片仔癀胶囊治疗转移性结肠癌随机双盲对照试验研究

Effect of Pientzehuang Capsule in Treating Metastatic Colon Cancer: A Randomized Double-blinded Controlled Trial

目的评价片仔癀胶囊对转移性结肠癌患者的临床疗效与安全性。方法采用随机双盲安慰剂对照研究方法,将患者按2:1的比例分配至试验组(79例)和对照组(38例),分别给予片仔癀胶囊和安慰剂,每次2粒,每日3次,连续治疗28天为1个疗程,以疾病出现进展为干预终点。检测患者肿瘤标志物(CEA、CA199)、血常规(RBC、WBC、NEU、PLT)及肝肾功能(ALT、AST、γ-GGT、TBIL、BUN、SCr),计算两组无进展生存期(PFS),观察两组患者不良事件(AE)。结果与本组治疗前比较,对照组治疗2个疗程后CA199降低(P<0.01),试验组治疗2个疗程后CEA和CA199降低(P<0.01)。与对照组同期比较,试验组治疗2个疗程后CA199升高(P<0.05)。使用片仔癀胶囊和用药周期≥3个疗程为保护因素(P<0.01,P<0.05)。片仔癀胶囊可提高患者1年无进展生存率(P=0.011)。结论服用片仔癀胶囊3个疗程以上,可降低患者肿瘤标志物CA199,提高PFS,且不增加AE。

Objective To evaluate the clinical efficacy and safety of Pientzehuang Capsule on metastasis of colon cancer patients. Methods A randomized, double-blinded,placebo-controlled study was conducted, patients were assigned to the experimental group(79 cases) and the control group(38 cases) in the ratio of 2∶1,they were treated with Pientzehuang Capsule and placebo respectively,2 capsules each time,three times a day, 28 days was considered as 1 course,the treatment lasted until the disease progressed. Tumor markers(CEA, CA199), blood routine(RBC, WBC, NEU, PLT) and liver and kidney functions(ALT, AST,γ-GGT, TBIL, BUN, SCr) were determined. Progression-free survival(PFS) was calculated and adverse events(AE) were observed in the two groups. Results Compared with the baseline,CA199 decreased after 2 courses in the control group(P< 0.01),CEA and CA199 decreased in the experimental group after 2 courses of treatment(P< 0.01). Compared with the control group, CA199 increased after 2 courses in the experimental group(P< 0.05). Taking Pientzehuang Capsule and 3 or more courses of medication were protective factors(P<0.01, P<0.05). Pientzehuang Capsule could improve the one-year PFS(P=0.011). Conclusion Taking Pientzehuang Capsule for more than 3 courses can decrease the tumor marker, CA199 and improve PFS without increasing AE.