帕洛诺司琼-咪达唑仑联合用药与单用帕洛诺司琼预防乳腺手术患者术后恶心呕吐和患者自控镇痛的疗效比较：一项前瞻性、随机、双盲研究：符合 CONSORT 标准的研究。
Comparison of efficacy between palonosetron-midazolam combination and palonosetron alone for prevention of postoperative nausea and vomiting in patients undergoing breast surgery and patient controlled analgesia: A prospective, randomized, double-blind study: A CONSORT-compliant study.
机构信息
Department of Anesthesia and Pain Medicine.
Biomedical Research Institute, Pusan National University Hospital, 179 Gudeok-ro, Seo-gu, Busan-si 49241, Korea.
出版信息
Medicine (Baltimore). 2021 Jul 2;100(26):e26438. doi: 10.1097/MD.0000000000026438.
BACKGROUND
Postoperative nausea and vomiting (PONV) is a common complaint in patients following general anesthesia. Various antiemetics, including 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists, are effective but still have limited efficacy. Therefore, combination therapy is preferable to using a single drug alone in high-risk patients. We performed a comparative study on the antiemetic effect of palonosetron, a 5-HT3 receptor antagonist, monotherapy vs palonosetron-midazolam combination therapy for the prevention of PONV.
METHODS
A total of 104 female patients scheduled for breast cancer surgery were enrolled. They were randomly divided into 2 groups, a palonosetron monotherapy group (group P) and palonosetron-midazolam combination therapy group (group PM). Both groups received 0.075 mg palonosetron intravenously after induction of anesthesia. Patient-controlled analgesia (PCA) was applied according to the allocated group. Intravenous (IV)-PCA in group P consisted of fentanyl 20 μg/kg plus normal saline (total volume: 100 ml); IV-PCA in group PM consisted of fentanyl 20 μg/kg plus midazolam 4 mg plus normal saline (total volume: 100 ml). Efficacy parameters were collected during 0 to 1, 1 to 6, 6 to 24, and 24 to 48 hours postoperative time intervals. These measures included complete response (defined as no PONV and no rescue anti-emetic use) rate, incidence of PONV, sedation score, rescue antiemetic use, rescue analgesic use, and numerical rating scale (NRS) for pain. The complete response rate during the 0 to 24 hours interval was analyzed as the primary outcome.
RESULTS
Although the complete response rate between 0 and 24 hours was higher in group PM (42.3% and 48.1% in group P and PM, respectively), there was no statistically significant difference (P = .55). The complete response rates in other time intervals were not different between the 2 groups as well. The sedation score and NRS score also showed no differences between the 2 groups.
CONCLUSIONS
The combination therapy of palonosetron with midazolam did not lead to a greater reduction in the incidence of PONV than monotherapy in patients undergoing breast surgery and receiving IV-PCA containing fentanyl.
背景
术后恶心和呕吐（PONV）是全麻后患者常见的主诉。各种止吐药，包括 5-羟色胺 3 型（5-HT3）受体拮抗剂，都有效，但疗效仍有限。因此，联合治疗优于高危患者单独使用单一药物。我们对预防 PONV 进行了一项关于 5-HT3 受体拮抗剂帕洛诺司琼单药治疗与帕洛诺司琼-咪达唑仑联合治疗的止吐效果的比较研究。
方法
共纳入 104 例行乳腺癌手术的女性患者。他们被随机分为 2 组，即帕洛诺司琼单药治疗组（P 组）和帕洛诺司琼-咪达唑仑联合治疗组（PM 组）。两组患者在麻醉诱导后均接受 0.075mg 帕洛诺司琼静脉注射。根据分组应用患者自控镇痛（PCA）。P 组静脉 PCA 为芬太尼 20μg/kg 加生理盐水（总量：100ml）；PM 组静脉 PCA 为芬太尼 20μg/kg 加咪达唑仑 4mg 加生理盐水（总量：100ml）。在术后 0 至 1、1 至 6、6 至 24 和 24 至 48 小时的时间间隔内收集疗效参数。这些措施包括完全缓解（定义为无 PONV 和无解救性止吐药使用）率、PONV 发生率、镇静评分、解救性止吐药使用、解救性镇痛药使用和数字评分量表（NRS）疼痛评分。对 0 至 24 小时间隔内的完全缓解率进行了分析，作为主要结局。
结果
尽管 PM 组 0 至 24 小时的完全缓解率更高（P 组和 PM 组分别为 42.3%和 48.1%），但无统计学差异（P=0.55）。两组在其他时间间隔的完全缓解率也没有差异。两组的镇静评分和 NRS 评分也无差异。
结论
在接受含芬太尼静脉 PCA 的乳腺癌手术患者中，与单药治疗相比，帕洛诺司琼联合咪达唑仑治疗并未导致 PONV 发生率降低。
Zotero 插件