参芪扶正注射液同步联合放疗治疗老年非小细胞肺癌的临床研究

Clinical study on Shenqifuzheng injection synchronously combined with radiotherapy for non-small cell lung cancer in the elderly

目的通过观察参芪扶正注射液同步联合放疗治疗老年非小细胞肺癌(non-smallcelllurgcancer,NSCLC)的疗效、外周血细胞免疫功能变化和不良反应,探讨有效可行的老年非小细胞肺癌的治疗策略。方法选择经病理确诊、初诊初治,年龄≥70岁的老年NSCLC患者67例,对比观察参芪扶正注射液与放疗同步应用(同步联合治疗组,26例)、单纯放疗(放疗组,23例)以及单纯参芪扶正注射液(参芪扶正注射液治疗组,18例)治疗老年USCLC的疗效、外周血细胞免疫功能变化和不良反应。结果①3组患者在平均年龄、性别构成比例、病理组织细胞类型、疾病分期和karnofsky(KPS)体力评分方面的比较,差异均无显著意义(P>0.05),表明各组间具有可比性;②同步联合治疗组有效率为76.2%,放疗组的有效率为65.2%,参芪扶正注射液治疗组的有效率为16.7%,提示放疗同步联合参芪扶正注射液治疗组的有效率最高,但与单纯放疗组的有效率比较,差异无显著意义(P>0.05),而单纯应用参芪扶正注射液治疗组患者的有效率显著低于其它两组,但病情稳定以上的患者达61.1%,提示不能放疗或不愿放疗的老年NSCLC患者采用参芪扶正注射液单独治疗,也可以有显著的临床受益。单纯放疗组老年NSCLC患者治疗后外周血淋巴细胞CD4/CD8比值以及自然杀伤细胞(NK)阳性细胞百分率均显著减少,而同步联合应用参芪扶正注射液治疗后,患者的相应指标得到显著改善(P<0.05)。执行放疗的两组患者中,未发生4级以上不良反应,单纯放疗组2级或3级急性放射性肺炎和急性放射性食管炎发生的比例偏高,但与同步联合治疗组比较,差异无显著意义(P>0.05);而2级或3级骨髓抑制不良反应在单纯放疗组要显著高于同步联合治疗组(P<0.05),提示参芪扶正注射液对放射性骨髓抑制有显著保护作用。结论参芪扶正注射液同步联合放疗治疗老年NSCLC可使老年NSCLC患者临床明显受益。

Objective Study the Shenqifnzheng injection synchronous combined with radiotherapy for elderly non-small cell lung cancer（NSCLC） , treatment effects, peripheral blood cell immune function and adverse reactions were observed, the purpose was to explore effective and feasi- ble in elder/y patients with non-small cell lung cancer. Methods Pathologically confirmed, newly diagnosed untreated, age greater than or equal to 70-year-old non-small cell lung cancer patients （67 cases） were observed in compared with radiotherapy and Shenqifuzheng injection synchronization ap- plication （synchronous combined treatment group, 26 cases ）, radiotherapy alone （radiotherapy group, 23 cases）, simple Shenqifuzheng Injection （Shenqifuzheng injection group, 18 patients） in treating elderly patients with non-small cell lung cancer. Peripheral blood cell immune function and adverse effects were detected before and after treatment. Results （1） three groups of patients in mean age, gender ratio, pathological cell type, disease stage, and KPS rating comparisons, differences were not statistically significant （ P 〉 0.05 ）, indicated that all groups were comparable ; （2）synchronous combined treatment group was 76.2% effective, radiotherapy group was 65.2% , Shenqifuzheng injection group was 16.7%. Suggesting radiotherapy combined Shenqifuzheng injection in the treat- ment group had the highest efficiency, but the difference was not significant compared with simply radiotherapy group（P 〉 0.05 ）. Shenqifuzheng injection treatment group was significantly lower than the efficiency of the other two groups, but stable rate over 61.1% , suggesting that the elderly non-small cell lung cancer patients can not or not willing to accept radiotherapy treated with Shenqifuzheng in- jection alone can also get significant clinical benefit. Radiotherapy alone group of elderly patients with non-small cell lung cancer whose CD4/CD8 ratio in peripheral blood lymphocytes and the percentage of NK positive cells were significantly reduced after treatment, while the synchronous combined with Shenqifuzheng injection, the corresponding index was significant improved （ P 〈 0.05 ）. In the two groups of radiotherapy, no adverse reactions occurred more than four grade, in radiotherapy alone group （P 〉 0.05 ）. However ,2 or 3 grade acute radiation pneumonia and acute radiation esophagitis oc- curred in a higher rate, but no significant difference compare with the simultaneous combination therapy group, and 2 or 3 grade bone marrow suppression side effec.t in radiotherapy alone group was sig- nificantly higher than the synchronous combined treatment group （ P 〈 0.05 ）. Conclusion Radio- therapy and Shenqifuzheng injection synchronously applicationed in elderly non-small cell lung cancer enable the patients with clinically significant benefit.