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  • PAN Kunming, LI Yanli, XU Chenqi, LI Ranyi, XU Qing, LI Xiaoyu
    Herald of Medicine. 2024, 43(2): 184-189. https://doi.org/10.3870/j.issn.1004-0781.2024.02.006

    Objective To analyze the achievement of target vancomycin concentration and the risk factors affecting the concentration to reach the target,providing a reference for the rational use of vancomycin and the implementation of therapeutic drug monitoring (TDM). Methods Patients who were hospitalized and received vancomycin TDM from January 2016 to June 2019 at Zhongshan Hospital,Fudan University were selected.Clinical data,vancomycin blood concentrations,and occurrences of acute kidney injury (AKI) during the hospitalization were collected.Factors affecting the attainment of target vancomycin concentrations were analyzed using logistic regression and grouped according to whether the target concentrations were attained.The correlation between drug concentration and the occurrence of AKI was analyzed. Results A total of 1 106 patients were included,with 70.7% being males and a median age of 60.0 (IQR=20) years.Surgical departments accounted for 76.4% of the distribution.The median duration of vancomycin therapy was 10.8 d (IQR=9.0).A total of 21.6% of patients had their first concentration monitored before administration of doses 4 and 5.The drug concentration monitoring results of 46.8% (518/1 106) of patients were in the range between 10-20 μg·mL-1,reaching the target concentration range.The incidence of vancomycin-associated AKI was 25.9%.The incidence of AKI varied among patients with different vancomycin concentrations:when the concentrations are <10,10-<15,15-20,and >20 μg·mL-1,the AKI rates are 15.8%,20.5%,25.8%,and 39.4%,respectively.Multivariate logistic regression analysis showed that target concentrations were more likely to be reached with a dosing course of >7-14 d (OR=1.688,P=0.001) and >14 d (OR=1.744,P=0.002) than with a dosing course of ≤7 d. Patients receiving conventional daily doses were more likely to achieve target concentrations than those receiving the non-conventional daily dose (OR=1.540,P=0.003). Conclusion The current status of vancomycin TDM in China still suffers from deficiencies,such as delayed timing of monitoring and low rate of target concentration attainment.Higher vancomycin concentrations are significantly associated with AKI,and the factors affecting the vancomycin concentration to reach the target mainly include treatment duration and the complexity of the dosing regimen.

  • LU Ping, WANG Jie, YIN Xiaoli, ZHANG Shunzhi, WU Wei
    Herald of Medicine. 2024, 43(2): 203-207. https://doi.org/10.3870/j.issn.1004-0781.2024.02.009

    Objective To assess the pharmacokinetic characteristics of two types of tofacitinib citrate tablets in healthy individuals and evaluate their bioequivalence and safety. Methods A randomized,two-period,self-crossing design was used with 36 subjects in two groups in both fasting and postprandial conditions.Each group received 5 mg tofacatile citrate tablets of either generic tofacitinib citrate tablets (T) or the reference product (R) per period,and the plasma concentration of tofacatile tablets was detected by LC-MS/MS.Phoenix WinNonlin software was used to calculate pharmacokinetic parameters and evaluate its bioequivalence. Results After single oral administration of test and reference preparations,the main pharmacokinetic parameters were as follows:Cmax values in fasting group were (57.54±13.95) and (59.17±12.31) ng·mL-1,respectively;AUC0-t values were (143.83±34.58) and (142.13±33.00) ng·h·mL-1,respectively;AUC0-∞ values were (147.39±35.27) and (146.15±34.64) ng·h·mL-1,respectively;tmax was 0.5 h for both;Cmax values in the postprandial group were (57.16±17.56) and (55.19±21.98) ng·mL-1;AUC0-t values were (165.47±41.63) and (162.04±41.84) ng·h·mL-1;AUC0-∞ values were (171.88±44.15) and (168.05±44.21) ng·h·mL-1;The t max was 1.0 h for both.The 90% confidence intervals for the geometric mean ratios of Cmax,AUC0-t and AUC0-∞ in fasting group and postprandial group were 96.35% (90.11%-103.03%) and 105.91% (95.20%-117.83%),101.02% (98.76%-103.34%) and 102.23% (99.67%-104.86%),100.77% (98.53%-103.06%) and 102.40% (99.81%-105.06%),all within the range of 80.00%-125.00%. Conclusion Both types of generic tofacitinib citrate tablets are bioequivalent and safe in Chinese healthy individuals.

