本文關(guān)鍵詞：中藥熏洗治療中軸型脊柱關(guān)節(jié)病的臨床研究　出處：《大連醫(yī)科大學(xué)》2016年碩士論文　論文類型：學(xué)位論文

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【摘要】：目的:探討中藥熏洗治療中軸型脊柱關(guān)節(jié)病的臨床療效及其安全性。方法:采用前瞻性的研究方法,將2014年01月至2014年12月就診于大連醫(yī)科大學(xué)附屬第二醫(yī)院風(fēng)濕免疫科的疾病處于活動期的中軸型脊柱關(guān)節(jié)病患者,按照預(yù)定的納入及排除標準,隨機分為2組,每組40人。實驗組應(yīng)用洛索洛芬鈉片60mg/日3次+中藥熏洗治療,對照組應(yīng)用洛索洛芬鈉片60mg/日3次治療,研究過程中2組患者持續(xù)口服洛索洛芬鈉片60mg/日3次治療,80例患者服用的洛索洛芬鈉片(商品名:樂松)均為第一三制藥(上海)有限公司生產(chǎn),批準文件:國藥準字H20030769,產(chǎn)品批號SN097LA。中藥熏洗治療療程為4周,30分鐘/日,選用大連鵬達醫(yī)療器械有限公司生產(chǎn)的型號為:SZ-88I的熏蒸治療儀(產(chǎn)品編碼:20130601)。主要療效指標包括4周、8周、12周時達到AS療效評價標準20%(ASAS20)、AS療效評價標準40%(ASAS40)的患者比例,次要療效指標包括不同時間點上2組患者BathAS疾病活動指數(shù)(BASDAI)、脊柱疼痛VAS評分、患者總體評分VAS(PGA)、BathAS功能指數(shù)(BASFI)、血沉(ESR)、C反應(yīng)蛋白(CRP)改善的情況。安全性評價包括隨時記錄在中藥熏洗治療過程中發(fā)生的不良事件,并判斷這些不良事件與中藥熏洗治療的因果關(guān)系,分別于0周、4周、8周、12周時檢測患者的血常規(guī)、肝生化、腎功能的情況。結(jié)果:1)4周時,實驗組達到ASAS20改善的患者共27例(67.5%),對照組達到ASAS20改善的患者為18例(45%),實驗組明顯優(yōu)于對照組,差異有統(tǒng)計學(xué)意義(P0.05);實驗組達到ASAS40改善的患者共13例(32.5%),對照組達到ASAS40改善的患者為11例(27.5%),實驗組優(yōu)于對照組,但差異無統(tǒng)計學(xué)意義(P0.05)。8周、12周時,2組間達到ASAS20、ASAS40改善的患者例數(shù)無明顯差異(P0.05)。2)4周時,實驗組BASFI明顯低于對照組,差異具有統(tǒng)計學(xué)意義(P0.05),2組間BASDAI、脊柱疼痛VAS評分、患者總體評分VAS(PGA)、血沉、CRP均無明顯差異(P0.05)。8周時,實驗組BASDAI、脊柱疼痛VAS評分、患者總體評分VAS(PGA)、CRP均明顯低于對照組,差異具有統(tǒng)計學(xué)意義(P0.05),2組間BASFI、血沉均無明顯差異(P0.05)。12周時,2組間BASFI、BASDAI、脊柱疼痛VAS評分、患者總體評分VAS(PGA)、血沉、CRP均無明顯差異(P0.05)。3)中藥熏洗治療過程中無不良事件發(fā)生。隨訪8周時,實驗組有1例患者出現(xiàn)轉(zhuǎn)氨酶(谷丙轉(zhuǎn)氨酶、谷草轉(zhuǎn)氨酶)輕度升高(40U/L轉(zhuǎn)氨酶80U/L),與對照組相比無明顯差異(P0.05)。12周時,2組患者血常規(guī)、肝生化、腎功能均未見異常。結(jié)論:中藥熏洗治療中軸型脊柱關(guān)節(jié)病可以較快的緩解患者癥狀,減輕疼痛,降低疾病活動度和炎癥指標,且安全性好,無嚴重不良反應(yīng)發(fā)生。
[Abstract]:Objective: to investigate the clinical efficacy and safety of fumigation and washing of traditional Chinese medicine in the treatment of medial axial spondyloarthropathy. From January 2014 to December 2014, the patients with crankshaft spondyloarthropathy were treated in the Department of Rheumatology and Immunology, second affiliated Hospital of Dalian Medical University. According to the scheduled inclusion and exclusion criteria, we were randomly divided into 2 groups with 40 persons in each group. The experimental group was treated with losuprofen sodium tablets at 60 mg / d for 3 times. The control group was treated with losuprofen sodium tablets at 60 mg / d 3 times a day. During the course of the study, the patients in the two groups were treated continuously with oral losuprofen sodium tablets 60 mg / d 3 times a day. Losoprofen sodium tablets (trade name: lozon) taken by 80 patients were all produced by 13th Pharmaceutical (Shanghai) Co., Ltd. Approval document: H20030769. Batch number SN097LA. the course of treatment was 4 weeks and 30 minutes / day. Dalian Pengda Medical Devices Co., Ltd. was selected to produce the type of the fumigation therapy instrument: SZ-88I (product code: 20130601). The main curative effects included 4 weeks and 8 weeks. The proportion of patients who reached ASAS20 and