A Randomized Parallel Controlled Study Of Jiawei Taohong Siwu Decoction In The Treatment Of Early Hormone-induced Osteonecrosis Of The Femoral Head

Purposes:To observe the clinical efficacy and safety of modified Taohong Siwu Decoction in the treatment of early steroid-induced osteonecrosis of the femoral head and provide the basis for clinical promotion and scientific research.Materials and methods:Sixty patients with early steroid-induced osteonecrosis of the femoral head who were treated in Department of Orthopedics,Shenyang Hospital of Traditional Chinese Medicine between January 2016 and December 2017 were selected.Dialectical type of TCM was type of kidney-deficiency and blood-stasis,and were randomly divided into treatment group and control group,with 30 in each group.The differences of age,sex,course of disease and staging were balanced(P> 0.05).After the same routine admission treatment was given to both groups,the treatment group was treated with modified Taohong Siwu Decoction(Shudihuang,Shuyiyiren,per 30 g,Danggui,Baishao,Chuanxiong,Taoren,Honghua,Chishao per 15 g,Zelan,Zexie,Shengdihuang,Chuanniuxi,Muxiang,Sharen per 10g),per 150 mL,morning and evening twice oral;the control group given Xianling Gubao Capsule,3 capsules / time,2 times / d.The two groups of patients were treated for 1 course of treatment(3 months),and the clinical symptoms,Harris scores,VAS scores,WHOQOL-BREF scores and adverse reaction were evaluated on the first day and the last day of treatment.To evaluate the clinical efficacy and safety of flavored Taohong Siwu Decoction and Xianling Gubao Capsule.Results:The clinical symptoms and scores of the treatment group and the control group were significantly improved after treatment(P <0.01),and the improvement in the treatment group was significantly better than that in the control group(P <0.01).No adverse reactions were found in the treatment group,but there were 2 adverse reactions in the control group—1 mild liver damage,and 1 mild nausea and vomiting.Conclusions:Modified Taohong Siwu Decoction for early steroid-induced osteonecrosis of the femoral head is clinically effective,without adverse reactions,safe and reliable,and can be widely used and further scientific research.