| Objective:Through randomized,controlled clinical trials,we evaluated the clinical efficacy and safety of Zhuanggufangchuang decoction powder(the dose is equivalent to half the amount of decoction pieces)in the treatment of Spleen and Kidney Merged Stagnation Blood Type of Postmenopausal low bone mass population.Methods:In accordance with the corresponding inclusion and excl usion criteria,a total of 150 low-bone mass postmenopausal women wit h spleen and kidney deficiency type were recruited between January 2016 and June 2017.They were randomly divided into 5 groups accordin g to the random number method,30 in each group.Among them,the si mple Zhaunggufang decoction powder group to was given Zhuanggufan g decoction powder orally,one dose daily,twice daily.The simple Zha unggufang Pieces group to was given Zhuanggufang decoction powder orally,one dose daily,twice daily.The Simple Western medicine group w as given to Alpha Acetylalcohol Soft Capsules,0.25 ug QD orally,Calci um Carbonate Vitamin D3 tablets,1.25 g QD orally.Western medicine co mbined with Zhuanggufang decoction powder group was treated with Z huanggufang decoctionpowder on the basis of medicine in Western medi cine group.Western medicine combined with Zhuanggufang pieces group was treated with Zhuanggufang pieces on the basis of medicine in we stern medicine group,6 months for a course of treatment.Monthly visits were performed once.The scores of symptom scores of traditional Chinese medicine and quantitative computer tomography(QCT)bone mineral density(BMD)were measured before and 6 months after treatment.Ser um 25-hydroxyvitamin D(25-(OH)D),serum osteocalcin(OC),procollag en type 1 N-propeptide(P1NP)and β-crosslinked C-terminal telopeptide of Type 1 collagen(β-CTX)were measured before treatment,3 months after treatment,and 6 months later.Detailed records of medications,c ombined medications and adverse reactions were recorded during the m onthly visit.Results:(1)Comparison of symptom scores of Chinese: Simple Zhu anggufang decoction powder group,Simple Zhuanggufang Piece group,Western medicine combined with Zhuanggufangzhusan group,Western m edicine combined with Zhuanggufang piece group can effectively reduce Chinese symptom scores(P< 0.01).There was no significant differenc e between the two groups(P>0.05),and the curative effect was better th an that of the western medicine group(P<0.01).However,the Western medicine group had no significant decrease before and after treatment(P>0.05).(2)The density of hydroxyapatite in lumbar vertebrae was compa red: The value of hydroxyapatite in lumbar vertebrae in Western medici ne combined with Zhuanggufang decoction powder group and Western medicine combined with Zhuanggufang piece tablet group was significan tly higher than before treatment(P<0.05).There was no significant diff erence between groups.(P>0.05),and the curative effect was better tha n that of Zhuanggufang decoction powder group,Zhuanggufang piece g roup and Western medicine alone group(P<0.05),while The density of lumbar hydroxyapatite in the simple Zhuanggufang decoction powder g roup,the simple Zhuanggufang piece group and the Western medicine gr oup was not significantly different from that before treatment(P>0.05).(3)Comparison of 25-(OH)D: The 25-(OH)D levels in the simple western medicine group,western medicine combined with Zhuanggufan g decoction powder group,and Western medicine combined with Zhuan ggufang Piece group were significantly higher than before treatment(P<0.01).There was no significant difference between the two groups(P>0.05),and the curative effect was better than that of Zhuanggufang decocti on powder group and Zhuanggufang piece group alone(P<0.01).Howeve r,the level of 25-(OH)D in the simple Zhuanggufang decoction powder group and the simple Zhuanggufang piece were not significantly chang ed before treatment(P>0.05).(4)Comparison of OC,P1 NP,and β-CTX: After 3 months of tre atment and 6 months of treatment,The scores of OC,P1 NP,and β-CT X in the Zhuanggufang decoction powder group,the simple Zhuanggufan g piece group,the Western medicine combined with Zhuanggufangzhusa n group,and the Western medicine combined with Zhuanggufang decoct ion powder group were significantly lower than before treatment(P<0.01).There was no significant difference between the groups(P>0.05),an d the efficacy was better than that of the simple western medicine group(P<0.01).In the western medicine group thant OC,P1 NP,and β-CTX were not significantly decreased bef ore treatment(P>0.05).(5)There were no obvious abnormalities in the safety indicators of all groups,and no adverse events or adverse reactions occurred.Conclutions:1.Zhuanggufang decoction powder can significantly relieve the symptoms of Spleen and Kidney Merged Stagnation Blood Type of Postmenopausal low bone mass patient,and its efficacy is comparable to that of Zhuanggufang pieces.2.Zhuanggufang decoction powder combined calcium and vitamin Dcan effectively improve the bone density of Spleen and Kidney Merged Stagnation Blood Type of Postmenopausal low bone mass patient,efficacy and decoction combined calcium and vitamin D equivalent.3.The mechanism of improving the low bone mass in postmenopausal women with Spleen and Kidney Merged Stagnation Blood may be to inhibit bone resorption,maintain balance of bone metabolism,and reduce bone loss.4.Zhuanggufang decoction powder treatment of Spleen and Kidney Merged Stagnation Blood Type of Postmenopausal low bone mass,no abnormal safety indicators,no adverse drug reactions. |