目的 评价真实世界中通络开痹片治疗关节炎［类风湿关节炎（rheumatoid arthritis，RA）、膝骨关节炎（knee osteoarthritis，KOA）］的效果及安全性，产生大样本量临床循证数据，为临床合理用药提供依据。方法 采取前瞻性研究方法，纳入12家中心2021—2022年收治的1001例RA及KOA患者，分为RA组和KOA组，均采用通络开痹片治疗，访视点是0、4、8、12周。随访并评估患者治疗12周的有效性［疼痛视觉模拟评分（visual analogue scale，VAS）、28个关节疾病活动性评分（disease activity score-28，DAS28）、健康评定问卷（health assessment questionnaire，HAQ）评分、中医症状评分、西安大略麦克马斯特大学（Western Ontario and McMaster University，WOMAC）骨关节炎指数评分等］及安全性。采用SAS9.4软件进行统计分析。结果 RA组基线时疼痛VAS评分为（5.09±1.70）分，治疗12周后下降至（2.75±1.51）分（P＜0.000 1）；DAS28评分基线为（4.97±1.31）分，治疗12周后下降至（3.55±1.12）分（P＜0.000 1），提示治疗前大多数患者处于中高活动度，治疗后36.68%患者达到低疾病活动度和病情缓解；临床疾病活动性指数（clinical disease activity index，CDAI）评分基线为（22.45±13.35）分，表明82.03%的受试者处于中高度活动，治疗12周后CDAI评分降低至（10.82±7.87）分（P＜0.000 1），表明57.29%的患者达到低度疾病活动度。KOA组基线时疼痛VAS评分为（5.14±1.64）分，治疗12周后降至（2.95±1.33）分（P＜0.000 1）；WOMAC评分基线为（63.44±33.91）分，治疗12周后降低至（35.21±21.77）分（P＜0.000 1）。两组的HAQ和中医症状评分均较基线改善，差异具有统计学意义（P＜0.000 1）。治疗期间发生的不良反应主要为神经系统不良发应（占比1%），其次为消化系统（0.7%）、皮肤（0.6%）、肝胆（0.5%）、心血管（0.5%）及全身整体不良反应（0.5%）。结论 通络开痹片可有效降低RA、KOA患者的疼痛程度，不增加不良事件的发生率，值得临床推广。

Objective To evaluate the therapeutic effect and safety of Tongluo Kaibi Tablet (通络开痹片) in the treatment of arthritis [rheumatoid arthritis (RA), knee osteoarthritis (KOA)] in the real world to produce a large sample size of clinical evidence-based data, so as to provide a basis for clinical rational drug use. Methods Using the prospective study method, 1001 patients with RA and KOA were enrolled in 12 centers from 2021 to 2022. All patients were treated with Tongluo Kaibi Tablet. The visits were 0, 4, 8 and 12 weeks. Patients were followed up and evaluated for effectiveness [pain visual analogue scale (VAS) score, disease activity score-28 (DAS28) score, health assessment questionnaire (HAQ) score, traditional Chinese medicine (TCM) symptom score, Western Ontario and McMaster University (WOMAC), etc.] and adverse event data for 12 weeks. The SAS9.4 software was used for statistical analysis. Results The pain VAS score of RA group was 5.09 ± 1.70 at baseline, and gradually decreased after treatment to 2.75 ± 1.51 (P < 0.000 1), DAS28 score decreased from 4.97 ± 1.31 at baseline to 3.55 ± 1.12 at week 12 (P < 0.000 1), indicating that most patients were in the middle and high activity before treatment, and 36.68% were in low activity and remission after treatment; The clinical disease activity index (CDAI) score with baseline of 22.45 ± 13.35 showed that 82.03% of subjects were moderately active, which decreased to 10.82 ± 7.87 at 12 weeks after treatment (P < 0.000 1), indicating that 57.29% of patients achieved low disease activity after treatment. The pain VAS score of the KOA group was 5.14 ± 1.64 at baseline, and decreased to 2.95 ± 1.33 12 weeks after treatment (P < 0.000 1), WOMAC score was 63.44 ± 33.91 at baseline and significantly decreased to 35.21 ± 21.77 12 weeks after treatment (P < 0.000 1). HAQ and TCM symptom scores improved from baseline in both groups, and the differences were statistically significant (P < 0.000 1). The main adverse reactions were nervous system (1%), followed by digestive system (0.7%), skin (0.6%), liver and gallbladder (0.5%), cardiovascular (0.5%) and systemic adverse reactions (0.5%). Conclusion Tongluo Kaibi Tablets can effectively reduce the degree of pain in patients with RA and KOA, without increasing the incidence of adverse events, which is worthy of clinical promotion.

R285.64