| 杨宇飞,许云,吴煜,王兰萍,李贞,张灵智,朱尧武,郭中宁,郭全,阎小平.祛邪胶囊减少大肠癌术后复发转移的临床随机双盲对照研究[J].中国中西医结合杂志,2007,(10):879-882 |
| 祛邪胶囊减少大肠癌术后复发转移的临床随机双盲对照研究 |
| Clinical Randomized Double-blinded Controlled Study on Quxie Capsule in Reducing Post-operational Relapse and Metastasis of Colorectal Cancer |
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| DOI： |
| 中文关键词: 中药 祛邪胶囊 术后大肠癌 复发转移 随机对照研究 |
| 英文关键词:Chinese drug Quxie Capsule post-operational colorectal cancer relapse and metastasis randomized controlled trial |
| 基金项目:中国临床肿瘤学科学基金(CSCO-丽珠中医药肿瘤研究基金,Y-2005-0034) |
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| 中文摘要: |
| 目的探讨祛邪胶囊对大肠癌根治术后续巩固治疗的影响。方法按照RCT的要求,通过区组随机设计,选取根治术后Ⅱ、Ⅲ期大肠癌患者48例,后剔除2例,失访2例,可评价患者44例,包括Ⅱ期28例,其中治疗组15例,对照组13例;Ⅲ期16例,其中治疗组8例,对照组8例。两组患者均在常规术后辅助治疗结束后开始干预措施,治疗组给予祛邪胶囊,对照组给予安慰剂胶囊,共6个月,分别就复发转移率、复发转移时间、中医症候评分、KPS评分、免疫功能以及祛邪胶囊的安全性进行观察。结果随访至2007年4月,1、2、3年复发转移率治疗组分别为0%(0/23)、0%(0/8)和50.0%(2/4),对照组分别为9.5%(2/21)、18.2%(2/11)和50.0%(3/6),两组比较,差异无显著性(P>0.05);复发转移时间治疗组平均为(31.5±7.8)个月;对照组为(19.0±13.9)个月,两组比较差异无显著性(P>0.05);治疗组治疗前后中医症候评分、KPS评分均有显著改善(P<0.05);治疗组治疗后B细胞与治疗前及对照组比较差异均有显著性(P<0.05)。结论祛邪胶囊有可能延缓复发转移出现的时间,但最终结果尚需再进行1～2年的观察才能得出。祛邪胶囊可明显改善患者生活质量,提高患者免疫功能,且服用安全,对于大肠癌术后防止复发转移有一定临床价值。 |
| 英文摘要: |
| Objective To investigate the clinical effect of Quxie Capsule (QXC) in subsequent therapy for post-operational colorectal cancer. Methods By the scheme matched to the requirement of randomized controlled trial, 44 patients chosen from 48 patients with colorectal cancer at post-operational period (with 2 dropped out and 2 loss of follow-up) were assigned into two groups (A and B) according to randomiced block design and received intervention treatment with QXC and placebo, respectively, which started after terminating the post-operational adjuvant treatment and lasted for 6 months. Out of the 44 patients, 28 were of stage Ⅱ (15 in Group A and 13 in Group B) and 16 of stage Ⅲ (8 in Group A and 8 in Group B). The relapse-metastasis (R-M) rate, median time of R-M, changes of symptoms, Karnofsky (KPS) score and immune function before and after intervention, as well as the safety of QXC were observed. Results The follow-up study till April 2007 showed, the 1-year, 2-year and 3-year R-M rate in Group A was 0%, 0% and 50%, and in Group B was 9.5%, 18.2% and 50.0%, respectively, showing insignificant difference between the two groups (P>0.05). Difference in median time of R-M between the two groups (31.5±7.8 months vs 19.0 ±13.9 months) also showed no statistical significance (P>0.05). However, the symptoms and KPS score in Group A were better obviously (P<0.05), with improvement in B lymphocyte (P<0.05) superior to that in Group B. No obvious adverse reaction to QXC was found. Conclusion QXC might be effective in delaying the R-M of colorectal cancer, but the ultimate confirmation only could be obtained through 1 to 2 years observation. Post-operational intervention with QXC in patients with colorectal cancer could apparently improve the quality of life and raise the immune function of patients, it is safe and might have some clinical significance in preventing the R-M of cancer. |
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