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急性虚血性脳卒中に対するイチョウ葉

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Abstract

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Background

Ginkgo biloba extract is widely used in the treatment of acute ischaemic stroke in China. We aimed to assess the evidence from randomised controlled trials and quasi‐randomised controlled trials on the use of Ginkgo biloba extract in acute ischaemic stroke.

Objectives

The primary objective was to determine whether Ginkgo biloba extract improves functional outcome without causing undue harm in patients with acute ischaemic stroke. Secondary objectives were to assess the effect of Ginkgo biloba extract on neurological impairment and quality of life.

Search methods

We searched the Cochrane Stroke Group Trials Register (last searched October 2004), the Trials Register of the Cochrane Complementary Medicine Field (last searched October 2004) and the Chinese Stroke Trials Register (last searched June 2004). In addition, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2004), MEDLINE (1966 to August 2004), EMBASE (1980 to June 2004), AMED (1985 to May 2002) and the China Biological Medicine Database (CBM‐disc, 1979 to August 2004). We searched relevant clinical trials and research registers and contacted pharmaceutical companies and researchers in an effort to identify further published and unpublished studies.

Selection criteria

Randomised controlled trials or quasi‐randomised controlled clinical trials comparing Ginkgo biloba extract with placebo or open control (no placebo) in patients with acute ischaemic stroke.

Data collection and analysis

Two reviewers independently selected trials for inclusion, assessed trial quality and extracted the data.

Main results

Fourteen trials were identified, of which 10 trials (792 patients) were included. Four trials are awaiting assessment. In the 10 included trials follow up was performed at 14 to 35 days after stroke. In all studies neurological outcome was assessed but none of them reported on disability (activities of daily living function) or quality of life. Only three trials reported adverse events. In nine trials, all of them assessed to be of inferior quality, significant improvement in neurological deficit at the end of the treatment was used as the outcome measure. When analysing these trials together, Ginkgo biloba extract was associated with a significant increase in the number of improved patients (Peto odds ratio (OR) 2.66; 95% confidence interval (CI) 1.79 to 3.94). One placebo‐controlled trial, assessed to be of good quality, reported neurological outcome as a continuous variable. It failed to show an improvement of neurological deficit at the end of treatment (weighted mean difference (fixed) 0.81; 95% CI ‐8.9 to 10.52). No deaths or major adverse events were reported during the follow‐up period.

Authors' conclusions

There was no convincing evidence from trials of sufficient methodological quality to support the routine use of Ginkgo biloba extract to promote recovery after stroke. High‐quality and large‐scale randomised controlled trials are needed to test its efficacy.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

一般語訳

急性虚血性脳卒中に対するイチョウ葉

中国伝統医学の一つであるイチョウ葉抽出物は中国では急性虚血性脳卒中の治療に広く使用されており、欧州においても時折使用されることがあるが、その有効性は明確ではない。 虚血性脳卒中へのイチョウ葉抽出物の使用について、実験による裏づけは限られている。しかしながらイチョウ葉抽出物は、脳内血流や脳組織へのブドウ糖の取り込みが大きく増大することが示されている。本レビューでは、急性虚血性脳卒中患者を対象に実施されたイチョウ葉抽出物について、ランダム化試験、あるいは準ランダム化試験を特定した。十分に質の高い方法論を用いた試験において、脳卒中後の回復を促すためにイチョウ葉抽出物の常用を裏づける説得力あるエビデンスは得られなかった。イチョウ葉抽出物の効果を検討する、質の高い大規模なランダム化比較試験の実施が必要である。