解毒散结方辅助治疗晚期非小细胞肺癌临床研究  

Clinical Study on Jiedu Sanjie Prescription in the Adjuvant Therapy of Advanced Non-small Cell Lung Cancer

作　　者：张国磊 诸君 韩力[1] 方志红[1] ZHANG Guolei;ZHU Jun;HAN Li;FANG Zhihong(Shanghai Municipal Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200071,China)

机构地区：[1]上海中医药大学附属市中医医院,上海200071

出　　处：《中国中医药信息杂志》2021年第9期111-116,共6页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：上海市自然科学基金(19ZR1452200);上海市全国中医药创新骨干人才培训项目(2019年);上海市卫生和计划生育委员会中医特色诊疗技术提升项目(zyjx-2017010);上海市卫生和计划生育委员会科研课题(201740059)。

摘　　要：目的观察解毒散结方对晚期(Ⅲb/Ⅳ期)非小细胞肺癌(NSCLC)三线治疗失败后患者的临床疗效及对生活质量的影响。方法采用随机数字表法将208例晚期NSCLC患者分为治疗组和对照组各104例。2组均予鸦胆子油乳注射液或复方苦参注射液,静脉滴注,d1~d14,间隔15 d后再进行下一周期,治疗3个周期;若治疗期间患者发生疼痛,予三阶梯止痛治疗。治疗组同时予解毒散结方,对照组同时予注射用盐酸吉西他滨(1000 mg/m^(2),第1日和第8日静脉注射)或注射用培美曲塞二钠(500 mg/m^(2),第1日静脉滴入),21 d为1个周期,治疗4个周期。比较2组近期临床疗效、生存率、中位无进展生存期、中医症状改善情况、Karnofsky功能状态(KPS)评分、WHO数字分级法(NRS)评分和安全性指标。结果对照组客观缓解率为14.14%(14/99),治疗组为4.95%(5/101),2组比较差异有统计学意义(P<0.05);对照组疾病控制率为59.59%(59/99),治疗组为45.54%(46/101),2组比较差异有统计学意义(P<0.05)。2组6个月、1年和2年生存率比较差异无统计学意义(P>0.05)。2组治疗后中位无进展生存期比较差异无统计学意义(P>0.05)。治疗组咳嗽、乏力和失眠改善率优于对照组(P<0.05),咯血、胸痛改善率与对照组比较差异无统计学意义(P>0.05)。与本组治疗前比较,治疗组治疗后KPS评分明显升高(P<0.05);2组治疗后比较,治疗组KPS评分明显高于对照组(P<0.05)。治疗组治疗后NRS评分下降率为19.80%,优于对照组的13.13%(P<0.05)。2组安全性指标比较差异无统计学意义(P>0.05)。结论解毒散结方辅助治疗晚期NSCLC患者近期临床疗效逊于单药化疗方案,但患者的生存率、中位无进展生存期与单药化疗相近,可明显改善患者中医症状,提高生活质量,缓解疼痛,安全性较好。Objective To study the clinical efficacy of Jiedu Sanjie Prescription for advanced(stageⅢb/Ⅳ)non-small cell lung cancer(NSCLC)after the failure of third-line treatment,and its effects on the quality of life of patients.Methods Totally 208 patients with advanced NSCLC were divided into treatment group and control group with 104 cases in each group according to random number table method.Both groups were given Brucea javanica oil emulsion injection or Compound Kushen Injection,intravenous drip,d1-d14,15 days later for next round of treatment,totally three rounds;if the patient had pain during treatment,three-step analgesia would be adopted.The treatment group was given Jiedu Sanjie Prescription at the same time,and the control group was given gemcitabine hydrochloride for injection(1000 mg/m^(2),intravenous injection on the 1st and 8th day)or pemetrexed disodium for injection(500 mg/m^(2),intravenous infusion on the 1st day),21 days for 1 round,4 rounds of treatment in total.The short-term clinical efficacy,survival rate,median progression-free survival time,improvement of TCM symptoms,Karnofsky performance status(KPS)score,numerical rating scale(NRS)score and safety indicators of both groups were compared.Results The objective remission rate of the control group was 14.14%(14/99),and the treatment group was 4.95%(5/101),with statistical significance(P<0.05);the disease control rate of the control group was 59.59%(59/99),and the treatment group was 45.54%(46/101),with statistical significance(P<0.05).There was no significant difference in survival rates of 6 months,1 year and 2 years between the two groups(P>0.05).There was no significant difference in the median survival time between the two groups after treatment(P>0.05).The improvement rate of cough,fatigue and insomnia symptoms in the treatment group was better than that in the control group(P<0.05),and the improvement rate of hemoptysis and chest pain symptoms was not statistically different from that in the control group(P>0.05).Compared with before treat

关 键 词：解毒散结方 单药化疗 非小细胞肺癌 临床疗效 生活质量 

分 类 号：R273.42[医药卫生—中西医结合]