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手术引流治疗原发性关节细菌性关节炎后使用抗生素治疗 2 周与 4 周的比较:一项前瞻性、随机、非劣效性试验。

Two weeks versus four weeks of antibiotic therapy after surgical drainage for native joint bacterial arthritis: a prospective, randomised, non-inferiority trial.

机构信息

Hand Surgery Unit, Hopitaux Universitaires de Geneve, Geneva, Switzerland.

Service of Infectious Diseases, Hopitaux Universitaires de Geneve, Geneva, Switzerland.

出版信息

Ann Rheum Dis. 2019 Aug;78(8):1114-1121. doi: 10.1136/annrheumdis-2019-215116. Epub 2019 Apr 16.

Abstract

OBJECTIVE

The optimal duration of postsurgical antibiotic therapy for adult native joint bacterial arthritis remains unknown.

METHODS

We conducted a prospective, unblinded, randomised, non-inferiority study comparing either 2 or 4 weeks of antibiotic therapy after surgical drainage of native joint bacterial arthritis in adults. Excluded were implant-related infections, episodes without surgical lavage and episodes with a follow-up of less than 2 months.

RESULTS

We enrolled 154 cases: 77 in the 4-week arm and 77 in the 2-week arm. Median length of intravenous antibiotic treatment was 1 and 2 days, respectively. The median number of surgical lavages was 1 in both arms. Recurrence of infection was noted in three patients (2%): 1 in the 2-week arm (99% cure rate) and 2 in the 4-week arm (97% cure rate). There was no difference in the number of adverse events or sequelae between the study arms. Of the overall 154 arthritis cases, 99 concerned the hand and wrist, for which an additional subgroup analysis was performed. In this per-protocol subanalysis, we noted three recurrences: one in the 2-week arm (97 % cure); two in the 4-week arm (96 % cure) and witnessed sequelae in 50% in the 2-week arm versus 55% in the 4-week arm, of which five (13%) and six (13%) needed further interventions.

CONCLUSIONS

After initial surgical lavage for septic arthritis, 2 weeks of targeted antibiotic therapy is not inferior to 4 weeks regarding cure rate, adverse events or sequelae and leads to a significantly shorter hospital stay, at least for hand and wrist arthritis.

TRIAL REGISTRATION NUMBER

NCT03615781.

摘要

目的

成人原发性关节细菌性关节炎术后抗生素治疗的最佳持续时间仍不清楚。

方法

我们进行了一项前瞻性、非盲法、随机、非劣效性研究,比较了成人原发性关节细菌性关节炎手术后引流后接受 2 周或 4 周抗生素治疗的效果。排除了与植入物相关的感染、未进行手术冲洗的发作和随访时间少于 2 个月的发作。

结果

我们共纳入了 154 例患者:4 周组 77 例,2 周组 77 例。静脉内抗生素治疗的中位数分别为 1 天和 2 天。两组的手术冲洗中位数均为 1 次。3 例(2%)患者出现感染复发:2 周组 1 例(治愈率 99%),4 周组 2 例(治愈率 97%)。两组间不良事件或后遗症的数量无差异。在 154 例关节炎病例中,99 例涉及手部和腕部,对此进行了亚组分析。在该意向治疗分析中,我们注意到 3 例复发:2 周组 1 例(治愈率 97%),4 周组 2 例(治愈率 96%),2 周组有 50%出现后遗症,而 4 周组有 55%,其中 5 例(13%)和 6 例(13%)需要进一步干预。

结论

在初次手术冲洗治疗化脓性关节炎后,2 周的靶向抗生素治疗在治愈率、不良事件或后遗症方面并不逊于 4 周,并且至少在手部和腕部关节炎方面可显著缩短住院时间。

临床试验注册号

NCT03615781。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/55d8/6691865/9b452730957b/annrheumdis-2019-215116f01.jpg

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