抗瘤丸结合西医常规疗法治疗恶性神经胶质瘤临床研究

Clinical study on Kangliu Pill combined with conventional therapy in the treatment of malignant gliomas

目的评价抗瘤丸结合西医常规疗法治疗恶性神经胶质瘤术后患者的疗效。方法将符合入选标准的2017年1月-2019年11月行恶性神经胶质瘤(Ⅲ~Ⅳ级)手术切除患者100例,按治疗方法分为治疗组48例、对照组52例,对照组采用常规手术加放化疗治疗,治疗组在对照组基础上加服抗瘤丸。随访1~2年,记录患者生存率、无进展生存期、中位生存期,采用Karnofsky功能状态评分(KPS)、生活质量评分(QOL)评价患者生存及生活质量,观察治疗期间的不良反应。结果治疗组1年、2年生存率[97.92%(47/48)、68.75%(33/48)]高于对照组[80.77%(42/52)、42.31%(22/52)](χ^(2)值分别5.847、7.051,P值分别为0.016、0.008);治疗组无进展生存期[(23.94±13.12)个月比(15.82±8.65)个月,t=3.63]高于对照组(P<0.01);采用寿命表法进行生存分析,得到治疗组中位生存期为21.13个月,对照组中位生存期为12.00个月,2组中位生存期、累计生存率比较差异均具有统计学意义(P=0.001);治疗组KPS、QOL评分均高于对照组,但组间比较差异均无统计学意义(P>0.05)。2组治疗期间均未发生严重不良反应。结论抗瘤丸辅助治疗可提高恶性神经胶质瘤术后患者生存率,延长无进展生存期、中位生存期,改善生活质量,提高疗效,且安全性较好。

Objective To evaluate the clinical efficacy of the Chinese herbal medicine compound Kangliu Pill combined with conventional Western medicine therapy in the treatment of patients with malignant glioma after surgery.Methods A total of 100 patients with malignant glioma(gradeⅢ-Ⅳ),who met the inclusion criteria and underwent surgery from January 2017 to November 2019,were divided into the treatment group of 48 patients and the control group of 52,according to the treatment method.The control group was treated with conventional surgery plus radiotherapy,and the treatment group was treated with Kangliu Pill on the basis of the control group.The patients were followed up for 1 to 2 years,and the survival rate,progression-free survival and median survival were recorded.The Karnofsky functional status score(KPS)and quality of life score(QOL)were used to evaluate the patients'survival and quality of life,and the adverse reactions during the treatment period were observed.Results After treatment,the 1-year survival rates[97.92%(47/48)vs.80.77%(42/52);χ^(2)=5.847,P=0.016]and 2-year survival rates[89.47%(33/48)vs.42.31%(22/52);χ^(2)=7.051,P=0.008]in the treatment group were significantly higher than those in the control group.After treatment,the progression-free survival[(23.94±13.12)months vs.(15.82±8.65)months;t=3.63,P<0.01]in the treatment group was significantly higher than that of the control group.After treatment,the survival analysis using the life table method yielded a median survival of 21.13 months in the treatment group and 12.00 months in the control group,with statistically significant differences in median survival and cumulative survival rates between two groups(P=0.001).The KPS and QOL scores in the treatment group were higher than those in the control group,but the differences between the groups were not statistically significant(P>0.05).There was no serious adverse events occurred during the treatment period in both groups.Conclusion Adjuvant therapy with Kangliu Pill can improve survival rate,prolong progression-free survival,median survival,improve quality of life,and enhance the efficacy of patients with malignant glioma after surgery.