论文部分内容阅读
【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 observe the effect of Shen-capsule on the survival and adverse reactions of patients with advanced non-small cell lung cancer (NSCLC). 【Methods】 Thirty-seven patients with advanced NSCLC who achieved remission or stable after first-line treatment with Shen-capsule combined with chemotherapy were divided into treatment group (group A, n = 21) and control group (group B, n = 16). Group A continued to take a capsule, 2 times a day, each 20 mg, medication to disease progression or intolerance; B group without special treatment. After 3 months, the recent control rate of disease was evaluated. Survival of the two groups were followed up and adverse drug reactions were observed. 【Results】 The immediate control rate (DCR) of group A was superior to group B (71.43% vs 37.5%) at 3 months, but the difference was not statistically significant (P> 0.05). The mean progression-free survival (PFS) in group A was 4.45 months (95% confidence interval, 3.86 to 5.03), superior to group B in 2.47 months (95% CI, 2.06 to 2.88) (P <0.01). The mean survival time (OS) in group A was 10.2 months (95% CI 9.2 to 11.2), which was better than that in group B 7.7 months (95% CI 6.9 to 8.5) (P <0.01). A group of patients did not appear serious adverse drug reactions. 【Conclusion】 SHENYI Capsule can maintain the treatment tolerance well and improve PFS and OS in patients with advanced NSCLC.