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抗生素预防与手术部位感染;一项前瞻性开放标签研究,旨在临床评估腹腔镜胆囊切除术中单剂量预防性使用头孢曲松后的血清和组织浓度。

Antibiotic prophylaxis and surgical site infections; a prospective open label study to clinically evaluate the serum and tissue concentration of single dose prophylactic ceftriaxone in laparoscopic cholecystectomy.

作者信息

Sheikh Salim, Malik Neeraj Kumar, Karim Bushra Ahmed

机构信息

Department of Pharmacology, Employee's State Insurance Corporation Medical College and Hospital, Faridabad, 121001, India.

Department of Pharmacology, VMMC & Safdarjung Hospital, New Delhi, 110029, India.

出版信息

Eur J Clin Pharmacol. 2020 Jun 25. doi: 10.1007/s00228-020-02940-x.

Abstract

OBJECTIVE

The goal of administering preoperative systemic prophylactic antibiotics is to have the concentration in the tissues at its optimum level at the start and throughout the surgery. The rationale for the use of antibiotics is not well accepted, possible side effects and development of microbial resistance patterns are potential risks along with the financial burden. Therefore, the present study was conducted with the aim to clinically evaluate the serum and tissue concentration of single dose prophylactic ceftriaxone during an ongoing laparoscopic cholecystectomy and to find out risk factors for postoperative surgical site infection.

METHOD

It was an open label prospective study in 50 consecutive patients who underwent elective laparoscopic cholecystectomy under prophylactic cover of ceftriaxone. Serum and tissue concentrations were estimated by HPLC during the ongoing surgery. Subjects were observed for any postoperative complications including SSI.

RESULTS

Serum and tissue concentrations of ceftriaxone were significant at test value of 4 mg/L. Body mass index was significantly correlated with the tissue concentration of ceftriaxone at the time of incision. The rate of SSI was 2%. It was significantly correlated with age more than 60 years, diabetes, and infected bile.

CONCLUSION

A single prophylactic iv dose of 1 g ceftriaxone immediately prior to skin incision in LC is good enough for prevention of SSI in Indian patients.

摘要

目的

术前给予全身性预防性抗生素的目的是在手术开始时及整个手术过程中使组织中的药物浓度处于最佳水平。抗生素的使用原理尚未得到充分认可,可能的副作用、微生物耐药模式的形成以及经济负担都是潜在风险。因此,本研究旨在临床评估在进行腹腔镜胆囊切除术期间单剂量预防性头孢曲松的血清和组织浓度,并找出术后手术部位感染的危险因素。

方法

这是一项开放标签的前瞻性研究,对50例连续接受择期腹腔镜胆囊切除术且在头孢曲松预防性覆盖下的患者进行研究。在手术过程中通过高效液相色谱法估计血清和组织浓度。观察受试者是否出现包括手术部位感染在内的任何术后并发症。

结果

头孢曲松的血清和组织浓度在测试值为4mg/L时具有统计学意义。体重指数与切开时头孢曲松的组织浓度显著相关。手术部位感染率为2%。它与60岁以上的年龄、糖尿病和胆汁感染显著相关。

结论

在印度患者中,在腹腔镜胆囊切除术皮肤切开前立即静脉注射1g单剂量预防性头孢曲松足以预防手术部位感染。

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