| Objective:The purpose of the study was to observe the effect of external washing recipe of Chinese medicine in the treatment of primary knee osteoarthritis.Methods:A randomized controlled clinical trial was designed to collect 114 patients--including 21 males and 83 females,who met the inclusive criteria--from June 2018 to January 2019 in General Orthopaedics Clinic in Wang Jing Hospital of China Academy of Chinese Medical Sciences.The experiment was randomly divided into control group and experimental group according to the ratio of 1:1.The control group was injected with sodium hyaluronate injection,3ml/time,once a week for 5 weeks.Tongzhi Surunjiang Capsule,taken orally,7 capsules per time,2 times per day for 5 weeks.On the basis of the control group,the experimental group was added with Chinese herbal medicine for external use,including external washing and hot compress.The prescription of Chinese herbal medicine was 20 g of Lycopodium Clavatum,20 g of Tuberculate Speranskia Herb,20 g of Lulutong,20 g of Rhizoma Homalonemae,10 g of Radices Cyathulae,10 g of Rhubarb and 15 g of Radix Clematidis.There are three time points to observe including before treatment,after treatment and one month after treatment.The scores of clinical symptoms and signs were recorded at each time point to understand the onset time,efficacy,safety and occurrence of adverse events.Results:In the course of treatment,there were 5 cases of exfoliation and 97 cases were observed,including 18 males and 79 females.1.Symptoms and signs scores evaluation:(1)General data comparison:There was no statistical difference in Kellgren and Lawrence image classification,sex data,age date,Lysholm score or individual symptoms between the two groups before treatment(P>0.05).(2)Evaluation of the totality effective rate:the totality effective rate of the experimental group and the control group:after treatment(93.8%vs 81.2%)and one month after treatment(93.8%vs 89.5%).Both the experimental group and the control group were effective,but the effective rate of the treatment group was higher than that of the control group after treatment and one month after treatment.(3)Symptom integral analysis:After treatment and one month after treatment,the total integral of the experimental group and the control group were improved,the difference was statistically significant(P<0.05).The scores of each item increased after treatment and one month after treatment,and the difference was statistically significant(P<0.05).After treatment,the scores of Pain,instability,squatting,swelling,climbing stairs,limping.interlocking,support in the experimental group were better than those in the control group,with statistical significance(P<0.05).One month after treatment,the scores of rPain.instability,squatting,swelling,climbing stairs,limping,interlocking of the two groups improved significantly,with statistical significance(P<0.05).However,the support demand integral of the experimental group did not change significantly(p>0.05),and the support demand of the control group was improved.2.Safety evaluation:The herb was given in External methodin the experiment.So it did not enter the systemic circulation,nor did it pass through the metabolism of liver and kidney.In the experiment,there were 5 cases of skin allergy,which were all improved after drug withdrawal,which indicated that the external washing prescription of Chinese medicine was more safe and reliable in the treatment of knee osteoarthritis.Conclusions:1.Chinese herbal medicine external washing prescription has a definite curative effect on knee osteoarthritis,which is better than simple oral and intra-articular injection alone2.External washing prescription of traditional Chinese medicine can effectively improve symptoms of joint pain and swelling,especially for rest pain,tenderness,swelling,mobility,limp and other symptoms3.It is more safe and reliable to treat knee osteoarthritis with external washing prescription of traditional Chinese medicine. |
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