Clinical Studies On The Compound Southern Star In Treating Prolonged Cold-damp Obstruction Type Of Knee Osteoarthritis

Background:Knee Osteoarthritis (KOA) is a common and comose clinical disease, Repeated illness, touching refractory,In40years later for multiple people, which is a second major disease After cerebrovascular disease leading to loss of ability to work, Whi le the external treatment of traditional Chinese medicine is a simple and effective method for the treatment.So far, all of the external plaster exist the following problems:The one is even less external plaster after the new drug clinical trials. The other is considerably more traditional Chinese medicine ointment useless after the new drug clinical trials;They are non-inferiority design of all positive control drug. Problems due to the choice of the positive control drug (the choice of the positive control drug has not been placebo-controlled clinical studies, not even after the new drug clinical trials) result in the effectiveness evaluation of the test drug.In view of the above issues, the trial evaluates the effect of relief pain of compound Southern Star balm, which is a pain and cold commonly used topical Plaster, compared to placebo and positive drug, which can provide the treatment basis for knee osteoarthritis pain on selecting commonly used topical plaster, which provides the basis for clinical studies of topical analgesic class Plaster when choices the positive control drug.Objective:1. The main purpose of:a placebo and drug control evaluate analgesic effect of compound Southern Star balm, which is a pain and cold commonly used topical Plaster, which can provide the treatment basis for knee osteoarthritis pain on selecting commonly used topical plaster.2. Secondary objectives:2.1The trail provides the basis for clinical studies of topical analgesic class Plaster when choices the positive control drug.2.2Specification clinical research program of pain class topical Plaster was formed.2.3The mechanism of analgesia, anti-inflammatory effects of pain and cold topical Plaster in treating alpine Blockage of knee osteoarthritis were exploredMethods:This study is a randomized, double-blind, positive control, placebo control, superiority design. In June-November2010in Foshan Hospital of Traditional Chinese Medicine orthopedic clinic patients, The trail selected150cases that met the inclusion criteria but does not include any of exclusion criteria. Clinical trials is based on the2:2:1control principles, including60cases of the experimental group, in60cases of the positive control drug,30cases of of the placebo control group. The treatment group was received the compound Southern Star balm; positive control group was treated with injury wet pain relief cream; placebo control group was given the acrylic pressure-sensitive adhesive tape. These three groups of patients were given treatment for6days to observe the three VAS scores of painful joints, TCM syndrome score, the WOMAC points, and serum β-endorphin, IL-6, E2content change and its adverse drug reaction.Results:VAS scores, TCM syndrome score and the WOMAC points of the three; groups of subjects are reduced, and the3groups before and after treatment were significant differences after treating6days(P<0.01), among which showed statistical significance.After6days of treatment, serum IL-6and E2levels of the three groups were i ncreased, but not statisticaly significant (P>0.05). Serum β-endorphin content in the test group and the positive control group before and after treatment has significant differences (P<0.05) and there are significant differences (P<0.05) compared with placebo;compound Sonthern Star balm was efficient better than a positive drug and placebo groups, but has not yet formed a significant difference (P>0.05).Conclusion:In summary, Compound Southern Star balm is a Chinese herb plasters, which treated the prolonged cold-damp obstruction type of knee osteoarthritis,clinical curative effect well and adverse reactions less, which is worthy of clinical application. The playing of Inflammatory and analgesic effects associated significantly with the increase of β-endorphin in the peripheral blood.