuejie, XU Lili, XIE Yanjun, CHANG Hong, SUN Chunxiao, LI Xia

2023, 20(8): 921-926.
DOI: 10.19803/j.1672-8629.20220602

Abstract ( 114 )

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Objective To study the clinical manifestations of adverse drug reactions (ADR) caused by lappaconitine hydrobromide as reference for clinical rational drug use. Methods A total of 535 reports of new and serious ADR involving lappaconitine hydrobromide in Shandong Provincial ADR Database from January 1, 2011 to December 31, 2021 were retrospectively analyzed. Results The new and serious adverse reactions of lappaconitine hydrobromide were more prevalent in people ages 45~65, and most of the ADR occurred within one day of administration. The ADR of lappaconitine hydrobromide mainly presented as multiple systemic and organ damage such as gastrointestinal damage, systemic damage, and damage to the skin and its attachments. The risks of abnormal liver function, allergic reactions or anaphylactic shock were not mentioned in the instructions. Conclusion The warning in the instructions for preparations of lappaconitine hydrobromide is inadequate. Marketing authorization holders need to study post-marketing data and improve the instructions to ensure the safety of patients.

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Medications of apatinib mesylate in patients with malignant tumors

ZHANG Xialan, YUAN Jing, WU Bin, QIN Yuanyuan

2023, 20(8): 927-932.
DOI: 10.19803/j.1672-8629.20220316

Abstract ( 82 )

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Objective To analyze the characteristics of medications with apatinib mesylate in the treatment of malignant tumors, and to provide reference for the safe clinical use of apatinib. Methods A retrospective investigation was conducted to retrieve information from the HIS system on the treatment of patients who had used apatinib in the Department of Oncology in our hospital between 2018 and 2020. Results Among the 69 patients taking apatinib, 49 were males and 20 were females, with an average age of 64.8±10.1 years old. The KPS scores were low, mostly 70 and 60. Clinical diagnosis was mostly gastric cancer, colon cancer, lung cancer, liver cancer and pancreatic cancer. Stage IV patients accounted for 82.6%. The proportions of patients who took apatinib of 500 mg qd and 250 mg qd were larger. This drug was most commonly used in combination with proton pump inhibitors, traditional Chinese medicine injections, antiemetic drugs and antibacterial drugs. About 20% of the patients' conditions were improved and stable based on imaging evaluation, but one in three patients progressed. The most common adverse reactions were fatigue, elevated blood pressure and skin damage. Conclusion Apatinib is widely used in malignant tumors in clinical practice, but there are cases of off-label use. Physicians should attach importance to rational use and adjust dosage quickly according to efficacy and adverse reactions. Clinical pharmacists should provide good pharmaceutical care, minimize the influence of drug interactions, and ensure safe drug use for patients.

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One case of pharmaceutical care of drug exposure during pregnancy

WANG Ran, LI Yifan, LIU Xiaoyan, FENG Xin

2023, 20(8): 933-934.
DOI: 10.19803/j.1672-8629.20220626

Abstract ( 203 )

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Objective To explore the characteristics of drug exposure during pregnancy and the risks of drug use during pregnancy, and to study the methods and procedures of pharmaceutical care. Methods The outpatient pharmaceutical care for one case of periconceptional drug exposure was used to analyze the possible impact of exposure to such risk drugs as quinolones during pregnancy, and to evaluate the risk of medication for allergic rhinitis during pregnancy. Results The information was collected through pharmacy consultation, and the risk of medication was analyzed individually with high-level evidence. The pharmacist recommended that the patient continue pregnancy and receive related ultrasound examination. The pharmacist also evaluated the treatment plan according to the patient's conditions and gave advice on treatment of allergic rhinitis. Conclusion Pharmacists can play an important role in evaluating the risk of drug exposure during perinatal pregnancy, and provide more individualized pharmaceutical care for patients.

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One case of abnormal uterine bleeding caused by Baofukang suppository

CHANG Yongzhuo, LI Ji, ZHANG Xiaoyan, ZHOU Chaofan

2023, 20(8): 935-938.
DOI: 10.19803/j.1672-8629.20230104

Abstract ( 161 )

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Objective To offer clinical pharmaceutical tips for the use of Baofukang suppository by retrospectively analyzing one case of abnormal uterine bleeding and reviewing literature. Methods The treatment process of one patient with chronic cervicitis was tracked, the causes of abnormal uterine bleeding after medication were analyzed, and related literature was retrieved. Results One patient with chronic cervicitis and vaginitis suddenly experienced abnormal uterine bleeding after using Baofukang suppository. After discontinuation of Baofukang suppository and medication with tranexamic acid tablets, vaginal bleeding stopped. When Baofukang suppository was used a second time, there was a large amount of vaginal bleeding accompanied by endometrial-like substances and abnormal menstrual cycle. After Baofukang suppository was discontinued, the patient experience no more abnormal uterine bleeding within six months. The menstrual cycle and volume returned to normal. Conclusion For patients without severe blood stasis but with spleen and stomach weakness or with qi and blood deficiency, Baofukang suppository should be used with caution to prevent breakouts and menstrual disorders. For patients with obvious qi stagnation and blood stasis but with full qi and healthy spleens and stomachs, Baofukang suppository can be used for a short period of time to avoid damaging the positive energy.

