自拟壮骨方治疗绝经后骨质疏松症的疗效及作用机制研究

Study on the curative effect and mechanism of action of self-made ZHUANGGU decoction in treatment of postmenopausal osteoporosis

目的:探讨自拟壮骨方治疗绝经后骨质疏松症的疗效及作用机制。方法:将纳入研究的240例绝经后骨质疏松症患者随机分为2组,每组120例。治疗组采用口服自拟壮骨方治疗,对照组采用口服尼尔雌醇片治疗。比较2组患者的骨密度及血清中钙、磷、碱性磷酸酶、雌二醇的水平,同时比较2组患者治疗后的疼痛改善情况。结果:1骨密度。治疗前2组患者腰椎和股骨颈骨密度比较,组间差异均无统计学意义[(0.73±0.26)g·cm-2,(0.71±0.29)g·cm-2,t=3.296,P=0.110;(0.84±0.03)g·cm-2,(0.85±0.02)g·cm-2,t=3.114,P=0.201]。治疗组治疗前后腰椎骨密度的差值大于对照组[(0.20±0.15)g·cm-2,(0.18±0.12)g·cm-2,t=4.012,P=0.021];2组患者股骨颈骨密度的差值比较,差异无统计学意义[(0.60±0.24)g·cm-2,(0.16±0.14)g·cm-2,t=1.062,P=0.080]。2血生化指标。治疗前2组患者血清中钙、磷、碱性磷酸酶、雌二醇浓度比较,组间差异均无统计学意义[(2.24±0.16)mmol·L-1,(2.22±0.14)mmol·L-1,t=5.659,P=0.431;(1.19±0.21)mmol·L-1,(1.18±0.22)mmol·L-1,t=3.314,P=0.158;(109.50±13.41)U·L-1,(108.71±20.42)U·L-1,t=1.354,P=0.762;(40.86±18.26)pmol·L-1,(41.14±19.04)pmol·L-1,t=1.918,P=0.656]。治疗组血清中钙和磷浓度治疗前后的差值均大于对照组[(1.61±0.46)mmol·L-1,(0.31±0.25)mmol·L-1,t=5.618,P=0.000;(0.60±0.24)mmol·L-1,(0.30±0.14)mmol·L-1,t=7.012,P=0.000];碱性磷酸酶和雌二醇浓度治疗前后的差值与对照组比较,差异均无统计学意义[(20.21±12.16)U·L-1,(16.11±10.12)U·L-1,t=1.368,P=0.612;(19.26±10.23)pmol·L-1,(16.76±9.67)pmol·L-1,t=1.386,P=0.748]。3疼痛改善情况。治疗组显效74例、有效35例、无效11例,对照组显效71例、有效34例、无效15例。治疗结束后2组患者疼痛改善情况比较,差异无统计学意义(Z=-0.547,P=0.584)。结论:自拟壮骨方具有类雌激素样作用,可通过提高雌激素水平,改善骨代谢,增加骨密度,减轻绝经后骨质疏松症患者的疼痛症状。

Objective：To study the curative effect and mechanism of action of self-made ZHUANGGU decoction in treatment of postm-enopausal osteoporosis（PMO）.Methods：Two hundred and forty patients with PMO were randomly divided into 2 groups,1 20 cases in each group.The patients in the treatment group was treated with oral application of self-made ZHUANGGU decoction,while others in the control group was treated with nilestriol tablet.Bone mineral density（BMD）and serum level of Ca,P,alkaline phosphatase（ALP）and estradiol （E2）were compared between the 2 groups.Meanwhile,the posttreatment pain degree was compared between the 2 groups.Results：There was no statistical difference in BMD of lumbar spine and femoral neck between the 2 groups before the treatment（0.73＋/-0.26 vs 0.71 ＋/-0.29 g/cm（2）,t=3.296,P=0.1 1 0;0.84＋/-0.03 vs 0.85 ＋/-0.02 g/cm（2）,t=3.1 1 4,P=0.201 ）.After the treatment,the lumbar spine BMD change of treatment group was greater than that of control group（0.20＋/-0.1 5 vs 0.1 8＋/-0.1 2 g/cm（2）,t=4.01 2,P=0.021 ）, and there was no statistical difference in the femoral neck BMD change between the 2 groups（0.60＋/-0.24 vs 0.1 6＋/-0.1 4 g/cm（2）, t=1 .062,P=0.080）.There was no statistical difference in serum level of Ca,P,ALP an E2 between the 2 groups before the treatment （2.24＋/-0.1 6 vs 2.22＋/-0.1 4 mmol/L,t=5.659,P=0.431;1 .1 9＋/-0.21 vs 1 .1 8＋/-0.22 mmol/L,t=3.31 4,P=0.1 58;1 09.50＋/-13.41 vs 108.71 ＋/-20.42 U/L,t=1.354,P=0.762;40.86 ＋/-18.26 vs 41.14＋/-19.04 pmol·L-1,t=1.918,P=0.656）.After the treatmeng,the change of serum level of Ca and P of treatment group was greater than that of control group（1 .61 ＋/-0.46 vs 0.31 ＋/-0.25 mmol/L,t=5.61 8,P=0.000;0.60＋/-0.24 vs 0.30＋/-0.1 4 mmol/L,t=7.01 2,P=0.000）,while there was no statistical differ-ence in the change of serum level of ALP and E2 between the 2 groups（20.21 ＋/-1 2.1 6 vs 1 6.1 1 ＋/-1 0.1 2 U/L,t=1 .368,P=0.61 2;1 9.26＋/-1 0.23 vs 1 6.76＋/-9.67 pmol/L,t=1 .386,P=0.748）.Seventy-four patients obtained an excellent result,35 good and 1 1 poor in the treatment group;while 71 patients obtained an excellent result,34 good and 1 5 poor in the control group.There was no statistical difference in the degree of pain relief between 2 groups after the treatment（Z=-0.547,P=0.584）.Conclusion：Self-made ZHUANGGU decoction has estrogen-like effects,so it can effectively reduce the pain symptoms of the patients with PMO through increasing estrogen levels and improving bone metabolism and increasing BMD.