消癌解毒方联合DCF方案治疗进展期胃癌
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摘要
目的:探讨消癌解毒方联合DCF方案治疗进展期胃癌的临床疗效。方法:将65例进展期胃癌患者按随机数字表法分为两组。对照组32例予以单一DCF方案治疗,观察组33例给予DCF方案+消癌解毒方治疗,观察比较两组客观病灶疗效、中医证候疗效及T淋巴细胞亚群(CD_4~+、CD_8~+、CD_3~+)、自然杀伤细胞(natural killer cell,NK)活性变化情况,并统计两组不良反应发生情况及社会、情绪、角色及躯体、认知各功能生存质量评分。结果:观察组缓解率为66.67%,对照组为65.63%,两组比较,差异无统计学意义(P>0.05);观察组中医证候有效率为87.88%,高于对照组59.38%,差异具有统计学意义(P<0.05);观察组治疗6周后CD_4~+、CD_3~+、NK活性均优于对照组,差异具有统计学意义(P<0.05);观察组不良反应发生率为18.18%,对照组为15.63%,两组比较,差异无统计学意义(P>0.05);治疗6周后观察组社会、情绪、角色及躯体、认知各功能评分均高于对照组,差异具有统计学意义(P<0.05)。结论:消癌解毒方联合DCF方案治疗进展期胃癌效果显著,安全性高,可改善T淋巴细胞亚群及NK活性,提高患者生命质量。
Objective:To investigate the clinical effects of Xiaoai Jiedu Decoction combined with DCF regimen in the treatment of advanced gastric cancer.Methods:Sixty-five patients with advanced gastric cancer were randomly divided into two groups according to the random number table method.32 patients in the control group were treated with a single DCF regimen,and 33 patients in the observation group were treated with DCF regimen+Xiaoai Jiedu Decoction.The effects of objective lesions,TCM syndromes and T lymphocyte subsets(CD_4~+,CD_8~+,CD_3~+) were compared.The changes of natural killer cell(NK) activity,and the incidence of adverse reactions and social,emotional,role and physical and life quality scores of the two groups were counted.Results:The remission rate was 66.67% in the observation group and 65.63% in the control group.There was no significant difference between the two groups(P>0.05).The effective rate of TCM syndrome treatment in the observation group was 87.88%,which was higher than that of the control group(59.38%).The difference was statistically significant(P<0.05).The activity of CD_4~+,CD_3~+ and NK in the observation group was higher than that in the control group after 6 weeks of treatment.The difference was statistically significant(P<0.05).The incidence of adverse reactions in the observation group was 18.18%.The control group was 15.63%.There was no significant difference between the two groups(P>0.05).After 6 weeks of treatment,the social,emotional,role,physical and cognitive scores of the observation group were higher than the control group,and the difference was statistically significant(P<0.05).Conclusion:Xiaoke Jiedu Decoction combined with DCF regimen has significant effect on advanced gastric cancer,and it has high safety.It can improve T lymphocyte subsets and NK activity and improve patients′ quality of life.
Objective:To investigate the clinical effects of Xiaoai Jiedu Decoction combined with DCF regimen in the treatment of advanced gastric cancer.Methods:Sixty-five patients with advanced gastric cancer were randomly divided into two groups according to the random number table method.32 patients in the control group were treated with a single DCF regimen,and 33 patients in the observation group were treated with DCF regimen+Xiaoai Jiedu Decoction.The effects of objective lesions,TCM syndromes and T lymphocyte subsets(CD_4~+,CD_8~+,CD_3~+) were compared.The changes of natural killer cell(NK) activity,and the incidence of adverse reactions and social,emotional,role and physical and life quality scores of the two groups were counted.Results:The remission rate was 66.67% in the observation group and 65.63% in the control group.There was no significant difference between the two groups(P>0.05).The effective rate of TCM syndrome treatment in the observation group was 87.88%,which was higher than that of the control group(59.38%).The difference was statistically significant(P<0.05).The activity of CD_4~+,CD_3~+ and NK in the observation group was higher than that in the control group after 6 weeks of treatment.The difference was statistically significant(P<0.05).The incidence of adverse reactions in the observation group was 18.18%.The control group was 15.63%.There was no significant difference between the two groups(P>0.05).After 6 weeks of treatment,the social,emotional,role,physical and cognitive scores of the observation group were higher than the control group,and the difference was statistically significant(P<0.05).Conclusion:Xiaoke Jiedu Decoction combined with DCF regimen has significant effect on advanced gastric cancer,and it has high safety.It can improve T lymphocyte subsets and NK activity and improve patients′ quality of life.
