Unidad de Investigación Clínica y Ensayos Clínicos, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
Departamento de Enfermeria, Facultad Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid, Madrid, Spain.
Eur J Clin Pharmacol. 2019 May;75(5):647-654. doi: 10.1007/s00228-018-02623-8. Epub 2019 Jan 16.
To evaluate pharmacokinetic parameters of ciprofloxacin in patients undergoing Roux-en-Y gastric surgery (RYGS).
Controlled, single-dose, open-label study in patients undergoing RYGS. Healthy overweight/obese patients 18-60 years old were included. The assessment was performed once in control patients and three times in case patients (before surgery and 1 and 6 months after surgery). In each visit, the subjects received a single oral dose of ciprofloxacin 500 mg. Venous blood samples were obtained at baseline and 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 8 and 14 h after ciprofloxacin intake. Pre- and post-surgery variables were compared using paired ANOVA or the Wilcoxon tests and control vs cases using ANOVA or Mann Whitney. Given the post-surgery change in body weight, the parameters were corrected by dose (mg)/body weight (kg). The analysis was performed using SPSS.
Ciprofloxacin C was significantly reduced 1 month after surgery (1840.9 ± 485.2 vs 1589.6 ± 321.8 ng/ml; p = 0.032) but not 6 months after. C on the sixth month was lower than C in control group (2160.4 ± 408.6 vs 1589.6 ± 321.8 ng/ml; p < 0.001). After correcting by the dose (mg)/patient's body weight, both C and AUClast showed significant decrease 1 and 6 months after surgery: C, 289.1 ± 65.3 and 263.5 ± 52.1 (ng/ml)/(dose (mg)/weight (kg)) respectively vs 429.3 ± 127.6 (ng/ml)/(dose (mg)/weight (kg)) at baseline; AUC, 1340.6 ± 243.0 and 1299.2 ± 415.4 (h × ng/ml)/(dose (mg)/weight (kg)) respectively vs 1896.7 ± 396.8 (h × ng/ml)/(dose (mg)/weight (kg)) at baseline. C 1 month post-surgery showed lower values than the control group (375.4 ± 77.4 vs 263.5 ± 52.1 ng/ml; p < 0.001).
Ciprofloxacin absorption is impaired 1 month and 6 months after RYGS. The effect on C and AUClast faded on the sixth month due to weight loss. It is no necessary to modify the doses of ciprofloxacin in these patients.
评估接受 Roux-en-Y 胃旁路手术（RYGS）的患者中环丙沙星的药代动力学参数。
在接受 RYGS 的患者中进行对照、单剂量、开放标签研究。纳入 18-60 岁的健康超重/肥胖患者。在对照患者中进行一次评估，在病例患者中进行三次评估（手术前和手术后 1 个月和 6 个月）。在每次就诊时，受试者均接受单次口服环丙沙星 500mg。在基线和环丙沙星摄入后 0.5、1、1.25、1.5、1.75、2、2.5、3、4、8 和 14 小时采集静脉血样。使用配对 ANOVA 或 Wilcoxon 检验比较术前和术后变量，并使用 ANOVA 或 Mann-Whitney 检验比较对照和病例。考虑到手术后体重的变化，通过剂量（mg）/体重（kg）对参数进行校正。分析使用 SPSS 进行。
手术后 1 个月时，环丙沙星 C 明显降低（1840.9±485.2 与 1589.6±321.8ng/ml；p=0.032），但手术后 6 个月时没有。第六个月的 C 低于对照组的 C（2160.4±408.6 与 1589.6±321.8ng/ml；p<0.001）。经剂量（mg）/患者体重校正后，手术后 1 和 6 个月时 C 和 AUClast 均显著降低：C，分别为 289.1±65.3 和 263.5±52.1（ng/ml）/（剂量（mg）/体重（kg））与基线时的 429.3±127.6（ng/ml）/（剂量（mg）/体重（kg））相比；AUC，分别为 1340.6±243.0 和 1299.2±415.4（h×ng/ml）/（剂量（mg）/体重（kg））与基线时的 1896.7±396.8（h×ng/ml）/（剂量（mg）/体重（kg））相比。手术后 1 个月的 C 值低于对照组（375.4±77.4 与 263.5±52.1ng/ml；p<0.001）。
RYGS 术后 1 个月和 6 个月时，环丙沙星的吸收受损。由于体重减轻，C 和 AUClast 的影响在第六个月消失。因此，无需在这些患者中调整环丙沙星的剂量。
