Effects Of Leigongteng Oral Solution On Bone Healing:an Experimental Research And Preliminary Clinical Application

Objective:The study was to identify the influence of Leigongteng oral solution on fracture union by experimental study and clinical preliminary observation.Methods:110three-month-old female Sprague-Dawley rats were enrolled in this study. The open osteotomy model was chosen. And rats were then randomly assigned to four groups: Group A were treated with1.25ml/kg Leigongteng oral solution (the low-does group), Group B were treated with2.5ml/kg Leigongteng oral solution (the medial-does group), Group C were treated with5.0ml/kg Leigongteng oral solution (high-does groups), Group D were treated with2.5ml/kg normal saline(the control group). And they were treated with intragastric administration once one day for2weeks. At2weeks,4weeks and6weeks after operation, they were checked with radiographs examination, ALP test, micro-CT, histomorphology observations and metrology analysis, immunohistochemical staining detection as well as biomechanical measurement, separately.From November2012to June2013, fifty-two patients with tibial fractures were randomly assigned to two groups:the observation group and control group. In the observation group, they were treated with20ml Leigongteng oral solution once; in the control group, they were treated with20ml normal saline once. The oral administration was once one day for4weeks The X-ray films were taken at1day,1,3,6months after treatment to observe clinical practice and the time of fracture union.Results:At the same time point, the comparisons were made among these groups. Satistical difference between Group A and Group D was not obvious (P>0.05), while there were obvious statistical difference among Group B、Group C and Group D, among Group A Group B and Group C, as well as between Group A and Group B(P<0.05); The Garrett score in the Group B was higher than the other groups, and the fracture healing degree in Group C was lower than the other groups; The ALP content tended to decrease when the time increased, and the ALP content in B groups was obviously higher than the other groups(P<0.05), Group C was slightly lower than the other groups(P<0.05), and the difference of ALP content between Group A and Group D was not obvious, but they were slightly higher than Group D at2weeks; Micro-CT:In the B groups, TV、BV and BVF was higher than the others(p<0.05); Histological examinations:compared with other groups, the B groups got more the formation of trabeculae and fibrous bone, and the trabeculae bone grew very sparse in C groups, and then the bone trabeculae density showed that there were statistically significant differences among three groups(P<0.05); Immunohistochemical staining detection:compared with the other groups, IL-10level of callus tissues in the B groups was obviously higher at the same time point (P<0.05), while TNF-α level was significantly lower than the other groups at the same time point(P<0.05); Biomechanics test:the maximum load in the Group B was superior to the Group A and Group D but it was not obvious(P>0.05), and the maximum load in the Group C was significantly inferior to the other groups (P<0.05).All patients except7cases were followed up for6months. The callus X-ray evaluation in the observation group was superior to the control group(P<0.05), and the fracture healing time was sooner than the control group(P<0.05).Conclusion:Moderate Leigongteng oral solution can affect on the bone healing. The high-does Leigongteng oral solution can significantly reduce callus growth, and delay fracture healing and increase the rate of bone union.