Efficacy of Qizhu Bishi Granules combined with methotrexate in treatment of patients with rheumatoid arthritis
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摘要:目的
探讨芪术痹湿颗粒联合甲氨蝶呤治疗类风湿关节炎(RA)的效果。
方法选取2023年1—5月石家庄市第三医院收治的140例RA患者为研究对象, 按照随机数字表法分为治疗组和对照组，每组70例。对照组予以甲氨蝶呤治疗，治疗组予以芪术痹湿颗粒联合甲氨蝶呤治疗，疗程均为3个月。比较2组总有效率，治疗前及治疗1、3个月后中医证候积分、关节肿胀数量、关节压痛数量、视觉模拟评分法(VAS)评分、28个关节疾病活动度评分(DAS28)、白细胞介素-1(IL-1)、肿瘤坏死因子-α(TNF-α)、红细胞沉降率(ESR)、超敏C反应蛋白(hs-CRP)、类风湿因子(RF)、抗环瓜氨酸肽抗体(抗CCP抗体)水平，以及治疗安全性。
结果治疗组总有效率为97.14%, 高于对照组的87.14%, 差异有统计学意义(P < 0.05); 治疗1、3个月后，治疗组中医证候积分、关节肿胀数量、关节压痛数量、VAS评分、DAS28、IL-1、TNF-α、ESR、hs-CRP、RF、抗CCP抗体水平均少于或低于对照组，差异有统计学意义(P < 0.05)。2组均未发生不良反应。
结论芪术痹湿颗粒联合甲氨蝶呤治疗RA能有效缓解患者临床症状，改善中医证候，减轻炎症反应，降低疾病活动度，治疗效果安全可靠。
Abstract:ObjectiveTo investigate the efficacy of Qizhu Bishi Granules combined with methotrexate in the treatment of patients with rheumatoid arthritis (RA).
MethodsA total of 140 RA patients in the Shijiazhuang City Third Hospital from January to May 2023 were selected as research objects and randomly divided into a treatment group and a control group, with 70 cases in eachgroup. The control group was treated with methotrexate, while the treatment group was treated with Qizhu Bishi Granules combined with methotrexate, and the treatment duration was 3 months for both groups. The total effective rate, score of traditional Chinese medicine (TCM) syndromes, the number of swollen joints, the number of tender joints, the Visual Analogue Scale (VAS) score for pain, the Disease Activity Score in 28 Joints (DAS28), interleukin-1 (IL-1), tumor necrosis factor-α (TNF-α), erythrocyte sedimentation rate (ESR), high-sensitivity C reactive protein (hs-CRP), rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibody (anti-CCP antibody) levels before treatment and at 1 month and 3 months after treatment as well as therapeutic safety were compared between the two groups.
ResultsThe total effective rate in the treatment group was 97.14%, which was significantly higher than 87.14% in the control group (P < 0.05). After 1 month and 3 months of treatment, the scores of TCM syndromes, the number of swollen joints, the number of tender joints, the VAS score, DAS28, IL-1, TNF-α, ESR, hs-CRP, RF and anti-CCP antibody levels in the treatment group were significantly lower than those in the control group (P < 0.05). No adverse reactions occurred in both group.
ConclusionQizhu Bishi Granules combined with methotrexate in treating RA can effectively alleviate clinical symptoms, improve TCM syndromes, reduce inflammatory responses, decrease disease activity, and the therapeutic efficacy is reliable and safe.
