【摘要】：研究目的:觀察補(bǔ)腎抗痹湯聯(lián)合甲氨蝶呤治療類風(fēng)濕性關(guān)節(jié)炎的療效與安全性。研究方法:臨床選取符合美國(guó)風(fēng)濕病學(xué)會(huì)(ACR)和歐洲抗風(fēng)濕聯(lián)盟(RULAR)2010年聯(lián)合推出RA分類診斷標(biāo)準(zhǔn)且病情處于中度以上活動(dòng)期(DAS28評(píng)分3.2)的患者78例,隨機(jī)分為兩組(治療組和對(duì)照組),每組各39例,治療組采用補(bǔ)腎抗痹湯聯(lián)合甲氨蝶呤治療,對(duì)照組采用甲氨蝶呤聯(lián)合來(lái)氟米特治療,觀察并記錄兩組患者治療前及治療后16周(8周為一療程,共兩個(gè)療程)后關(guān)節(jié)壓痛計(jì)數(shù)、關(guān)節(jié)腫脹計(jì)數(shù)、疼痛視覺(jué)模擬評(píng)分(VAS)、患者對(duì)病情的總體評(píng)估(Pt GA)、醫(yī)生對(duì)病情的總體評(píng)估(Ph GA)、健康評(píng)估問(wèn)卷(HAQ)及實(shí)驗(yàn)室指標(biāo):血常規(guī)、尿常規(guī)、肝腎功能、類風(fēng)濕因子(RF)、抗CCP抗體、血沉(ESR)、C反應(yīng)蛋白(CRP),并比較兩組治療后ACR20、ACR50、ACR70緩解率及治療前后DAS28平均值的變化。研究結(jié)果:78例類風(fēng)濕性關(guān)節(jié)炎患者均完成了為期16周的研究,補(bǔ)腎抗痹湯聯(lián)合甲氨蝶呤組以下稱治療組及甲氨喋吟聯(lián)合來(lái)氟米特組以下稱對(duì)照組各39例。在疾病療效方面,兩組在療程8周、16周時(shí)無(wú)顯著性差異,在實(shí)驗(yàn)室指標(biāo)方面如:ESR、CRP、RF方面兩組對(duì)比無(wú)統(tǒng)計(jì)學(xué)差異,抗CCP兩組在治療8周后無(wú)顯著性差異,但在治療16周后治療組抗CCP平均值較對(duì)照組低,并且差異有統(tǒng)計(jì)學(xué)意義。在毒副作用方面,治療組與對(duì)照組在治療后的肝腎功能異常發(fā)生情況比較無(wú)顯著差異。兩組中出現(xiàn)消化道不適癥狀不良反應(yīng)方面,治療組與對(duì)照組比較無(wú)顯著性差異,在白細(xì)胞下降發(fā)生方面,治療組遠(yuǎn)遠(yuǎn)低于對(duì)照組,差異有統(tǒng)計(jì)學(xué)意義,且對(duì)照組出現(xiàn)顯著脫發(fā)6例,治療組無(wú)脫發(fā)不良反應(yīng)出現(xiàn),差異有統(tǒng)計(jì)學(xué)意義。結(jié)論:補(bǔ)腎抗痹湯聯(lián)合甲氨蝶呤治療類風(fēng)濕性關(guān)節(jié)炎療效確切,安全性高。
[Abstract]:Objective: to observe the efficacy and safety of Bushen Kangbi decoction combined with methotrexate in the treatment of rheumatoid arthritis. Methods: a total of 78 patients who met the requirements of the American Rheumatology Society (ACR) and the European Union against Rheumatism (RULAR) in 2010 were enrolled in the study. 78 patients with moderate or more active phase (DAS28 score 3.2) were enrolled in the study. They were randomly divided into two groups (treatment group and control group) with 39 cases in each group. The treatment group was treated with Bushen Kangbi decoction combined with methotrexate, while the control group was treated with methotrexate combined with leflunomide. To observe and record the joint tenderness count, joint swelling count, pain visual analogue score (VAS),) in both groups before and 16 weeks after treatment (8 weeks as a course of treatment, two courses of treatment). (Pt GA), Doctor's overall assessment of the condition (Ph GA), health assessment questionnaire (HAQ) and laboratory indicators: routine blood routine urine routine liver and kidney function rheumatoid factor (RF), anti CCP antibody ESR (ESR), C reactive protein (CRP), The remission rate of ACR20,ACR50,ACR70 and the changes of DAS28 before and after treatment were compared between the two groups. Results: 78 cases of rheumatoid arthritis were studied for 16 weeks, 39 cases in each group were treated with Bushen Kangbi decoction combined with methotrexate group and 39 cases in methotrexate combined with leflunomide group. There was no significant difference between the two groups in the course of treatment for 8 weeks and 16 weeks, but there was no significant difference between the two groups in laboratory indexes such as ESR,CRP,RF, and no significant difference between the two groups after 8 weeks of treatment. But after 16 weeks of treatment, the average value of anti-CCP in the treatment group was lower than that in the control group, and the difference was statistically significant. There was no significant difference in the incidence of liver and kidney dysfunction between the treatment group and the control group. There was no significant difference between the treatment group and the control group in the occurrence of leukopenia in the treatment group, which was significantly lower than that in the control group. There were 6 cases of alopecia in the control group and 6 cases in the treatment group without alopecia, the difference was statistically significant. Conclusion: Bushen Kangbi decoction combined with methotrexate is effective and safe in the treatment of rheumatoid arthritis.
【學(xué)位授予單位】：南昌大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R593.22

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