Bernard P, Vaillant L, Martin C, Beylot C, Quentin R, Touron D
Service de Dermatologie, CHU de Limoges.
Ann Dermatol Venereol. 1997;124(5):384-9.
Superficial pyoderma occurs frequently. Generally, the benign infection is caused by Staphylococcus aureus and/or a group A streptococci. The subject is controversial, but treatment usually is based on narrow-spectrum antibiotics active against both germs.
A multicentric, randomized, double-blind, double-placebo study was conducted to compare pristinamycin (1 g b.i.d.) with a reference antibiotic, oxacillin (1 g b.i.d.) for 10 days. Inclusion criteria were: both sexes, age 15-80 years, clinical diagnosis of superficial pyoderma (impetigo, wound infection within the last 15 days, furunculosis, carbuncle, perionyxis), informed consent. The general practitioner investigators (n = 52) were assisted by 9 dermatologist-coordinators. Clinical diagnosis was validated by a committee of experts at the end of the study after analyzes of the photos and bacteriological results obtained on samples taken at the practitioner's office on visit 1 (D0), visit 3 (D14 +/- 3) and visit 4 (D25 +/- 3). Successful treatment was defined by clinical, bacteriological and photographic efficacy at visit 3 (equivalence analysis: one-way 95 p. 100 confidence interval).
There were 293 included patients given pristinamycin (n = 151) or oxacillin (n = 142). Mean age of analyzed patients was 40 +/- 17 years. Diagnosis was confirmed in 255 patients in accordance with the protocol: furunculosis or carbuncle (n = 100), recently superinfected wound (n = 97), impetigo (n = 41), acute perionyxis (n = 17). Thirty-five patients (12 p. 100) were considered to have been wrongly included. The germs most often isolated were: Staphylococcus aureus (n = 126), group A streptococci (n = 13), group B streptococci (n = 5) and P. multocida (n = 3). At visit 3, the two treatments were found to be equivalent with a success rate of 86.7 p. 100 for pristinamycin and 89.8 p. 100 for oxacillin (CI [*9.97]). Tolerance was statistically comparable between the two treatments (27 to 32 percent minor side effects).
This study is the first performed in outpatients attended by general practitioners with diagnostic confirmation on both bacteriological and photographic evidence of superficial pyoderma. The results obtained demonstrate the good reliability of such studies although 12 p. 100 of the patients were wrongly included, a factor which should be taken into account for future studies. The efficacy and tolerance of pristinamycin were statistically equivalent to those of oxacillin for all the patients with superficial pyoderma. Nevertheless, the subgroup of patients with folliculitis gave rather heterogeneous bacteriology and therapeutic results.
浅表脓皮病很常见。一般来说，这种良性感染是由金黄色葡萄球菌和/或A组链球菌引起的。该问题存在争议，但治疗通常基于对这两种细菌有效的窄谱抗生素。
进行了一项多中心、随机、双盲、双安慰剂研究，比较普ristinamycin（1克，每日两次）与参考抗生素苯唑西林（1克，每日两次），疗程为10天。纳入标准为：男女不限，年龄15 - 80岁，浅表脓皮病的临床诊断（脓疱病、过去15天内的伤口感染、疖病、痈、甲沟炎），知情同意。52名全科医生研究者得到9名皮肤科协调员的协助。研究结束时，由专家委员会根据在第1次就诊（D0）、第3次就诊（D14 ± 3）和第4次就诊（D25 ± 3）时在医生办公室采集的样本的照片和细菌学结果对临床诊断进行验证。成功治疗的定义为第3次就诊时的临床、细菌学和影像学疗效（等效性分析：单向95%置信区间）。
共纳入293例患者，给予普ristinamycin（n = 151）或苯唑西林（n = 142）。分析患者的平均年龄为40 ± 17岁。255例患者的诊断符合方案：疖病或痈（n = 100）、近期发生二重感染的伤口（n = 97）、脓疱病（n = 41）、急性甲沟炎（n = 17）。35例患者（12%）被认为纳入错误。最常分离出的细菌为：金黄色葡萄球菌（n = 126）、A组链球菌（n = 13）、B组链球菌（n = 5）和多杀巴斯德菌（n = 3）。在第3次就诊时，发现两种治疗等效，普ristinamycin的成功率为86.7%，苯唑西林为89.8%（CI [*9.97]）。两种治疗的耐受性在统计学上相当（轻微副作用发生率为27%至32%）。
本研究是首次在全科医生诊治的门诊患者中进行，对浅表脓皮病的细菌学和影像学证据进行诊断确认。尽管12%的患者纳入错误，但所获得的结果证明了此类研究具有良好的可靠性，这一因素在未来研究中应予以考虑。对于所有浅表脓皮病患者，普ristinamycin的疗效和耐受性在统计学上与苯唑西林相当。然而，毛囊炎患者亚组的细菌学和治疗结果差异较大。
