French R, Cowan F, Mansour D, Morris S, Hughes D, Robinson A, Proctor T, Summerbell C, Logan S, Guillebaud J
Department of STDs, The Mortimer Market Centre, University College London Medical School, off Capper Street, London, UK, WC1E 6AU.
Cochrane Database Syst Rev. 2001(2):CD001776. doi: 10.1002/14651858.CD001776.
To assess the contraceptive efficacy, tolerability and acceptability of hormonally impregnated intrauterine systems (IUSs) in comparison to other reversible contraceptive methods.
Literature was identified through database searches, reference lists and individuals/organisations working in the field.
All randomised controlled trials comparing IUSs with other forms of reversible contraceptives and reporting on pre-determined outcomes in women of reproductive years. The primary outcomes were pregnancy due to method/user failure and continuation rate.
The quality assessment of studies and data extraction were completed independently by two blinded reviewers. A quality checklist was designed to identify general methodological and contraceptive specific factors which could bias results. Events per women months and single decrement life table rates were extracted where possible for pregnancy, continuation, adverse events and reasons for discontinuation. Events per total number of women at follow up were collected for hormonal side effects and menstrual disturbance. When appropriate, data were pooled at the same points of follow up to calculate rate ratios in order to determine the relative effectiveness of one method compared to another. For the single decrement life table rates, the rate differences were pooled to determine the absolute difference in effectiveness of one method compared to another. Interventions were only combined if the contraceptive methods were similar. Non-hormonal IUDs were divided into three categories for the purpose of comparison with IUSs: IUDs >250mm2 (i.e. CuT 380A IUD and CuT 380 Ag IUD), IUDs <=250mm2 (i.e. Nova-T, Multiload, CuT 200 and CuT 220 IUDs) and non-medicated IUDs.
Nineteen RCTs comparing hormonally impregnated IUSs to a reversible contraceptive method met the inclusion criteria and it was possible to include eight of these in the meta-analyses, four comparing LNG-20 IUSs with non-hormonal IUDs, one comparing the LNG-20 IUS with Norplant-2 and three comparing Progestasert with non-hormonal IUDs. No significant difference was observed between the pregnancy rates for the LNG-20 users and those for the IUD >250mm2 users. However, women using the LNG-20 IUS were significantly less likely to become pregnant than those using the IUD <=250mm2. Women using the LNG-20 IUS were more likely to experience amenorrhoea and device expulsion than women using IUDs >250mm2. LNG-20 users were significantly more likely than all the IUD users to discontinue because of hormonal side effects and menstrual disturbance, which on further breakdown of the data was due to amenorrhoea. When the LNG-20 IUS was compared to Norplant-2, the LNG-20 users were significantly more likely to experience amenorrhoea and oligomenorrhoea, but significantly less likely to experience prolonged bleeding and spotting. No other significant differences were observed. Progestasert users were significantly less likely to become pregnant and less likely to continue on the method than non-medicated IUD users after one year, but no significant differences was noted for these two outcomes when Progestasert users were compared to IUD<=250mm2 users. The only other significant differences found in the meta-analyses were that Progestasert users were less likely to expel the device and more likely to discontinue the method because of menstrual bleeding and pain than users of IUDs <=250mm2.
REVIEWER'S CONCLUSIONS: Current evidence suggests LNG-20 IUS users are no more or less likely to have unwanted pregnancies than IUD >250mm2 and Norplant-2 users. The LNG-20 IUS was more effective in preventing either intrauterine or extrauterine pregnancies than IUDs <=250mm2. The contraceptive effectiveness of Progestasert was significantly better than non-medicated IUDs, but no difference was observed when compared to IUDs<=250mm2. Continuation of LNG-20 IUS use was similar to continuation of the non-hormonal IUDs and Norplant-2. Amenorrhoea was the main reason for the discontinuation for the LNG-20 IUS and women should be informed of this prior to starting this method.
评估激素浸渍宫内节育系统(IUS)与其他可逆性避孕方法相比的避孕效果、耐受性和可接受性。
通过数据库检索、参考文献列表以及该领域的个人/组织来识别文献。
所有比较IUS与其他形式可逆性避孕药具并报告育龄期女性预定结局的随机对照试验。主要结局为方法/使用者失败导致的妊娠和续用率。
研究的质量评估和数据提取由两名盲法评审员独立完成。设计了一份质量清单,以识别可能使结果产生偏差的一般方法学和避孕特定因素。尽可能提取每位女性每月的事件数以及单减生命表率,用于妊娠、续用、不良事件和停用原因。收集随访时每位女性的激素副作用和月经紊乱事件数。在适当情况下,在相同随访点合并数据以计算率比,以确定一种方法相对于另一种方法的相对有效性。对于单减生命表率,合并率差以确定一种方法相对于另一种方法有效性的绝对差异。仅当避孕方法相似时才合并干预措施。为了与IUS进行比较,非激素宫内节育器分为三类:面积>250mm2的宫内节育器(即铜T 380A宫内节育器和铜T 380银宫内节育器)、面积<=250mm2的宫内节育器(即Nova-T、Multiload、铜T 200和铜T 220宫内节育器)和无药宫内节育器。
19项比较激素浸渍IUS与可逆性避孕方法的随机对照试验符合纳入标准,其中8项可纳入荟萃分析,4项比较LNG-20 IUS与非激素宫内节育器,1项比较LNG-20 IUS与Norplant-2,3项比较Progestasert与非激素宫内节育器。LNG-20使用者的妊娠率与面积>250mm2的宫内节育器使用者的妊娠率之间未观察到显著差异。然而,使用LNG-20 IUS的女性怀孕的可能性明显低于使用面积<=250mm2的宫内节育器的女性。与使用面积>250mm2的宫内节育器的女性相比,使用LNG-20 IUS的女性更易出现闭经和节育器脱落。LNG-20使用者因激素副作用和月经紊乱而停用的可能性显著高于所有宫内节育器使用者,进一步分析数据发现这是由于闭经所致。当将LNG-20 IUS与Norplant-2进行比较时,LNG-20使用者更易出现闭经和月经过少,但出现长时间出血和点滴出血的可能性显著降低。未观察到其他显著差异。一年后,Progestasert使用者怀孕的可能性显著低于无药宫内节育器使用者,且继续使用该方法的可能性也较低,但将Progestasert使用者与面积<=250mm2的宫内节育器使用者进行比较时,这两个结局未观察到显著差异。荟萃分析中发现的唯一其他显著差异是,与面积<=250mm2的宫内节育器使用者相比,Progestasert使用者节育器脱落的可能性较小,因月经出血和疼痛而停用该方法的可能性较大。
目前的证据表明,LNG-20 IUS使用者意外怀孕的可能性与面积>250mm2的宫内节育器使用者和Norplant-2使用者相同或更低。LNG-20 IUS在预防宫内或宫外妊娠方面比面积<=250mm2的宫内节育器更有效。Progestasert的避孕效果显著优于无药宫内节育器,但与面积<=250mm2的宫内节育器相比无差异。LNG-20 IUS的续用情况与非激素宫内节育器和Norplant-2的续用情况相似。闭经是LNG-20 IUS停用的主要原因,在开始使用该方法前应告知女性这一点。