Jürgensen O, Stenzel I, Wirth A, Sina D, Taubert H D
Fortschr Med. 1976 Mar 18;94(9):515-21.
Within 2 years 258 women aged 16 to 42 years were fitted with a copper-7-IUD (Gravigard, Searle). 45% of these patients were nulliparous women. Follow-up studies were provided in 236 cases in a total of 2717 women-months according to an average time of observation of 11.5 women-months per patient. Altogether there occurred 5 unwanted pregnancies with a Pearl-Index of 2.3. Partial or total expulsion occurred in 27 cases (11%). Fourteen out of 27 expulsions were noticed within the first 2 months after insertion. Removals for medical reasons were requested in 36 cases-in the majority (26 cases) because of bleeding and pain. Thirteen women desired removal of the IUD in order to get either pregnant or sterilized. The continuation rate after 2 years was 73%. The highest number of drop-outs occurred within the first year after insertion (60 cases = 23%) whereas only 4% drop-outs occurred in the 2nd year. It was suggested that the low continuation rate might be partially due to the high number of physicians (19) participating in this study. The most important side effects of the copper-7-IUD in situ were irregular bleeding, intermenstrual pain and discharge. Irregular bleeding and pain decreased markedly after the first year, while slightly prolonged periods persisted in 30 to 50% of all patients. Compared with oral contraceptives copper IUDs hav less severe side effects but less safety at the same time-especially for the younger fertile age group. Therefore they should be offered to young nulliparous women only for a limited period of time.
在两年内,为258名年龄在16至42岁的女性放置了铜-7宫内节育器(Gravigard,瑟尔公司生产)。这些患者中有45%为未生育女性。对236例患者进行了随访研究,总计观察2717女性-月,平均每位患者观察11.5个女性-月。总共发生了5例意外妊娠,Pearl指数为2.3。27例(11%)出现了部分或完全排出。27例排出中有14例在插入后的头两个月内被发现。36例因医疗原因要求取出,大多数(26例)是由于出血和疼痛。13名女性希望取出宫内节育器以便怀孕或绝育。两年后的持续使用率为73%。退出率最高的情况发生在插入后的第一年(60例 = 23%),而第二年仅有4% 的退出率。有人认为持续使用率低可能部分归因于参与这项研究的医生数量众多(19名)。铜-7宫内节育器在体内的最重要副作用是不规则出血、经间期疼痛和分泌物增多。不规则出血和疼痛在第一年之后明显减少,而30%至50%的患者经期仍稍有延长。与口服避孕药相比,铜宫内节育器副作用较轻,但同时安全性较低,尤其是对年轻的育龄组。因此,仅应在有限的时间段内为年轻未生育女性提供铜宫内节育器。