青蒿琥酯联合NP方案治疗中晚期非小细胞肺癌的随机对照研究

目的：探讨青蒿琥酯联合化疗治疗中晚期非小细胞肺癌（nonsmall-cell lung cancer,NSCLC）的疗效和安全性。方法：采用临床随机对照研究的方法将120例NSCLC患者分成两组。单纯化学治疗组（对照组）60例,采用NP方案化疗：长春瑞滨25mg/m^2溶于生理盐水40ml中,静脉推注,1次/d,第1、8天;顺铂25mg/m^2溶于生理盐水500ml中,静脉滴注,1次/d,第2～4天给予。青蒿琥酯联合化疗组（试验组）60例：青蒿琥酯120mg溶于生理盐水20ml中,每周期化疗第1天开始静注,1次/d,第1～8天,化疗方法同对照组。两组均以21d为1个周期,并治疗2个周期以上。至少2个周期治疗结束后对其近期有效率、疾病控制率、疾病进展时间（time to progression,TTP）、中位生存时间（mean survival ti me MST）、1年生存率和毒副反应进行评价。结果：试验组和对照组近期有效率、MST和1年生存率分别为45.1%、44周、45.1%和34.5%、45周、32.7%,两组比较差异无统计学意义（P〉0.05）。两组疾病控制率和TTP分别为88.2%、24周和72.7%、20周,两组比较差异有统计学意义（P〈0.05）。两组的不良反应发生率对比差异无统计学意义（P〉0.05）,主要毒副作用为血液系统和消化系统毒性。结论：青蒿琥酯可用于临床治疗NSCLC。青蒿琥酯联合化疗能提高NSCLC患者近期疾病控制率,延长TTP,安全性良好。

Artesunate combined with vinorelbine plus cisplatin in treatment of advanced non-small cell lung cancer:A randomized controlled trial

OBJECTIVE: To our knowledge, there has been no clinical report of artesunate in the treatment of lung cancer. This study was designed to compare the efficacy and toxicity of artesunate combined with NP (a chemotherapy regimen of vinorelbine and cisplatin) and NP alone in the treatment of advanced non-small cell lung cancer (NSCLC). METHODS: One hundred and twenty cases of advanced NSCLC were randomly divided into simple chemotherapy group (control group, n=60) and combined artesunare with chemotherapy group (trial group, n=60). Patients in the control group were treated with NP regimen, including vinorelbine (25 mg/m(2), once-a-day intravenous injection, at the 1st and 8th day) and cisplatin (25 mg/m(2), once-a day intravenous drip, at the 2nd to 4th day). Patients in the trial group were treated with the basal therapy NP (in the same method and doses as control group) and artesunate (120 mg, once-a-day intravenous injection, from the 1st day to 8th day, for 8 days). At least two 21-day-cycles of treatment were performed. The short-term survival rate, disease controlled rate (DCR), time to progression (TTP), mean survival time (MST) and 1-year survival rate were analyzed as the primary end points, and the toxicity and safety were estimated. RESULTS: There were no significant differences in the short-term survival rate, MST and 1-year survival rate between the trial group and the control group, which were 45.1% and 34.5%, 44 weeks and 45 weeks, 45.1% and 32.7%, respectively (P>0.05). The DCR of the trial group (88.2%) was significantly higher than that of the control group (72.7%) (P<0.05), and the trial group's TTP (24 weeks) was significantly longer than that of the control group (20 weeks) (P<0.05). No significant difference was found in toxicity between the two groups, such as myelosuppression and digestion reaction (P>0.05). CONCLUSION: Artesunate can be used in the treatment of NSCLC. Artesunate combined with NP can elevate the short-term survival rate and prolong the TTP of patients with advanced NSCLC without extra side effects.