Zhou Yun, Peng Ling, Li Yingjie, Chen Lixun
Zhejiang Food and Drug Administration, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310003, P.R. China.
Department of Thoracic Oncology, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310003, P.R. China.
Biomed Rep. 2013 Nov;1(6):873-878. doi: 10.3892/br.2013.161. Epub 2013 Aug 28.
Hand-foot syndrome (HFS) is a dose-limiting adverse event of capecitabine, which commonly leads to early discontinuation of capecitabine-based therapy in the palliative and adjuvant settings. Although pyridoxine has been used for the prevention of capecitabine-associated HFS, its efficacy is controversial. The aim of this study was to evaluate whether prophylactic pyridoxine reduces the incidence of capecitabine-associated HFS by performing a meta-analysis of the literature involving available studies. Systematic searches for trials were undertaken through PubMed, Embase, Web of Science, the Cochrane Library, the American Society of Clinical Oncology (ASCO) and the ASCO Gastrointestinal Cancers Symposium, updated to March, 2013, to identify relevant studies. A meta-analysis was conducted with eligible studies that evaluated the efficacy of the prophylactic use of pyridoxine against capecitabine-induced HFS. We performed a meta-analysis of five studies (n=793 patients) that evaluated the efficacy of the prophylactic use of pyridoxine in cancer patients treated with capecitabine. The odds ratio (OR) comparing prophylactic pyridoxine to placebo was 0.91 [95% confidence interval (CI): 0.67-1.24] for HFS of all grades; OR=1.17 (95% CI: 0.82-1.67) for HFS ≥ grade 2 and OR=1.05 (95% CI: 0.60-1.85) for HFS ≥ grade 3. Based on our meta-analysis, prophylactic pyridoxine did not appear to reduce the incidence of HFS in patients receiving capecitabine.
手足综合征（HFS）是卡培他滨的剂量限制性不良事件，在姑息治疗和辅助治疗中，它常导致基于卡培他滨的治疗提前终止。尽管吡哆醇已用于预防卡培他滨相关的HFS，但其疗效仍存在争议。本研究的目的是通过对现有研究的文献进行荟萃分析，评估预防性使用吡哆醇是否能降低卡培他滨相关HFS的发生率。通过PubMed、Embase、科学网、考克兰图书馆、美国临床肿瘤学会（ASCO）和ASCO胃肠道癌症研讨会对试验进行系统检索，更新至2013年3月，以确定相关研究。对评估预防性使用吡哆醇预防卡培他滨诱导的HFS疗效的合格研究进行荟萃分析。我们对五项研究（n = 793例患者）进行了荟萃分析，这些研究评估了预防性使用吡哆醇在接受卡培他滨治疗的癌症患者中的疗效。对于所有级别的HFS，预防性使用吡哆醇与安慰剂相比的比值比（OR）为0.91 [95%置信区间（CI）：0.67 - 1.24]；对于2级及以上HFS，OR = 1.17（95% CI：0.82 - 1.67），对于3级及以上HFS，OR = 1.05（95% CI：0.60 - 1.85）。基于我们的荟萃分析，预防性使用吡哆醇似乎并未降低接受卡培他滨治疗患者的HFS发生率。
