CAJ | 학술논문

目的：评价清热解毒活血法外治类风湿关节炎（RA）活动期关节炎症的临床疗效和安全性。方法：纳入120例辨证为热毒蕴结、气滞血瘀型 RA 活动期的患者。随机分为治疗组60例，对照组60例，治疗组采用具有清热解毒活血作用的消炎止痛膏，对照组采用安慰剂，1贴／d，选择1个受累关节外用。每个疗程7 d，共治疗2个疗程，观察关节肿痛总积分（包括疼痛、肿胀、关节发热、压痛等）；疼痛视觉模拟评分法（Visual Analogue Scale ／Score，简称 VAS 评分）及血沉（ESR）变化。结果：治疗组总效率（60.4％）明显优于对照组（20.0％）。完成治疗后治疗组的关节症状总积分、VAS 评分均明显改善（P ＜0.01），且显著优于对照组（P ＜0.01）。治疗组 ESR 较治疗前明显下降（P ＜0.01），但与对照组比较无统计学意义（P ＞0.05）。2组不良事件无统计学意义。结论：清热解毒活血外治法能明显改善类风湿关节炎活动期关节红肿热痛症状，起效较快，安全性好，值得进一步深入研究并在临床推广应用。
목적：평개청열해독활혈법외치류풍습관절염（RA）활동기관절염증적림상료효화안전성。방법：납입120례변증위열독온결、기체혈어형 RA 활동기적환자。수궤분위치료조60례，대조조60례，치료조채용구유청열해독활혈작용적소염지통고，대조조채용안위제，1첩／d，선택1개수루관절외용。매개료정7 d，공치료2개료정，관찰관절종통총적분（포괄동통、종창、관절발열、압통등）；동통시각모의평분법（Visual Analogue Scale ／Score，간칭 VAS 평분）급혈침（ESR）변화。결과：치료조총효솔（60.4％）명현우우대조조（20.0％）。완성치료후치료조적관절증상총적분、VAS 평분균명현개선（P ＜0.01），차현저우우대조조（P ＜0.01）。치료조 ESR 교치료전명현하강（P ＜0.01），단여대조조비교무통계학의의（P ＞0.05）。2조불량사건무통계학의의。결론：청열해독활혈외치법능명현개선류풍습관절염활동기관절홍종열통증상，기효교쾌，안전성호，치득진일보심입연구병재림상추엄응용。
Objective:To observe the clinical efficacy and safety of the external therapy by heat detoxification and blood accelera-tion in treating active RA.Methods:In this double-blinded parallel controlled clinical trail,120 patients with active RA were ran-domly divided into two groups,with 60 cases in each.The intervention of the treatment group was sticking Xiaoyanzhitong Paste on one suffered joint one piece a day.The Patients in control group received Placebo.Clinical and laboratory parameters were observed and tested in two groups before and after the two-week treatment course.Results:The total efficiency rate of the treatment group (60.4%)was significantly better than that of the control group (20.0%)(P <0.01 ).Comparison of the total score of joint symptoms and VAS between two groups showed the same result (P <0.01).ESR in the treatment group decreased obviously,but no significant difference was detected between the two groups.The incidence of adverse events was similar between the two groups (P >0.05).Conclusion:The study proves that compared with placebo,Xiaoyanzhitong Paste is a better anti-inflammatory analge-sic for patients with active RA.Main symptoms are significantly improved,while no obvious adverse events are seen in the study. External therapy by heat detoxification and blood acceleration may be a safe and effective treatment for active RA.