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Development and validation of a clinical risk score nomogram for predicting voriconazole trough concentration above 5 mg/L: a retrospective cohort study. 用于预测伏立康唑谷浓度超过 5 毫克/升的临床风险评分提名图的开发与验证:一项回顾性队列研究。
IF 1.9 4区 医学 Q3 INFECTIOUS DISEASES Pub Date : 2024-07-08 DOI: 10.1080/1120009X.2024.2376453
Mengyuan Xie, Manxue Jiang, Jian Xu, Yulin Zhu, Lingti Kong

The therapeutic range of voriconazole (VRC) is narrow, this study aimed to explore factors influencing VRC plasma concentrations > 5 mg/L and to construct a clinical risk score nomogram prediction model. Clinical data from 221 patients with VRC prophylaxis and treatment were retrospectively analyzed. The patients were randomly divided into a training cohort and a validation cohort at a 7:3 ratio. Univariate and binary logistic regression analysis was used to select independent risk factors for VRC plasma concentration above the high limit (5 mg/L). Four indicators including age, weight, CYP2C19 genotype, and albumin were selected to construct the nomogram prediction model. The area under the curve values of the training cohort and the validation cohort were 0.841 and 0.802, respectively. The decision curve analysis suggests that the nomogram model had good clinical applicability. In conclusion, the nomogram provides a reference for early screening and intervention in a high-risk population.

伏立康唑(Voriconazole,VRC)的治疗范围较窄,本研究旨在探讨VRC血浆浓度> 5 mg/L的影响因素,并构建临床风险评分提名图预测模型。研究人员回顾性分析了221名接受过VRC预防和治疗的患者的临床数据。患者按 7:3 的比例随机分为训练组和验证组。采用单变量和二元逻辑回归分析来选择 VRC 血浆浓度超过高限(5 mg/L)的独立风险因素。选取了年龄、体重、CYP2C19 基因型和白蛋白等四个指标来构建提名图预测模型。训练队列和验证队列的曲线下面积值分别为 0.841 和 0.802。决策曲线分析表明,提名图模型具有良好的临床适用性。总之,提名图为高危人群的早期筛查和干预提供了参考。
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引用次数: 0
Sorafenib tosylate-loaded nanosuspension: preparation, optimization, and in vitro cytotoxicity study against human HepG2 carcinoma cells. 甲苯磺酸索拉非尼负载纳米混悬液:制备、优化和对人HepG2癌细胞的体外细胞毒性研究。
IF 1.8 4区 医学 Q3 INFECTIOUS DISEASES Pub Date : 2024-07-01 Epub Date: 2023-10-25 DOI: 10.1080/1120009X.2023.2273095
Harpreet Kaur Khanuja, Rajendra Awasthi, Harish Dureja

This study aimed to optimize nanosuspension of sorafenib tosylate (an anticancer hydrophobic drug molecule) using a central composite design. Nanosuspension was prepared using a nanoprecipitation-ultrasonication approach. FTIR and DSC analyses demonstrated that the drug and excipients were physicochemically compatible. X-ray powder diffraction analysis confirmed amorphous form of the payload in the formulation. The optimized formulation (batch NSS6) had a zeta potential of -18.1 mV, a polydispersity of 0.302, and a particle size of 97.11 nm. SEM analysis confirmed formation of rod-shaped particles. After 24 h, about 64.45% and 86.37% of the sorafenib tosylate was released in pH 6.8 and pH 1.2, respectively. The MTT assay was performed on HepG2 cell lines. IC50 value of the optimized batch was 39.4 µg/mL. The study concluded that sorafenib tosylate nanosuspension could be a promising approach in the treatment of hepatocellular cancer.

