古方青娥丸加味干预早期非创伤性股骨头缺血性坏死骨转换标志物、血流变及炎症相关因子的变化

Effects of Jiawei Qing'e Wan on bone turnover markers, blood rheology and inflammation-associated factors in patients with early-stage non-invasive osteonecrosis of the femoral head

背景:股骨头缺血性坏死治疗的关键是防治及改善微循环障碍及逆转骨转换。《皇帝内经》中记载古方青娥丸已用于治疗骨质疏松症("骨痿"),目前在临床上亦用青娥丸加味方治疗早期非创伤性股骨头缺血性坏死,疗效显著。目的:探讨古方青娥丸加味治疗早期对非创伤性股骨头缺血性坏死患者骨转换标志物、血流变及炎症相关因子的影响,阐述其作用机制。方法:纳入60例早期非创伤性股骨头缺血性坏死患者(69髋),随机分为2组,治疗组(n=30)给予基础+青娥丸加味治疗,对照组(n=30)给予基础+钙片治疗,疗程24周。于治疗前后测量2组患者骨髓水肿程度、Harris评分、疼痛目测类比评分、体内血脂指标、血液流变学参数、肿瘤坏死因子α及骨转换标志物等相关因子水平的变化,并进行对比。结果与结论:(1)治疗前治疗组与对照组发生骨髓水肿分别为26髋和24髋,发生率分别为74%和71%(P>0.05)。24周后,治疗组及对照组的骨髓水肿治疗有效率(消退+改善率)分别为81%和29%(P<0.05);(2)治疗前2组患者目测类比评分及Harris评分,血脂各指标及血液流变学各参数,血清肿瘤坏死因子α、β-胶原特殊序列、N端骨钙素、总Ⅰ型前胶原氨基端延长肽差异无显著性意义(P>0.05)。在治疗组中,治疗后患者部分血脂指标及部分血液流变学参数明显改善(P<0.05),治疗后目测类比评分、血清肿瘤坏死因子α、β-胶原特殊序列、N端骨钙素、总Ⅰ型前胶原氨基端延长肽水平明显低于治疗前及对照组(P<0.05),而Harris评分则明显高于治疗前及对照组(P<0.05)。在对照组中,治疗后患者血脂各指标及血液流变学各参数、目测类比评分、Harris评分、血清肿瘤坏死因子α、β-胶原特殊序列、N端骨钙素、总Ⅰ型前胶原氨基端延长肽水平与治疗前差异无显著性意义(P>0.05);(3)结果表明,青娥丸加味可有效改善早期股骨头缺血性坏死患者脂质代谢水平、血黏度、肿瘤坏死因子α及骨转换标志物相关因子水平,从而间接改善微循环状态及骨转换,缓解骨髓水肿及临床症状,提高患者生活质量。

BACKGROUND： Improvement of the microcirculation and reversal of bone turnover are the key to treat avascular necrosis of femoral head. Qing＇e Wan has been used for osteoporosis treatment（＂bone atrophy＂） described in the Inner Canon of Yellow Emperor, and now Jiawei Qing＇e Wan is also used for treating early-stage non-invasive osteonecrosis of femoral head（ONFH） achieving satisfactory outcomes. OBJECTIVE： To investigate the effect of Jiawei Qing＇e Wan on bone turnover markers, hemorheology and inflammation-associated factors in patients with early stage ONFH and to clarify the underlying mechanism. METHODS： A total of 60 patients with early stage of ONFH（69 hips） were enrolled and randomized into treatment and control groups（n=30 per group）, followed by given the basic treatment combined with Jiawei Qing＇e Wan and caltrate for 24 weeks, respectively. Bone marrow edema, Harris score, visual analogue scale score, lipid levels, blood rheological parameters, tumor necrosis factor-α and bone turnover marker levels were detected before and after treatment and compared between groups. RESULTS AND CONCLUSION： Before treatment, the treatment and control groups had 26 and 24 hips with bone marrow edema, with the incidence rate of 74.29% and 70.59%, respectively（P〈0.05）. After 24-week treatment, the treatment efficiency（subside＋improvement） of bone marrow edema in the treatment and control group was 80.77% and 29.17%, respectively（P〈0.05）. There were no significant differences in the visual analogue scale, Harris score, lipid levels, blood rheological parameters, and levels of tumor necrosis factor-α, β-Crosslaps, N-osteocalcin and N-terminal peptide of type I procollagen（T-PINP） between groups before treatment（P〉0.05）. In the treatment group, the lipid levels and some of the blood rheological parameters after treatment were improved significantly（P〈0.05）, and the visual analogue scale, and levels of tumor necrosis factor-α, β-Crosslaps, N-osteocalcin and T-PINP were significantly lower than those in the control group and before treatment（P〈0.05）, while Harris scores were significantly higher than those before treatment and the control group（P〈0.05）. All above indicators showed no significant differences before and after treatment in the control group（P〉0.05）. These results suggest that Jiawei Qing＇e Wan can effectively improve lipid metabolism, blood viscosity, and the levels of tumor necrosis factor-α and bone turnover markers in patients with early-stage ONFH, thereby improving the blood microcirculation and bone turnover, and relieving the clinical symptoms of bone marrow edema, which heightens the life quality of patients.