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27 March 2023, Volume 21 Issue 3
    

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  • LI Qi-long, ZHONG Wu, ZHU He, FAN Shi-yong
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 1-6. https://doi.org/10.3969/j.issn.1672-3384.2023.03.001
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    Corona virus disease 2019 (COVID-19) is still prevalent worldwide. For individuals who contraindicated to or cannot produce adequate immune response to COVID-19 vaccine, there is still a large number of unmet demand for prophylaxis drugs. This article reviewed the research progress of prophylaxis drugs for COVID-19, including antibody drugs and small molecule drugs. Currently, evusheld is the only approved drug with pre-exposure prophylaxis effect, however it may not be effective for some variants of Omicron (XBB, XBB.1.5, BQ.1 and BQ.1.1). In order to cope with the constant variation of severe acute respiratory syndrome coronavirus 2, the research and development of prophylaxis drugs for COVID-19 is still facing great challenges.
  • WANG Qing, WANG Bao-yan, JI Run, WANG Yi-mei, QIAO Tong
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 7-11. https://doi.org/10.3969/j.issn.1672-3384.2023.03.002
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    Isolated distal deep vein thrombosis (IDDVT) is a subtype of deep vein thrombosis of lower extremities, which has not attracted enough attention due to its hidden symptoms, but it still has the risk of developing into proximal deep vein thrombosis and pulmonary embolism. As for whether IDDVT requires anticoagulant therapy, anticoagulant drug dosage, and the course of anticoagulant therapy, no consensus has been reached at home and abroad. In this paper, the epidemiology, risk factors, anticoagulant therapy and other aspects were summarized. For IDDVT patients with severe symptoms and additional risk factors, anticoagulant therapy is the first choice, and new oral anticoagulants at therapeutic dosages are preferred. The anticoagulant time should be maintained for at least 3 months, which can reduce the risk of thrombosis recurrence. There is still a lack of large randomized controlled trails to demonstrate the benefits and risks of anticoagulant therapy, and more clinical trial data are needed to support it.
  • Comment of New Drug
  • YANG Ling-chen, XIE Fei, HU Chun
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 12-17. https://doi.org/10.3969/j.issn.1672-3384.2023.03.003
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    Bepirovirsen (research code: IONIS HBVRx,GSK3228836) is an antisense oligonucleotides (ASO) jointly developed by Ionis Pharmaceuticals and GSK Biologicals,for the treatment of chronic hepatitis B (CHB). CHB is a global public health concern caused by the pathogen hepatitis B virus (HBV). Bepirovirsen has the dual function of inhibiting HBV replication and promoting the body's autoimmune clearance of HBV. Currently, it has entered the phaseⅢ clinical study stage, and published clinical study results show that bepirovirsen can continuously clear HBsAg and HBV-DNA. The drug will lead to a new treatment option for patients with CHB, which is expected to functionally cure CHB. The review provides a brief overview of the basic information, mechanism of action, preclinical research and clinical research of bepirovirsen.
  • LIU Yue, ZHANG Bin, ZHANG Hai-ying
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 18-22. https://doi.org/10.3969/j.issn.1672-3384.2023.03.004
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    Belumosudil is a Rho-associated coiled-coil-containing protein kinase (ROCK) inhibitor that has been developed by Kadmon Pharmaceuticals for the treatment of chronic graft-versus-host disease (cGVHD) and systemic sclerosis. It is received its first approval in July 2021 in the US for the treatment of adult and pediatric patients aged ≥ 12 years with cGVHD after failure of at least two prior lines of systemic therapy. This article summarizes the pharmacological effects and mechanisms, pharmacokinetics, clinical efficacy evaluation, safety evaluation, and usage of belumosudil, so as to provide references for clinical rational drug use.
