Chen Min, Zhang Lingli, Wang Qian, Shen Jiantong
Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, China.
PLoS One. 2013 Aug 20;8(8):e72245. doi: 10.1371/journal.pone.0072245. eCollection 2013.
Hand-foot syndrome (HFS) is a relatively frequent dermatologic toxic reaction to certain anti-cancer chemotherapies. The syndrome can evolve into a distressing condition that limits function and affects quality of life. Pyridoxine (vitamin B6) has been used empirically for the prevention of HFS caused by anti-cancer therapy. However, evidence of its efficacy remains controversial.
METHODOLOGY//PRINCIPAL FINDINGS: Systematic literature searches were conducted on the Cochrane Library, PUBMED, EMBASE, LILACS, CBM, CNKI, VIP, WANFANG and the U.S. ClinicalTrials.gov website. We included all related randomized controlled trials (RCTs) irrespective of language. Reviewers from different professions independently assessed all potential studies and extracted data. Subgroup analysis was planned according to dose of pyridoxine. 5 RCTs involving 607 patients were contributed to the meta-analysis. No significant differences were found between patients receiving pyridoxine and placebo for prevention of incidence of HFS and grade 2 or worse HFS (relative risk (RR) 0.96, 95%confidence interval (CI) 0.86-1.06; RR0.95, 95%CI 0.73-1.24, respectively). Similarly, no significant improvement in quality of life was detected among patients. However, significant difference was found for prevention of grade 2 or worse HFS with pyridoxine 400 mg daily compared to 200 mg (RR0.55, 95%CI 0.33-0.92).
CONCLUSIONS/SIGNIFICANCE: There is inadequate evidence to make any recommendation about using pyridoxine for prevention of HFS caused by chemotherapy. However, pyridoxine 400 mg may have some efficacy. Further studies of large sample sizes are needed to evaluate the efficacy and safety of pyridoxine, especially at high dose, in comparison with placebo.
手足综合征(HFS)是某些抗癌化疗药物相对常见的皮肤毒性反应。该综合征可发展成一种令人痛苦的状况,限制功能并影响生活质量。维生素B6已被经验性地用于预防抗癌治疗引起的HFS。然而,其疗效证据仍存在争议。
方法//主要发现:在考克兰图书馆、PUBMED、EMBASE、LILACS、CBM、CNKI、维普、万方和美国临床试验.gov网站上进行了系统的文献检索。我们纳入了所有相关的随机对照试验(RCT),不考虑语言。来自不同专业的评审员独立评估所有潜在研究并提取数据。根据维生素B6的剂量计划进行亚组分析。5项涉及607名患者的RCT被纳入荟萃分析。在预防HFS发生率和2级或更严重HFS方面,接受维生素B6和安慰剂的患者之间未发现显著差异(相对风险(RR)0.96,95%置信区间(CI)0.86 - 1.06;RR0.95,95%CI 0.73 - 1.24)。同样,在患者中未检测到生活质量有显著改善。然而,与每日200毫克相比,每日400毫克维生素B6在预防2级或更严重HFS方面发现有显著差异(RR0.55,95%CI 0.33 - 0.92)。
结论/意义:没有足够的证据就使用维生素B6预防化疗引起的HFS提出任何建议。然而,400毫克维生素B6可能有一定疗效。需要进一步进行大样本研究,以评估维生素B6,特别是高剂量时与安慰剂相比的疗效和安全性。