| Research Background:Knee osteoarthritis is a degenerative joint disease, is caused by degeneration of the synovial joints with joint pain, stiffness, and activities of joint disease characterized by limited. Light person performance is associated with the activity of pd symptoms of joint stiffness and intermittent pain, the person that weigh is persistent severe pain and joint activities is limited, more serious will appear limp and joint instability, ultimately lead to the loss of joint function, seriously affecting people’s normal work and life. High incidence of the disease, especially in the elderly population is a kind of common disease, frequently-occurring disease, is difficult to cure, easy recurrence, clinical characteristics, seriously affecting people’s quality of life.Currently, for more severe knee osteoarthritis patients, conservative therapy of Chinese and western medicine are not good, often require surgical treatment. And for knee osteoarthritis patients early, all use drugs such as Chinese and western medicine conservative treatment. Methods of western medicine treatment of this disease is relatively limited, and the side effects is more, also nots allow to ignore to the side effects of liver, kidney, both is unfavorable for long suit. Compared with traditional Chinese medicine in the diagnosis and treatment of knee osteoarthritis is more unique, through treatment based on syndrome differentiation, and overall adjustment, inside and outside, have relieve symptoms, improve function, forward the advantages of the effect is good. Chinese medicine for external use for medicine as one kind of commonly used in the treatment of knee osteoarthritis, because of its side effects, simple, small curative effect, economical and practical characteristics, deeply patients, clinicians have been widely used.Clinical ResearchPurpose of Research:1. Objectively evaluate the clinical efficacy of treating the knee osteoarthritis by Xuan Bi lotion.2. Clear the clinical characteristics and advantages of Xuan Bi lotion, provide evidence-based medical basis for its clinical application.Methods:Using the method of clinical observation,the subjects were outpatients of the Wang Jing Hospital of CACMS.According to the case into and out of the standard choice case,112cases, using stochastic random number table method,58cases of test group and control group54cases.Experimental group accepted the hot compress on knee by Xuan Bi lotion.Every medicine use2days,2times a day, every time20minutes, treatment for2weeks (continuous). Control group received the Didofenac Diethylamine Gel brushing coated the knee. Every time apply amount is about3-5cm or more ointment,3times a day. treatment for2weeks (continuous). Use the VAS pain score and the HSS knee joint integral to compare the analgesic effect and clinical curative effect before and after treatment.Results:Before treatment, experimental group and control group has no statistical significance in the difference of gender, age, course, scores of clinical symptoms(P>0.05). Before treatment, the baseline of the treatment group and the control group is consistent, comparable, and reliability.Through evaluation results of the curative effect, it can be seen that the treatment of knee osteoarthritis by Xuan Bi lotion is positive.Short-term efficiency (on2weeks)was77.6%, obvious efficiency was13.8%. total efficiency was91.4%.1month follow-up, the efficiency was77.6%, obvious efficiency was6.9%, total efficiency was84.5%. Through the chi-square test of curative effect, two groups have significant statistical difference (P<0.01). Average efficacy index of the experimental group on third visit and follow-up were higher than the control group. Through the T test of efficacy index, two groups have significant statistical difference (P <0.01).Through the comparison of the two groups of the HSS knee score on every visit time compared with the score before treatment, there was significantly statistical difference in both treatment group and control group starting from the second visit (P<0.01).Through the comparison of the two groups of the VAS pain score on every visit time compared with the score before treatment, there was statistical difference in treatment group on the first visit(P<0.05).There was significantly statistical difference in both treatment group and control group starting from the second visit (P<0.01).Through the comparison of the two groups of the difference of HSS knee score on every visit time with the score before treatment.The treatment group’s difference of HSS knee score were greater than the control group’s.And, there was significantly statistical difference between treatment group and control group starting from the first visit (P<0.01).Through the comparison of the two groups of the difference of VAS pain sore on every visit time with the score before treatment.The treatment group’s difference of VAS pain score(absolute value) were greater than the control group’s.And, there was significantly statistical difference between treatment group and control group starting from the first visit (P<0.01).Through the analysis of HSS knee score and VAS pain score at each visit point of the two groups, It can be infer that the clinical symptoms and pain of knee osteoarthritis kept improveing within2weeks under treatment. At1month follow-up visit,the score was lower than the third visit’s. Two groups of patients were not seen at the end of the course to achieve clinical control.One patients appeared slight skin rash whthin the area where the Xuan Bi lotion used. After drug withdrawal,symptoms disappeared automatically. There was no other adverse reactions. Each patient of the two groups’ safety evaluation indicators was not beyond the normal range before and after treatment.Conclusion:1.Xuan Bi lotion can effectively improve the clinical symptoms of knee osteoarthritis, and the short-term curative effect is stable.2.The curative effect of knee osteoarthritis treated by Xuan bi lotion was obviously better than the Didofenac Diethylamine Gel’s.3. The security of Xuan Bi lotion is higher,.Less adverse reaction occurred.In conclusion, through controlled clinical study, we have obtained the curative effect of treating knee osteoarthritis by the Xuan Bi lotion, achieved the purpose of the study. It provided the basis of evidence-based for the clinical application. At the same time, it laid the foundation for further study. |
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