复方乌头微乳剂治疗活动期类风湿性关节炎寒湿痹阻证的临床疗效  

Clinical Efficacy of Fufang Wutou Microemulsion on Rheumatoid Arthritis at Active Stage with Cold Dampness Syndrome

作　　者：李玉奎[1,2] 冯传博 刘爱真[2] 贾江 LI Yu-kui;FENG Chuan-bo;LIU Ai-zhen;JIA Jiang(Shangqiu Medical College, Shangqiu 476000, China;Central Hospital of Shangqiu, Shangqiu 476100, China;Luoyang No. 1 Hospital of Traditional Chinese Medicine, Luoyang 471022, China)

机构地区：[1]商丘医学高等专科学校,河南商丘476000 [2]商丘市中心医院,河南商丘476100 [3]洛阳市第一中医院,河南洛阳471022

出　　处：《中国实验方剂学杂志》2018年第8期194-199,共6页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：河南省高等学校重点科研项目(15b360009)

摘　　要：目的：探讨复方乌头微乳剂治疗活动期类风湿性关节炎（RA）寒湿痹阻证的临床疗效及对血清C-反应蛋白（CRP）,肿瘤坏死因子-α（TNF-α）,白细胞介素-1（IL-1）和IL-6等炎症因子的影响。方法：将120例符合要求的患者采用区组随机法,分为对照组和观察组各60例。两组患者均口服美洛昔康片,7.5 mg/次,1次/d;和白芍总苷胶囊,2粒/次,3次/d。对照组采用双氯芬酸二乙胺乳胶剂,按照痛处面积大小,适量外用,3次/d。观察组采用复方乌头微乳剂,根据痛处面积大小,适量外用,3次/d。两组疗程均为连续治疗4周。记录治疗前后关节疼痛和关节压痛评分,肿胀、关节僵硬、关节活动不利等主要临床症状评分;评价治疗前后疾病活动程度（DAS28）评分,简化的疾病活动性指数（SDAI）,健康评价问卷评分（HAQ）;检测血沉（ESR）,CRP,类风湿因子（RF）,TNF-α,IL-1和IL-6水平;进行皮肤刺激和毒副反应观察。结果：观察组ACR20,ACR50分别为91.67%,56.67%,分别高于对照组的68.33%,36.67%（P〈0.05,P〈0.01）,两组患者ACR70组间比较,差异无统计学意义;观察组关节疼痛、关节压痛、关节肿胀、关节僵硬和活动不利评分均低于对照组,主要临床症状消失率均低于对照组（P〈0.05,P〈0.01）;观察组患者DAS28,SDAI,HAQ评分及ESR和CRP水平均低于对照组（P〈0.01）;观察组RF,IL-1,IL-6和TNF-α水平均低于对照组（P〈0.01）;经Ridit分析,两组患者皮肤刺激反应差异无统计学意义;治疗过程中,观察组患者未发现有关川乌和马钱子的过敏反应和毒副反应。结论：采用复方乌头微乳剂治疗活动期RA患者,能明显控制临床症状和疾病的发展,减轻急性炎症反应,缓解临床疗效,且安全,但临床使用仍需严密观察不良反应。Objective： To discuss the clinical efficacy of fufang Wutou microemulsion in treating rheumatoid arthritis（RA） at active stage and its effect on levels of serum C-reactive protein（CRP）,tumor necrosis factor-α（TNF-α）,interleukin-1（IL-1） and interleukin-6（IL-6）. Method： Totally 120 patients with HDD were randomly divided into control group（60 cases） and observation group（60 cases） by random number table. Both groups＇ patients got meloxicam tablets,7. 5 mg/time,1 time/day. And glycosides of Baishao capsules,2 grains/day,3 times/day. Patients in control group were also given diclofenac diethylamine emulgel according to the area of painful place,3 times/day. And observation group was also given fufang Wutou microemulsion according to the area of painful place,3 times/day. And a course of treatment was 4 weeks. Before and after treatment,scores of arthralgia,tender joint,swelling,joint stiffness and difficulties in joint activity were recorded.And scores of degree of disease activity（DAS28 scale）,simplified disease activity index（SDAI） and health assessment questionnaire（HAQ） were graded. Levels of erythrocyte sedimentation rate（ESR）,CRP,rheumatoid factors（RF）,TNF-α,IL-1 and IL-6 were detected. And the safety was evaluated. Result： ACR20 and ACR50 in observation group were 91. 67% and 56. 67%,which were higher than 68. 33% and 36. 67% in control group（P〈0. 05,P〈0. 01）,with no statistical significance in ACR70 between two groups. Scores of arthralgia,tender joint,swelling,joint stiffness and difficulties in joint activity were lower than those in control group,and the disappearance rate of main symptoms was also lower than that in control group（P〈0. 05,P〈0. 01）. Sores of DAS28,SDAI and HAQ and levels of ESR,CRP,RF,IL-1,IL-6 and TNF-α were lower than those in control group（P〈0. 01）. By Ridit,there was no statistical significance in skin irritation between two groups. And no side effect caused by Chuanwu or Maqianzi was found. Conclusion：

关 键 词：类风湿性关节炎 活动期 炎症反应 复方乌头微乳剂 安全性 

分 类 号：R5[医药卫生—内科学] R259[医药卫生—临床医学]