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槲寄生制剂(欧洲槲寄生)用于癌症患者的疗效和安全性。一项系统评价。

Efficacy and safety of mistletoe preparations (Viscum album) for patients with cancer diseases. A systematic review.

作者信息

Melzer Jörg, Iten Felix, Hostanska Katarina, Saller Reinhard

机构信息

Institute of Complementary Medicine, Department of Internal Medicine, University Hospital Zurich, Switzerland.

出版信息

Forsch Komplementmed. 2009 Aug;16(4):217-26. doi: 10.1159/000226249. Epub 2009 Jul 17.

DOI:10.1159/000226249
PMID:19729932
Abstract

BACKGROUND

Mistletoe is often used as a complementary approach in oncology. Despite experimental anti-tumour effects and several reviews there remains controversy about its clinical role.

PATIENTS AND METHODS

Potentially relevant trials were identified to perform a systematic review (databases: e.g. EMBASE, MEDLINE; hand search: e.g. bibliographies; search terms: e.g. mistletoe). To be included, randomised or comparative clinical trials at least had to examine mistletoe preparations standardized according to manufacturing process and to describe interventions explicitly. Additionally, cohort studies were included for reasons of external validity. Results were summarised in tables.

RESULTS

18 clinical trials (>6,800 participants) were included. Their internal quality was mostly low. Due to heterogeneity between trials a meta-analysis was impossible. Regarding efficacy, findings were inconsistent regarding life expectancy, relation to tumour entity, dosing and treatment duration. Yet, studies indicate that quality of life (QoL) is improved. As these findings do not seem to be limited to one of the different parenteral mistletoe preparations reviewed the treatment may be summarised under the umbrella term 'mistletoe therapy'. Regarding safety, 1 serious adverse event (AE) related to mistletoe was described; non-serious AEs were local reactions at injection site. Allergic reactions were rare.

CONCLUSION

Supportive 'mistletoe therapy' seems safe and beneficial for QoL in adult patients with solid tumours. But there is an urgent need to confirm its efficacy in patient-centred care in a complex oncological setting. This has to be evaluated systematically in prospective observational trials with validated, multidimensional patient-rated QoL questionnaires and comparisons of different preparations and dosages.

摘要

背景

槲寄生常用于肿瘤学的辅助治疗方法。尽管有实验表明其具有抗肿瘤作用且已有多篇综述,但关于其临床作用仍存在争议。

患者与方法

通过检索潜在相关试验进行系统评价(数据库:如EMBASE、MEDLINE;手工检索:如参考文献;检索词:如槲寄生)。纳入的随机或对照临床试验至少需研究按照生产工艺标准化的槲寄生制剂,并明确描述干预措施。此外,为保证外部有效性纳入了队列研究。结果汇总于表格中。

结果

纳入18项临床试验(>6800名参与者)。其内部质量大多较低。由于各试验间存在异质性,无法进行荟萃分析。关于疗效,在预期寿命、与肿瘤实体的关系、给药剂量和治疗持续时间方面的研究结果不一致。然而,研究表明生活质量(QoL)有所改善。由于这些结果似乎并不局限于所综述的不同肠胃外槲寄生制剂中的某一种,该治疗可统称为“槲寄生疗法”。关于安全性,描述了1例与槲寄生相关的严重不良事件(AE);非严重AE为注射部位的局部反应。过敏反应罕见。

结论

支持性的“槲寄生疗法”对成年实体瘤患者的生活质量似乎安全且有益。但迫切需要在复杂的肿瘤学环境中以患者为中心的护理中确认其疗效。这必须在前瞻性观察性试验中使用经过验证的、多维度的患者自评生活质量问卷以及对不同制剂和剂量进行比较来系统评估。

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