| ObjectivesTo study the syndrome-classification's influence of AI treating patients with breast cancer in Gongguqi, in order to offer the clinical evidence for the therapy with syndrome differentiation of Chinese medicine entering AI treatment stage. To exploratory study the inhibitory action and the mechanism of action which possibly existed in Chinese medicine treatment of breast cancer AIBL, and to provide the basis for the futhur study of the therapy, medication, and efficacy evaluation of Chinese medicine in controlling breast cancer AIBL.Methods1 Subgroup analyse the clinical research which classify syndrome of breast cancer patients in Gongguqi by means of clustering analysis. To compare the differences of the type of syndrome between team HR(+) and team HR(-), and between team AI and team SERM.224 women with breast cancer treated with non-steroidal AI<3 months were selected in the study. They were required to have evidence of low bone loss, excluding osteoporosis. All patients were nonrandomly assigned to treatment group (12 cases, take non-steroidal AI and Chinese medicine orally) and control group (12 cases, take non-steroidal orally). The changes of clinical synptoms and auxiliary examination results were observed between pretreatment and post-treatment.Result1 Part one, Subgroup analysis of the clinical research which classify syndrome of breast cancer patients in Gongguqi. 1.1 Subgroup analysis between HR(+) and HR(-)The syndrome distribution of team HR(+) was different from team HR(-) significantly (P<0.05), but both of them had the highest proportion of impairment of liver and kidney, team HR(+) had 39.8%and team HR(-) had 39.3%. The distribution of sick without symptoms in these two teams had a significant difference (P<0.05), it had a higher proportion in team HR(-) than in team HR(+).1.2 Subgroup analysis between AI and SERMIn cases of HR(+), there was no significance between the syndrome distribution of team AI and team HR(-) by statistics evaluation(P>0.05), but both of them had the highest proportion of impairment of liver and kidney. The propotion of nephrasthenia syndrome in the three groups was, team AI (66.6%) >team SERM(63.6%)>team HR(-) (62.7%), it had no significant difference(P >0.05).2 Part two, The clinical influence's research of Chinese medicine treating patients with AI therapy.2.1 Changes of bone metabolism makers2.1.1 Bone formation makers PINPComparison between treatment group and control group had no significant difference (P>0.05), but the mean of PINP was less than baseline in both groups after experiment, and the decline in treatment group was less than in control group.2.1.2 Bone resorption makersβ-CtxComparison between treatment group and control group had no significant difference (P>0.05), but the mean ofβ-Ctx was higher after experiment in both groups after experiment, and treatment group increased less than control group.2.2 Changes of sex hormone levelsComparison between treatment group and control group had no significant difference (P>0.05), but compare with the E2 level of the baseline, treatment group increased slightly, while control group decreased slightly.2.3 Changes in the quality of life2.3.1 JOA lumbodorsal pain scoring systemComparison between treatment group and control group, skelalgia in control group was significant worse than in treatment group (P<0.05). The improvement index had significance, treatment group was higher than control group (P< 0.05). The improvement rate had no significance (P>0.05), but the decline in treatment group was less than in control group.In control group, lumbodorsal pain, gait and symptom score significantly decreased from the baseline (P<0.05).2.3.2 Kupermann index after reformationComparison between treatment group and control group had no significant difference, but the increase of the symptom score of treatment group is less than control group (P>0.05).In treatment group, insomnia, symptom of urinary system, lassitude all significant lighten than the baseline (P<0.05); temperament was more serious than the baseline (P<0.05).In control group, the differences of hectic fever and sweat, temperament, pain of joints and muscle, symptom score of pretreatment and post-treatment were all significance, pretreatment was better than post-treatment (P<0.05).2.4 Changes of treatment safety indexComparison of liver and kidney function index between treatment group and control group had no significant difference (P>0.05), both groups had no edverse effect reported during trial period.Conclusion1 Breast cancer patients with different expressions of hormone receptor in Gongguqi have different distributions of syndrome, using of the adjuvant hormonal therapy maybe one of the main influential factor. The propotion of nephrasthenia syndrome in patients under AI therapy was higher than HR(-) (people who didn't take the adjuvant hormonal therapy), which pointed invigorate the kidney maybe one of the important ways of controlling AIBL of breast cancer.2 Chinese medicine may help promoting bone formation and restraining bone resorption.3 The possible mechanism of Chinese medicine in controlling breast cancer AIBL was to affecting bone metabolism, by the way of up-scaling the E2 level.4 Chinese medicine may help to make joint symptoms better and to improve loin and legs function. 5 Chinese medicine may help control aromatase inhibitors-associated endocrine disturbance of post-menopause.6 Clinical use of Chinese medicine was safe.7 Whether Chinese medicine would speed the recurrence and metastasis of breast cancer by means of increasing the E2's level, was pending further study.
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