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戈那瑞林注射液联合米非司酮片治疗子宫平滑肌瘤的临床研究

Clinical trial of gonarelin injection combined with mifepristone tablets in the treatment of uterine leiomyoma

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【作者】 张美龄韩凤贤周冰符爱贞程虹

【Author】 ZHANG Mei-ling;HAN Feng-xian;ZHOU bing;FU Ai-zhen;CHENG Hong;Department of Obstetrics and Gynecology,Haikou City Maternal and Child Health Hospital;

【通讯作者】 周冰;

【机构】 海口市妇幼保健院妇产科

【摘要】 目的观察戈那瑞林注射液联合米非司酮片治疗子宫平滑肌瘤的临床疗效及安全性。方法将146例子宫平滑肌瘤患者随机分为对照组和试验组,每组73例。对照组予以米非司酮每次25 mg,qd,口服,月经来潮第1天开始服用;试验组在对照组治疗的基础上,予以戈那瑞林每次25μg,每周1次,皮下注射。2组患者治疗12周。比较2组患者的临床疗效,雌二醇和炎性因子水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为90.41%(66例/73例)和78.08%(57例/73例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的雌二醇分别为(12.65±4.34)和(18.35±4.06)pg·m L-1,白细胞介素-6分别为(19.11±2.03)和(23.47±2.74)μg·L-1,肿瘤坏死因子-α分别为(22.19±3.13)和(28.84±3.64)ng·L-1,C反应蛋白分别为(16.29±4.89)和(24.37±5.52)mg·L-1,差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要为注射部位疼痛,对照组无药物不良反应。试验组和对照组的总药物不良反应发生率分别为1.37%和0,差异无统计学意义(P>0.05)。结论戈那瑞林注射液联合米非司酮片治疗子宫平滑肌瘤的临床疗效显著,其能显著改善患者的雌二醇水平和炎性症状,且不增加药物不良反应的发生率。

【Abstract】 Objective To observe the clinical efficacy and safety of gonarelin injection combined with mifepristone tablets in the treatment of uterine leiomyoma.Methods A total of 146 patients with uterine leiomyoma were randomly divided into control and treatment groups with 73cases per group.Control group was given mifepristone 25 mg per time,qd,orally,and started on the first day of menstruation.Treatment group was given gonarelin 25μg per time,once a week,subcutaneous injection,on the basis of control group.The clinical efficacy,levels of estradiol and inflammatory factors,and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 90.41%(66 cases/73 cases)and78.08%(57 cases/73 cases)with significant difference(P<0.05).After treatment,the main indexes of treatment and control groups were compared:estradiol were(12.65±4.34)and(18.35±4.06)pg·m L-1,interleukin-6 were(19.11±2.03)and(23.47±2.74)μg·L-1,tumor necrosis factor-αwere(22.19±3.13)and(28.84±3.64)ng·L-1,C-reactive protein were(16.29±4.89)and(24.37±5.52)mg·L-1,the differences were statistically significant(all P<0.05).The adverse drug reactions in the treatment group were pain at the injection site,while there were no adverse drug reactions in the control group.The incidences of adverse drug reactions in the treatment and control groups were 1.37%and 0without significant difference(P>0.05).Conclusion Gonarelin injection combined with mifepristone tablets has a definitive clinical efficacy in the treatment of uterine leiomyoma,which can significantly improve the levels of estradiol and inflammatory factors,without increasing the incidence of adverse drug reactions.

【基金】 海南省自然科学基金资助项目(4602252011395)
  • 【文献出处】 中国临床药理学杂志 ,The Chinese Journal of Clinical Pharmacology , 编辑部邮箱 ,2019年19期
  • 【分类号】R737.33
  • 【被引频次】3
  • 【下载频次】61
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