| Rheumatoid arthritis(RA) is a chronic, systemic and autoimmune disease, which infringes the joints and tissues around joints. The disease is characterized by recurrent synovitis and lead to joint deformity and dysfunction eventually. It is very difficult to treatment that its etiology is not clear. The main treatment is control the inflammation and joint injury, and delay the pathological lesions caused by immunoreaction. RA is belongs to category of "Arthralgia Syndrom" in traditional Chinese medicine(TCM), which get significant effects under the guide of differential treatment of TCM.In clinical application, toxic herbs have a significant therapeutic effect on the treatment of arthralgia syndrom, such as Tripterygium Wilfordii Hook, Asarum, Aconitum (Radix aconiti kusnezoffii, monkshood roots and aconite). Aconite widely used in the treatment of RA because it’s has a good effects of anti-inflammat-ory, analgesic and immunosuppression. In view of the toxicity of the aconite, its clinical application can be limited.Objective:The clinical study of the efficacy and safety of the aconite compound on the treatment of the RA(cold damp syndrome), that attempt to summarize the correlation of toxicity, syndrome and efficacy, and the guideline of application of high dose of aconite eventualy.Methods:Collecting160cases of RA (cold damp syndrome) that with the treatment of aconite, and grouping into conventional dose15g,20g,30g and50g group accord to the different dose of aconite, each group of40patients in treatment for eight weeks. Reording the dosage, usage, compatibility, boiling, efficacy and adverse reactions of the application of aconite, All patients were recorded clinical symptoms and signs and syndromes total score at before treatment and2,4,6and8weeks after treatment, while rheumatoid factor (rheumatoid factor, RF), ESR (Erythrocyte Sedimentation Rate, ESR), C-reactive protein (C-reactive protein, CRP), DAS28(disease activity score in28joints, DAS28) score, as well as Blood-routine,Urine-routine,Stool-routine, ECG were measured before and after treatment in order to evaluate the clinical efficacy and safety of compound aconite and safety.Results:1. This study included a total of160patients with rheumatoid arthritis(RA), which fall off in8cases(3cases of15g group,2cases of20g group,1cases of30g group and2cases of50g group),2cases were rejected due to breach of treatment and combined with other therapeutic effects of drugs(1case of30g group and lease of50g group). Completed the trial cases of150cases, which expulsion rate was5%, elimination rate was1.25%, the loss rate was6.75%, less than20%.2. The duration of morning stiffness, tender joint count, swollen joint count, hands mean grip strength and self-evaluation of all patients were improved significantly after treatment2weeks, the difference was statistically significant (P<0.05). The improvement of above indexes was significant in50g group than other groups by the2,4,6,8weeks (P<0.01),30g group was significant different form the other two groups by the6,8weeks (P<0.05), while there were no difference in the15g and20g group at all time points (P>0.05).3. Between pre and post treatment, there were significant differentces in ESR, CRP, RF of the four groups(P<0.01).50g group was significantly better than other groups (P<0.01),30g group was better Compared with the other two groups (P<0.01),15g and20g group were no difference (P>0.05).4.The arthralgia, arthroncus, morning stiffness, joint tenderness, joint movement disorder, aversion to cold and other symptoms of TCM were significantly improved in four groups after treatment, the difference was statistically significant (P<0.05). The improvement of50g group in the aspects of arthralgia, arthroncus, morning stiffness, joint tenderness, joint movement disorder and aversion to cold was significant compare with other groups at2,4,6,8weeks (P <0.01), while the difference between the group of15g,20g and30g was not statistically significant (P>0.05). Meanwhile, there was no significant difference between the four groups in the symptom of cold limbs, night pain and lassitude.5. The DAS28score were improved significantly of all the4groups after treatment of2weeks (P<0.05),50g group was decreased obviously than other groups (P<0.01) and30g group was significant different form the other two groups (P<0.01), while there was no statistical significance between the15g and20g group(P>0.05).50g group was significantly better than other groups in the decrease of DAS28score (P<0.01),30g group was significant different form the other two groups (P<0.01),15g and20g group was no difference (P>0.05).6.The total effective rates in the group of15g,20g,30g and50g were91.89%,92.11%,92.11%,97.3%and the cured and markedly effective rates were0%,2.63%,7.89%,95.35%,35.14%. The cured and markedly effective rate of50g group was higher than other groups with significant difference (P<0.01),while the total effective rate was no significant difference in the four groups (P>0.05).7. Between pre and post treatment, the Blood-routine,Urine-routine,Stool-routine, ECG and liver and kidney function were all in normal range. The50g group had Two cases of adverse reaction, due to improper boiling. Half an hour later,all the symptoms disappeared.Conclusion:The aconite as toxic herbs, it has a great effect on anti-inflammatory, analgesic and immunomodulatory for the treatment of RA, and also has a significant clinical effect. The key of the clinical application is to play its efficacy and to avoid or reduce its toxicity. Through clinical observation,we can draw a preliminary conclusion:By the premise of dialectical exacting, when doctors choose the appropriate dose, the reasonable compatib-ility and correct boiling method, the aconite is safe and effective in clinical application. |
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