骨龙胶囊联合抗风湿药治疗类风湿关节炎的临床观察

Clinical observation of Gulong capsules combined with DMARDs in treating rheumatoid arthritis

目的:观察骨龙胶囊联合改善病情的抗风湿药物(disease-modifying anti-rheumatic drugs,DMARDs)治疗类风湿关节炎的临床疗效和安全性。方法:选择2012年3月-2013年9月7家医院收治的类风湿关节炎患者240例,随机分为试验组和对照组,各120例,其中试验组用药为骨龙胶囊联合甲氨蝶呤组40例,骨龙胶囊联合来氟米特组80例;对照组中,骨龙胶囊模拟剂联合甲氨蝶呤组(即单用甲氨蝶呤)40例,骨龙胶囊模拟剂联合来氟米特组(即单用来氟米特)80例,疗程均为12周,比较骨龙胶囊联用甲氨蝶呤组与单用甲氨蝶呤组、骨龙胶囊联用来氟米特组与单用来氟米特组之间,达到美国风湿病学会(ACR)评分标准改善程度≥20%(ACR20)的患者比例、中医证候疗效、患者28处关节疾病活动度积分(DAS28)评分以及体征评分之间的差异,并进行安全性比较。结果:骨龙胶囊联合甲氨蝶呤组ACR20(80.56%)高于单用甲氨蝶呤组(58.82%),差异有统计学意义(P<0.05)。中医证候疗效比较,治疗4周后骨龙胶囊联合甲氨蝶呤组有效率高于甲氨蝶呤单用组,差异有统计学意义(P<0.05);治疗8,12周,骨龙胶囊联合甲氨蝶呤组仍高于单用甲氨蝶呤组,但差异无统计学意义,骨龙胶囊联合甲氨蝶呤组在缓解症状起效时间上快于单用甲氨蝶呤组。DAS28评分比较,治疗12周后,骨龙胶囊联合甲氨蝶呤组、单用甲氨蝶呤组DAS28与各自基线相比差异有显著统计学意义(P<0.001)。两组均值和中位数在治疗12周后均有明显降低,骨龙胶囊联合甲氨蝶呤组的降低幅度-(1.73±0.95)大于单用甲氨蝶呤组-(1.00±0.81),差异有统计学意义(P<0.05)。骨龙胶囊联合来氟米特组ACR20(80.00%)高于单用来氟米特组(63.38%),差异有统计学意义(P<0.05)。中医证候疗效比较,治疗4,8周后,骨龙胶囊联合来氟米特组有效率高于单用来氟米特组,但差异无统计学意义;治疗12周后,骨龙胶囊联合来氟米特组中医症候疗效(94.29%)优于单用来氟米特组(76.06%),差异有统计学意义(P<0.05);DAS28评分比较,治疗12周后骨龙胶囊联合来氟米特组、单用来氟米特组DAS28与各自基线相比,差异有显著统计学意义(P<0.001)。两组均值和中位数在治疗12周后均有明显降低,骨龙胶囊联合来氟米特组的降低幅度-(1.51±0.89)大于单用甲氨蝶呤组-(0.71±0.81),差异有显著统计学意义(P<0.001)。骨龙胶囊联合DMARDs组与单用DMARDs组不良反应及不良事件的发生率差异无统计学差异。结论:骨龙胶囊联合DMARDs治疗类风湿关节炎疗效优于单用DMARDs,可显著改善患者的临床症状和体征,是治疗类风湿关节炎有效的治疗方案。

Objective: To observe the clinical efficacy and safety of Gulong capsules combined with antirheumatic drugs( disease-modifying anti-rheumatic drugs,DMARDs) in the treatment of rheumatoid arthritis( RA). Methods: A total of 240 patients with RA admitted to seven hospitals from March 2012 to September 2013 were randomly divided into the experimental group and the control group,with 120 patients in each group. In the experimental group,40 cases were treated with Gulong capsules combined with methotrexate,and 80 cases were treated with Gulong capsules combined with leflunomide. In the control group,40 cases were treated with Gulong capsules simulation agent combined with methotrexate group( i. e.,methotrexate alone),and 80 cases were treated with Gulong capsules simulation agent combined with leflunomide( leflunomide alone). The treatment course was12 weeks. Comparison was made between Gulong capsules combined with methotrexate group and methotrexate monotherapy group,and Gulong capsules combined with leflunomide group and leflunomide monotherapy group.The proportion of patients with improvement degree ≥ 20% of the American College of Rheumatology( ACR)scoring criteria( ACR20),traditional Chinese medicine( TCM) syndrome efficacy,disease activity score in 28 joints( DAS28),physical signs score of patients,and safety were compared. Results: The ACR20 of Gulong capsules combined with methotrexate group( 80. 56%) was significantly higher than that of methotrexate monotherapy group( 58. 82%)( P < 0. 05). After 4 weeks of treatment,the TCM syndrome effective rate of Gulong capsules combined with methotrexate group was statistically significantly higher than the methotrexate monotherapy group( P < 0. 05). At 8 weeks and 12 weeks,the TCM syndrome effective rate of the Gulong capsules combined with methotrexate group was still higher than the methotrexate monotherapy group,but without statistically significant difference. The onset of symptom relief in the Gulong capsules combined with methotrexate group was faster than that in the methotrexate monotherapy group. The DAS28 scores were statistically significantly reduced after 12 weeks of treatment than baseline in both Gulong capsules combined with methotrexate group and methotrexate monotherapy group( P < 0. 001). The mean and median values of the two groups were significantly reduced after 12 weeks of treatment,and the reduction range of the Gulong capsules combined with methotrexate group-( 1. 73 ±0. 95) was greater than that of methotrexate monotherapy group-( 1. 00 ± 0. 81)( P < 0. 05). The ACR20 in Gulong capsules combined with leflunomide group( 80. 00%) was significantly higher than that in leflunomide monotherapy group( 63. 38%)( P < 0. 05). The TCM syndrome effective rate after 4 weeks and 8 weeks of treatment of Gulong capsules combined with leflunomide group was higher than that of leflunomide monotherapy group,but without statistically significant difference. After 12 weeks of treatment,the curative effect of Gulong capsules combined with leflunomide for TCM symptoms( 94. 29%) was better than that of leflunomide alone( 76. 06%),and the difference was statistically significant( P < 0. 05). The mean and median DAS28 score of Gulong capsules combined with leflunomide group and leflunomide monotherapy group were significantly reduced after 12 weeks of treatment( P < 0. 001). The reduction range of Gulong capsules combined with leflunomide-( 1. 51 ± 0. 89) was significantly greater than that of methotrexate monotherapy group-( 0. 71 ± 0. 81)( P < 0. 001). There was no statistical difference in the incidence of adverse reactions and adverse events between Gulong capsules combined with DMARDs group and DMARDs alone. Conclusion: Gulong capsules combined with DMARDs has better curative effect than DMARDs alone for the treatment of RA,and it is an effective treatment option for RA that can significantly improve the patient’s clinical signs and symptoms.