左炔诺孕酮宫内缓释系统对比口服孕激素治疗子宫内膜增生的Meta分析

Meta-analysis of Levonorgestrel Intrauterine Sustained Release System Versus Oral Progesterone for Endometrial Hyperplasia

目的系统评价左炔诺孕酮宫内缓释系统(LNG-IUS)对比口服孕激素在治疗子宫内膜增生(EH)中的作用。方法检索PubMed、EMbase、The Cochrane Library数据库及相关文献的参考文献,查阅关于LNG-IUS对比口服孕激素治疗EH的随机对照试验(RCT),采用RevMan 5.3软件进行数据分析。结果总共纳入10篇 RCT文献,共计968例患者。Meta分析结果显示:①无论治疗3个月或6个月,LNG-IUS组逆转率均优于口服孕激素组(用药3月:OR=2.56,95%CI为1.55~4.25,P=0.0003,I2=0;用药6月:OR=3.85,95%CI为2.11~7.01,P<0.0001,I2=9%);②不同治疗时间及随访时间节点的两组复发率存在较大变异,尚不足以阐明何组复发率更低;③治疗不良反应发生率方面,LNG-IUS组恶心发生率低于口服孕激素组(OR=0.36,95%CI为0.23~0.56,P<0.00001,I2=0),不规则阴道流血发生率高于口服孕激素组(OR=2.63,95%CI为1.44~4.80,P=0.002,I2=0),两组体重增加发生率及头痛发生率差异无统计学意义,但针对头痛发生率的研究间可能存在异质性;④LNG-IUS组患者满意度高于口服孕激素组(OR=8.39,95%CI为4.39~16.05,P<0.00001,I2=0);⑤LNG-IUS组治疗6个月的成本显著高于口服孕激素(P<0.001)。结论 LNG-IUS治疗EH的疗效优于口服孕激素,患者满意度亦更高,但在不良反应发生率方面各有优缺,而远期的成本效益分析尚需进一步研究探讨。

Objective To evaluate the effect of levonorgestrel intrauterine sustained release system (LNG-IUS) versus oral progesterone in the treatment of endometrial hyperplasia (EH). Methods The PubMed, EMbase, The Cochrane Library database and related literature were searched for a randomized controlled trial (RCT) of LNG-IUS versus oral progesterone for EH, and RevMan 5.3 software was used for data analysis. Results A total of 10 RCTs were included, for a total of 968 patients. Meta analysis results show:①Regardless of treatment at 3 or 6 months,the LNG-IUS group had a better reversal rate than the oral progesterone group (medication for three months: OR=2.56, 95%CI 1.55~4.25, P=0.0003, I2=0;Medication for six months: OR=3.85, 95%CI 2.11~7.01, P<0.0001,I2=9%);②There was a large variation in the recurrence rate between the two groups at different treatment time and follow-up time, which was not enough to clarify which group had a lower recurrence rate;③In the incidence of adverse reactions, the incidence of nausea in the LNG-IUS group was lower than that in the oral progesterone group (OR=0.36,95%CI 0.23~0.56,P<0.00001, I2=0), and the incidence of irregular vaginal bleeding was high the oral progesterone group (OR=2.63, 95%CI 1.44~4.80, P=0.002, I2=0), there was no significant difference in the incidence of weight gain and the incidence of headache between the two groups, but for the incidence of headache. There may be heterogeneity between studies;④Patients in the LNG-IUS group had higher satisfaction than the oral progesterone group (OR=8.39,95%CI 4.39~16.05, P<0.00001,I2=0);⑤The cost of treatment for 6 months in the LNG-IUS group was significantly higher than that of oral progesterone(P<0.001).Conclusion LNG-IUS is superior to oral progesterone in the treatment of EH, and patient satisfaction is higher. However, there are advantages and disadvantages in the incidence of adverse reactions, and the long-term cost-benefit analysis needs further study.