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韩西医联合治疗面瘫患者的临床疗效及成本效益:一项多中心前瞻性观察研究

Clinical outcomes and cost-effectiveness of collaborative treatment with Korean and Western medicine in patients with facial palsy: a multicenter prospective observational study.

作者信息

Acharya Shiva Raj, Kim Linae, Kim NamKwen

机构信息

Research Institute for Korean Medicine, Pusan National University, Yangsan, Republic of Korea.

Center for Big Data and Comparative Effectiveness Research, Economic Evaluation in Health and Medicine, School of Korean Medicine, Pusan National University, 20, Geumo-ro Mulgeum-eup, Yangsan-si, Gyeongsangnam-do, 50612, Republic of Korea.

出版信息

BMC Complement Med Ther. 2025 May 15;25(1):178. doi: 10.1186/s12906-025-04910-1.

Abstract

BACKGROUND

Effective and cost-efficient treatment approaches are crucial in healthcare to optimize patient outcomes. This study evaluates and compares the clinical outcomes and cost-effectiveness of Korean and Western medicine collaborative treatment (CT) with usual care (UC) for patients with facial palsy (FP).

METHODS

A two-arm comparative, multicenter, prospective, observational study was conducted at 11 nationwide hospitals participating in the fourth phase of the national pilot project for CT. A total of 130 FP patients were enrolled at baseline, with follow-up assessments at 4 weeks and 12 weeks post-baseline. Clinical outcomes were evaluated using the House-Brackmann Grading Scale (HBGS), Numeric Rating Scale (NRS), EuroQol-5 Dimensions (EQ-5D-5L), and EuroQol-Visual Analogue Scale (EQ-VAS) at all three time points of the study. The cost-effectiveness evaluation was assessed using Cost per QALYs (Quality-Adjusted Life Years), Incremental Cost-Effectiveness Ratio (ICER), and Net Monetary Benefit (NMB).

RESULTS

The mean HBGS, NRS and EQ-VAS scores significantly improved in both groups over time (each, p < 0.05). Compared to UC, CT demonstrated significantly higher EQ-5D-5L scores (0.94 ± 0.11 vs. 0.91 ± 0.13), and this effect remained significant even after adjusting for age, sex, duration, and income level (β = 0.06, p < 0.05). From a limited societal perspective, the total cost difference between the two groups was not statistically significant; however, the QALYs gained were significantly higher in patients who received CT than those who received UC (0.010 QALYs vs. 0.008 QALYs). The ICER for CT was estimated at 28.1 million Korean Won (KRW) per QALY. The probability that CT would be more cost-effective than UC exceeded 50% at a WTP threshold of 30.5 million KRW per QALY.

CONCLUSIONS

Our study highlights that CT enhances a better quality of life and is more cost-effective for FP treatment, suggesting it is a valuable alternative to usual care. Further large-scale clinical trials and cost-effectiveness studies are warranted to explore its broader application and validate these findings.

TRIAL REGISTRATION

The study design was registered with the Clinical Research Information Service (CRIS) of South Korea at https://cris.nih.go.kr/ (KCT0007682) on September 07, 2022.

摘要

背景

有效且具有成本效益的治疗方法对于优化医疗保健中的患者治疗效果至关重要。本研究评估并比较了韩国医学与西医联合治疗(CT)与常规护理(UC)对面瘫(FP)患者的临床疗效和成本效益。

方法

在参与全国CT试点项目第四阶段的11家全国性医院进行了一项双臂比较、多中心、前瞻性观察性研究。共有130名FP患者在基线时入组,并在基线后4周和12周进行随访评估。在研究的所有三个时间点,使用House-Brackmann分级量表(HBGS)、数字评定量表(NRS)、欧洲五维健康量表(EQ-5D-5L)和欧洲视觉模拟量表(EQ-VAS)评估临床疗效。使用每质量调整生命年成本(QALYs)、增量成本效益比(ICER)和净货币效益(NMB)评估成本效益。

结果

两组的平均HBGS、NRS和EQ-VAS评分均随时间显著改善(均p < 0.05)。与UC相比,CT组的EQ-5D-5L评分显著更高(0.94±0.11对0.91±0.13),即使在调整年龄、性别、病程和收入水平后,这种效果仍然显著(β = 0.06,p < 0.05)。从有限的社会角度来看,两组之间的总成本差异无统计学意义;然而,接受CT治疗的患者获得的QALYs显著高于接受UC治疗的患者(0.010 QALYs对0.008 QALYs)。CT的ICER估计为每QALY 2810万韩元。在每QALY意愿支付阈值为3050万韩元时,CT比UC更具成本效益的概率超过50%。

结论

我们的研究强调,CT可提高生活质量,对面瘫治疗更具成本效益,表明它是常规护理的一种有价值的替代方案。有必要进行进一步的大规模临床试验和成本效益研究,以探索其更广泛的应用并验证这些发现。

试验注册

该研究设计于2022年9月7日在韩国临床研究信息服务(CRIS)注册,网址为https://cris.nih.go.kr/(KCT0007682)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce5b/12079986/9b95fe97c23f/12906_2025_4910_Fig1_HTML.jpg

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