三种国产宫内节育器随机化多中心比较性研究(二年随访总结)

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全围13省、市共23个单位,对不锈钢金属单环,V铜200及T铜220C进行随机化临床多中心比较性研究。自1983年7月1日至1984年3月31日共接受对象6,236例,其中210例作放置前后的月经血量和相应的血红蛋白测定。全组二年中仅有45例失访,随访率达99.28%。而二年末的每百妇女累积续用率分别为68.08%、85.99%及87.59%。结果表明:金单的脱落率和妊娠率显著地高于V铜及T铜(P<0.001);但因医疗原因取出率则以金单显著低于V铜及T铜(P<0.05~0.01)。副反应的发生率,三种宫内节育器均以放置后第一个月为最多,金单较二种带铜节育器显著为少(P<0.001),而V铜与T铜则甚为相近。它们均能引起月经血量的增加和血红蛋白的降低,以第3月经周期最为明显。到第24月经周期时仍未完全恢复到原有水平,但与第3周期相比,已有显著改善。 A total of 13 provinces and municipalities, a total of 23 units, a single ring of stainless steel, V copper 200 and T copper 220C randomized clinical multicenter comparative study. From July 1, 1983 to March 31, 1984 a total of 6,236 patients were accepted, of which 210 were placed before and after the menstrual blood volume and the corresponding hemoglobin determination. Only 45 cases of the whole two years were lost, the follow-up rate reached 99.28%. The cumulative utilization rates per 100 women at the end of two years were 68.08%, 85.99% and 87.59% respectively. The results showed that the exfoliation rate and pregnancy rate were significantly higher than those of V and T copper (P <0.001), but the rates of withdrawal were significantly lower than those of V and T (P <0.05 and 0.01) ). The incidence of side effects, the three intrauterine devices were placed in the first month after the most, the single than the two with copper IUD significantly less (P <0.001), and V copper and T copper is very similar. Both of them can cause an increase of menstrual blood volume and a decrease of hemoglobin, most notably in the third menstrual cycle. By the 24th menstrual cycle, it still has not fully recovered to its original level but has shown a significant improvement over the third cycle.
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