【作者】 王磊；

【导师】 王义军；

【作者基本信息】 北京中医药大学 ， 中医学， 2014， 硕士

【摘要】 目的：通过随机分组、设置阳性药物对照组、前瞻性研究的试验方法,对清热解毒除湿痛痹法治疗原发性急性痛风性关节炎进行临床观察研究。以期客观观察及评价其近期临床疗效、安全性以及提高患者患病后日常生活质量的效果,从而明确此治疗方法在治疗原发性急性痛风性关节炎上的临床特点及优势,为该治疗方法的临床推广提供切实可靠的循证医学依据。方法：采用随机分组、阳性药物对照的实验途径,选取符合纳入标准的74例急性原发性痛风性关节炎患者,使用随机数余数分组法将以上74例患者随机分为治疗组37例(A组),对照组37例(B组),其中治疗组服用中药(自拟处方颗粒剂型中草药)以及非甾体类抗炎药NSAIDs(醋氯芬酸肠溶胶囊),对照组只服用非甾体类抗炎药NSAIDs(醋氯芬酸肠溶胶囊),经过7天的治疗周期后,分别记录并观察两组患者服药前后的临床症状和体征(如关节休息痛、关节压痛、关节肿胀、中医证候等)以及实验室检查指标(如血尿酸SUA、动态红细胞沉降率ESR、血清C反应蛋白CRP、肝功能、肾功能)的变化情况,并且计算治疗前后关节肿痛指数、静息疼痛VAS评分及中医证候评分,依据《中医病证诊断疗效标准》中的疗效标准进行对比统计分析,以期尽量客观地反映中医清热解毒除湿痛痹法治疗原发性急性痛风性关节炎的临床治疗效果以及安全性。结果：1.两组病例治疗前后自身比较,均能明显减低关节肿痛指数、静息疼痛VAS评分,差异具有统计学意义(P<0.05)；对两组病例进行组间比较,差异无统计学意义(P>0.05)。2.在中医证候评分方面,经过治疗后治疗组自身比较评分有改善,差异具有统计学意义(P<0.05),对照组治疗前后无显著差异(P>0.05)；对两组病例进行组间比较,差异有统计学意义(P<0.05),并且治疗组的临床疗效优于对照组。3.治疗前后两组分别自身比较,治疗组血尿酸SUA有改善差异具有统计学意义(P<0.05),对照组SUA治疗前后无显著差异(P>0.05),治疗前后两组血清C反应蛋白CRP改善差异均具有统计学意义(P<0.05)；对两组病例SUA进行组间比较,差异有统计学意义(P<0.05),并且治疗组的临床疗效优于对照组,组间CRP无显著差异(P>0.05)。结论：以中医清热解毒除湿通痹法所拟中药方剂联用醋氯芬酸肠溶胶囊治疗原发性急性痛风性关节炎,在降低患者血尿酸(SUA)水平、改善关节疼痛、关节肿胀以及中医证候评分方面临床疗效明显优于单独使用醋氯芬酸肠溶胶囊,中药颗粒剂与非甾体抗炎药联用未见明显不良反应以及毒副作用,安全性较高,是临床上治疗急性痛风性关节炎的行之有效治疗方法,适用于中医辨证为湿热蕴结证的痛风患者,应该予以在临床推广。更多还原

【Abstract】 Objective: Depending on randomized controlled group and prospective experimental research methods,this study had a observation at the clinical effection of method for clearing heat-toxin during dehumidification and dredging channel in treatment of primary acute gouty arthritis. The study aim at having a result of the observation and evaluation of its recent clinical efficacy, safety, and the improvement of the quality of daily life in patients with AGA.Thereby we can have a clear cognize that tells us the clinical features and advantages of the method for primary AGA.As a result,the basement of evidence-based medicine to provide effective and reliable basis for this clinical treatments will be offered.Methods:Using experimental approach which took positive drug as randomized control group,74cases of primary acute gouty arthritis in patients met the inclusion criteria was selected. By using a random number remainder grouping method,the74cases of patients were randomly divided into the treatment group (A group of37), the control group of37patients (group B).The treatment group took the medicine (herbs from the proposed prescription dosage form) and NSAIDs (non-steroidal anti-inflammatory drugs (aceclofenac enteric-coated capsules),while the control group took only NSAIDs(aceclofenac enteric-coated capsules).After seven days of treatment cycles,results(such as joint pain, rest,joint tenderness, joint swelling, TCM changes in climate, etc.) before and after medication and observation of clinical signs and symptoms of the two groups of patients and laboratory parameters (such as blood uric acid SUA, dynamic erythrocyte sedimentation rate ESR, serum C-reactive protein CRP, liver function, kidney function) were recorded,. Resting pain VAS(Visual Analogue Scale) score and TCM syndrome score and joint swelling index is calculated before and after treatment.According to " TCM Syndrome Diagnostic efficacy of the standard " in the comparative statistical analysis,the study tried to objectively reflect the traditional Chinese medicine treatment of clearing heat-toxin during dehumidification and dredging channel for primary clinical outcomes of acute gouty arthritis and mske sure the security.Results:1.Before and after the treatment,outcomes of two groups of patients themselves compared proves that both group can significantly reduce joint swelling index, resting pain VAS score, the difference was statistically significant (P<0.05); conducted on two groups of cases, the difference was not statistically significant (P>0.05).2. In the aspect of TCM syndrome score, outcomes of two groups of patients themselves were compared after treatment, the difference was statistically significant (P<0.05), the difference of the controlled group was not statistically significant (P>0.05); conducted on two groups of cases, the difference was statistically significant (P<0.05), and clinical efficacy in the treatment group was better than the controlled group.3. Before and after the treatment,two groups themselves were compared.with uric acid (SUA) improved with a statistically significant difference (P<0.05).The SUA of the controlled group was not statistically significant (P>0.05),the differences of both groups’CRP were statistically significant (P<0.05);conducted on the SUA of two groups of cases,the differences were statistically significant (P<0.05), and the clinical efficacy in the treatment group were better than the comparison groups. The differences between the CRP of the two groups were not statistically significant (P>0.05)Conclusion: TCM treatment of clearing heat-toxin during dehumidification and dredging channel with herbs from the proposed prescription dosage form combined with aceclofenac enteric-coated capsules in the treatment of primary acute gouty arthritis, can reduce serum uric acid (SUA) levels, improve joint pain, joint swelling and medicine syndrome score.And the clinical efficacy was superior to using aceclofenac enteric-coated capsules alone.TCM herbal granules combined with non-steroidal anti-inflammatory drugs shew no significant adverse reactions and side effects but high security.This treatment is effective on the treatment of patients suffering from acute gout gouty arthritis with TCM syndromes of heat accumulation. And this method should be spreaded in clinical practice.更多还原