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药物遗传学指导下选择妇科手术患者术后镇痛药的可行性:一项前瞻性、随机、试点研究。

Feasibility of pharmacogenetic-guided selection of postoperative analgesics in gynecologic surgery patients: a prospective, randomized, pilot study.

作者信息

Hoffecker Glenda, Mulugeta-Gordon Lakeisha, Wittner Victoria, Wang Xingmei, Gysler Stefan, Deagostino-Kelly Mary, Tuteja Sony

机构信息

Department of Pharmacy.

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Penn Medicine Hospital of University of Pennsylvania.

出版信息

Pharmacogenet Genomics. 2025 Aug 1;35(6):183-191. doi: 10.1097/FPC.0000000000000568. Epub 2025 May 6.

Abstract

OBJECTIVES

Evaluate the feasibility of implementing a multigene pharmacogenetic (PGx) test and genotype-guided pharmacist recommendations into gynecologic perioperative workflows and fidelity to pharmacist genotype-guided postoperative analgesic recommendations.

METHODS

A randomized, prospective, open-label pilot study was conducted in gynecologic patients undergoing abdominal surgery. Participants received multigene PGx testing and were randomized to the PGx-guided group where results were returned to the electronic health record with pharmacist genotype-guided postoperative analgesic recommendations or usual care. Primary outcomes included the proportion of PGx results and pharmacist recommendations completed before surgery, the number of prescriptions in alignment with pharmacist recommendations, and the proportion of analgesics prescribed differing from usual care.

RESULTS

Of the 101 participants analyzed, all were female, 50 ± 14 years old, 49% were Black, 48% were White, 60% were treated by gynecologic oncology, and 76% underwent minimally invasive surgery. PGx results were returned to the genomics results portal a median of 7 (interquartile range: 6-9) business days after ordering the test. A majority (85%) of results were returned before the participant's surgery. Pharmacist genotype-guided analgesic recommendations were completed for 35 (73%) of the 48 participants in the PGx-guided group. And, 32 (91%) of the prescribed nonsteroidal anti-inflammatory drugs and 23 (66%) of the prescribed opioids matched the pharmacist's recommendations. Barriers included missed pharmacist notes when surgery dates were moved and low use of study-specific order set.

CONCLUSION

PGx test results were available before most surgeries, but the pharmacist recommendations were not always followed. Enhanced implementation strategies will need to be developed in future genotype-guided protocols.

摘要

目的

评估在妇科围手术期工作流程中实施多基因药物遗传学(PGx)检测及基因型指导的药师建议的可行性,以及对药师基因型指导的术后镇痛建议的遵循程度。

方法

对接受腹部手术的妇科患者进行了一项随机、前瞻性、开放标签的试点研究。参与者接受多基因PGx检测,并被随机分为PGx指导组,该组的检测结果会连同药师基于基因型指导的术后镇痛建议一起录入电子健康记录,另一组则接受常规护理。主要结局包括术前完成PGx检测结果及药师建议的比例、与药师建议相符的处方数量,以及所开镇痛药与常规护理不同的比例。

结果

在分析的101名参与者中,均为女性,年龄50±14岁,49%为黑人,48%为白人,60%由妇科肿瘤医生治疗,76%接受了微创手术。PGx检测结果在下单后中位数为7(四分位间距:6 - 9)个工作日返回基因组学结果门户。大多数(85%)结果在参与者手术前返回。PGx指导组的48名参与者中有35名(73%)完成了药师基于基因型指导的镇痛建议。并且,所开非甾体抗炎药中有32种(91%)、所开阿片类药物中有23种(66%)与药师的建议相符。障碍包括手术日期更改时药师记录缺失,以及研究特定医嘱集的使用率较低。

结论

大多数手术前可获得PGx检测结果,但并非总是遵循药师的建议。未来在基因型指导方案中需要制定强化实施策略。

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