摘要
目的:观察香菇多糖(LNT)注射液联合吉西他滨(GEM)+顺铂(DDP)方案(GP方案)一线治疗晚期非小细胞肺癌(NSCLC)的近期疗效和不良反应。方法:经组织学和/或细胞学确诊的初治晚期NSCLC患者71例,随机分为对照组(GP方案)和观察组(LNT联合GP方案)。对照组应用GEM 1000mg/m2,第1天、第8天;DDP25mg/m2,第1～3天;观察组在此基础上加用香菇多糖注射液1mg,每周2次静脉滴注。21d为1周期。完成2～4周期后进行疗效评定。结果:观察组35例患者中,获部分缓解(PR)13例,稳定(SD)19例,进展(PD)3例,有效率(RR)为37.1%(13/35),疾病控制率(DCR)为91.4%(32/35),中位治疗至疾病进展生存时间(TTP)为6.8个月,中位生存时间(MST)为12.3个月,1年生存率为45.7%(16/35);对照组36例患者中,获PR13例,SD 18例,PD 5例;RR为36.1%(13/36),DCR为86.1%(31/36),TTP为6.5个月,MST为11.6个月,1年生存率为41.7%(15/36)。两组比较差异无统计学意义(P>0.05)。KPS改善率:观察组为77.1%(27/35),对照组为38.9%(14/36),差异有统计学意义(P<0.05)。两组主要不良反应为血液学毒性、消化道反应和脱发。其中观察组与对照组相比,Ⅲ～Ⅳ度粒细胞减少发生率(14.3%/36.1%)显著降低,差异有统计学意义(P<0.05),Ⅲ～Ⅳ度恶心呕吐发生率(11.4%/19.4%)亦有一定程度降低(P>0.05)。结论:香菇多糖注射液联合GP方案一线治疗晚期非小细胞肺癌具有改善患者生活质量和增效减毒作用,可作为化疗的重要辅助用药。
AIM. To therapeutic and adverse and gemcitabine（GEM） evaluate the short-term effect of lentinan（LNT） plus cisplatin（DDP） （GP regimen）as the first-line treatment for advanced non-small cell lung cancer （NSCLC）. METH- ODS： A total of 71 patients were randomly assigned to two regimens. 71 advanced NSCLC ca- ses diagnosed by clinical pathology or cellular bi opsy were divided into control group treated with GP regimen and observation group treated with lentinan and GP regimen. The usage of GP was gemcitabine 1000 mg/m2 ,dl, d8 ; cisplatin 25 mg/m2, i. v. ,dl-d3; for intravenous use in con- trol group; based on the above, in observation group,lentinan was administered by 1 mg, twice a week intravenously. The chemotherapy interval was 21 days,and the clinical therapeutic and ad- verse effect were assessed after 2 to 4 cycles. RESULTS：Among 35 cases in observation group （LNT ＋GP group）：13 patients had PR,19 patients had SD and 3 patients had PD. RR and DCR was 37.1% （13/35） and 91.4% （32/35） respectively. TTP was 6.8 months, MST was 12.3 months and the 1-year survival rate was 45.7% （16/35）; while those of control group （GP group） ：13 patients had PR, 18 patients had SD and 5 patients had PD. RR and DCR was 36. 1%（13/36）and 86. 1% （31/36）respectively. TTP was 6.5 months, MST was 11. 6 months and the 1-year survival rate was 41.7%（15/36）. The variance of short-term therapeutic effect had no statistic significance（P^0.05）. The improve rate of Karnofsky Performance Status（KPS） was 77.1%（27/35） and 38.9%（14/36）for observa- tion group and control group（P〈0.05）,respec- tively. The main side-effects of the two groups included hematologic toxicites,digestive tract re- action and hairloss. The incidence of III/IV neu- tropenia was significantly less incurred in obser- vation group than that in control group（14.3%/ 36.1%,P〈0.05） ; The incidence of III/IV nau- sea and vomiting was less incurred in observa- tion group than that in control group（11. 4%/ 19.4%, P〉0.05）. CONCLUSION： LNT com- bined with GP regimen as the first-line treatment for advanced NSCLC can ameliorate life quality, enhance efficacy and reduce side-effects. So lenti- nan can become an important remedy adjuvant of chemotherapy.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2013年第1期71-77,共7页
Chinese Journal of Clinical Pharmacology and Therapeutics
关键词
非小细胞肺癌
香菇多糖
吉西他滨
顺铂
化学治疗
Non-small cell lung cancer
Len- tinan
Gemeitabine
Cisplatin
Chemotherapy
