复方苦参注射液联合吉西他滨+顺铂方案治疗晚期非小细胞肺癌56例临床观察

目的:观察复方苦参注射液联合吉西他滨(gemcitabine,GEM)+顺铂(cisplatin,DDP)方案(GP方案)治疗非小细胞肺癌(non-small-cell lung cancer,NSCLC)的疗效及不良反应。方法:将2007年1月—2010年2月收治的112例晚期NSCLC患者以随机抽样法分为对照组(GP)和治疗组(复方苦参注射液联合GP)。对照组给予吉西他滨1 g.m-2,d1、8,静脉滴注;顺铂25 mg.m-2,d1～3,静脉滴注,21 d为1个周期。治疗组给予GP方案(剂量及用法同化疗组)化疗同时给予复方苦参注射液20 mL溶于0.9%氯化钠注射液250 mL中静脉滴注,每日1次,连用14 d。至少化疗2个周期后评价疗效和不良反应,并随访生存期。结果:对照组50例可评价疗效,治疗组53例可评价疗效。治疗组有效率(RR)为40.5%(21/53),疾病控制率(DCR)为88.1%(46/53),较对照组[RR为30.0%(15/50),DCR为86.0%(43/50)]有所提高,但差异无统计学意义(P>0.05)。治疗组在总生存期(OS)、Karnofsky(KPS)评分方面优于对照组(P<0.05);无进展生存期(PFS)方面,2组比较差异无统计学意义(P>0.05)。2组患者的不良反应主要为骨髓抑制和消化系统反应,治疗组白细胞计数下降、贫血、恶心、呕吐的发生率低于对照组(P<0.05)。结论:复方苦参注射液联合GP方案治疗晚期NSCLC能延长OS,改善患者的生活质量,减少不良反应的发生。

Efficacy and Toxicity of Compound Matrine Injection Combined with Gemcitabine Plus Cisplatin for Advanced Non-Small-Cell Lung Cancer:Analysis of 56 Cases

OBJECTIVE: To evaluate the efficacy and toxicity of compound matrine injection combined with GP regimen(gemcitabine plus cisplatin) for non-small-cell lung cancer(NSCLC).METHODS: A total of 112 patients with advanced NSCLC admitted to our hospital between Jan.2007 and Feb.2010 were randomized to either control group(GP regimen: gemcitabine 1 g.m-2 on day 1 and day 8 by iv gtt plus cisplatin 25 mg.m-2 from day 1 to day 3 by ivgtt,with every 21 days defined as 1 cycle) or treatment group receiving add-on compound matrine injection(20 mL) that mixed with 0.9% sodium chloride injection(250 mL) once a day for 14 consecutive days in addition to GP regimen(with dosage and administration similar to those defined for control group).After treatment for at least 2 cycles,the efficacy and toxicity in the two groups were evaluated and the survival was followed-up.RESULTS: The efficacy evaluation was achieved for 50 cases in the control group and 53 in the treatment group.In the treatment group,the response rate(RR) was 40.5%(21 /53) and the disease control rate(DCR) was 88.1%(46 /53),which were slightly higher than in the control group [with RR at 30.0%(15 /50) and DCR at 86.0%(43 /50) ],but the differences were not statistically significant(P > 0.05).The overall survival(OS) and karnofsky score in the treatment group were superior to those in the control group(P < 0.05).The differences of median progression-free survival between the two groups were not statistically significant(P > 0.05).The major toxicity in the two groups included bone marrow depression and reactions of digestive system,however,the incidences of white leucopenia,anemia,nausea and vomiting in the treatment group were lower than in the control group(P < 0.05).CONCLUSION: Addition of compound matrine injection to GP regimen in treating non-small cell lung cancer has the advantage of prolonging patients’overall survival,improving patients quality of life meanwhile lowering the incidences of toxicity of chemotherapy.