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表 1 2组临床资料比较(x±s)[n(%)]
临床资料 分类 治疗组(n=70) 对照组(n=70) 年龄/岁 42.65±10.39 43.78±11.44 病程/年 8.44±2.51 8.90±2.85 体质量指数/(kg/m2) 23.90±1.12 23.87±1.03 性别 男 29(41.43) 33(47.14) 女 41(58.57) 37(52.86) 疾病阶段 早期 30(42.86) 35(50.00) 进展期 40(57.14) 35(50.00) X线片分期 Ⅰ期 12(17.14) 8(11.43) Ⅱ期 28(40.00) 28(40.00) Ⅲ期 30(42.86) 34(48.57) 关节功能分级 Ⅰ级 13(18.57) 8(11.43) Ⅱ级 39(55.71) 44(62.86) Ⅲ级 18(25.72) 18(25.71) 
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表 2 2组疗效比较[n(%)]
组别 n 显效 有效 无效 总有效 治疗组 70 51(72.86) 17(24.29) 2(2.86) 68(97.14)* 对照组 70 40(57.14) 21(30.00) 9(12.86) 61(87.14) 与对照组比较, * P < 0.05。
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表 3 2组中医证候积分比较(x±s)
分 评估项目 组别 n 治疗前 治疗1个月后 治疗3个月后 关节肌肉疼痛 治疗组 70 4.13±0.55 1.95±0.26*# 0.51±0.18*# 对照组 70 4.02±0.73 2.38±0.44* 1.10±0.16* 关节疼痛遇寒加重 治疗组 70 3.86±0.91 1.44±0.30*# 0.34±0.11*# 对照组 70 3.92±0.87 2.07±0.35* 0.85±0.20* 关节重着 治疗组 70 4.50±0.63 1.33±0.24*# 0.42±0.13*# 对照组 70 4.47±0.80 2.95±0.31* 1.29±0.36* 肿胀散漫 治疗组 70 3.20±0.41 0.88±0.20*# 0.52±0.14*# 对照组 70 3.16±0.39 1.69±0.33* 1.37±0.18* 肌肤麻木不仁 治疗组 70 3.56±0.52 0.94±0.20*# 0.46±0.10*# 对照组 70 3.47±0.45 1.87±0.28* 1.50±0.27* 关节屈伸不利 治疗组 70 2.98±0.63 0.62±0.21*# 0.30±0.10*# 对照组 70 3.13±0.56 2.05±0.24* 1.22±0.25* 与治疗前比较, * P < 0.05; 与对照组比较, #P < 0.05。
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表 4 2组关节肿胀数量、关节压痛数量比较(x±s)
个 指标 组别 n 治疗前 治疗1个月后 治疗3个月后 关节肿胀数量 治疗组 70 9.05±2.79 5.86±1.30*# 3.15±0.64*# 对照组 70 15.35±3.11 9.00±2.13* 7.28±1.40* 关节压痛数量 治疗组 70 10.80±3.04 5.17±1.54*# 2.12±0.33*# 对照组 70 16.10±3.56 8.56±1.26* 4.40±0.85* 与治疗前比较, * P < 0.05; 与对照组比较, #P < 0.05。
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表 5 2组疼痛VAS评分、DAS28比较(x±s)
分 指标 组别 n 治疗前 治疗1个月后 治疗3个月后 疼痛VAS评分 治疗组 70 8.53±1.16 3.49±0.86*# 1.55±0.31*# 对照组 70 8.30±0.95 5.66±1.03* 3.70±0.44* DAS28 治疗组 70 7.64±1.48 5.03±0.90*# 3.76±0.82*# 对照组 70 7.29±1.23 6.00±1.24* 5.26±0.95* VAS: 视觉模拟评分法; DAS28: 28个关节疾病活动度评分。与治疗前比较, * P < 0.05; 与对照组比较, #P < 0.05。
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表 6 2组IL-1、TNF-α、ESR、hs-CRP比较(x±s)
指标 组别 n 治疗前 治疗1个月后 治疗3个月后 IL-1/(pg/mL) 治疗组 70 93.28±18.96 37.44±7.28*# 28.92±8.51*# 对照组 70 56.34±14.50 50.01±10.33* 45.26±11.79* TNF-α/(pg/mL) 治疗组 70 313.41±89.66 50.05±13.29*# 13.43±4.52*# 对照组 70 304.65±97.42 99.76±18.34* 32.65±10.01* ESR/(mm/h) 治疗组 70 99.25±19.60 42.00±8.73*# 27.88±5.43*# 对照组 70 93.03±22.54 78.43±10.55* 66.10±9.87* hs-CRP/(mg/L) 治疗组 70 41.89±9.88 22.30±7.17*# 7.86±1.25*# 对照组 70 42.43±11.35 36.51±5.28* 29.89±7.30* IL-1: 白细胞介素-1; TNF-α: 肿瘤坏死因子-α; ESR: 红细胞沉降率; hs-CRP: 超敏C反应蛋白。
与治疗前比较, * P < 0.05; 与对照组比较, #P < 0.05。
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表 7 2组RF、抗CCP抗体比较(x±s)
指标 组别 n 治疗前 治疗1个月后 治疗3个月后 RF/(IU/mL) 治疗组 70 107.80±22.76 93.26±8.77*# 80.98±11.32*# 对照组 70 105.48±19.55 100.15±10.28* 97.7±9.64* 抗CCP抗体/(RU/mL) 治疗组 70 95.13±31.58 86.51±12.27*# 78.98±14.51*# 对照组 70 110.10±36.00 102.24±10.83* 99.60±12.37* RF: 类风湿因子; 抗CCP抗体: 抗环瓜氨酸肽抗体。与治疗前比较, * P < 0.05; 与对照组比较, #P < 0.05。
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