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背景腿部疏松结缔组织炎是常见的皮肤及皮下组织细菌感染。研究者比较了低剂量青霉素与安慰剂对疏松结缔组织炎反复发作的预防作用。方法采用双盲、随机对照研究。将英国和爱尔兰共28家医院收治的腿部疏松结缔组织炎反复发作≥2次的患者纳入研究。按计算机生成代码将患者随机分组;由中心药房配发研究药物〔青霉素(250 mg/次,2次/d)或安慰剂,为期12个月〕。主要观察结果为首次复发时间。对入选者进行了3年的跟踪随访。由于3年间的再发风险性会发生改变,因此本研究仅在预防期内对主要指标进行假设检验。结果入选患者总数为274例。两组患者基线特性相似。疏松结缔组织炎首次复发的中位时间为:青霉素组626 d,安慰剂组532 d。预防期内,青霉素组136例患者中30例(22%)复发,安慰剂组138例患者中51例(37%)复发〔RR=0.55;95%CI(0.35,0.86),P=0.01〕,为预防1次复发需要治疗的次数为5次〔95%CI(4,9)〕。在未进行干预跟踪期间,两组首次复发率无差异(两组均为27%)。与安慰组比较,青霉素组患者反复发作次数少(119次与164次,P=0.02)。两组不良事件发生次数无明显差异(青霉素组37,安慰剂组48;P=0.50)。结论对腿部疏松结缔组织炎患者而言,预防期内使用青霉素可有效防止复发,但是停药后这种防护作用会逐渐减弱。
Background loose connective tissue of the leg is a common bacterial infection of the skin and subcutaneous tissue. The researchers compared the preventive effects of low doses of penicillin and placebo on recurrent episodes of loose connective tissue inflammation. Methods Double-blind, randomized controlled study. Patients in the United Kingdom and Ireland at 28 hospitals who had recurrent â € œ2 loose loose connective tissue inflammation were included in the study. Patients were randomized by computer generated code; study drugs (penicillin (250 mg / time, 2 times / d) or placebo were dispensed by the central pharmacy for a period of 12 months]. The main observation was the first relapse time. The participants were followed up for 3 years. Because of the risk of recurrence over a 3-year period, the study only tested hypotheses on key indicators during the prophylaxis period. Results The total number of patients selected for the 274 cases. The baseline characteristics of both groups were similar. The median time to first recurrence of loose connectiveitis was 626 days for penicillin and 532 days for placebo. During the prophylaxis period, 30 (22%) of 136 patients in the penicillin group relapsed and 51 (37%) of 138 patients in the placebo group relapsed (RR = 0.55; 95% CI, 0.35, 0.86; , The number of treatments required to prevent a relapse was 5 (95% CI (4,9)). There was no difference in the first recurrence between the two groups (27% in both groups) during follow-up without intervention. Patients in the penicillin group experienced fewer episodes of repeated attacks compared with the placebo group (119 vs 164, P = 0.02). There was no significant difference in the number of adverse events between the two groups (penicillin 37 vs placebo 48; p = 0.50). Conclusion For patients with loose connective tissue at the leg, the use of penicillin during the prophylaxis period can effectively prevent the recurrence, but this protective effect will be gradually weakened after withdrawal.