Compound The Tripterygium Balm Treatment For Knee Arthritis Experiments And Clinical Studies

Objective; Osteoarthritis(OA) is one of the common reheumatic disease in older patient ,and occurs more often in the knees .This disease belongs to the category of "bi zheng"'m Traditional Chinese Medicine(TCM),and it's therapeutic principle is as follows : tonifying the liver and kidney , promoting blood circulation to remove obstruction in the channels, dispersing wind and removing dampness. To externally use the Chinese herbal drug on local can rapidly control the arthritic inflammation . One of that is the compound Tripterygium Wilfordii(TW) Hook film 梐 self-developed external use drug created by Pro. Dengzhaoahi . In order to realize it's transdermal absorption and evaluate it's clinical effect on OA , we apply a simple external drug of TW as a comparison.Setting: the second hospital affiliated to Guangzhou University of Traditional Chinese Medicine.Patients/participants: All the patients involved in the study were the successive outpatients of the department of osteologic disease of the second hospital affiliated to Guangzhou University of Traditional Chinese Medicine from December,2001 to March,2002. The selected cases were those meeting the ARA criteria for Osteoarthritis, 1986, and the revised criteria based on the clinical golden rule of Traditional Chinese Medicine.Methods:1. Zoopery : Apply the drug to knee joint of SD rats , then examine the locate and the plasma concentration of Triptolide , which labelled by tritium , to realize it's transdermal absorption.2. Clinical trial : The study was designed as a randomized single-blind controlled trial of the topical application of TW . The study duration was 2 weeks. Patients who meet the entry criteria were randomly assigned to receive TW Co. Or TW Single. Patients were instructed to apply the drug to painful and/or swollen knee joints 3 times everyday. Patient pain > stiffness an function were recorded by physician , and evaluated by the Western Ontario and Mcemaster University (WOMAC) Osteoarthritis Index .All the data were input to computer to analyze.Result:K Zoopery :Triptolide's peak concentration in synovium is two hour(l 1.593 ng/100mg) in compound group, while that in single group is one and a half hour(14.533 ng/100mg),the latter is faster and several fold higher than the former. Triptolide's Peakconcentration in plasma in both two group is one hour(in compound group is 1.446 ng/0.1ml, while in single group isl.579 ng/0.lml) ,the latter is higher than the former .2. Clinical trial: After 2 weeks treatment, all the WOMAC index were significantly improved in both group . Except the stiffness index , a remarkable difference is seen between the two groups.Conclusions: The present study shows that the compound Tripterygium Wilfordii(TW) Hook film can pass through the skin of the mice , and come to synovium. It can improve the pain> stiffness and function in OA patients by promoting blood circulation to remove obstruction in the channels, dispersing wind and removing dampness .So it can be used as a safely and effectively external use drug in OA.