Journal of International Reproductive Health/Family Planning ›› 2016, Vol. 35 ›› Issue (5): 375-382.

• 论著 • Previous Articles     Next Articles

Systemic Evaluation on the Efficacy and Safety of GT300 and MCu110

ZHANG Min,SUN Zhi-ming,ZHANG Xue-ning,YANG Yue-hua,XU Hao-qin   

  1. State Contraceptive Adverse reaction Surveillance Center,Jiangsu Institute of Planned Parenthood Research,Nanjing 210036,China
  • Received:1900-01-01 Revised:1900-01-01 Published:2016-10-25 Online:2016-10-25
  • Contact: SUN Zhi-ming

Abstract: Objective: To evaluate the efficacy, safety and acceptability of GT300 and MCu intrauterine device(IUD). Methods:Databases including PubMed, EMBASE, CENTRAL, POPLINE, CBMdisc, CMCI, CNKI, VIP and Wanfang and websites including the Clinical Trials were used to search in this study. The inclusion and exclusion criteria were set according to the PICO-S principle. The meta-analysis was performed by the Revman 5.3.3 software. Results:Three articles matched to the criteria were recruited for meta-analysis. Within the 12 months and 24 months follow-up, the pregnant rate of GT300 IUD was significant higher than that of MCu IUD (RR=3.33,95%CI:1.35-8.25,RR=3.00,95%CI:1.28-7.01). Within the 6 months, 12 months and 24 months follow-up, the expulsion rate of GT300 IUD was significant higher than that of MCu IUD (RR=6.00,95%CI:1.77-20.30;RR=5.55,95%CI:5.25-13.68;RR=3.75,95%CI:1.73-8.12). Within the 6 months, 12 months and 24 months follow-up, the rate of side effects of GT300 IUD(including bleeding, pain, and the occurrence of leucorrhea) was significant higher than that of MCu IUD(P<0.05). Within the 6 months, 12 months and 24 months follow-up, the rate of medical remove of GT300 IUD was significant higher than that of MCu IUD(RR=3.33,95%CI:1.35-8.25;RR=2.31,95%CI:1.21-4.39;RR=2.65,95%CI:1.60-4.38). Within the 3 months, 6 months, 12 months and 24 months follow-up, the continuation rate of GT300 was significant lower than that of MCu IUD(RR=0.12,95%CI:0.01-0.96;RR=0.21,95%CI:0.10-0.41;RR=0.27,95%CI:0.17-0.44;RR=0.32,95%CI: 0.22-0.46). Conclusions:There are few RCT studies to assess the efficacy, safety and acceptability of GT300 IUD when compared with MCu IUD. It is necessary to have the multicenter RCT studies with the large samples, scientific methodology and standards, especially the high-quality and long-term studies, so as to evaluate the efficacy, safety and acceptability of two IUDs.

Key words: Intrauterine devices, copper, Contraceptive devices, female, Meta-analysis, GT300, MCu IUD