| BACKGROUND: Acute gout arthritis is an independent risk factor for many diseases,and the prevention and control of gout is gaining more and more attention.It was found that the wet turbid spleen is the core pathogenesis of gout,which was carried out by our research team by the method of syndrome investigation and specialist questionnaire survey in the early stage.The spleen should be strengthened and clarified while removing turbidity,which is taking care of the essential part along with the symptoms.Also not to leave out partial therapies to remove the heat and dampness,expedite meridians,and relieve pain.It is proposed to treat spleen and reduce turbidity by oral Chinese medicine called Jianpi Jiangzhuo Granule(JPJZ Granule),reduce turbidity and clearing heat by externally applying traditional Chinese medicine Jiangzhuo Qingre Granule(JPQR Granule)to treat acute gout arthritis.OBJECTIVE: To study the efficacy and safety of traditional Chinese medicine granules(orally taken and partially applied)for strengthening spleen and reducing turbidity in acute gout arthritis.METHOD: A multicenter,randomized,parallel controlled trial design was applied.Adult patients with acute gout arthritis diagnosis were included,consistent with the TCM syndrome of wet turbid spleen syndrome,and the partial syndrome of heat arthralgia syndrome.They were randomly assigned into treatment group and control group,and both groups were given basic treatment.The treatment group was given oral administration of JPJZ Granule,and was partially washed and wet wrapped.The control group was given oral diclofenac sodium entericcoated tablets.Both groups were treated for 10 days.Main efficacy indicators: 1)partial joint pain,joint swelling and activity limitation improvement(notable effective,effective,inefficient).2)TCM syndrome score index =(baseline syndrome score-post-intervention syndrome score)÷ Baseline syndrome score × 100%.Secondary efficacy indicators: 1)the proportion of using colchicine in the two groups during the intervention period.2)the changed percentage of erythrocyte sedimentation level,blood uric acid level,and white blood cell count before and after intervention.3)Recurrence rate during a 30-day-follow-up.Safety indicators: liver function,renal function,and incidence of adverse events during intervention period.RESULT: This study included inpatients and outpatients,who visited during November 2014 to January 2019,of Dongzhimen Hospital of Beijing University of Chinese Medicine,Dongzhimen Hospital of Beijing University of Chinese Medicine East Area(formerly Tongzhou Hospital of Beijing)and the Third Affiliated Hospital of Beijing University of Chinese Medicine.57 Subjects were randomly assigned to the treatment group while 56 to the control group.The baseline demographic data were basically consistent between two groups.The main efficacy indicators: 1)partial joint pain,joint swelling and activity limitation improvement,compared with baseline,the treatment group score decreased by 72.8% ± 31.7%,the control group score decreased by 83.0% ± 23.4%(P > 0.05).Of the treatment group,the proportion of notable effective,effective,and inefficiency was 56.5%,28.3% and 13.0%,respectively,while that of control group was 74.4%,23.3%,and 2.3%.There was no statistically significant difference between the two groups(P = 0.055 >0.05).2)TCM syndrome score index.Wet turbidity syndrome index decreased by 31.8 %(decreased value 1.56±2.22)in the treatment group(P <0.01),and 5.8 %(decreased value 0.60±2.50)in the control group(P >0.05).Wet turbidity syndrome index compared between two groups was significant(P <0.05).The corrected score of wet turbidity syndrome after intervention was 2.45 in the treatment group and 3.72 in the control group(P <0.05).The spleen deficiency syndrome index was 35.7 %(decreased value 1.12±2.11)in the treatment group(P <0.01),and 32.0 %(decreased value 1.83±2.91)in the control group(P <0.01).Spleen deficiency syndrome index compared between two groups was insignificant(P > 0.05).Secondary efficacy indicators: 1)the proportion of using colchicine in the two groups during the intervention period,the treatment group was 24.4 %(11/45),the control group was 6.8%(3/44)(P <0.05).2)Changes in erythrocyte sedimentation rate,blood uric acid and white blood cell count after intervention:(1)erythrocyte sedimentation rate,compared with baseline after treatment,the deceased percentage of treatment group was-8.3%(decreased value4.84±18.08 mm/h)(P > 0.05).The deceased percentage of the control group was 3.7 %(decreased value 4.28±8.51mm/h)(P <0.01).The baseline of erythrocyte sedimentation level was not balanced between groups,and corrected erythrocyte sedimentation level after the intervention was 18.38 mm/h in the treatment group and 14.00 mm/h in the control group(P >0.05).(2)White blood cell count,compared with baseline after treatment,the decreased percentage in the treatment group was 18.5%[decreased value(2.05±2.35)×109/L](P <0.01),and 16.3%[decreased value(1.50±1.93)×109/L] in the control group(P <0.01).The decreased percentage was insignificant between the groups(P>0.05).(3)Blood uric acid level,compared with baseline after treatment,the decreased percentage of the treatment group was-7.3%(decreased value-7.75±99.50 ?mol/L)(P>0.05),and in the control group that was-1.4%(decreased value 8.91±100.76 ?mol/L)(P > 0.05).The comparison of deceased percentage between groups was insignificant(P > 0.05).3)Recurrence rate within a 30-day-follow-up,in the treatment group was 22.2%(10/45),and in the control group was 6.7%(3/ 45)(P < 0.05).Safety indicators: 1)Comparison of liver function,total bilirubin in the treatment group,baseline and after intervention were 15.90±6.50mmol/L,12.83±5.30mmol/L,respectively(P <0.05),and were 19.45±26.82mmol/L and 12.60±5.13mmol/L,respectively in the control group(P<0.05).There was no difference between ALT and AST before and after intervention(P>0.05).2)Comparison of renal function,blood urea nitrogen levels in the treatment group,baseline and intervention were 5.42±2.54mmol/L and 5.02±2.36mmol/L,respectively(P <0.05).There was no difference in serum creatinine between the two groups before and after intervention(P >0.05).3)Adverse events,there were 4 cases in the treatment group,including nausea,rash,and mild upper abdomen discomfort.There were 4 cases in the control group included diarrhea and sputum with blood(important adverse event),nausea with severe upper abdomen discomfort,two of which discontinued.The incidence of adverse events was 7.8%(4/51)in the treatment group and the control group was 8.2%(4/49)(P > 0.05),no serious adverse events occurred.CONCLUSION: The therapy Jianpi Jiangzhuo Granule and Jiangzhuo Qingre Granule combined internal with external treatment can improve partial joint pain,joint redness and mobility limitation in patients with acute gout arthritis in treatment group,the effect is equivalent to oral diclofenac sodium in the control group.The wet turbidity of TCM syndrome is improved in the treatment group,the effect is better than oral diclofenac sodium in the control group.Treatment group might show a better safety than control group. |
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