  • XU Yuehua, QIAN Zhouyi, ZHAO Yang, HUANG Qiongye, SUN Luning, WANG Yongqing, SUN Zhiming, TANG Wenwen
    Herald of Medicine. 2023, 42(12): 1779-1784. https://doi.org/10.3870/j.issn.1004-0781.2023.12.006

    Objective A simple,specific and rapid LC-MS/MS method was established to determine flumatinib and its two major metabolites in human plasma for clinical therapeutic drug monitoring. Methods The determination was performed on an ACQUITY UPLC HSS T3 column (2.1 mm×50 mm,1.8 μm) with mobile phases consisting of acetonitrile and 10 mmol·L-1 ammonium formate (containing 0.1% formic acid) with gradient elution at the flow rate of 0.5 mL·min-1.The elution time was 6 min.The temperature of the column was 38 ℃.The ion source was electrospray ion source and the scanning mode was multiple reaction monitoring scanning in positive ion mode. Results The mass concentrations of flumatinib and its metabolites (flumatinib M1 and flumatinib M3) have a good linear relationship within the concentration range investigated.The precision and stability of the method are good.The precision is less than 15%,and the relative deviation is within±15%.The extraction recoveries of flumatinib and its metabolites approach nearly 100%. Conclusion The method is simple and sensitive,and can accurately determine the plasma concentration of flumatinib and its metabolites,providing a basis for clinical rational drug use.

  • ZHANG Xuenong, WANG Yanyan, LI Lie, ZHANG Min, SONG Liping, YI Mengjuan, WU Xiandi, YOU Hui
    Herald of Medicine. 2023, 42(12): 1785-1790. https://doi.org/10.3870/j.issn.1004-0781.2023.12.007

    Objective To study the pharmacokinetic characteristics of clobazam tablet in Chinese healthy subjects and evaluate the bioequivalence of test preparation (T) and reference preparation (R) under fasting or fed conditions. Methods A randomized,open-label,single-dose,two-period,two-way crossover bioequivalence trial was performed.34 healthy subjects were enrolled in fasting study and 30 in fed study.Each subjects received a single dose of T 20 mg or R 20 mg with a washout period of 28 days.Plasma concentrations of clobazam and its active metabolite,N-desmethylclobazam were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS).The pharmacokinetic parameters of clobazam and N-desmethylclobazam were calculated by non-compartment model.Geometric mean values for the T/R ratios of clobazam's main pharmacokinetic parameters and their corresponding 90 percent confidence intervals (CI) were evaluated to assess bioequivalence of the two preparations. Results In fasting study,the 90 percent CI of the geometric mean values for the T/R ratios were 94.46 to 103.82 percent for Cmax,99.64 to 103.62 percent for AUC0-t and 99.39 to 103.51 percent for AUC0-∞,respectively.In fed study,the 90 percent CI of the geometric mean values for the T/R ratios of were 93.86 to 106.02 percent for Cmax,100.37 to 104.51 percent for AUC0-t and 100.71 to 104.63 percent for AUC0-∞,respectively. Conclusion In this study,the 90 percent CI of the geometric mean values of Cmax,AUC0-t and AUC0-∞ for T/R ratios were all within the acceptable bioequivalence limits of 80 to 125 percent for clobazam.Therefore two formulations were considered bioequivalent.

