温肺化饮法治疗非小细胞肺癌恶性胸腔积液

Study of Warming Lung to Reduce Watery Phlegm as Treatment for Non-small Cell Lung Cancer with Malignant Pleural Effusion

目的:观察温肺化饮法治疗非小细胞肺癌(NSCLC)恶性胸腔积液(MPE)的临床疗效。方法:63例NSCLC合并MPE患者,随机分为试验组和治疗组,试验组36例,对照组27例。试验组给予温肺化饮法中药联合顺铂(DDP)胸腔灌注治疗,对照组给予单纯DDP胸腔灌注治疗,首要观察指标治疗两组MPE的控制率(DSR),次要观察指标包括Karnofsky评分(KPS),临床证候疗效,毒副反应,中位生存期(MST)。结果:全部63例随机患者参与评价。首要观察指标MPE的DSR试验组是94.44%(34例),对照组77.78%(21例),具有统计学差异(P<0.05)。次要观察指标,两组患者KPS评分、临床证候疗效,试验组均优于对照组,毒副反应均不明显。MST试验组是11.0月相比对照组是7.5月[HR=0.21,95%CI(0.12,0.37),P<0.05]。结论:温肺化饮法联合DDP胸腔灌注可有效治疗NSCLC合并MPE。

Objective： This clinical study aimed to evaluate the efficacy of the therapy of warming the lung to reduce watery phlegm for treating non-small cell lung cancer（NSCLC） with malignant pleural effusion（MPE）. Method： In this study,63 NSCLC patients with MPE were randomly divided into test group and control group,with 36 patients in test group and 27 patients in control group. The test group received the Chinese medicine therapy of warming the lung to reduce watery phlegm combined with chemotherapy with cisplatin treatment through pleural effusion. The control group received single chemotherapy with cisplatin treatment through pleural effusion.The primary observation index was disease stabilization rate（DSR） of MPE,the secondary observation indexes included karnofsky（KPS）,traditional symptoms,toxicities and median survival time（MST）. Result： We evaluated all the 63 patients. The DSR of MPE was 94. 44%（34 patients） in the test group and 77. 78%（21patients） in the control group（P〈0. 05）. Compared to the control were,the KPS and traditional symptoms were both better. No unexpected toxicities were observed. The MST was 11. 0 months in the test group and 7. 5 months in the control group（hazard ratio [HR = 0. 21,95% CI（0. 12,0. 37）,P〈0. 05]. Conclusion： The Chinese medicine therapy of warming the lung to reduce watery phlegm combined with chemotherapy with cisplatin treatment through pleural effusion is effective to NSCLC with MPE.