Caballero Martínez F, Plaza Nohales C, Pérez Canal C, Lucena Martín M J, Holgado Catalán M, Olivera Cañadas G
Unidad Docente de Medicina Familiar, Insalud Area 6 de Madrid.
Aten Primaria. 1996 Sep 30;18(5):211-6.
To compare the efficacy, tolerance and safety of two types of cryotherapy, performed by family physicians, for benign cutaneous lesions: low freezing (-59 degrees C) with dimethyl either-propane cryogenic spray (DMEP) and intense freezing (196 degrees C) with conventional liquid nitrogen (LN).
A randomised, multi-centered, controlled clinical trial, with single-blind assessment.
Three primary care teaching teams in the Community of Madrid.
Ten MIR from family & community medicine intervened. There were 124 patients, who had 174 benign cutaneous lesions, suitable for cryotherapy. There were 3 voluntary withdrawals, none because of an adverse reaction. Interventions, in each case there was local application for a standard time of the randomised agent. Control-group intervention, 81 cases: swab soaked in LN. Study-group intervention, 93 cases: swab saturated with DMEP spray. Maximum of three freezings per case, at weekly intervals.
A doctor made a blind assessment of the results (elimination, adverse reaction, aesthetic result) 15 days after treatment.
No clinically relevant differences between the efficacy, tolerance and safety of the two cryogenic agents used in primary care were found. The low freezing of DMEP was sufficient for the cryotherapy of benign lesions.
比较家庭医生实施的两种冷冻疗法治疗良性皮肤病变的疗效、耐受性和安全性:使用二甲基醚 - 丙烷低温喷雾剂(DMEP)进行低温冷冻(-59℃)和使用传统液氮(LN)进行深度冷冻(-196℃)。
一项随机、多中心、对照临床试验,采用单盲评估。
马德里自治区的三个初级保健教学团队。
10名来自家庭与社区医学的医学住院实习医生参与。共有124例患者,患有174处适合冷冻治疗的良性皮肤病变。有3例自愿退出,均非因不良反应。干预措施,每种情况均在标准时间局部应用随机分配的药物。对照组干预,81例:用浸有LN的棉签。研究组干预,93例:用饱和DMEP喷雾剂的棉签。每例最多冷冻三次,每周一次。
治疗15天后,由一名医生对结果(病变消除情况、不良反应、美学效果)进行盲法评估。
在基层医疗中使用的两种冷冻剂的疗效、耐受性和安全性方面未发现临床相关差异。DMEP的低温冷冻足以用于良性病变的冷冻治疗。