培土治痹汤治疗类风湿关节炎伴胃肠道症状(脾胃虚弱证)的临床观察
Clinical Observation on the Treatment of Rheumatoid Arthritis with Gastrointestinal Symptoms (Spleen and Stomach Weakness Syndrome) by Peitu Zhibi Decoction

目的：观察培土治痹汤治疗类风湿关节炎伴胃肠道症状(脾胃虚弱证)的临床疗效及安全性。方法：将60例符合纳入标准的RA患者随机分为对照组(30例，予甲氨蝶呤 + 塞来昔布 + 奥美拉唑)和治疗组(30例，在对照组基础上加服培土治痹汤)。治疗4周后，比较两组关节症状评分(VAS, DAS28, TJC, SJC)、血清炎症指标(CRP, ESR, RF, IL-6)、胃粘膜炎症积分、中医证候积分及不良反应。结果：治疗后，治疗组在VAS、DAS28、TJC、SJC、CRP及中医证候积分方面疗效均优于对照组(P < 0.05)；中医证候总有效率(93.3%)和疾病活动度总有效率(90.0%)均高于对照组(73.3%, 80.0%)。治疗后两组ESR、RF、IL-6及胃粘膜疗效指数方面差异无统计学意义(P > 0.05)，两组疗效相当。安全性方面，两组不良反应发生率差异无统计学意义(P > 0.05)。结论：培土治痹汤可有效改善类风湿关节炎伴胃肠道症状脾胃虚弱证患者的临床症状及炎症反应，并且安全性良好。
Objective: To observe the clinical efficacy and safety of Peitu Zhibi Decoction in the treatment of rheumatoid arthritis with gastrointestinal symptoms (spleen and stomach deficiency syndrome). Methods: 60 patients with RA who met the inclusion criteria were randomly divided into control group (30 cases, treated with methotrexate + celecoxib + omeprazole) and treatment group (30 cases, treated with Peitu Zhibi Decoction on the basis of control group). After 4 weeks of treatment, the joint symptom scores (VAS, DAS28, TJC, SJC), serum inflammatory indexes (CRP, ESR, RF, IL-6), gastric mucosal inflammation scores, TCM syndrome scores and adverse reactions were compared between the two groups. Results: After treatment, the treatment group showed better efficacy than the control group in terms of VAS, DAS28, TJC, SJC, CRP, and Traditional Chinese Medicine (TCM) symptom scores (P < 0.05); the overall effective rate of TCM symptoms (93.3%) and the overall effective rate of disease activity (90.0%) were both higher than those of the control group (73.3%, 80.0%). There were no statistically significant differences between the two groups in terms of ESR, RF, IL-6, and gastric mucosa efficacy index after treatment (P > 0.05), with both groups showing comparable efficacy. In terms of safety, there was no significant difference in the incidence of adverse reactions between the two groups (P > 0.05). Conclusion: Peitu Zhibi Decoction can effectively improve the clinical symptoms and inflammatory response of patients with rheumatoid arthritis with gastrointestinal symptoms and spleen-stomach weakness syndrome, and has good safety.