BACKGROUND:This study assessed the real-world hepatotoxicity of third-generation aromatase inhibitors (AIs) for breast cancer using pharmacovigilance approaches. METHODS:FAERS data (Q1 2004-Q1 2025) were analysed using a data-driven disproportionality analysis framework incorporating traditional frequentist metrics and an information-theoretic Bayesian network. RESULTS:A total of 24 liver-related adverse events and 7 clinical outcomes were extracted in this study. Letrozole associated with the highest number of hepatotoxicity cases and showed the highest BCPNN-supported reporting signal. Exemestane exhibited the earliest hepatotoxicity onset (median 49 days), significantly earlier (p = 0.047) than anastrozole (61.5 days) and letrozole (56 days). CONCLUSION:AIs present distinct hepatotoxic profiles. Exemestane requires early vigilance due to its rapid onset, while letrozole exhibits the highest signal. Proactive liver monitoring and individualised management are crucial. Future research should integrate artificial intelligence with multi-modal real-world data for predictive risk assessment.

IntroductionAntibody-drug conjugates (ADCs) targeting the human epidermal growth factor receptor 2 (HER2), including trastuzumab deruxtecan (T-DXd) and trastuzumab emtansine (T-DM1), have already altered the treatment landscape for HER2-positive malignancies. Interstitial lung disease (ILD) associated with ADCs presents as a fatal adverse reaction, yet it remains inadequately characterized in real-world contexts.AimThis study was to refine the risk profiles of these agents using ILD cases drawn from the FDA Adverse Event Reporting System (FAERS) to examine the clinical features.MethodILD cases were extracted from FAERS. Disproportionality analyses and survival analyses were used to assess risk signals, onset kinetics, and mortality.ResultsT-DXd exhibited stronger ILD signals and shorter time-to-onset than T-DM1 (acute respiratory distress syndrome [73d vs. 403d, p = 0.033], pneumonitis [62.5d vs. 106d, p = 0.035]). No statistically significant differences were observed in fatal cases.ConclusionT-DXd exhibits more reporting cases and an earlier onset time of ILD compared to T-DM1. Proactive monitoring, including earlier radiographic screening, is warranted, particularly for patients at risk of acute respiratory distress syndrome and pneumonitis.Impact StatementsThis study provides crucial evidence through large-scale real-world data that T-DXd is associated with a significantly higher number of reported cases of ILD and a shorter time to onset compared to T-DM1. This comprehensive characterization of ILD signals and timing in real-world clinical practice provides direct evidence for clinicians to conduct risk-benefit assessments and highlights the importance of early detection strategies starting within months of T-DXd therapy.

Agarwood, chenxiang, is a traditional Chinese medicine. It is the resinous heartwood of Aquilaria sinensis. The qinan germplasm of A. sinensis is a high-quality resource. This study aimed to investigate the chemical compounds and biological activities of agarwood produced from the qi-nan germplasm (QNA) and evaluated the quality of the QNA according to existing standards. The QNA was extracted by using supercritical CO2 (SCE) and then by 90 % EtOH (ETE). SCE was detected with gas chromatography-mass spectrometry (GC-MS) to identify 13 compounds, including sesquiterpenoids and 2-(2-phenylethyl)chromones. ETE was isolated by using column chromatography methods to yield two new compounds: 5-hydroxy-2-[2-(4-methoxy)phenethyl]chromone (1) and qinansin A (2), and 13 known compounds (3-15). The various biological activities of SCE, ETE, and these isolated compounds were evaluated. Compound 1 , compound 2 , 2-(2-phenylethyl)chromone (4), 2-[2(-4methoxy)phenethyl]chromone (5), 2-[2-(2-hydroxy)phenethyl]chromone (6), chenanone A (8), (E)-1-chloro-4- (4-methoxyphenyl) but-3-en-2-one (9), (E)-1,5-diphenylpentan-1-en-3-one (12), and selina-4,11(13)-diene12,15-dial (14) demonstrated antifungal activity against Epidermophyton floccosum, Trichophyton rubrum, and Microsporum gypseum, with IC50 values ranging from 3.50-83.45 mu & Mcy;. Moreover, compound 12 exhibited antiinflammatory activity (NO production inhibition; IC50 = 23.42 mu M); additionally, compound 8 showed antioxidant activity (DPPH free radical scavenging; IC50 = 40.89 mu M), and compound 14 showed cytotoxicity to five cancer cell lines and human normal lung epithelial BEAS-2B cells, with IC50 values ranging from 3.35-16.95 mu M. The quality of the QNA was evaluated according to the Chinese Pharmacopoeia and the local standards of Hainan Province, China. The findings indicated that the alcoholic extract contents and the contents of 2-(2-phenylethyl) chromone and 2-[2-(4-methoxyphenyl)ethyl]chromone of QNA were within high-quality ranges, and they increased with prolonged agarwood formation time. These results could provide a basis for the further development and utilization of QNA.

