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Purpose <p>To assess the benefits of the traditional Chinese medicine (TCM) Qufenghuoxue formula, on the treatment of chemotherapy-induced peripheral neuropathy (CIPN) in patients with lung cancer receiving paclitaxel (PTX).</p> Methods <p>Patients with CIPN grading 2–3 were randomly assigned to three groups of TCM, vitamin B1, or warm water. The intervention duration consisted of four cycles, 3&#xa0;weeks each, coinciding with the follow-up period. Primary efficacy endpoint was the proportion of patients achieving CIPN relief, defined by reduction in CIPN severity grade, while secondary endpoint evaluated completion of the recommended PTX dosing.</p> Results <p>TCM significantly reduced grade 2–3 CIPN incidence and increased symptom relief (48.6% vs 12.0% vs 7.5%; <i>P</i> &lt; 0.001) with a shorter median time to recovery compared with vitamin B1 and warm water, respectively. Additionally, it improved scores of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group–Neurotoxicity subscale (11.5 vs 20.4 vs 22.4), neuropathy pain scale (16.8 vs 27.7 vs 29.2) and quality of life (42.6 vs 36.0 vs 33.6; all <i>P</i> &lt; 0.001) and also showed greater potential of completing the recommended dose level of PTX (83.8% vs 74.6% vs 59.7%; <i>P</i> = 0.0034) compared with vitamin B1 and warm water. With warm water as reference, the hazard ratio of PTX dose reductions/cessation due to CIPN was 0.34 (95% confidence interval [CI]: 0.168–0.67, <i>P</i> = 0.002) for TCM and 0.56 (95% CI: 0.314–1.008; <i>P</i> = 0.053) for vitamin B1.</p> Conclusion <p>Qufenghuoxue formula may be a promising strategy for the treatment of CIPN in patients receiving PTX.</p> <p>Trial Registration</p> <p>Chinese Clinical Trial Registry; No.: ChiCTR2300069949. Registered 30 March 30, 2023, URL: <a href="http://www.chictr.org/cn/">www.chictr.org/cn/</a>.</p>

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The Efficacy and Safety of Traditional Chinese Medicine Qufenghuoxue Formula on Treating Peripheral Neuropathy Induced by Paclitaxel in Advanced Lung Cancer: A Randomized Clinical Trial

  • 期刊论文

  • 发表日期：

    2025年12月22日

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  • Yijun Song,
  • Zhidan Hua,
  • Mengting Sun,
  • Nuo Xu,
  • Xinyuan Lu,
  • Dawei Yang,
  • Xixi Gu,
  • Yuanlin Song,
  • Jun She

摘要

Purpose

To assess the benefits of the traditional Chinese medicine (TCM) Qufenghuoxue formula, on the treatment of chemotherapy-induced peripheral neuropathy (CIPN) in patients with lung cancer receiving paclitaxel (PTX).

Methods

Patients with CIPN grading 2–3 were randomly assigned to three groups of TCM, vitamin B1, or warm water. The intervention duration consisted of four cycles, 3 weeks each, coinciding with the follow-up period. Primary efficacy endpoint was the proportion of patients achieving CIPN relief, defined by reduction in CIPN severity grade, while secondary endpoint evaluated completion of the recommended PTX dosing.

Results

TCM significantly reduced grade 2–3 CIPN incidence and increased symptom relief (48.6% vs 12.0% vs 7.5%; P < 0.001) with a shorter median time to recovery compared with vitamin B1 and warm water, respectively. Additionally, it improved scores of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group–Neurotoxicity subscale (11.5 vs 20.4 vs 22.4), neuropathy pain scale (16.8 vs 27.7 vs 29.2) and quality of life (42.6 vs 36.0 vs 33.6; all P < 0.001) and also showed greater potential of completing the recommended dose level of PTX (83.8% vs 74.6% vs 59.7%; P = 0.0034) compared with vitamin B1 and warm water. With warm water as reference, the hazard ratio of PTX dose reductions/cessation due to CIPN was 0.34 (95% confidence interval [CI]: 0.168–0.67, P = 0.002) for TCM and 0.56 (95% CI: 0.314–1.008; P = 0.053) for vitamin B1.

Conclusion

Qufenghuoxue formula may be a promising strategy for the treatment of CIPN in patients receiving PTX.

Trial Registration

Chinese Clinical Trial Registry; No.: ChiCTR2300069949. Registered 30 March 30, 2023, URL: www.chictr.org/cn/.