痹玉康Ⅰ号合剂治疗类风湿关节炎寒湿痹阻证的疗效及安全性观察  

Therapeutic effect and safety of Biyukang Mixture Ⅰ on rheumatoid arthritis patients of cold-dampness obstruction syndrome

作　　者：张秦[1] 马丛[1] 温博 陈爱萍[1] 施阳[1] 路素言[1] 王北[1] 邵培培[1] ZHANG Qin;MA Cong;WEN Bo;CHEN Ai-ping;SHI Yang;LU Su-yan;WANG Bei;SHAO Pei-pei(Department of Rheumatology,Beijing Hospital of TCM Affiliated to the Capital Medical University,Beijing 100010)

机构地区：[1]首都医科大学附属北京中医医院风湿病科,北京100010

出　　处：《北京中医药》2020年第7期679-683,共5页Beijing Journal of Traditional Chinese Medicine

基　　金：北京市医院管理局“培育”项目(PZ2017023);北京中医药“薪火传承3+3工程”专项王为兰名家研究室(2014-SZ-A-30);燕京流派创新性传承“拳头”工程-风湿病科。

摘　　要：目的观察痹玉康Ⅰ号合剂治疗类风湿关节炎(RA)的疗效及安全性。方法选择2017年1月—2019年5月首都医科大学附属北京中医医院风湿病科门诊及住院RA寒湿痹阻证患者120例,采用随机、对照、双盲、双模拟方法,随机分为治疗组与对照组各60例。治疗组予痹玉康Ⅰ号合剂、雷公藤多苷片安慰剂、非甾体类抗炎药(NSAIDs),对照组予雷公藤多苷片、痹玉康Ⅰ号合剂安慰剂、NSAIDs,疗程均为12周。观察治疗2、4、6、8、12周时2组的疾病活动度评分(DAS28)、健康评价问卷(HAQ)、中医证候评分。结果治疗组治疗12周时中医证候疗效总有效率为93.3%,对照组为90.0%,治疗组优于对照组,但差异无统计学意义(P>0.05);2组随治疗时间延长,中医证候有效率较治疗前逐渐增高(P<0.05);治疗组治疗12周时达到美国风湿病学会(ACR)20疗效标准的患者比例为93.3%,对照组为90.0%,治疗组优于对照组,但差异无统计学意义(P>0.05)。2组随治疗时间延长,达到ACR20的患者比例均较治疗前逐渐增多(P<0.05)。2组均未发现严重不良事件。结论痹玉康Ⅰ号合剂治疗寒湿痹阻证RA与雷公藤多苷片疗效相当,且安全性高。Objective To observe the efficacy and safety of Biyukang Mixture Ⅰ on rheumatoidarthritis(RA).Methods A total of 120 RA with cold-dampness obstruction syndrome inpatients and outpatients received from January 2017 to May 2019 by the Department of Rheumatology,Beijing Hospital of TCM Affiliated to the Capital Medical University were randomly divided into treatment group and control group with randomized, controlled, double-blind, double simulation method, with 60 cases in each group.The treatment group was given Biyukang Mixture Ⅰ, Tripterygium wilfordii polyglycoside tablets placebo and nonsteroidal anti-inflammatory Drugs(NSAⅠDs), the control group was given Tripterygium wilfordii polyglycoside tablets, Biyukang Mixture Ⅰ placebo and NSAⅠDs both for 12 weeks.A 28-joint Disease Activity Score(DAS28), health assessment questionnaire(HAQ)and TCM syndrome scores were administered to both two groups at week 2, week 4, week 6, week 8 and week 12. Results At week 12, the total effectiveness of treatment group was 93.3%, that of control group was 90%, the treatment group was better than the control group, but the difference was not statistically significant(P>0.05);with the treatment getting longer, the effectiveness was increased in TCM syndrome(P<0.05). The ACR20 patients in treatment group was 93.3%, while that in the control group was 90%. The treatment group was superior to the control group, but the difference was not statistically significant(P>0.05), with the treatment getting longer, the patients reaching ACR20 became more and more compared with that before the treatment(P<0.05).Serious adverse events was not found in both groups. Conclusion Biyukang Mixture Ⅰ has similar effect as Tripterygium wilfordii polyglycoside tablets on cold-dampness obstruction syndrome of RA with high safety.

关 键 词：痹玉康Ⅰ号 类风湿关节炎 寒湿痹阻证 

分 类 号：R259[医药卫生—中西医结合]