引文
[1]LORDICK F,KANG Y K,CHUNG H C,et al.Capecitabine and cisplatin with or without cetuximab for patients with previously untreated advanced gastric cancer (EXPAND):a randomised,open-label phase 3 trial[J].Lancet Oncology,2013,14(6):490-499.
[2]王志兵,嵇冰,陈建华,等.替吉奥胶囊联合奥沙利铂化疗对进展期胃癌根治术患者的影响[J].中国医药导报,2015,12(17):109-112.
[3]李大成,熊亚军.扶正抗癌方联合mFOLFOX4化疗方案治疗进展期胃癌临床研究[J].中医学报,2016,31(9):1253-1257.
[4]中华人民共和国卫生部医政司.中国常见恶性肿瘤诊治规范[M].北京:北京医科大学、中国协和医科大学联合出版社,1991.
[5]郑筱萸.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002:361-390.
[6]SATOH T,XU R H,CHUNG H C,et al.Lapatinib plus paclitaxel versus paclitaxel alone in the second-line treatment of HER2-amplified advanced gastric cancer in Asian populations:TyTAN-α randomized,phase Ⅲ study[J].J Clinical Oncology,2014,32(19):2039-2049.
[7]OHTSU A,AJANI J A,BAI Y X,et al.Everolimus for previously treated advanced gastric cancer:results of the randomized,double-blind,phase Ⅲ GRANITE-1 study[J].J Clinical Oncology,2013,31(31):3935-3943.
[8]方锦舒,王祥,朱宝龙.培土固本方对进展期胃癌患者术后生存质量的影响[J].中医学报,2016,31(9):1258-1261.
[9]HIRONAKA S,UEDA S,YASUI H,et al.Randomized,open-label,phase Ⅲ study comparing irinotecan with paclitaxel in patients with advanced gastric cancer without severe peritoneal metastasis after failure of prior combination chemotherapy using fluoropyrimidine plus platinum:WJOG 4007 trial[J].J Clinical Oncology,2013,31(35):4438-4444.
[10]梁云,梁振杰,李思文.OLF方案与DCF方案在基层医院治疗晚期胃癌疗效比较[J].实用医学杂志,2016,32(24):4070-4072.
[11]KANG Y K,RHA S Y,TASSONE P,et al.A phase Ⅱa dose-finding and safety study of first-line pertuzumab in combination with trastuzumab,capecitabine and cisplatin in patients with HER2-positive advanced gastric cancer[J].British J Cancer,2014,111(4):660-666.
[12]欧畅,唐志宇,宋益青,等.DCF化疗方案联合复方苦参、艾迪注射液治疗进展期胃癌临床观察[J].中国中医急症,2016,25(8):1606-1607.
[13]HONG M,KIM W S,KO Y H.Indolent CD56-positive clonal T-cell lymphoproliferative disease of the stomach mimicking lymphomatoid gastropathy[J].Korean journal of pathology,2014,48(6):430.
[14]许钟,曹辉,黄国美,等.参芪扶正注射液辅助DCF方案治疗进展期胃癌的Meta分析[J].山东医药,2014,54(41):45-47.
[15]椰慧楠,秦宝丽,宿朦,等.DOF方案与DCF方案对进展期胃癌患者近期疗效及毒副反应对比研究[J].现代中西医结合杂志,2015,24(9):964-966.
[16]杨世荣,赵成茂,王嵘,等.益气健脾解毒方联合西医治疗晚期胃癌的临床分析[J].现代中西医结合杂志,2015,24(36):4061-4063.
