| Objective: 1.To observe the clinical efficacy of aconitum decoction in the treatment of lumbar osteoarthritis with Yang-deficiency,cold-dampness,and arthralgia syndrome.2.To observe whether aconitum decoction has a regulating effect on the body constitution of patients with lumbar osteoarthritis of Yang deficiency,cold and damp syndrome;3.Observe the change rule of heat value of infrared thermograph at mingmen point and yaoyangguan point in patients with lumbar osteoarthritis of Yang deficiency and cold dampness syndrome.Methods: a total of 80 subjects were enrolled in the experimental group(40 subjects)and the control group(40 subjects).Intervention of aconitum decoction plus or minus(formula granule)was given to the test group.The control group was treated with diclofenac sodium enteric-coated tablets(Beijing novartis,25mg/ tablet),twice a day and once 50 mg.Both groups were treated for 4 weeks,and efficacy and safety were evaluated after 4 weeks.Results:1.A total of 40 patients were in the experimental group,of whom 8 were lost.The clinical control,significant effect,effective and ineffective were 3,13,12 and 4,respectively,with an effective rate of 87.5%.In the control group,there were 40 patients and 9 patients were lost.The clinical control,significant effect,effective and ineffective were 0,7,19 and 5 patients,respectively.The effective rate was 83.9%.The rank-sum test showed that there was a significant difference in the distribution of effective rate between the two groups(P < 0.05).The total score of symptoms in the two groups was significantly better after treatment than before treatment(P < 0.01),but the comparison between the two groups showed that the total score of the test group was significantly lower(P < 0.01).The experimental group was superior to the control group in improving the disadvantage of "squatting or bending" flexion and extension(P < 0.01).The mean VAS score of patients in the two groups after treatment was significantly improved compared with that before treatment(P < 0.01),but there was no significant difference between the two groups after treatment(P >0.05).2.After treatment,the conversion scores of yang-deficiency qualitative items in both groups were lower than those before treatment(P < 0.01),while the mean conversion scores were significantly lower in the experimental group(P < 0.01)after treatment than those before treatment(P < 0.01),but the yang-deficiency constitutions in both groups were not changed after treatment.3.After treatment,the calorific value of infrared thermograms at mingmen point and yaoyangguan point showed an upward trend(P < 0.01),which was significantly increased in the experimental group by comparison between the two groups(P < 0.01).According to the analysis,the higher the VAS score,the lower the temperature of yaoyangguan and mingmen(P < 0.01,-0.6 < Pearson correlation coefficient <-0.4).However,there was no correlation between the conversion of Yang deficiency and the calorific value of infrared thermograms at mingmen point and yaoyangguan point before and after treatment(P > 0.05).4.A total of 5 patients in the two groups had adverse reactions,and 2 patients in the experimental group had mild gastrointestinal symptoms(incidence rate: 6.25%).Three patients in the control group had mild gastrointestinal symptoms(6.45%)and mild skin rash(3.23%).Both groups of patients with adverse reactions could continue the study after treatment.Conclusion: 1.The effect of aconitum decoction and diclofenac sodium enteric-coated tablets in the treatment of lumbar osteoarthritis with Yang deficiency,cold dampness and arthralgia syndrome can relieve pain and improve symptoms.Among them,aconitum decoction and diclofenac sodium enteric-coated tablets to alleviate pain similar effect.In addition,aconitum decoction can improve the symptoms of "adverse flexion and extension".2.Aconitum decoction may improve the effect of yang-deficiency constitution,but whether it can transform yang-deficiency constitution is still uncertain. |
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