The Study Of Treat The Blood Hyper-coagulable State After The Traumatic Fracture With The TCM

ObjectiveClinic researchObserve the elderly patients’blood clotting after the femoral shaft fracture. Observe the effect of the using Tong Mai Tang(a special TCM soup for this research) treating the blood hyper-coagulable state after the femoral shaft fracture surgery. Observe the effect of preventing BVT. At the same time observe the occurrence of lower extremity deep vein thrombosis in these patients. In order to provide some clinical data for the treating the blood hyper-coagulable state after the femoral shaft fracture surgery with the traditional Chinese medicine.Animal experimentObserve the rat’s blood clotting after the femoral shaft fracture. Observe the effect of the using Tong Mai Tang treating the rat’s blood hyper-coagulable state after the femoral shaft fracture surgery. And compare the effect of using low molecular weight heparin(LMWH). This experiment could provide some reference for the making the mode of blood hyper-coagulable state. This experiment could help us to know the mechanism of high coagulation state. This experiment could observe the effect of the treating blood high coagulation state with Tong Mai Tang. This experiment could provide some experiment data for treating the blood hyper-coagulable state after the trauma with the traditional Chinese medicine.MethodsClinical researchThis is a randomized controlled trial (RCT) approach. From March 2014 to October 2014,60 elderly femoral shaft fracture patients who meet the standard participants were selected into our research as participantsOn the first day, we did a test on each participant(include D dimer (DDi), prothrombin time (PT) and platelet count (PLC)).We also have a color ultra-sonography test on each participants’lower thighs.On the second day, we did a surgery for each participant. Then we divided these 60 participants into two groups(30 cases in each group). Group A were treated with the TCM, Group B were treated with the Rivaroxaban (a western medicine).The period of reach is 10 days (the 3th day to the 11th day).On the day of 3"’,5th,9th,11th, we gave a test for each participant (include D-Di, PT and PLC).On each day, We also have a color ultra-sonography test on each participants’lower thighs. On each day, the outlook of lower thigh, face, tongue was observed. The pulse also was be checked. The occurrence of thrombosis of lower limbs were observed. At last,we compared the data of the each two group.Animal experimentsSelect 90 SPF healthy SD rats as the research object. Before the trial(On the first day), we did a test on each rat (include D-D, the AT-Ⅲ, PT, APTT, FDP). Then, On the second day,we did a surgery for each rat. Then we divided these 60 rats into 3 groups(30 cases in each group). Group A were treated with the TCM, Group B were treat with the low molecular weight heparin (LMWH, a western medicine), Group B were treat with nothing.On the day of 3rd,5th,9th,11th, we gave a test for each rats (include D-D、AT-Ⅲ、PT、APTT. FDP).The outlook of each rat’s lower thigh was observed. In addition, if some rats were diagnosed as the vascular thrombosis, we soon exposed the rat’ s deep vein in the lower limb, then use an electron microscope to observe the change of the vein of lower thigh. ResultsClinical researchFor the total of 40 cases, in the perioperative period (after an injury and before the operation), each patient D-Di, PLC is higher than the normal, PT is shorter than normal, but there is no DVT case was found after color ultra-sonography test. Each patient had a limb swelling, pain and lower thigh limited. These evidences tell us that these patients got into the hypereoagulable state after fracture. On the first day (before the operation), there is no significant statistical difference (p> 0.05) in each two group by the blood clotting test. Since the 3rd day(1 day after surgery), eachpatient’s D-Di, PLC was increased, PT was reduced, and then reached the peak on 5th. From 5th to 11th, D-Di, PLC was gradually reducing in each two group, PT was gradually extending in each two group. On the day of 3th,5th,9th,11th, by the result of color ultra-sonography test, no blood clot was found on each participant, it is prove that these two drug can prevent the occurrence of postoperative DVT. Compared with the result of 3rd, each participant in each two group got swelling relief and pain relief.At the same time, their face, tongue and pulse was improved. By the TCM symptoms, the effect of Group A is better than group B, there is a significant statistical difference (p<0.05). By the change of D-Di, PLC, there is a significant statistical difference (p> 0.05). It prove that there is no statistical differences between these two drugs.Making rat’s modelBefore the trial, we did a test on each rat (include D-D, AT-III, PT, APTT, FDP), the result conform the law of normal distribution.90 rats were got the surgery, On the second day (the surgery day),3 rats were dead due to the excessive anesthesia; 4 rats were dead due to the surgery fail; 2 rats were dead due to the over bleeding.81 rat were remained and all of them conform the requirement of the trial.Animal experiments60 rats were randomly divided into three groups:A group (TCM group), B group (LMWH group), C group (blank group). ③3rd day(1 day after surgery): All of the 81 rats’test result (include D-D, AT-Ⅲ, PT, APTT) was more than the result of 1st day. Randomly selected 3 rats from each group, and then check their lower limb venous by the electron microscopy. The result was that the vessels was been constricted and red blood cell was been agglomerated, and the endothelium-cell became thickening. It was certified that the we had made a right model:rats in hypereoagulable state after trauma. ②Since the 3rd day to the 5th’day, the hypereoagulable state in each group was getting worse, C group was especial severe.③Since the 5th day to the 11th day, the the hypereoagulable state of A and B group was getting better.The hypereoagulable state of the group C was gradually getting deteriorated, and reached its peak on 5"’day.By the electron microscope observation, the lower limb vein thrombosis in group C was also increased.④On the 7th day,3 rats were dead in group C. On the 9thday, another 3 rats were dead in group C, All the rats were dead by the pulmonary embolism (PE). The mortality caused by the DVT in Group C was 23.8%. ⑤compared the result of 5th day to that of 11th day, the change rate is no statistical difference (P> 0.05) in the group A and group B. It is confirmed that the effect of A drug is equal to B drugConelusionClinical researchAfter the surgery, the elderly patients with femoral fractures is easy to get into the hypereoagulable state.So they need timely intervention; Both the TCM and the Rivaroxaban can treat the patients with blood hypereoagulable state, both of them can prevent the occurrence of DVT. There is no significant statistical difference between these two drugs.Making rat’s modelThis method can successfully establish a model of femoral fracture.It have a good security, high uniformity, high success rate, high repeatability.Animal experimentsRats after surgery will quickly get into the hypereoagulable state. And the hypereoagulable state will gradually get worse.It will reach the peak on 3th day days after surgery, if there is no timely intervention, it will get into the period of DVT. At last, it will be dead caused by the PE. Both of the TCM and the LMW can improve the rat’s hypereoagulable state, and they also can prevent the occurrence of DVT.There is no significant statistical difference between these two drugs.