| Objective:The purpose of this study is to evaluate the change of KOA pain and the improvement of knee joint function before and after the treatment of phase I-III(Kellgren Lawrence classification)by clinical observation of Yuanhu Zhitong dropping pill,and to evaluate its efficacy and further evaluate its clinical safety by comparing with diclofenac sodium sustained-release capsule.Methods:From July 2019 to December 2019,60 subjects of KOA I-III(Kellgren Lawrence classification)who were hospitalized in the First Affiliated Hospital of Gansu University of traditional Chinese medicine were studied by single center,randomized controlled and non inferiority clinical trials.60 patients who met the trial criteria were randomly divided into two groups,namely the trial group and the control group.The experimental group was intervened by Yuanhu Zhitong dropping pill and the control group by diclofenac sodium sustained-release capsule.One week after treatment and four weeks after treatment,the patients were followed up to compare the pain(VAS score),gastrointestinal function(GSRS score),knee joint function(WOMAC score),safety(ECG,blood routine,biochemical function,complications),and to evaluate the effectiveness and safety of Yuanhu Zhitong dropping pill in the treatment of KOA I-III(Kellgren Lawrence type).Result:60 patients were included in this study.There were 30 cases in the experimental group and 7 cases dropped off,among which 4 cases were asked to leave the group due to the effect was not obvious,2 cases lost their visit,1 case used other drugs that affected the efficacy without permission,and finally participated in the statistics of 23 cases;there were 30 cases in the control group and 5 cases dropped off,among which 3 cases were terminated due to adverse reactions,1 case lost the visit,1 case used other drugs that affected the efficacy without permission during the study,and finally participated in the statistics of 25 cases.VAS score: the average VAS score of the experimental group and the control group before and after treatment was 34.91 ± 9.62 and 37.88 ± 12.26,compared with the average VAS score of the experimental group and the control group after 4 weeks of treatment,20.26± 6.52 and 20.92 ± 8.52,the pain in the two groups was relieved before and after treatment(P< 0.05).According to the test level of α = 0.025(one side),it can be considered that the VAS score of the two groups was not inferior.WOMAC score: The mean values of the test group and the control group were 33.61 ±6.89,36.56 ± 10.45,28.61 ± 7.13 and 28.68 ± 6.59,23.13 ± 6.46 and 23.08 ± 5.82,respectively.The total score and items of WOMAC in the two groups were lower than those in the same group(P < 0.05)after one week and four weeks of treatment(P < 0.05).According to the test level of α = 0.025(one side),it was considered that the score of WOMAC in the two groups was not inferior.GSRS score: The mean values of the experimental group and the control group were21.00 ± 8.20,19.08 ± 3.05,19.00 ± 4.57 and 21.72 ± 3.73,17.00 ± 2.64 and 25.88 ± 7.90,respectively,before treatment,1 week and 4 weeks of treatment.The results showed that the effect of the experimental group was significant in improving the gastrointestinal function,and the gastrointestinal function of the control group was heavier(P < 0.05).The adverse drug reactions of the control group were greater than that of the experimental group.Conclusion:1.Yuanhu Zhitong Drop Pills can effectively alleviate the pain symptoms of knee joints in patients with mild to moderate KOA,and its analgesic effect is not weaker than sodium diclofenac sustained-release capsules;2.Yuanhu Zhitong Drop Pill can effectively improve the function of knee joint in patients with mild to moderate KOA,especially in terms of stiffness and difficulty of joint movement,and its effect is not weaker than diclofenac sodium sustained-release capsules;3.Taking Yuanhu Zhitong dropping pill(≦4 weeks)has good safety and is superior to diclofenac sodium sustained-release capsule in gastrointestinal reaction. |
