A prospective, parallel, random, placebo-controlled clinical study on effects of Fuzheng Kangyan Formula combined with gefitinib on non-small cell lung cancer (stage IV) of qi deficiency and blood stasis type

ZHANG Yile; CHEN Qi; ZHANG Wei

doi:10.16305/j.1007-1334.2019.03.010

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A prospective, parallel, random, placebo-controlled clinical study on effects of Fuzheng Kangyan Formula combined with gefitinib on non-small cell lung cancer (stage IV) of qi deficiency and blood stasis type

更新时间：2022-08-31

- A prospective, parallel, random, placebo-controlled clinical study on effects of Fuzheng Kangyan Formula combined with gefitinib on non-small cell lung cancer (stage IV) of qi deficiency and blood stasis type
- Shanghai Journal of Traditional Chinese Medicine Vol. 53, Issue 3, Pages: 37-41(2019)
- 作者机构：
  
  1. 上海中医药大学附属曙光医院呼吸科,上海,201203
- 作者简介：
- 基金信息：
- DOI：10.16305/j.1007-1334.2019.03.010
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ZHANG Yile, CHEN Qi, ZHANG Wei. A prospective, parallel, random, placebo-controlled clinical study on effects of Fuzheng Kangyan Formula combined with gefitinib on non-small cell lung cancer (stage IV) of qi deficiency and blood stasis type. [J]. Shanghai Journal of Traditional Chinese Medicine 53(3):37-41(2019)
DOI：

ZHANG Yile, CHEN Qi, ZHANG Wei. A prospective, parallel, random, placebo-controlled clinical study on effects of Fuzheng Kangyan Formula combined with gefitinib on non-small cell lung cancer (stage IV) of qi deficiency and blood stasis type. [J]. Shanghai Journal of Traditional Chinese Medicine 53(3):37-41(2019) DOI： 10.16305/j.1007-1334.2019.03.010.

摘要

目的：观察扶正抗岩方联合吉非替尼治疗气虚血瘀型非小细胞肺癌(Ⅳ期)的临床疗效。方法：将60例气虚血瘀型非小细胞肺癌(Ⅳ期)患者随机分为对照组与治疗组,每组30例。对照组予吉非替尼+中药安慰剂,治疗组予吉非替尼+扶正抗岩方。两组均服药至肿瘤进展而终止,观察比较近期疗效、远期疗效(无进展生存期)、KPS评分变化及不良反应情况。结果：①试验期间,无病例脱落。②治疗组有效率、肿瘤控制率分别为53.33%、93.33%,对照组相应分别为43.33%、90.00%；组间近期疗效比较,差异无统计学意义(P>0.05)。③组间无进展生存期比较,差异有统计学意义,治疗组明显长于对照组(P<0.05)。④组间治疗后比较,治疗组KPS评分明显高于对照组(P<0.05)。⑤两组不良反应比较,腹泻、恶心或呕吐发生情况等级差异有统计学意义,治疗组明显轻于对照组(P<0.05)。结论：扶正抗岩方联合吉非替尼治疗气虚血瘀型非小细胞肺癌(Ⅳ期),可以明显延长患者的无进展生存期,改善其生活质量,减轻EGFR-TKI药物的不良反应。

Abstract

Objective:To evaluate the clinical efficacy of Fuzheng Kangyan Formula combined with gefitinib on non-small cell lung cancer (NSCLC) (stage IV) of the qi deficiency and blood stasis type. Methods60 patients were randomly assigned into control group and treatment group, 30 patients in each group. The control group was given gefitinib + placebo and the treatment group received gefitinib + Fuzheng Kangyan Formula. Drugs were given until tumor progression. The short- and long-term efficacy (progress-free survival, PFS), changes in KPS score and adverse reactions were observed and compared. Results:①There were no drop-outs during the trial. ②The effective rate and tumor control rate were 53.33% and 93.33% respectively in the treatment group and 43.33% and 90.00% respectively in the control group. There was no statistically significant difference in short-term efficacy between the groups (P>0.05). ③There was statistically significant difference in PFS between the groups, which was longer in the treatment group than in the control group (P<0.05). ④After treatment, the KPS score was significantly higher in the treatment group than in the control group (P<0.05). ⑤Severity of adverse reactions including diarrhea, nausea and vomiting was significantly different, which was obviously lower in the treatment group than in the control group (P<0.05).

关键词

非小细胞肺癌气虚血瘀证扶正抗岩方吉非替尼分子靶向药物无进展生存期

Keywords

non-small cell lung cancerqi deficiency and blood stasis syndromeFuzheng Kangyan Formulagefitinibmolecular targeted agentprogress-free survival

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