  • WEI Juan-juan, ZHANG Meng-di, SHI Xiu-jin, LIN Yang
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 23-27. https://doi.org/10.3969/j.issn.1672-3384.2023.03.005
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    Bisoprolol and amlodipine is the only long-acting single pill combination(SPC) of beta-blocker and calcium channel blocker approved in China at present. Many clinical studies have demonstrated the efficacy, safety and tolerability of bisoprolol and amlodipine. The pharmacological characteristics, pharmacokinetics, clinical efficacy evaluation, safety, adherence and guideline recommendations of this drug were reviewed to provide evidence for clinical safety and rational use of this drug in the clinical practice.
  • Original Article
  • WANG Ke, DONG Xian-zhe, FENG Ying-nan, WANG Zhi-zhou, ZHUANG Wei, LUAN Jia-jie, KONG Shu-jia, YUE Xiao-lin, ZHANG Lan
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 28-33. https://doi.org/10.3969/j.issn.1672-3384.2023.03.006
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    Objective To compare the efficacy and safety between generic in volume-based procurementand and original drug. Methods Data were collected from the hospital electronic medical record system, and the information of inpatients using azacitidine in Xuanwu Hospital of Capital Medical University,Yijishan Hospital of Wannan Medical College and Yunnan Cancer Hospital from January 1, 2019 to March 31, 2022 were collected, including basic information, disease and medication information. The patients were divided into the original drug group and the generic drug group. The basic information, treatment remission and adverse reactions of patients using azacitidine-containing chemotherapy regimen were compared. Results There were 55 patients in the generic drug (manufacturer 1) group and 53 patients in the original drug group. There were no significant differences in gender, age, height, weight, type of medical insurance, smoking, drinking, family history of cancer, treated diseases, disease classification and chronic diseases between the two groups (P>0.05). A total of 38 patients in the generic drug (manufacturer 2) group were included, and there was no significant difference in the baseline between the two groups after propensity score matching (P>0.05). There was no significant difference in the incidence of myelosuppression, secondary infection, gastrointestinal reaction, liver function injury, fever and fatigue between the original drug group and the generic drug group (P>0.05). There was no significant difference in the response rate within 2 courses of treatment between the generic drug group and the original drug group (all P>0.05). Conclusion There is no significant difference in efficacy and safety between the selected generic azacitidine and the original azacitidine.
  • WANG An-qi, LI Lan, PENG Yi-jie, LIU Wen-chun
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 34-38. https://doi.org/10.3969/j.issn.1672-3384.2023.03.007
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    Objective To investigated the preventive effect of clostridium butyricum duplex viable on children with antibiotic-associated diarrhea (AAD) and the effect of intestinal flora. Methods Children who received antibiotic treatment in the Pediatrics Department of Enshi Central Hospital from December 2019 to December 2021 were selected as the research subjects, and divided into the control group and the observation group by random number table method. The control group was given conventional anti-infective treatment, and the observation group was additionally treated with clostridium butyricum dual viable bacteria powder. The length of hospital stay, antibiotic application time, AAD incidence, defecation frequency, diarrhea duration, intestinal flora, inflammatory factors and adverse reactions were compared in two groups. Results A total of 120 children were observed, 60 in the control group and to 60 in the observation group. The length of hospital stay and antibiotic application time in the control group were longer compared with observation group of each group was (9.32±0.64)d vs (7.32±0.56)d, (9.17±0.61)d vs (7.28±0.54)d (all P<0.05). The incidence of AAD in the control group was significantly higher compared with the observation group (31.67% vs 11.67%) (χ2=7.070, P=0.008). The number of bowel movements in the control group on the 1st, 4th and 7th days of treatment were more than those in the observation group, and the duration of diarrhea was longer than that in the observation group, the time of diarrhea occurred earlier than that in the observation group (all P<0.05). One week after treatment, the numbers of EubacteriumBifidobacterium and Lactobacillus in the two groups were increased, and compared with the control group, the numbers of the observation group were higher (t=8.868, 13.633, 7.221, all P<0.001). The numbers of Escherichia coli and Enterococcus decreased after treatment, and that were lower in the observation group compared with the control group (t=22.533, 12.230, all P<0.001). One week after treatment, the serum levels of TNF-α, IL-2 and IL-6 in the two groups were decreased, and compared with the control group, the TNF-α, IL-2 and IL-6 in the observation group were lower (all P<0.001). Conclusion Clostridium butyricum duplex viable can effectively reduce the incidence of AAD in hospitalized children treated with antibacterial drugs, alleviate their clinical symptoms, improve the intestinal flora, and reduce inflammatory response.
