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Brain and Nerve No to Shinkei Volume 33, Issue 3 （March 1981）

Brain and Nerve 脳と神経 33巻3号（1981年3月発行）

Japanese English

原著

L-DOPA治療中のパーキンソン症候群に対するシンメトレルの併用効果 THE ADDITIVE EFFECT OF AMANTADINE HYDROCHLORIDE (SYMMETREL^R) ON PARKINSONIAN PATIENTS RECEIVING LEVODOPA TREATMENT 塩沢瞭一 ¹ , 加瀬正夫 ² , 黒岩義五郎 ³ , 楢林博太郎 ⁴ , 西谷裕 ⁵ , 大本堯史 ⁶ , 豊倉康夫 ⁷ , 宇尾野公義 ⁸ Ryoichi Shiozawa ¹ , Masao Kase ² , Yoshigoro Kuroiwa ³ , Hirotaro Narabayashi ⁴ , Yutaka Nishitani ⁵ , Takashi Ohmoto ⁶ , Yasuo Toyokura ⁷ , Kimiyoshi Uono ⁸ ¹虎の門病院神経内科 ²関東逓信病院神経内科 ³九州大学医学部附属脳神経病研究施設 ⁴順天堂大学医学部脳神経内科 ⁵国立療養所宇多野病院神経内科 ⁶岡山大学医学部脳神経外科 ⁷東京大学医学部神経内科 ⁸都立神経病院神経内科 ¹Department of Neurology, Toranomon Hospital ²Neurology Service, Kanto Teishin Hospital ³Neurological Institute, Faculty of Medicine, Kyushu University ⁴Department of Neurology, School of Medicine, Juntendo University ⁵Department of Neurology, Utano National Hospital ⁶Department of Neurological Surgery, Okayama University, Medical School ⁷Department of Neurology, Faculty of Medicine, University of Tokyo ⁸Department of Neurology, Tokyo Metropolitan Neurological Hospital pp.301-309

発行日 1981年3月1日 Published Date 1981/3/1

DOI https://doi.org/10.11477/mf.1406204735

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Abstract 文献概要
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はじめに

　塩酸アマンタジン（Symrnetrel^R，以下SYM）が抗パーキンソン剤としての有効性を証明されて既に久しい。以来，今日まで多数の治験報告がなされているが，他剤特にL-DOPAとの併用効果に関する研究業績は意外に少ない^2,3,6,7）。昭和50年本剤は，本邦においても発売を許可されたが，その際L-DOPAとの併用時の安全性について臨床調査を行うことが指示された。

　先にわれわれはSYM研究会を組織し，SYMとTrihexyphenidylとの二重盲検試験を実施したが^5），今回再び同様の研究会を組織し、第4相の臨床治験としてL-DOPA使用例にSYM併用を行つた場合の有効性および安全性について検討を行なつた。本研究の目的は，L-DOPAに対するSYMの相乗効果としてどの程度のことが期待でき，また随伴症状についてはどのような点に注意を払うべきかを知ることにある。

A phase IV open trial on amantadine hydro-chloride (Symmetrel^R) was carried out in 86 cases at 8 medical institutions in order to investigate its efficacy and safety when added to the parkin-sonian patient receiving levodopa therapy. The patients enrolled to the study were on the main-tainance dose of levodopa. Symmetrel was added initially by 100mg per day, thereafter increased to 200mg per day.

60 cases: studied for efficacy.

77 cases: studied for side effects.

9 cases: dropped out

The results are summarized as follows:

1) The severity rate at the respective stages of first diagnosis, start of Symmetrel, one month and three months after Symmetrel, and at final assessment were compared according to the Yahr's classification. The patients with Grades I and II at the respective stages were 38.4%, 52.6%, 61.1%, and 62.8%. The last two values were significantly higher than that obtained at the start of Symmetrel.

2) The patients having shown an improvement as compared with the severity of first diagnosis were: 21.7% at the start of Symmetrel, 32.2% after one month, 44.4% after three months, and 45.1% at final assessment.

3) The patients were divided into the following three groups.

Group I —Pre-treatment with levodopa were effective.

Group II —Pre-treatment with levodopa did not produce any changes in symptoms.

Group III —Pre-treatment with levodopa aggravated the symptoms without any favorable effects.

In 14 cases of Group I, further improvement was obtained in 15.4% after one month, in 25.0% after three months, and in 27.3% at final assessment.

In 37 cases of Group II, improvement was obtained in 18.9%, 35.3% and 36.4%, re- spectively. In 9 cases of Group III, improve- ment was seen in 77.8%, 62.5% and 71.4%, respectively.

These results suggest that Symmetrel has an excellent additive effect on the patients with poor response to levodopa treatment.

4) Side effects occured in 52.0% (40 of 77 cases) after Symmetrel combination, many of them being in mild to moderate severity. In 12 cases, reduction of the dose or discontinuance of Symmetrel was necessary because of severe side effects. The main symptoms were visual hallucination (4 cases) and dyskinesia (3 cases).

5) There were no significant changes in labora- tory findings between the start and the end of study.

It is concluded from this study that Symmetrel combination can be strongly recommended in the case where parkinsonian patients poorly respond to levodopa therapy. There was, however, a small but unnegligible incidence of hallucination or dyskinesia which required discontinuance of Sym-metrel treatment. This must be kept in mind when Symmetrel is added to levodopa.