BACKGROUND AND AIMS:Malnourished patients, who undergo gastrointestinal (GI) surgery, have a higher risk of postoperative complications, including higher rates of morbidity and mortality. Generally, a low-fiber diet is recommended after GI surgery. This study investigated the tolerance and clinical outcomes of an enteral formula supplemented with partially hydrolyzed guar gum (PHGG)-a soluble, prebiotic dietary fiber known to benefit gastrointestinal health-in Chinese patients following GI surgery, using a standard fiber-free formula as the control.. METHODS:This study enrolled 631 patients requiring enteral nutrition following GI surgery. Participants were subsequently randomized to receive either a fiber-enriched formula containing 15 g/L PHGG (experimental group, n = 313) or a standard fiber-free formula (control group, n = 318) for 5 days. Data on feeding effectiveness, tolerability, and clinical outcomes were subsequently collected. RESULTS:The incidence of diarrhea was 9.6 % (95 % confidence interval [CI]: 6.3 to 12.8) in the experimental group and 10.1 % (95 % CI: 6.8 to 13.4) in the control group, with an absolute difference of -0.5 (95 % CI: -5.1 to 4.2) confirming non-inferiority (P < 0.001). In patients who consumed ≥4500 kcal over 5 days (averaging 900 kcal/day), the experimental group showed significantly improved feeding tolerance, with a reduced prevalence of diarrhea and abdominal distension (10.4 % vs 24.7 %, P = 0.045; 19.4 % vs 38.4 %, P = 0.016). Patients with gastric cancer in the experimental group had significantly less abdominal distension (22.7 % vs 48.8 %; P = 0.014). Regarding weight preservation, the experimental group demonstrated benefits in weight preservation at discharge (%weight change: -1.39 vs -2.33, P = 0.049). Thirty days after surgery, the experimental group had better EQ-5D scores, especially in E4 pain/discomfort and E5 anxiety. CONCLUSIONS:The PHGG-enriched enteral nutrition formulation is well-tolerated and non-inferior to a fiber-free formula among patients following GI surgery. To maximize its benefits on GI tolerance and body weight preservation, a daily intake of 800-900 kcal is suggested, though this warrants further validation. The trial protocol was registered at www.chictr.org.cn (Identifier: ChiCTR2000038429).

