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目的通过研究亚砷酸和FOLFOX4方案联合应用与单用FOLFOX4方案在转移性肝癌治疗中疗效的比较,以评估亚砷酸在转移性肝癌中的临床应用价值,并监测其不良反应,评估其临床应用的安全性,为临床用药奠定基础。方法选取我院2006年7月至2007年12月期间晚期胃肠道肿瘤伴肝转移的患者共26例,随机分成2组,分别采用亚砷酸联合FOLFOX4方案(治疗组)以及单用FOLFOX4方案进行治疗(对照组),观察并比较其疗效。结果26例患者均完成至少2个周期的联合治疗。随访6～24个月(中位随访时间12.5个月),治疗组平均生存时间242d,中位生存时间281d;对照组平均生存时间227d,中位生存时间246d,2组比较差异无统计学意义(P>0.05)。疼痛:治疗组完全缓解(CR)2例,部分缓解(PR)5例,稳定(SD)2例,客观有效(CR+PR+SD)为9例;对照组CR1例,PR3例,SD2例,客观有效(CR+PR+SD)为6例,2组客观有效情况比较差异无统计学意义(P>0.05)。客观疗效:2组中均无CR病例,其中治疗组PR5例,无效(NC)6例,进展(PD)2例,客观有效(CR+PR)为5例,受益(CR+PR+NC)为11例;对照组PR2例,NC4例,PD7例,客观有效(CR+PR)为2例,受益(CR+PR+NC)为6例。2组客观有效情况比较差异无统计学意义(P>0.05),但治疗组受益情况优于对照组,差异有统计学意义(P<0.05)。不良反应主要表现为胃肠道反应和骨髓抑制,2组比较差异无统计学意义(P>0.05),未见砷中毒反应。结论亚砷酸联合FOLFOX4方案治疗可以取得较好的疗效,亚砷酸不会增加常规化疗的毒副反应。
Objective To evaluate the clinical value of arsenious acid in the treatment of metastatic liver cancer by comparing the efficacy of the combination of arsenious acid and FOLFOX4 regimen with that of the single FOLFOX4 regimen in the treatment of metastatic liver cancer and to monitor its adverse reactions and evaluate its clinical efficacy Application of safety, lay the foundation for clinical medication. Methods Twenty-six patients with advanced gastrointestinal cancer and liver metastasis from July 2006 to December 2007 in our hospital were randomly divided into 2 groups. Patients were treated with arsenious acid combined with FOLFOX4 (treatment group) and FOLFOX4 alone Treatment (control group), observe and compare their efficacy. Results 26 patients completed at least 2 cycles of combination therapy. The median survival time was 242 days and the median survival time was 281 days. The mean survival time of the control group was 227 days, and the median survival time was 246 days. There was no significant difference between the two groups (P> 0.05). Pain: 2 cases of complete remission (CR), 5 cases of partial remission (PR), 2 cases of stable (SD) and 9 cases of objectively effective (CR + PR + SD) in the treatment group; CR1 cases, PR3 cases and SD2 cases , Objectively effective (CR + PR + SD) was 6 cases, there was no significant difference between the two groups in objective and effective conditions (P> 0.05). Objective efficacy: There were no CR cases in the two groups, including PR5 cases, 6 cases of NC, 6 cases of PD, 5 cases of objective and effective (CR + PR), CR (PR + NC) (CR + PR) in 2 cases and CR + PR + NC in 6 cases in control group. There was no significant difference between the two groups in the objective and effective conditions (P> 0.05), but the treatment group was better than the control group, the difference was statistically significant (P <0.05). Adverse reactions mainly manifested as gastrointestinal reactions and bone marrow suppression, no significant difference between the two groups (P> 0.05), no arsenic poisoning reaction. Conclusion Arsenious acid combined with FOLFOX4 regimen can achieve good results, arsenic acid does not increase the side effects of conventional chemotherapy.