[17]林琪,陈明聪,徐雪明,等.XELOX方案联合消癌平注射液治疗进展期胃癌疗效观察[J].中国中西医结合消化杂志,2015,23(6):435-437.
[18]郭海,赵晓峰,吉福志,等.周仲瑛教授消癌解毒方治疗消化系统肿瘤机制[J].吉林中医药,2016,36(7):671-673.
[2]王志兵,嵇冰,陈建华,等.替吉奥胶囊联合奥沙利铂化疗对进展期胃癌根治术患者的影响[J].中国医药导报,2015,12(17):109-112.
[3]李大成,熊亚军.扶正抗癌方联合mFOLFOX4化疗方案治疗进展期胃癌临床研究[J].中医学报,2016,31(9):1253-1257.
[4]中华人民共和国卫生部医政司.中国常见恶性肿瘤诊治规范[M].北京:北京医科大学、中国协和医科大学联合出版社,1991.
[5]郑筱萸.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002:361-390.
[6]SATOH T,XU R H,CHUNG H C,et al.Lapatinib plus paclitaxel versus paclitaxel alone in the second-line treatment of HER2-amplified advanced gastric cancer in Asian populations:TyTAN-α randomized,phase Ⅲ study[J].J Clinical Oncology,2014,32(19):2039-2049.
[7]OHTSU A,AJANI J A,BAI Y X,et al.Everolimus for previously treated advanced gastric cancer:results of the randomized,double-blind,phase Ⅲ GRANITE-1 study[J].J Clinical Oncology,2013,31(31):3935-3943.
[8]方锦舒,王祥,朱宝龙.培土固本方对进展期胃癌患者术后生存质量的影响[J].中医学报,2016,31(9):1258-1261.
[9]HIRONAKA S,UEDA S,YASUI H,et al.Randomized,open-label,phase Ⅲ study comparing irinotecan with paclitaxel in patients with advanced gastric cancer without severe peritoneal metastasis after failure of prior combination chemotherapy using fluoropyrimidine plus platinum:WJOG 4007 trial[J].J Clinical Oncology,2013,31(35):4438-4444.
[10]梁云,梁振杰,李思文.OLF方案与DCF方案在基层医院治疗晚期胃癌疗效比较[J].实用医学杂志,2016,32(24):4070-4072.
[11]KANG Y K,RHA S Y,TASSONE P,et al.A phase Ⅱa dose-finding and safety study of first-line pertuzumab in combination with trastuzumab,capecitabine and cisplatin in patients with HER2-positive advanced gastric cancer[J].British J Cancer,2014,111(4):660-666.
[12]欧畅,唐志宇,宋益青,等.DCF化疗方案联合复方苦参、艾迪注射液治疗进展期胃癌临床观察[J].中国中医急症,2016,25(8):1606-1607.
[13]HONG M,KIM W S,KO Y H.Indolent CD56-positive clonal T-cell lymphoproliferative disease of the stomach mimicking lymphomatoid gastropathy[J].Korean journal of pathology,2014,48(6):430.
[14]许钟,曹辉,黄国美,等.参芪扶正注射液辅助DCF方案治疗进展期胃癌的Meta分析[J].山东医药,2014,54(41):45-47.
[15]椰慧楠,秦宝丽,宿朦,等.DOF方案与DCF方案对进展期胃癌患者近期疗效及毒副反应对比研究[J].现代中西医结合杂志,2015,24(9):964-966.
[16]杨世荣,赵成茂,王嵘,等.益气健脾解毒方联合西医治疗晚期胃癌的临床分析[J].现代中西医结合杂志,2015,24(36):4061-4063.
[17]林琪,陈明聪,徐雪明,等.XELOX方案联合消癌平注射液治疗进展期胃癌疗效观察[J].中国中西医结合消化杂志,2015,23(6):435-437.
[18]郭海,赵晓峰,吉福志,等.周仲瑛教授消癌解毒方治疗消化系统肿瘤机制[J].吉林中医药,2016,36(7):671-673.