Chiumente Marco, De Rosa Mauro, Messori Andrea, Proli Enrica Maria
Scientific Direction, SIFaCT - Italian Society for Clinical Pharmacy and Therapeutics, Milan.
Board of directors, SIFaCT - Italian Society for Clinical Pharmacy and Therapeutics, Milan.
Clinicoecon Outcomes Res. 2017 Aug 29;9:525-535. doi: 10.2147/CEOR.S139335. eCollection 2017.
Epidemiological studies on uterine fibroids (UFs) are mostly based on surveys or analyses of small samples of patients. In 50% of women, the quality of life is worsened by disease-related symptoms; furthermore, treatments imply a remarkable health care cost. The aim of this observational study was to analyze a large sample of Italian patients with UFs and to assess the epidemiology, the appropriateness of treatments, and the consumption of disease-related resources.
Data were collected through a data-linkage technique from five administrative databases. Women aged between 18 and 55 years and resident in three local health authorities (north-central-south Italy) were selected over the period from 1st January 2009 to 31st December 2015. The inclusion criteria were a surgical procedure with diagnosis of UFs or a pharmacological treatment with gonadotropin-releasing hormone (GnRH) analogs or ulipristal acetate. Besides the overall descriptive analysis, two comparisons were evaluated: surgery versus no surgery and treatment with GnRH analogs versus ulipristal acetate.
A total of 5,665 women with UFs were selected from an overall population of 2,400,000 people. In the north, 73.6% of patients underwent surgery, as opposed to only 16.7% in the south; 70% of surgeries were hysterectomies. The average cost per patient was €3,249 (duration of follow-up = up to 7 years). The southern district had the highest number of drug prescriptions; in particular, 49% of patients took >10 packages of GnRH analogs.
This study is the first on this topic conducted in Italy using a large sample size. The analysis of resource consumption revealed a high heterogeneity in the choice of drug treatments by gynecologists (especially in the south); in the north, marked variations were seen in the rates of surgery. The long-term use of GnRH was inappropriate.
关于子宫肌瘤（UFs）的流行病学研究大多基于对小样本患者的调查或分析。在50%的女性中，与疾病相关的症状会使生活质量下降；此外，治疗意味着可观的医疗保健成本。这项观察性研究的目的是分析大量意大利子宫肌瘤患者样本，并评估其流行病学、治疗的适宜性以及与疾病相关资源的消耗情况。
通过数据链接技术从五个行政数据库收集数据。选取2009年1月1日至2015年12月31日期间年龄在18至55岁之间、居住在三个地方卫生当局（意大利北部、中部、南部）的女性。纳入标准为接受过诊断为子宫肌瘤的外科手术或使用促性腺激素释放激素（GnRH）类似物或醋酸乌利司他进行的药物治疗。除了总体描述性分析外，还评估了两项比较：手术与非手术以及GnRH类似物治疗与醋酸乌利司他治疗。
从240万人的总体人群中总共选取了5665名子宫肌瘤女性患者。在北部，73.6%的患者接受了手术，而南部仅为16.7%；70%的手术为子宫切除术。每位患者的平均费用为3249欧元（随访时间 = 最长7年）。南部地区的药物处方数量最多；特别是，49%的患者服用了超过10包GnRH类似物。
本研究是意大利首次针对该主题进行的大样本研究。资源消耗分析显示，妇科医生在药物治疗选择上存在高度异质性（尤其是在南部）；在北部，手术率存在显著差异。GnRH的长期使用是不合适的。
