Abstract
No specific and effective treatment modality is available for patients with recurrent spontaneous abortion (RSA) who are positive for autoantibodies, and/or do not respond to the conventional allogeneic lymphocyte therapy. Sairei-to, a herbal formula, was tested to evaluate its efficacy in preventing abortion for those patients. All of 441 patients with RSA of precluded chromosomal abnormality was treated with Sairei-to before and after establishment of pregnancy. The efficacy was evaluated in the following three separate groups; Group 1 (228 patients with positive antinuclear antibodies (ANA) and/or anti-cardiolipin antibodies (ACA), Group 2 (79 patients with combined auto- and alloimmune RSA and Group 3 (134 patients with alloimmune RSA including 64 patients who did not respond to conventional alloimmunization therapy alone). In Group 1, relatively high live birth rates per pregnancy were achieved in autoimmune RSA at around 65%. In Group 2, relatively high live birth rates per pregnancy of 63 to 78% were observed in alloimmune RSA complicated with the autoantibodies. In Group 3, Sairei-to in addition to alloimmunization was successful even in alloimmune RSA which resisted against conventional alloimmunization alone with a comparably high live birth rate per pregnancy (66.7%) to that achieved in alloimmune RSA treated with alloimmunization alone (78.7%). Sairei-to is effective not only for patients with alloimmune RSA complicated with positive ANA and/or ACA but for patients with alloimmune RSA resisting against the conventional allogeneic lymphocyte therapy. Amendment of diagnostic criteria for alloimmune RSA was argued in view of T cell-mediated tolerance induction instead of B cell tolerance concept.