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CRLX101治疗实体瘤的临床结果与有效性:一项系统评价与荟萃分析

Clinical Outcomes and Effectiveness of CRLX101 for Solid Tumors: A Systematic Review and Meta-analysis.

作者信息

Shamaeizadeh Nahal, Sadeghi Erfan, Varshosaz Jaleh

机构信息

Department of Pharmaceutics, Novel Drug Delivery Systems Research Centre, School of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran.

Department of Biostatistics and Epidermiology, Research Consultation Center (RCC), Shiraz University of Medical Sciences, Shiraz, Iran.

出版信息

Curr Med Chem. 2024 Feb 20. doi: 10.2174/0109298673263933231206101556.

Abstract

BACKGROUND

While it has been demonstrated that delivery of cytotoxic chemotherapy using nanoparticles greatly improves patient drug tolerance and reduces toxicity when compared to the standard formulation, the crucial question of whether they also increase anticancer efficacy remains. The CRLX101 is a nanoparticle composed of cyclodextrin and 20(S)-camptothecin cytotoxic chemotherapy.

OBJECTIVE

In order to compare the efficacy of the CRLX101 to its corresponding traditional formulation, we carried out this systematic literature search for randomized clinical and non-randomized trials.

METHODS

Multiple electronic databases, including PubMed, Scopus, Embase, Web of Science, the Cochrane Library, and clinicaltrials.gov, were used to conduct a thorough literature search. By employing a technique akin to a random-effects model, the median of the study-specific was taken into account as the pooled median estimate with a 95% confidence interval.

RESULTS

Finally, nine clinical studies were chosen for the meta-analysis. The treatment and control groups' overall survival were examined in five and three trials, respectively. Additionally, six out of nine trials and two out of nine trials, respectively, examined the treatment and control groups for progression-free survival (PFS). Meta-analysis revealed that the treatment group had a lower median overall survival (OS) but a greater median progression-free survival than the control group.

CONCLUSION

Our meta-analysis shows that CRLX101 outperforms camptothecin in PFS despite its inferior OS. Unresolved pharmacology limits carrier-mediated drug therapeutic application. Carrier-mediated dosages may differ from normal formulations because they are rarely studied.

摘要

背景

虽然已经证明,与标准制剂相比,使用纳米颗粒递送细胞毒性化疗药物可大大提高患者的药物耐受性并降低毒性,但它们是否也能提高抗癌疗效这一关键问题仍然存在。CRLX101是一种由环糊精和20(S)-喜树碱细胞毒性化疗药物组成的纳米颗粒。

目的

为了比较CRLX101与其相应传统制剂的疗效,我们进行了这项系统的文献检索,以查找随机临床试验和非随机试验。

方法

使用多个电子数据库,包括PubMed、Scopus、Embase、科学网、考克兰图书馆和clinicaltrials.gov,进行全面的文献检索。通过采用类似于随机效应模型的技术,将研究特异性的中位数作为合并中位数估计值,并给出95%置信区间。

结果

最后,选择了9项临床研究进行荟萃分析。分别在5项和3项试验中检查了治疗组和对照组的总生存期。此外,9项试验中的6项和9项试验中的2项分别检查了治疗组和对照组的无进展生存期(PFS)。荟萃分析显示,治疗组的总生存期(OS)中位数较低,但无进展生存期中位数高于对照组。

结论

我们的荟萃分析表明,尽管CRLX101的总生存期较差,但其在无进展生存期方面优于喜树碱。未解决的药理学问题限制了载体介导的药物治疗应用。载体介导的剂量可能与正常制剂不同,因为它们很少被研究。

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