【作者】 孙晓燕；

【导师】 杨兴升；

【作者基本信息】 山东大学 ， 妇产科学， 2012， 硕士

【摘要】 目的：评价曼月乐治疗月经过多的疗效。材料和方法：1.计算机检索PUBMED数据库、MEDLNE数据库、万方数据库、中国科技期刊数据库(CNKI)、CBM数据库及有关的参考文献，语种限英语和汉语，检索时间不限。2.纳入标准及排除标准：收集所有曼月乐治疗月经过多相关的随机对照临床试验。对收集的文章进行筛选和评价，剔除不合本文研究目的或不合质量要求的文章。3.数据收集和分析：由作者独立进行资料提取和质量评估。采用ReVMan5.1软件进行meta分析。结果：本研究共纳入16个随机对照临床试验，16篇文献，包括1335例患者。其中13篇文献评3分，为高质量文献；3篇文献评2分，为低质量文献。Meta分析发现：1、与口服药物治疗比较：(1)随访至6个月及12个月时，曼月乐的有效率均显著高于口服药物，差异有统计学意义(6个月时，RR=3.77,95%CI=[2.47,5.74], P<0.00001；12个月时，RR=1.62,95%CI=[1.26,2.07], P=0.0001〈0.05)。(2)随访至12个月时，曼月乐的失败率较低，差异有统计学意义（RR=0.38，95%CI=[0.21,0.68], P=0.001<0.05)c(3)随访至3个月，12个月时，曼月乐组的MBL减少量百分比更为显著，差异有统计学意义(3个月时=，RR=50.60，95%CI [47.62,53.58], P<0.00001;12个月时，RR=66.91’95%CI=[42.61,91.20], P<0.00001)；随访至6个月，12个月时，曼月乐组的PBAC减少量百分比均显著高于口服药物组，差异有统计学意义（6个月时，RR=31.83=,95%CI=[1.07,62.59]，P0.04<0.05;12个月时=，RR=58.69,95%CI [10.10，107.28]，P=0.02<0.05)。2.与子宫内膜去除术比较：(1)随访至12个月时二者的有效率无显著性差异（RR=0.88,95%CI=[0>.76,1.03], P=0.120.05)o(2)随访至12个月时二者的闭经率无显著性差异（RR=0.81,95%CI二[0.34,1.90]，P=0.62>0.05)o(3)随访至12个月时曼月乐组的失败率更高，差异有统计学意义(RR=2.26，95%CI=[1.23<,4.17]，P=0.0090.05)o(4)随访至6个月，12个月时二者的PBAC评分均无显著性差异（6个月时，RR=-19.99，95%CI=[-54.05,14.07]=，P0.25>0.05；12个月时，RR=1.75，95%CI=[-39.58,43.08], P=0.93〉0.05)。(5)二者的患者满意度无显著性差异（RR=0.93=，95%CI[0.83,1.04],P=0.18>0.05)。3.与子宫全切术比较：(1)治疗后子宫切除术组患者的性生活问题更少。按照意向性分析，子宫切除组患者术后6个月时性生活满意度度显著增加(P=0.005)，性生活问题显著减少（P=0.002)，12个月时性生活问题仍低于基线水平(P=0.05),5年后伴侣的性生活满意度增加(P=0.04)。曼月乐组患者在性生活满意度及性生活问题上与放环前相比无显著差异，12个月时伴侣的性生活满意度降低（P=0.05),5年后仍无改观（P=0.001)。按照实际情况分析，子宫切除组患者5年后伴侣的性生活满意度降低(P=0.02)，而曼月乐组患者术后12个月时伴侣的性生活满意度并没有显著降低(P=0.06)。(2)生活质量评分：与治疗前相比，治疗后子宫全切术组在社会方面、环境方面、国家环境评分明显增加，而曼月乐组在身体方面、精神方面、社会方面、环境方面及国家环境等五项评分均显著增加。结论：1.与口服药物治疗相比，曼月乐的治疗有效率更高，失败率较低，疗效更为显著。2.曼月乐及子宫内膜去除术在治疗月经过多方面均有显著疗效，二者的有效率、闭经率及患者满意度均无显著差异，但曼月乐的失败率更高。3.曼月乐与子宫全叻相比，史为经济，治疗后曼月乐组的斗：沾质量评价更高，但子宫仝切患者的性化活问题较少。更多还原

