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热球囊消融术与腹腔镜次全子宫切除术治疗月经过多的手术疗效比较:一项随机研究

Thermal balloon ablation versus laparoscopic supracervical hysterectomy for the surgical treatment of heavy menstrual bleeding: a randomized study.

作者信息

Sesti Francesco, Ruggeri Velia, Pietropolli Adalgisa, Piancatelli Raffaella, Piccione Emilio

机构信息

Section of Gynecology and Obstetrics, Department of Surgical Sciences, School of Medicine, Tor Vergata University Hospital, Rome, Italy.

出版信息

J Obstet Gynaecol Res. 2011 Nov;37(11):1650-7. doi: 10.1111/j.1447-0756.2011.01596.x. Epub 2011 Jul 25.

DOI:10.1111/j.1447-0756.2011.01596.x
PMID:21790890
Abstract

AIM

To compare postoperative outcomes and effects on quality of life following thermal balloon ablation (TBA) or laparoscopic supracervical hysterectomy (LSH) in women with heavy menstrual bleeding (HMB).

MATERIAL AND METHODS

Sixty-eight women requiring surgical treatment for HMB were randomly allocated into two treatment arms: TBA (n = 34) and LSH (n = 34). The randomization procedure was based on a computer-generated list. The primary outcome was a comparison of the effects on menstrual bleeding (Pictorial Blood Loss Assessment Chart [PBAC]) between the two procedures. The secondary outcome measures were quality of life, improvement of bleeding patterns, intensity of postoperative pain, and early postoperative complications. Continuous outcome variables were analyzed using Student's t-test. Discrete variables were analyzed with the χ2 test or Fisher's exact test. P < 0.05 was considered statistically significant.

RESULTS

The PBAC score was significantly reduced in both treatment groups. After LSH all women had amenorrhea. After TBA there was a significant improvement of bleeding frequency and length. The postoperative pain intensity at 24 h was significantly minor in women treated with TBA rather than with LSH. The Medical Outcomes Survey Short Form 36 (SF-36) score improved in both groups. However, LSH showed a negative impact on the emotional state. No intraoperative complications occurred, and no case was returned to the theatre in either group.

CONCLUSION

The effectiveness of TBA as a possible treatment of HMB is confirmed. However, LSH showed a definitive improvement of the symptoms, and a better life quality profile. Further controlled prospective studies are required for identifying the best surgical approach in women with HMB.

摘要

目的

比较热球囊消融术(TBA)与腹腔镜次全子宫切除术(LSH)治疗月经过多(HMB)女性的术后结局及对生活质量的影响。

材料与方法

68例因HMB需手术治疗的女性被随机分为两个治疗组:TBA组(n = 34)和LSH组(n = 34)。随机化程序基于计算机生成的列表。主要结局是比较两种手术对月经出血的影响(图片失血评估图[PBAC])。次要结局指标包括生活质量、出血模式改善情况、术后疼痛强度及早期术后并发症。连续结局变量采用学生t检验进行分析。离散变量采用χ²检验或Fisher精确检验进行分析。P < 0.05被认为具有统计学意义。

结果

两个治疗组的PBAC评分均显著降低。LSH术后所有女性均闭经。TBA术后出血频率和持续时间有显著改善。TBA治疗的女性术后24小时的疼痛强度明显低于LSH治疗的女性。两组的医学结局调查简表36(SF - 36)评分均有所改善。然而,LSH对情绪状态有负面影响。术中无并发症发生,两组均无病例返回手术室。

结论

证实了TBA作为HMB一种可能治疗方法的有效性。然而,LSH显示出症状的明确改善和更好的生活质量概况。需要进一步的对照前瞻性研究来确定HMB女性的最佳手术方法。

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