Abstract:

Objective To explore the clinical efficacy and safety of Tongluo Huoxue tincture combined with pestle needle for lumbar disc herniation（blood stasis and qi stagnation type）. Methods Randomized controlled trial was conducted and the patients were assigned to control group（n = 35）and observation group（n = 35）. T he control group was treated with conventional lumbar disc pestle needle，and the observation group was treated with Tongluo Huoxue tincture combined with pestle needle. After 4 weeks of treatment，visual analogue scale（VAS） score，Oswestry Disability Index（ODI）score，Japanese Orthopaedic Association（JOA）score，difference of clinical effect and the changing situation of TNF⁃α、IL⁃1βin the plasma and safety of the treatment were evaluated. Results After treatment，the VAS score，ODI score and JOA score of the same group were all significantly superior to those before treatment（P < 0.01），and the JOA score and ODI score of the observation group were both superior to those of the control group，and the difference was statistically significant（P < 0.05）. But there was no statistical significance in VAS score between the two groups after treatment（P > 0.05）. After treatment，the effective rate of the control group was 75.8%，while the effective rate of the observation group was 93.9%，which shows that the clinical efficacy of the observation group was better than the control group（P < 0.05）. The contents of TNF⁃α and IL⁃1β in plasma were both superior to those before treatment in the same group，and the difference was statistically significant（P < 0.01），and the TNF⁃α、IL⁃1β content in the plasma of patients from the observation group after treatment were both superior to these of patients from the control group，the difference was statistically significant（P < 0.05）. There was no significant difference in the safety of the treatment between the two groups. Conclusion The treatment of Ton⁃ gluohuoxue tincture combined with pestle needle could relieve clinical symptoms of lumbar disc herniation（blood stasis and qi stagnation type）obviously，and the clinical effect was superior to the treatment of pestle needle alone.

Key words:

Tongluo huoxue tincure, pestle needle, lumbar disc herniation, clinical research