The Research Of Bitongxiao Unguent For Acute Closed Soft Tissue Injury In Efficacy And Safety

Objective:To evaluate the clinical efficacy and safety of Bitongxiaogao Unguent in treating acute closed soft tissue injury(syndrome of qi stagnation and blood stasis).To explore the effective dose of Bitongxiaogao Unguent for the treatment of acute closed soft tissue injury(syndrome of qi stagnation and blood stasis)?Methods:Select 240 cases who suffer from acute closed soft tissue injury(syndrome of qi stagnation and blood stasis)following center stratified,blocked randomization,double-blindness,placebo-controlled,multicenter study method.According to the principle of 1:1:1 distribution,they were randomly divided into high-dose group,low-dose group and the placebo-control group which were got corresponding treatment.After seven days as one course,they were observed the pain score,traditional Chinese medicine(TCM)symptom,physical sign and single grade changes in order to evaluate the effectiveness of drugs.Meanwhile,The patients were observed the laboratory indexes of the blood routine,urine routine stool routine,cereal third transaminase(ALT),urea nitrogen(BUN),creatinine(Cr)and electrocardiogram(ECG)during the test,as well as the incidence of adverse reactions were be observed to evaluate the safety of Bitongxiaogao Unguent.Results:Bitongxiaogao Unguent in the treatment of acute closed soft tissue injury(syndrome of qi stagnation and blood stasis)has obvious curative effect and high safety.Curative effect evaluation:Comparison of the three groups' pain VAS assessment before treatment and after based on MITTP,the difference were statistically significance(P<0.001),the pain VAS all had varying degrees of relief,especially the high dose experiment group.Comparison of the three groups' total symptoms integral before treatment and after based on MITTP,the difference were statistically significance(P<0.001),the total symptoms integral all had varying degrees of relief,especially the high dose experiment group.Comparison of the three groups' curative effect evaluation of TCM symptoms before treatment and after based on MITTP,the difference were statistically significance(P<0.037)of fully test.The high dose experiment group had the best curative effect Whether on the significant efficiency or the total efficiency based on TCM symptom score,and they are respectively 82.3%and 94.9%after use the durg.Comparison of the three groups' single traditional Chinese medicine indexs before treatment and after,the difference were statistically significance(P<0.581),and the concequence of the single indexs after treatment were significantly lowered,besides the constipation of the lacebo group and the high dose experiment group.Safety evaluation:In the present clinical observation,the incidence of the adverse drug event is 0%of both the test group and control group during the treatment.The laboratory indexes before and after the treatment of the two groups patients are normal.These all means that Bitongxiaogao Unguent has high clinical security.Conclusion:Bitongxiaogao Unguent can improve the symptoms such as pain,swelling,ecchymosis and so on of acute closed soft tissue injury(syndrome of qi stagnation and blood stasis)patients,which proved the definite curative effect.The laboratory indexes and the zero incidence of adverse reaction testified the safety.Therefore,it is worthy of clinical popularization and aPPPlication.Meanwhile,it is recommended to expand the number of cases for further determine the efficacy and safety for the treatment of acute closed soft tissue injury.