加味五参越鞠汤治疗乳腺癌放疗后气阴两虚证的临床研究
发布时间：2018-12-11 12:58
【摘要】：目的:通过客观观察加味五参越鞠汤治疗乳腺癌放疗后气阴两虚证的疗效及其安全性,为临床运用本方提供客观的依据,拓展乳腺癌放疗后气阴两虚证的治疗思路。方法:本课题按照随机分组原则,通过组间以及自身前后比较的方法,把符合纳入标准的60例病人按1:1的比例随机分成两组,即治疗组和对照组各30例。对照组予贞芪扶正胶囊6粒/次,口服,2次/日。治疗组予加味五参越鞠汤150ml/袋,6袋/剂,1袋/次,口服,3次/日。本实验将14天作为一疗程,共进行1疗程。最后就两组患者治疗前后的中医证候及单个症状评分、肿瘤标志物(CEA、CA15-3)、KPS评分及相关安全性指标在组间及组内进行比较,做出评价。结果:1.中医证候评分:两组治疗前后中医证候评分比较,差异具有统计学意义(P0.05),且治疗组优于对照组(P0.05)。组间比较:对于治疗后单个中医症状,五心烦热、口咽干燥、纳呆的组间比较(P0.05),提示治疗组优于对照组。两组对于神疲乏力、胸闷气短、自汗盗汗、眠差症状治疗无明显差异(P0.05)。组内比较:治疗前后实验组对于神疲乏力、胸闷气短、五心烦热、自汗盗汗、口咽干燥、纳呆、眠差等症状的组内比较都提示治疗有效(P0.05);同时组内的前后比较提示对照组对于神疲乏力、胸闷气短、五心烦热、自汗盗汗、眠差有所改善(P0.05),而对于口咽干燥、纳呆症状无改善(P0.05)。2.KPS评分:治疗前后各组组内的KPS评分比较均存在统计学差异(P0.05),而治疗后两组组间比较并无明显统计学差异(P0.05)。两组都可以提高患者的生活质量。3.肿瘤标记物:对于肿瘤标记物(CEA、CA15-3),治疗前后各组组内比较均无统计学差异(P0.05)。而治疗后两组组间比较也无统计学差异(P0.05)。提示在短期内两组均无明显降低相关肿瘤标志物的疗效。4.安全性指标:所有患者于观察期间都没有出现不良反应。通过统计学分析,在血常规(RBC、WBC、PLT)、肝功能(ALT、AST)以及肾功能(Cr、UREA)等相关安全性指标方面,两组患者在治疗前后无论是组内还是组间比较均无统计学差异(P0.05),证明两组在治疗乳腺癌放疗后气阴两虚证均安全。结论:加味五参越鞠汤可以有效改善乳腺癌放疗后气阴两虚证患者的相关症状,且其疗效优于贞芪扶正胶囊,并且能提高患者的生活质量,但对于肿瘤标记物(CEA、CA15-3)短期内尚无明显疗效;且加味五参越鞠汤在治疗过程中是安全可靠的。
[Abstract]:Objective: to observe the efficacy and safety of modified Wushen Yueju decoction in the treatment of Qi and Yin deficiency syndrome after radiotherapy for breast cancer, to provide objective basis for clinical application and to expand the treatment ideas of Qi and Yin deficiency syndrome after radiotherapy for breast cancer. Methods: according to the principle of random grouping, 60 patients who met the inclusion criteria were randomly divided into two groups, 30 cases in the treatment group and 30 cases in the control group, according to the principle of random grouping. The control group was given 6 capsules of Zhenqi Fuzheng capsule once a day. The treatment group was treated with modified Wushenyueju decoction 150ml/ bag, 6 bags / dose, 1 bag / time, oral, 3 times a day. In this experiment, 14 days as a course of treatment, a total of one course of treatment. Finally, the TCM syndromes and single symptom scores, tumor markers (CEA,CA15-3), KPS scores and related safety indexes) before and after treatment were compared and evaluated between the two groups. Results: 1. TCM syndrome score: the two groups before and after treatment of TCM syndrome score comparison, the difference was statistically significant (P0.05), and the treatment group was better than the control group (P0.05). Comparison between groups: for a single TCM symptoms after treatment, five upset heat, dry oropharynx, and the comparison between the groups (P0.05), suggesting that the treatment group is better than the control group. There was no significant difference between the two groups in the treatment of fatigue, chest tightness and shortness of breath, spontaneous sweating and night sweating and poor sleep symptoms (P0.05). Comparison within the group: before and after treatment, the experimental group for the symptoms of fatigue, chest tightness and shortness of breath, five upset heat, sweating and sweating, dryness of the mouth and pharynx, insufferance, sleep loss and other symptoms of the group indicated that the treatment was effective (P0.05); At the same time, the comparison before and after in the control group indicated that the control group had improved in terms of fatigue, shortness of breath and chest tightness, five upset heat, self-sweating and night sweating, and poor sleep (P0.05), while for the dry oropharynx, there was no significant difference between the two groups. 2.KPS score: before and after treatment, there were significant differences in KPS scores between the groups (P0.05), but there was no significant difference between the two groups after treatment (P0.05). Both groups could improve the patient's quality of life. Tumor markers: for tumor markers (CEA,CA15-3), there was no statistical difference between the groups before and after treatment (P0.05). After treatment, there was no statistical difference between the two groups (P0.05). The results suggested that there was no significant decrease in the efficacy of tumor markers in both groups in a short period of time. 4. 4. Safety measures: no adverse reactions occurred in all patients during the observation period. In terms of blood routine (RBC,WBC,PLT), liver function (ALT,AST) and renal function (Cr,UREA), There was no statistical difference between the two groups before and after treatment (P0.05), which proved that both Qi and Yin deficiency syndrome were safe in the treatment of breast cancer after radiotherapy. Conclusion: modified Wushen Yueju decoction can effectively improve the symptoms of patients with deficiency of Qi and Yin after radiotherapy of breast cancer, and its curative effect is better than Zhenqi Fuzheng capsule, and can improve the quality of life of patients, but it can improve the tumor marker (CEA,). There was no obvious effect of CA15-3 in the short term. The modified Wushen Yueju decoction is safe and reliable in the course of treatment.
