Cao X, Zhang W, Gao G, Van Kets H, Wildemeersch D
Tianjin Municipal Institute for Family Planning, People's Republic of China.
Eur J Contracept Reprod Health Care. 2000 Jun;5(2):135-40. doi: 10.1080/13625180008500386.
To compare the clinical performance of two intrauterine devices (the frameless GyneFix intrauterine device (IUD) and the TCu380A IUD) during long-term use.
This was a randomized comparative study. A total of 157 insertions of the GyneFix IUD were compared with 156 insertions of the TCu380A IUD in the Tianjin Municipal Institute for Family Planning, China. Only parous women were included in the study. Insertions were conducted by the first three authors. The trial extended over a 9-year period, with over 10,000 woman-months of experience.
The study showed that both devices are highly efficacious. No pregnancies occurred with the GyneFix IUD (cumulative pregnancy rate 0.0), compared to one pregnancy with the TCu380A IUD (cumulative pregnancy rate 0.64). The cumulative expulsion rate with the GyneFix IUD was 1.91 (three expulsions occurred, two of which were during the first 6 months), compared to a cumulative expulsion rate of 5.13 (eight expulsions) with the TCu380A (p = 0.1112). The total use-related discontinuation rate (terminations were mainly due to bleeding disturbances) was significantly lower (p = 0.0051) with the GyneFix IUD (4.46) than with the TCu380A IUD (14.10) and resulted in a higher rate of continuation with the GyneFix IUD compared to the TCu380A IUD (92.36 versus 83.97). Neither perforations nor cases of pelvic inflammatory disease were encountered with either device in this study, demonstrating the safety of the anchoring system.
The results of the present clinical trial are in agreement with the findings of other multicenter, randomized, comparative, clinical trials that have investigated these two IUDs in China, as well as with the findings of other large-scale international studies conducted with the frameless IUD.
比较两种宫内节育器（无支架吉妮宫内节育器（IUD）和TCu380A IUD）长期使用期间的临床性能。
这是一项随机对照研究。在中国天津市计划生育研究所，对157例吉妮IUD置入与156例TCu380A IUD置入进行了比较。研究仅纳入经产妇。置入由前三位作者进行。该试验持续了9年，有超过10000个妇女月的经验。
研究表明两种节育器均高度有效。吉妮IUD未发生妊娠（累积妊娠率0.0），而TCu380A IUD有1例妊娠（累积妊娠率0.64）。吉妮IUD的累积脱落率为1.91（发生3次脱落，其中2次在前6个月），而TCu380A IUD的累积脱落率为5.13（8次脱落）（p = 0.1112）。吉妮IUD的总使用相关终止率（终止主要因出血紊乱）显著低于TCu380A IUD（4.46比14.10，p = 0.0051），且与TCu380A IUD相比，吉妮IUD的继续使用率更高（92.36对83.97）。本研究中两种节育器均未出现穿孔或盆腔炎病例，证明了固定系统的安全性。
本临床试验结果与中国其他对这两种IUD进行研究的多中心、随机、对照临床试验结果一致，也与其他使用无支架IUD进行的大规模国际研究结果一致。
