吉非替尼片联合康莱特胶囊治疗ⅢB/Ⅳ期非小细胞肺癌的临床研究  

Clinical trial of gefitinib tablets combined with Kanglaite capsules in the treatment of stage ⅢB/Ⅳ non-small cell lung cancer

作　　者：王俊艳[1] 魏素菊[1] 洪雷[1] 张帆[1] 刘承媛 孔雁[1] 

机构地区：[1]河北医科大学第四医院肿瘤内科,石家庄050000

出　　处：《中国临床药理学杂志》2017年第17期1631-1633,共3页The Chinese Journal of Clinical Pharmacology

基　　金：河北省科技支撑计划基金资助项目(13277752D)

摘　　要：目的观察吉非替尼片联合康莱特胶囊治疗ⅢB/Ⅳ期存在表皮生长因子受体(EGFR)敏感突变的非小细胞肺癌患者的临床疗效及安全性。方法将80例ⅢB/Ⅳ期存在EGFR敏感突变的非小细胞肺癌患者随机分为对照组40例和试验组40例。对照组予以吉非替尼250 mg·d-1,qd,口服;试验组在对照组治疗的基础上,予以康莱特胶囊每次2.7 g,qid,口服。2组患者均治疗至肿瘤进展或患者不能耐受。比较2组患者的临床疗效和药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为17.50%(7/40例)和7.50%(3/40例),疾病控制率分别为92.50%(37/40例)和87.50%(35/40例),无进展生存时间分别为17.70个月和16.30个月,差异均无统计学意义(均P>0.05)。试验组的药物不良反应主要有腹泻、皮疹、食欲缺乏等,对照组的药物不良反应主要有腹泻、皮疹、恶心等。试验组与对照组的总药物不良反应发生率分别为60.00%和85.00%,差异有统计学意义(P<0.05)。结论吉非替尼片联合康莱特胶囊治疗ⅢB/Ⅳ期非小细胞肺癌能显著降低药物不良反应的发生率,且存在延长疾病进展时间的趋势。Objective To observe the clinical efficacy and safety of ge- fitinib tablets combined with Kanglaite capsules in the treatment of stage ⅢB/Ⅳ non- small cell lung cancer （NSCLC） with epidermal growth factor receptor （EGFR） sensitive mutations. Methods Eighty patients of stage ⅢB/Ⅳ NSCLC with EGFR sensitive mutations were randomly divided into control group and treatment group Control group was given gefitinib 250 mg · d group received Kanglaite capsule 2. 7 mg, qid, with 40 cases per group. -1, qd, oral. Treatment oral, on the basis of con- trol group. Two groups were treated to tumor progression or intolerant. The clinical efficacy and adverse drug reactions were compared between two groups. Results After treatment, the total effective rates in control and treatment groups were 17.50% （7/40 cases） and 7.50% （3/40 ca- ses）, disease control rates （DCR） in control and treatment groups were 92.50% （37/40 cases） and 87.50% （35/40 cases） ,progress free sur- vival in control and treatment groups were 17.7 months and 16.3 months, the differences were statistically significant （ all P 〉 0. 05）. The adverse drug reactions in treatment group were based on diarrhea, rashand loss of appetite, which in control group reactions in treatment and control groups Conclusion Gefitinib tablet combined with maybe extend the progress free survival. were based on diarrhea, rash and nausea. The incidences of adverse drug were 60. 00% and 85.00% with significant difference （ P 〈 0. 05 ）. Kanglaite capsule can reduce the incidence of adverse drug reaction, and

关 键 词：康莱特胶囊 吉非替尼片 非小细胞肺癌 安全性 

分 类 号：R734.2[医药卫生—肿瘤]