Biele M, Campori G, Colombo R, De Giorgio G, Frascione P, Sali R, Starnini G, Milani M
Dermatology Service, Casa Circondariale Civitavecchia, Rome, Italy.
J Eur Acad Dermatol Venereol. 2006 Jul;20(6):717-20. doi: 10.1111/j.1468-3083.2006.01623.x.
Scabies is a very common skin infection in convicts. The SIMSPE Society (Società Italiana di Medicina e Sanità Penitenziaria) has organized and conducted a multicentre, randomized, comparative, parallel group, investigator-blinded trial to evaluate the efficacy and tolerability of synergized pyrethrins foam (PF) in comparison with benzyl benzoate (BB) lotion.
A total of 240 convicted patients, enrolled in eight National Jail Institutions, with a clinical diagnosis of scabies, were treated with PF (n = 120) for three consecutive days or BB (n = 120) for five consecutive days. Primary study endpoints were the clinical cure rate and the local tolerability. Secondary endpoints were clinical evolution of scabietic lesions and itching intensity. Study outcomes were assessed using appropriate semiquantitative scores at baseline and after 2 and 4 weeks. A second treatment cycle was applied if after 2 weeks the patient was not judged clinically cured.
At week 2, a total of 75% (95% CI: 66-82%) and 71% (95% CI: 62-78%) of patients showed a complete clinical cure rate in the PF and BB groups, respectively. At week 4, the percentage of totally cured patients increased up to 95% (95% CI: 89-97%) and 91% (95% CI: 83-94%) in the PF and BB groups, respectively (P = NS between groups). At week 4, 5% in the PF group and 9% in the BB group complained of itching. Burning and irritation after treatment applications were more common in the BB group in comparison with the PF group. The tolerability score was better in the PF group in comparison with to BB group (2.9 vs. 2.2; P = 0.0001). A total of 95% of patients in the PV group had a good tolerability score (i.e. = 3) in comparison with 41% in the BB group.
Our results show that a 3-day treatment with pyrethrins thermofobic foam is at least as effective as a 5-day treatment with benzyl benzoate lotion in convicted subjects with scabies. The foam formulation is better tolerated than the benzyl benzoate lotion.
疥疮是罪犯中一种非常常见的皮肤感染。意大利监狱医学与卫生协会（SIMSPE Society）组织并开展了一项多中心、随机、对照、平行组、研究者盲法试验，以评估增效除虫菊酯泡沫（PF）与苯甲酸苄酯（BB）洗剂相比的疗效和耐受性。
共有240名来自八个国家监狱机构、临床诊断为疥疮的罪犯患者，连续三天接受PF治疗（n = 120）或连续五天接受BB治疗（n = 120）。主要研究终点为临床治愈率和局部耐受性。次要终点为疥疮皮损的临床演变和瘙痒强度。在基线以及2周和4周后使用适当的半定量评分评估研究结果。如果2周后患者未被判定临床治愈，则进行第二个治疗周期。
在第2周时，PF组和BB组分别有75%（95%CI：66 - 82%）和71%（95%CI：62 - 78%）的患者显示出完全临床治愈率。在第4周时，PF组和BB组完全治愈患者的百分比分别增至95%（95%CI：89 - 97%）和91%（95%CI：83 - 94%）（组间P = 无统计学差异）。在第4周时，PF组有5%的患者和BB组有9%的患者抱怨瘙痒。与PF组相比，BB组治疗后烧灼感和刺激感更常见。PF组的耐受性评分优于BB组（2.9对2.2；P = 0.0001）。PF组共有95%的患者耐受性评分良好（即≥3），而BB组为41%。
我们的结果表明，对于患有疥疮的罪犯，3天的除虫菊酯隔热泡沫治疗至少与5天的苯甲酸苄酯洗剂治疗一样有效。泡沫制剂的耐受性优于苯甲酸苄酯洗剂。
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