麝香乌龙丸治疗类风湿关节炎患者的随机对照临床研究

发布时间：2018-06-27 01:17

本文选题：麝香乌龙丸 + 类风湿关节炎　；参考：《华北理工大学》2016年硕士论文

【摘要】：目的本研究按照随机对照的实验原则,通过观察麝香乌龙丸对寒湿痹阻型类风湿关节炎患者的类风湿因子(RF)、血沉(ESR)、C反应蛋白(CRP)和抗环瓜氨酸肽抗体(Anti-CCP)指标及肿胀关节数、压痛关节数、双手平均握力、晨僵时间、HAQ评分、疼痛指数、疲乏指数、患者对病情的整体评估、医生对病情的整体评估和中医证候积分等临床症状体征评分体系的影响,进一步客观、准确地评价其临床疗效,为其临床应用提供依据。方法将符合标准的120例类风湿关节炎患者按随机数字表法分为治疗组与对照组各60例,所有患者均应用常规西药进行基础治疗;治疗组在此基础上加用麝香乌龙丸,每次3g,1日2次;对照组加服白芍总苷胶囊,每次0.6g,1日3次。两组均治疗2个月。比较治疗后两组的临床疗效,观察治疗前后两组患者的各项症状及体征积分和类风湿因子(RF)、血沉(ESR)、C反应蛋白(CRP)和抗环瓜氨酸肽抗体(Anti-CCP)指标的变化情况,并记录治疗过程中发生的不良反应。结果1实验完成情况方面,本研究共纳入120例类风湿关节炎患者,治疗过程中,因患者不能坚持服药,脱落病例6例(治疗组1例,对照组5例)。完成试验的有效病例数为114例,脱落率为5%。2临床症状体征评分方面,在不同访视点,治疗组患者的压痛关节数、疼痛指数、患者对病情的整体评估、医生对病情的整体评估和中医证候积分改善情况始终优于对照组,两组的差异经比较有统计学意义(P0.05);各访视点两组患者对肿胀关节数、晨僵时间、双手平均握力、HAQ评分和疲乏指数方面的改善情况相当,两组的差异经比较无统计学意义(P0.05)。3实验室指标方面,治疗后两组患者的实验室指标RF、ESR、CRP和AntiCCP均较治疗前明显改善,组内比较差异有统计学意义(P0.05);治疗后两组的RF、ESR、CRP和Anti-CCP的差异经组间比较,无统计学意义(P0.05)。4中医证候疗效方面,治疗组与对照组总有效率分别为91.53%和89.09%,两组疗效比较差异有统计学意义(P0.05)。5西医DAS28-3疗效方面,治疗组与对照组总有效率分别为89.83%和81.82%,两组疗效比较差异有统计学意义(P0.05)。6安全性评价方面,研究观察期间,两组患者均未出现血尿常规、肝肾功能异常。治疗组有3例出现恶心、纳差,症状较轻,可自行消失。对照组有14例出现腹痛、腹泻现象,症状较轻,可自行缓解。结论麝香乌龙丸具有显著的抗炎镇痛效果,能迅速缓解寒湿痹阻型类风湿关节炎患者的临床症状,降低疾病活动度,临床疗效确切,具有良好的安全性。
[Abstract]:Objective to observe the indexes of rheumatoid factor (RF), erythrocyte sedimentation rate (ESR) C reactive protein (CRP) and anti-cyclic citrullin-peptide antibody (Anti-CCP) and the number of swollen joints of Shexiang Wulong pills in patients with rheumatoid arthritis with cold and damp arthralgia according to the principle of random control. The effects of the number of tenderness joints, the average grip strength of both hands, the morning stiffness time, the HAQ score, the pain index, the fatigue index, the overall assessment of the patient's condition, the doctor's overall assessment of the condition and the score of TCM syndromes and other clinical symptoms and signs, etc. Further objective and accurate evaluation of its clinical efficacy, to provide a basis for its clinical application. Methods 120 patients with rheumatoid arthritis were randomly divided into treatment group (n = 60) and control group (n = 60). The control group was treated with total glucoside of paeony (0.6 g, 3 times a day). Both groups were treated for 2 months. The clinical effects of the two groups were compared after treatment. The scores of symptoms and signs, rheumatoid factor (RF), erythrocyte sedimentation rate (ESR) C-reactive protein (CRP) and anti-cyclic citrullin-peptide antibody (Anti-CCP) were observed before and after treatment. Adverse reactions during treatment were recorded. Results 1 in this study, 120 patients with rheumatoid arthritis were included in the study. During the course of treatment, 6 cases (1 case in the treatment group and 5 cases in the control group) fell off because the patients could not insist on taking the medicine. There were 114 effective cases and 5.2 clinical symptom and sign scores. The number of tenderness joints, the pain index, and the overall assessment of the patient's condition were evaluated at different visit points. The doctors' overall evaluation of the condition and the improvement of TCM syndrome score were always better than the control group, the difference between the two groups was statistically significant (P0.05); the number of swollen joints and the time of morning stiffness in the two groups of patients at each visiting point were better than those in the control group. The improvement of HAQ score and fatigue index were similar between the two groups. There was no significant difference between the two groups (P0.05). After treatment, the laboratory indexes RFESR-CRP and AntiCCP in the two groups were significantly improved compared with those before treatment. The difference between the two groups was statistically significant (P0.05); after treatment, the difference of CRP and Anti-CCP between the two groups was not statistically significant (P0.05), and there was no significant difference between the two groups (P0.05) in the curative effect of TCM syndromes. The total effective rates of the treatment group and the control group were 91.53% and 89.09, respectively. The difference between the two groups was statistically significant (P0.05). The total effective rates of treatment group and control group were 89.83% and 81.82, respectively. The difference between the two groups was statistically significant (P0.05) in terms of safety evaluation. During the study period, there was no blood urine routine and abnormal liver and kidney function in both groups. There were 3 cases of nausea, anorexia and mild symptoms in the treatment group. There were 14 cases of abdominal pain and diarrhea in the control group. Conclusion Shexiang Wulong pill has obvious anti-inflammatory and analgesic effect, which can relieve the clinical symptoms of rheumatoid arthritis with cold and dampness obstruction and reduce disease activity.
【学位授予单位】：华北理工大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R259

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