Vilos G A, Fortin C A, Sanders B, Pendley L, Stabinsky S A
Department of Obstetrics and Gynecology, University of Western Ontario, St. Joseph's Health Center, 268 Grosvenor Street, London, Ontario, Canada N6A 4V2.
J Am Assoc Gynecol Laparosc. 1997 Nov;4(5):559-65. doi: 10.1016/s1074-3804(05)80089-1.
To evaluate the safety and efficacy of thermal balloon endometrial ablation in women with menorrhagia, and to identify factors influencing outcome.
Prospective, observational study (Canadian Task Force classification II-2).
Three Canadian university-affiliated teaching hospitals.
One hundred twenty-one women suffering from menorrhagia serious enough to make them candidates for endometrial ablation or hysterectomy. Patients without obvious structural or (pre)malignant abnormalities were included if their uterine cavities sounded to less than 12 cm, they were in good health, and had undergone hysteroscopy or pelvic ultrasound and endometrial biopsy within 6 months and had a normal Papanicolaou smear within 1 year.
A balloon catheter was placed through the cervix and after inflation in the endometrial cavity with 5% dextrose in water, was heated to 87 +/- 5 degrees C. Two-thirds of patients avoided general anesthesia and very few required cervical dilatation to admit the 4.5-mm diameter catheter. Balloon pressures were 90 to 140 mm Hg in 13 patients; pressures between 140 and 190 mm Hg were well tolerated by the rest. Nineteen women underwent 12 minutes of therapy, and the rest had 8-minute sessions.
No intraoperative complications occurred, and minor postoperative morbidity occurred in 4% of patients. Preoperative and postoperative bleeding was assessed by pad counts and patient self-reports. The degree of dysmenorrhea was recorded similarly. A paired t test was used to compare pretreatment with posttreatment pad counts. A Wilcoxon signed rank test was employed to evaluate the effect of treatment on dysmenorrhea. The effects on outcome of several independent variables were analyzed by multiple and logistic regression. Success of the procedure was constant over the year (range 86-90%). Treatment led to significant decreases in menstrual flow, duration, and pain (p <0.0001). No significant effects of parity, uterine position or cavity depth, timing, or various endometrial-thinning regimens were found. Increasing age was significantly associated with increased odds of success (p < 0.05). Excluding the 19 women who underwent 12 minutes of therapy did not change statistical results, whereas excluding the 13 treated with balloon pressures less than 140 mm Hg improved the results. Conclusion. The facts that bleeding and dysmenorrhea were significantly reduced by thermal balloon endometrial ablation, that no intraoperative complication occurred, and that postoperative morbidity was minimal, lead us to conclude that this is potentially a safe and effective technique. Larger studies and longer follow-up are required to substantiate this impression.
评估热球囊子宫内膜消融术治疗月经过多女性的安全性和有效性，并确定影响治疗结果的因素。
前瞻性观察性研究（加拿大工作组分类II - 2）。
加拿大三所大学附属医院。
121名月经过多严重到足以使其成为子宫内膜消融术或子宫切除术候选者的女性。如果子宫腔探条长度小于12 cm、身体健康、在6个月内接受过宫腔镜检查或盆腔超声检查及子宫内膜活检且1年内巴氏涂片检查正常，无明显结构或（前）恶性异常的患者纳入研究。
通过宫颈置入球囊导管，在球囊内注入5%葡萄糖水溶液使其在子宫内膜腔内膨胀后，加热至87±5℃。三分之二的患者避免了全身麻醉，很少有人需要宫颈扩张以置入直径4.5 mm的导管。13例患者球囊压力为90至140 mmHg；其余患者对140至190 mmHg之间的压力耐受性良好。19名女性接受了12分钟的治疗，其余患者接受8分钟的治疗。
术中无并发症发生，4%的患者术后出现轻微并发症。术前和术后出血通过卫生巾计数和患者自我报告进行评估。痛经程度也采用类似方法记录。采用配对t检验比较治疗前和治疗后的卫生巾计数。采用Wilcoxon符号秩检验评估治疗对痛经的影响。通过多元回归和逻辑回归分析几个独立变量对治疗结果的影响。该手术成功率在一年中保持稳定（范围86 - 90%）。治疗导致月经量、经期和疼痛显著减少（p <0.0001）。未发现产次、子宫位置或宫腔深度、治疗时间或各种子宫内膜变薄方案有显著影响。年龄增加与手术成功几率增加显著相关（p <0.05）。排除接受12分钟治疗的19名女性并未改变统计结果，而排除球囊压力小于140 mmHg治疗的13名患者则改善了结果。结论。热球囊子宫内膜消融术显著减少了出血和痛经，术中无并发症发生，术后并发症极少，这些事实使我们得出结论，这可能是一种安全有效的技术。需要更大规模的研究和更长时间的随访来证实这一观点。