Background Programmed cell death protein 1 (PD-1) inhibitors are commonly used worldwide for the management of non-small cell lung cancer (NSCLC). However, it remains unclear whether pembrolizumab and sintilimab, two of the most widely used PD-1 inhibitors in China, have significantly different effects on patients with NSCLC. A multicenter retrospective cohort study was designed and implemented using propensity-score matching (PSM) analysis to compare the effectiveness and safety profiles of pembrolizumab and sintilimab in patients with advanced NSCLC undergoing comprehensive therapy. Methods A total of 225 patients who received comprehensive therapy including pembrolizumab (n = 127) or sintilimab (n = 98), from 1 January to 31 December 2020 and met the eligibility criteria were included. PSM analysis (1:1) was performed to balance potential baseline confounding factors. For both treatments, Kaplan-Meier analysis and Cox regression were used to compare 1-year progression-free survival (PFS), disease control rate (DCR), objective response rate (ORR), and rates of all adverse events (AEs). Results PSM analysis resulted in 63 matched pairs of patients. After PSM, the median PFS was 8.68 months in the sintilimab group and 9.46 months in the pembrolizumab group. The 1-year PFS showed no significant difference between the pembrolizumab and sintilimab groups before and after PSM (P = 0.873 and P = 0.574, respectively). Moreover, within the matched cohort, the pembrolizumab group had an ORR of 30.2% and a DCR of 84.1%, whereas the sintilimab group exhibited an ORR of 41.3% and a DCR of 88.9%. There were no significant differences in the ORR and DCR between the two groups (P = 0.248 and P = 0.629, respectively). The incidence of grade 3 or 4 treatment-related AEs was significantly higher in the pembrolizumab group than that in the sintilimab group (42.9% vs. 33.3%, P = 0.043). Multivariable Cox proportional hazards regression analysis indicated that the lines of treatment and regimens significantly influenced the PFS of patients (P <0.05). Conclusions This study demonstrated the similar effectiveness of sintilimab and pembrolizumab in the treatment of patients with advanced NSCLC, with sintilimab potentially displaying a superior clinical safety profile. Clinical trial registration https://www.medicalresearch.org.cn/, identifier MR4423000113.

Background:The rate at which the anticancer drug paclitaxel is cleared from the body markedly impacts its dosage and chemotherapy effectiveness. Importantly, paclitaxel clearance varies among individuals, primarily because of genetic polymorphisms. This metabolic variability arises from a nonlinear process that is influenced by multiple single nucleotide polymorphisms (SNPs). Conventional bioinformatics methods struggle to accurately analyze this complex process and, currently, there is no established efficient algorithm for investigating SNP interactions. Methods:We developed a novel machine-learning approach called GEP-CSIs data mining algorithm. This algorithm, an advanced version of GEP, uses linear algebra computations to handle discrete variables. The GEP-CSI algorithm calculates a fitness function score based on paclitaxel clearance data and genetic polymorphisms in patients with nonsmall cell lung cancer. The data were divided into a primary set and a validation set for the analysis. Results:We identified and validated 1184 three-SNP combinations that had the highest fitness function values. Notably, SERPINA1, ATF3 and EGF were found to indirectly influence paclitaxel clearance by coordinating the activity of genes previously reported to be significant in paclitaxel clearance. Particularly intriguing was the discovery of a combination of three SNPs in genes FLT1, EGF and MUC16. These SNPs-related proteins were confirmed to interact with each other in the protein-protein interaction network, which formed the basis for further exploration of their functional roles and mechanisms. Conclusion:We successfully developed an effective deep-learning algorithm tailored for the nuanced mining of SNP interactions, leveraging data on paclitaxel clearance and individual genetic polymorphisms.

Cyclic dipeptides (CDPs), known for their diverse biological activities, have potential therapeutic applications in mental and behavioral disorders (MBDs), particularly schizophrenia. This study explores the CDPs’ therapeutic potential using bibliometric analysis, network pharmacology, molecular docking, and experimental verification, focusing on the interactions with the SIGMA1 receptor. A literature review over three decades utilizing the Web of Science Core Collection (WOSCC) was conducted to identify the emerging trends in CDPs research. A compound library was constructed from the PubChem database, and target prediction using SwissTargetPrediction revealed 800 potential protein targets. A compound–target network highlighted the key interactions with kinases, G protein-coupled receptors, and chromatin-modifying enzymes. Enrichment analysis revealed significant associations with schizophrenia and other MBDs. Schizophrenia-related targets among the potential protein targets were identified using the GEO database. Molecular docking results showed interactions of MC4R, OPRK1, SIGMA1, and CDK5R1 with various CDPs compounds, with SIGMA1 being especially noteworthy. Most CDPs exhibited lower binding energies than the control compounds NE-100 and duloxetine. Experimental validation demonstrated that CDPs such as Cyclo(Ala-Gln), Cyclo(Ala-His), and Cyclo(Val-Gly) exhibited IC50 values of 13.4, 19.4, and 11.5 μM, respectively, against SIGMA1, indicating biological activity. Our findings underscore their potential as therapeutic agents for schizophrenia, highlighting the need for further modifications to enhance specificity and efficacy. This work paves the way for future investigations into CDPs, contributing to developing targeted treatments for schizophrenia and related mental health disorders.