本研究旨在使用中心复合设计优化甲苯磺酸索拉非尼(一种抗癌疏水性药物分子)的纳米混悬液。采用纳米沉淀超声方法制备了纳米悬浮液。FTIR和DSC分析表明,该药物与辅料具有物理化学相容性。X射线粉末衍射分析证实了制剂中有效载荷的无定形形式。优化配方(批次NSS6)的ζ电位为-18.1 mV,多分散性0.302,粒径97.11 nm。SEM分析证实了棒状颗粒的形成。24小时后 h、 约64.45%和86.37%的甲苯磺酸索拉非尼在pH 6.8和pH 1.2下分别释放。MTT法检测HepG2细胞株。优化批次的IC50值为39.4 µg/mL。该研究得出结论,托磺酸索拉非尼纳米混悬剂可能是治疗肝细胞癌症的一种有前途的方法。
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引用次数: 0
Nivolumab-induced Lambert-Eaton myasthenic syndrome: an immune-related adverse event in nonsmall cell lung cancer. 尼沃单抗诱导的Lambert-Eaton肌无力综合征:非小细胞肺癌癌症的一种免疫相关不良事件。
IF 1.9 4区 医学 Q3 INFECTIOUS DISEASES Pub Date : 2024-07-01 Epub Date: 2023-10-14 DOI: 10.1080/1120009X.2023.2267896
Syed Tabish Rehman, Syeda Mahnoor Azeem, Areeba Akbar, Omer Shafiq, Syed Shehryar Azeem, Shabbir Hussain A Ali

Nivolumab is an anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody and was the first immune checkpoint inhibitor drug approved for use in advanced non-small cell lung cancer (NSCLC). In this report, we describe a rare case of Lambert-Eaton myasthenic syndrome (LEMS), which developed as a side effect of nivolumab in a patient with metastatic lung squamous cell carcinoma. Our patient, who was previously treated with nivolumab for metastatic squamous cell carcinoma of the lung, appeared with a headache, swollen face, dysarthria, asthenia, xerostomia, and drooping eyelid. Early testing indicated no thymomas or newly developing tumors in whole-body scans, and the blood workup was normal. We came to the conclusion that nivolumab-induced LEMS was the cause of the symptoms after performing nerve conduction investigations ruling out other differentials. We believe our clinical experience of this rare and unexpected adverse event should be shared.

Nivolumab是一种抗程序性细胞死亡蛋白1(抗PD-1)单克隆抗体,是第一种被批准用于晚期非小细胞肺癌癌症(NSCLC)的免疫检查点抑制剂药物。在本报告中,我们描述了一例罕见的Lambert Eaton肌无力综合征(LEMS),该综合征是nivolumab在一名转移性肺鳞状细胞癌患者中产生的副作用。我们的患者曾接受nivolumab治疗转移性肺鳞状细胞癌,出现头痛、面部肿胀、构音障碍、乏力、口干和眼睑下垂。早期检测显示,全身扫描中没有胸腺瘤或新发肿瘤,血液检查正常。在进行神经传导研究排除其他差异后,我们得出结论,nivolumab诱导的LEMS是症状的原因。我们认为,应该分享我们对这种罕见和意外不良事件的临床经验。
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引用次数: 0
Benefit from Almonertinib after Osimertinib treat EGFR 19 exon deletion NSCLC induced Severe rash: a case report. 奥西美替尼治疗EGFR 19外显子缺失NSCLC诱导的严重皮疹后阿莫替尼的益处:一例报告。
IF 1.9 4区 医学 Q3 INFECTIOUS DISEASES Pub Date : 2024-07-01 Epub Date: 2023-11-01 DOI: 10.1080/1120009X.2023.2276574
Qichen Zhang, Peng Xie, Xiaoming Hou, Chengpeng Zhao, Ling Duan, Hui Qiao

Osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), has been recommended as a first-line treatment of EGFR-positive non-small cell lung cancer (NSCLC). Skin rash is one of the most common side effects of osimertinib, and can have an impact on patients' quality of life and follow-up. However, there are few reports on the safety and efficacy of switching therapy with osimertinib and the other three generations of TKIs. In this paper, we present a case of NSCLC with an EGFR exon 19 deletion (19del) and MET gene amplification who developed a severe rash after 2 months of treatment with osimertinib that did not recur after switching to replacement therapy with aumonertinib. Our findings indicate that aumonertinib is as effective as osimertinib in treating EGFR19del, while also exhibiting a lower occurrence of adverse skin reactions. This may result in an improved quality of life for patients.