  • XU Lan-lan, CHE Xian-hua, JIN Ye, LI Xue-zheng
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 39-43. https://doi.org/10.3969/j.issn.1672-3384.2023.03.008
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    Objective To explore the risk factors of liver injury in patients using voriconazole, and to screen the high-risk population of liver injury. Methods A retrospective study was conducted on patients treated with voriconazole in Yanbian University Hospital from January 2015 to December 2021. For each eligible patient, demographic details, medical history, laboratory parameters were collected from the hospital information system (HIS). Results Among 230 patients included in this study, 20 patients had liver injury, with an incidence of 8.7%. The results of the binary logistic regression analysis showed that hypoproteinemia (OR = 0.887, P = 0.014) and combined use of proton pump inhibitors (PPIs) (OR = 0.338, P = 0.035) were independent risk factors of liver injury induced by voriconazole induced. Conclusion During clinical use of voriconazole, patients with hypoproteinemia and combined use of PPIs should be given more attention. In addition, the liver function and blood drug concentration should be monitored, and the individualizd drug administration plan should be carried out by pharmace utical care services.
  • WEI Shi-feng, ZHAO Zhi-gang
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 44-49. https://doi.org/10.3969/j.issn.1672-3384.2023.03.009
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    Objective To evaluate the clinical effect and safety of thymosin in the treatment of patients with coronavirus disease 2019 (COVID-19) based on evidence-based medicine, and to provide references for clinical rational use of drugs. Methods The databases of CNKI, Wanfang, VIP, Sinomed, PubMed, Web of Science, Cochrane Library and other clinical trial registration websites were searched, and the relevant literature and clinical trials of thymosin in the treatment of COVID-19 were summarized and analyzed. The AMSTAR2 scale and the GRADE grading system were used to evaluate the methodological and evidence quality levels of the included systematic reviews / meta-analyses. Results At present, there are no specific recommendation for thymosin in the treatment of COVID-19. The use of thymosin for immunoenhancement treatment of COVID-19 was mentioned only in the Standardization and Hierarchical Diagnosis and Treatment Process of COVID-19 in Shanghai (2022 edition) and Diagnosis and Treatment Protocol for COVID-19 in Xiangya Hospital Central South University (on trial). Two systematic reviews / meta-analyses showed that thymosin treatment for COVID-19 did not improve clinical outcomes. The safety of thymosin in patients with COVID-19 is unknown, there may be a higher risk of medication. Conclusion The effectiveness of thymosin in the treatment of COVID-19 patients is not supported by clear evidence, and thymosin is not recommended for the treatment of COVID-19.
  • KOU Li-qiu, XIE Xiao-lu, CHEN Xiu, NIE Dan, LI Ya-ling
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 50-55. https://doi.org/10.3969/j.issn.1672-3384.2023.03.010
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    Objective To systematically evaluate the clinical efficacy and safety of olaparib maintenance treatment for platinum-sensitive ovarian cancer with breast cancer susceptibility gene (BRCA) mutations.Methods The database of PubMed, Cochrane, Web of Science, CNKI, Wanfang, and VIP were searched to collect randomized controlled trials of olaparib (the observation group) versus placebo (the control group) for the treatment of platinum-sensitive ovarian cancer with BRCA mutation. RevMan 5.3 software was applied for meta-analysis. Results Five studies were finally included. According to the results of the meta-analysis, the median progression-free survival (HR=0.35, 95%CI:0.22 to 0.56, P<0.00001) and total survival (HR=0.77, 95%CI:0.62 to 0.95, P=0.02) of the patients in the observation group were significantly longer than those in the control group, and the difference was statistically significant. The incidence of adverse reactions such as arthralgia, abdominal pain, constipation in the observation group was not statistically significant (P>0.05) compared with the control group; However, the incidence of headache, dyspepsia, fever and so on was more frequent than that in the control group, and the differences was statistically significant (P<0.05). However, the degree of these adverse reactions was mild, mostly grade 1 to 2 responses, most patients can be controlled by symptomatic treatment and (or) olaparib dose adjustment, and only a minimal number of patients require discontinuation of stop olaparib. Conclusion Olaparib maintenance treatment in patients with BRCA-mutated platinum-sensitive ovarian cancer is effective, safe and controllable, and it is worth to be recommended for clinical use.
