【作者】 黄晓燕；

【导师】 刘友章；

【作者基本信息】 广州中医药大学 ， 中医内科学， 2010， 博士

【摘要】 目的：1.临床研究：通过开展随机、对照、盲法临床实验,探讨痛风康Ⅱ号颗粒和外敷痛风Ⅰ号外敷方对急性痛风性关节炎患者的临床疗效和安全性,为建立安全有效的、科学的、规范的痛风性关节炎中医综合治疗优化方案提供重要依据。2.实验研究：通过观察痛风康Ⅱ号颗粒对急性痛风性关节炎模型大鼠关节症状和血清IL-4、TNF-α的影响,探讨痛风康Ⅱ号颗粒治疗急性痛风性关节炎的可能机制。方法：1.临床研究：收集符合诊断要求的,广州中医药大学第一附属医院门诊和住院的急性痛风性关节炎病例40例,随机分为治疗组和对照组,每组各20例。两组均进行基础治疗,此外,治疗组采用痛风康Ⅱ号颗粒和外敷痛风Ⅰ号外敷方治疗；对照组采用安慰剂治疗,疗程5天。在治疗前、治疗第3天、治疗后分别观察病例的关节疼痛、关节急性红肿、关节功能障碍积分；在每天晚上8时由患者自行采用11点疼痛等级量表记录关节疼痛积分；治疗前和治疗后检查血常规和谷丙转氨酶(ALT)、尿素氮(BUN)、肌酐(CREA)水平。2.实验研究：将60只SPF级SD大鼠随机分为六组,每组10只：空白组、模型组、对照组、中药高剂量组、中药中剂量组、中药低剂量组。空白组和模型组大鼠采用生理盐水灌胃,对照组采用双氯酚酸钠溶液灌胃,中药各剂量组分别采用痛风康Ⅱ号颗粒配置的不同浓度的溶液灌胃,每天1次,共5天。实验第3天灌胃前,除空白组外其余5组均采用尿酸钠溶液关节腔注射方法造模,建立急性痛风性关节炎模型,空白组注入相同体积的生理盐水。造模后8小时、72小时分别观察大鼠炎症指数及功能障碍指数；造模前、造模后1小时、4小时、8小时、24小时、72小时分别测量大鼠右踝关节周径；实验第5天灌胃后2小时采血检测各组大鼠血清工L-4、TNF-α的含量。结果：1.临床研究：参加试验的两组病例在年龄、体重指数、病程、合并症等方面无明显差异(P>0.05),具有可比性。治疗前后比较,治疗组在关节疼痛积分和关节红肿积分、关节功能障碍积分均降低,具有非常显著性差异(P<0.01),对照组治疗前后无明显差异(P>0.05)；在治疗后各项积分比较,治疗组比对照组明显降低,具有显著性差异(P<0.01)。治疗组的总有效率达到100%,对照组达40%。在安全性评价上,治疗组和对照组对ALT、BUN、CREA无明显影响(P>0.05)；治疗组对白细胞、中性粒细胞计数具有降低作用(P<0.05),对照组治疗前后无明显差异(P>0.05)。两组均对红细胞和血小板计数无影响。2.实验研究：各组关节炎症指数、关节功能障碍指数积分比较,模型组积分最高(P<0.05)。造模后8小时和72小时比较,中药各剂量组和对照组积分均降低(P<0.05),模型组无明显变化(P>0.05)。造模后1小时至8小时各组关节周径比较,模型组较中药各剂量组和对照组增大(P<0.05),造模后24小时和72小时,各组比较无明显差异(P>0.05)。模型组血清IL-4含量较其余5组明显减少(P<0.01),中药各剂量组含量与扶他林组比较无明显差异(P>0.05)。模型组血清各组TNF-α含量较其余5组明显增多(P<0.001),中药各剂量组TNF-α的含量与扶他林组比较无明显差异(P>0.05)。结论：1.痛风康Ⅱ号颗粒和痛风Ⅰ号外敷方可降低急性痛风性关节炎患者关节疼痛、关节红肿、关节功能障碍积分,对急性痛风性关节炎具有消肿止痛作用。2.痛风康Ⅱ号颗粒和痛风Ⅰ号外敷方可降低急性痛风性关节炎患者血尿酸及白细胞、中性粒细胞计数,对肝、肾功能指标无明显影响,痛风康Ⅱ号颗粒和外敷痛风Ⅰ号外敷方对急性痛风性关节炎患者具有安全性。3.痛风康Ⅱ号颗粒可改善急性痛风性关节炎大鼠的关节炎表现。4.痛风康Ⅱ号颗粒可升高急性痛风性关节炎大鼠血清IL-4含量,降低TNF-α的含量。更多还原

【Abstract】 Objective:1. Clinical research:Through randomized, controlled, blinded clinical trials to investigate the "Tongfengkang II granule" and "Tongfeng I external application" of topical side on acute gouty arthritis clinial efficacy and safety, to establish safty, effective, science, the standard TCM integrated treatment of gouty arthritis medicine, providing an important basis for optimization.2. Experimental Research:By observing the influence of "Tongfengkang II granule" on ratmodel of acute gouty arthritis and joint symptoms of serum IL-4 and TNF-a to explore the effect of "Tongfengkang II granule" treatment of acute gouty arthritis of the possible mechanisms.Method:1. Clinical Research:gathering 40 acute gouty arthritis patients which met the diagnostic requirements, from the Guangzhou University of Chinese Medicine, First Affiliated Hospital outpatient and inpatient. To randomly divided into treatment group and control group,20 patients in each group. Both groups were treated for infrastructure. In addition, the treatment group were treated by "Tongfengkang II granule" and "Tongfeng I external application" that treatment of topical. The control group treated with placebo. All treatment in 5 days. Observing the index of the patients’Joint pain; acute joint swelling and joint dysfunction on before and after the treatment and the 3 treatment day. At 8 pm each day, the patients recorded the joint pain rating with 11-point pain rating scale, blood test with alanine aminotransferase(ALT), urea nitrogen(BUN), creatinine(CREA) level after the treatment. perimeter joints in each group in 1 to 8 hours after modeling. Model group is greater than the other group (P<0.05). In 24 hours and 72 hours after the modeling, the comparison in each group is no significant difference between groups (P>0.05). The levels of IL-4 in serum of the model group was significantly reduced compared with the other 5 (P<0.01). The levels of TNF-a in serum in each group compared with the other 5 were significantly increased (P<0.01), traditional Chinese medicine the dose content of TNF-a compared with voltaren no significant difference (P> 0.05).Conclusion:1. "Tongfengkang II granule" and "Tongfeng I external application" can be reduced the index of patinets joint pain, joint swelling, joint dysfunction. On acute gouty of arthritis pain with swelling effect.2. "Tongfengkang II granule" and "Tongfeng I external application" may lower the leukocytes and neutrophil in the patients. On liver, and kidney function had no significant effect, "Tongfengkang II granule" and "Tongfeng I external application" had not side effect.3. "Tongfengkang II granule" can improve the acute gouty arthritis in rats.4. "Tongfengkang II granule" can raise the levels of the IL-4 in serum and lower the levels of the TNF-a in serum in the rats.更多还原