Osimertinib是第三代表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI),已被推荐为EGFR阳性非小细胞肺癌NSCLC)的一线治疗药物。皮疹是奥西替尼最常见的副作用之一,会影响患者的生活质量和随访。然而,很少有关于奥西替尼和其他三代TKI转换疗法的安全性和有效性的报道。在这篇论文中,我们报告了一例EGFR外显子19缺失(19del)和MET基因扩增的NSCLC,在2 奥西替尼治疗数月,在改用奥替尼替代治疗后没有复发。我们的研究结果表明,奥莫替尼在治疗EGFR19del方面与奥西替尼一样有效,同时也表现出较低的皮肤不良反应发生率。这可能会提高患者的生活质量。
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引用次数: 0
Bendamustine plus Rituximab versus R-miniCHOP: which is better for unfit patients with diffuse larger B-cell lymphoma? 苯达莫司汀联合利妥昔单抗与 R-miniCHOP:对于体质不佳的弥漫性大 B 细胞淋巴瘤患者,哪种疗法更好?
IF 1.8 4区 医学 Q3 INFECTIOUS DISEASES Pub Date : 2024-07-01 Epub Date: 2023-06-04 DOI: 10.1080/1120009X.2023.2219592
Dongdong Zhang, Youhong Dong, Liling Zhang
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引用次数: 0
Characteristics and predictors of infusion-related reactions to rituximab in patients with B-cell non-Hodgkin lymphoma. B细胞非霍奇金淋巴瘤患者对利妥昔单抗输注相关反应的特征和预测因素。
IF 1.8 4区 医学 Q3 INFECTIOUS DISEASES Pub Date : 2024-07-01 Epub Date: 2023-10-20 DOI: 10.1080/1120009X.2023.2270833
Nour Faqeer, Rawaa Alrabie, Rand Al-Haddadin, Mohammad Ma'koseh

This retrospective study aimed to assess the characteristics and predictors of infusion-related reactions (IRRs) to rituximab in patients with B-cell non-Hodgkin lymphoma (B-NHL). The medical records of adult patients with B-NHL who received their first cycle of rituximab from August 2020 to August 2022 were reviewed. IRRs were defined as any signs experienced by patients during rituximab infusion and graded according to the Common Terminology Criteria for Adverse Events. During the study period, 334 patients were included; among them, 100 patients (30%) developed IRRs (mean age 54.7 (SD 13.2) years). Of the reported IRRs, 90% were grade II reactions, and 10% were grade III reactions. The multivariate analysis identified indolent lymphoma [OR 1.90, p = 0.025], no hydrocortisone as premedication [OR 3.03, p = 0.029], thrombocytopenia [OR 2.55, p = 0.009], and absolute lymphocyte count ≥ 2000 lymphocytes/microL [OR 1.74, p = 0.045] as independent predictors for IRRs.

这项回顾性研究旨在评估B细胞非霍奇金淋巴瘤(B-NHL)患者对利妥昔单抗的输注相关反应(IRRs)的特征和预测因素。回顾了2020年8月至2022年8月接受第一周期利妥昔单抗治疗的B-NHL成年患者的医疗记录。IRRs被定义为患者在利妥昔单抗输注过程中出现的任何体征,并根据不良事件通用术语标准进行分级。在研究期间,纳入334名患者;其中,100名患者(30%)出现IRRs(平均年龄54.7(SD 13.2)岁)。在报告的IRR中,90%为II级反应,10%为III级反应。多变量分析确定惰性淋巴瘤[OR 1.90,p = 0.025],术前不使用氢化可的松[OR 3.03,p = 0.029],血小板减少症[OR 2.55,p = 0.009],绝对淋巴细胞计数≥2000个淋巴细胞/微升[OR 1.74,p = 0.045]作为IRRs的独立预测因子。
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引用次数: 0
Adjuvant chemotherapy for elderly patients with colorectal cancer: a single-centre observational study in Japan. 老年癌症患者辅助化疗:日本的一项单中心观察研究。
IF 1.9 4区 医学 Q3 INFECTIOUS DISEASES Pub Date : 2024-07-01 Epub Date: 2023-10-25 DOI: 10.1080/1120009X.2023.2273096
Kazuaki Okamoto, Hiroaki Nozawa, Shigenobu Emoto, Koji Murono, Kazuhito Sasaki, Soichiro Ishihara

