三级医院接受手术抗菌药物预防的手术患者双盲随机对照试验：临床药师的干预措施
Double blind randomized controlled trial for subjects undergoing surgery receiving surgical antimicrobial prophylaxis at tertiary hospital: the clinical pharmacist's interventions.
作者信息
Elnour Asim Ahmed, Al-Khidir Israa Y, Elkheir Habab, Elkhawad Abdalla, O Ahmed A Mohammed, A Al-Kubaissi Khalid, Nahar Ghadah, Alrwili Shahad Fayad, Alshelaly Donia Ahmed, Saleh Amjad, Aljaber Latefa Khulif, Alrashedi Abrar Ayad
机构信息
PhD, MSc. Program of Clinical Pharmacy, College of Pharmacy, Al Ain University, Abu Dhabi campus, Abu Dhabi-United Arab Emirates. AAU Health and Biomedical Research Center, Al Ain University, Abu Dhabi, United Arab Emirates.
PhD. Assistant Professor, Clinical Pharmacist, University of Hail (UOH), Hail - King Saudia Arabia (KSA).
出版信息
Pharm Pract (Granada). 2022 Oct-Dec;20(4):2727. doi: 10.18549/PharmPract.2022.4.2727. Epub 2022 Sep 8.
BACKGROUND
A surgical site infection (SSI) has significant clinical, humanistic and economic consequences. Surgical antimicrobials prophylaxis (SAP) is a reliable standard to prevent SSIs.
OBJECTIVE
The objective was to test that the clinical pharmacist's interventions may facilitate the implementation of SAP protocol and subsequent reduction of SSIs.
METHODS
This was double blinded randomized controlled interventional hospital-based-study at Khartoum State-Sudan. A total of 226 subjects underwent general surgeries at four surgical units. Subjects were randomized to interventions and controls in a (1:1) ratio where patient, assessors and physician were blinded. The surgical team has received structured educational and behavioral SAP protocol mini courses by way of directed lecturers, workshops, seminars and awareness campaigns delivered by the clinical pharmacist. The clinical pharmacist provided SAP protocol to the interventions group. The outcome measure was the primary reduction in SSIs.
RESULTS
There were (51.8%, 117/226) females, (61/113 interventions versus 56/113 controls), and (48.2%, 109/226) males (52 interventions and 57 controls). The overall rate of SSIs was assessed during 14 days post-operatively and was documented in (35.4%, 80/226). The difference in adherence to locally developed SAP protocol regarding the recommended antimicrobial was significant (P <0.001) between the interventions group (78, 69%) and the controls group (59, 52.2%). The clinical pharmacist's implementation of the SAP protocol revealed significant differences in SSIs with reduction in SSIs from 42.5% to 25.7% versus the controls group from 57.5% to 44.2% respectively, P = 0.001 between the interventions group and the controls group respectively.
CONCLUSION
The clinical pharmacist's interventions were very effective in sustainable adherence to SAP protocol and subsequent reduction in SSIs within the interventions group.
背景
手术部位感染（SSI）会产生重大的临床、人文和经济后果。外科抗菌药物预防（SAP）是预防手术部位感染的可靠标准。
目的
目的是检验临床药师的干预措施是否有助于实施SAP方案并随后减少手术部位感染。
方法
这是一项在苏丹喀土穆州一家医院进行的双盲随机对照干预研究。共有226名受试者在四个外科科室接受了普通外科手术。受试者按1:1的比例随机分为干预组和对照组，患者、评估人员和医生均处于盲态。手术团队通过临床药师提供的定向讲座、研讨会、讲习班和宣传活动，接受了结构化的教育和行为SAP方案迷你课程。临床药师向干预组提供了SAP方案。结果指标是手术部位感染的初步减少情况。
结果
女性占（51.8%，117/226）（干预组61例，对照组56例），男性占（48.2%，109/226）（干预组52例，对照组57例）。术后14天评估了手术部位感染的总体发生率，记录为（35.4%，80/226）。干预组（78例，69%）和对照组（59例，52.2%）在遵循当地制定的关于推荐抗菌药物的SAP方案方面存在显著差异（P<0.001）。临床药师实施的SAP方案显示，手术部位感染存在显著差异，干预组的手术部位感染率从42.5%降至25.7%，而对照组从57.5%降至44.2%，干预组与对照组之间P=0.001。
结论
临床药师的干预措施在干预组中对于持续遵循SAP方案以及随后减少手术部位感染非常有效。
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