  • CUI Hua, YU Chun-hua, QIN Peng-fei, YAN Mei-xing, QU Su-xin
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 56-61. https://doi.org/10.3969/j.issn.1672-3384.2023.03.011
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    Objective To explore the establishment and application of evaluating the suitability of pediatric drugs. Methods Five types of pediatric anti-allergic drugs, which are currently used in Qingdao Women and Children's Hospital, are evaluated at two levels: technical appropriateness and appropriateness of use. With application of Delphi method, indexes and weights of the appropriateness evaluation are determined. By constructing index evidence with the help of literature research method and questionnaires, their standardized scores are calculated and then multiplied by weights to obtain the comprehensive scores of drugs. After that the most suitable anti-allergic drugs for children are evaluated. Results By comparison, the suitability of desloratadine dry suspension and loratadine syrup were better. Conclusion The Delphi hierarchical analysis-based method for evaluating the suitability of pediatric drugs can objectively measure the relationship between the advantages and disadvantages of multiple drugs and provide a basis for the rational use of pediatric drugs.
  • XING Xiao-min, ZHOU Peng-xiang, WANG Jing-long, LIU Dong-hua, WANG Yong-jie, LI Jing
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 62-67. https://doi.org/10.3969/j.issn.1672-3384.2023.03.012
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    Objective To rapidly evaluate the efficacy, safety and economy of pregabalin in perioperative pain management of thoracic surgery, and provide evidence-based basis for the selection of clinical treatment plan. Methods PubMed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang, SinoMed and domestic and international health technology assessment websites were searched, and the retrieval time limit was from the establishment of the database to December 31, 2021. Two researchers independently conducted literature screening, data extraction and quality evaluation according to the inclusion and exclusion criteria, and comprehensively and qualitatively analyzed and compared the study results. Results A total of 28 articles were initially selected, and 4 studies were included eventually,including 3 systematic reviews/meta-analyses and 1 economics study. There were some differences in the results between different studies, and the literature mainly focused on thoracotomy. In terms of efficacy and safety, preoperative pregabalin (mostly 150 mg) was beneficial to reduce acute pain and opioid consumption, and there was no significant difference in adverse reactions such as sedation and dizziness; postoperative multiple doses (75 mg bid or 150 mg bid) reduced acute and chronic pain, opioid consumption, and neuropathic pain, but increased the incidence of dizziness and somnolence. In terms of economics, pregabalin 75 mg bid for 5 days after surgery could save surgical services and anesthesia-related costs compared with epidural analgesia. Conclusion Based on the current limited evidence, pregabalin has good efficacy and economies in the perioperative pain management of thoracic surgery, and it is necessary to pay attention to its safety when using multiple doses. The evidence of thoracoscopic surgery is limited and the conclusion still needs to be confirmed by further studies and clinical practice.
