仙灵骨葆胶囊联合甲氨蝶呤治疗类风湿关节炎继发骨质疏松症有效性的系统评价

Systematic Review of Efficacy of Xianling Gubao Capsules Combined with Methorexatein the Treatment of Rheumatoid Arthritis with Osteoporisis

目的:系统评价仙灵骨葆胶囊联合甲氨蝶呤治疗类风湿关节炎(rheumatoid arthritis,RA)继发骨质疏松症(osteoporosis,OP)的有效性,为中药治疗该病提供参考依据。方法:检索the Cochrane Library、PubMed、EMBase、中国知网、万方数据库、中国生物医学文献数据库和维普数据库,纳入比较仙灵骨葆胶囊联合甲氨蝶呤(研究组)与单独使用甲氨蝶呤(对照组)治疗RA继发OP的随机对照试验(randomized controlled trial,RCT),检索时限从建库起至2020年10月。按纳入与排除标准筛选文献、提取资料并评价纳入研究的方法学质量后,采用Rev Man 5.4软件进行荟萃分析(Meta分析)。结果:共4篇RCT文献纳入分析,包括270例患者,其中研究组患者135例,对照组患者135例。分别对显效率、总有效率、骨密度(bone mineral density,BMD)、晨僵时间和关节功能指数进行有效性评价。Meta分析结果显示,两组患者在显效率(RR=1.59,95%CI=1.16~2.20,P=0.005)、总有效率(RR=1.29,95%CI=1.13~1.48,P=0.0003)、股骨颈BMD(MD=0.03,95%CI=0.02~0.04,P<0.00001)、晨僵时间(MD=-6.17,95%CI=-7.72~-4.63,P<0.00001)和关节功能指数(MD=-0.33,95%CI=-0.39~-0.27,P<0.00001)等方面的差异均有统计学意义,研究组患者上述指标明显优于对照组;两组患者腰椎BMD比较,差异无统计学意义(MD=0.05,95%CI=-0.00~0.10,P=0.06>0.05)。结论:仙灵骨葆胶囊可有效提高甲氨蝶呤治疗RA继发OP的显效率、总有效率,改善股骨颈BMD、晨僵时间和关节功能指数。

OBJECTIVE:To systematically evaluate the efficacy of Xianling Gubao capsules combined with methorexatein the treatment of rheumatoid arthritis(RA)with osteoporisis(OP),so as to provide reference for the treatment of the disease with traditional Chinese medicine.METHODS:The Cochrane Library,PubMed,EMBase,CNKI,Wanfang database,CBM and VIP database were retrieved to collect the randomized controlled trial(RCT)of Xianling Gubao capsules combined with methorexatein(study group)vs.methotrexate alone(control group)the treatment of RA with OP.The retrieval time was from the establishment of the database to Oct.2020.According to the inclusion and exclusion criteria,literature were screened,data were extracted,and the methodological quality of the included literature was evaluated.Rev Man 5.4 software was used for Meta-analysis.RESULTS:A total of 4 literature that met the criteria were included,with a total of 270 cases,including 135 cases in the study group and 135 cases in the control group.Significant efficiency,total effective rate,bone mineral density(BMD),morning stiffness time and joint function index were evaluated.Meta-analysis showed that two groups the differences of significant efficiency(RR=1.59,95%CI=1.16-2.20,P=0.005),total effective rate(RR=1.29,95%CI=1.13-1.48,P=0.0003),BMD of femoral neck(MD=0.03,95%CI=0.02-0.04,P<0.00001),morning stiffness time(MD=-6.17,95%CI=-7.72--4.63,P<0.00001)and joint function index(MD=-0.33,95%CI=-0.39--0.27,P<0.00001)and other aspects were statistically significant,the above indexes in the study group were significantly better than those in the control group.There was no significant difference in BMD of lumbar spine between two groups(MD=0.05,95%CI=-0.00-0.10,P=0.06>0.05).CONCLUSIONS:Xianling Gubao capsules can effectively increase the significant efficiency and total effective rate of methotrexate in the treatment of RA with OP,and improve the BMD of femoral neck,morning stiffness time and joint function index.