| Research objective:Prospectively study, objectively observe and assess the clinical effects and safety of Xibitong (medicine for curing paralysis of the knee)(with main functions of tonifying liver and kidney, diuresis and dehumidification, and promoting blood circulation to arrest pain), as well as understand the features and advantages of this medicine, so as to provide experimental basis for future promotion.Methods:Randomly divide the patients with early knee osteoarthritis in the outpatient department I for arthrosis of Wangjing Hospital, China Academy of Traditional Chinese Medicine into experimental group A (30cases) and control group B (30cases). In experimental group A, providing Zhang Hongmei-the advisor with modified clinical prescription, traditional Chinese medicine of fried-free granules:Xibitong ingredients (this prescription has applied for the preparations of Wangjing Hospital, China Academy of Traditional Chinese Medicine and accordingly being named):Chinese Foxglove15g, poria cocos15g, rhizoma alismatis9g, pulp of dogwood fruit12g, roasted Rhizoma Atractylodis Macrocephalae9g, radix clematidis9g, homalomena occulta9g, medicinal cyathula root9g, rhizoma corydalislOg and liquorice6g. Usage:take medicine after mixing it with water, one dose per day, taking twice. Observation period:3weeks for a course of treatment, and continuously taking medicine for one course of treatment. Provide control group B with Kangguzengsheng jiaonang (capsule for curing hyperostosis)(produced by Jiangsu Kanion Pharmaceutical Co., Ltd.100granules per box, with0.35g of each granule) Usage:take5granules at a time, and three times per day. Take3weeks for a course of treatment, and continuously taking medicine during course of treatment. Keep follow-up records before treatment,1week later and after one course of treatment,3timing points in total. Carry out knee TCM syndrome grading, WOMAC grading [1], and evaluate the efficiency and safety. Record and analyze the results to further understand the clinic effect of Xibitong on early knee osteoarthritisRecord and analyze the collected experimental data by SPSS22.0Results:1. It is found by comparing the WOMAC grading of group A and group B before treatment that the WOMAC grading of group A is (110.5333±8.42710), and that of group B is (107.6000±6.06630). Before treatment, it is found by statistical analysis on WOMAC grading between the two groups that there is no obvious differences and it is of no statistical significance. It is found by comparing the two groups before and after treatment that there is obvious improvement and obvious differences (P<0.05), and it is of statistical significance. It is found from the inter-comparison between the two groups that there is no obvious difference (P>0.05), and it is of no statistical significance. The effect of group A is better than group B as concerning about the improvement degree.2.TCM symptoms curative effect observation results show that:The treatment group30cases, The total effective rate was93.3%, The clinical control of0,15cases were markedly improved (50%), Effective in13patients (43.3%), Is invalid in2patients (6.7%); Control group30cases, The total effective rate was93.11%, Clinical control0cases,11cases were markedly improved (36.7%), Effective16cases (53.3%), Is invalid in3patients (10.00%). After statistics processing, Two groups show significant differences rate and total effective rate control (P>0.05), Description of TCM symptoms curative effect of treatment group and control group have no significant differences.Conclusion:1、The two groups has curative effect in the early knee osteoarthritis with deficiency of liver and kidney and Qi-stagnation and blood stasis, but the curative effect of group A is better than that of group B in curing arthralgia and improving function.2、There is no obvious difference between the two groups in improving TCM syndrome. It is obvious that the effects of Xibitong are comparable to the listed Kangguzengsheng jiaonang in curing early knee osteoarthritis with deficiency of liver and kidney and Qi-stagnation and blood stasis.3、It is found from the safety evaluation of group A and group B that except for a few individual cases in group B are suffered from slight gastrointestinal tract discomfort, other cases are free of untoward effect after took medicines. It is proved that Xibitong is safe and reliable.4、Xibitong is effective in curing early knee osteoarthritis and provides clinic basis for curing knee osteoarthritis by means of tonifying the liver and kidney, diuresis and dehumidification, and promoting blood circulation to arrest pain. |
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