康艾注射液联合伊立替康和卡铂治疗广泛期小细胞肺癌的临床研究

目的研究康艾注射液联合注射用盐酸伊立替康和注射用卡铂治疗广泛期小细胞肺癌的临床疗效。方法选取2012年6月—2017年4月在南京市胸科医院呼吸科收治的广泛期小细胞肺癌患者100例为研究对象,将所有患者随机分为对照组和治疗组,每组各50例。对照组患者静脉滴注注射用盐酸伊立替康,350 mg/m~2溶入生理盐水100 m L中,60 min给药完毕;同时静脉滴注注射用卡铂,剂量按照5×(肌酐清除率+25),溶入5%葡萄糖250 m L中,60 min给药完毕。治疗组在对照组治疗的基础上静滴康艾注射液,40 m L溶于生理盐水250 m L中。疗程为10 d,每21天重复1次,两组患者均进行6个疗程。评价两组患者临床疗效,同时比较治疗前后免疫功能和毒副反应。结果治疗后,对照组、治疗组客观缓解率(ORR)、疾病控制率(CBR)分别为60.0%、68.0%,90.0%、96.0%,两组ORR和CBR比较差异无统计学意义。治疗后,对照组CD4~+/CD8~+、NK细胞水平显著升高,治疗组B细胞、CD4~+、CD4~+/CD8~+和NK细胞水平均显著升高,同组治疗前后比较差异具有统计学意义(P0.05);且治疗后治疗组B细胞、CD4~+、CD4~+/CD8~+和NK细胞水平均显著高于对照组,两组比较差异具有统计学意义(P0.05)。治疗组毒副反应发生率为32%,显著低于对照组的62%,两组比较差异有统计学意义(P0.05)。结论康艾注射液联合注射用盐酸伊立替康和注射用卡铂治疗广泛期小细胞肺癌具有较好的临床疗效,可有效提高机体免疫功能,降低腹泻和骨髓抑制等毒副作用的发生率,具有一定的临床推广应用价值。

Clinical study on Kangai Injection combined with irinotecan and carboplatin in treatment of extensive small cell lung cancer

Objective To investigate the clinical efficacy of Kangai Injection combined with Irinotecan Hydrochloride for injection and Carboplatin for injection in treatment of extensive small cell lung cancer. Methods Patients (100 cases) with extensive small cell lung cancer in Nanjing Chest Hospital from June 2012 to April 2017 were randomly divided into control and treatment groups, and each group had 50 cases. Patients in the control group were given Irinotecan Hydrochloride for injection, 350 mg/m² added into normal saline 100 mL, intravenous drip within 60 min, and patients in the control group were also given Carboplatin for injection with dosage of 5×(creatinine clearance +25), added into 5% glucose solution 250 mL, intravenous drip within 60 min. Patients in the treatment group were iv administered with Kangai Injection on the basis of the control group, 40 mL added into normal saline 250 mL. The course was 10 d, repeated every 21 d, and patients in two groups were treated for 6 cycles. After treatment, the clinical efficacies were evaluated, the immune function and toxic reaction in two groups before and after treatment were compared. Results After treatment, the ORR and CBR in the control and treatment groups were 60.0% and 68.0%, 90.0% and 96.0%, respectively, but there was no difference between two groups. After treatment, the levels of CD4⁺/CD8⁺, NK cells in control group were significantly increased, and the levels of B cells, CD4⁺, CD4⁺/CD8⁺, and NK cells in treatment group were significantly increased, and the difference was statistically significant in the same group (P<0.05). After treatment, the levels of B cells, CD4⁺, CD4⁺/CD8⁺ and NK cells in the treatment group were significantly higher than those in the control group, with significant difference between two groups (P<0.05). During the treatment, the toxic reaction (32%) in the treatment group was significantly lower than 62% in the control group, with significant difference between two groups (P<0.05). Conclusion Kangai Injection combined with Irinotecan Hydrochloride for injection and Carboplatin for injection has clinical curative effect in treatment of extensive small cell lung cancer, can improve immune function of patients and reduce the incidence of toxic effects such as diarrhea and bone marrow suppression, which has a certain clinical application value.