摘要
目的 探究环孢素A联合地屈孕酮治疗不明原因复发性流产(URSA)的疗效及对T淋巴细胞亚群的影响.方法 前瞻性选取2021年8月至2022年12月阜阳市人民医院收治的URSA患者100例,按照随机数字表法分为对照组及观察组,每组各50例,对照组予以地屈孕酮治疗至孕12周,观察组在地屈孕酮治疗基础上加用环孢素A,用药至超声提示有胎心搏动停药.比较治疗前、治疗后(孕12周)两组妊娠结局、激素[β-绒毛膜促性腺激素(β-HCG)、孕酮、雌二醇]、Th细胞因子[干扰素-γ(IFN-γ)、肿瘤坏死因子-α(TNF-α)、白细胞介素-10(IL-10)]、T淋巴细胞亚群(CD4+、CD8+、CD4+/CD8+)水平及安全性.结果 观察组妊娠成功率为86.00%,明显高于对照组(68.00%),差异有统计学意义(P<0.05).治疗12 d后,观察组β-HCG、孕酮、雌二醇水平分别为[(126.36±16.07)mIU/mL、(25.19±5.78)ng/mL、(227.58±31.62)pg/mL],均高于对照组[(98.87±12.35)mIU/mL、(20.76±6.84)ng/mL、(179.30±34.59)pg/mL],差异均有统计学意义(P<0.05);治疗14 d后,观察组的β-HCG倍增水平为(276.53±28.04)mIU/mL,高于对照组[(183.25±17.38)mIU/mL],差异有统计学意义(P<0.05).治疗12 d后,观察组IFN-γ、TNF-α 水平分别为(7.79±1.20)pg/mL、(8.59±1.67)pg/mL,均低于对照组[(11.14±1.25)pg/mL、(11.32±2.75)pg/mL],差异均有统计学意义(P<0.05),观察组IL-10为(3.32±0.37)pg/mL,高于对照组[(2.29±0.34)pg/mL],差异均有统计学意义(P<0.05).治疗12d后,观察组CD4+、CD4+/CD8+水平分别为(29.46±4.22)%、1.14±0.22,均低于对照组[(34.58±4.18)%、1.53±0.34],观察组 CD8+水平为(26.40±4.11)%,高于对照组[(23.18±3.52)%],差异均有统计学意义(P<0.05).两组治疗前后凝血、肝肾功能及血常规等检查结果均无明显异常改变.两组在治疗期间均未出现严重药物不良反应.结论 环孢素A联合地屈孕酮可明显提高妊娠后血清β-HCG、孕酮和雌二醇水平,调节免疫失衡并且明显提高URSA患者的妊娠成功率.
Abstract
Objective To investigate the efficacy of Cyclosporine A combined with dydrogesterone in the treatment of unexplained recur-rent spontaneous abortion(URSA)and its effect on T lymphocyte subsets.Methods A total of 100 patients with URSA admitted to the Fuyang City Peoples Hospital from August 2021 to December 2022 were prospectively selected and divided into the control group and the observation group according to the random number table method,with 50 cases in each group.The control group was treated with dydrogesterone,and the observation group was treated with Cyclosporine A combined with dydrogesterone.The pregnancy outcomes,hormones[β-chorionic gonadotropin(β-HCG),progesterone,estradiol],Th cytokines[interferon-γ(IFN-γ),tumor necrosis factor-α(TNF-α),interleukin-10(IL-10)],T lymphocyte subsets(CD4+,CD8+,CD4+/CD8+)levels and safety were compared between the two groups.Results The pregnancy success rate of the observation group was 86.00%,which was significantly higher than that of the control group(68.00%),and the difference was statis-tically significant(P<0.05).At 12 days of treatment,the levels of β-HCG,progesterone and estradiol in the observation group were[(126.36±16.07)mIU/mL,(25.19±5.78)ng/mL,(227.58±31.62)pg/mL],which were higher than those in the control group[(98.87±12.35)mIU/mL,(20.76±6.84)ng/mL,(179.30±34.59)pg/mL],and the differences were statistically significant(P<0.05);after 14 days of treatment,the doubling level of β-HCG in the observation group was(276.53±28.04)mIU/mL,which was also higher than that in the control group[(183.25±17.38)mIU/mL],and the difference was statistically significant(P<0.05).At 12 days of treatment,the levels of IFN-γ and TNF-α in the observation group were(7.79±1.20),(8.59±1.67)pg/mL,which were lower than those in the control group[(11.14±1.25),(11.32±2.75)pg/mL],the IL-10 in the observation group was(3.32±0.37)pg/mL,which was higher than that in the control group[(2.29±0.34)pg/mL],and the differences were statistically significant(P<0.05).At 12 days of treatment,the levels of CD4+,CD4+/CD8+in the observation group were(29.46±4.22)%,1.14±0.22,which were lower than those in the control group[(34.58±4.18)%,1.53±0.34],and the CD8+in the observation group was(26.40±4.11)%,which was higher than that in the control group[(23.18±3.52)%],and the differences were statistically significant(P<0.05).There were no obvious abnormal changes in coagulation,liver and kidney function and blood routine examination results before and after treatment in the two groups.There were no serious adverse drug re-actions in the two groups during the treatment.Conclusion Cyclosporine A combined with dydrogesterone can increase the levels of β-HCG,estradiol and progesteroneand,regulate immune imbalance and significantly improve the pregnancy success rate of URSA patients.
基金项目
2021年安徽医科大学校科研基金立项资助项目(2021xkj211)