清热活血方案治疗类风湿关节炎患者的多中心、随机、对照研究

A Multicenter,Randomized,and Controlled Study on Heat-Clearing and Blood-Activating Therapy for Rheumatoid Arthritis Patients

目的探究清热活血综合治疗方案对改善湿热痹阻、瘀血阻络证类风湿关节炎(Rheumatoid arthritis,RA)患者DAS28、食欲、红细胞沉降率、C反应蛋白及不良反应的影响。方法选取2014年1月—2015年12月期间于中国中医科学院广安门医院等16个研究中心就诊的286例RA患者按随机、对照、双盲分为中医治疗组和西医治疗组,每组各143例。中医治疗组给予清热活血方颗粒+清热活血外敷剂+甲氨蝶呤片模拟剂+硫酸羟氯喹片模拟剂;西医治疗组给予甲氨蝶呤片+硫酸羟氯喹片+中药内服安慰剂颗粒+外敷安慰剂。比较两组患者0周、12周、24周DAS28缓解率、红细胞沉降率、C反应蛋白,两组患者0周、4周、12周、24周食欲及治疗过程中不良事件。结果两组患者DAS28改善方面比较,差异无统计学意义(P>0.05)。中医治疗组患者在食欲表现上优于西医治疗组,但差异无统计学意义(P>0.05);中医治疗组在红细胞沉降率和C反应蛋白方面劣于对照组,差异有统计学意义(P<0.05),在不良反应方面明显优于对照组,差异有统计学意义(P<0.05)。结论尽管有趋势,但不能证明清热活血方案改善RA患者食欲不振情况。治疗组不良反应发生率低于对照组。治疗组在缓解疾病活动度上与对照组无差异,而在降低ESR、CRP方面劣于对照组。

Objective To explore the effects of a heat-clearing and blood-activating comprehensive treatment on the disease activity score 28(DAS28),appetite,erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),and adverse reactions in rheumatoid arthritis(RA)patients with the syndrome of damp-heat obstruction and blood stasis blocking the collaterals.Methods 286 RA patients who were treated between January 2014 and December 2015 at 16 research centers,including the Guang′anmen Hospital of the China Academy of Chinese Medical Sciences,were randomly divided into a traditional Chinese medicine(TCM)treatment group and a Western medicine treatment group,with 143 patients in each group.The TCM treatment group was given heat-clearing and blood-activating granules,heat-clearing and blood-activating external application,methotrexate tablet simulants,and hydroxychloroquine sulfate tablet simulants.The Western medicine treatment group was given methotrexate tablets,hydroxychloroquine sulfate tablets,TCM oral placebo granules,and topical placebo.The DAS28 remission rate,ESR,and CRP levels were compared between the two groups at 0,12,and 24 weeks.Appetite and adverse events were compared at 0,4,12,and 24 weeks.Results There was no statistically significant difference between the two groups regarding DAS28 improvement(P>0.05).Although the TCM treatment group showed better improvement in appetite compared to the Western medicine group,the difference was not statistically significant(P>0.05).However,the TCM group showed inferior results in ESR and CRP compared to the control group,with statistically significant differences(P<0.05).The incidence of adverse reactions was significantly lower in the TCM group compared to the control group,with a statistically significant difference(P<0.05).Conclusion While there was a trend,the heat-clearing and blood-activating treatment did not show statistically significant improvement in appetite for RA patients.However,the incidence of adverse reactions was lower than in the control group.The TCM treatment group showed no difference in reducing disease activity compared to the control group but was less effective in reducing ESR and CRP levels.