吡咯替尼相关性腹泻不同预防策略的临床观察研究

Clinical observational studies on different prevention strategies for pyrotinib-related diarrhea

探讨晚期乳腺癌患者使用吡咯替尼治疗时,不同预防策略对腹泻发生率及严重程度的影响,以优化治疗耐受性。方法:选择2021年1月-2023年12月收治的132例使用吡咯替尼的人表皮生长因子受体-2(her-2)阳性乳腺癌患者,按简单随机法分为对照组和观察组。对照组仅在出现腹泻后对症治疗,观察组在开始治疗后立即给予不同的预防药物,A组为洛派丁胺,B组为蒙脱石散,C组为益生菌联合腹部热敷。主要观察指标为所有级别腹泻发生率、≥3级腹泻的发生率、因腹泻导致吡咯替尼剂量下调发生率。次要观察指标包括≥3级腹泻首次发作时间、≥3级腹泻发作次数及持续时间、≥3级腹泻累积持续时间、生活质量评分及其他不良反应。结果:与对照组相比,三个观察组均能在一定程度上降低腹泻发生率及吡咯替尼剂量下调发生率,延缓腹泻首次发生时间、减少发作次数及缩短腹泻持续时间,但与对照组相比,仅有观察组A组≥3级腹泻的发生率及吡咯替尼剂量下调率比较差异有统计学意义。结论:吡咯替尼治疗过程中使用洛派丁胺进行腹泻一级预防能显著改善重度腹泻发生率,蒙脱石散、益生菌联合腹部热敷等预防措施能一定程度上改善吡咯替尼治疗的耐受性,提高乳腺癌患者抗肿瘤治疗依从性。

Objective:To evaluate the incidence and severity of diarrhea in patients with advanced breast cancer receiving pyrotinib as antitumor therapy by adopting different prevention strategies,in order to explore how to improve the tolerability of pyrotinib treatment.Methods:A total of 132 patients with human epithelial growth factor recepetor-2(her-2)positive breast cancer receiving pyrotinib treated from January 2021 to December 2023 were selected and divided into control group and observation group using simple randomization.The control group only used antidiarrheal drugs symptomatically after the occurrence of diarrhea,while the observation group adopted a primary prevention protocol for diarrhea,with different prophylactic drugs administered immediately after the start of treatment.Group A received loperamide,Group B received montmorillonite,and Group C received probiotics combined with abdominal hot compress.The primary observation indicators included the incidence of all grades of diarrhea,the incidence of grade≥3 diarrhea,and the incidence of dose reduction.The secondary observation indicators included the time of the first onset of grade≥3 diarrhea,the frequency and duration of grade≥3 diarrhea,the cumulative duration of grade≥3 diarrhea,quality of life scores,and other adverse reactions.Results:Compared with the control group,all three study groups were able to reduce the incidence of diarrhea and the incidence of pyrotinib dose reduction to some extent,delay the first occurrence of grade≥3 diarrhea,reduce the number of attacks,and shorten the duration of diarrhea.However,only the loperamide group showed a statistically significant difference in the incidence of grade≥3 diarrhea compared with the control group.Conclusion:The use of loperamide for primary prevention of diarrhea during pyrotinib treatment can significantly improve the occurrence of diarrhea-related adverse reactions.Preventive measures such as montmorillonite and probiotics combined with abdominal hot compress can also improve the tolerability of pyrotinib treatment to a certain extent and enhance the compliance of breast cancer patients with antitumor therapy.