Adjuvant chemotherapy improves the prognosis of patients with colorectal cancer (CRC) following radical resection. The aim of the present study is to review appropriate chemotherapeutic regimens for elderly patients. We examined 1138 Japanese patients who were operated for high-risk stage II or stage III CRC between July 2010 and June 2021 at our hospital. Patients were divided according to an age of 70 years. The efficacy of adjuvant therapy was analyzed in association with age and adjuvant chemotherapeutic regimens. A total of 507 patients (45%) were ≥70 years old. They were less likely to receive adjuvant chemotherapy (p < 0.001) or palliative chemotherapy after recurrence (p < 0.001) than patients aged <70 years. Cancer-specific survival (CSS) in stage III CRC patients was longer in the <70 years group than in the ≥70 years group (p = 0.006); however, CSS by regimens did not significantly differ between these groups. Adjuvant chemotherapy was associated with the longer relapse-free survival of stage III CRC patients in the <70 years group (p = 0.005). Although adjuvant chemotherapy was associated with a favourable CSS regardless of age, the implementation rate of adjuvant chemotherapy for elderly CRC patients was low, which may explain shorter CSS in stage III CRC patients the ≥70 years group than in the <70 years group.

辅助化疗可改善癌症根治术后患者的预后。本研究的目的是回顾适合老年患者的化疗方案。我们检查了2010年7月至2021年6月期间在我院接受高风险II期或III期CRC手术的1138名日本患者。患者按70岁年龄分组 年。根据年龄和辅助化疗方案分析辅助治疗的疗效。507名患者(45%)≥70 岁他们接受辅助化疗的可能性较小(p p p = 0.006);然而,不同方案的CSS在这些组之间没有显著差异。辅助化疗与第三期CRC患者的无复发生存期延长相关 = 0.005)。尽管无论年龄大小,辅助化疗都与良好的CSS相关,但老年CRC患者辅助化疗的实施率较低,这可能解释了III期CRC患者CSS较短(≥70 年组
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引用次数: 0
Rapid health technology assessment of the novel endonuclease inhibitor baloxavir for the treatment of influenza. 新型核酸内切酶抑制剂巴洛沙韦治疗流感的快速卫生技术评估。
IF 1.9 4区 医学 Q3 INFECTIOUS DISEASES Pub Date : 2024-07-01 Epub Date: 2023-09-28 DOI: 10.1080/1120009X.2023.2263270
Guangliang Huang, Yunfei Tian, Wenyan Cui, Xinhui Zhang, Yonghong Zhao, Xiuju Liu
<p><p>Through a Rapid Health Technology Assessment (RHTA), we evaluated the efficacy, safety and cost-effectiveness of baloxavir in the treatment of influenza, providing the necessary scientific information and evidence-based basis for healthcare professionals and health insurance decision-makers in making rational selections. Through systematic searches of <i>Pubmed</i>, <i>Embase</i>, <i>Web of Science</i>, <i>The Cochrane Register of Clinical Trials</i> database and the official website of Health Technology Assessment (HTA) agencies, we collected systematic reviews (SR)/Meta-analysis, cost-effectiveness evaluations and HTA reports of baloxavir for influenza, with a search time frame of date of database establishment to July 31, 2022. We then performed data extraction, literature screening and quality evaluation on the literature that met our selection criteria, after which the results of the studies were pooled and qualitatively described for analysis. 