| Objective:To assess the efficacy and safety of bivalent and quadrivalent vaccine in the prevention of cervical cancer.Methods:The Cochrane Library,PubMed,EMbase,Ovid,CNKI,CBM and WanFang Data,to collect about bivalent and quadrivalent vaccine associated with the efficacy and safety of randomized controlled study,search time from January 2000 to March 2018.Two reviewers independently screened literature according to the inclusion and exclusion criteria,extracted data and assessed the methodological quality of the included studies.Then meta-analysis was conducted using RevMan5.3 soft ware.Results:Six of the 24 randomized controlled articles were included,which is included 1441patients.The experimental group was inoculated with 3-dose bivalent vaccine and the control group was inoculated with 3-dose quadrivalent vaccine.The results of meta analysis show that:1.At the 7th month after inoculate two vaccines,the positive rate of anti-HPV16 anti-HPV18 antibody in serum of the two groups was similar,and there was no significant difference between the two groups(RR=1.00,95%CI(0.92,1.09),Z=0.08,P=0.94>0.05?RR=1.02,95%CI(0.96,1.08),Z=0.56,P=0.58>0.05).2.At the 7th month after inoculate two vaccines,the positive rate of anti-HPV31 and HPV45 antibody in the serum of bivalent vaccine population was higher than that of quadrivalent vaccine,and the difference was statistically significant(RR=1.72,95%CI(1.51,1.97),Z=8.15,P<0.00001?RR=3.90,95%CI(2.63,5.78),Z=6.78,P<0.00001).3.At the 7th month after inoculate the two vaccines,bivalent vaccine HPV16 antibody geometric mean titer is higher than that of the quadrivalent vaccine,the difference was statistically significant(WMD=0.52,95%CI(0.45,0.60),Z=14.36,P<0.00001).4.Seventh months after inoculate the two vaccines,the geometric mean titer of HPV18 antibody in bivalent vaccine population was higher than that in quadrivalent vaccine,and the difference was statistically significant(WMD=0.64,95%CI(0.50,0.79),Z=8.58,P<0.00001).5.Seventh months after inoculate two vaccines,The positive rate of HPV16 antibody in genital secretions was not statistically significant(RR=1.04,95%CI(0.98,1.12),Z=1.27,P=0.20>0.05);Because of the high heterogeneity(?~2=3.51,P=0.06,I~2=71%),the positive rate of HPV18 antibody in genital secretions was not able to be analyzed quantitatively by Meta-analysis.But all the literatures showed that the bivalent vaccine group was higher than the tetravalent vaccine group.6.Adverse Reactions:(1)On the 7th day after vaccination,the positive rate of pain at injection site was analyzed by Meta.The results showed that the positive rate was highly heterogeneous(?~2=10.70,P=0.002,I~2=91%)and could not be quantitatively explained.But the literatures showed that the bivalent vaccine group was higher than the quadrivalent vaccine group;(2)On the 7th day after vaccination,the positive rate of severe injection site pain in the bivalent vaccine group was higher than that in the quadrivalent vaccine group,and the difference was statistically significant(RR=4.57,95%CI(3.01,6.94),Z=7.12,P<0.00001);(3)On the 7th day after vaccination,the positive rate of body temperature?39.0?in the bivalent vaccine group was similar to that in the quadrivalent vaccine group,and the difference was not statistically significant(RR=1.42,95%CI(0.16,12.80),Z=0.31,P=0.75>0.05).Conclusions:Effectiveness:Seventh months after inoculating two vaccines,there was no significant difference in HPV16/18 antibody positive rate and HPV16/18 antibody positive rate in genital tract secretion between the two vaccine groups.and the antibody geometric average titer was higher in bivalent vaccine than that of quadrivalent vaccine;Acooding to HPV 31 and HPV 45 in the 7th month after inoculating two vaccines,the serum antibody positive rate and the antibody geometric average titer,Bivalent vaccine was higher than that of quadrivalent vaccine.Adverse Reactions:the adverse reactions of bivalent vaccines are slightly higher than those of quadrivalent vaccines.These adverse reactions are transient and do not require medical intervention.In a word,both bivalent and quadrivalent vaccines are effective and safe.However,due to the quantitative and qualitative limitations of the included studies,these findings need to be further validated by more high-quality,rigorous randomized blind controlled trials and extended follow-up time. |
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