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康复新液防治化疗所致口腔黏膜炎的疗效:随机对照试验的系统评价与Meta分析

Efficacy of Kangfuxin liquid for preventing and treating chemotherapy-induced oral mucositis: a systematic review and meta-analysis of randomized controlled trials.

作者信息

Sun Wei, Jian Yang, Feng Xiaolin, Zhao Minru, Liu Yuan

机构信息

Department of Laboratory Medicine, The General Hospital of Western Theater Command, Chengdu, China.

Department of Clinical Pharmacy, The General Hospital of Western Theater Command, Chengdu, China.

出版信息

Front Pharmacol. 2025 Apr 8;16:1565345. doi: 10.3389/fphar.2025.1565345. eCollection 2025.

Abstract

OBJECTIVE

Chemotherapy-induced oral mucositis (CTOM) is a common side effect affecting 20%-40% of cancer patients receiving chemotherapy. Kangfuxin liquid (KFXL) has been used clinically to prevent and treat CTOM, but the evidence has not been systematically evaluated. This study aimed to evaluate the preventive and therapeutic effects of KFXL on CTOM.

METHODS

Nine electronic databases were searched to identify KFXL-related randomized controlled trials (RCTs) for the prevention and treatment of CTOM from inception to September 2024. The primary outcomes were incidence rate, efficacy rate and cure rate, and the secondary outcomes was healing time.

RESULTS

Twenty-one trials involving 1825 patients were included in this review. The results of our meta-analysis showed that, compared with basic oral care (BOC), KFXL significantly reduced the incidence rate of CTOM and severe CTOM (RR = 0.54, p < 0.00001; RR = 0.23, p < 0.00001, respectively), improved the efficacy rate of CTOM and severe CTOM (RR = 1.23, p = 0.0003; RR = 1.99, p = 0.05, respectively), improved the cure rate of CTOM (RR = 2.06, p = 0.0004),and accelerated the healing process (MD = -2.48, p < 0.00001). However, KFXL and other drugs have the same efficacy rate in treating CTOM and severe CTOM (RR = 1.00, p = 0.99; RR = 1.00, p = 1.00, respectively), and the same cure rate in CTOM (RR = 0.91, p = 0.39), and the same healing time (MD = -0.01, p = 1.00).

CONCLUSION

The results suggest that KFXL may provide more benefit in the prevention and treatment for CTOM compared to BOC. Although KFXL may be a promising drug for the prevention and treatment of CTOM, the evidence is insufficient to prove its superiority over other guideline-recommended treatment.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/PROSPERO/view/CRD42024585859, ID: CRD42024585859.

摘要

目的

化疗引起的口腔黏膜炎(CTOM)是一种常见的副作用,影响20%-40%接受化疗的癌症患者。康复新液(KFXL)已在临床上用于预防和治疗CTOM,但相关证据尚未得到系统评价。本研究旨在评估KFXL对CTOM的预防和治疗效果。

方法

检索九个电子数据库,以识别从数据库建立至2024年9月期间与KFXL预防和治疗CTOM相关的随机对照试验(RCT)。主要结局为发生率、有效率和治愈率,次要结局为愈合时间。

结果

本综述纳入了21项涉及1825例患者的试验。荟萃分析结果显示,与基础口腔护理(BOC)相比,KFXL显著降低了CTOM和重度CTOM的发生率(RR = 0.54,p < 0.00001;RR = 0.23,p < 0.00001),提高了CTOM和重度CTOM的有效率(RR = 1.23,p = 0.0003;RR = 1.99,p = 0.05),提高了CTOM的治愈率(RR = 2.06,p = 0.0004),并加速了愈合进程(MD = -2.48,p < 0.00001)。然而,KFXL与其他药物在治疗CTOM和重度CTOM方面的有效率相同(RR = 1.00,p = 0.99;RR = 1.00,p = 1.00),在CTOM方面的治愈率相同(RR = 0.91,p = 0.39),愈合时间相同(MD = -0.01,p = 1.00)。

结论

结果表明,与BOC相比,KFXL在预防和治疗CTOM方面可能更具优势。尽管KFXL可能是预防和治疗CTOM的一种有前景的药物,但证据不足以证明其优于其他指南推荐的治疗方法。

系统评价注册

https://www.crd.york.ac.uk/PROSPERO/view/CRD42024585859,ID:CRD42024585859。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/981b/12011798/4ad0d471569a/fphar-16-1565345-g001.jpg

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