| Objective1.To validate "The Powder for the joint swelling and pain" treatment of acute gouty arthritis clinical efficacy.2. To explore the difference of curative effect of "The Powder for the joint swelling and pain" for external application and aceclofenac sodium dispersible tablets orally in the treatment of acute gouty arthritis respectively.3. To confirm the toxicity of "The Powder for the joint swelling and pain" for the treatment of acute gouty arthritis was significantly lower than that of aceclofenac sodium dispersible tablets.MethodsAccording to the diagnostic criteria, inclusion criteria and exclusion criteria,90 cases of acute gouty arthritis was qualified screening from the patients which received treatment in our hospital. The subjects will be randomly divided into 3 groups,30 cases in each group. All patients under the same basic treatment, the control group were treated with oral aceclofenac sodium dispersible tablets, NO.1 of experimental group by simple external "The Powder for the joint swelling and pain", No.2 of experimental group with external application of "The Powder for the joint swelling and pain " combined with oral aceclofenac sodium dispersible tablets. Among them, "The Powder for the joint swelling and pain" changed daily 1 times, Aceclofenac Dispersible Tables sig:0.1g bid after meals,7 days of observation.Compared with control group and experimental group 1, observation the differences of two kinds of drugs on acute gouty arthritis curative effect; comparison between control group and experimental group 2, to observate of "The Powder for the joint swelling and pain" whether has exact clinical effects or not; on the basis of the above work, comparison of the toxicity of different treatment schemes.All experimental data were statistically analyzed by SPSS17.0 statistical software, test uses the two-sided test, The count data about gender and age of different groups, If it is non hierarchical data using chi square test. The measurement data of uric acidã€pain scoreã€course of disease, If the datas accord with normaldistribution and homogeneity of variance, The wihtin group datas of before and after treatment were compared by paired T-test, the comparison between two groups using two independent samples T-test, variance analysis was used to compare between the three groups. The measurement data do not accord with normal distribution and homogeneity of variance, or the hierarchical and count datas using non parametric test. With P< 0.05, the difference was statistically significant, P< 0.01, has the significant difference of statistical significance.Results1.The efficacy of the three groups:the control group were 30 cases, in which the fall off in 2 cases, the total effective rate was 71.42%; the experimental group of No.1, a total of 30 cases, in which the fall off in 4 cases, the total effective rate was 73.07%; the experimental group of No.2, a total of 30 cases, the total effective rate was 96.67%, Efficiency between the control group and experimental group of No.1 has no difference statistical significance(P> 0.05); But between the control group and the experimental group of No.2, experimental group of No.1 and experimental group of No.2, the efficiency difference has statistics significance(P<0.05).2. Comparison of the blood uric acid levels of three groups of cases before and after treatment, blood uric acid levels after treatment lower than before treatment (P< 0.01); And comparison the difference of the blood uric acid level of three groups of cases before and after treatment, the difference between the three groups is not all equal (P< 0.05); Further compared between two groups, the treatment group 2 is better than the control group and treatment group 1 (P< 0.05), while the difference between the control group and treatment group 1 has no statistical significance (P> 0.05).3. Comparison of the level of blood sedimentation of three groups of cases before and after treatment, after treatment lower than before treatment (P＜-0.01); And comparison the difference of the blood sedimentation level of three groups of cases before and after treatment, do not think that difference between three groups are not equal (P> 0.05).4.Comparison of pain score of three groups of cases before and after treatment, pain score after treatment lower than before treatment (P< 0.01); And comparison the difference of the pain score of three groups of cases before and after treatment, the difference between the three groups is not all equal (P< 0.05); Further compared between two groups, the treatment group 2 is better than the control group and treatment group 1 (P< 0.05), while the difference between the control group and treatment group 1 has no statistical significance (P> 0.05).5. Adverse reaction:the control group, in total of 28 cases, the adverse reaction rate was 25%; the treatment group of No.1, its effective cases was 26, the rate of adverse reaction was 7%; the treatment group of No.2, its effective cases was 30, the adverse reaction rate was 13%, the rate of adverse reactions between the three groups, the difference was statistically significant (P< 0.05); Compared between two groups, treatment group 1, the incidence of adverse reaction, is lower than the control group (P< 0.05), the differences between the control group and treatment groupK treatment group 2 has no statistical significance (P> 0.05). Conclusion1. " The Powder for the joint swelling and pain" has exact clinical curative effect on acute gouty arthritis.2.Simply use "The Powder for the joint swelling and pain" or aceclofenac dispersion tablets , all has the clinical curative effect on acute gouty arthritis, but no significant difference between the two kinds of schemes of clinical efficacy.3. Aceclofenac Dispersible Tables oral combined with " The Powder for the joint swelling and pain" can significantly improve the clinical efficacy.4. The toxicity of "The Powder for the joint swelling and pain" for external application of acute gouty arthritis is obviously lower than the oral aceclofenac sodium dispersible tablets. |