10 studies were included, including 6 SR/Meta-analysis, three economics studies, and 1 HTA report. In terms of efficacy, baloxavir had an advantage over oseltamivir for all three types of influenza patients (otherwise healthy patients, high-risk patients, and patients are not separated into groups with and without underlying health conditions) concerning change in virus titer from baseline at 24 and 48 h; about otherwise healthy patients and high-risk patients, baloxavir had an advantage over peramivir; pertaining to high-risk patients, baloxavir had an advantage over laninamivir; the above differences between groups were all statistically significant. In terms of safety, in otherwise healthy patients and patients are not separated into groups with and without underlying health conditions, baloxavir significantly reduced the incidence of DRAEs and nausea compared with oseltamivir, as well as significantly reduced the incidence of DRAEs compared with laninamivir; in patients are not separated into groups with and without underlying health conditions, baloxavir significantly reduced the incidence of AEs and diarrhoea compared with oseltamivir; the differences between the above groups were all statistically significant. Economically, in Japanese adult influenza patients and high-risk populations, the Quality-Adjusted Life Years (QALY) of baloxavir slightly triumphed over that of laninamivir (Δ = 0.000112 and 0.00209 QALY per 1 patient, respectively); moreover, the incremental cost-effectiveness ratio (ICER: 2,231,260 and 68,855 yen/QALY, respectively) was below the willingness-to-pay (WTP) threshold (5,000,000 yen/QALY); in Chinese adult influenza patients without underlying diseases and adult high-risk influenza patients, baloxavir had a higher QALY compared with oseltamivir (Δ = 0.000246 and 0.000186 respectively), however, their ICER (12,230 and 64,956 RMB/QALY) was above the local WTP threshold (10,000 RMB/QALY) and thus did not provide a cost-effectiveness advantage. Baloxavir had a favorable
通过快速健康技术评估(RHTA),我们评估了巴洛西韦治疗流感的疗效、安全性和成本效益,为医疗保健专业人员和健康保险决策者做出合理选择提供了必要的科学信息和循证依据。通过系统搜索Pubmed、Embase、Web of Science、Cochrane临床试验注册数据库和卫生技术评估(HTA)机构的官方网站,我们收集了巴洛西韦治疗流感的系统评价(SR)/Meta分析、成本效益评估和HTA报告,数据库建立的搜索时间框架为2022年7月31日。然后,我们对符合我们选择标准的文献进行了数据提取、文献筛选和质量评估,然后将研究结果汇总并进行定性描述以进行分析。包括10项研究,其中6项 SR/Meta分析、三项经济学研究和1份HTA报告。就疗效而言,巴洛沙韦对所有三种类型的流感患者(健康患者、高危患者和没有潜在健康状况的患者未分为两组)的病毒滴度在24和48时与基线相比的变化都优于奥司他韦 h;对于其他健康患者和高危患者,巴洛西韦比哌拉米韦有优势;对于高危患者,巴洛沙韦比拉那米韦有优势;上述各组间差异均有统计学意义。就安全性而言,在其他健康患者和没有潜在健康状况的患者中,与奥司他韦相比,巴洛西韦显著降低了DRAE和恶心的发生率,与拉那米韦相比,也显著降低了DRE的发生率;在没有将患者分为有和没有潜在健康状况的组的情况下,与奥司他韦相比,巴洛西韦显著降低了AE和腹泻的发生率;上述各组间差异均有统计学意义。在经济上,在日本成年流感患者和高危人群中,巴洛西韦的质量调整生命年(QALY)略高于拉那米韦(Δ分别为0.000112和0.00209 QALY/1名患者);此外,增量成本效益比(ICER:22231260和68855 日元/QALY)低于支付意愿阈值(5000000 日元/QALY);在没有基础疾病的中国成人流感患者和成人高危流感患者中,巴洛西韦的QALY高于奥司他韦(Δ分别为0.000246和0.000186),但其ICER(12230和64956元/QALY)高于当地的WTP阈值(10000元/QALY),因此没有提供成本效益优势。与神经氨酸酶抑制剂(NAI)相比,巴洛西韦具有良好的疗效和安全性,目前可用的证据表明,它仅在日本具有经济优势。
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引用次数: 0
Case series of metastatic breast cancer patients with visceral crisis treated with CDK4/6 inhibitors. 应用CDK4/6抑制剂治疗转移性癌症内脏危象的病例系列。
IF 1.9 4区 医学 Q3 INFECTIOUS DISEASES Pub Date : 2024-07-01 Epub Date: 2023-11-09 DOI: 10.1080/1120009X.2023.2279831
Marissa Meegdes, Marleen G A M van der Velde, Sandra M E Geurts, Maartje A C E van Kats, M Wouter Dercksen, Vivianne C G Tjan-Heijnen