Macrophage-to-osteoclast differentiation (osteoclastogenesis) plays an essential role in tumor osteolytic bone metastasis (BM), while its specific mechanisms remain largely uncertain in lung adenocarcinoma BM. In this study, we demonstrate that integrin-binding sialoprotein (IBSP), which is highly expressed in the cancer cells from bone metastatic and primary lesions of patients with lung adenocarcinoma, can facilitate BM and directly promote macrophage-to-osteoclast differentiation independent of RANKL/M-CSF. In vivo results further suggest that osteolytic BM in lung cancer specifically relies on IBSP-induced macrophage-to-osteoclast differentiation. Mechanistically, IBSP regulates the Rac family small GTPase 1 (Rac1)NFAT signaling pathway and mediates the forward shift of macrophage-to-osteoclast differentiation, thereby leading to early osteolysis. Moreover, inhibition of Rac1 by EHT-1864 or azathioprine in mice models can remarkably alleviate IBSP-induced BM of lung cancer. Overall, our study suggests that tumor-secreted IBSP promotes BM by inducing macrophage-to-osteoclast differentiation, with potential as an early diagnostic maker for BM, and Rac1 can be the therapeutic target for IBSP-promoted BM in lung cancer.

AimThis study comprehensively assesses the incidence and profiles of treatment-related adverse events (trAEs) of immune checkpoint inhibitor (ICI)-based therapies across cancer at various sites.MethodsWe systematically searched the PubMed, Embase, and Cochrane databases for trials investigating ICI-based therapies published between their inception and August 2023.ResultsIn total, 147 studies involving 45,855 patients met the inclusion criteria. Among them, patients treated with ICIs reported 39.8% and 14.9% of all-grade and grade ≥3 immune-related adverse events (irAEs), respectively. The most common all-grade irAEs were dermatological and gastrointestinal issues, diarrhea, and pruritus, whereas patients who received ICIs showed most common grade ≥3 irAEs, including gastrointestinal events, diarrhea, increased aspartate aminotransferase and alanine transaminase levels, and hepatic and dermatological events. The overall trAE incidence in patients treated with ICIs was 83.2% for all-grade trAEs and 38.2% for grade ≥3 trAEs. TrAE incidence was highest for patients treated with cytotoxic T lymphocyte antigen-4 inhibitors for all-grade and grade ≥3 trAEs, with incidences of 86.4% and 39.2%, respectively. ICIs combined with targeted therapy showed the highest all-grade and grade ≥3 trAEs, with incidences of 96.3% and 59.4%, respectively. The most common all-grade trAEs were anemia, decrease in white blood cell count, decrease in neutrophil count, nausea, fatigue, diarrhea, and alopecia; patients who received ICIs presented relatively high incidences of grade ≥3 trAEs.ConclusionThis study provided comprehensive data regarding irAEs and trAEs in patients receiving ICIs. These results should be applied in clinical practice to provide an essential reference for safety profiles of ICIs.Systematic review registrationINPLASY platform, identifier INPLASY202380119.

