Mumford S D, Kessel E
Center for Research on Population and Security, Research Triangle Park, North Carolina.
Fertil Steril. 1992 Jun;57(6):1151-76. doi: 10.1016/s0015-0282(16)55068-7.
To compare the findings of the case-control and cohort studies used to indict the Dalkon Shield (A.H. Robins Company, Inc., Richmond, VA) with the findings of the Dalkon Shield clinical trials.
All published reports on the Dalkon Shield were identified through MEDLARS system (United States National Library of Medicine) searches and by cross checking all references in these reports. The same approach was used to identify all case-control and cohort studies of the purported relationship between intrauterine devices (IUDs) and pelvic inflammatory disease (PID).
Only studies of interval patients that included 50 or more women and 6 or more months of follow up that computed standard IUD event rates (rates of pregnancy and expulsion and removal for pain and bleeding) were selected for this study. All case-control and cohort studies identified were included except two case-control studies that included women with sterile chronic salpingitis.
The 16 case-control and 2 cohort studies found or suggested that the Dalkon Shield increased the risk of PID. The 71 clinical trials of the Dalkon Shield show that when this device is inserted by an experienced clinician it is a safe and effective contraceptive method, comparable with other IUDs used at the time. There was no evidence of an increased risk of PID found in these clinical trials.
This study offers convincing evidence that the indictment of the Dalkon Shield was a mistake. Additionally, this study shows that physician skill and experience is far more important to successful IUD insertion than previously recognized, a finding with considerable implications for IUD study designs and for marketing strategies.
比较用于指控盾形节育器（弗吉尼亚州里士满市A.H.罗宾斯公司生产）的病例对照研究和队列研究结果与盾形节育器临床试验结果。
通过医学文献分析和检索系统（美国国立医学图书馆）搜索，并交叉核对这些报告中的所有参考文献，识别出所有已发表的关于盾形节育器的报告。采用相同方法识别所有关于宫内节育器（IUD）与盆腔炎（PID）之间所谓关系的病例对照研究和队列研究。
本研究仅选择对间隔期患者进行的研究，这些研究纳入了50名或更多女性且随访时间为6个月或更长时间，并计算了标准宫内节育器事件发生率（妊娠率、因疼痛和出血而排出及取出率）。除两项纳入患有无菌性慢性输卵管炎女性的病例对照研究外，所有识别出的病例对照研究和队列研究均被纳入。
16项病例对照研究和2项队列研究发现或表明盾形节育器会增加盆腔炎风险。盾形节育器的71项临床试验表明，当由经验丰富的临床医生插入该装置时，它是一种安全有效的避孕方法，与当时使用的其他宫内节育器相当。在这些临床试验中未发现盆腔炎风险增加的证据。
本研究提供了令人信服的证据，证明对盾形节育器的指控是一个错误。此外，本研究表明，医生的技能和经验对成功插入宫内节育器远比之前认识到的更为重要，这一发现对宫内节育器研究设计和营销策略具有重要意义。
