香菇多糖联合吉西他滨+顺铂方案一线治疗晚期非小细胞肺癌近期疗效与不良反应观察

摘要/Abstract

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 1000 mg/m²,第1天、第8天;DDP 25 mg/m²,第1~3天;观察组在此基础上加用香菇多糖注射液 1 mg,每周2次静脉滴注。21 d 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PR 13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。

关键词: 非小细胞肺癌, 香菇多糖, 吉西他滨, 顺铂, 化学治疗

Abstract: AIM: To evaluate the short-term therapeutic and adverse effect of lentinan(LNT) and gemcitabine(GEM) plus cisplatin(DDP)(GP regimen)as the first-line treatment for advanced non-small cell lung cancer(NSCLC). METHODS: A total of 71 patients were randomly assigned to two regimens. 71 advanced NSCLC cases diagnosed by clinical pathology or cellular biopsy 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,d1,d8;cisplatin 25 mg/m², i.v.,d1-d3; for intravenous use in control 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 adverse 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 observation group and control group(P<0.05),respectively.The main side-effects of the two groups included hematologic toxicites,digestive tract reaction and hairloss.The incidence of Ⅲ/Ⅳ neutropenia was significantly less incurred in observation group than that in control group(14.3%/36.1%,P<0.05); The incidence of Ⅲ/Ⅳ nausea and vomiting was less incurred in observation group than that in control group(11.4%/19.4%, P>0.05).CONCLUSION: LNT combined with GP regimen as the first-line treatment for advanced NSCLC can ameliorate life quality,enhance efficacy and reduce side-effects.So lentinan can become an important remedy adjuvant of chemotherapy.

Key words: Non-small cell lung cancer, Lentinan, Gemcitabine, Cisplatin, Chemotherapy

中图分类号:

R734.2

赵文英, 陈冬云, 陈景华. 香菇多糖联合吉西他滨+顺铂方案一线治疗晚期非小细胞肺癌近期疗效与不良反应观察[J]. 中国临床药理学与治疗学, 2013, 18(1): 71-77.

ZHAO Wen-ying, CHEN Dong-yun, CHEN Jing-hua. Observation of short-term therapeutic and adverse effect of lentinan and gemcitabine plus cisplatin as the first-line treatment for advanced non-small cell lung cancer[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2013, 18(1): 71-77.

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