  • ZHANG Xiaoying, YE Zhenjie, WU Lingjie, YUAN Jinjin, YU Xiaoling
    Herald of Medicine. 2024, 43(2): 207-214. https://doi.org/10.3870/j.issn.1004-0781.2024.02.010

    Objective To develop an ultra-performance liquid chromatography-mass spectrometry (UPLC-MS /MS) method for the simultaneous quantification of dolutegravir,raltegravir,efavirenz,lamivudine and tenofovir in human plasma and to apply it to the therapeutic monitoring. Methods Dolutegravir-D5,raltegravir-D4,efavirenz-D5,lamivudine-13C-15N2and tenofovir-D7 were used as internal standard,respectively.All samples were extracted using the protein precipitation method with acetonitrile and then diluted for analysis.Chromatographic separation was performed on Shim-pack XR-ODS Ⅲ(2.0 mm×50 mm,1.6 μm)column.Mobile phases A and B consisted of 0.1% formic acid in water and acetonitrile respectively.A programmed mobile phase gradient was used at a flow rate of 0.3 mL·min-1and column temperature of 40 ℃.The tandem mass spectrometer was equipped with an electrospray ionization (ESI) source operating in multiple reaction monitoring (MRM) modes.After methodological validation,it can be used for therapeutic drug monitoring in HIV patients. Results There was good linearity in the validated concentration ranges of 62.5-3 000 ng·mL-1for dolutegravir,10-500 ng·mL-1for raltegravir,125-6 000 ng·mL-1for efavirenz,10-500 ng·mL-1for lamivudine and 10-500 ng·mL-1for tenofovir with the linear correlation coeffificients of determination(R2) of all higher than 0.998.The accuracy of both intra-day and inter-day studies ranged from 94.0%-109.3%,and the relative standard deviations were less than 7%.The IS-normalized matrix factor and extraction recoveries of all analytes were 95.7%-106.0%and 98.7%-104.5%at all concentrations.All analytes were stable in plasma at a certain storage environment.The trough blood concentrations of dolutegravir,efavirenz,lamivudine and tenofovir were 107.7-2 366.0,740.0-3 410.0,38.5-1 229.3,31.6-224.4ng·mL-1in HIV patients,respectively. Conclusion The method is highly aceurate,easy to perform,low-cost,and suitable for therapeutic drug monitoring of dolutegravir,raltegravir,efavirenz,lamivudine and tenofovir in HIV patients.

  • ZHUANG Weiping, HU Qin, JIANG Hongliang, HUANG Jiangeng, WU Dongcheng
    Herald of Medicine. 2023, 42(12): 1791-1795. https://doi.org/10.3870/j.issn.1004-0781.2023.12.008

    Objective To develop an accurate,rapid and sensitive flow cytometry method for the determination of anti-mesenchymal stem cell antibody in cynomolgus monkey serum. Methods After the solutions of mesenchymal stem cell were centrifuged and washed,and the suspension was taken,positive controls or actual samples were added and incubated with mesenchymal stem cell,then were incubated with protein L-PE solution.After the removal of the free protein L-PE,the mean fluorescence intensity of the PE was detected by flow cytometry. Results The method sensitivity is 115.54 ng·mL-1,far higher than the non-clinical research recommended sensitivity of 250-500 ng·mL-1.The precision of intra-assay and inter-assay were less than 20%.Assay cut points,low positive control concentration determination,sensitivity,precision and stability were validated in this study. Conclusion The method is proved to be sensitive,specific,rapid and suitable for the determination of anti-mesenchymal stem cell antibody in monkey serum and immunogenicity study.

  • YU Xiaxia, ZENG Yutong, YANG Jiahong, WU Jing, XU Yan, HUANG Yin
    Herald of Medicine. 2023, 42(12): 1796-1801. https://doi.org/10.3870/j.issn.1004-0781.2023.12.009

