【摘要】：目的:通過客觀觀察加味五參越鞠湯治療乳腺癌放療后氣陰兩虛證的療效及其安全性,為臨床運用本方提供客觀的依據(jù),拓展乳腺癌放療后氣陰兩虛證的治療思路。方法:本課題按照隨機分組原則,通過組間以及自身前后比較的方法,把符合納入標(biāo)準(zhǔn)的60例病人按1:1的比例隨機分成兩組,即治療組和對照組各30例。對照組予貞芪扶正膠囊6粒/次,口服,2次/日。治療組予加味五參越鞠湯150ml/袋,6袋/劑,1袋/次,口服,3次/日。本實驗將14天作為一療程,共進行1療程。最后就兩組患者治療前后的中醫(yī)證候及單個癥狀評分、腫瘤標(biāo)志物(CEA、CA15-3)、KPS評分及相關(guān)安全性指標(biāo)在組間及組內(nèi)進行比較,做出評價。結(jié)果:1.中醫(yī)證候評分:兩組治療前后中醫(yī)證候評分比較,差異具有統(tǒng)計學(xué)意義(P0.05),且治療組優(yōu)于對照組(P0.05)。組間比較:對于治療后單個中醫(yī)癥狀,五心煩熱、口咽干燥、納呆的組間比較(P0.05),提示治療組優(yōu)于對照組。兩組對于神疲乏力、胸悶氣短、自汗盜汗、眠差癥狀治療無明顯差異(P0.05)。組內(nèi)比較:治療前后實驗組對于神疲乏力、胸悶氣短、五心煩熱、自汗盜汗、口咽干燥、納呆、眠差等癥狀的組內(nèi)比較都提示治療有效(P0.05);同時組內(nèi)的前后比較提示對照組對于神疲乏力、胸悶氣短、五心煩熱、自汗盜汗、眠差有所改善(P0.05),而對于口咽干燥、納呆癥狀無改善(P0.05)。2.KPS評分:治療前后各組組內(nèi)的KPS評分比較均存在統(tǒng)計學(xué)差異(P0.05),而治療后兩組組間比較并無明顯統(tǒng)計學(xué)差異(P0.05)。兩組都可以提高患者的生活質(zhì)量。3.腫瘤標(biāo)記物:對于腫瘤標(biāo)記物(CEA、CA15-3),治療前后各組組內(nèi)比較均無統(tǒng)計學(xué)差異(P0.05)。而治療后兩組組間比較也無統(tǒng)計學(xué)差異(P0.05)。提示在短期內(nèi)兩組均無明顯降低相關(guān)腫瘤標(biāo)志物的療效。4.安全性指標(biāo):所有患者于觀察期間都沒有出現(xiàn)不良反應(yīng)。通過統(tǒng)計學(xué)分析,在血常規(guī)(RBC、WBC、PLT)、肝功能(ALT、AST)以及腎功能(Cr、UREA)等相關(guān)安全性指標(biāo)方面,兩組患者在治療前后無論是組內(nèi)還是組間比較均無統(tǒng)計學(xué)差異(P0.05),證明兩組在治療乳腺癌放療后氣陰兩虛證均安全。結(jié)論:加味五參越鞠湯可以有效改善乳腺癌放療后氣陰兩虛證患者的相關(guān)癥狀,且其療效優(yōu)于貞芪扶正膠囊,并且能提高患者的生活質(zhì)量,但對于腫瘤標(biāo)記物(CEA、CA15-3)短期內(nèi)尚無明顯療效;且加味五參越鞠湯在治療過程中是安全可靠的。
[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.
【學(xué)位授予單位】：云南中醫(yī)學(xué)院
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R273

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