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艾迪注射液联合化疗的安全性和有效性临床研究

A clinical study on safety and efficacy of Aidi injection combined with chemotherapy.

作者信息

Xu Hong-xia, Huang Xin-en, Li Ying, Li Cheng-guang, Tang Jin-hai

机构信息

Department of Chemotherapy, Jiangsu Cancer Hospital and Research Institute, Nanjing, China.

出版信息

Asian Pac J Cancer Prev. 2011;12(9):2233-6.

PMID:22296362
Abstract

OBJECTIVE

To observe the efficacy, side effects and impact on the quality of life of Aidi Injection combined with leucovorin calcium/5-fluorouracil/oxaliplatin (FOLFOX4 regimen) in the treatment of advanced colorectal cancer patients.

METHODS

A consecutive cohort of 100 patients were divided into two groups: the experimental group was treated with Aidi injection and FOLFOX4 while the control group was only administered FOLFOX4. After more than two courses of treatment, efficacy, quality of life and side effects were evaluated.

RESULTS

The response rate of experimental group was not significantly different with that of control group (P>0.05), but differences were significant in clinical benefit response and KPS score. Iin addition, gastrointestinal reaction and the incidence of leukopenia were lower than that of control group (P<0.05).

CONCLUSIONS

Aidi injection combined with FOLFOX4 is associated with reduced toxicity of chemotherapy, enhanced clinical benefit response and improved quality of life of patients with advanced colorectal cancer. Aidi injection deserves to be further investigated by randomized control clinical trails.

摘要

目的

观察艾迪注射液联合亚叶酸钙/5-氟尿嘧啶/奥沙利铂(FOLFOX4方案)治疗晚期结直肠癌患者的疗效、副作用及对生活质量的影响。

方法

将连续入选的100例患者分为两组:试验组采用艾迪注射液联合FOLFOX4方案治疗,对照组仅给予FOLFOX4方案治疗。经过两个以上疗程的治疗后,评估疗效、生活质量及副作用。

结果

试验组的有效率与对照组相比差异无统计学意义(P>0.05),但临床获益反应和KPS评分差异有统计学意义。此外,试验组胃肠道反应及白细胞减少发生率低于对照组(P<0.05)。

结论

艾迪注射液联合FOLFOX4方案可降低化疗毒性,增强临床获益反应,提高晚期结直肠癌患者的生活质量。艾迪注射液值得通过随机对照临床试验进一步研究。

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