CT诊断的单纯性急性阑尾炎对抗生素原发性无反应及阑尾炎复发的预后因素：两项随机临床试验的二次分析
Prognostic factors associated with primary non-responsiveness to antibiotics and appendicitis recurrence for CT-diagnosed uncomplicated acute appendicitis: secondary analysis of two randomized clinical trials.
作者信息
Selänne Liisa, Hurme Saija, Sippola Suvi, Rautio Tero, Nordström Pia, Rantanen Tuomo, Pinta Tarja, Ilves Imre, Mattila Anne, Sävelä Eeva-Liisa, Rintala Jukka, Paajanen Hannu, Grönroos Juha, Haijanen Jussi, Salminen Paulina
机构信息
Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.
Department of Surgery, University of Turku, Turku, Finland.
出版信息
Br J Surg. 2025 Jul 3;112(7). doi: 10.1093/bjs/znaf143.
BACKGROUND
Antibiotics are safe and efficient for CT-diagnosed uncomplicated acute appendicitis. Identifying predictive factors of primary non-responsiveness or recurrence would further improve antibiotic treatment success and safety.
METHODS
All patients treated with antibiotics in two large RCTs (APPAC and APPAC II) were included. The primary non-responsiveness analysis compared patients operated on within 30 days after randomization for complicated appendicitis with either patients presenting with uncomplicated appendicitis at surgery within 30 days or patients with successful antibiotic treatment during 3-year follow-up. Prognostic factors for appendicitis recurrence were assessed by comparing patients with successful antibiotic treatment with patients with acute appendicitis operated on after 30 days of initial antibiotics.
RESULTS
Of 856 patients randomized to antibiotics (mean(s.d.) age of 36(12) years; 365 (42.6%) were women), 832 were eligible for non-responsiveness analysis and 732 for appendicitis recurrence analysis. Findings associated with primary non-responsiveness on admission included an appendiceal diameter ≥15 mm (adjusted risk ratio (RR) 4.00 (95% c.i. 2.00 to 7.92) (P < 0.001)) and a body temperature >38°C (adjusted RR 2.76 (95% c.i. 1.27 to 6.03) (P = 0.011)). During the first 6-30 h after admission, C-reactive protein (CRP) ≥100 mg/l (negative predictive value of 99%) and leucocyte count ≥9 × 109/l were associated with primary non-responsiveness (adjusted RR 8.29 (95% c.i. 3.69 to 18.63) (P < 0.001) and adjusted RR 4.44 (95% c.i. 1.79 to 11.05) (P = 0.001) respectively). No prognostic findings for appendicitis recurrence were identified.
CONCLUSION
Patients with an appendiceal diameter ≥15 mm and a body temperature >38°C may not be optimal candidates for non-operative treatment for uncomplicated acute appendicitis. Patients with CRP <100 mg/l at 24 h of antibiotic treatment for uncomplicated acute appendicitis have a 99% likelihood of successful antibiotic therapy.
REGISTRATION NUMBERS
NCT03236961 and NCT01022567 (http://www.clinicaltrials.gov).
背景
抗生素对CT诊断的单纯性急性阑尾炎安全有效。识别原发性无反应或复发的预测因素将进一步提高抗生素治疗的成功率和安全性。
方法
纳入两项大型随机对照试验（APPAC和APPAC II）中所有接受抗生素治疗的患者。原发性无反应分析将随机分组后30天内因复杂性阑尾炎接受手术的患者与30天内手术时表现为单纯性阑尾炎的患者或3年随访期间抗生素治疗成功的患者进行比较。通过比较抗生素治疗成功的患者与初始抗生素治疗30天后接受急性阑尾炎手术的患者，评估阑尾炎复发的预后因素。
结果
在856例随机接受抗生素治疗的患者中（平均（标准差）年龄36（12）岁；365例（42.6%）为女性），832例符合无反应分析条件，732例符合阑尾炎复发分析条件。入院时与原发性无反应相关的发现包括阑尾直径≥15 mm（调整风险比（RR）4.00（95%置信区间2.00至7.92）（P<0.001））和体温>38°C（调整RR 2.76（95%置信区间1.27至6.03）（P = 0.011））。入院后最初6 - 30 小时内，C反应蛋白（CRP）≥ 100 mg/l（阴性预测值99%）和白细胞计数≥9×10⁹/l与原发性无反应相关（调整RR分别为8.29（95%置信区间3.69至18.63）（P<0.001）和调整RR 4.44（95%置信区间1.79至11.05）（P = 0.001））。未发现阑尾炎复发的预后相关发现。
结论
阑尾直径≥15 mm且体温>38°C的患者可能不是单纯性急性阑尾炎非手术治疗的最佳人选。单纯性急性阑尾炎抗生素治疗24小时时CRP<100 mg/l的患者抗生素治疗成功的可能性为99%。
注册号
NCT03236961和NCT01022567（http://www.clinicaltrials.gov）
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