目的 探讨贝伐珠单抗联合化疗治疗非小细胞肺癌(NSCLC)患者的疗效及不良反应,并分析可能影响贝伐珠单抗治疗效果的影响因素.方法 选取2017年1月至2019年12月中国医学科学院北京协和医学院肿瘤医院接受贝伐珠单抗联合化疗治疗的晚期NSCLC患者为研究对象.采用SPSS 22.0软件进行统计学分析,采用log-rank检验进行单因素分析,Cox回归模型进行多因素分析.结果 共纳入77例贝伐珠单抗联合化疗治疗的NSCLC患者,客观缓解率为27.3%,疾病控制率为67.5%,中位无进展生存期(PFS)为7.0个月;使用前T分期为T1～T2(HR=2.627,P=0.048)、贝伐珠单抗使用时机为化疗第1个周期后(HR=0.214,P=0.018)、贝伐珠单抗使用周期＞4个周期(HR=0.219,P=0.001)是影响患者PFS的独立预后因素.与同期行常规化疗未使用贝伐珠单抗治疗的患者匹配后相比,接受贝伐珠单抗联合化疗治疗的患者出现高血压、出血、蛋白尿及尿素氮的风险增高,但未发生严重的不良反应.结论 贝伐珠单抗联合化疗治疗NSCLC患者疗效确切,安全可控,尤其对于第1个周期化疗后使用贝伐珠单抗、使用周期＞4个周期、T分期越早(T1～T2)的患者使用贝伐珠单抗治疗的效果越好.

Background Immunotherapy shows promise as a treatment option for various cancers. However, there is growing concern over potential complications from hepatitis B virus (HBV) reactivation after checkpoint blockade immunotherapy. Although most of the previous clinical trials on immune checkpoint inhibitors (ICIs) excluded patients with HBV, a few case reports and retrospective studies of HBV reactivation have been published. The aim of this study is to assess the risk of hepatitis B virus reactivation (HBVr) in patients receiving ICIs for advanced cancer. Methods English and Chinese language literature published prior to April 30, 2023, was searched in PubMed, EMBASE, Web of Science, Cochrane, SinoMed, CNKI and Wanfang Data for studies reporting HBVr rates in cancer patients treated with ICIs. A pooled risk estimate was calculated for HBVr rates with 95% confidence intervals ( CI ). Results Data from 34 studies including 7126 patients were retrieved and analyzed. The pooled HBVr rate in cancer patients treated with ICIs was 1.3% ( I 2 = 90.44%, 95% CI : 0.2–2.9%, P < 0.001). Subgroup analysis revealed that patients diagnosed with hepatocellular carcinoma (HCC), HBV carriers, and patients from Asian regions or in developing countries have a higher rate of HBVr. Conclusions Our meta-analysis demonstrated a low risk of HBVr in patients treated with ICIs for advanced cancer. ICI treatment may be safely used in patients with existing HBV infection or chronic hepatitis B, accompanied by regular monitoring and appropriate antiviral prophylaxis if necessary. Graphical Abstract

目的 探讨培美曲塞罕见下肢皮肤不良反应临床特征及处理措施.方法 分析1例非小细胞肺癌患者应用注射用培美曲塞二钠致小腿罕见皮肤毒性病例,结合相关文献,总结本类罕见皮肤毒性临床表现及适宜治疗方式.结果 本例患者主要临床表现为肿胀、多形红斑、瘙痒、色素沉着、疼痛、硬化、发热,与国外报道的培美曲塞相关性硬皮样改变相似,应用抗菌药物治疗效果不明显,在降低培美曲塞化疗剂量,使用激素、抗组胺药物对症治疗后明显缓解.结论培美曲塞相关硬皮样改变未列入培美曲塞已知不良反应,常被误诊为蜂窝织炎或丹毒,可严重影响患者生存质量,应引起临床重视.

目的:比较第三批国家药品集中带量采购中标的卡培他滨仿制药与卡培他滨原研药在真实世界中的安全性与有效性.方法:以 2020 年 11 月至 2021 年 11 月中国医学科学院肿瘤医院使用仿制与原研卡培他滨治疗的患者为研究对象,收集患者人口学特征、治疗相关信息、不良事件发生情况及疗效评价等信息.将患者分为仿制药组和原研药组,进行安全性和有效性评价.结果:纳入研究的患者共 254 例,经倾向性评分匹配后,仿制药组和原研药组各 118 例,两组患者在基本特征及不良反应方面的差异均无统计学意义(P≥0.05).利用一线治疗的病例进行有效性评价,两组患者客观缓解率、疾病控制率的差异均无统计学意义(P=0.05;P=0.196).结论:仿制与原研卡培他滨在有效性和安全性方面的差异无统计学意义.

