Clark Nina M, Schembri Michael, Jacoby Vanessa L
University of California, San Francisco School of Medicine, and the Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, California.
Obstet Gynecol. 2017 Nov;130(5):1057-1063. doi: 10.1097/AOG.0000000000002309.
To evaluate the association between the U.S. Food and Drug Administration (FDA) communication discouraging use of power morcellators on changes in surgical practice for women with uterine leiomyomas.
This is a cross-sectional study using data from 2013 to 2014 in the Healthcare Cost and Utilization Project State Inpatient and State Ambulatory Surgical Databases from Arizona, Florida, Kentucky, and New Jersey. Women with a diagnosis of leiomyomas who underwent hysterectomy or myomectomy were included in the analysis. Multivariable models were used to assess changes in the proportion of hysterectomies performed laparoscopically, vaginally, or by laparotomy in the 15 months before the FDA safety communication in April 2013 (January 2013 to March 2014) to the 9 months after the FDA communication (April to December 2014). Changes in the proportion of women who underwent myomectomy compared with hysterectomy were also evaluated during this time period.
There were 77,637 hysterectomy and myomectomy cases analyzed from states with both inpatient and ambulatory surgery data; 59% of patients were outpatients. Overall, there was a 4% (95% CI 3.2-4.8%) decrease in the use of laparoscopic hysterectomy for treatment of uterine leiomyomas from 62% of all hysterectomies before the FDA communication on morcellation to 58% afterward. Changes in surgical practice were more pronounced in the inpatient compared with outpatient setting; inpatient laparoscopic hysterectomy decreased by 7% (95% CI 6.1-7.9%) from 24% to 17% of all hysterectomies with an accompanying increase in abdominal hysterectomy of 8% (95% CI 6.7-8.6%) from 71% to 79%. There were no significant changes in the proportion of women with leiomyomas who underwent myomectomy compared with hysterectomy.
The FDA communication discouraging the use of power morcellators was associated with a decline in laparoscopy to perform hysterectomy, particularly in the inpatient setting. There was no change in the selection of myomectomy compared with hysterectomy for leiomyoma treatment after the FDA communication.
评估美国食品药品监督管理局（FDA）发出的不鼓励使用动力旋切器的通告与子宫肌瘤女性患者手术方式改变之间的关联。
这是一项横断面研究，使用了2013年至2014年亚利桑那州、佛罗里达州、肯塔基州和新泽西州医疗成本与利用项目州住院患者数据库及州门诊手术数据库中的数据。纳入分析的是诊断为子宫肌瘤且接受子宫切除术或肌瘤切除术的女性。采用多变量模型评估在2013年4月FDA发布安全通告前15个月（2013年1月至2014年3月）至FDA通告后9个月（2014年4月至12月）期间，腹腔镜、经阴道或开腹子宫切除术所占比例的变化。在此期间，还评估了接受肌瘤切除术与子宫切除术的女性比例的变化。
对来自有住院和门诊手术数据的州的77637例子宫切除术和肌瘤切除术病例进行了分析；59%的患者为门诊患者。总体而言，用于治疗子宫肌瘤的腹腔镜子宫切除术的使用率从FDA发布关于旋切术的通告前占所有子宫切除术的62%降至通告后的58%，下降了4%（95%可信区间3.2 - 4.8%）。与门诊环境相比，住院环境中手术方式的改变更为明显；住院患者的腹腔镜子宫切除术从占所有子宫切除术的24%降至17%，下降了7%（95%可信区间6.1 - 7.9%），同时腹式子宫切除术从7%增至79%，增加了8%（95%可信区间6.7 - 8.6%）。与子宫切除术相比，接受肌瘤切除术的子宫肌瘤女性比例没有显著变化。
FDA发出的不鼓励使用动力旋切器的通告与腹腔镜子宫切除术的减少有关，尤其是在住院环境中。FDA通告后，在子宫肌瘤治疗中，与子宫切除术相比，肌瘤切除术的选择没有变化。
