Clinical Efficacy And Safety Of Recombinant Human Tumor Necrosis Factor-fc Fusion Protein In Ankylosing Spondylitis: A Meta-analysis

Objective: To evaluate the clinical efficacy and safety of recombinant human tumor necrosis factor-Fc fusion protein(rhTNFR-Fc)for patients with ankylosing spondylitis(AS).Methods: Randomized controlled trials(RCTs)of recombinant human tumor necrosis factor-Fc fusion protein for AS with traditional medicines as control group from PubMed,Cochrane Library,ISI,CNKI,VIP,CBM and WanFang Database were searched,from the date of their establishment to February 2017.Relevant RCTs were included according to the exclusion and inclusion criteria.All included RCTs were made quality assessment of with the Cochrane Collaboration's tool for assessing risk of bias and Review Manager 5.3software provided by the Cochrane Collaboration was used to perform meta-analysis.Results: Seventeen RCTs involving 1,410 patients were included.Meta-analysis results showed that there were statistical differences between rhTNFR-Fc treatment group and control group in the clinical effective rate[RR=1.38,95%CI(1.17,1.62)],BASDAI[MD=-1.42,95%CI(-1.76,-1.08)],BASFI[MD=-1.51,95%CI(-1.80,-.21)],ASAS20[RR=2.12,95%CI(1.53,2.94)],spinal pain[SMD=-0.74,95%CI(-0.99,-0.50)],morning stiffness[SMD=-1.19,95%CI(-1.53,-0.85)],occiput-to-wall distance[MD=-0.68,95%CI(-1.33,-0.03)],chest expansion[MD=0.24,95%CI(0.01,0.48)],scoliosis[MD=2.68,95%CI(1.04,4.32)],Schober's test[MD=0.68,95%CI(0.44,0.91)],erythrocyte sedimentation rate[SMD=-0.70,95%CI(-0.90,-0.51)],C-reactive protein[SMD=-0.62,95%CI(-0.79,-0.46)] and TNF-?[SMD=-0.79,95%CI(-1.17,-0.41)],also in adverse reactions of local skin injection[RR=5.39,95%CI(2.50,11.65)],upper respiratory tract infection[RR=3.97,95%CI(1.02,15.42)],leukopenia[RR=0.23,95%CI(0.08,0.67)],gastrointestinal adverse reactions[RR=0.10,95%CI(0.04,0.28)] and hepatic dysfunction[RR=0.32,95%CI(0.15,0.66)].Conclusion: Compared with traditional medicines,rhTNFR-Fc can improve clinical efficacy in the treatment of ankylosing spondylitis significantly,improve the clinical effective rate,BASDAI,BASFI,ASAS20,spinal pain,morning stiffness,occiput-to-wall distance,chest expansion,scoliosis and Schober's test,reduce the levels of ESR,CRP and TNF-?.In adverse reactions,the frequency of gastrointestinal adverse reactions,hepatic dysfunction and leukopenia decreases,while the frequency of local skin injection adverse reactions and upper respiratory tract infection increases.It still needs large sample,high quality,long-term clinical observation to evaluate the clinical efficacy and safety of rhTNFR-Fc for AS and explore the optimal dosing cycle and dosage setting scheme further.