【Abstract】 Objective To evaluate the clinical efficacy of the levonorgestrel releasingintrauteirne system (Mirena) in the treatment of menorrhagia.Materials and method1、Searchstrategy We searched PUBMED，MEDLINE, CNKI，CBM disc，Wan fang database and reference lists of articles. Languages were restricted toChinese and English.2、Selectioncriteira Tirals were included if they were randomized controlledtrials about the levonorgestrel releasing intrauteirne system (Mirena) for the treatmentof menorrhagia.3、Datacollection and analysis Data extraction and quality assessment wasperformed independently by the author. All the calculations and statistical tests weredone with the RevMan5.1software.ResultSixteen tirals involving1335patients were identified and included in this review.Among the16inclusive studies,13were considered as high quality studies and3were considered as low quality studies. The findings suggest that:1. Compared to the traditional oral medicine:(1)The effective rate was higher in the LNG-IUS group than the oral medicinegroup both at6-month follow up(RR=3.77，95%CI=[2.47,5.74],P<0.0000l)and at12-month follow up(RR=1.62,95%CI=[1.26,2.07],P=0.0001<0.05).(2)The failure rate was lower in the LNG-IUS group than the oral medicinegroup at12-month follow up(RR=0.38，95%CI=[0.21,0.68]=，P0.001<0.05).(3)Reduction in MBL was more signiifcant in the LNG-IUS group at3-monthfollow up(RR:50.60，95%CI=[47.62,53.58],P<0.00001) and12-month followup(RR=66.91,95%CI=[42.61,91.20]〈,P0.00001); Reduction in PBAC score wasmore significant in the LNG-IUS group at6-month follow up(RR=31.83,95%CI=[1.07，62.59]，P=0.04<0.05) and at12-month follow up(RR=58.69=，95%CI[10.10， 107.28],P=0.02<0.05).2.Compared to Endometrial ablation:(1)There were no statistical significance in the effective rate bewteen the twogroups at12-month follow up(RR=0.88,95%CI=[0.76,1.03]，P=0.12〉0.05).(2)There were no statistical significance in amenorrhoea rate ewteen the twogroups at12-month follow up(RR=0.81,95%CI=[0.34,1.90]>,P=0.620.05).(3)The failure rate was higher in the LNG-IUS group than the Endometiralablation group at12-month follow up(RR=2.26,95%CI=[1.23,4.17],P=0.009<0.05).(4)There were no statistical significance in PBAC scores between the twogroups at6-month follow up(RR=-19.99，95%CI=[-54.05,14.07,P=0.25>0.05) or at12-month ofllow up(RR=1.75=，95%CI [-39.58,43,08]，P二0.93〉0.05).(5)There were no statistical significance in the patients satisfaction between thetwo groups(RR=0.93,95^001==[0.83,1,04,P=0.18>0.05).3.Compared to hysterectomy:(1)Among patients underwent hysterectomy, the sexual satisfaction increased (P=0.005) and the sexual problems decreased (P=0.002) at6-month follow up. At12months atfer the treatment, the decrease in the sexual problems still exist (P=0.05). At5-year follow up, the partner satisfaction increased (P=0.04).Among theLNG-IUS users，there was no change either in the sexual satisfaction or in the sexualproblems. The satisfaction with partner decreased at12-month follow up (P=0.05)and still keep so at5-year follow up (P=0.001).(2)Compared the QOL scores of the two groups pre-treatment andpost-treatment, three of the five mean domain scores (physical, environmental,environmental-TR) increased in patients underwent hysterectomy, wheres all fivemean domain scores were increased in LNG-IUS users.Conclusion1.LNG-IUS had a supeiror effect than oral medicine in treating menorrhagia.Compared to the oral medicine group, the LNG-IUS group had higher effective rateand lower failure rate.2.LNG-IUS had a similar therapeutic effect with Endometrial ablation for the treatment of menorrhagia. There were no statistical significance in effective rate,amenorrhoea rate and the patient satisfaction between the two group. However, theLNG-IUS group has a higher failure rate than the Endometrial ablation group.3. LNG-IUS was a cost-effective alternative to hysterectomy for the treatment ofmenorrhagia. Hysterectomy lead to improvement to sexual satisfaction and decreasedsexual problems among patients with menorrhagia, while LNG-IUS didn’t have suchan effect. Although both treatments improved health-related QOL, LNG-IUS seemedto have better effects on psychological and social life.更多还原