摘要
目的：为防止放置宫内节育器（ＩＵＤ）引起的月经过多，扩大含消炎痛和铜的２种不锈钢ＩＵＤ即药铜环１６５和活性γ型ＩＵＤ（γ－ＩＵＤ）的临床试验，并观察５年的效果、副反应和月经血量情况。方法：由全国１２所医院随机放置药铜环１６５、γ－ＩＵＤ各１０００例，以ＴＣｕ２２０ＣＩＵＤ为对照；放置后定期随访达５年，以生命表法统计效果；对其中各２０名志愿者于放器前和放置后定期进行月经血量测定。结果：５年时每百妇女的妊娠率，药铜环１６５为３．２、γ－ＩＵＤ为２．７、ＴＣｕ２２０Ｃ为３．２；每百妇女的脱落率各为７．７、２．３和２．４；每百妇女的因症取出率各为５．０、３．８和６．４；每百妇女的续放率各为７９．８、８８．７和８４．９。第１年内平均出血天数以药铜环１６５最短；月经血量测定说明γ－ＩＵＤ放置后血量减少，而ＴＣｕ２２０Ｃ明显增加。结论：药铜环１６５效果好，平均出血天数少，放、取技术同金属单环，易为基层接受；γ－ＩＵＤ效果好、出血少。二者均可推广。
Objective: A five year multicenter comparative study was conducted to observe the clinical efficacy, side effects, and menstrual blood loss (MBL) of medicated stainless steel ring 165 (MSSR 165), medicated γ Intrauterine devices (γ IUD) (both containing indomethacin and copper) and TCu220C for exploring new kinds of IUD to reduce MBL after IUD insertion. Methods: MSSR 165 and medicated γ IUD, with TCu220C as a control, were randomly inserted (one thousand in each group) in women 12 hosptials nation wide in October 1988. Follow ups were performed at the time of 3, 6, 12, 24, 36, 48 and 60 months after IUD insertion. The efficacy of the IUDs was calculated with life table method. A quantitative comparison of MBL was made before and 3, 6, 12, 24, 36 and 60 months after the IUD insertion in 20 volunteers. Results: At the end of 5 years, the pregnancy rates of MSSR 165, medicated γ IUD and TCu220C were 3.2, 2.7 and 3.2. The expulsion rates were 7.7, 2.3 and 2.4, while the removal rates for medical reasons were 5.0, 3.8 and 6.4. The cumulative continuation rates were 79.8, 88.7 and 84.9 per 100 women respectively. The average total bleeding time in the first year of MSSR 165 was 22 days, the shortest one among the three IUDs. The quantitative comparison of MBL showed that the γ IUD reduced the MBL and the TCu220C increased the MBL apparently. Conclusion: With good clinical efficacy, short menstrual bleeding time, as well as the same appearance and insertion technic as stainless steel ring, the MSSR 165 will be easily accepted at the grass root level. The γ IUD had good clinical efficacy and higher continuation rate, whereas the side ef fect of bleeding was not obvious. Both medicated SSR165 and γ IUD could be recommended for promotion.
出处
《中华妇产科杂志》
CAS
CSCD
北大核心
1997年第2期97-101,共5页
Chinese Journal of Obstetrics and Gynecology
基金
国家计划生育委员会资助
关键词
宫内避孕器
IUO
避孕环
药铜环
Intrauterine devices, copper Intrauterine devices, medicaped
