肉毒桿菌素注射於腦性麻痺病童痙攣性腓腸肌之療效–比較兩種稀釋方法之隨機分派研究

The effect of botulinum toxin type-A injection into the spastic gastrocemius muscle in children with cerebral palsy -A randomized trial comparing two different dilute volume

胡國琦(Gwo-Chi Hu)

指導教授 ： 簡國龍

共同指導教授 ： 劉仁沛(Jen-Pei Liu)

國立臺灣大學/公共衛生學院/預防醫學研究所/碩士(2006年)

https://doi.org/10.6342/NTU.2006.02029

摘要

肉毒桿菌素已經被證明對於腦性麻痺病童的下肢痙攣是一種有效的治療方法，但是肉毒桿菌素本身是一種非常昂貴且有毒性的藥劑，所以藉由調整藥物配置方法，使用較高體積的生理食鹽水稀釋藥物，是一種提高每單位劑量的肉毒桿菌素的治療效果的方法。
本隨機對照研究的目的在比較相同劑量的肉毒桿菌素用高體積和低體積的生理食鹽水稀釋去治療腦性麻痺病童痙攣性腓腸肌的療效，20位雙側痙攣麻痺性和2位四肢痙攣麻痺性的腦性麻痺病童參與本研究，每位病童藉由隨機分配的方法決定何腳接受高體積稀釋的肉毒桿菌素注射，另一隻腳就接受低體積稀釋的肉毒桿菌素注射。在治療前和注射後一個月及二個月評估動、靜態踝關節活動角度、腓腸肌複合動作電位之面積、腓腸肌的肌肉張力，做為療效的指標。
本研究結果顯示接受高體積稀釋的肉毒桿菌素注射腳比低體積稀釋的肉毒桿菌素注射腳有顯著增加動態踝關節活動角度 (P=0.0002)、減少腓腸肌複合動作電位之面積 (P<0.0001)、降低腓腸肌的肌肉張力 (P=0.0055)；兩組所有的療效指標在治療後各個時間點評估都比治療前有顯著改善；而接受高體積稀釋的肉毒桿菌素注射腳組並沒有產生更多比例的疼痛和無力的藥品不良反應。以高體積 (5毫升) 比低體積 (1毫升) 稀釋的500單位肉毒桿菌素(Dysport®) 對腦性麻痺病童下肢痙攣確實有較好的療效。
正確地使用肉毒桿菌素治療不但可以減少副作用產生的機率，同時也可以減少治療的費用，本研究的結果顯示增加稀釋肉毒桿菌素的體積會影響理想療效。

關鍵字

腦性麻痺 ； 痙攣 ； 肉毒桿菌素 ； 稀釋

並列摘要

Botulinum toxin A (BTX-A) has been shown to be an effective treatment of lower limb spasticity in children with cerebral palsy. BTX-A is an expensive and potentially toxic agent. Enhancing the efficacy of per unit dose by modifying drug preparation with higher diluent volumes is a potential options.
The object of this parallel randomized controlled study is to compare the effect of equivalent dose of BTX-A (Dysport®) in high-volume (500unit/5ml) and low-volume (500unit/1ml) injections on spastic gastrocnemius muscle in children with cerebral palsy. Twenty spastic diplegia and two spastic quadriplegia participated in the study. The children were randomized to receive high-volume preparation of BTX-A in one leg and low-volume preparation of BTX-A in the other leg. All children were assessed at baseline, four and eight weeks following injection. The analyzed parameters included dynamic and static ankle joint range of motion, area of the compound muscle action potential for gastrocnemius muscle, calf muscle tone .
The legs in high-volume preparation treatment showed significant increasing dynamic ankle joint ROM (P=0.0002), improvement of modified Ashworth scale (P<0.0001), decreasing area of CMAP (P=0.0055). Both groups demonstrated significant improvement in all measurements at four and eight weeks after injection. The high-volume group did not increase side effect, such as pain and weakness. A high volume preparation with a 5-fold dilution of BTX-A does yield better results than a low-volume preparation. A judicious use of BTX-A will result in fewer side effects and significant cost reduction. This study showed that the dilution volume has implication on the desired treatment effect of BTX-A.

並列關鍵字

cerebral palsy ； spasticity ； botulinum toxin ； dilution

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