犀黄丸联合伊立替康和顺铂治疗局限期小细胞肺癌的临床研究

Clinical trial of Xihuang pill combined with irinotecan and cisplatin chemotherapy in the treatment of limited stage small cell lung cancer

目的观察伊立替康联合顺铂和犀黄丸治疗局限期小细胞肺癌临床疗效及安全性。方法 100例局限期小细胞肺癌患者随机分为对照组50例与试验组50例,对照组予以静脉滴注盐酸伊立替康注射液60 mg·m^(-2),每周期第1,8日,顺铂注射液75 mg·m-2静脉滴注,每周期第1日,试验组在对照组的基础上给予口服犀黄丸6 g,每日1次。2组患者均21 d为1个周期,共治疗4个周期。治疗结束后比较2组临床疗效、血清乳酸脱氢酶(LDH)、组织多肽特异抗原(TPS)、胃泌素释放肽前体(Pro GRP)、神经元特异性烯醇化酶(NSE)、癌胚抗原(CEA)、鳞状细胞癌抗原(SCC)、细胞角蛋白19片段(CYFR21-1)、总生存率及药物不良反应发生情况。结果治疗后,试验组和对照组的总有效率分别为88.00%(44/50例)和60.00%(30/50例)(P<0.05)。治疗后,对照组与试验组LDH分别为(301.29±45.37),(232.78±33.57)U·L^(-1),TPS分别为(57.29±6.39),(48.39±4.90)U·L^(-1),Pro GRP分别为(57.39±8.79),(22.91±4.70)U·L^(-1),NSE分别为(19.29±2.91),(13.29±1.89)μg·L^(-1),CEA分别为(7.38±1.61),(5.24±0.87)μg·L^(-1),SCC分别为(3.29±0.72),(2.12±0.34)ng·L^(-1),CYFR21-1分别为(4.49±0.73),(2.40±0.38)ng·L^(-1),差异有统计学意义(P<0.05)。试验组出现恶心呕吐3例,脱发2例,总药物不良反应发生率为10.00%(5/50例),对照组出现恶心呕吐3例,头疼2例,脱发2例,总药物不良反应发生率为14.00%(7/50例),差异无统计学意义(P>0.05)。试验组死亡4例,总生存率为92.00%(46/50例),对照组死亡15例,总生存率为70.00%(35/50例),差异有统计学意义(P<0.05)。结论伊立替康联合顺铂和犀黄丸治疗局限期小细胞肺癌的临床疗效显著提高,且不增加药物不良反应发生率。

Objective To evaluate the efficacy and safety of Xihuang pill combined with irinotecan plus cisplatin chemotherapy in the treatment of limited stage small cell lung cancer. Methods A total of 100 patients with limited stage small cell lung cancer were divided into control group （n =50） and treatment group （n = 50）. The control group was treated with irinotecan hydrochloride injection 60 mg· m-Eiv on the 1st and 8th day of each treatment cycle and cisplatin injection 75 mg · m-2iv on the 1st day for each treatment cycle. Treatment group was treated with 6 g of Xihuang pill, qd, on the basis of control group. All groups were treated for 4 treatment cycles （21 d per treatment cycle）. Clinical efficacy, serum lactate dehydrogenase （LDH）, tissue polypeptide specific antigen （TPS）, gastrin releasing peptide （GRP）, neuron specific enolase （NSE）, overall survival rate and adverse reaction were compared with control group after treatment. Results After treatment, the clinical efficacy in treatment group and control group were 88.00% （44/50 cases） and 60. 00% （30/50 cases）, with significant difference（P 〈 0. 05 ）. In control group and treatment group, LDH were（301.29 ±45. 37）, （232. 78 ±33. 57）U · L^-1 ,TPS were （57.29 ±6. 39）, （48. 39 ±4. 90）U · L^-1 , ProGRP were（57. 39 ± 8.79）, （22. 91 ± 4. 70） U · L^-1, NSE were respectively （ 19.29 ± 2. 91 ）, （ 13.29 ± 1.89 ） μg · L^-1, CEA were（7.38 ±1.61） ,（5.24 ±0. 87） μg · L^-1,SCC were （3.29 ±0.72） ,（2. 12 ±0. 34）ng · L^-1 ,CYFR21 -1 were （4. 49 ± 0. 73 ）, （ 2. 40 ± 0. 38 ） ng· L^-1, the difference were statistically significant （ P 〈 0. 05 ）. Adverse drug reactions in treatment group were nauseous （3 cases） and alopecia （2 eases）, and the adverse drug reaction rate was 10. 00% （5/50 cases）. The adverse drug reactions in control group were nauseous （3 cases）, headache （2 cases） and alopecia （2 cases） , the adverse drug reaction rate was 14. 00% （7/50 eases）. There was no statistically difference in adverse drug reactions between the two groups （ P 〉 0. 05 ） . A total of 4 patients were dead in the treatment group （ survival rate 92. 00% ）, while 15 patients were dead in control group （ survival rate was 70. 00% ）, with significant difference （P 〈 0. 05）. Conclusion The Xihuang pill combined with irinotecan plus cisplatin chemotherapy exerted considerable efficacy and high safety in the treatment of limited stage small cell lung cancer.