  • JIANG Yao-hui, XIE Jun
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 68-74. https://doi.org/10.3969/j.issn.1672-3384.2023.03.013
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    Objective To evaluate the economics and effectiveness of adding empagliflozin to standard treatment in the treatment of heart failure with reduced ejection fraction (HFrEF) in China. Methods A multistate Markov model was developed to yield clinical and economic outcomes of adding empagliflozin to standard treatment for 65-year-old patients with HFrEF. A cost-effectiveness analysis was performed mostly based on data from the EMPEROR-Reduced(Empagliflozin Outcome Trial in Patients with Chronic Heart Failure and a Reduced Ejection Fraction) trial and national statistical database. The primary outcome were total and incremental costs and quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER). Results Compared with the standard treatment, the cost of total population in the empagliflozin group was 33 585.55 yuan, 5223.34 yuan higher than that in the control group, and the total utility scores were 3.98 QALYs, 0.14 QALYs higher than that in the control group, resulting in the calculated ICER of 36 849.47 yuan /QALYs, which was lower than a willingness-to-pay(WTP)threshold of 80 976.00 yuan/QALYs. The simulation results of non-diabetic and diabetic populations were consistent with the total populations. Univariate sensitivity analysis showed that cardiovascular death in both groups was the first driver of cost-effectiveness among total populations. Probability sensitivity analysis showed that when WTP was 80 976.00 yuan /QALY, the probability of adding empagliflozin to standard therapy was 60.3%. Conclusion When WTP was 80 976.00 yuan /QALY, adding empagliflozin to standard therapy was proved to be a little more cost-effective option for the treatment of HFrEF from a China healthcare system perspective, which promoted the rational use of empagliflozin for HFrEF especially in diabetic populations.
  • LI Lei, LIU Jing, SHEN Juan, KONG Wei, SUN Jing, QIN Kan
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 75-79. https://doi.org/10.3969/j.issn.1672-3384.2023.03.014
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    Objective To establish a quantitative model for the rational evaluation of proton pump inhibitors(PPIs), providing a reference for the rational evaluation of PPIs. Methods Based on the instruction of pantoprazole injection and relevant national regulations, an evaluation method for the injection of pantoprazole was established using the attribute hierarchy model (AHM) and technique for order preference by similarity to an ideal solution (TOPSIS). The rationality evaluation was conducted on patients randomly selected from the rational drug use system of Hefei First People's Hospital from January 1 to December 31, 2021, who used pantoprazole for injection. Results A total of 100 medical records were included. The reasonable cases (Ci=1.0) of pantoprazole injection in the sample were 22%; 1.0<Ci≤0.8 accounted for 13%; those with lower than 0.6 accounted for 65%. The average value of the sample was 0.21. The three items with the worst rationality were indications (35%), frequency of administration (67%), and documentation of the reasons for medication in the medical records (69%). Conclusion The quantitative model-based rational evaluation method for PPIs can identify and quantify clinical issues related to the use of PPIs. The evaluation criteria are more objective and specific, which allows for clearer identification of the degree of irrationality, and thus helps to improve the issues more effectively.
  • WANG Deng, CAO Qing, YAN Kang-kang, TIAN Yan-yan, WANG Xin
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 80-84. https://doi.org/10.3969/j.issn.1672-3384.2023.03.015
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    Objective To evaluate the effect of standardized directory implementation for improving dispensing accuracy and the quality of finished infusion of pharmacy intravenous admixture service (PIVAS). Methods Standardized directory of intravenous infusion dosing and mixing was implemented in PIVAS, which contained five subdirectories, i.e., "the standardized directory of the maximum fluid volume that the transfusion bag/bottle can carry" "the standardized directory of amount of fluid for dissolving drugs and choice of syringes" "the standardized directory of dissolving methods" "the standardized directory of standard solution preparation in incomplete dose drug", and "the standardized directory of drug suction operation". The operation of dosing and mixing was standardized, and the effects were evaluated before and after the implementation. Results Implementation of standardized directory in the hospital standardized the operation of intravenous infusion dosing and mixing, which significantly improved the rate of reaching the standard of drug residue, reduced the incidence of quality error of neonatal parenteral nutrition solution and the error rate of dosing and mixing,the average increase was 20.83%, and the difference between evaluated before and after in the three drugs was statistically significant. The quality error rate of neonatal parenteral nutrient solution has a decreasing trend (1.73% vs 2.16%,P > 0.05).At the same time, the error rate of dosing and mixing was significantly reduced (0.115‰ vs 0.156‰,P < 0.05), and the accuracy of dosing and mixing were improved. Conclusion The implementation of standardized directory of intravenous infusion dosing and mixing in PIVAS is helpful to improve the accuracy of dosing and mixing and the safety and effectiveness of clinical drug use.
