Nicol Carole, Jacquot Julien, Chebane Leila, Combret Sandrine, Pecquet Pauline-Eva, Massy Nathalie, Bagheri Haleh
Service de pharmacologie médicale, centre de pharmacovigilance de Toulouse, CIC1436, faculté de médecine, CHU de Toulouse, 31000 Toulouse, France.
Centre régional de pharmacovigilance de Bourgogne, CHU de Dijon, 21000 Dijon, France.
Therapie. 2024 Sep-Oct;79(5):577-587. doi: 10.1016/j.therap.2024.02.003. Epub 2024 Feb 24.
Bariatric surgery is the only treatment for severe obesity (BMI>35kg/m) currently recognized as effective both in achieving tangible and lasting weight loss, and in improving obesity-related comorbidities such as type 2 diabetes, hypertension, and cardiovascular complications. Bariatric surgery, like any other surgery of the digestive tract, can have an impact on nutrient absorption, as well as on drug absorption. The literature on drug management in bariatric surgery patients concerned mainly of case reports and retrospective studies involving a small number of patients. No official guidelines are available.
We conducted a literature search on the consequences of bariatric surgery in terms of drug bioavailability and/or effect. The Medline® (PubMed) database was searched using the following keywords: "bariatric surgery", "bioavailability", "gastric bypass", and "obesity". We completed this review with an analysis of reports of adverse drug reactions (ADRs) in post-bariatric surgery patients for obesity registered in the National pharmacovigilance database (PVDB). We selected all cases with the mention of "bariatric surgery and/or gastrectomy" as "medical history". After reading the cases, we excluded those in which the patient had undergone surgery for an indication other than obesity, where the route of administration was other than oral, and cases in which ADRs resulted from voluntary overdose, attempted suicide, allergy, switch to Levothyrox® new formulation, meningioma under progestative drugs, inefficacy related to generic substitution and medication error.
The literature search identified mainly "case report" about the impact of bariatric surgery on so-called "narrow therapeutic window" drugs. We identified 66 informative cases out of a total of 565 cases selected (11%) in the PVDB. Nevertheless, the information does not allow a clear relationship between the occurrence of the ADR and the influence of bariatric surgery.
There is a lack of official information and/or recommendations on medication use in subjects who have undergone bariatric surgery. Apart from under-reporting, ADRs reports remain largely uninformative. Health professional and patients would be awareness for improving, quantitatively and qualitatively the reporting of ADRs in this population.
减重手术是目前唯一被认为对严重肥胖（BMI>35kg/m²）有效的治疗方法，既能实现切实且持久的体重减轻，又能改善与肥胖相关的合并症，如2型糖尿病、高血压和心血管并发症。与其他消化道手术一样，减重手术会对营养物质吸收以及药物吸收产生影响。关于减重手术患者药物管理的文献主要是涉及少数患者的病例报告和回顾性研究。目前尚无官方指南。
我们对减重手术在药物生物利用度和/或效果方面的影响进行了文献检索。使用以下关键词在Medline®（PubMed）数据库中进行搜索：“减重手术”、“生物利用度”、“胃旁路手术”和“肥胖”。我们通过分析国家药物警戒数据库（PVDB）中登记的肥胖症减重手术患者的药物不良反应（ADR）报告来完善本综述。我们选择所有提及“减重手术和/或胃切除术”作为“病史”的病例。阅读病例后，我们排除了那些因非肥胖适应症接受手术的患者、给药途径非口服的患者，以及ADR由自愿过量用药、自杀未遂、过敏、改用左甲状腺素新剂型、孕激素类药物治疗下的脑膜瘤、通用名替换无效和用药错误导致的病例。
文献检索主要发现了关于减重手术对所谓“治疗窗窄”药物影响的“病例报告”。在PVDB中筛选出的565例病例中，我们确定了66例提供信息的病例（11%）。然而这些信息无法明确ADR的发生与减重手术影响之间的关系。
对于接受减重手术患者用药，缺乏官方信息和/或建议除报告不足外，ADR报告在很大程度上仍缺乏信息。医疗专业人员和患者应提高认识，在数量和质量上改善该人群ADR的报告情况。