There is an ongoing clinical dilemma of how best to treat patients who present themselves with visceral crisis. The time needed to undo the state of visceral crisis is the most relevant outcome for this patient group. We describe four patients treated with CDK4/6 inhibitor plus endocrine therapy for HR+/HER2- metastatic breast cancer who presented themselves with a visceral crisis. Two of them are male and three of them had synchronous metastatic breast cancer. Two patients had lymphangitis carcinomatosis of the lungs, one extensive disease of the eye and one of the liver. Time to first clinical response was observed within a few weeks in three patients. For one patient a switch to chemotherapy was needed. These cases show that treatment with CDK4/6 inhibitors can achieve a rapid response in patients experiencing visceral crisis. We conclude that chemotherapy is not the sole possibility in visceral crisis, and that CDK4/6 inhibitors can be considered as well.

如何最好地治疗出现内脏危机的患者,这是一个持续的临床难题。消除内脏危机状态所需的时间是这一患者群体最相关的结果。我们描述了四名接受CDK4/6抑制剂联合内分泌治疗的HR+/HER2转移性癌症患者,他们出现了内脏危机。其中两人是男性,三人患有同步转移性癌症。两名患者患有肺淋巴管炎癌,一名患有广泛的眼部疾病和一名患有肝脏疾病。三名患者在几周内观察到首次临床反应时间。有一个病人需要转为化疗。这些病例表明,CDK4/6抑制剂的治疗可以在经历内脏危象的患者中实现快速反应。我们的结论是,化疗并不是内脏危象的唯一可能性,CDK4/6抑制剂也可以考虑。
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引用次数: 0
Assessing the prevalence and severity of cisplatin-induced nephrotoxicity in a minority- low socioeconomic population in the Bronx, New York. 评估纽约布朗克斯区少数族裔--社会经济地位较低人群中顺铂引起的肾毒性的发生率和严重程度。
IF 1.9 4区 医学 Q3 INFECTIOUS DISEASES Pub Date : 2024-06-30 DOI: 10.1080/1120009X.2024.2363105
M Bakri Hammami, Paola Gudino, Juan Diego Rodriguez Salazar, Charan Vegivinti, Asma Qasim, Anjali Acharya

Studies evaluating Cisplatin-induced nephrotoxicity in minorities are limited. We conducted a retrospective review of adult patients receiving cisplatin from 2019 to 2023 at an inner-city hospital. Renal indices were obtained at baseline and after cycles 1, 2, and 3 of Cisplatin. A total of 93 patients were included, 46% were male. Median age was 57 years. About 40% were Black, 13% White, and 42% Hispanic. About 54% were uninsured. About 16% of the patients developed AKI after cycle 1 of cisplatin, 5% after cycle 2%, and 17% after cycle 3. There was no statistically significant correlation between race, sex, BMI and development of cisplatin-induced AKI. Repeated measures ANOVA test indicated a statistically significant and cumulative rise in creatinine level following cisplatin therapy [Wilks' Lambda = 0.003, F(1,26)=13.7, η2 = 0.44]. Our study in a minority, low socioeconomic population highlights the progressive kidney injury following each cycle of cisplatin therapy. Further studies targeting this specific population are warranted to develop tailored interventions.

评估少数民族顺铂诱发肾毒性的研究非常有限。我们对一家市内医院2019年至2023年接受顺铂治疗的成年患者进行了回顾性研究。我们在顺铂的基线和第 1、2、3 周期后采集了肾脏指数。共纳入 93 名患者,46% 为男性。中位年龄为 57 岁。约 40% 为黑人,13% 为白人,42% 为西班牙裔。约 54% 的患者没有保险。约 16% 的患者在顺铂第一周期后出现 AKI,5% 的患者在第二周期后出现 AKI,17% 的患者在第三周期后出现 AKI。种族、性别、体重指数与顺铂诱发的 AKI 之间没有明显的统计学相关性。重复测量方差分析检验表明,顺铂治疗后肌酐水平的累积上升具有统计学意义[Wilks' Lambda = 0.003, F(1,26)=13.7, η2 = 0.44]。我们在少数族裔、社会经济地位较低的人群中进行的研究强调了顺铂治疗每个周期后的渐进性肾损伤。有必要针对这一特定人群开展进一步研究,以制定有针对性的干预措施。
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引用次数: 0
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Journal of Chemotherapy
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