de Armas Elizabeth, Sarracent Yamina, Marrero Eva, Fernández Octavio, Branford-White Christopher
Centro Nacional de Sanidad Agropecuaria (CENSA), Carretera de Jamaica y Autopista Nacional, San José de Las Lajas, La Habana, Cuba.
Curr Med Res Opin. 2005 Nov;21(11):1711-5. doi: 10.1185/030079905X65493.
Rhizophora mangle aqueous bark extract (RMABE) (CIKRON-H), has been used as antiseptic and skin wound healing promoter. The present study was a randomised, single-blinded, placebo control trial conducted to asses the efficacy of RMABE in treating oral aphthous ulcers.
Patients (n = 32) with aphthous ulcers were randomised to received placebo solution or RMABE topically, once a day, from Monday to Friday, until they healed. The efficacy of the treatment was evaluated by physician clinical observations (time to heal, change in condition), the quality of the patient's life and the tolerability through recording adverse effects.
No demographic differences were noted between the two groups at base-line. Seven days after treatment, 12 of the 17 patients in the RMABE group (71%) were completely healed of their aphthous ulcers, with repaired mucosa and no symptoms of ulcers, compared with one in 15 patients in the placebo group (7%) (p < 0.0001). The time taken for the signs and symptoms of ulcers to diminish was also higher in the placebo than in RMABE-treatment group (erythema: placebo 10.54 +/- 1.24, RMABE 4.94 +/- 0.72 days, p = 0.0003; ardour: placebo 7.00 +/- 0.76, RMABE 2.93 +/- 0.49 days, p = 0.0001; and pain: placebo 7.43 +/- 1.21, RMABE 2.92 +/- 0.23 days, p = 0.0011). No subject showed any sign of adverse effects.
These observations demonstrate that the R. mangle aqueous bark extract reduced the time to repair mucosal tissue, erythema, ardour and pain persistence. There was no evidence any adverse effects. This is the first time that the R. mangle extract has been reported to have mouth mucosa healing properties.
红树科植物红树的树皮水提取物(RMABE)(CIKRON - H)已被用作防腐剂和皮肤伤口愈合促进剂。本研究是一项随机、单盲、安慰剂对照试验,旨在评估RMABE治疗复发性口腔溃疡的疗效。
将患有口腔溃疡的患者(n = 32)随机分为两组,分别接受安慰剂溶液或RMABE局部治疗,从周一至周五每天一次,直至溃疡愈合。通过医生的临床观察(愈合时间、病情变化)、患者生活质量以及记录不良反应来评估治疗效果。
两组在基线时未观察到人口统计学差异。治疗7天后,RMABE组17例患者中有12例(71%)复发性口腔溃疡完全愈合,黏膜修复且无溃疡症状,而安慰剂组15例患者中仅有1例(7%)愈合(p < 0.0001)。安慰剂组溃疡体征和症状减轻所需时间也比RMABE治疗组更长(红斑:安慰剂组10.54 ± 1.24天,RMABE组4.94 ± 0.72天,p = 0.0003;灼热感:安慰剂组7.00 ± 0.76天,RMABE组2.93 ± 0.49天,p = 0.0001;疼痛:安慰剂组7.43 ± 1.21天,RMABE组得2.92 ± 0.23天,p = 0.0011)。所有受试者均未出现任何不良反应迹象。
这些观察结果表明,红树树皮水提取物可缩短黏膜组织修复时间、减轻红斑、灼热感和疼痛持续时间。且无任何不良反应迹象。这是首次报道红树提取物具有口腔黏膜愈合特性。