本帖最後由 lsc0019 於 2009-5-12 01:00 編輯
作者：Fran Lowry
出處：WebMD醫學新聞
April 27, 2009 — 根據線上發表於4月2日International Wound Journal期刊的一篇隨機控制試驗結果，使用非細胞基質(AM)皮膚移植物治療糖尿病足潰瘍，可以獲得比標準治療更快速、更完整的癒合。
加州Advanced Clinical Research公司的Alexander Reyzelmen等作者寫道，生物工程皮膚移植物，包括AM移植物，可以作為對傳統傷口處置無反應之糖尿病下肢治療的替代方法；雖然有多個研究報告了用於長期傷口的結果，但多數並非針對評估AM治療用於糖尿病足潰瘍的隨機控制研究。
本研究的主要目標是比較接受AM治療與接受標準傷口處置的病患，在12週時的完整癒合程度。次級目標是比較兩個治療組的平均達到癒合時間。完整癒合的定義是100%再度上皮化且無引流。
作者們報告46個隨機指派接受AM治療與39個隨機指派接受標準處置的病患結果。多數病患有第2型糖尿病且肥胖(AM組的平均身體質量指數為33.1 lbs/in2，標準處置組為34.6 lb/in2)；所有病患在整個研究期間都維持代謝控制。
AM組的平均潰瘍表現是3.6 cm2，標準處置組為5.1 cm2。
AM治療組的病患使用一次人類非細胞皮膚再生組織基質移植物(4 × 4 cm Graftjacket Regenerative Tissue Matrix–Ulcer Repair, Wright Medical Technology, Inc公司)。使用縫合或者釘住的方式讓這個AM移植物定位，之後使用含銀的非粘著性填料(Silverlon, Argentum Medical, LLC公司)。次級敷料包括水凝膠襯墊或者潤濕紗布，依照由研究者確認的比率常規運用。
標準處置組的病患依照醫師判斷，使用海藻酸鹽、泡棉、親水性凝膠或水凝膠等進行潤濕傷口治療。大多數案例的敷料每天改變。在兩組中，繼續治療直到達到完整上皮化或者提供12週照護為止。
AM治療組的46名病患中有32人(69.6%)達到完整癒合，標準處置組的39名病患有18人(46.2%)達到；此一差異是顯著的，P值為 0.0289，AM治療組的癒合勝算是標準處置組的2.7倍。AM治療組達到完整癒合的平均時間是5至7週，標準處置組是6至8週。AM治療組的未癒合比率為30.4%，標準處置組為53.8%、顯著較高。並未發生感染或者移植物相關併發症。
研究者寫道，相較於其他生物工程皮膚移植物，AM移植物有許多好處。它們在移植部位促進細胞分化，提供支架建立皮膚組織，通常使用一次即可達到目標。因為它們從人類組織衍生而得，它們可以容易地被身體的免疫系統辨識，而不會誘發未來物或發炎組織反應。
作者指出，需要更長期的追蹤來強化此研究。研究結論中，有高百分比的潰瘍位置獲得改善，再繼續觀察4到12週以確認是否有更多潰瘍癒合，確認進一步的癒合比率差異，或治療組之間的完整癒合時間。
美國糖尿病協會前任董事會成員、紐約市Mount Sinai醫學院資深講師、Peter Sheehan醫師在接受Medscape Diabetes & Endocrinology邀請對此研究提出評論時表示，目前治療糖尿病足潰瘍並無太多選項，所以任何進展都是受歡迎的。
他表示，雖然研究結果顯示使用非細胞基質之病患有較高的癒合比率，但也非十拿九穩。
Sheehan醫師表示，研究限制為病患隨機分組的方式。被隨機分到標準處置組的病患有較大的潰瘍。一開始的兩個癒合預測因子為潰瘍大小與潰瘍期間，因此，大潰瘍不出所料地不會如同小潰瘍的癒合一樣好。這是本研究的一個問題。
兩組之間的潰瘍位置各異。他表示，這對研究結果是否有影響難以預測，但是這顯示分組方面並未全然隨機。
不過，Sheehan醫師依舊認為這些資料是令人鼓舞的。它們給臨床醫師信心，認為非細胞基質有效且成為另一種治療選項。
Wright Medical Technology, Inc. 公司支持本研究。資深作者、 David G. Armstrong博士宣告接受Wright Medical Technology, Inc公司的研究資金， Sheehan醫師宣告沒有相關財務關係。
Int Wound J. 線上發表於2009年4月2日。
Acellular Matrix Skin Graft Better Than Standard Care for the Treatment of Diabetic Foot Ulcers
By Fran Lowry
Medscape Medical News
April 27, 2009 — Treating diabetic foot ulcers with an acellular matrix (AM) skin graft resulted in faster and more complete healing than standard treatment, according to the results of a randomized controlled trial published online April 2 in the International Wound Journal.
