巨赤芽球性貧血に対してビタミンB12(コバラミン)の投与は経口と筋注どちらがいいの?

題名:巨赤芽球性貧血に対して経口と筋注でのビタミンB12(コバラミン)の投与の比較検討.単施設,前向き研究

論文:Oral versus intramuscular cobalamin treatment in megaloblastic anemia: a single-center, prospective, randomized, open-label study.
Clin Ther. 2003 Dec;25(12):3124-34.

巨赤芽球性貧血における,VitB12の補充について経口と筋注を比較した論文.

【Abstract】

目的

ビタミンB12は巨赤芽球性貧血の原因として最も多く,ビタミンB12(コバラミン)の筋肉内注射によって治療される.何人かの研究者は傾向でのビタミンB12の投与は効果があるとして,忍容性が高く,コストも安いと報告している.

方法

Adnan Menderes University Research and Practice Hospital(トルコ)の血液部門で実施された,90日間の前向きランダム化されたオープンラベル試験である.

ビタミンB12欠乏による巨赤芽球性貧血を有する16歳以上の患者に無作為に1,000μgのVitB12を1日1回経口投与させる群と1日1回10日間1,000μgのVitB12を1日1回筋肉内注射する群に分けた.10日後は,1週間に1度の投与を4週間継続し,その後は1ヶ月に1回の投与を生涯にわたって投与した.患者は治療後,day5からday10の間に網状赤血球が検出されるまで網状赤血球の測定を継続した.治療の有効性はday0,day10,day30,day90の血液パラメーター(CBC)およびday0およびday90のVitB12を測定することによって評価した.認知機能の評価のためにVitB12投与前後にMMSEを使用した.振動位置覚の検査に125-Hz diapozone を使用した.(125 ヘルツの何か?).神経学的な感覚障害のアセスメントに soft-touch and pinprick 試験を実施し,投与前と比べての神経障害を同定した.耐用性の評価は採血と患者へのインタビューを用いた.また,内服薬と注射の費用からコストを評価した.

結果

60人の患者が振り分けられ,26人が内服(16 men, 10 women; 平均年齢, 60 ±15 years),筋注群は34人(17 men, 17 women; 平均年齢, 64 ±10 years).全ての患者で網状赤血球が観察された.内服群と筋肉注射群は共に,day30,day90においてday0と比べて全ての血液検査が改善した.(Hbは増加した. [both P<0.001]; MCVは低下した. [both P<0.001]; WBC数 は増加した.[day 30, P<0.01; day 90, P<0.001]; and 血小板数は増加した. [both P<0.001])VitB12 濃度はday0に比べてday90まで優位に増加した.(P<0.001).これらの結果は内服群と筋注群のパターンは似ていた.神経学的所見は,9人の患者(15.0%)に末梢神経障害.7人の患者(11,7%)認知機能(記憶障害,集中力の障害)の変化,および5人の患者(8.3%)における振動感覚の障害がday0の時点で確認された..神経学的改善はday30の時点で内服群9例中7例(77.8%),筋注群12例中9例(75.0%)で認めた.

まとめ

VitB12欠乏による巨赤芽球性貧血の患者で経口と筋注では同様に有効であった.

内服群では,筋注群と比較して,より良好な耐用性が高く.コストが安く済んだ.

サンプルのサイズが小さく,今後長期的な研究が必要である.

英単語

cognitive function:認知機能

Tolerability :耐用性

【Table and figure】

【原文】

BACKGROUND:

Cobalamin (vitamin B12) deficiency, the most common cause of megaloblastic anemia, is treated with intramuscular (IM) cobalamin. It has been suggested by some investigators that oral (p.o.) cobalamin treatment may be as effective in the treatment of this condition, with the advantages of ease of administration and lower cost.

OBJECTIVE:

This study assessed the effects and cost of p.o. versus i.m. cobalamin treatment in patients with megaloblastic anemia due to cobalamin deficiency.

METHODS:

This was a 90-day, prospective, randomized, open-label study conducted at the Division of Hematology, Department of Internal Medicine, Adnan Menderes University Research and Practice Hospital (Aydin, Turkey). Patients aged > or =16 years with megaloblastic anemia due to cobalamin deficiency were randomized to receive 1000-microg cobalamin p.o. once daily for 10 days (p.o. group) or 1000-microg cobalamin i.m. once daily for 10 days (i.m. group). After 10 days, both treatments were administered once a week for 4 weeks, and after that, once a month for life. Patients were assessed for the presence of reticulocytosis between treatment days 5 and 10 until it was detected. Therapeutic effectiveness was assessed by measuring hematologic parameters on days 0, 10, 30, and 90 and serum vitamin B12 concentration on days 0 and 90. The Mini-Mental State Examination was used before and after the B12 therapy for cognitive function assessment and 125-Hz diapozone was used for vibration threshold testing. Neurologic sensory assessment, including soft-touch and pinprick examinations, was used to identify neuropathy at baseline and study end. Tolerability was assessed using laboratory tests and patient interview. Cost was assessed using the cost of the study drug and of the injection.

RESULTS:

Sixty patients completed the study 26 in the p.o. group (16 men, 10 women; mean [SD] age, 60 [15] years) and 34 in the i.m. group (17 men, 17 women; mean [SD] age, 64 [10] years). Reticulocytosis was observed in all patients. In the p.o. group, at days 30 and 90, all hematologic parameters changed significantly versus day 0 (mean hemoglobin levels increased [both P<0.001]; mean corpuscular volume decreased [both P<0.001]; mean white blood cell count increased [day 30, P<0.01; day 90, P<0.001]; and mean platelet count increased [both P<0.001]). The mean serum vitamin B12 concentration increased significantly from day 0 to 90 (P<0.001). These hematologic parameters and the recovery patterns were similar between the 2 groups. Neurologic findings included sensitive peripheral neuropathy in 9 patients (15.0%), alteration of cognitive function (loss of memory, impaired concentration) in 7 patients (11.7%), and loss of sense of vibration in 5 patients (8.3%). Neurologic improvement was detected in 7 of 9 patients (77.8%) in the p.o. group and 9 of 12 patients (75.0%) in the i.m. group at day 30.

CONCLUSIONS:

In this study of patients with megaloblastic anemia due to cobalamin deficiency, p.o. cobalamin treatment was as effective as i.m. cobalamin treatment. P.o. treatment also was better tolerated and less expensive compared with IM treatment. However, because of the small sample size and the short term of this study, further long-term studies are needed to determine the efficacy of p.o. cobalamin treatment.

コメントを残す

メールアドレスが公開されることはありません。

このサイトはスパムを低減するために Akismet を使っています。コメントデータの処理方法の詳細はこちらをご覧ください