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目的 观察复方斑蝥胶囊联合GP方案治疗中晚期非小细胞肺癌患者的临床疗效。方法 选取2015年11月—2017年4月空军军医大学唐都医院收治的90例中晚期非小细胞癌患者作为研究对象,所有患者随机分为对照组和治疗组,每组各45例。对照组患者采用GP方案治疗,第1、8天静脉滴注注射用盐酸吉西他滨1 000 mg/m2,第1~3天静脉滴注顺铂氯化钠注射液80~100 mg/m2。治疗组在对照组治疗的基础上口服复方斑蝥胶囊,3粒/次,2次/d。以21 d为1个化疗周期,2个化疗周期为1个疗程,两组患者均治疗2个疗程。观察两组患者的临床疗效,比较两组患者的无进展生存时间(PFS)、总生存时间(OS)、生活质量评分、蛋白表达和毒副反应发生情况。结果 治疗后,对照组客观缓解率(ORR)和疾病控制率(DCR)分别为68.9%和84.4%,均分别明显低于治疗组的84.4%和95.6%,两组比较差异具有统计学意义(P<0.05)。治疗后,治疗组患者的PFS、OS均显著高于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者躯体功能、认知功能、社会功能、情绪功能评分及总分均明显升高,同组治疗前后比较差异具有统计学意义(P<0.05);治疗后,治疗组的上述评分和总分均明显高于较对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组Ki67蛋白、bcl-2蛋白低表达,Bax蛋白高表达,同组治疗前后比较差异具有统计学意义(P<0.05);治疗后,治疗组蛋白表达水平显著优于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,治疗组血液系统毒性、脱发、肝脏功能异常、肾脏功能异常、胃肠道反应、皮肤毒性发生率和总发生频次均显著低于对照组,两组比较差异具有统计学意义(P<0.05)。结论 复方斑蝥胶囊联合GP方案治疗非小细胞肺癌临床疗效确切,可有效延长患者的生存时间,提高生活质量,改善蛋白表达,降低毒副反应,具有一定的临床推广应用价值。
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[Abstract]
Objective To observe the clinical efficacy of Compound Banmao Capsules combined with GP regiment in treatment of advanced non-small cell lung cancer. Methods Patients (90 cases) with advanced non-small cell lung cancer in The Second Affiliated Hospital of Air Force Military Medical University from November 2015 to April 2017 were randomly divided into control and treatment groups, and each group had 45 cases. Patients in the control group were given GP chemotherapy, iv administer with Gemcitabine Hydrochloride for injection at the first and eighth day, 1 000 mg/m2, and iv administer with Cisplation and Sodium Chloride Injection at the first day to the third day, 80-100 mg/m2. Patients in the treatment group were po administered with Compound Banmao Capsules on the basis of the control group, 3 capsules/time, twice daily. One chemotherapy cycle had 21 d, 2 chemotherapy cycles as a course of treatment, and patients in two groups were treated for 2 courses. After treatment, the clinical efficacy was evaluated, and the PFS, OS, quality of life scores, protein expression, and side effects in two groups were compared. Results After treatment, the ORR and DCR in the control group were 68.9% and 84.4%, which were significantly lower than 84.4% and 95.6% in the treatment group, respectively, and there were differences between two groups (P<0.05). After treatment, PFS and OS in the treatment group were significantly higher than those in the control group, and there was difference between two groups (P <0.05). After treatment, the scores of somatic function, cognitive function, social function, emotional function, and total scores in two groups were significantly increased, and the difference was statistically significant in the same group (P<0.05). After treatment, above scores and total scores in the treatment group were significantly higher than those in the control group, with significant difference between two groups (P<0.05). After treatment, protein expression of Ki67 and bcl-2 in two groups was significantly decreased, but the protein expression of Bax was significantly increased, and the difference was statistically significant in the same group (P<0.05). After treatment, the protein expressions in the treatment group were significantly better than those in the control group, with significant difference between two groups (P < 0.05). After treatment, the incidence and frequency of adverse reactions such as hematological toxicity, alopecia, liver dysfunction, kidney dysfunction, gastrointestinal reaction and skin toxicity were significantly lower than those in the control group, with significant difference between two groups (P<0.05). Conclusion Compound Banmao Capsules combined with GP regiment has definite clinical efficacy in treatment of advanced non-small cell lung cancer, can effectively prolong survival time and improve the quality of life, improve protein expression, and reduce toxic and side effects, which has a certain clinical application value.
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