Clinical And Experimental Study On Treatment To Obstruction Due To Cold-Damp Type Of Degenerative Lumbar Spinal Stenosis With Zhui Guan Ling Fang

Objective: To observe and study Zhui Guan Ling Fang’s anti-inflammative and analgesic effect, influence on micro-circulation as well as their machenism through clinical treatment to obstruction due to cold-damp type of degenerative lumbar spinal stenosis （DLSS） and the corresponding experimentsApproach: With the designs of random blocks, parallel comparison and single-center experiments, 40 patients with DLSS were selected and allocated into two groups at random, 20 were treated with Zhui Guan Ling Fang named treatment group and the other 20 treated with NSAIDS Diclofenac called control group. During the observation of one treatment course of four week’s time, the paitents were given the prescription everyday and visited once a week with written note. The related clinical symptoms and signs presented pre and post treatment were noted down and analyzed with VAS and JOA Grade Point System so as to find out difference in the key ones between the two groups and evaluate the effect. Safety evaluation was preformed with oral LD₅₀ and maximum dose test in mouse fed by Zhui Guan Ling Granula. Anti-inflammatory effect was observed by watching the swelling degrees of the mouse’ear auricle and influence on the permeability of abdominal capillary vessels. The analgesic effect was determined with body-torsion and hot-plate methods. And effect on the micro-circulation was judged by the influence of the micro-circulation on the mouse’s ear auricle.Result: All the 40 patients were observed completely. The pronounced effective rate was 75% in the treatment group and 65% in the control group. In the treatment group difference of pain before and after the treatment was significant （P<0.01） when checked with VAS and JOA Grade Point Evaluation System, but it showed no statistic significance when comparied with the control group（P>0.05）. In the treatment group one week after treatment, improvement of lumbago, leg pain, gait and living ability was significant in comparison with those before the treatment （P<0.05） . When comparied with the control group, the improvement of lumbago and leg pain was also significant （P<0.05）. The improvement of gait and living ability showed no statistic significance between the two groups （P>0.05）. There was no statistic significance in those symptoms and signs neither between the two groups in the last three weeks of the course （P>0.05） . Gastrointestinal discomfort occurring as side effect during the treatment was significantly less in the treatment group than that in the control group （P<0.05） .The experiments found no LD₅₀ in the mouse’s mouth after oral administration of Zhui Guan Ling granula. The maximum oral dose test showed no pronounced toxic reaction and death of the mouse within two weeks after oral administration. The prescription could alleviate swelling of the mouse’s ear auricle and lower the permeability of abdominal capillary vessel of the mouse, statistically significant in comparison with the blank group （P<0.05） .It could reduce body torsion and increase pain threthhold of the mouse, statistically significant in comparison with the blank group （ P< 0.01） It could also enlarge the caliber of artery vessels in the mouse’s ear auricle and decrease A/V caliber ratio, thereby accelarating blood circulation in the microvessels and showing pronounced difference between the two groups.Conclusion: Zhui Guan Ling Fang is effective in improving the symptoms and signs produced by obstruction due to cold-damp type of DLSS. The general effect is similar to that of Diclofenac. The improvement in pain, limp and living ability after treatment was obvious and durative, which showed no statistic significance in comparison with Diclofenac group except a slow pain allevation. Safety test found a lower incidence of gastrointestinal reaction in the treatment group than Diclofenac group and thereby proved it a safe prescription. To sum up, this prescription is safe, possesses antiinflammative and analgesic function and improve microcirculation by dialating minor vessels.