| [Aims]The research aims at assessing the effects of "Wenyang Yiqi Fang" on breast cancer patients’ quality of life, the side effects of the third generation aromatase inhibitors, TCM symptoms and estrogen, blood lipid, body mass index, clearing the effectiveness of Wenyang Yiqi Fang" on improvement of quality of life, reducing the side reactions of the third generation aromatase inhibitors, improvement of TCM symptoms, estrogen, blood lipid, body mass index in breast cancer patients with Yang deficiency type, providing data support for the treatment of breast cancer and the clinical application of "Wenyang Yiqi Fang", making an objective evaluation of the efficacy of traditional Chinese medicine in the prevention and treatment of breast cancer.[Methods]This research used a prospective, randomized, double-blind, placebo-controlled clinical study. The patients should complete enrollment examination, including blood, liver and kidney function, estrogen, blood lipid. then patients would recive the distributed drugs. During the 90 days of observation, recording the SF-36, FACT-B, the side effects of the third generation aromatase inhibitors, TCM symptom score and body mass index at the beginning,14th,30th, 60th,90th day,and estrogen, blood lipid at the 30th,60th day. Patients should complete the examination after the treatment, and would gain 30 days of "Wenyang Yiqi Fang" particles according to their wishes. Then researchers entered and locked all case data, the setted blind method organization staff and the project responsible person expose the results. Then researchers used SPSS 21 statistical software for data analysis, finaly evaluated the clinical efficacy and safety of "Wenyang Yiqi Fang".[Results]In this study, we selected 60 patients who met the inclusion criteria from December 2014 to November 2015 in the Dongfang Hospital of BUCM. Due to adverse reactions to terminate 2 cases,1 cases of automatic withdrawal,57 cases completed the 90 days of clinical observation, including the experimental group of 28 cases, the control group of 29 cases. There was no difference between the two groups in the age, pathology, breast cancer stage, endocrine therapy drug distribution and course, blood, liver and kidney function, blood lipids, estrogen, body mass index, P<0.05. The two groups were comparable, the results were as follows:1 Quality of life. The SF-36 table, in the exclusion of the floor and ceiling effect, compared with the control group, "Wenyang Yiqi Fang" had an advantage in general health (GH), physiological function (PF), vitality (VT), social function (SF) and mental health (MH) by the non parametric test(P< 0.05). The control group had an advantage in bodily pain (BP) and vitality (VT) with statistical differences. The FACT-B table, The experimental group had higher scores than before in the social/family, function, physiological, emotional and additional attention state(P< 0.05), the control group had higher scores than before in additional attention (P< 0.05), but there was no difference in the scores of additional attention between two groups after treatment. The test group had an advantage of treatment in general, especially in the social/family, functional, physiological, emotional state.2 The side effects of the third generation aromatase inhibitors. The total effective rate of the experimental group after treatment was 57.14%, and the control group was 20.69%, P<0.05. The test group improved in hot flushes, sweating and insomnia after treatment(P<0.05), while the improvement of the control group was not obvious (P>0.05).3 Symptoms of TCM. The clinical total effective rate was 78.57% and 65.52% in the experimental group and control group, P<0.05. The test group was significantly improved in weakness, urine clear long, thin stool, insomnia, sweating (P<0.05), The control group improved in the urine clear long, thin stool (P<0.05). But there was no difference bewteen the two groups in urine clear long and thin stool after treatment.4 Blood lipid, estrogen and body mass index. The experimental group had 24 cases with complete data before and after the treament, while 20 cases in the control group, both group had complete body mass index. But they both had no significant difference before and after treatment (P>0.05).5 Security. Adverse reactions,2 patients in the experimental group had adverse reactions,it may be related to the "Wenyang Yiqi Fang", but the statistical results were not significant (P> 0.05). Laboratory indexes, the test group had 2 cases,1 case and 0 case in blood routine, liver function, renal function, while the control group had 1 case,0 case and 0 case(P>0.05).[Conclusions]1 "Wenyang Yiqi Fang" can improve the quality of life of patients with endocrine therapy after breast cancer operation;2 "Wenyang Yiqi Fang" can reduce the hectic fever, sweating, insomnia and other adverse reactions caused by the third generation aromatase inhibition. The total clinical efficiency is 57.14%;3 "Wenyang Yiqi Fang" can improve TCM symptoms, such as less fatigue, sweating, urine clear long, loose stools thin and insomnia, in patients with endocrine therapy after breast cancer operation, whom with Yang deficiency type, the overall efficiency is 78.57%;4 "Wenyang Yiqi Fang" can stabilize the blood lipid, estrogen and body mass index in patients with breast cancer after operation;5 "Wenyang Yiqi Fang" has a certain clinical security. |
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