ASASS40 at 12 weeks. The secondary curative effect indexes included BathAS disease activity index (BathAS), VAS score of spinal pain (VAS) and total score (VAS PGA) of the two groups at different time points. BathAS function index (BathAS). Safety evaluation included recording adverse events in the course of fumigation and judging the causal relationship between these adverse events and fumigation therapy. The blood routine, liver biochemistry and renal function of the patients were detected at 4 weeks, 8 weeks and 12 weeks, respectively. Results at 1 week, 1 week and 4 weeks, the blood routine, liver biochemistry and renal function of the patients were detected. There were 27 patients with ASAS20 improvement in the experimental group and 18 patients with ASAS20 improvement in the control group. The experimental group was significantly better than the control group. The difference was statistically significant (P 0.05). There were 13 patients with ASAS40 improvement in the experimental group and 11 patients with ASAS40 improvement in the control group. The experimental group was superior to the control group. However, there was no significant difference in the number of patients with improvement of ASAS20 and ASAS40 between the two groups at P0.05.8 weeks and 12 weeks. There was no significant difference between the two groups at 4 weeks. The BASFI in the experimental group was significantly lower than that in the control group, the difference was statistically significant (P 0.05). The VAS score of spinal pain and the total score of the patients were significantly lower than those of the control group (P 0.05). There was no significant difference between ESR and CRP at the week of P0.05, the experimental group had BASDAI, VAS score for spinal pain, and total score for patients with PGA). The CRP was significantly lower than that of the control group (P 0.05), and there was no significant difference in BASFI between the two groups at week 12 (P 0.05), and there was no significant difference in erythrocyte sedimentation rate (ESR) between the two groups (P 0.05). BASDAI, VAS score for Spinal pain, VAS overall score, ESR. There were no adverse events in the course of fumigation and washing of traditional Chinese medicine (P0.05. 3). During 8 weeks follow-up, one patient in the experimental group had transaminase (transaminase) (alanine aminotransferase). Glutamic oxaloacetic transaminase (alt) increased slightly by 40 U / L aminotransferase (80 U / L). There was no significant difference in blood routine and liver biochemistry between the two groups at week 12 compared with the control group. Conclusion: fumigation and washing of traditional Chinese medicine can relieve symptoms, relieve pain, reduce disease activity and inflammation index, and have good safety. No serious adverse reactions occurred.
【學(xué)位授予單位】：大連醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2016
【分類號】：R274.9

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