| Objective To study the curative effect and security of Gubitong Recipe on treating knee osteoarthritis(KOA),to enrich the theory of KOA and provide new ideas and methods for the prevention and treatment of KOA in Traditional Chinese Medicine.And to observe the effect of Gubitong Recipe on the morphology of articular cartilage in rat knee osteoarthritis model,and to provide a basis for further exploration of the mechanism of KOA.Methods 1.Clinical study:A prospective,randomized controlled study was conducted in 80 patients with KOA who were enrolled in the China-Japan Friendship Hospital from September 2016 to February 2017.The treatment group(40 cases)and the control group(40 cases)were treated with Gubitong Recipe and aminoglucose capsules respectively for 4 weeks randomly.Compared liver and kidney function,blood,urine and other safety indicators,WOMAC osteoarthritis index and TCM syndrome quantification standard score.2.Experimental study:Thirty-six SD rats were randomized into a blank group,a model group,a positive drug group,the low-dose,middle-dose and high-dose groups of gubitong formula,6 rats in each one.In the later 5 groups,Hulth was used to prepare OA model.Since the 3rdday,drug gavage was applied after the operation.In 4 weeks of medication,the rats were sacrificed and the materials were collected-The gross observation and HE staining were adopted.Mankin’s scale was used for the evaluation.The data were analyzed statistically.Results 1.Clinical study:There were 73 cases(treatment group 37 cases,control group 36 cases,)of the final subjects,shedding rate<20%.There was no significant difference in the baseline on age,course of disease,TCM syndrome quantification score and WOMAC osteoarthritis index(P>0.05).After treatment,TCM syndrome score and WOMAC score in the treatment group were significantly lower than those in the control group(P<0.01).The TCM syndrome score and WOMAC score of the treatment group were significantly lower than those of the control group(P<0.01).The total effective rate(78.4%)in the treatment group was significantly lower than that(44.4%)in the control group(P<0.01).The incidence of adverse reactions in the treatment group(8.1%)was lower than that(11.7%)in the control group(P<0.01).2.Experimental study:In every gubitong formula group and the glucosamine hydrochloride group,Mankin’s score was lower than that in the model group(P<0.05).In the high-dose and low-dose gubitong formula groups,Mankin’s score was lower than that in the low-dose group and the glucosamine hydrochloride group,indicating the significant difference(P<0.05).Conclusion:1.Gubitong Recipe can significantly improve the score of TCM syndrome and WOMAC and can effectively relieve knee pain,stiffness and improve knee function in patients with KOA;2.The incidence of adverse reactions in Gubitong Recipe group was low,and it is safe and good in treating with KOA;3.Gubitong Recipe can reduce the rate of using acetaminophen in patients with KOA;4.Gubitong recipe can delay the pathological development of joint cartilage in OA animal,suggesting that this formula delays the apoptosis of chondrocytes possibly through improving the repair ability of chondrocytes. |