"Bioengineered skin grafts, including [AM] grafts, are promising alternatives for diabetic lower extremity wounds that often are unresponsive to traditional wound management modalities," write Alexander Reyzelmen, DPM, from Advanced Clinical Research, LLC, Castro Valley, California, and coauthors. "While several studies have reported outcomes in chronic wounds, most are not randomized controlled studies specifically evaluating AM therapy use in diabetic foot ulcers."
The primary aim of the study was to compare the proportion of ulcers that completely healed at 12 weeks in patients receiving AM therapy and those receiving standard wound management. A secondary aim was to compare the mean time to healing between the 2 treatment groups. Complete healing was defined as 100% re-epithelialization without drainage.
The authors reported outcomes from 46 patients randomly assigned to AM therapy and 39 patients randomly assigned to standard management. Most of the patients had type 2 diabetes and were obese (mean body mass index, 33.1 lbs/in2 in the AM group and 34.6 lb/in2 in the standard management group). Metabolic control was maintained in all patients throughout the duration of the study.
The mean ulcer size at presentation was 3.6 cm2 in the AM group and 5.1 cm2 in the standard management group.
Patients in the AM therapy group received a single application of a human acellular dermal regenerative tissue matrix graft (4 × 4 cm Graftjacket Regenerative Tissue Matrix–Ulcer Repair, Wright Medical Technology, Inc). The AM graft was sutured or stapled in place, and then a silver-based nonadherent dressing (Silverlon, Argentum Medical, LLC) was applied. Secondary dressings consisting of hydrogel bolsters or moist gauze were applied routinely at a rate determined by the investigator.
Patients in the standard management group received moist-wound therapy with alginates, foams, hydrocolloids, or hydrogels at the discretion of the treating physician. Dressings were changed daily in most cases. In both groups, treatment was continued until complete epithelialization was achieved or 12 weeks of care had been provided.
Complete healing was achieved in 32 (69.6%) of the 46 patients in the AM group and in 18 (46.2%) of the 39 patients in the standard treatment group. This difference was significant, with a P value of .0289, with odds of healing in the AM group 2.7 times higher than in the standard group. The mean time to complete healing was 5 to 7 weeks in the AM group and 6 to 8 weeks in the standard treatment group. The nonhealing rate in the AM group was 30.4% but was significantly higher — 53.8% — in the standard treatment group. No infections or graft-related complications occurred.
AM grafts have several advantages over other bioengineered skin grafts, the study authors write. They promote cellular proliferation at the graft site and provide a scaffold for building dermal tissue, which can often be achieved in a single application. Because they are derived from human tissue, they are easily recognized by the body's immune system and do not provoke a foreign body or inflammatory tissue response.
The study would have been strengthened by a longer follow-up, the authors add. "A large percentage of ulcers were improving in size at the conclusion of the study, and observing the ulcers for another 4 – 12 weeks would be beneficial in determining how many more ulcers would heal and also in identifying any further differences in healing proportion or mean complete healing time between treatment groups."
Asked to comment on this study by Medscape Diabetes & Endocrinology, Peter Sheehan, MD, senior faculty at Mount Sinai School of Medicine, New York City, and a former member of the board of directors of the American Diabetes Association, said there is not much choice for treating diabetic foot ulcers at present, "so anything that will advance the field would be welcome."
Although the results of the study, which showed a higher proportion of patients being healed after treatment with the acellular matrix, are promising, "It's not a slam dunk," he said.
A limitation of the study was the way in which patients were randomized, Dr. Sheehan said. "The patients who were randomized to the standard treatment group tended to have larger ulcers. Two predictors of healing at baseline are ulcer size and ulcer duration. So those of larger size predictably are not going to heal as well as those of smaller size. That is a problem with the study."
The location of the ulcers also varied between the groups. Whether this had an effect on the study outcome is difficult to predict, "but it does show that the randomization was not totally effective," he said.
Nevertheless, Dr. Sheehan maintained that the data are encouraging. "They give clinicians some confidence that acellular matrix may be effective and become another option in our treatment algorithm."
This study was sponsored by Wright Medical Technology, Inc. Senior author David G. Armstrong, DPM, PhD, disclosed that he received research funding from Wright Medical Technology, Inc. Dr. Sheehan has disclosed no relevant financial relationships.
Int Wound J. Published online April 2, 2009. |
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