目的 分析艾迪注射液在临床的使用情况,系统评价其安全性及其关键影响因素,为艾迪注射液临床合理用药提供参考依据.方法 以全国11家医院HIS信息系统作为真实世界数据的来源,采用描述性统计学分析方法,对使用艾迪注射液患者的基本信息、诊断、辨证、给药情况、人群特征、临床用药特点、不良事件(AE)/不良反应(ADR)及其关键影响因素等数据进行系统评价.结果 临床上艾迪注射液广泛用于非小细胞肺癌、妇科肿瘤和结直肠癌等肿瘤的治疗,艾迪注射液的主要使用剂量为50～100 mL·d-1,使用时间为5～10 d;影响艾迪注射液联合方案治疗肿瘤的安全性因素包括联合方案、癌种、给药剂量、给药时间和患者情况等;艾迪注射液用药日均剂量>100 mL,AE发生率最低,第1、第2周期艾迪减轻毒性和不良反应趋势最明显;艾迪注射液能明显减轻肿瘤患者肝肾功能损伤.结论 艾迪注射液治疗各种恶性肿瘤安全性良好,能明显降低各种化疗方案不良反应发生率,值得临床广泛应用.

Purpose: To establish a pharmacist-led olaparib follow-up program for ovarian cancer patients, provide patient education, get information on adverse drug reactions (ADRs), and identify and manage drug-related problems. Methods: Ambulatory adult patients with ovarian cancer receiving olaparib were enrolled. At least one follow-up session was conducted by clinical pharmacists. Pharmacists collected data on the type and grade of ADRs, drug adherence, olaparib dosing, concomitant medications, and pharmacists’ suggestions. Results: 83 patients were enrolled with the median age of 58. The average number of the follow-up sessions provided to each patient was 1.31, and the average duration of each follow-up was 17.78 min. The olaparib starting dose for most patients (97.59%) was 600 mg/d. 36.14% of the patients had missed olaparib doses and 27.71% of the patients had dose adjustments due to ADRs. The most common ADRs (incidence≥10%) were: fatigue (40.96%), anemia (36.14%), leukopenia (36.14%), nausea (28.92%), thrombocytopenia (16.87%), anorexia (16.87%), dyspepsia (15.66%). The tolerability profiles were generally similar between patients treated for “first-line maintenance” and those treated for “recurrence maintenance” (p > .05). There were 42% of the patients who were concomitantly taking medications without exact chemical contents (such as formulated Chinese medicines and Chinese decoctions), and common types of concomitant medications with exact drug names were antihypertensive, anti-hyperglycemic, and anti-hyperlipidemic medications. The pharmacists identified 4 clinically significant drug-drug interactions (DDIs) in two patients. Pharmacists made 196 suggestions mainly related to rational use of the medications and management of ADRs. Conclusion: The study provides the first report about pharmacist-led follow-up service for olaparib. The types of ADRs were similar to those previously observed in clinical trials, and the profiles of ADRs in different types of patients (first-line maintenance vs. recurrence maintenance) were also similar. Pharmacists identified drug-related problems (such as adherence, DDIs and management of ADRs) and offer suggestions for the patients.

Purpose. The management of outpatients with cancer painis very important for medication safety. Medical interviews by CP is conducive to pain management. Our objective was to describe the contribution of the clinical pharmacist (CP) to outpatients in pain-relief clinic. Methods. This was a prospective, case-by-case self-control study. One clinical pharmacist conducted three questionnaire surveys. The first happened in the clinic face to face, the second by telephone one week later after the visit and the third by telephone two weeks later. The interventions by CP and comprehensive pain assessment (scored by NRS, sleep, mood and general activities) were both recorded. Analgesic-related knowledge were delivered by CP and were measured both before and after therapy. 1.Department of Pharmacy ,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China E-mail: erxia100@163.com2.Department of Comprehensive Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China E-mail: doccong@vip.163.com Results. 51 patients were enrolled. The top 5 interventions in the first telephone interview(second survey) was suggestions for treating adverse drug reactions(47%), correcting the wrong usage(35%), medication education(26%), recommendations for dosage adjustment(18%) and suggestions for further treatment(15%). While in the second telephone interview (third survey), the rankings were totally inverted. Comprehensive pain assessment showed better in the first interview and then worse in the second. Analgesic-related knowledge increased significantly after the education by CP. Conclusions. CP made a totally different interventions at the different stages of medication in the outpatients with cancer pain,which may be related to the pain control. Patients’ knowledge regarding analgesics significantly increased after education by CP.

