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旧方新用:PHY906 作为癌症辅助疗法的探索之旅。

Old formula, new Rx: the journey of PHY906 as cancer adjuvant therapy.

机构信息

PhytoCeutica Inc., Branford, CT 06405, USA.

出版信息

J Ethnopharmacol. 2012 Apr 10;140(3):614-23. doi: 10.1016/j.jep.2012.01.047. Epub 2012 Feb 3.

DOI:10.1016/j.jep.2012.01.047
PMID:22326673
Abstract

ETHNOPHARMACOLOGICAL RELEVANCE

PHY906, is a decoction of a mixture of the four herbs Scutellaria baicalensis Geori, Glycyrrhiza uralensis Fisch, Paeonia lactiflora Pall, and Ziziphus jujuba Mill. A combination of these four herbs has been in continuous use in traditional Chinese medicine for over 1800 years for treating a variety of gastrointestinal distress such as diarrhea, cramps, nausea, vomiting etc.

AIM OF THE STUDY

Preclinical and clinical studies to find PHY906 enhances the therapeutic indices of a broad spectrum of anticancer agents.

MATERIALS AND METHODS

Using various mouse tumor xenograft and allograft models, PHY906 has been shown to enhance the chemotherapeutic efficacy of a variety of anticancer agents in various cancers. The PHY906 clinical program consists of five trials in three different types of cancers in both the United States and Taiwan. To date, approximately 150 subjects have received PHY906 in combination with chemotherapy in these five clinical studies.

RESULTS

Preclinical studies have shown that PHY906 enhances the therapeutic indices of a broad spectrum of anticancer agents. These findings have been examined in clinical studies for colorectal, liver, and pancreatic cancers when PHY906 is used as an adjuvant to chemotherapy and the results were promising; i.e. PHY906 could reduce chemotherapy-induced toxicities and/or increase chemotherapeutic efficacy. Furthermore, PHY906 did not affect the pharmacokinetics of the chemotherapeutic agents used. Some information has been obtained regarding the mechanism of action of PHY906 in preclinical studies. A comprehensive platform, PhytomicsQC that integrates chemical and biological fingerprints together with a novel biostatistical methodology has been developed to assess the quality of different batches of PHY906.

CONCLUSIONS

Over a ten-year period, the multiplex technology "PhytomicsQC" has been used to show batch-to-batch consistency of PHY906 production. Advanced clinical trials are ongoing to demonstrate the effectiveness of PHY906 as adjuvant therapy for cancer patients undergoing chemotherapy.

摘要

民族药理学相关性

PHY906 是由黄芩、甘草、白芍和大枣四种草药组成的复方煎剂。这四种草药的组合在传统中医中已连续使用了 1800 多年,用于治疗各种胃肠道不适,如腹泻、痉挛、恶心、呕吐等。

研究目的

临床前和临床研究发现 PHY906 可提高广谱抗癌药物的治疗指数。

材料和方法

使用各种小鼠肿瘤异种移植和同种异体移植模型,已证明 PHY906 可增强各种癌症中多种抗癌药物的化疗疗效。PHY906 的临床计划包括在美国和台湾进行的三种不同类型癌症的五项临床试验。迄今为止,大约 150 名患者在这五项临床研究中接受了 PHY906 联合化疗。

结果

临床前研究表明,PHY906 可提高广谱抗癌药物的治疗指数。这些发现已在结直肠癌、肝癌和胰腺癌的临床研究中进行了检查,当 PHY906 用作化疗的辅助药物时,结果令人鼓舞;即 PHY906 可以降低化疗引起的毒性和/或提高化疗疗效。此外,PHY906 不影响所用化疗药物的药代动力学。在临床前研究中获得了有关 PHY906 作用机制的一些信息。已经开发了一种综合平台“PhytomicsQC”,该平台将化学和生物学指纹与新型生物统计学方法相结合,用于评估不同批次 PHY906 的质量。

结论

在过去的十年中,使用多重技术“PhytomicsQC”来证明 PHY906 生产的批次间一致性。正在进行高级临床试验,以证明 PHY906 作为接受化疗的癌症患者辅助治疗的有效性。

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