Department of General Surgery, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China.
Department of Emergency Medicine, The Affiliated Hospital of Qingdao University, Qingdao, China.
BMJ Open. 2022 May 2;12(5):e057793. doi: 10.1136/bmjopen-2021-057793.
Emerging evidence has shown that an antibiotic first strategy is a viable treatment option for uncomplicated acute appendicitis (AA). Although there has recently been an interest and increase in the use of antibiotics as the primary strategy for treating uncomplicated AA, there is no consensus regarding the optimum antibiotic regimen. In particular, the long-term outcomes of different antibiotic regimens, such as the recurrence rate, still lack evidence. Given that the flora of the appendix is mainly anaerobic bacteria, we hypothesised that antianaerobe regimens could decrease the recurrence rate compared with those that did not include antianaerobic antibiotics.
The OPTIMA(Optimising the treatment for uncomplicated acute appendicitis) trial is a multicentre, double-blinded placebo-controlled superiority randomised study aimed to evaluate the role of antianaerobic antibiotics in the resolution of uncomplicated AA. Patients (18-65 years) with uncomplicated AA (without gangrenous, perforated appendicitis, appendiceal abscess, or appendiceal fecaliths) are eligible for inclusion. The primary endpoint of this study is the success rate of the treatment, defined as the resolution of AA resulting in discharge from the hospital without surgical intervention and recurrent symptoms within one year. Secondary endpoints include mortality, postintervention complications, recurrent symptoms up to one year after treatment, hospital stay, sick leave, treatment cost, pain symptom scores and quality of life. Data are reported as the number of cases (%), median (range) and relative risk, which will be analysed using the Mann-Whitney U test or χ test, as appropriate. -value<0.05 will be considered significant.
The protocol has been approved by the Ethics Committee of Jinling Hospital on 13 November 2018 (2018NZKY-027-01). The trial findings will be published in peer-reviewed journals.
ChiCTR1800018896.
新出现的证据表明，抗生素首选用药策略是治疗单纯性急性阑尾炎（AA）的可行治疗选择。尽管最近人们对将抗生素作为治疗单纯性 AA 的主要策略的兴趣和使用有所增加，但对于最佳抗生素方案仍没有共识。特别是，不同抗生素方案的长期结果，如复发率，仍然缺乏证据。鉴于阑尾的菌群主要为厌氧菌，我们假设抗厌氧菌方案与不包括抗厌氧抗生素的方案相比，可能会降低复发率。
OPTIMA（优化单纯性急性阑尾炎治疗）试验是一项多中心、双盲安慰剂对照优效性随机研究，旨在评估抗厌氧菌抗生素在治疗单纯性 AA 中的作用。患有单纯性 AA（无坏疽性、穿孔性阑尾炎、阑尾脓肿或阑尾粪石）的 18-65 岁患者符合纳入条件。该研究的主要终点是治疗成功率，定义为 AA 得到解决，无需手术干预即可出院，且在一年内无复发症状。次要终点包括死亡率、干预后并发症、治疗后一年内复发症状、住院时间、病假、治疗费用、疼痛症状评分和生活质量。数据以病例数（%）、中位数（范围）和相对风险报告，将使用 Mann-Whitney U 检验或 χ 检验进行分析，具体取决于数据类型。-值<0.05 被认为具有统计学意义。
该方案已于 2018 年 11 月 13 日获得金陵医院伦理委员会的批准（2018NZKY-027-01）。试验结果将发表在同行评议的期刊上。
ChiCTR1800018896。
