Pregnancy interruption with RU 486 in combination with dl-15-methyl-prostaglandin-F2 alpha-methyl ester: the Chinese experience.

ABSTRACT

PIP: In a multicenter study taking place across 4 centers in Beijing, People's Republic of China, pregnancies of up to 49 days of amenorrhea (DA) were interrupted with RU486 (RU 38486, mifepristone, 600 mg, orally once), followed 36-60 hours later by administration of dl-15-methyl-PGF2alpha-methyl ester (PGO5, 1 mg vaginal suppository). 166 women were included in this study; however, 3 were excluded from efficacy assessment because of noncompliance to the protocol. Complete pregnancy interruption without additional surgical procedure (success) was obtained in 136 women (86.6%, 95% confidence interval; 81.3-91.9%). The success rate was significantly (P=0.013) higher for pregnancies below 91.3%), than for pregnancies greater than 42 DA (76.6%). The time elapsed between RU486 intake and complete expulsion was 2.8 +or- 1.5 SD days (range 1-12 days). Expulsion took place at the latest 4 days after RU486 in 125 women (94.7%), and in 107 of these women, it occurred 3.1 +or- 1.7 SD hours after PGO5 administration. Uterine bleeding occurred in all women after RU486 intake, whatever the outcome of treatment, and latest 11.5 +or- 4.8 SD days (range 3-36 days). It was considered that 6.15% of the women had more or much more abundant bleeding. It led to a slight but significant decrease in hemoglobin as measured both 8 and 14 days after RU486 intake. In 5 women, hemoglobin decreased by 4 g/dl or more, but no patient required a blood transfusion. The clinical and biological tolerance of the treatment was otherwise very satisfactory--mild to moderate pain was reported in approximately 80% of the women after PGO5 administration, and in approximately 20% of the patients, nausea, vomiting, and diarrhea were observed. These were usually moderate, although in 1 case, severe vomiting occurred after RU486 intake and necessitated vacuum aspiration before PGO5 administration. A moderate and transient increase in SGPT (to less than 1.5 times the upper normal limit) was noted in 3 women after RU486 and before PGO5, and in 5 women after both.