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Evaluation of Rapid Colon Preparation with MGV-5

MGV-5-第Ⅲ期臨床試驗-大腸手術前處置

摘要


背景 傳統的大腸手術前準備包括:飲食上的限制,口服緩瀉劑以及灌腸。但是,此種方式很花費時間而且常令病人不舒服,又有可能造成病人過度脫水,所以發展出“經口大腸灌洗法”。 目的 此為前瞻性第三期臨床實驗,以接受大腸手術的患者為對象,比較投與MGV-5之經口腸管洗淨法及傳統灌腸洗淨法作為大腸手術前處置之腸管洗淨效果。此試驗經衛生署及馬偕紀念醫院人體試驗委員會同意。 方法 100位接受大腸直腸手術之病人隨機分配成兩組,每組各50名病人,分別為經口腸管洗淨的MGV-5組;及傳統灌腸洗淨組。比較兩組間的項目如下:腸管洗淨效性,生命徵象的改變,症狀,副作用,安全性,病人接受性,手術後併發症,紅血球數,白血球數及其分化,血小板,肝功能,以及腎功能。 結果 所有項目比較結果,兩組間並無統計上明顯的差異。而且,兩者之洗淨效果皆達89%以上,在安全性上,兩者皆達100%。 結論 在執行上,MGV-5法原則上不進行灌腸,可以減少病人在進行大腸手術前的疼病不適感此點值得臨床上參考。

並列摘要


Background. The traditional cleansing method of large bowel usually involves dietary restrictions, purgatives and enema. They are time-consuming and uncomfortable, and may result in dehydration. Aim. This is a phase Ⅲ, prospective, randomized, and single-blind clinical trial to make a comparison between traditional mechanical preparation ( magnesium citrate + Ducolax orally with enema) and MGV-5 (polyethylene glycol orally without enema). The study was approved by the ethic committee of Mackay Memorial Hospital and the National Department of Health. Materials and Methods. MGV-5 was used without enema for rapid colon cleansing in a consecutive series of 50 patients. The efficacy, change of vital signs, associated symptoms, side effects, patient acceptance and postoperative complications were evaluated. Blood was drawn for CBC with differential count, platelet, liver and renal function. The results were then compared with those of 50 patients who received traditional mechanical preparation. Results. There was no significant difference both in safety and cleansing effect between these two groups. Both groups showed more than 89% of cleansing effect and both groups reached 100% of safety. Conclusion. Since MGV-5 doesn’t need any annoying enema and reduces patient discomfort, it should be strongly considered in patients prior to colon surgery.

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