    Objective To establish a high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the simultaneous determination of seven vitamin Bs (VBs) in rat plasma. Methods The plasma samples were pretreated using the protein precipitation method.The chromatographic separation was achieved using an Agilent ZORBAX SB-Aq column (2.1 mm×150 mm,3.5 μm),with a mobile phase composed of 0.01% formic acid (A) and methanol (B) in a gradient elution mode.The flow rate was set at 0.3 mL·min-1 and the column temperature was maintained at 30 ℃.Mass spectrometric detection was performed using positive ion mode in multiple reaction monitoring.2,4,5,6-Deuteronicotinamide was used as the internal standard. Results Methodological validation results showed that the lowest limits of quantitation (LOQs) for the seven VBs ranged from 7.5 to 300 ng/mL,while the highest LOQs ranged from 1 000 to 20 000 ng·mL-1.Within a certain concentration range,all compounds showed a good linearity (r2>0.992 2).The accuracies ranged from 86.0% to 117.6%,and both intra- and inter-batch precision were less than 20%.Additionally,all analytes demonstrated extraction recoveries greater than 86.1%.No significant matrix effects were observed,and the stability was good.The established validation method was successfully applied to the pharmacokinetics study of single intragastric administration of VB solution in SD rats. Conclusion The analytical method established in this study is simple,rapid,sensitive,and exclusive for the simultaneous determination of VB in real plasma samples.This LC-MS/MS method provides a new analytical tool for further exploring the physiological and pathological effects of VB.

  • XU Guojia, JIANG Xin, XIA Bin, SI Luqin, HUANG Jiangeng, LI Dan, ZHANG Yongjun
    Herald of Medicine. 2023, 42(12): 1772-1778. https://doi.org/10.3870/j.issn.1004-0781.2023.12.005

    Objective The metabolites of tolvaptan in rats were identified by ultra-performance liquid chromatography-quadrupole-exactive orbitrap high-resolution mass spectrometry (UFLC-Q-Exactive Orbitrap MS),and the possible metabolic pathways of tolvaptan in rats were discussed. Methods Plasma,urine and fecal samples from rats were collected after a single oral administration of 60 mg·kg-1 tolvaptan solid dispersion solution.The protein in the samples was precipitated with acetonitrile.UFLC-Q-exactive orbitrap MS technology was adopted for the sample analysis and the data were processed by Xcalibur 2.0 software. Results According to the retention time,precise relative molecular mass,characteristic fragment ions and related literature reports of each compound,35 metabolites were identified in rat biological samples.Moreover,23,26 and 30 metabolites in the plasma,urine and feces were identified,respectively.The major metabolic pathways of tolvaptan were identified as hydroxylation,carboxylation,hydrolysis,dehydrogenation,glucuronidation and acetylation. Conclusion Our study confirmed the major metabolites of tolvaptan in rats,enriched the metabolite spectrum of tolvaptan in vivo,and provided an experimental basis for the in-depth study of the pharmacodynamic substance basis of tolvaptan.

  • HUANG Xuan, XIE Han, GE Weihong, ZHOU Yujie
    Herald of Medicine. 2024, 43(2): 215-220. https://doi.org/10.3870/j.issn.1004-0781.2024.02.011

    Originally used as an antimalarial drug,hydroxychloroquine is now widely used in the treatment of rheumatic immune diseases due to its cost-effectiveness,safety,and efficacy.In addition to its immunomodulatory effects,hydroxychloroquine also exhibits antithrombotic,anti-hypolipidemic,and anti-hypoglycemic properties.Hydroxychloroquine blood levels are correlated with clinical outcomes and adverse reactions,and can reflect patient compliance.However,due to the complex pharmacokinetic profile of hydroxychloroquine,significant inter-individual differences in blood concentration exist even with the administration of the same dosage.This study investigates the factors affecting the blood concentration of hydroxychloroquine in terms of physiological factors,pathological factors,metabolic enzyme gene polymorphisms,and drug-related factors.The aim is to provide a reference for rational clinical use and the development of individualized dosing.

