杜续愈骨方联合碳酸钙D3片及骨化三醇软胶囊治疗原发性骨质疏松症肾阳虚证的多中心临床研究OA

Objective:To observe the clinical efficacy of Duxu Yugu Fang(杜续愈骨方,DYF)combined with calcium carbonate D3 tablets and calcitriol soft capsules in the treatment of primary osteoporosis(OP)with syndrome of kidney-yang deficiency.Methods:A ran-domized,controlled,multicenter clinical trial was conducted.A total of 160 primary OP patients with syndrome of kidney-yang deficiency were enrolled in the trial and were randomized into the DYF group and the mimetic agent group,with 80 cases in each group.All patients in the 2 groups were treated with oral application of calcium carbonate D3 tablets and calcitriol soft capsules;moreover,the ones in DYF group were further treated with oral application of DYF granules,while those in the mimetic agent group with DYF mimetic agent granules.All pa-tients were treated for consecutive 3 months with the identical medication methods.The bone mineral density(BMD)at the lumbar spine and hip,low back pain visual analogue scale(VAS)score,and traditional Chinese medicine(TCM)syndrome scores,including scores for low back pain,soreness and weakness in the waist and knees,lower limb pain,and difficulty walking,were assessed and compared between the two groups before the treatment,at 1 month after the beginning of the treatment,and after the end of the treatment,respectively.Further-more,the serum levels of alkaline phosphatase(ALP),procollagen Ⅰ N-terminal propeptide(P Ⅰ NP),and β-C-terminal telopeptide of typeⅠ collagen(β-CTX)were measured and compared between the two groups before the treatment and after the end of the treatment,respec-tively.Results:①General situation.Three patients in the DYF group and 4 ones in the mimetic agent group withdrew from the trial,finally,77 ones in the DYF group and 76 ones in the mimetic agent group were included in the study.②Lumbar spine and hip BMD.The lumbar spine and hip BMD presented an upward trend over time in the two groups(F=1 249.353,P=0.000;F=738.701,P=0.000;F=299.109,P=0.000;F=937.118,P=0.000).No significant differences were observed between the two groups in BMD at these two sites before the treatment and at 1 month after the beginning of the treatment(t=0.565,P=1.000;t=0.548,P=1.000;t=0.254,P=1.000;t=0.233,P=1.000),while,after the end of treatment,the BMD at these two sites were higher in DYF group compared to mimetic agent group(t=2.545,P=0.036;t=2.562,P=0.034).③T-scores for lumbar spine and hip BMD.The T-scores for lumbar spine and hip BMD also presented an upward trend over time in the two groups(F=390.406,P=0.000;F=33.522,P=0.000;F=344.446,P=0.000;F=230.351,P=0.000).No significant differences were observed between the two groups in the T-scores for BMD at these two sites before the treatment and at 1 month after the beginning of the treatment(t=0.122,P=1.000;t=0.059,P=1.000;t=0.454,P=1.000;t=0.431,P=1.000),while,after the end of treatment,the T-scores for BMD at these two sites were higher in DYF group compared to mimetic agent group(t=2.494,P=0.041;t=2.605,P=0.030).④Low back pain VAS score.The low back pain VAS score demon-strated a downward trend over time in the two groups(F=441.111,P=0.000;F=259.770,P=0.000).No significant differences were observed between the two groups in the low back pain VAS score before the treatment(t=1.262,P=0.627),while at 1 month after the be-ginning of the treatment and after the end of treatment,the low back pain VAS score was lower in DYF group compared to mimetic agent group(t=-7.015,P=0.000;t=-4.107,P=0.000).⑤Bone metabolism indexes.After the end of treatment,the serum levels of ALP,P Ⅰ NP,and β-CTX were lower in DYF group compared to mimetic agent group(t=5.598,P=0.000;t=2.130,P=0.035;t=5.018,P=0.000).In the DYF group,these indexes decreased after the end of treatment compared to pretreatment(t=-27.530,P=0.000;t=-14.052,P=0.000;t=-18.489,P=0.000),whereas,in the mimetic agent group,no significant differences were observed between the 2 time points in these indexes(t=0.550,P=0.584;t=0.372,P=0.711;t=0.987,P=0.326).⑥TCM syndrome scores.The scores for low back pain,lower limb pain,and difficulty walking all demonstrated a downward trend over time in the two groups(F=347.163,P=0.000;F=224.089,P=0.000;F=255.586,P=0.000;F=208.349,P=0.000;F=289.750,P=0.000;F=69.176,P=0.000).No significant differences were observed between the two groups in the scores for low back pain,lower limb pain,and difficulty walking before the treatment(t=-0.990,P=0.972;t=0.077,P=1.000;t=-0.558,P=1.000),while at 1 month after the beginning of the treat-ment and after the end of treatment,the scores for low back pain,lower limb pain,and difficulty walking were all lower in DYF group com-pared to mimetic agent group(t=-5.158,P=0.000;t=-6.244,P=0.000;t=-4.239,P=0.000;t=-2.702,P=0.023;t=-3.795,P=0.000;t=-11.800,P=0.000).The scores for soreness and weakness in the waist and knees also showed a downward trend over time in the two groups(F=412.504,P=0.000),and were lower in DYF group compared to mimetic agent group(t=-5.412,P=0.000).Conclusion:DYF combined with calcium carbonate D3 tablets and calcitriol soft capsules can improve bone metabolism,increase BMD,re-lieve low back pain,and ameliorate TCM syndromes in treatment of primary OP with syndrome of kidney-yang deficiency.Its therapeutic efficacy is superior to that of the latter two alone.