密骨胶囊对乳腺癌芳香化酶抑制剂相关骨丢失患者骨密度及骨代谢的影响

Effects of Migu capsule on bone mineral density and bone metabolism in breast cancer patients with aromatase inhibitor-associated bone loss

关键词:  密骨胶囊  乳腺癌  芳香化酶抑制剂  骨密度  骨代谢

Key words:  Migu capsule  breast cancer  aromatase inhibitors  bone mineral density  bone metabolism

摘要:

目的 观察密骨胶囊联合钙尔奇D对乳腺癌芳香化酶抑制剂治疗相关骨丢失（aromatase inhibitors-associated bone loss， AIBL）患者骨密度（bone mineral density， BMD）及骨代谢的影响。方法 将符合入选标准的70例AIBL患者随机分为对照组和实验组，两组各35例。对照组给予来曲唑+钙尔奇D，实验组在对照组的基础上加服密骨胶囊。2组均治疗12个月。检测治疗前后患者L2L4、大粗隆、左股骨颈骨密度变化，血清代谢指标钙（calcium， Ca）、25-羟基维生素D3（25-hydroxy vitamin D3， 25-OH D3）及骨转换标志物Ⅰ型胶原交联C-末端肽（type Ⅰ collagen carboxy-terminal peptide， CTX）、Ⅰ型胶原交联N-末端肽（type Ⅰ collagen aminoterminal peptide， NTX）、1型原胶原氨基端前肽（procollagen type 1 N-terminal prope-ptide， P1NP）的水平，并评价用药的安全性。结果 与治疗前比较，实验组治疗后L2L4、大粗隆及左股骨颈BMD值升高,对照组降低，两组比较均有统计学意义（P＜0.05），且两组变化值比较，差异均有统计学意义（P＜0.001）；与治疗前比较，两组的25-OH D3均较前升高，与同组治疗前比较差异均有统计学意义（P＜0.05），实验组血清25-OH D3升高程度优于对照组，治疗前后两组变化值比较，差异有统计学意义（P＜0.001）；与治疗前相比，治疗后两组血清骨转换标志物β-CTX、NTX较前降低，P1NP较前升高，两组比较差异有统计学意义（P＜0.05），实验组血清β-CTX、NTX和P1NP变化程度大于对照组，治疗前后两组变化值比较，差异有统计学意义（P＜0.001）。治疗期间，两组患者均未出现明显的不良反应；两组患者血清雌二醇（E2）治疗前后及组间比较，差异均无统计学意义（P＞0.05）。结论 密骨胶囊联合钙尔奇D可增加乳腺癌AIBL患者的BMD，改善骨代谢。

Abstract:

Objective To observe the effects of Chinese medicine Migu capsule combined with caltrate D on bone mineral density(BMD) and bone metabolism in breast cancer patients with aromatase inhibitor-associated bone loss(AIBL). Methods Seventy breast cancer patients with AIBL were randomly divided into study group and control group with 35 cases in each group. All patients received letrozole and caltrate D for treatment for 12 months, and Migu capsules were given to study group additionally. The BMD in the lumbar vertebrae 2-4(L2-L4), greater trochanter, left femoral neck, serum metabolic markers calcium(CA), 25 hydroxy vitamin D3(25-OH D3) and bone turnover markers collagen type Ⅰ cross-linked C-terminal peptide(CTX)， type Ⅰ collagen cross-linked N-terminal peptide(NTX), procollagen type 1 N-terminal prope-ptide(P1NP) were measured in patients before and after treatment; and safety of medication was evaluated. Results The BMD values of L2-4, greater trochanter, and left femoral neck were significantly increased in the study group and decreased in the control group after treatment(P<0.05). The 25-OH D3 levels were significantly increased in both groups after treatment(P<0.05); while the 25-OH D3 level in in the study group was higher than that in the control group(P<0.001). The β-CTX and NTX were decreased and P1NP was increased in both groups after treatment(P<0.05); while the extent of changes in study group was greater than that of the control group(P<0.001). There was no significant difference in serum estradiol(E2) levels between the two groups before and after treatment(P>0.05). And there were no significant adverse events in both groups during the treatment. Conclusion The combination of Chinese medicine Migu capsule and caltrate D can increase BMD and improve bone metabolism in breast cancer patients with AIBL.