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目的:观察和评估子宫内膜异位症患者应用左炔诺孕酮宫内缓释系统(levonorgestrel-releasing intrauterine system,LNG-IUS)的安全性。方法:共59例子宫内膜异位患者纳入研究。将LNG-IUS放置在患者子宫腔内,LNG-IUS放置前与放置后6个月及12个月对患者的痤疮、面部色素沉着、月经前乳房胀痛、体重及生活质量进行评分及比较,并观察LNG-IUS不良反应发生情况。结果:LNG-IUS放置前和放置后6个月痤疮评分分别为1.00(0.00,3.00)和0.00(0.00,2.00),差异无统计学意义(P>0.05),而放置后12个月痤疮评分为0.00(0.00,1.00),差异有统计学意义(P<0.01)。放置前和放置后6个月及12个月的面部色素沉着评分均为1.00(0.00,1.00),差异无统计学意义(均P>0.05)。放置前和放置后6个月及12个月的月经前乳房胀痛评分分别为2.20(0.00,4.00),1.50(0.00,4.00)及1.00(0.00,3.00),差异均有统计学意义(P<0.05,P<0.01)。放置前和放置后6个月及12个月的体重分别为59.00(55.00,64.00)kg,59.50(55.00,64.00)kg及59.00(54.00,64.00)kg,差异均无统计学意义(均P>0.05)。放置前和放置后6个月及12个月的生活质量评分差异均有统计学意义(均P<0.01)。放置前和放置后6个月及12个月月经间期出血分别为4例(6.78%),16例(27.12%)及14例(23.73%)。其他不良反应有脱发(1例)和全身肿胀感(2例)。结论:LNG-IUS是一种治疗子宫内膜异位症的安全疗法。
Objective: To observe and evaluate the safety of levonorgestrel-releasing intrauterine system (LNG-IUS) in patients with endometriosis. Methods: A total of 59 patients with endometriosis were included in the study. The LNG-IUS was placed in the uterine cavity of patients. The patients were evaluated for acne, facial pigmentation, premenstrual breast tenderness, weight and quality of life before and 6 months and 12 months after placement. And observe the LNG-IUS adverse reactions occurred. Results: The scores of acne before and 6 months after LNG-IUS were 1.00 (0.00, 3.00) and 0.00 (0.00, 2.00), respectively, with no significant difference (P> 0.05) 0.00 (0.00,1.00), the difference was statistically significant (P <0.01). The facial pigmentation scores at 6 and 12 months before and after placement were both 1.00 (0.00 and 1.00), with no significant difference (all P> 0.05). Pre-menstrual breast tenderness scores before and 6 months and 12 months after placement were 2.20 (0.00, 4.00), 1.50 (0.00, 4.00) and 1.00 (0.00, 3.00) respectively, with significant differences between the two groups <0.05, P <0.01). The body weights at 6 and 12 months before and after placement were 59.00 (55.00 and 64.00) kg, 59.50 (55.00 and 64.00) kg and 59.00 (54.00 and 64.00) kg, respectively, with no significant difference (all P> 0.05). There were significant differences in quality of life scores before and 6 months and 12 months after placement (all P <0.01). Four months (6.78%), 16 (27.12%) and 14 (23.73%) patients had menstrual bleeding before and 6 and 12 months after placement, respectively. Other adverse reactions are hair loss (1 case) and systemic swelling (2 cases). Conclusion: LNG-IUS is a safe treatment for endometriosis.