摘要
【目的】观察参一胶囊继续单药维持治疗对晚期非小细胞肺癌(NSCLC)患者的生存影响及不良反应。【方法】经参一胶囊联合化疗一线治疗后取得缓解或稳定的37例晚期NSCLC患者意向性分为治疗组(A组,21例)和对照组(B组,16例)。A组继续服用参一胶囊,每天2次,每次20 mg,服药至疾病进展或无法耐受;B组未予特殊治疗。3个月后评估疾病近期控制率,随访比较2组生存情况并观察药物不良反应。【结果】3个月时A组疾病近期控制率(DCR)优于B组(71.43%VS 37.5%),但差异无统计学意义(P﹥0.05)。A组平均疾病无进展生存期(PFS)为4.45个月[95%可信区间(Confidence Interval,CI)为3.86～5.03],优于B组的2.47个月(95%CI为2.06～2.88)(P<0.01)。A组平均生存时间(OS)为10.2个月(95%CI为9.2～11.2),优于B组的7.7个月(95%CI为6.9～8.5)(P<0.01)。A组患者未出现严重药物不良反应。【结论】参一胶囊单药继续维持治疗耐受性好,可改善晚期NSCLC患者PFS及OS。
Objective To evaluate the efficiency of using Shenyi Capsule as continuous maintenance therapy on the survival of advanced non-small cell lung cancer （NSCLC） patients after first line conventional cisplatin- based chemotherapy, and to observe the safety . Methods Thirty-seven patients achieving partial response or disease stabilization after the combined treatment of Shenyi Capsule with first line conventional cisplatin-based chemotherapy were divided into maintenance group （N=21） and control group （N=16）. Both groups received symptomatic treatment after the combined therapy. Additionally, maintenance group was given Shenyi Capsule orally alone at the dose of 20 mg （bid） as maintenance therapy and the medication continued until the disease became aggravation or the patients gave up. Short-term disease control rate （DCR） after treatment for 3 months, and survival rate and adverse effects during the follow-up were observed. Results Maintenance group had higher DCR than the control group （71.43% vs 37.5%）, but the difference was insignificant （P 〉 0.05）. The mean progression-free survival （PFS） was 4.45 months in the maintenance group with the 95% confidence interval （CI） being 3.86-5.03 , higher than 2.47 months （95% CI being 2.06-2.88） in the control group, and the difference was significant （P〈0.01） The overall survival （OS） period was 10.2 months （95% CI being 9.2-11.2） in the maintenance group, higher than 7.7 months （95% CI being 6.9-8.5） in the control group, and the difference was significant （P〈0.01）. Conclusion Maintenance therapy of Shenyi Capsule alone is safe, and is effective on improving PFS and OS in advanced non-small cell lung cancer patients.
出处
《广州中医药大学学报》
CAS
北大核心
2013年第3期337-340,共4页
Journal of Guangzhou University of Traditional Chinese Medicine
基金
广东省中医药管理局立项课题(编号:2010292)
