Shire Biqing Pill in Treatment of Rheumatoid Arthritis with Damp-heat Obstruction Syndrome and Its Effect on OPG/RANKL/RANK Signaling Pathway and TNF-α / 中国实验方剂学杂志

ABSTRACT

ObjectiveTo study the clinical efficacy of Shire Biqing pill in the treatment of rheumatoid arthritis （damp-heat obstruction syndrome） and its effect on the expression of serum osteoprotegerin （OPG）， nuclear factor-κB receptor activating factor ligand （RANKL）， and tumor necrosis factor-α （TNF-α）， and to explore its mechanism from the perspective of bone destruction. MethodPatients with rheumatoid arthritis （damp-heat obstruction syndrome） were randomly divided into two groups， with 36 patients in each group. The control group was treated with methotrexate tablets and celecoxib capsule， while the treatment group was treated with Shire Biqing pill based on the control group. The treatment period was 3 months. The pain visual analogue scale （VAS） score， joint tenderness number， joint swelling number， disease activity score （DAS28-ESR）， traditional Chinese medicine （TCM） symptom quantitative score， and related adverse reactions were recorded before and after treatment， and the peripheral serum OPG， RANKL， TNF-α， erythrocyte sedimentation rate （ESR）， and Creactive protein （CRP） were detected. ResultAfter treatment， the total effective rate was 88.57% （31/35） in the treatment group and 79.41% （27/34） in the control group. The total effective rate of the treatment group was higher than that of the control group （Z=-2.089， P<0.05）. The pain VAS score， joint tenderness number， joint swelling number， and DAS28-ESR of the two groups were significantly lower than those before treatment （P<0.05）， and the pain VAS score， joint tenderness number， joint swelling number， and DAS28-ESR of the treatment group were significantly better than those of the control group after treatment （P<0.05）. Compared with that before treatment， the TCM symptom quantitative score in the two groups decreased significantly （P<0.05）， and the decrease was more obvious in the treatment group than in the control group （P<0.05）. Compared with those before treatment， the levels of RANKL， TNF-α， ESR， and CRP in the two groups decreased and the level of OPG increased （P<0.05）， and the changes in the treatment group were more obvious that in the control group （P<0.05）. There were no serious adverse events or serious adverse reactions during this clinical trial. ConclusionShire Biqing pill can effectively improve the clinical symptoms of rheumatoid arthritis （damp-heat obstruction syndrome） with good safety. Shire Biqing pill effectively regulate the OPG/RANKL/RANK system and reduce the pro-inflammatory factor TNF-α， which may be its mechanism in the intervention in rheumatoid arthritis bone destruction.