一项比较水胶体、苯妥英钠和单纯敷料治疗压疮的随机临床试验[国际标准随机对照试验编号：ISRCTN33429693]
A randomized clinical trial comparing hydrocolloid, phenytoin and simple dressings for the treatment of pressure ulcers [ISRCTN33429693].
作者信息
Hollisaz Mohammad Taghi, Khedmat Hossein, Yari Fatemeh
机构信息
Department of Rehabilitation, Baqyiatollah Hospital, Baqyiatollah University of Medical Sciences, Tehran, Iran.
出版信息
BMC Dermatol. 2004 Dec 15;4(1):18. doi: 10.1186/1471-5945-4-18.
BACKGROUND
Pressure sores are important and common complications of spinal cord injury. Many preventive and therapeutic approaches have been tried and new trials are evolving. One relatively recent method is application of a hydrocolloid dressing (HD). In this study we compared the therapeutic effects of HD on pressure ulcer healing with two other topical applications, phenytoin cream (PC) and simple dressing (SD).
METHODS
Ninety-one stage I and stage II pressure ulcers of 83 paraplegic male victims of the Iran-Iraq war were randomly allocated to three treatment groups. Mean age and weight of the participants were 36.64 +/- 6.04 years and 61.12 +/- 5.08 kg, respectively. All the patients were managed in long term care units or in their homes for 8 weeks by a team of general practitioners and nurses, and the ulcer status was recorded as "Complete healing", "Partial healing", "Without improvement" and "Worsening".
RESULTS
Complete healing of ulcers, regardless of location and stage, was better in the HD group than the PC [23/31(74.19%) vs 12/30(40%); difference: 34.19%, 95% CI = 10.85-57.52, (P < 0.01)] or the SD [23/31(74.19%) vs 8/30(26.66%); difference: 47.53%, 95% CI = 25.45-69.61, (P < 0.005)] groups. Complete healing of stage I ulcers in the HD group [11/13(85%)] was better than in the SD [5/11(45%); difference: 40%, 95% CI = 4.7-75.22, (P < 0.05)] or PC [2/9 (22%); difference: 63%, 95% CI = 29.69-96.3, (P < 0.005)] groups. Complete healing of stage II ulcer in the HD group [12/18 (67%)] was better than in the SD group [3/19(16%); difference: 51%, 95% CI = 23.73-78.26, (P < 0.005)], but not significantly different from the PC group [10/21 (48%); difference: 19%, 95% CI = -11.47-49.47, (P > 0.05)]. We performed a second analysis considering only one ulcer per patient (i.e. 83 ulcers in 83 patients). This "per patient" analysis showed that complete ulcer healing in the HD group was better than in the PC [20/28(71.4%) vs 11/28 (39.3%); difference: 32.1%, 95% CI = 7.4-56.7, (P < 0.01)] or SD [20/28(71.4%) vs 8/27 (29.6%); difference: 41.8%, 95% CI = 17.7-65.8, (P < 0.005)] groups.
CONCLUSION
We deduced that HD is the most effective method investigated for treating stage I and II pressure ulcers in young paraplegic men.
背景
压疮是脊髓损伤的重要且常见并发症。人们已经尝试了许多预防和治疗方法，并且新的试验也在不断发展。一种相对较新的方法是应用水胶体敷料（HD）。在本研究中，我们比较了HD与其他两种局部应用药物，即苯妥英乳膏（PC）和单纯敷料（SD），对压疮愈合的治疗效果。
方法
将83名因两伊战争导致截瘫的男性受害者的91处I期和II期压疮随机分为三个治疗组。参与者的平均年龄和体重分别为36.64±6.04岁和61.12±5.08千克。所有患者在长期护理病房或家中由一组全科医生和护士管理8周，并将溃疡状况记录为“完全愈合”“部分愈合”“无改善”和“恶化”。
结果
无论溃疡的位置和分期如何，HD组溃疡的完全愈合情况均优于PC组[23/31（74.19%）对12/30（40%）；差异：34.19%，95%可信区间=10.85 - 57.52，（P<0.01）]或SD组[23/31（74.19%）对8/30（26.66%）；差异：47.53%，95%可信区间=25.45 - 69.61，（P<0.005）]。HD组I期溃疡的完全愈合情况[11/13（85%）]优于SD组[5/11（45%）；差异：40%，95%可信区间=4.7 - 75.22，（P<0.05）]或PC组[2/9（22%）；差异：63%，95%可信区间=29.69 - 96.3，（P<0.005）]。HD组II期溃疡的完全愈合情况[12/18（67%）]优于SD组[3/19（16%）；差异：51%，95%可信区间=23.73 - 78.26，（P<0.005）]，但与PC组[10/21（48%）；差异：19%，95%可信区间=-11.47 - 49.47，（P>0.05）]无显著差异。我们进行了第二项分析，仅考虑每位患者一处溃疡（即83名患者的83处溃疡）。这种“每位患者”分析表明，HD组溃疡的完全愈合情况优于PC组[20/28（71.4%）对11/28（39.3%）；差异：32.1%，95%可信区间=7.4 - 56.7，（P<0.01）]或SD组[20/28（71.4%）对8/27（29.6%）；差异：41.8%，95%可信区间=17.7 - 65.8，（P<0.005）]。
结论
我们推断，HD是所研究的治疗年轻截瘫男性I期和II期压疮的最有效方法。
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