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江婷,罗伊扬,施易辉,王彬彬.中药外治预防消化道肿瘤中奥沙利铂所致周围神经毒性随机对照试验的Meta分析[J].浙江中西医结合杂志,2022,32(9):
中药外治预防消化道肿瘤中奥沙利铂所致周围神经毒性随机对照试验的Meta分析
The prevention and treatment of Oxaliplatin-induced peripheral neurotoxicity with the external treatment of Traditional Chinese Medicine in digestive tract cancer : A Meta-analysis of Randomized Trials
投稿时间:2021-08-18  修订日期:2022-07-05
DOI:
中文关键词:  中药  外治  消化道肿瘤  奥沙利铂所致周围神经毒性  Meta分析  
英文关键词:The prevention of Oxaliplatin-induced peripheral neurotoxicity with the external treatment of Traditional Chinese Medicine in digestive tract cancer : A Meta-analysis of Randomized Trials
基金项目:
作者单位E-mail
江婷 浙江中医药大学附属第一医院 18702536353@163.com 
罗伊扬 浙江中医药大学  
施易辉 浙江中医药大学  
王彬彬* 浙江中医药大学附属第一医院 wbbwz@163.com 
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中文摘要:
      目的 评价中药外治预防消化道肿瘤中奥沙利铂所致周围神经毒性的疗效,为临床提供循证医学证据。方法 检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献数据库(CBM)及PubMed、Web of Science数据库,检索时限为建库至2021年07月16日,收集消化道肿瘤中有关中药外治预防奥沙利铂所致周围神经毒性的临床随机对照研究,根据纳排标准筛选符合要求的研究,使用Review Manager 5.3软件进行Meta分析。结果 纳入21项研究,共1646例患者,其中中药外治组829例,对照组817例。Meta分析结果表明:与空白/安慰剂组相比,中药外治显著降低了周围神经毒性的总发生率(RR=0.59, 95%CI:[0.52, 0.66], P<0.00001)和严重神经毒性的发生率 (RR=0.38,95%CI:[0.31, 0.45], P<0.00001)。与西药组相比,中药外治联合西药有效预防了周围神经毒性的发生(RR=0.47, 95%CI:[0.32, 0.70], P=0.0002)和严重神经毒性的发生(RR=0.23,95%CI:[0.09, 0.59], P=0.002)。不论奥沙利铂使用剂量为130-135mg/m2或80-85mg/m2时,中药外治显著减轻了周围神经毒性的总发生率(RR=0.56,95%CI:[0.49, 0.64],P<0.00001)、(RR=0.57,95%CI[0.48, 0.68], P<0.00001)和严重神经毒性的发生率 (RR=0.40,95%CI:[0.31, 0.52], P<0.00001)、(RR=0.32,95%CI:[0.22, 0.46], P<0.00001)。结论 中药外治可有效预防消化道肿瘤中奥沙利铂所致周围神经毒性的发生率,且不论奥沙利铂的给药剂量是130-135mg/m2或80-85mg/m2,均不影响结果的一致性。但由于纳入分析的临床试验质量不高,仍需大样本、多中心、随机对照试验进一步验证。
英文摘要:
      Objective: To evaluate the efficacy of external treatment of Traditional Chinese Medicine(TCM) in the prevention of Oxaliplatin-induced peripheral neurotoxicity in digestive tract cancer, and to provide evidence-based medical evidence for clinical practice. Methods: The Chinese databases (CNKI, Wanfang, VIP,CBM) and English databases (PubMed, Web of Science) were searched for the clinical randomized controlled studies on the external treatment of TCM in the prevention of Oxaliplatin-induced neurotoxicity in digestive tract cancer. The time range was limited from the establishment of the databases to July 16, 2021. The qualified studies were selected according to the inclusion and exclusion criteria, and meta-analysis was carried out with Review Manager 5.3. Results: 21 studies with 1646 patients were included, in which 829 cases were in the experimental group and 817 cases were in the controlled group. Meta-analysis results show that compared with the blank/placebo group, external treatment of TCM can significantly reduce the overall incidence of peripheral neurotoxicity (RR=0.59, 95%CI: [0.52, 0.66], P<0.00001) and severe neurotoxicity Incidence rate (RR=0.38, 95%CI: [0.31, 0.45], P<0.00001). Compared with the western medicine group, external Chinese medicine combined with western medicine enable to effectively prevent the occurrence of peripheral neurotoxicity (RR=0.47, 95%CI: [0.32, 0.70], P=0.0002) and severe neurotoxicity (RR=0.23, 95%CI: [0.09, 0.59], P=0.002). Regardless of the oxaliplatin dosage of 130-135mg/m2 or 80-85mg/m2, the external treatment of TCM can reduce the overall incidence of peripheral neurotoxicity (RR=0.56, 95%CI: [0.49, 0.64] , P<0.00001), (RR=0.57, 95%CI[0.48, 0.68], P<0.00001) and the incidence of severe neurotoxicity (RR=0.40, 95%CI: [0.31, 0.52], P<0.00001), (RR=0.32, 95%CI: [0.22, 0.46], P<0.00001).Conclusion: The external treatment of TCM can effectively prevent the peripheral neurotoxicity caused by Oxaliplatin in digestive tract cancer and regardless of whether the dose of Oxaliplatin is 130-135mg/m2 or 80-85mg/m2, it does not affect the consistency of the results. However, the quality of clinical trials included in the analysis is not high enough, a large sample, multi-center and randomized controlled trial is needed to verify the results.
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