  • LI Chun-da, PAN Gu-jie, RU Jin-cheng, CHEN Jin-qiang
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 85-89. https://doi.org/10.3969/j.issn.1672-3384.2023.03.016
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    Objective To analyze the effect of N-acetylcysteine (NAC) combined with antituberculosis quadruple drug regimen(HRZE)in elderly patients with chronic obstructive pulmonary diseases (COPD) combined with pulmonary tuberculosis. Methods The elderly patients with COPD combined with pulmonary tuberculosis diagnosed and treated in Shaoxing Central Hospital from June 2018 to June 2020 were randomly divided into control group and observation group. The control group received HRZE for therapy, and on this basis, the observation group received NAC for therapy. The lesion absorption, cavity reduction, pulmonary function, arterial blood gas index, cytokine level of the both groups were compared before and after therapy, and the adverse reactions during therapy were compared between the both groups. Results Totally 92 patients were included, including 46 patients in control group and 46 patients in observation group. There were no significant differences in lesion absorption, cavity reduction rate and incidence of adverse reactions between the two groups (P>0.05). After treatment, the mean values of forced expiratory volume at the forced expiratory volume in one second (FEV1), forced vital capacity (FVC), partial oxygen pressure (PaO2) and partial carbon dioxide pressure (PaCO2) in observation group were (1.55±0.30) L, (1.88±0.32) L, (74.14±8.24) mm Hg and (40.74±5.35) mm Hg; while the mean values of FEV1, FVC, PaO2 and PaCO2 in the control group were (1.40±0.28) L, (1.71±0.36) L, (68.35±7.52) mm Hg and (44.85±6.28) mm Hg. After treatment, the mean values of TNF-α, IL-8 and interferon-γ (IFN-γ) in observation group were (52.73±15.38) ng/L, (62.38±16.84) pg/mL, (16.34±4.52) ng/L; While the mean values of TNF-α, IL-8 and IFN-γ in the control group were (65.84±18.20) ng/L, (75.38±20.44) pg/mL and (21.62±5.33) ng/L. Compared with treatment before, the levels of FEV1, FVC and PaO2 in the two groups were significantly increased (P<0.05), while the levels of PaCO2, TNF-α, IL-8 and IFN-γ were significantly decreased (P<0.05), and the change range of the above indicators in the observation group was significantly better than that in the control group (P<0.05). Conclusion NAC combined with HRZE has a significant clinical effect in the treatment of elderly COPD patients with pulmonary tuberculosis, which can effectively control the disease condition, restore normal pulmonary function, restrain the inflammation and immune response .
  • Case Research
  • SHEN Qian, ZHANG Xiang-hui, LIU Ting, KANG Li-min, YU Jing-jie
    CLINICAL MEDICATION JOURNAL. 2023, 21(3): 90-92. https://doi.org/10.3969/j.issn.1672-3384.2023.03.017
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    Herein we reported a case of albuminuria in a 11-year-old children caused by dasatinib ,the routine examination of urine was abnormal, occult blood and urine protein appeared and continued to worsen. According to the diagnosis of the clinician, other pathological factors were excluded and considered as the adverse reaction of dasatinib. The clinical pharmacist suggested that the drug should be stopped and enalapril should be given symptomatic treatment. After stopping the drug for 1 week, the urine routine test was reviewed, and the indicators were significantly improved. The follow-up treatment was continued with imatinib mesylate tablets, and there was no proteinuria in the reexamination. Based on the literature reports, we considered that albuminuria after using dasatinib may be related to the inhibition of vascular endothelial growth factor (VEGF), which suggests that children should first have renal function and urine routine examination before using dasatinib and other TKIs, and clinicians should regularly review relevant indicators during medication and pay attention to monitoring and follow-up after drug use.