  • Herald of Medicine. 2024, 43(3): 321-333. https://doi.org/10.3870/j.issn.1004-0781.2024.03.001
    Objective To provide a comprehensive evaluation framework for assessing the value of clinical pharmacy services, and to offer guidance for improving and optimizing the provision of clinical pharmacy services. Methods The World Health Organization (WHO) handbook for guideline development were used for the research design of the evaluation system guidelines. The Delphi method was used to identify clinical questions. The secretariat conducted systematic searches and collected existing evidence for the identified questions. Systematic reviews and evidence grading were performed,and evidence summaries were created. Based on the analysis report from the secretariat,the writing group developed specific guidelines. The Australian Joanna Briggs Evidence Level System, and the Grading of Recommendations Assessment,Development,and Evaluation (GRADE) system recommended by the World Health Organization in 2004 were used to grade the quality of evidence for this guideline. Consensus on recommendations and evidence grading was reached through a Delphi process. Finally,the practice Guidelines for the Value Evaluation of Clinical Pharmacy Services (First Edition) were established. Results More than 100 experts participated in the voting process by the Delphi method,and 23 value indicators for assessing the value of clinical pharmacy were included in the guidelines. The included indicators were searched and relevant systematic reviews,meta-analyses,network meta-analyses,and original studies were identified following the PICO principle. The Guideline Development Committee reviewed each search strategy. Consensus was reached on the definition and content of the included indicators,and 20 recommendations for the value assessment of clinical pharmacy were determined. Conclusion This guideline provides a set of indicators for measuring the quality and effectiveness of clinical pharmacy services,which is of great significance for improving the quality of clinical pharmacy services.
  • ZHONG Like, MI Xiufang, SHU Qi, XU Gaoqi, HE Chaoneng, ZHU Junfeng
    Herald of Medicine. 2024, 43(2): 196-202. https://doi.org/10.3870/j.issn.1004-0781.2024.02.008

    Objective To establish a quality control method for monitoring the blood concentrations of cyclosporin A and tacrolimus by HPLC-MS/MS,and to evaluate the quality control samples using the Westgard multi-rule theory. Methods HPLC-MS/MS was used to determine the concentration of cyclosporin A and tacrolimus in human whole blood.The quality control samples of low,medium and high concentration levels in the therapeutic drug monitoring process were statistically analyzed,Levery-Jennings and Z-score quality control charts were drawn,and the Westgard multi-rule theory was applied for in-house quality control evaluation. Results The established method was fully validated with linear ranges of 10.40-1 040.00 ng·mL-1and 0.50-49.50 ng·mL-1,the quantification limits were 10.40 and 0.50 ng·mL-1,respectively.The extraction recoveries were 108.61%-113.24%and 101.99%-109.37%,respectively.The matrix factors normalized by internal standard were 106.68%-111.27%and 95.70%-97.81%for cyclosporin A and tacrolimus,respectively.The intra-day and inter-day accuracy and precision were less than 15.0%.Other parameters were also validated and met the acceptance criteria.Levery-Jennings and Z-score quality control charts showed that there were 4 warnings (violation of the 12s rule) in the results of the 26 groups of quality control samples in the third quarter of 2022,and no phenomenon was observed to be out of control. Conclusion The established in-house quality control system for therapeutic drug monitoring of cyclosporin A and tacrolimus can effectively ensure the accuracy of blood drug concentration detection.

  • FAN Jing, TANG Haoxiang, WANG Yinghui, FAN Weibin, XIE Jiao, LIN Bin
    Herald of Medicine. 2024, 43(2): 190-195. https://doi.org/10.3870/j.issn.1004-0781.2024.02.007

