Taiwanese journal of obstetrics & gynecology · 2019
A randomized controlled trial of etanercept in the treatment of refractory recurrent spontaneous abortion with innate immune disorders.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Fu Jinhua, Li Lin, Qi Lijuan, Zhao Long
Аннотация
OBJECTIVE: To evaluate the effectiveness of etanercept in the treatment of refractory recurrent spontaneous abortion with innate immune disorders.
MATERIALS AND METHODS: A randomized controlled trial in patients with refractory innate immune RSA was conducted in our hospital. 188 patients were selected, all with at least 4 consecutive miscarriages and caused by innate immunity disorders. Patients were randomly allocated into 2 groups. One group (n = 95) used etanercept 25 mg per week starting from the first day after menstruation, while the other (n = 93) with placebo. Delivery of a healthy baby without malformations was regarded as the primary outcome.
RESULTS: In etanercept group, 85 (89.47%) patients delivered a healthy baby, while in placebo group, this number was only 67 (72.04%) [P = 0.01, OR = 3.30; 95% CI(1.49～7.32)]. Significantly lower levels of TNF-α and NK cell activity were observed in gestation weeks 4-10 in etanercept group versus placebo group (P < 0.05).
CONCLUSION: The results provide a proof of principle that etanercept can be an attractive therapeutic strategy for refractory innate immune RSA.
MATERIALS AND METHODS: A randomized controlled trial in patients with refractory innate immune RSA was conducted in our hospital. 188 patients were selected, all with at least 4 consecutive miscarriages and caused by innate immunity disorders. Patients were randomly allocated into 2 groups. One group (n = 95) used etanercept 25 mg per week starting from the first day after menstruation, while the other (n = 93) with placebo. Delivery of a healthy baby without malformations was regarded as the primary outcome.
RESULTS: In etanercept group, 85 (89.47%) patients delivered a healthy baby, while in placebo group, this number was only 67 (72.04%) [P = 0.01, OR = 3.30; 95% CI(1.49～7.32)]. Significantly lower levels of TNF-α and NK cell activity were observed in gestation weeks 4-10 in etanercept group versus placebo group (P < 0.05).
CONCLUSION: The results provide a proof of principle that etanercept can be an attractive therapeutic strategy for refractory innate immune RSA.