强骨止痛方治疗芳香化酶抑制剂所致乳腺癌骨丢失性疼痛

Clinical Study of Qianggu Zhitong Decoction for Treating Aromatase Inhibitors-induced Bone Loss Related Pain in Breast Cancer Patients

目的:观察强骨止痛方对芳香化酶抑制剂致绝经期后乳腺癌患者骨丢失性疼痛的作用。方法:芳香化酶抑制剂治疗中并腰背及(或)下肢痛患者54例,随机分为2组,分别予强骨止痛方(治疗组)、钙尔奇D(对照组)干预3个月。治疗前后分别以视觉标尺法(VAS)评价疼痛,总维生素D(VITD-T)、骨钙素(BGP)、甲状旁腺素(i PTH)、降钙素、Ⅰ型胶原氨基末端肽(CTx)监测骨代谢、双能X线吸收测定法(DEXA)监测骨密度,血清CEA、CA153、CA125、E2监测对肿瘤及激素影响,血常规、生化监测安全性。结果:治疗组和对照组VAS评分均显著下降[(4.0±0.8)vs(2.0±0.8),(3.9±0.9)vs(2.8±0.8)],治疗组总有效率、显效率与对照组相比有显著差异(92.3%vs 81.0%;69.2%vs 33.3%);治疗后两组血清VITD-T含量均升高[治疗组(12.96±4.97)vs(15.47±5.79);对照组(12.38±3.87)vs(14.36±3.78)];分层分析中,在围绝经期组、显效组及低骨量组升高显著。两组血清CTx均较治疗前下降,分层分析中,低骨量组CTx下降显著[(0.78±0.29)vs(0.71±0.30)]。辨证为脾肾亏虚者与肝肾亏虚者比较,股骨骨密度低[(0.83±0.21)vs(1.03±0.15)],BGP高[(35.99±13.38)vs(23.20±8.03)];肝肾亏虚者VITD-T增加[(16.86±5.76)vs(14.99±5.09)]、BGP下降[(21.11±7.92)vs(31.11±13.76)]均优于脾肾亏虚者。结论:强骨止痛方显著改善骨量减少所致疼痛,疗效优于碳酸钙D3,对雌激素无明显影响;其作用与VITD-T、降低BGP、降低CTx有关;围绝经者、低骨量者敏感性优于高龄、骨质疏松者;辨证肝肾亏虚者为早期阶段,干预效果较佳。

Objectives To observe the effect of Qianggu Zhitong Decoction （QZD） on aromatase inhibitors-induced bone loss （CTIBL） pain in post-menopausal breast cancer patients. Methods Total 54 patients treated by aromatase inhibitors and suffering from lower back and/or leg pain were selected as research sbujects. The patients were randomly divided into treatment group and control group. The patients in treatment group were treated by QZD, while the patients in control group were treated by Caltrate for 3 months. Before and after treatment, the patients’ pain was evaluatedby visual analogue scale （VAS）. Bone metabolism was monitored by VITD-T, bone gla-protein （BGP）,immunoreactive parathyroid hormone （iPTH）, calcitonin and cross-linked N-telopeptide of type I collagen （CTx）. Bone density was monitored by dual-energy X-ray absorptiometry （DEXA）. The effect of the tumor and hormone was monitored by serum CEA, CA153, CA125 and E2. And the drug-safety was monitored by blood routine and biochemistry Results The VAS of reatment group and control group decreased signi？cantly （4.0±0.8 vs 2.0±0.8, 3.9±0.9 vs 2.8±0.8）. The differences of total effective rate and marked effective rate between treatment group and control group were quite remarkable （92.3% vs 81.0%, 69.2% vs 33.3%）. After treatment, the VITD-T of two groups increased [（12.96±4.97）vs （15.47±5.79）] in treatment group, （12.38±3.87） vs （14.36±3.78） in control group] and increased signi？cantly in perimenopausal group, marked effective group and low bone mass （LBMD） group on the basis of Strati？ed analysis. The CTx of two groups decreased in two groups, and decreased obviously in LBMD group [（0.78±0.29） vs （0.71±0.30）] on the basis of Strati？ed analysis. Compared with the liver and kidney de？ciency group, the femoral BMD of the spleen and kidney de？ciency group was lower [（0.83±0.21） vs （1.03±0.15）] and the BGP was higher [（35.99±13.38） vs （23.20±8.030）]. The VITD-T increased more sharply [（16.86±5.76） vs （14.99±5.09）] and the BGP decreased obviously [（21.11±7.93） vs （31.11±13.76）] in the liver and kidney de？ciency group. Conclusion QZD could relievethe pain caused by osteopenia, further effectively than Caltrate. It had no obvious effect on estrogen. QZD was effective related to increasing VITD-T and decreasing BGP and CTx. Perimenopausal patients and LBMD patients were more sensitive to QZD than old age patients and osteoporosis patients. The intervention in patients with liver and kidney de？ciency was better in early stage.