    Objective To establish a highly sensitive,stable,and universally applicable ultra-high-performance liquid mass spectrometry tandem method (UPLC-MS/MS) for simultaneous determination of nirmatrelvir and ritonavir blood concentrations in human plasma. Methods The separation was performed on an ACQUITY UPLC BEH C18 column (2.1 mm×50 mm,1.7 μm) with gradient elution,and the mobile phase consisted of 0.1% formic acid-water and 100% acetonitrile at the flow rate of 0.3 mL·min-1.The column temperature was 45 ℃,and the injection volume was 2 μL.Electrospray ionization as ion source (ESI+) was used as the ion source and multiple reactions monitoring mode (nirmatrelvir m/z 500.20→319.10,nirmatrelvir-D9 m/z 508.59→328.10,ritonavir m/z 721.30→426.10,13C,2H3-ritonavir m/z 725.30→426.10) was adopted.Thirty patients with coronavirus disease 2019(COVID-19) treated with nirmatrelvir and ritonavir at the People's Hospital of Changxing County in Jan.2023 were selected to measure their steady-state trough concentrations of nirmatrelvir and ritonavir after 3 days of treatment. Results The linear range of nirmatrelvir was 0.100-10.0 μg·mL-1 (R2=0.997 2),and the linear range of nirmatrelvir was 0.050-5.00 μg·mL-1 (R2=0.995 2).The recovery rates of nirmatrelvir and lopinavir were both >90% and the intra-batch and inter-batch precision relative standard deviations (RSDs) were both <10%.Additionally,the recovery ranges for nirmatrelvir and lopinavir were 91.5%-97.0%,and the matrix effects ranged from 92.4% to 97.7%.The results of clinical samples showed that the plasma concentrations of nirmatrelvir and ritonavir in patients with COVID-19 varied greatly among individuals. Conclusion The method for simultaneous determination of nirmatrelvir and ritonavir concentrations in human plasma established in this study is convenient,highly specific,highly accurate,with high precision,which is suitable for monitoring the concentrations of nirmatrelvir and ritonavir in patients.

  • Expert Panel of Beijing Pharmaceutical Association Smart Pharmacy and Intelligent Management Professional Committee, Branch of Rational Drug Use and Comprehensive Evaluation, Expert Panel of Chinese Pharmacists Association Regional Pharmaceutical Care Promotion Working Committee, Expert Panel of China Smart Pharmaceutical Alliance
    Herald of Medicine. 2024, 43(1): 1-4. https://doi.org/10.3870/j.issn.1004-0781.2024.01.001

    Ensuring the rational drug use in healthcare institutions is an important instruction issued by the National Health Commission to strengthen the comprehensive supervision of health care.With the rapid improvement of the healthcare services in China and the continuous expansion of outpatient and emergency treatment scale,the number of prescriptions has increased sharply.The prescription information review system based on rational drug use database has become an important tool for pharmaceutical care.Supported by the Beijing Pharmaceutical Association Smart Pharmacy and Intelligent Management Professional Committee,Branch of Rational Drug Use and Comprehensive Evaluation,Chinese Pharmacists Association Regional Pharmaceutical Care Promotion Working Committee and China Smart Pharmaceutical Alliance,experts from healthcare institutions work on the expert consensus on the information audit of outpatient and emergency prescriptions in healthcare institutions.This consensus aims to promote the standardization and unification of outpatient and emergency prescription information audit from medical institutions at all levels,help build a standardized prescription information audit system and a rational drug use database with all-around information,enhance the accuracy of prescription and acceptance by doctors and patients,and further improve the level of rational drug use in healthcare institutions in China and promote the informatization and intelligent development of hospital pharmaceutical care.

  • LYU Ziyan, BIAN Yuan, CAI Linxuan, TONG Rongsheng, CHEN Min
    Herald of Medicine. 2024, 43(1): 5-12. https://doi.org/10.3870/j.issn.1004-0781.2024.01.002

    Objective To formulate a pharmaceutical service pathway to standardize the pharmacists' whole process of pharmaceutical services for breast cancer patients in medical institutions,promote the standardization of pharmacists' work and improve the rationality of drug use for breast cancer patients in medical institutions. Methods The editorial committee aimed at several challenging problems in the whole process of pharmaceutical services for breast cancer patients in medical institutions through systematic search,referring to the latest domestic and international guidelines and expert consensus of breast cancer and under the relevant drug administration regulations in China,collected and sorted out the professional opinions of doctors,pharmacists,and methodological experts,developed questionnaires and held two rounds of expert argumentation meetings,and finally screened out the most valuable results.The whole process management pathway of pharmaceutical care for breast cancer patients was formulated,and the referral principles of hospitals at different levels and the contents of pharmacist training and assessment were clarified. Results The whole process management pathway of pharmaceutical services for breast cancer patients was developed,including information collection,analysis,evaluation,development implementation of intervention plans,and follow-up. Conclusion This pharmaceutical service pathway can standardize and guide pharmacists in hospitals at different levels to carry out pharmaceutical services for breast cancer patients,achieve the whole process of monitoring drug use,and ensure rational drug use and treatment effectiveness for patients.

