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探索阿育吠陀乳膏治疗癌症患者紫杉烷诱导的周围神经病变的有效性:一项先导性、随机双盲临床试验。

Exploring the Effectiveness of Ajwain Cream in Treating Taxane-induced Peripheral Neuropathy in Cancer Patients: A Pilot, Randomised and Double-blind Clinical Trial.

作者信息

Heydarirad Ghazaleh, Mirzaei Hamid Reza, Gharehgozlou Reyhaneh, Buentzel Judith, Namazi Mohammad Reza, Pasalar Mehdi

机构信息

Traditional Medicine and Materia Medica Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Cancer Research Center, Department of Radiation Oncology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

出版信息

Indian J Palliat Care. 2024 Jan-Mar;30(1):71-76. doi: 10.25259/IJPC_32_2023. Epub 2024 Jan 6.

DOI:10.25259/IJPC_32_2023
PMID:38633679
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11021054/
Abstract

OBJECTIVES

Chemotherapy-induced peripheral neuropathy is a common disorder among cancer patients receiving various chemotherapeutic protocols. The present study aimed to explore the feasibility of ajwain ( [L.] Sprague) cream in treating peripheral neuropathy symptoms triggered by taxane chemotherapeutic agents.

MATERIALS AND METHODS

This was a pilot, double-blind, and randomised clinical trial on patients with peripheral neuropathy attributable to chemotherapy with taxane drugs during 2021-2022 in Tehran. Patients received ajwain or placebo cream for four weeks and filled out the chemotherapy-induced peripheral neuropathy assessment tool (CIPNAT) at the start and end finale of the trial. Side effects were also noted.

RESULTS

Thirty patients suffering from breast, lung, gastro-intestinal, or prostate cancer were allocated to each of the drug and placebo groups. The mean difference in CIPNAT score between the groups was 0.83, demonstrating the statistical ineffectiveness of the drug compared with the placebo ( = 0.372). The safety profile showed promising outcomes at the end of the trial.

CONCLUSION

Although the effectiveness of ajwain cream was unacceptable in treating chemotherapy-induced peripheral neuropathy symptoms, multicentre controlled trials with ample sample size are mandatory for an all-inclusive inference.

摘要

目的

化疗引起的周围神经病变是接受各种化疗方案的癌症患者中常见的病症。本研究旨在探讨阿育吠陀([L.] Sprague)乳膏治疗紫杉烷类化疗药物引发的周围神经病变症状的可行性。

材料与方法

这是一项于2021年至2022年在德黑兰针对因紫杉烷类药物化疗导致周围神经病变的患者开展的先导性、双盲随机临床试验。患者接受阿育吠陀乳膏或安慰剂乳膏治疗四周,并在试验开始和结束时填写化疗引起的周围神经病变评估工具(CIPNAT)。同时记录副作用情况。

结果

30例患有乳腺癌、肺癌、胃肠道癌或前列腺癌的患者被分别分配到药物组和安慰剂组。两组之间CIPNAT评分的平均差异为0.83,表明与安慰剂相比该药物在统计学上无效(P = 0.372)。安全性方面在试验结束时显示出良好结果。

结论

尽管阿育吠陀乳膏在治疗化疗引起的周围神经病变症状方面效果不佳,但为了得出全面的结论,必须进行样本量充足的多中心对照试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0509/11021054/7eda5661c9cc/IJPC-30-071-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0509/11021054/93a631f150f3/IJPC-30-071-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0509/11021054/ad88c60b952e/IJPC-30-071-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0509/11021054/7eda5661c9cc/IJPC-30-071-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0509/11021054/93a631f150f3/IJPC-30-071-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0509/11021054/ad88c60b952e/IJPC-30-071-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0509/11021054/7eda5661c9cc/IJPC-30-071-g003.jpg

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