研究动态
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癌症患者药物依从性和临床结果的先进消息干预:随机对照试验。

Advanced Messaging Intervention for Medication Adherence and Clinical Outcomes Among Patients With Cancer: Randomized Controlled Trial.

发表日期:2023 Aug 31
作者: Chen-Xu Ni, Wen-Jie Lu, Min Ni, Fang Huang, Dong-Jie Li, Fu-Ming Shen
来源: MEDICINE & SCIENCE IN SPORTS & EXERCISE

摘要:

药物依从性对于改善癌症患者治疗的临床效果至关重要。依从性不足和药物不良反应可能会降低癌症治疗的有效性,包括生活质量。常用的药物依从性干预方法不断发展,第五代(5G)信息传递时代已经到来。本研究我们进行了一项前瞻性、初步的随机对照试验,以评估5G信息传递对中国癌症患者的药物依从性和临床效果的影响。研究人群为接受培美曲塞化疗的非小细胞肺癌患者,他们需要定期补充叶酸(FA)和维生素B12。干预组和对照组分别被分配到5G信息传递和二代(2G)信息传递。患者的药物依从性和生活质量在基线、1个月和3个月的时间点进行评估。此外,还测量了化疗相关的血液学或非血液学毒性,以及FA和维生素B12的血清水平。在2021年1月至5月评估对符合条件的567名患者中,一共纳入了154名(27.2%)患者。总体上,80名患者随机分配到对照组,74名患者随机分配到干预组。在1个月(69人中的62人,90%对74人中的56人,76%;调整后的比值比2.67,95% CI 1.02-7.71)和3个月(60人中的50人,83%对64人中的48人,75%;调整后的比值比2.36,95% CI 1.00-5.23)的时间点,5G信息传递干预组的依从性比对照组显著更高。相应地,5G信息传递组患者的FA和维生素B12血清水平高于对照组。在血液学毒性方面,干预组的白细胞减少发生率显著低于对照组(对照组80人中的25人,31%对干预组74人中的12人,16%;P=.04)。两组在非血液学毒性和生活质量方面没有差异。总之,我们得出结论:与传统的2G文本信息传递相比,5G信息传递干预能够更好地改善癌症患者的药物依从性和临床结果。 Chinese Clinical Trial Registry ChiCTR2200058188;https://www.chictr.org.cn/showproj.html?proj=164489.©Chen-Xu Ni, Wen-Jie Lu, Min Ni, Fang Huang, Dong-Jie Li, Fu-Ming Shen. 原始发表于JMIR Cancer (https://cancer.jmir.org),2023年8月31日。
Medication adherence is crucial for improving clinical outcomes in the treatment of patients with cancer. The lack of adherence and adverse drug reactions can reduce the effectiveness of cancer therapy including the quality of life. The commonly used intervention methods for medication adherence continue to evolve, and the age of fifth-generation (5G) messaging has arrived.In this study, we conducted a prospective, pilot randomized controlled trial to evaluate the effect of 5G messaging on medication adherence and clinical outcomes among patients with cancer in China.The research population was patients with nonsmall cell lung cancer undergoing pemetrexed chemotherapy who require regular folic acid (FA) and vitamin B12 supplements. The intervention and control groups were assigned to 5G messaging and second-generation (2G) messaging, respectively. The patients' medication adherence and quality of life were assessed at baseline and 1-month and 3-month time points. Moreover, the chemotherapy-related hematologic or nonhematologic toxicities, as well as the serum levels of FA and vitamin B12, were measured.Of the 567 patients assessed for eligibility between January and May 2021, a total of 154 (27.2%) patients were included. Overall, 80 were randomized to the control group and 74 to the intervention group. The odds of adherence in the 5G messaging intervention group were significantly higher than the control group at the 1-month (62/69, 90% vs 56/74, 76%; adjusted odds ratio 2.67, 95% CI 1.02-7.71) and 3-month (50/60, 83% vs 48/64, 75%; adjusted odds ratio 2.36, 95% CI 1.00-5.23) time points. Correspondingly, the FA and vitamin B12 serum levels of patients in the 5G messaging group were higher than those of the control group. Regarding hematologic toxicities, only the incidence of leukopenia in the intervention group was lower than that in the control group (25/80, 31% in the control group vs 12/74, 16% in the intervention group; P=.04). There were no differences in nonhematologic toxicities and quality of life between the 2 groups.In summary, we conclude that compared with conventional 2G text-based messaging, a 5G messaging intervention can better improve medication adherence and clinical outcome among patients with cancer.Chinese Clinical Trial Registry ChiCTR2200058188; https://www.chictr.org.cn/showproj.html?proj=164489.©Chen-Xu Ni, Wen-Jie Lu, Min Ni, Fang Huang, Dong-Jie Li, Fu-Ming Shen. Originally published in JMIR Cancer (https://cancer.jmir.org), 31.08.2023.