Evidence Base Medicine Report Reporter: PGY 王婉莉 日期：2016/07/29

實證醫學5步驟: 步驟一：形成臨床問題 步驟二：搜尋最佳證據 步驟三：嚴格評讀文獻 步驟四：實際臨床應用 步驟五：評估執行效果

Clinical Problem 55歲李先生是一糖尿病病人，因右腳腳趾頭破皮，自己買藥膏敷傷口一直沒有癒合，之後因傷口發黑、化膿就醫。一開始，醫師建議將右下肢第四趾截掉，之後因為傷口感染至右腳掌，之後傷口感染遲遲無法痊癒。

PICO Patient Diabetic foot infection and critical limb ischemia Intervention Vascular intervention (PTA: percutaneous transluminla angioplasty) Comparison bypass surgery Outcome Limb salvage

Journal Search Data base Key words Pubmed Cochrane Library Diabetic foot infection and critical limb ischemia Vascular intervention PTA: percutaneous transluminla angioplasty Limb salvage Date: 2014/01/01~present

Journal Search

Journal Search Exclusion: less evidence base level, inappropriate topic, no authority

Reference-1 Evidence: ?

Reference-1: Abstract Critical limb ischemia (CLI) encompasses the most extreme end of the peripheral artery disease (PAD) spectrum leading to significant morbidity and mortality. defined as >2 weeks of extremity rest pain, ulcers or extremity gangrene, secondary to objectively proven peripheral artery disease. risk factor modification is of the utmost importance involving tobacco cessation, and treatment of underlying conditions like diabetes mellitus, hyperlipidemia and hypertension.

Reference-1: Abstract medical therapy involves wound care and also consists of antiplatelet therapy, anti-inflammatory therapy including statin use or ACE inhibitors. Surgical therapies include distal bypass surgery, thromboendartectomy and amputation. Endovascular techniques include percutaneous transluminal angioplasty, bare metal stents, atherectomy, drug-coated balloon and drug-eluting stents.

CLI is considered the end-stage of PAD, requiring a thoughtful and multidisciplinary approach, risk-benefit analysis and treatment of comorbid conditions. Conservative and surgical treatments, along with endovascular techniques, have allowed excellent opportunities for treating complicated patients for wound healing and limb salvage.

Reference-2 Evidence: level Ia (Meta-analysis of RCT)

Reference-2: Method Randomized clinical trials comparing results between angioplasty and bypass surgery in CLI were identified by searching Pubmed (2000-2014) and EMBASE (2000-2014) using the search terms “angioplasty” or “bypass”, “CLI” and “clinical trials”. Primary outcome subjected to meta-analysis was amputation (of trial leg) free survival in 5 years. Secondary outcomes were 30-day mortality; mortality, re-interventions and leg salvage in 1, 3 and 5 years. 

Reference-2: Result 7 clinical trials were selected for meta-analysis. No significant difference was found in the primary outcome-amputation free survival, between angioplasty and bypass surgery groups. The amputation free survival in 1, 3 and 5 years were 332/498 (66.7%), 169/346 (48.8%) and 21/60 (35%) in angioplasty group, 484/749 (64.6%), 250/494 (50.6%) and 46/132 (34.8%), in bypass group. The 30 days mortality rate was significantly higher in bypass treatment group [79/1304 (6.1%)] than in angioplasty group [30/918 (3.3%) [95% CI 0.55 [0.36, 0.86], P=0.008).

However, there was no statistical significance in 1, 3 and 5 years mortality between these two groups. Two clinical trials showed that there was no difference in leg salvage between angioplasty and bypass surgery groups either. In addition, no difference was observed in re-vasculation between the two groups.

Reference-2: Conclusions Angioplasty is non-inferior to bypass surgery in regarding the amputation free survival, re-vasculation, leg amputation and overall mortality. However, angioplasty is safer, simple, and less invasive and less cost procedure. It should be considered as the first choice for feasible CLI patients.

Application to Patients 目前沒有證據等級1的實驗證明CLI的治療準則。 通常依病人的特質來選擇治療方式 此篇較高證據等級可以證實Angioplasty與 bypass有著幾乎相同的預後 應用在這個病人上，除了控制感染，內科治療外， angioplasty是在盡可能保存肢體的目的上的一個可行的方法。

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