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比较阿瑞匹坦与昂丹司琼预防术后恶心呕吐(PONV)的疗效:一项针对接受乳房和甲状腺手术患者的双盲随机对照试验。

Comparing the efficacy of aprepitant and ondansetron for the prevention of postoperative nausea and vomiting (PONV): A double blinded, randomised control trial in patients undergoing breast and thyroid surgeries.

作者信息

Jeyabalan Salome, Thampi Suma Mary, Karuppusami Reka, Samuel Kunder

机构信息

Department of Anesthesia, Christian Medical College and Hospital, Vellore, Tamil Nadu, India.

Department of Biostatistics, Christian Medical College and Hospital, Vellore, Tamil Nadu, India.

出版信息

Indian J Anaesth. 2019 Apr;63(4):289-294. doi: 10.4103/ija.IJA_724_18.

Abstract

BACKGROUND AND AIMS

Aprepitant, a Neurokinin-1 receptor antagonist, has been evaluated in abdominal and neurosurgeries, but its effect is less clear in breast and thyroid surgeries, which are also known to be high risk for post-operative nausea and vomiting (PONV). This study was done to compare the antiemetic efficacy of ondansetron and aprepitant in women undergoing mastectomy and thyroidectomy.

METHODS

One hundred and twenty-five ASA I and II, female patients, aged between 18 and 65 years were randomly assigned into Group I (ondansetron group, = 62) or Group II (aprepitant group, = 63), by computer-generated random sequencing. Per protocol analysis was done to assess the incidence and severity of PONV, use of rescue antiemetics, and patient satisfaction with PONV control between the two groups, till 24 h post-surgery.

RESULTS

In the immediate postoperative period, 79.7% of patients in Group I and 85.2% in Group II were free of emesis ( value: 0.49). In Group I, the first episode of vomiting occurred within a median duration 90 min (IQR 2575: 45-147) postoperatively, whereas the median duration in Group II was 160 min (IQR 25-75: 26-490), with request for rescue antiemetic at 60 min in Group I (IQR 25-75: 27-360) and 147 min in Group II (IQR 25-75: 11-457).

CONCLUSION

A single dose of oral aprepitant has comparable effects to injection ondansetron administered eighth hourly in preventing PONV, the severity of nausea, number of rescue antiemetics, and the time to first emetic episode in the 24-h postoperative period.

CTRI REG NO

REF/2017/06/014637.

摘要

背景与目的

阿瑞匹坦是一种神经激肽-1受体拮抗剂,已在腹部手术和神经外科手术中进行了评估,但其在乳房和甲状腺手术中的效果尚不清楚,而这两种手术也被认为是术后恶心呕吐(PONV)的高风险手术。本研究旨在比较昂丹司琼和阿瑞匹坦在接受乳房切除术和甲状腺切除术的女性中的止吐效果。

方法

125例年龄在18至65岁之间的美国麻醉医师协会(ASA)I级和II级女性患者,通过计算机生成的随机序列随机分为I组(昂丹司琼组,n = 62)或II组(阿瑞匹坦组,n = 63)。按照方案进行分析,以评估两组术后24小时内PONV的发生率和严重程度、急救止吐药的使用情况以及患者对PONV控制的满意度。

结果

术后即刻,I组79.7%的患者和II组85.2%的患者未出现呕吐(P值:0.49)。I组首次呕吐发作的中位时间为术后90分钟(四分位间距25%-75%:45-147),而II组的中位时间为160分钟(四分位间距25%-75%:26-490),I组在60分钟(四分位间距25%-75%:27-360)需要使用急救止吐药,II组在147分钟(四分位间距25%-75%:11-457)需要使用。

结论

单剂量口服阿瑞匹坦在预防术后24小时内的PONV、恶心严重程度、急救止吐药的使用次数以及首次呕吐发作时间方面,与每8小时注射一次昂丹司琼的效果相当。

临床试验注册编号

REF/2017/06/014637

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5211/6460978/dd2244aa71db/IJA-63-289-g001.jpg

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