de Graaff Jurgen C, Ubbink Dirk Th, Legemate Dink A, Tijssen Jan G p, Jacobs Michael J h m
Department of Vascular surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
J Vasc Surg. 2003 Sep;38(3):528-34. doi: 10.1016/s0741-5214(03)00414-2.
The definition of critical limb ischemia (CLI) requiring vascular intervention is still under debate. The clinical eye of the physician and ankle blood pressure measurements used so far may fall short in appreciation of the severity of disease, which makes decision-making for a vascular intervention subjective. In previous studies two simple functional tests, ie, transcutaneous oxygen pressure (tcPo(2)) and toe blood pressure (TP) measurements, provided reliable information about the need for vascular intervention. Therefore we evaluated the diagnostic value of tcPo(2) and TP in management of clinically suspected critical leg ischemia. Study design This was a diagnostic randomized controlled clinical trial. Subjects were ambulatory and hospitalized patients in a referral university hospital.
Ninety-six patients (128 legs) with clinically suspected critical limb ischemia were referred to the vascular laboratory for routine investigation. Two diagnostic management strategies were compared: conventional strategy, ie, clinical judgment and ankle pressure determined the diagnostic and therapeutic approach, and a new strategy in which tcPo(2) and TP determined the diagnostic and therapeutic approach. Main outcome measures included clinical outcome, defined as pain relief, wound healing, and limb survival.
At 18-month follow-up, 26 of 62 legs treated with the conventional approach and 28 of 66 legs treated with the new approach were treated conservatively. The new method did not score significantly different from the conventional method insofar as clinical outcome: pain score, 50 versus 48; number of amputations, 8 versus 10; and number of deaths, 11 versus 8 deaths, respectively.
Two simple objective diagnostic tests, TP and tcPo(2), did not improve clinical outcome when incorporated into routine management of suspected critical limb ischemia. Nevertheless, these techniques might still be helpful for physicians less experienced with treating critical limb ischemia and who are in doubt regarding the need for vascular intervention.
需要进行血管介入治疗的严重肢体缺血（CLI）的定义仍存在争议。目前医生的临床判断以及踝部血压测量可能无法充分评估疾病的严重程度，这使得血管介入治疗的决策具有主观性。在先前的研究中，两项简单的功能测试，即经皮氧分压（tcPo₂）和趾血压（TP）测量，为是否需要进行血管介入治疗提供了可靠信息。因此，我们评估了tcPo₂和TP在临床疑似严重下肢缺血管理中的诊断价值。研究设计：这是一项诊断性随机对照临床试验。研究对象为一所转诊大学医院的门诊和住院患者。
96例（128条腿）临床疑似严重肢体缺血的患者被转诊至血管实验室进行常规检查。比较了两种诊断管理策略：传统策略，即临床判断和踝部血压决定诊断和治疗方法；新策略，即tcPo₂和TP决定诊断和治疗方法。主要结局指标包括临床结局，定义为疼痛缓解、伤口愈合和肢体存活。
在18个月的随访中，采用传统方法治疗的62条腿中有26条、采用新方法治疗的66条腿中有28条接受了保守治疗。就临床结局而言，新方法与传统方法的得分无显著差异：疼痛评分分别为50分和48分；截肢数量分别为8例和10例；死亡数量分别为11例和8例。
将TP和tcPo₂这两项简单的客观诊断测试纳入疑似严重肢体缺血的常规管理中，并未改善临床结局。然而，对于治疗严重肢体缺血经验不足且对是否需要进行血管介入治疗存在疑问的医生来说，这些技术可能仍有帮助。
