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对217名女性使用三种一次性塑料宫内节育器尾丝取出器的随机对照研究。

Randomised comparative study in 217 women of three disposable plastic IUCD thread retrievers.

作者信息

Bounds W, Hutt S, Kubba A, Cooper K, Guillebaud J, Newman G B

机构信息

Margaret Pyke Centre for Study and Training in Family Planning, London, UK.

出版信息

Br J Obstet Gynaecol. 1992 Nov;99(11):915-9. doi: 10.1111/j.1471-0528.1992.tb14442.x.

Abstract

OBJECTIVE

To assess the relative efficacy of three disposable plastic instruments in the retrieval of 'missing' IUCD threads.

DESIGN

A prospective randomised comparative single centre study.

SETTING

Family Planning Clinic in London, UK.

SUBJECTS

217 of 350 IUCD users referred to the research team with 'missing' IUCD threads entered the study.

INTERVENTION

All women initially underwent exploration of the endocervical canal with Spencer Wells forceps. When this procedure did not retrieve the threads, the patients were entered into the study. A maximum of two randomly chosen plastic IUCD thread retrievers were then used in any one patient to explore the uterine cavity and capture the 'missing' threads. The order in which the two retrievers were employed was also determined at random. Four separate entries into the uterine cavity were permitted with each instrument, the endocervical canal being explored with Spencer Wells forceps after each retraction of the instrument to identify the possible descent of the threads.

MAIN OUTCOME MEASURES

Threads brought down beyond the external cervical os, or threads brought to within the endocervical canal and then grasped by Spencer Wells forceps.

RESULTS

In approximately 40% of all patients, the threads were retrieved with Spencer Wells forceps alone and a further 40% with the disposable plastic retrievers. About 5% had no retrievable threads, and only 2.5% of the referred patients required general anaesthesia for removal of their IUCD. The analysis of the comparative trial was confined to the 197 patients with retrievable threads which could not be brought below the external os with Spencer Wells forceps. The first plastic retriever used was successful in 50% of patients. The Retrievette (59%) and the Emmett (53%) performed better than the Mi-Mark Helix (37%) in this study. The difference was statistically significant (P = 0.03) and the 95% confidence interval for the difference of the Mi-Mark Helix from the other two retrievers was 4% to 33%. This retrieval rate for the Mi-Mark Helix was much worse than in previously reported studies, though one doctor did have a better success rate with this retriever. The success rates, using a second plastic retriever randomly chosen from the two not used in the first attempt, were almost identical to those observed with the first retrievers: 63%, 56% and 36%. The success rate did not appear to be influenced by the length of thread, day of cycle, device type or parity. The success of the second retriever tried did not seem to be influenced by the retriever that had failed previously.

CONCLUSIONS

Based on our experience, the initial exploration of the endocervical canal with Spencer Wells forceps is invaluable. If this simple manoeuvre fails to retrieve the 'missing' threads, either the Retrievette or the Emmett thread retrievers are useful tools in general practice or in the family planning clinic setting.

摘要

目的

评估三种一次性塑料器械在取出“丢失”的宫内节育器尾丝方面的相对疗效。

设计

一项前瞻性随机对照单中心研究。

地点

英国伦敦的计划生育诊所。

研究对象

350名因宫内节育器尾丝“丢失”而被转介至研究团队的宫内节育器使用者中,有217人进入研究。

干预措施

所有女性最初均用斯宾塞·韦尔斯钳探查宫颈管。若此操作未能取出尾丝,则将患者纳入研究。然后,在任何一名患者身上最多随机选用两种塑料宫内节育器尾丝取出器,用于探查子宫腔并取出“丢失”的尾丝。两种取出器的使用顺序也随机确定。每种器械允许四次分别进入子宫腔,每次器械回撤后用斯宾塞·韦尔斯钳探查宫颈管,以确定尾丝是否可能下移。

主要观察指标

尾丝带出至宫颈外口以外,或尾丝带至宫颈管内并随后被斯宾塞·韦尔斯钳夹住。

结果

在所有患者中,约40%仅用斯宾塞·韦尔斯钳就取出了尾丝,另外40%用一次性塑料取出器取出。约5%的患者没有可取出的尾丝,仅2.5%的被转介患者在取出宫内节育器时需要全身麻醉。比较试验的分析仅限于197名用斯宾塞·韦尔斯钳无法将尾丝带出宫颈外口的可取出尾丝的患者。首次使用的塑料取出器在50%的患者中成功。在本研究中,Retrievette(59%)和Emmett(53%)的表现优于Mi-Mark Helix(37%)。差异具有统计学意义(P = 0.03),Mi-Mark Helix与其他两种取出器的差异的95%置信区间为4%至33%。尽管有一位医生使用该取出器的成功率较高,但Mi-Mark Helix的取出率比先前报道的研究要低得多。使用从首次尝试未使用的两种中随机选择的第二种塑料取出器的成功率与首次取出器观察到的成功率几乎相同:分别为63%、56%和36%。成功率似乎不受尾丝长度、月经周期天数、器械类型或产次的影响。第二次尝试的取出器的成功率似乎不受先前失败的取出器的影响。

结论

根据我们的经验,先用斯宾塞·韦尔斯钳探查宫颈管非常重要。如果这种简单操作未能取出“丢失”的尾丝,那么Retrievette或Emmett尾丝取出器在全科医疗或计划生育诊所环境中都是有用的工具。

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