Four multicentre clinical trials on interruption of early pregnancy (less than or equal to 49 days of
amenorrhea) using
RU 486 have been conducted in China, including 2321 subjects. The data from trials 1, 2 and 4 are presented here.
RU 486 (600 mg as a single dose) was given to 299 women. A further 422 women were given
RU 486 (600 mg) plus a
vaginal suppository containing the Chinese domestic
prostaglandin PGO5 (1 mg) 36-60 hours later. Complete abortion was achieved in 63.5% of patients receiving
RU 486 alone and in 94.1% of patients receiving
RU 486 plus PG (p less than 0.001).
RU 486 given alone showed decreasing efficacy as the duration of
amenorrhea increased. However,
RU 486 combined with PG was equally effective at all time points studied (less than or equal to 35 days of
amenorrhea: 98.1%, 36-42 days: 92%, 42-49 days: 87.4%). When compared with
RU 486 alone
Ru 486 + PG also produced a shorter bleeding time and a lower volume of blood loss (n = 21, 52 ml vs n = 13, 117 ml). Two patients from the RU 486+PG group and 4 given
RU 486 alone suffered heavy
bleeding, necessitating emergency
curettage. No transfusions were required. The time elapsed between
RU 486 intake and expulsion of the conceptus was significantly shorter in the RU 486+PG group (n = 97, 31 days) than that in the
RU 486 alone group (n = 95, 4.4 4.4 days). Main side effects,
nausea/
vomiting and
headache/
dizziness, were mainly due to
RU 486. PG increased the incidence of
diarrhea and uterine
cramp.(ABSTRACT TRUNCATED AT 250 WORDS)