益肾强骨方治疗肾阳虚型骨质疏松症临床研究

Clinical Study on Yishen Qianggu Prescription for Osteoporosis of Kidney Yang Deficiency Type

目的:观察益肾强骨方治疗肾阳虚型骨质疏松症(OP)的临床疗效。方法:将132例肾阳虚型OP患者按随机数字表法分为观察组和对照组各66例。对照组口服盐酸钙D3片和阿法骨化醇胶囊,观察组在对照组基础上加用益肾强骨方治疗。比较2组临床疗效、不良反应,并比较2组治疗前后中医证候积分,骨吸收指标[Ⅰ型胶原交联羧基末端肽(CTX-Ⅰ)、Ⅰ型胶原羧基端肽β特殊序列(β-CTX)、抗酒石酸酸性磷酸酶(TRAP)],骨形成指标[总Ⅰ型胶原氨基端前肽(PINP)、骨钙素(BGP)、骨碱性磷酸酶(BALP)],Wards三角区、股骨颈、腰椎L_(1~4)骨密度水平。结果:治疗前,2组腰膝酸软、腰脊疼痛、下肢痿弱、步履维艰等中医证候积分比较,差异无统计学意义(P>0.05);治疗后,2组上述中医证候积分均降低(P<0.05),且观察组低于对照组(P<0.05)。治疗前,2组CTX-Ⅰ、β-CTX、TRAP水平比较,差异无统计学意义(P>0.05);治疗后,2组CTX-Ⅰ、β-CTX、TRAP水平均降低(P<0.05),且观察组低于对照组(P<0.05)。治疗前,2组PINP、BGP、BALP水平比较,差异无统计学意义(P>0.05);治疗后,2组PINP、BGP、BALP水平均升高(P<0.05),且观察组高于对照组(P<0.05)。治疗前,2组Wards三角区、股骨颈、腰椎L_(1~4)骨密度T值比较,差异无统计学意义(P>0.05);治疗后,2组上述部位骨密度T值均升高(P<0.05),且观察组高于对照组(P<0.05)。观察组治疗总有效率93.65%,高于对照组80.00%(P<0.05)。治疗期间,观察组与对照组总不良反应发生率分别为7.94%、7.69%,2组比较,差异无统计学意义(P>0.05)。结论:益肾强骨方治疗肾阳虚型OP疗效确切,安全可靠,其机制可能与抑制骨吸收,促进骨形成,提高骨密度水平有关。

Objective:To observe the clinical effect of Yishen Qianggu Prescription for osteoporosis(OP)of kidney yang deficiency type.Methods:A total of 132 patients with OP of kidney yang deficiency type were divided into the observation group and the control group according to the random number table method,with 66 cases in each group.The control group was given oral administration of Calcium Carbonate and Vitamin D3 Tablets and Alfacalcidol Capsules,and the observation group was additionally treated with Yishen Qianggu Prescription based on the treatment of the control group.The clinical effects,incidence of adverse reactions,traditional Chinese medicine(TCM)syndrome scores,and levels of bone resorptive markers,including carboxy-terminal cross-linked telopeptide of typeⅠcollagen(CTX-Ⅰ),βcarboxy-terminal telopeptide of type I collagen(β-CTX)and tartrate-resistant acid phosphatase(TRAP),markers of bone formation,including procollagen type IN-terminal propeptide(PINP),osteocalcin(BGP)and bone-specific alkaline phosphatase(BALP),and bone density of Ward's triangle,femoral neck and L_(1-4)lumbar vertebrae were compared before and after treatment between the two groups.Results:Before treatment,there was no significant difference being found in the comparisons of TCM syndrome scores of soreness and weakness of the lumbar and knees,pain of the lumbar spine,wilting and weakness of lower extremities and difficult walking between the two groups(P>0.05);after treatment,the above four TCM syndrome scores in the two groups were decreased(P<0.05),and the above four scores in the observation group were lower than those in the control group(P<0.05).Before treatment,there was no significant difference being found in the comparisons of levels of CTX-Ⅰ,β-CTX and TRAP between the two groups(P>0.05);after treatment,the levels of CTX-Ⅰ,β-CTX and TRAP in the two groups were decreased(P<0.05),and the above three levels in the observation group were lower than those in the control group(P<0.05).Before treatment,there was no significant difference being found in the comparisons of levels of PINP,BGP and BALP between the two groups(P>0.05);after treatment,the levels of PINP,BGP and BALP in the two groups were increased(P<0.05),and the above three levels in the observation group were higher than those in the control group(P<0.05).Before treatment,there was no significant difference being found in the comparisons of the T values of bone density of Ward's triangle,femoral neck and L_(1-4)lumbar vertebrae between the two groups(P>0.05);after treatment,the T values of bone density of Ward's triangle,femoral neck and L_(1-4)lumbar vertebrae in the two groups were increased(P<0.05),and the T values of bone density of above three parts in the observation group was higher than that in the control group(P<0.05).The total effective rate was 93.65%in the observation group,higher than that of 80.00%in the control group(P<0.05).During treatment,the incidence of adverse reactions was 7.94%in the observation group and 7.69%in the control group,there being no significance in the difference(P>0.05).Conclusion:Yishen Qianggu Prescription has a definite curative effect on OP of kidney yang deficiency type with good safety,and its mechanism may be related to the inhibition of bone absorption,promotion of bone formation and the increase in level of bone density.