OBJECTIVETo study the immunoregulation effects of Tiaomian No. 3 (TM3) for recurrent spontaneous abortion (RSA) caused by shortage of blocking antibodies.

METHODSTotally 61 patients with RSA caused by shortage of blocking antibodies were randomly assigned to the treatment group (31 cases) and the control group (30 cases) by lot method. Patients in the treatment group were treated with TM3, while those in the control group were treated with active immunotherapy using lymphocytes of their spouses. The therapeutic course for all was 3 months. Another 10 healthy females in the same age ranges were recruited as the healthy control group. The blocking antibodies (Ab1), anti-idiotypic antibodies (Ab2), T-lymphocyte cell subsets (CD4 and CD8), serum interleukin 10 (IL-10), and macrophage colony-stimulating factor (M-CSF) levels were determined before and after treatment.

RESULTS(1) After treatment the positive conversion rate of Ab1 and/or Ab2 was 87.1% (27/31) in the treatment group and 86.7% (26/30) in the control group, showing no statistical difference (P > 0.05). (2) In the two groups, CD4 decreased and CD8 increased. The CD4/CD8 ratio was in the normal level after treatment, showing statistical difference when compared with before treatment (P < 0.05). (3) In the two groups, IL-10 and M-CSF levels were higher after treatment, showing statistical difference when compared with before treatment (P < 0.05). (4) The 1-year conception rate was 58.1% (18/31) in the treatment group, significantly higher than that in the control group (46.7%, 14/30, P < 0.05).

CONCLUSIONSTM3 could promote the positive conversion rate of Ab1, promote the production of IL-10 and M-CSF cytokines, thus strengthening the protection for fetus by the mother and the normal maintenance for pregnancy. The 1-year successful pregnancy rate obviously increased in the treatment group.