Rhodes R S, Heyneman C A, Culbertson V L, Wilson S E, Phatak H M
Department of Pharmacy Practice and Administrative Sciences, College of Pharmacy, Idaho State University, Pocatello, ID, USA.
Ann Pharmacother. 2001 Jun;35(6):675-81. doi: 10.1345/aph.10267.
To compare the healing of stage II decubitus ulcers with topically applied phenytoin sodium with two other standard topical treatment procedures in a long-term care setting; and to assess the extent of systemic absorption after topical application in the phenytoin group.
Forty-seven nursing home patients with stage II decubitus ulcers were chosen for this study. The patients were matched for age, gender, and size and severity of wounds, and randomly assigned to each treatment group. Clinical assessment of decubitus ulcers was performed at the beginning of treatment and at each dressing change. Ulcers were examined for the presence of healthy granulation tissue, reduction in surface dimensions, and time to healing. Two phenytoin sodium plasma concentrations were to be obtained on all patients in the phenytoin group.
Topical phenytoin therapy resulted in a shorter time to complete healing and formation of granulation tissue when compared with DuoDerm dressings or triple antibiotic ointment applications (p < or = 0.05). The mean +/- SD time to healing in the phenytoin group was 35.3 +/- 14.3 days compared with 51.8 +/- 19.6 and 53.8 +/- 8.5 days for the DuoDerm and triple antibiotic ointment groups, respectively. Healthy granulation tissue in the phenytoin group appeared within two to seven days in all subjects. Patients in the standard treatment groups required six to 21 days to produce new granulation tissue. Serum phenytoin sodium concentrations were nondetectable. No patient withdrew from the study secondary to adverse treatment effects.
Both the phenytoin and standard treatment groups showed progress over the study period. However, the phenytoin group demonstrated more rapid results in all aspects of ulcer healing.
在长期护理环境中,比较局部应用苯妥英钠治疗Ⅱ期褥疮溃疡的愈合情况与其他两种标准局部治疗方法;并评估苯妥英钠组局部用药后全身吸收的程度。
本研究选取了47例患有Ⅱ期褥疮溃疡的养老院患者。这些患者在年龄、性别、伤口大小和严重程度方面进行了匹配,并随机分配到各治疗组。在治疗开始时以及每次换药时对褥疮溃疡进行临床评估。检查溃疡是否存在健康的肉芽组织、表面尺寸的缩小情况以及愈合时间。苯妥英钠组的所有患者要检测两次血浆苯妥英钠浓度。
与多爱肤敷料或三联抗生素软膏相比,局部应用苯妥英钠治疗能缩短完全愈合时间和肉芽组织形成时间(p≤0.05)。苯妥英钠组平均愈合时间为35.3±14.3天,而多爱肤组和三联抗生素软膏组分别为51.8±19.6天和53.8±8.5天。苯妥英钠组所有受试者在两到七天内出现健康的肉芽组织。标准治疗组的患者需要六到二十一天才能产生新的肉芽组织。未检测到血清苯妥英钠浓度。没有患者因不良治疗反应退出研究。
在研究期间,苯妥英钠组和标准治疗组均有进展。然而,苯妥英钠组在溃疡愈合的各个方面都显示出更快的效果。