  • JIAO Quanhui, ZHONG Lingyun, CHENG Ziwen, LYU Xiaobin, ZHANG Changhua
    Herald of Medicine. 2024, 43(3): 408-413. https://doi.org/10.3870/j.issn.1004-0781.2024.03.014

    Ferroptosis is a unique iron-dependent cell death pattern,a novel death phenotype distinct from apoptosis,various forms of necrosis,and autophagy.Numerous active ingredients extracted from traditional Chinese medicine have been found to exert anti-cancer effects by inducing ferroptosis in various cancers.An increasing number of studies have found that the regulation of ferroptosis can influence the sensitivity of tumor cells to drugs and even reverse drug resistance.When combined with chemotherapy drugs such as cisplatin,5-FU and gemcitabine, some natural products enhance cancer cells’ sensitivity to chemotherapeutic drugs by inducing ferroptosis.This paper mainly summarizes traditional Chinese medicine and its natural products that can exert anti-cancer effects by inducing ferroptosis,providing new insights for cancer treatment and drug resistance reversal.Additionally, it contributes to exploring the potential advantages of traditional Chinese medicine, thereby expanding its scope of application.

  • YIN Jiaxin, SONG Yuxiao, ZHANG Bicheng
    Herald of Medicine. 2024, 43(3): 352-359. https://doi.org/10.3870/j.issn.1004-0781.2024.03.004

    Immunotherapy,represented by immune checkpoint inhibitors (ICIs),has significantly changed the treatment strategy of non-small cell lung cancer (NSCLC) and has become an important therapy for all stages of NSCLC.However,there is an urgent need for further clarification regarding ICIs for elderly patients with advanced NSCLC.Treatment strategies for ICIs were guided by assessing survival data of elderly NSCLC patients included in clinical trials.We concluded that treatment regimens such as ICI monotherapy,dual immunotherapy,and ICIs combined with chemotherapy could be carried out in elderly NSCLC patients with a performance status (PS) score <2.Elderly NSCLC patients treated with ICIs could achieve similar benefits as younger patients and are generally well tolerated.However,as age increases (especially above 80 years),the efficacy decreased and the incidence of immune-related adverse events (irAEs) gradually increased.Therefore,ICIs should be carefully selected for advanced NSCLC patients at an advanced age.Compared to age,PS was a key factor causing patients to be excluded from ICIs and poorer survival outcomes.In conclusion,immunotherapy in elderly patients with advanced NSCLC is extremely challenging,and many issues still need further exploration in this field.

  • WANG Xinli, XUE Yan
    Herald of Medicine. 2024, 43(3): 360-365. https://doi.org/10.3870/j.issn.1004-0781.2024.03.005

    Elderly breast cancer patients have different characteristics from young breast cancer patients,and their treatment faces many challenges.The treatment for elderly patients with breast cancer is often based on retrospective studies or evidence of general population lacks Class I clinical evidence. This article summarized the relevant clinical studies of advanced breast cancer with different molecular subtypes,explored the optional treatments and development directions for advanced elderly breast cancer,and provided reference for clinicians.

  • Personalized Drug Therapy Key Laboratory of Sichuan Province, Department of Pharmacy, Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital, Affiliated Hospital of University of Electronic Science and Technology of China, Chinese Society of Clinical Pharmacy, Professional Committee of Pharmacoepidemiology of Chinese Pharmaceutical Society, Pharmacoepidemiology Committee of Sichuan Pharmaceutical Society
    Herald of Medicine. 2023, 42(12): 1737-1751. https://doi.org/10.3870/j.issn.1004-0781.2023.12.001

