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| Efficacy and safety analysis of dydrogesterone tablets in the treatment of the patients with threatened abortion due to luteal phase defect |
1.Jinhua Hospital Affiliated to Zhejiang University School of Medicine, Jinhua, Zhejiang Province, 321000；
2.Jinhua Maternal and Child Health Hospital, Zhejiang Province；3.Jinhua Ophthalmic Hospital, Zhejiang Province |
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Abstract To investigate the efficacy and safety of dydrogesterone tablets in the treatment of the patients with threatened abortion (TA) caused by luteal phase defect (LPD). Methods: A total of 99 patients with TA caused by LPD were selected and were divided into study group (n=50) and control group (n=49) by random number table method from May 2018 to May 2021. The patients in the study group were treated with oral dydrogesterone tablets and the patients in the control group were treated with intramuscular injection of progesterone. The curative effect of the patients in the two groups after treatment was evaluated. The symptom relief time and the incidence of adverse reactions of the patients in the two groups were recorded. The serum levels of progestational hormones, such as beta-human chorionic gonadotropin (β-hCG), estradiol (E2), and progesterone (P), and the levels of cytokines, such as tumor necrosis factor alpha (TNF-α), interferon gamma (IFN-γ), and interleukin 10 (IL-10) of the patients in the two groups before and after treatment were measured. The patients in the two groups after treatment were followed up till the end of pregnancy, and the pregnancy outcomes of the patients were compared between the two groups. Results: The success rates of miscarriage prevention of the patients in study group and control group were 90.0% and 81.6%, respectively, but without statistically significant differences (P＞0.05). Compared with that of the patients in the control group, the time of relief vaginal bleeding, abdominal pain and distension, low back pain, or frequent uterine contraction of the patients in the study group was significantly shorter (P＜0.05). After treatment, the levels of serum β-hCG, E2, P, and IL10 of the patients in the two groups had increased significantly, while the levels of TNF-α and INF-γ of the patients in the two groups had decreased significantly. Meanwhile, the levels of serum E2, P, and IL-10 of the patients in the study group were significantly higher than those of the patients in the control group, while the levels of TNF-α and INF-γ of the patients were significantly lower than those of the patients in the control group (P＜0.05). The incidences of the adverse reactions, premature delivery, and premature rupture of membranes of the patients in the study group were 14.00%, 2.00%, and 10.00%, respectively, which were significantly lower than those (30.61%, 16.33%, and 23.53%) of the patients in the control group (P＜0.05). Conclusion: Dydrogesterone tablets for treating the patients with TA caused by LPD can effectively increase their serum sex hormones levels, improve the levels of their cytokines, and promote the rapid remission of their clinical symptoms. In addition, the treatment can achieve a comparable success rate of miscarriage prevention to that of intramuscular injection of progesterone, with fewer adverse reactions and less influence on the patients and their neonates.
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