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

ABSTRACT

In a multicenter study taking place in four centers in Beijing (People's Republic of China), pregnancies up to 49 days of amenorrhea (DA) were interrupted with RU 486 (RU 38486, mifepristone, 600 mg orally once), followed 36-60 hours later by administration of dl-15-methyl-PGF 2 alpha-methyl ester (PG05, 1 mg vaginal suppository). One-hundred-and-sixty women were included in the study, three of whom being excluded from efficacy assessment because of non-compliance 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 above 42 days of amenorrhea (DA) (76.6%). The time elapsed between RU 486 intake and complete expulsion was 2.8 +/- 1.5 (sd) days (range 1-12 days). Expulsion took place at the latest 4 days after RU 486 in 125 women (94.7%), and in 107 of these women, it occurred 3.1 +/- 1.7 (sd) hours after PG05 administration. Uterine bleeding occurred in all women after RU 486 intake whatever the outcome of treatment and lasted 11.5 +/- 4.8 (sd) days (range 3-36 days). It was judged more or much more abundant than usual periods in 6.15% of the women. It led to a slight but significant decrease in hemoglobin as measured eight and 14 days after RU 486 intake. In five women, hemoglobin decreased by 4 g/dl or more, but no patient required a blood transfusion.(ABSTRACT TRUNCATED AT 250 WORDS)

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.