    Objective To provide medical institutions with expert recommendations for the rational off-label use of key monitored drugs and to guide healthcare professionals in further standardizing the application of national monitored drugs. Methods The research design for reaching expert consensus on the rational clinical use of national monitored drugs beyond their approved indications followed the guidelines of the World Health Organization (WHO).A systematic search was conducted to extensively collect common issues related to the off-label use of the second batch of national monitored drugs in various provinces.The Delphi method was used to survey experts and identify common off-label use items for the key monitored drugs.Literature research and expert experience were utilized to collate and form relevant body of evidence,and quality evaluation was carried out in accordance with the GRADE approach.Consensus was reached again through the Delphi method regarding the recommended advice and evidence level,which ultimately led to the formation of the “Expert Consensus on the Rational Clinical Use of Nationally Monitored Drugs Beyond Their Approved Indications.” Results A survey questionnaire was conducted among 60 experts through an online survey,and a consensus on off-label use items was reached using the Delphi method,covering drug categories such as proton pump inhibitors,antibiotics,glucocorticoids,and other medications.A total of 37 clinical issues were identified,resulting in a total of 38 recommended pieces of advice. Conclusion This consensus provides a reference and supplement for medical institutions to develop clinical application norms and prescription (medical order) review rules for national monitored drugs,to ensure the effectiveness and safety of their use.It further improves the quality of medical services,reduces the risk of adverse events related to national monitored drugs,promotes rational drug use.

  • WANG Liqiang, DENG Haiyi, LIU Ming, LIN Xinqing, XIE Xiaohong, XIE Zhanhong, QIN Yinyin, OUYANG Ming, ZHOU Chengzhi
    Herald of Medicine. 2024, 43(3): 365-373. https://doi.org/10.3870/j.issn.1004-0781.2024.03.006

    Patients with severe tumors do not refer to the patients with end-stage tumors,but rather to the patients with a performance status(PS) score between 2 and 4 in certain stages due to various reasons,such as acute or chronic comorbidities,tumor itself,or treatment-related adverse events.To these patients,there is a high probability of achieving survival benefit and/or improvement in PS scores after synergistic management of available life-support technologies and anti-tumor therapies based on dynamic and precise testing.Elderly patients with tumors frequently present with one or more chronic illnesses and have poor tolerance and compliance to treatment.Moreover,their treatment regimens often lack high-quality clinical evidence,making them more susceptible to developing severe tumors.The management of severe tumors in the elderly is based on three basic diagnosis and treatment technologies:dynamic and precise detection,powerful life support technologies,and skillful application of current anti-tumor treatments.In specific clinical practice,the following 7 flexible and individualized treatment strategies should be adopted for different tumor types:1.concurrent management of cancer and comorbidities,2.upgrading and downgrading of anti-tumor drugs based on PS score,3.dynamic accurate detection,4.skillful combinations for increasing efficacy and reducing toxicity,5.complete overview,paying equal attention to systemic therapy and local therapy,6.safety first in medication for the elderly,7.multi-disciplinary participation,individualized and comprehensive treatment.This article introduced the concept of severe tumors in the elderly and the associated management strategies,to increase awareness and provide feasible guidance for clinical practice.

  • SUN Yiting, TENG Zan, LIU Yunpeng, QU Xiujuan
    Herald of Medicine. 2024, 43(3): 374-380. https://doi.org/10.3870/j.issn.1004-0781.2024.03.007

    Senescence is the major risk factor that promotes development of different stages of chronic liver diseases and is closely related to occurrence of hepatocellular carcinoma.Significant differences consist in clinicopathological features and tumor microenvironment between elderly and young patients with hepatocellular carcinoma.With rapid development of systemic therapy,immune checkpoint inhibitors combined with targeted therapy have greatly improved the prognosis of patients with advanced hepatocellular carcinoma.The selection of treatment decisions for elderly patients with hepatocellular carcinoma requires to consider unique age-related issues.Adequate communication and necessary evaluation should be carried out before making decisions.Elderly patients with hepatocellular carcinoma are speculated to benefit from combination immunotherapy based on age subgroup analysis of large clinical studies.However,data of effects and security obtained from clinical trials has certain limitations when being applied in elderly populations of real world.The optimal therapeutic strategies for elderly patients with hepatocellular carcinoma still remain to be further explored in large-scale prospective clinical studies.