中药熏洗治疗中轴型脊柱关节病的临床研究

发布时间：2018-01-18 05:16

本文关键词：中药熏洗治疗中轴型脊柱关节病的临床研究　出处：《大连医科大学》2016年硕士论文　论文类型：学位论文

【摘要】：目的:探讨中药熏洗治疗中轴型脊柱关节病的临床疗效及其安全性。方法:采用前瞻性的研究方法,将2014年01月至2014年12月就诊于大连医科大学附属第二医院风湿免疫科的疾病处于活动期的中轴型脊柱关节病患者,按照预定的纳入及排除标准,随机分为2组,每组40人。实验组应用洛索洛芬钠片60mg/日3次+中药熏洗治疗,对照组应用洛索洛芬钠片60mg/日3次治疗,研究过程中2组患者持续口服洛索洛芬钠片60mg/日3次治疗,80例患者服用的洛索洛芬钠片(商品名:乐松)均为第一三制药(上海)有限公司生产,批准文件:国药准字H20030769,产品批号SN097LA。中药熏洗治疗疗程为4周,30分钟/日,选用大连鹏达医疗器械有限公司生产的型号为:SZ-88I的熏蒸治疗仪(产品编码:20130601)。主要疗效指标包括4周、8周、12周时达到AS疗效评价标准20%(ASAS20)、AS疗效评价标准40%(ASAS40)的患者比例,次要疗效指标包括不同时间点上2组患者BathAS疾病活动指数(BASDAI)、脊柱疼痛VAS评分、患者总体评分VAS(PGA)、BathAS功能指数(BASFI)、血沉(ESR)、C反应蛋白(CRP)改善的情况。安全性评价包括随时记录在中药熏洗治疗过程中发生的不良事件,并判断这些不良事件与中药熏洗治疗的因果关系,分别于0周、4周、8周、12周时检测患者的血常规、肝生化、肾功能的情况。结果:1)4周时,实验组达到ASAS20改善的患者共27例(67.5%),对照组达到ASAS20改善的患者为18例(45%),实验组明显优于对照组,差异有统计学意义(P0.05);实验组达到ASAS40改善的患者共13例(32.5%),对照组达到ASAS40改善的患者为11例(27.5%),实验组优于对照组,但差异无统计学意义(P0.05)。8周、12周时,2组间达到ASAS20、ASAS40改善的患者例数无明显差异(P0.05)。2)4周时,实验组BASFI明显低于对照组,差异具有统计学意义(P0.05),2组间BASDAI、脊柱疼痛VAS评分、患者总体评分VAS(PGA)、血沉、CRP均无明显差异(P0.05)。8周时,实验组BASDAI、脊柱疼痛VAS评分、患者总体评分VAS(PGA)、CRP均明显低于对照组,差异具有统计学意义(P0.05),2组间BASFI、血沉均无明显差异(P0.05)。12周时,2组间BASFI、BASDAI、脊柱疼痛VAS评分、患者总体评分VAS(PGA)、血沉、CRP均无明显差异(P0.05)。3)中药熏洗治疗过程中无不良事件发生。随访8周时,实验组有1例患者出现转氨酶(谷丙转氨酶、谷草转氨酶)轻度升高(40U/L转氨酶80U/L),与对照组相比无明显差异(P0.05)。12周时,2组患者血常规、肝生化、肾功能均未见异常。结论:中药熏洗治疗中轴型脊柱关节病可以较快的缓解患者症状,减轻疼痛,降低疾病活动度和炎症指标,且安全性好,无严重不良反应发生。
[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.
【学位授予单位】：大连医科大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R274.9

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