作　　者： (王柏公）; (王丽萍）; (白人骁）;

机构地区： 天津达仁堂京万红药业有限公司

出　　处： 《中华中医药杂志》 2017年第8期3840-3843,共4页

摘　　要： 目的:观察痹祺胶囊对膝骨性关节炎(OA)的临床疗效及安全性,为临床决策提供依据。方法:采用多中心、随机、对照临床研究方案,将符合纳入标准的221例患者随机分为2组。其中,试验组(Ⅰ组)166例,对照组(Ⅱ组)55例,两组患者基本资料在统计学上无显著性差异,具有可比性。研究期间Ⅰ组口服痹祺胶囊,1.2g/次,3次/d;Ⅱ组口服藤黄健骨丸,2丸/次,2次/d。2组均以3周为1个疗程,连续观察2个疗程。观察治疗前及治疗后中医证候积分,疼痛视觉模拟评分(VAS),美国纽约特种外科医院(HSS)膝关节评分,并记录不良反应。结果:治疗后临床疗效判定,Ⅰ组临床痊愈40例,显效59例,有效53例,无效14例,Ⅱ组临床痊愈4例,显效9例,有效26例,无效16例。治疗后证候总体疗效判定,Ⅰ组临床痊愈35例,显效59例,有效58例,无效14例,Ⅱ组55例,临床痊愈4例,显效9例,有效26例,无效16例。Ⅰ组对证候的总体改善程度优于Ⅱ组(P<0.05)。治疗6周后两组的中医证候积分、VAS评分、HSS膝关节评分均较治疗前有差异统计学意义(P<0.01,P<0.05),且组间比较均具有统计学差异(P<0.01)。两组均未发生不良反应。结论:痹祺胶囊治疗OA临床疗效确切,且具有良好的安全性。 Objective: To observe the clinical effects and safety of Biqi Capsule(BQC) for osteoarthritis. Methods: A trial of multi-center, randomized, and controlled study was conducted. Two hundred and twenty-one participants with osteoarthritis(OA), diagnosed according to the criteria of the American College of Rheumatology revised in 1995, were included and randomly assigned into GroupⅠ(166 cases) and Group Ⅱ(55 cases). There were no significant differences in the baseline level between the two groups. During the research period, participants in Group Ⅰ were treated with Biqi Capsule 1.2g, tid, orally. At the same time, the participants in Group Ⅱ were treated with Tenghuangjiangu Pill, two pill once, bid, orally. All participants got 2 courses of treatments lasted for 6 weeks totally. The scores of Chinese medicine symptoms, visual analogue scale, HSS knee functional score were assessed before and after the interventions. All adverse effects were recorded as well. Results: After the administrations, there were 40 cases with clinical recovery, in the total 166 cases in Group Ⅰ, the were 40 cases with clinical recovery, 59 cases with marked effect, 53 cases with effective results, and 14 cases with no effect. In the total 55 cases in Group Ⅱ, there were 4 cases with clinical recovery, 9 cases with marked effect, 26 cases with effective results, and 16 cases with no effect. The patients in Group Ⅰ improved more compared with Group Ⅱ(P<0.05). According to the Chinese medicine clinical synthesis curative effect determination standard, there were 35 cases with clinical recovery, 59 cases with marked effect, 58 cases with effective results, 14 cases with no effect in Group Ⅰ, and there were 4 cases with clinical recovery, 9 cases with marked effect, 26 cases with effective results, 16 cases with no effect in Group Ⅱ. The Chinese medicine syndromes of the participants in Group Ⅰ improved more compared with Group Ⅱ(P<0.05). After the administrations lasted 6 weeks, the scores of Chinese medicine symptoms

关 键 词： 膝骨性关节炎 痹祺胶囊 多中心随机对照临床试验