祖师麻片联合美洛昔康治疗膝骨关节炎急性期的临床研究

Clinical study of Zushima Tablets combined with meloxicam in treatment of acute knee osteoarthritis

目的探讨祖师麻片联合美洛昔康治疗膝骨关节炎急性期的临床效果。方法选取2019年2月—2020年10月天津中医药大学第一附属医院收治的126例膝骨关节炎急性期患者,以随机数字表法将其分成对照组(n=63)和治疗组(n=63)。对照组口服美洛昔康片,7.5 mg/次,2次/d。治疗组在对照组治疗基础上口服祖师麻片,0.9 g/次,3次/d。两组均连续治疗4周后评价其疗效。观察两组的临床疗效,同时比较治疗前后两组膝关节疼痛视觉模拟量表(VAS)评分、晨僵时间、膝关节活动度、Lequesne指数总分、关节炎影响测量量表2-短卷(AIMS2-SF)总分、红细胞沉降率(ESR)及血清C反应蛋白(CRP)、白细胞介素(IL)-17、转化生长因子(TGF)-β1水平和基质金属蛋白酶-3(MMP-3)与金属蛋白酶组织抑制因子-1(TIMP-1)比值(MMP-3/TIMP-1)。结果治疗后,治疗组总有效率为96.8%,较对照组87.3%显著升高(P<0.05)。治疗后,两组膝VAS评分均显著降低,晨僵时间均显著缩短,膝关节主、被动活动度均显著提高(P<0.05);治疗后,治疗组膝关节疼痛VAS评分、晨僵时间及膝关节活动度改善均优于对照组(P<0.05)。治疗后,两组Lequesne指数总分均显著低于本组治疗前,但AIMS2-SF总分均显著高于本组治疗前(P<0.05);且治疗后,治疗组Lequesne指数总分和AIMS2-SF总分改善优于对照组(P<0.05)。治疗后,两组患者ESR及血清CRP、IL-17、MMP-3/TIMP-1较本组治疗前均显著下降,但TGF-β1均显著上升(P<0.05);且治疗后,治疗组ESR及血清学指标改善优于对照组(P<0.05)。结论祖师麻片联合美洛昔康治疗膝骨关节炎急性期具有较好的疗效,可安全有效地减轻患者膝关节疼痛,改善关节功能,抑制机体炎症反应,促进病情的稳定,提高生活质量,值得临床推广应用。

Objective To investigate the clinical effect of Zushima Tablets combined with meloxicam in treatment of acute knee osteoarthritis. Methods A total of 126 patients with acute knee osteoarthritis admitted to the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from February 2019 to October 2020 were selected and divided into control group(n=63) and treatment group(n=63) by random number table method. Patients in the control group were po administered with Meloxicam Tablets, 7.5 mg/time, twice daily. Patients in the treatment group were po administered with Zushima Tablets on the basis of the control group, 0.9 g/time, three times daily. Both groups were evaluated after 4 weeks of continuous treatment. The clinical efficacy of the two groups was observed, and visual analog scale(VAS) score, morning stiffness time, range of motion of knee joint,total score of Lequesne index, total score of Arthritis Impact Scale 2-short volume(AIMS2-SF), erythrocyte sedification rate(ESR),serum C-reactive protein(CRP), interleukin(IL)-17, transformation growth factor(TGF)-β1, matrix metalloproteinase-3(MMP-3) to tissue inhibitor of metalloproteinase-1(TIMP-1) ratio(MMP-3/TIMP-1) between the two groups before and after treatment were compared. Results After treatment, the total effective rate of the treatment group was 96.8%, which was significantly higher than that of the control group(87.3%, P < 0.05). After treatment, knee VAS score was significantly decreased, morning stiffness time was significantly shortened, and the active and passive activity of knee joints were significantly increased in both groups(P < 0.05). After treatment, VAS score, morning stiffness time and range of motion of knee in the treatment group were better than those in the control group(P < 0.05). After treatment, the total Lequesne index scores of the two groups were significantly lower than before treatment,but the total AIMS2-SF scores were significantly higher than before treatment(P < 0.05). After treatment, the total score of Lequesne index and AIMS2-SF in the treatment group improved better than that in the control group(P < 0.05). After treatment, ESR, serum CRP, IL-17, and MMP-3/TIMP-1 in two groups were significantly decreased compared with before treatment, but TGF-β1 was significantly increased(P < 0.05). After treatment, the improvement of ESR and serological indexes in the treatment group was better than that in the control group(P < 0.05). Conclusion Zushima tablets combined with meloxicam has satisfactory overall efficacy in the treatment of acute knee osteoarthritis, and can safely and effectively relieve knee joint pain, improve joint function, inhibit body inflammation, promote stability of the disease, and improve the life quality, which is worthy of clinical promotion and application.