沙利度胺联合ＧＰ方案与ＧＰ方案治疗晚期非小细胞肺癌临床对照研究

目的　探讨沙利度胺联合ＧＰ方案治疗晚期非小细胞肺癌（ＮＳＣＬＣ）的疗效、毒副反应及对生活质量的影响。方法　６１例晚期ＮＳＣＬＣ患者随机分为两组：吉西他滨联合顺铂及沙利度胺（ＴＧＰ）组３１例，吉西他滨联合顺铂（ＧＰ）组３０例。ＴＧＰ组：吉西他滨（ＧＥＭ）１０００ｍｇ／ｍ^２，第１、８天；顺铂（ＤＤＰ）２０ｍｇ／ｍ^２，第１～４天；沙利度胺２００ｍｇ／ｄ，第１～６０天。ＧＰ组剂量同ＴＧＰ组。２１天为１周期，２周期后评价疗效。根据ＲＥＣＩＳＴ标准评价疗效，按ＷＨＯ毒副反应标准评价毒副反应，按ＥＯＲＴＣＱＬＱ-Ｌ４３量表评价患者的生活质量。结果　ＴＧＰ组的有效率（ＣＲ＋ＰＲ）为４５.１％，ＧＰ组有效率为４０.０％，两组有效率比较，差异无统计学意义（Ｐ＞０.０５）。ＴＧＰ组和ＧＰ组中位生存时间（ＭＳＴ）分别为１０.０和９.２个月，差异无统计学意义。两组１年生存率分别为３５.４％和３０.０％，差异无统计学意义。生活质量（ＥＯＲＴＣＱＬＱ-Ｌ４３生活量表评价）：化疗后ＴＧＰ组整体生活质量较ＧＰ组有显著提高、食欲明显增加，恶心呕吐发生率ＴＧＰ组低于ＧＰ组（Ｐ＜０.０５），便秘的发生率明显增加（Ｐ＜０.０５），其余各项在两组化疗后均无明显差异。结论　沙利度胺联合ＧＰ方案未能改善晚期ＮＳＣＬＣ患者的近期有效率及生存期，但能改善患者化疗期间的生活质量而不增加毒副反应。

The control clinical study on the treatment of advanced non-small cell lung cancer by TGP regimen and GP regimen

Objective To evaluate the efficacy and toxicity of thalidomide combined with gemcitabine and cisplatin（TGP regimen）,record the quality of life for patients with non-small cell lung cancer（NSCLC）.Methods Thirty-one advanced NSCLC patients were treated with TGP regimen,while the other 30 advanced NSCLC patients were treated with GP regimen.TGP regimen was taken as follow： gemcitabine 1000mg/m^2,d1,d8;cisplatin 20mg/m^2,d1-d4;thalidomide 200mg/d,for 2 months.The dosage of GP regimen was the same to TGP regimen.The efficacy and toxicity were evaluated after two treatment cycles.Quality of life was evaluated by EORTC QLQ-L43 scale.Results The overall response rates of TGP group and GP group were 45.1% and 40.0%,respectively,and the median survival time were 10.0 months and 9.2 months,respectively（P〉0.05）.The one-year survival rates of TGP group and GP group were 35.4% and 30.0%,respectively（P=0.427）.The overall life quality was significantly improved in the TGP group.The incidence of nausea and vomiting in TGP group was less than GP group（P〈0.05）.However,the incidence of constipation in TGP group was more often than GP group（P〈0.05）.Conclusion The TGP regimen can not improve the recent response rate and survival time for advanced NSCLC patients,but can improve the quality of life during the chemotherapy without increasing toxicity.