中国骨质疏松杂志

补肾壮骨方防治芳香化酶抑制剂引起的骨代谢异常的临床研究

Clinical study on the prevention and treatment of aromatase inhibitor-associated bone metabolic disorder with nourishing kidney and strong bone prescription in women with breast cancer

DOI：10.3969/j.issn.1006.7108.2018.09.015

中文关键词: 中医中药补肾壮骨方乳腺癌芳香化酶抑制剂相关骨丢失 ERα基因单核苷酸多态性

英文关键词:traditional Chinese medicine nourishing kidney and strong bone prescription breast cancer aromatase inhibitor-associated bone loss ERα single nucleotide polymorphism

基金项目:上海市海派中医流派传承研究基地建设项目（ZY3-CCCX-1-1004）；上海市卫生和计划生育委员会科研项目（201540036）

作者	单位
殷玉莲1 张卫红2 周悦1 叶媚娜1 陈红风1*	1.上海中医药大学附属龙华医院中医乳腺科上海 200032 2.上海市宝山区中西医结合医院乳腺外科上海 201901

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中文摘要:

目的观察补肾壮骨方防治芳香化酶抑制剂相关骨丢失（AIBL）的临床疗效及安全性，分析其与ERα基因rs9340799、rs2234693位点单核苷酸多态性（SNPs）的相关性。方法将116名接受AIs治疗的乳腺癌患者随机分为治疗组及对照组，均行SNPs测序，并口服钙剂+维生素D及常规中药治疗，治疗组同时加用补肾壮骨方（仙灵脾15g、补骨脂15g、骨碎补15g、菟丝子15g、淮牛膝30g）。比较两组患者治疗前、治疗后3个月和6个月的骨代谢指标PINP、β-CTX、腰椎及股骨骨密度（BMD）及雌二醇、促卵泡刺激素水平，并分析骨代谢变化与SNPs分型的关联性。结果治疗6个月，治疗组腰椎及股骨BMD表现均优于对照组（P<0.05），有效率高于对照组（P <0.001）。治疗组的骨形成指标PINP高于对照组，骨重吸收指标β-CTX值明显低于对照组（P<0.05）。ERα基因rs9340799与rs2234693位点SNPs对腰椎BMD值变化存在影响，纯合型A、T等位基因的腰椎BMD值治疗前后比较无统计学差异（P＞0.05）。携带C、G等位基因患者的腰椎BMD值呈下降趋势。治疗期间，2组所有患者均未发现血常规、肝肾功能、血清雌二醇和促卵泡刺激素异常。结论补肾壮骨方具有较好防治AIBL的作用，能增加患者腰椎、股骨BMD，提高PINP水平和降低β-CTX水平。AIs对携带纯合型A、T基因的患者骨代谢影响较小，而C、G等位基因可能是患者发生AIBL的易感基因，补肾壮骨方能改善所有基因型患者的骨代谢异常，且具有安全性。

英文摘要:

Objective To observe the clinical efficacy and safety of nourishing kidney and strong bone prescription on prevention and treatment of aromatase inhibitor (AI)-related bone loss (AIBL), and to analyze the correlation between the bone loss and the single nucleotide polymorphisms (SNPs) of two ERα genes at rs9340799 and rs2234693. Methods One hundred and sixteen breast cancer patients treated with AI were divided into 2 groups randomly. Genome DNA was collected and sequenced for ERα gene. Patients in both groups received AI therapy, calcium + vitamin D treatment, and Chinese medicine treatment. Patients in the treatment group received nourishing kidney and strong bone prescription (herba epimedii 15g, fructus psoraleae 15g, drynaria rhizome 15g, cuscuta 15g, and achyranthes bidentata 30g) in addition. BMD, bone metabolites, and estrogen levels were measured in the two groups before, 3 and 6 months after the treatment. The changes in bone metabolism and SNPs of ERα gene were analyzed and compared. Results After 6-months treatment, the lumbar BMD and T value in the treatment group were higher than those in the control group (P<0.05), and the efficacy in the treatment group was higher than that in the control group (P< 0.001). PINP was higher, and β-CTX was lower in the treatment group than those in the control group (P < 0.05). ERα gene rs9340799 and rs2234693 had a significant effect on BMD of the lumbar spine. The BMD of lumbar spine in patients with homozygous A and T alleles did not show a significant decrease before and after treatment (P>0.05). The BMD of lumbar spine in patients with C and G alleles decreased. During the treatment, no patients were found abnormal in hepatorenal function, serum estradiol, and follicle-stimulating hormone. Conclusion Nourishing kidney and strong bone prescription has a certain role in the prevention and treatment for AIBL. It improves BMD of the lumbar vertebrae and femur, increases PINP level and reduces β-CTX level. AIs has little effect on bone metabolism in patients with A/T allele. Patients with C/G allele may be AIBL susceptible gene type. Nourishing kidney and strong bone prescription can safely improve each SNPS classification of patients with abnormal bone metabolism.

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