加味左归丸治疗肾阴虚型绝经后骨质疏松症的临床研究

Clinical study on treatment of postmenopausal osteoporosis of kidney-yin deficiency with “Jiawei Zuogui Pill”

目的观察加味左归丸治疗肾阴虚型绝经后骨质疏松症的临床疗效。方法将80例肾阴虚型绝经后骨质疏松症患者随机分为治疗组和对照组,每组40例。对照组予碳酸钙D_3口服;治疗组在对照组治疗措施基础上加用加味左归丸。两组疗程均为1年,观察骨密度(L_2-L_4、髋部股骨颈及Ward三角)、中医证候积分及雌二醇(E_2)、25羟基维生素D_3[25(OH)Vit D_3]、抗酒石酸酸性磷酸酶(TRACP)、骨源性碱性磷酸酶(BALP)等生化指标的变化情况。结果 1组间治疗后比较,L_2-L_4、股骨颈、Ward三角骨密度水平差异有统计学意义,即治疗组显著高于对照组(P<0.05)。2治疗前后组内比较,两组中医证候积分值均明显下降(P<0.05);组间治疗前后差值比较,治疗组中医证候积分下降程度比对照组明显(P<0.05)。3组间治疗后比较,治疗组25(OH)Vit D_3水平的上升程度及TRACP、BALP水平的下降程度均比对照组明显(P<0.05)。结论加味左归丸治疗肾阴虚型绝经后骨质疏松症,可显著提高骨密度,改善临床症状。

Objective To evaluate the clinical effects of ＂Jiawei Zuogui Pill＂ in the treatment of postmenopausal osteoporosis of kidney-yin deficiency. Methods Eighty subjects were randomly divided into two groups. The treatment group（40 cases） was treated with ＂Jiawei Zuogui Pill＂ and calcium carbonate D3 , while the control group （40 case） was treated with calcium carbonate D3 only. Both groups were treated for one year. The changes of bone mineral density（BMD） （L2-L4 and hip femoral neck and Ward＇ s triangle）, the score of traditional Chinese Medcine （TCM） syndrome, estradiol （ E2 ）, 25 hydroxy vitamin D3 [ 25 （OH） VitD3 ], antitartaric acid phosphatase （ TRACP）, bone alkaline phosphatase （BALP） and other biochemical indexes were compared. Results （1）The level of BMD （ L2-L4, neck of femur and Ward＇ s region） increased significantly in treatment group compared with control group after treatment （ P 〈 0.05 ）. （2） Compared before and after treatment within groups, the score of TCM syndrome in each group decreased significantly （ P 〈 0.05 ）. Compared with the control group, the reduction of the score in treatment group was more remarkable（ P 〈 0.05 ）. （3）Compared before and after treatment, the level of 25 （OH）D3 increased significantly （ P 〈 0.05 ）, while TPACP and BALP decreased significantly （ P 〈 0.05 ） in treatment group. There was no signitlcant change in control group. Conclusion ＂Jiawei Zuogui Pill＂ can increase BMD and relieve the symptoms of kidney-yin deficiency in the treatment of postmenopausal osteoporosis.