背景:与每日多次胰岛素注射(MDI)相比,持续皮下胰岛素输注(CSII)费用明显更高,在中国1型糖尿病(T1DM)患者中尚未广泛使用.因此,在中国,关于临床和患者报告的结果仍然存在显著的知识差距。
目的:本研究旨在比较糖化血红蛋白(HbA1C),胰岛素治疗相关生活质量(ITR-QOL),根据中国现实条件下的倾向评分匹配,MDI和CSII治疗的成年T1DM患者对低血糖(FOH)的恐惧。
方法:选择2021年6月至2023年6月在国家代谢中心连续接受MDI或CSII治疗超过12个月的四百名成人T1DM患者作为研究对象。使用胰岛素治疗相关生活质量测量问卷中文版(ITR-QOL-CV)和中文版低血糖恐惧调查-担忧量表(CHFSII-WS)评估他们的QOL和FOH,同时收集他们的HbA1C。使用倾向评分匹配对两组之间的潜在混杂变量进行匹配。
结果:在纳入研究的420名患者中,MDI组315例,CSII组105例。102对成功匹配。匹配后,CSII组ITR-QOL-CV量表总分显著高于MDI组(87.08±13.53vs.80.66±19.25,P=0.006)。其中,日常生活的维度,社会生活,心理状态差异均有统计学意义(P<0.05)。CHFSII-WS的得分(8.33±3.49vs.11.77±5.27,P=0.003)和HbA1C(7.19±1.33%vs.7.71±1.93%,CSII组P=0.045)低于MDI组。
结论:25.0%的T1DM成人接受CSII治疗。与接受MDI治疗的成人T1DM患者相比,那些用CSII治疗的患者有更高的ITR-QOL,更少的FoH,在中国的现实条件下更好地控制HbA1C。因此,无论经济因素如何,CSII建议用于成人T1DM患者以优化治疗效果和结果。
BACKGROUND: Compared with multiple daily insulin injections (MDI), continuous subcutaneous insulin infusion (CSII) is significantly more expensive and has not been widely used in Chinese type 1 diabetes mellitus (T1DM) patients. So there are still significant knowledge gaps regarding clinical and patient-reported outcomes in China.
OBJECTIVE: This study aims to compare the glycated hemoglobin (HbA1C), insulin therapy related quality of life (ITR-QOL), fear of hypoglycemia (FOH) of adult T1DM patients treated with MDI and CSII based on propensity score matching in real-world conditions in China.
METHODS: Four hundred twenty adult T1DM patients who were treated with MDI or CSII continuously for more than 12 months in a national metabolic center from June 2021 to June 2023 were selected as the study subjects. Their QOL and FOH were evaluated with Insulin Therapy Related Quality of Life Measure Questionnaire-Chinese version (ITR-QOL-CV) and the Chinese Version Hypoglycemia Fear Survey-Worry Scale (CHFSII-WS), and their HbA1C were collected at the same time. Potential confounding variables between the two groups were matched using propensity score matching.
RESULTS: Of the 420 patients included in the study, 315 were in MDI group and 105 were in CSII group. 102 pairs were successfully matched. After matching, the total score of ITR-QOL-CV scale in CSII group was significantly higher than that in MDI group (87.08 ± 13.53 vs. 80.66 ± 19.25, P = 0.006). Among them, the dimensions of daily life, social life, and psychological state were all statistically different (P < 0.05). The scores of CHFSII-WS (8.33 ± 3.49 vs. 11.77 ± 5.27, P = 0.003) and HbA1C (7.19 ± 1.33% vs. 7.71 ± 1.93%, P = 0.045) in CSII group were lower than those in MDI group.
CONCLUSIONS: 25.0% of T1DM adults are treated with CSII. Compared with adult T1DM patients treated with MDI, those treated with CSII have higher ITR-QOL, less FoH, and better control of HbA1C in real-world conditions in China. Therefore, regardless of economic factors, CSII is recommended for adult T1DM patients to optimize the therapeutic effect and outcomes.