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Research progress in safe use of Psoralea corylifolia based on evolution of toxicity/efficacy

DILHUMAR Dilmurat, SHI Wei, WANG Jiabo, GAO Yuan

2023, 20(8): 939-945.
DOI: 10.19803/j.1672-8629.20220409

Abstract ( 42 )

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Psoralea corylifolia L. is a traditional non-toxic Chinese herbal medicine, which is used for the treatment of osteoporosis, fractures, osteoarthritis and other diseases. However, liver injury caused by Chinese herb preparations, including Psoralea corylifolia, is frequently reported over the years, which affects the clinical and safe use of psoralen. This study is expected to provide data for evaluation and prevention of safety risks of Psoralea corylifolia.

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Research progress in clinical use of large-dose Radix Aconiti Lateralis Preparata

YANG Liang, TAO Rui, HU Huizi, WANG Zihan, ZHANG Yan, DONG Yan, CHU Zhaoyi, ZHANG Zizhen, GENG Jiahao, LI Shuai, XU Nuo, MA Zengchun, GAO Yue

2023, 20(8): 946-949.
DOI: 10.19803/j.1672-8629.20230060

Abstract ( 85 )

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Objective To review the clinical applications of Radix Aconiti Lateralis Preparata at large doses, and provide reference for related treatments. Methods Based on the dosage of Radix Aconiti Lateralis Preparata specified in the Pharmacopoeia of the People's Republic of China (2020 Edition) and by means of literature review, the current usage of Radix Aconiti Lateralis Preparata at large doses was investigated. Treatments within different dosage ranges, in different stages and for different diseases were discussed in terms of toxicology, applications, studies on ancient prescriptions, modern clinical applications, different dosages and real cases. Results Large dosages of Radix Aconiti Lateralis Preparata had special effect. The dosage of Radix Aconiti Lateralis Preparata, which varied greatly depending on the stage and type of the disease, ranged from 30 to 200 g or even exceeded 200 g as was recorded in literature. However, most of the dosages ranged from 30 to 60 g. When used, fuzi had to be processed or decocted in water. When the prescribed range was 3 to 15 g stated in the Pharmacopoeia of the People's Republic of China, its toxicity was usually reduced via compatibility, processing or otherwise. Conclusion The use of high-dose Radix Aconiti Lateralis Preparata has been widely reported, and the therapeutic effect against a variety of diseases is remarkable. However, Fuzi should still be used with caution in clinic to ensure safety.

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Research progress in safety of PPAR agonists

ZHANG Qin, ZHANG Luyong, JIANG Zhenzhou

2023, 20(8): 950-955.
DOI: 10.19803/j.1672-8629.20230001

Abstract ( 35 )

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Peroxisome proliferator-activated receptors (PPAR) are important nuclear receptors that regulate the expression of genes responsible for energy metabolism, inflammatory response, cellular development and differentiation. Their agonists have been developed for the treatment of metabolic diseases such as diabetes, dyslipidemia and atherosclerosis. However, the adverse effects of PPAR agonists limit their use in clinical practice. This paper summarizes the types of toxicity and toxicity mechanisms associated with isotype-specific PPAR agonists and presents reports of adverse reactions to dual PPAR agonists and pan-PPAR agonists in clinical trials in order to better understand the toxic effects of PPAR agonists and provide references for the design of safer PPAR agonists.

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Research progress in tofacitinib for juvenile idiopathic arthritis

LI Yamei, SHUI Rong

2023, 20(8): 956-960.
DOI: 10.19803/j.1672-8629.20220611

Abstract ( 67 )

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Juvenile idiopathic arthritis, an autoimmune disease, is a common childhood arthritis with unclear etiology and high heterogeneity. Tofacitinib, as a novel oral specific inhibitor of small molecule Janus kinases (mainly JAK1 and JAK3), has revolutionized the treatment of several types of skin diseases in different age groups. Tofacitinib was approved in September 2020 for active polyarticular juvenile idiopathic arthritis 2 years of age and older by the United States Food and Drug Administration. There are relatively few applications in children with juvenile idiopathic arthritis, leaving evidence about safety, efficacy, and tolerability for use in children limited. This article summarizes the research progress in the treatment of juvenile idiopathic arthritis with tofacitinib in terms of the mechanism of action, pharmacokinetic characteristics, clinical application and safety so as to provide reference for future multicenter clinical studies.

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