目的 本研究拟通过具体案例,探讨临床药师在妇科肿瘤药物治疗中的药学服务路径.方法 根据妇科肿瘤患者的疾病特点,以案例为依据,阐释药师如何开展符合妇科肿瘤特点的药学服务.结果 妇科肿瘤是具有综合治疗特色的肿瘤,患者的用药主要包括围手术期用药和化疗用药,药学技术服务的需求较大.临床药师可以在围手术期预防性使用抗菌药物、术后感染的方案制定、化疗方案的剂量调整、患者用药教育、药物输注建议、不良反应的识别和处理等方面提供药学服务.结论 临床药师在妇科肿瘤的治疗团队中协助医师制定和调整治疗方案、为护士在药物配置和给药方法方面提供咨询,以及指导患者安全合理用药,是医、护、患沟通的桥梁,对药物治疗产生了积极作用.

PurposePaclitaxel liposome (Lipusu) is the first commercialized liposomal formulation of paclitaxel. There has been little data collected on the pharmacokinetics (PK) of paclitaxel liposome, especially in relation to patient use. This study aimed to build a population pharmacokinetic (PopPK) model and further explore the exposure–safety relationship for paclitaxel liposome in patients with non-small cell lung cancer (NSCLC).MethodsData from 45 patients with a total of 349 plasma concentrations were analyzed. The PopPK model was built using the non-linear mixed effect modeling technique.ResultsThe PK of paclitaxel liposome were well described by a three-compartment model with first-order elimination. For a dose of 175 mg m–2, the estimated clearance of total plasma paclitaxel was 21.55 L h–1. Age, sex, body weight, total bilirubin, albumin, serum creatinine, and creatinine clearance did not influence the paclitaxel PK. Exposure to paclitaxel had no significant change in the presence of the traditional Chinese medicine, aidi injection. The exploratory exposure–safety relationship was well described by a generalized linear regression model. Higher probabilities of grade >1 neutropenia were observed in patients with higher exposure to paclitaxel.ConclusionThis PopPK model adequately described the PK of paclitaxel liposome in patients with NSCLC. Predicted exposure of paclitaxel did not change in the presence of the traditional Chinese medicine, aidi injection. The exposure–safety analysis suggested that a higher risk of neutropenia was correlated with higher exposure to paclitaxel.

目的 分析汇总我国上市的新型抗肿瘤药物导致心脏毒性的类型及发生率,为临床安全用药提供依据.方法 检索国家药品监督管理局(NMPA)官网,整理可能导致心脏毒性的新型抗肿瘤药物并查阅说明书,整理作用靶点、心脏毒性类型和发生率;检索PubMed、中国知网、万方及维普数据库,查阅关于心脏毒性类型的报道.检索时间均为2000年1月1日至2020年6月30日.结果 新型抗肿瘤药物自2000年在我国上市,现有45种可能导致心脏毒性的药物,包括靶向制剂39种和免疫检查点抑制剂6种;覆盖9种常见的肿瘤类型;文献检索结果显示35种新型抗肿瘤药物可以不同程度导致心脏毒性,类型方面占说明书中描述内容的75％,另有6种药物出现说明书中描述以外新的损伤类型.结论 新型抗肿瘤药物导致心脏毒性临床表现不一,使用前应建立基线、加强用药管理和监测,保障肿瘤患者治疗顺利完成.