目的 探讨雷丸胶囊联合注射用盐酸吉西他滨治疗晚期肺癌的临床疗效。方法 选取2013年8月—2015年8月在河北北方学院附属第一医院进行治疗的晚期肺癌患者101例为研究对象，根据用药的差别分成对照组（50例）和治疗组（51例）。对照组于第1、8天静脉滴注注射用盐酸吉西他滨，1 000 mg/m²加入到生理盐水250 mL中。治疗组在对照组基础上口服雷丸胶囊，1粒/次，3次/d。两组患者均以3周为1个疗程，连续治疗2个疗程。观察两组的临床疗效，比较两组的Karnofsky（KPS）评分、生活质量调查表（SF-36）评分和生存情况。结果 治疗后，对照组和治疗组的临床有效率分别为48.00%、70.59%，疾病控制率分别为74.00%、94.12%，两组比较差异有统计学意义（P<0.05）。治疗后，两组KPS评分、SF-36评分均显著升高，同组治疗前后比较差异有统计学意义（P<0.05）；且治疗组这些观察指标明显高于对照组，两组比较差异具有统计学意义（P<0.05）。治疗后，治疗组肿瘤进展时间、中位生存期、1年生存率以及2年生存率的改善情况均要优于对照组，两组比较差异有统计学意义（P<0.05）。结论 雷丸胶囊联合注射用盐酸吉西他滨治疗晚期肺癌具有较好的临床疗效，可改善患者的生存情况与生活质量，安全性较好，具有一定的临床推广应用价值。

Objective To investigate the clinical efficacy of Leiwan Capsules combined with Gemcitabine Hydrochloride for injection in treatment of advanced lung cancer. Methods Patients (101 cases) with advanced lung cancer in the First Affiliated Hospital of Hebei North University from August 2013 to August 2015 were randomly divided into the control group (50 cases) and the treatment group (51 cases). Patients in the control group were iv administered with Gemcitabine Hydrochloride for injection at the first and eighth day, 1 000 mg/m² added into normal saline 250 mL. Patients in the treatment group were po administered with Leiwan Capsules on the basis of the control group, 1 grains/time, three times daily. Patients in two groups were treated for 2 courses, 3 weeks as 1 course. After treatment, the clinical efficacies were evaluated, and KPS scores, SF-36 scores, and survival situation in two groups were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 48.00% and 70.59%, respectively, the disease control rates in the control and treatment groups were 74.00% and 94.12%, respectively, and there was difference between two groups (P < 0.05). After treatment, the KPS scores and SF-36 scores in two groups were significantly increased, and the difference was statistically significant in the same group (P < 0.05). And the observational indexes in the treatment group were significantly higher than those in the control group, with significant difference between two groups (P < 0.05). After treatment, the improvement of tumor progression time, median survival, 1 year survival rate, and 2 year survival rate in the treatment group was significantly better than those in the control group, and there was difference between two groups (P < 0.05). Conclusion Leiwan Capsules combined with Gemcitabine Hydrochloride for injection has clinical curative effect in treatment of advanced lung cancer, can improve survival situation and quality of life, with good safety, which has a certain clinical application value.

河北省科技计划项目（162777297）