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与氯胺T相比,N-氯代牛磺酸治疗有脓性覆盖物的慢性腿部溃疡的耐受性和疗效:一项随机II期研究。

Tolerability and efficacy of N-chlorotaurine in comparison with chloramine T for the treatment of chronic leg ulcers with a purulent coating: a randomized phase II study.

作者信息

Nagl M, Nguyen V A, Gottardi W, Ulmer H, Höpfl R

机构信息

Institute of Hygiene and Social Medicine, Leopold-Franzens-University of Innsbruck, Fritz-Pregl-Str. 3, A-6010 Innsbruck, Austria.

出版信息

Br J Dermatol. 2003 Sep;149(3):590-7. doi: 10.1046/j.1365-2133.2003.05432.x.

DOI:10.1046/j.1365-2133.2003.05432.x
PMID:14510994
Abstract

BACKGROUND

The well-known active chlorine compound chloramine T (CAT) with broad-spectrum antimicrobial activity is in common therapeutic use for leg ulcers with purulent coatings; however, this treatment is painful. The tolerability of the less aggressive N-chlorotaurine (NCT), an endogenous compound also produced in vivo by stimulated human granulocytes, could be superior.

OBJECTIVES

To assess the tolerability and efficacy of NCT in the cleaning of purulent coatings in chronic leg ulcers in comparison with CAT.

METHODS

In a double-blind, randomized phase IIb clinical study 40 patients were treated for a median of 7 days (range 3-14) with a 1% aqueous solution of either NCT (20 subjects) or CAT (20 subjects) by twice-daily application of dressings soaked in the test solutions. Criteria for evaluation of tolerability were intensity and duration of pain caused by the ulcer therapy and scores of tissue toxicity (necrosis, granulation tissue and re-epithelialization). Therapeutic efficacy was graded as scores of intensity of purulent coating of the ulcers.

RESULTS

The concentration tolerated in vitro by human epidermoid carcinoma cells was at least 10-fold higher for NCT (0.01%) compared with CAT (0.0001-0.001%). There was significantly less pain caused by NCT compared with CAT (P < 0.05) on days 1 and 4 and a trend for a shorter duration of pain (P = 0.093). The scores of intensity of coating improved without difference in both treatment groups, whereas granulation and re-epithelialization appeared earlier in the NCT group (P < 0.05). Non-quantitative microbiological cultures from ulcer smears revealed persistence of colonization by bacterial species in approximately half of both treatment groups.

CONCLUSIONS

Both active chlorine compounds were helpful in reducing purulent coatings. Because of its lower toxicity and better tolerability, NCT is of advantage in the treatment of leg ulcers.

摘要

背景

著名的活性氯化合物氯胺T(CAT)具有广谱抗菌活性,常用于治疗有脓性分泌物的腿部溃疡;然而,这种治疗方法会引起疼痛。刺激性人类粒细胞在体内也会产生内源性化合物N-氯代牛磺酸(NCT),其刺激性较小,耐受性可能更好。

目的

与氯胺T(CAT)相比,评估N-氯代牛磺酸(NCT)清洁慢性腿部溃疡脓性分泌物的耐受性和疗效。

方法

在一项双盲、随机IIb期临床研究中,40例患者接受治疗,中位治疗时间为7天(范围3 - 14天),20例患者使用1% N-氯代牛磺酸(NCT)水溶液,20例患者使用1%氯胺T(CAT)水溶液,每日两次用浸泡在测试溶液中的敷料进行治疗。耐受性评估标准包括溃疡治疗引起的疼痛强度和持续时间以及组织毒性评分(坏死、肉芽组织和再上皮化)。治疗效果根据溃疡脓性分泌物强度评分进行分级。

结果

人表皮样癌细胞在体外耐受的N-氯代牛磺酸(NCT)浓度(0.01%)至少是氯胺T(CAT)(0.0001 - 0.001%)的10倍。与氯胺T(CAT)相比,N-氯代牛磺酸(NCT)在第1天和第4天引起的疼痛明显更少(P < 0.05),且疼痛持续时间有缩短趋势(P = 0.093)。两个治疗组的分泌物强度评分均有所改善,但无差异,而肉芽组织和再上皮化在N-氯代牛磺酸(NCT)组出现得更早(P < 0.05)。溃疡涂片的非定量微生物培养显示,两个治疗组中约一半患者的细菌定植持续存在。

结论

两种活性氯化合物均有助于减少脓性分泌物。由于N-氯代牛磺酸(NCT)毒性较低且耐受性更好,在腿部溃疡治疗中具有优势。

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