| Objective: This project aims to identify the clinical efficacy and safety of Qingre Dehumidifying Analgesia Liquid Combined with Sodium Hyaluronate for mild-tomoderate knee osteoarthritis of Wind-Damp-Heat-Impeding Type by Prospective clinically random control study,In order to build a foundation for exploring the mechanism of oral Qingre Dehumidifying Analgesia Liquid Combined with Sodium Hyaluronate for treatment of knee osteoarthritis of Wind-Damp-Heat-Impeding Type.Methods: According to the inclusion criterias,we selected a total of 72 patients with mild-to-moderate Knee Osteoarthritis of Wind-Damp-Heat-Impeding Type(according to the clinical diagnosis and treatment project of the state administration of TCM 2010 disease of knee osteoarthritis,standard screening knee osteoarthritis of Wind-Damp-Heat-Impeding Type)who were admitted to the first affiliated hospital of Gansu University of Chinese Medicine between October 2016 and August 2017.We used IBM SPSS Statistics software 23.0 to complete random grouping.They were randomly divided into 2 groups,and each group had 36 cases.There was no significant difference in comparing the two groups,such as age,duration of illness,gender,BMI,and lateral knee joint kellengren-Lawrence radiology diagnostic classification(P>0.05).Two groups of patients were given sodium hyaluronate injected into knee joint cavity.In addition,the experiment group took the Chinese native medicine Qingre Dehumidifying Analgesia Liquid,and the control group took acetaminophen tablets,and 4 weeks for a period of treatment.Curative effect evaluation was used by VAS,Western Ontario McMaster Universities Osteoarthritis Index.At the same time,we calculated clinical total effective rate after treatment,and the basis was the Western Ontario McMaster Universities Osteoarthritis Index.The nodes that collected these indicators were before the treatment,at the end of the treatment,after the end of the treatment in the third month and the sixth month.In addition,the SF-36 health questionnaire was used in our study to observe the general health status before and after the treatment.Color High Frequency Doppler technique was used to check the thickness of the knee joint effusion,synovial thickness and thickness of weight-bearing area of the medial femoral.By returning venous blood samples to test liver function,kidney function,and observation any adverse reaction of patients during treatment and followup.Evaluation of adverse reaction and the correlation of the study,in order to evaluation the clinical safety after treatment.Results: After the treatment,the two treatment groups' patients,experiment group and the Control group,had improved in symptoms and signs.Among them,4 cases of clinical were cured,29 cases curative effect was distinct,3 cases with no obvious improvement after treatment.These results confirmed that the total effective rate of the experiment group was 91.7%.In the experiment group,3 cases of clinical were cured,and effective,28 cases were effective,and 5 cases were ineffective.The total effective rate was 86.1%.The total effective rate of experiment group was higher than that of the control group(P < 0.05).VAS score and WOMAC score were significantly improved at the end of treatment and at the 3rd,6th after the treatment.VAS score of the experiment group was better than that of the control group in the 6th month after treatment(P < 0.05).There was no significant difference in VAS score between the treatment group and the control group at the end of treatment and the 3rd month after treatment(P > 0.05).At the end of the treatment of the third months and sixth months,we evaluated again,the improvement of the treatment group index observation was better than that of control group(P < 0.05).After treatment with contrast before treatment of the two groups,these levels of RF,RP,BP,GH,VT,SF,RE,EWB were significantly improved(P < 0.01);Comparison between the two groups,the levels of RP,BP,VT,SF,RE and EWB of treatment group is significantly higher than that control group(P < 0.01).Comparison with two groups,the sixth months after treatment,the RP,BP,VT,SF,RE and the level of EWB in experiment group were significantly higher than that of control group(P < 0.01).After the treatment,the improvement of RF levels of the experiment group was better than that of the control group(P < 0.05).There was no significant difference in the improvement of GH level in the two groups after treatment(P>0.05).Color High Frequency Doppler examination results showed that after the treatment of the sixth month,the knee joint effusion was lower than that of before the treatment(P<0.05),and the experiment group was better than that of control group(P< 0.05).After the treatment of the sixth month,the thickness of weightbearing area of the medial femoral and thickness of the synovial membrane for two groups of patients had no obvious improvement(P>0.05).There was no significant difference in the thickness of weight-bearing area of the medial femoral and thickness of the synovial membrane(P>0.05);compared with before treatment,levels of liver function,kidney function had no significant difference(P>0.05).Two groups of patients had no serious adverse events occurred during the follow-up period,and no adverse reaction occurred.Comparing the two groups of patients' safety,there were no differences too.Conclusions: 1.Both of taking Qingre Dehumidifying Analgesia Liquid combined with Sodium Hyaluronate and taking acetaminophen tablets combined with Sodium Hyaluronate had better short-term efficacy for patients with mild to moderate knee osteoarthritis.2.The clinical efficacy of taking Qingre Dehumidifying Analgesia Liquid combined with Sodium Hyaluronate was better than that of taking acetaminophen tablets combined with Sodium Hyaluronate.3.Qingre Dehumidifying Analgesia Liquid has the effect of Qingre dehumidifying,xuan bi and relieve pain,invigorate liver and kidney,dredge the meridian.And its effect of early treatment for patients with mild-to-moderate knee osteoarthritis was accurate.4.Taking Qingre Dehumidifying Analgesia Liquid combined with Sodium Hyaluronate injected into knee joint cavity treatment for knee osteoarthritis of Wind-Damp-HeatImpeding Type had high clinical safety. |
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