Krige Jake E, Lindfield Kimberly, Friedrich Lawrence, Otradovec Constance, Martone William J, Katz David E, Tally Frank
University of Cape Town Health Sciences Faculty, Cape Town, South Africa.
Curr Med Res Opin. 2007 Sep;23(9):2147-56. doi: 10.1185/030079907X219652.
Compare the rapidity of the resolution of clinical signs and symptoms of complicated skin and skin structure infections (cSSSIs) caused by gram-positive organisms between daptomycin and comparator agents.
A subset of South African patients with gram-positive cSSSIs and no or one comorbid condition from two phase III clinical trials were included in the analysis. Patients were treated with daptomycin (n = 174) or comparator (penicillinase-resistant penicillins [n = 146] or vancomycin [n = 6]). The presence and severity of eight clinical signs and symptoms were evaluated at baseline, day 3 or 4 of treatment, end of therapy, and at test of cure (6-20 days after the last dose).
Of the 326 patients included in this analysis, the clinical success rates between daptomycin and comparator treatments was comparable. Overall, the severity of symptoms in the daptomycin-treated patients improved more quickly (p = 0.04) than comparator treatment. At the day 3/4 evaluation, of the eight signs and symptoms, severity significantly decreased for induration (p = 0.03) and erythema (p = 0.05); a statistical trend was noted for necrotic tissue (p = 0.10) and edema (p = 0.10) in daptomycin-treated patients. Daptomycin treatment resulted in a shorter median duration of therapy than those receiving comparator treatment (7 vs. 8 days, p < 0.0001). Both treatments were well tolerated.
Daptomycin produced a more rapid clinical improvement than comparators, as evidenced by significant reductions in the severity of induration and erythema, with a shorter duration of antibiotic therapy. However, this population was relatively young and healthy; therefore, these results may not be generalizable to all populations.
比较达托霉素与对照药物在治疗革兰氏阳性菌引起的复杂皮肤和皮肤结构感染（cSSSIs）时，临床体征和症状的缓解速度。
分析纳入了两项III期临床试验中的部分南非患者，这些患者患有革兰氏阳性cSSSIs，且无合并症或仅有一种合并症。患者接受达托霉素治疗（n = 174）或对照药物治疗（耐青霉素酶青霉素[n = 146]或万古霉素[n = 6]）。在基线、治疗第3或4天、治疗结束时以及治愈检测时（最后一剂后6 - 20天）评估八种临床体征和症状的存在情况及严重程度。
在该分析纳入的326例患者中，达托霉素治疗组与对照药物治疗组的临床成功率相当。总体而言，达托霉素治疗的患者症状严重程度改善比对照药物治疗更快（p = 0.04）。在第3/4天评估时，在八种体征和症状中，达托霉素治疗的患者硬结（p = 0.03）和红斑（p = 0.05）的严重程度显著降低；坏死组织（p = 0.10）和水肿（p = 0.10）有统计学趋势。达托霉素治疗的中位治疗持续时间比接受对照药物治疗的患者短（7天对8天，p < 0.0001）。两种治疗耐受性均良好。
达托霉素比对照药物能使临床改善更快，硬结和红斑严重程度显著降低以及抗生素治疗持续时间更短证明了这一点。然而，该人群相对年轻且健康；因此，这些结果可能不适用于所有人群。