【学位授予单位】：云南中医学院
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R273
本文编号：2372592
[Abstract]:Objective: to observe the efficacy and safety of modified Wushen Yueju decoction in the treatment of Qi and Yin deficiency syndrome after radiotherapy for breast cancer, to provide objective basis for clinical application and to expand the treatment ideas of Qi and Yin deficiency syndrome after radiotherapy for breast cancer. Methods: according to the principle of random grouping, 60 patients who met the inclusion criteria were randomly divided into two groups, 30 cases in the treatment group and 30 cases in the control group, according to the principle of random grouping. The control group was given 6 capsules of Zhenqi Fuzheng capsule once a day. The treatment group was treated with modified Wushenyueju decoction 150ml/ bag, 6 bags / dose, 1 bag / time, oral, 3 times a day. In this experiment, 14 days as a course of treatment, a total of one course of treatment. Finally, the TCM syndromes and single symptom scores, tumor markers (CEA,CA15-3), KPS scores and related safety indexes) before and after treatment were compared and evaluated between the two groups. Results: 1. TCM syndrome score: the two groups before and after treatment of TCM syndrome score comparison, the difference was statistically significant (P0.05), and the treatment group was better than the control group (P0.05). Comparison between groups: for a single TCM symptoms after treatment, five upset heat, dry oropharynx, and the comparison between the groups (P0.05), suggesting that the treatment group is better than the control group. There was no significant difference between the two groups in the treatment of fatigue, chest tightness and shortness of breath, spontaneous sweating and night sweating and poor sleep symptoms (P0.05). Comparison within the group: before and after treatment, the experimental group for the symptoms of fatigue, chest tightness and shortness of breath, five upset heat, sweating and sweating, dryness of the mouth and pharynx, insufferance, sleep loss and other symptoms of the group indicated that the treatment was effective (P0.05); At the same time, the comparison before and after in the control group indicated that the control group had improved in terms of fatigue, shortness of breath and chest tightness, five upset heat, self-sweating and night sweating, and poor sleep (P0.05), while for the dry oropharynx, there was no significant difference between the two groups. 2.KPS score: before and after treatment, there were significant differences in KPS scores between the groups (P0.05), but there was no significant difference between the two groups after treatment (P0.05). Both groups could improve the patient's quality of life. Tumor markers: for tumor markers (CEA,CA15-3), there was no statistical difference between the groups before and after treatment (P0.05). After treatment, there was no statistical difference between the two groups (P0.05). The results suggested that there was no significant decrease in the efficacy of tumor markers in both groups in a short period of time. 4. 4. Safety measures: no adverse reactions occurred in all patients during the observation period. In terms of blood routine (RBC,WBC,PLT), liver function (ALT,AST) and renal function (Cr,UREA), There was no statistical difference between the two groups before and after treatment (P0.05), which proved that both Qi and Yin deficiency syndrome were safe in the treatment of breast cancer after radiotherapy. Conclusion: modified Wushen Yueju decoction can effectively improve the symptoms of patients with deficiency of Qi and Yin after radiotherapy of breast cancer, and its curative effect is better than Zhenqi Fuzheng capsule, and can improve the quality of life of patients, but it can improve the tumor marker (CEA,). There was no obvious effect of CA15-3 in the short term. The modified Wushen Yueju decoction is safe and reliable in the course of treatment.
【学位授予单位】：云南中医学院
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R273
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