Sun Peter, Liu Jamae, Charles Hearns, Hulbert John, Bissler John
a Kailo Research Group , Indianapolis , IN , USA.
b Novartis Pharmaceuticals Corporation , East Hanover , NJ , USA.
Curr Med Res Opin. 2017 May;33(5):821-827. doi: 10.1080/03007995.2017.1286307. Epub 2017 Mar 21.
To examine outcomes of clinical procedures for renal angiomyolipoma associated with tuberous sclerosis complex (TSC) based on US national health claims databases.
This retrospective cohort study selected two cohorts of TSC patients, who underwent either embolization or nephrectomy (either partial or complete) for renal angiomyolipoma in the years from 2000 through 2011. Based on claims diagnosis codes, we estimated the prevalence rates of 10 angiomyolipoma-related conditions and 50 embolization- or nephrectomy-related conditions in the pre- and post-baseline periods respectively, and made cross-year and cross-period comparison of these rates with repeated measures analysis methods.
The embolization cohort (N = 4280) and the nephrectomy cohort (N = 3842) had mean baseline ages of 50.7 and 51.7 years with 52.5% and 51.3% males, respectively. After the intervention, the embolization cohort had statistically significant reductions (all p < .05) in gross hematuria (-27.7%), retroperitoneal hemorrhage (-8.4%), and abdominal mass (-6.9%), and increases in hypertension (15.5%), renal mass or unspecified disorder of kidney and ureter (13.8%), anemia (5.1%), and renal insufficiency (3.3%). Similarly, the nephrectomy cohort saw statistically significant reductions (all p < .05) in gross hematuria (-30.6%), flank pain (-7.5%), and abdominal mass (-6.4%), but increases in hypertension (11.9%), renal insufficiency (10.4%), and anemia (7.6%). Embolization was associated with post-procedure increases in renal mass or unspecified kidney/ureter disorder (13.9%), other disorders of kidney and ureter (3.4%), non-acute renal insufficiency (3.1%), flank pain (3.7%), renal insufficiency (3.2%), etc. (all p < .05). Nephrectomy was associated with post-procedure increases in postoperative ileus (5.3%), pain and headache (4.8%), paralytic ileus (3.6%), etc. (all p < .05).
Both embolization and nephrectomy were effective, but associated with increases in certain angiomyolipoma-related conditions. Further, the embolization effect on gross hematuria, retroperitoneal hemorrhage, and abdominal mass might subside after the intervention year.
基于美国国家医疗理赔数据库，研究与结节性硬化症（TSC）相关的肾血管平滑肌脂肪瘤临床治疗结果。
这项回顾性队列研究选取了两组TSC患者，他们在2000年至2011年间因肾血管平滑肌脂肪瘤接受了栓塞治疗或肾切除术（部分或完全切除）。根据理赔诊断编码，我们分别估算了基线期前后10种与血管平滑肌脂肪瘤相关病症以及50种与栓塞或肾切除术相关病症的患病率，并采用重复测量分析方法对这些患病率进行跨年度和跨时期比较。
栓塞治疗队列（N = 4280）和肾切除队列（N = 3842）的平均基线年龄分别为50.7岁和51.7岁，男性分别占52.5%和51.3%。干预后，栓塞治疗队列中肉眼血尿（-27.7%）、腹膜后出血（-8.4%）和腹部肿块（-6.9%）有统计学显著下降（均p < 0.05），而高血压（15.5%）、肾肿块或未明确的肾和输尿管疾病（13.8%）、贫血（5.1%）和肾功能不全（3.3%）有所增加。同样，肾切除队列中肉眼血尿（-30.6%）、胁腹痛（-7.5%）和腹部肿块（-6.4%）有统计学显著下降（均p < 0.05），但高血压（11.9%）、肾功能不全（10.4%）和贫血（7.6%）有所增加。栓塞治疗与术后肾肿块或未明确的肾/输尿管疾病（13.9%）、其他肾和输尿管疾病（3.4%）、非急性肾功能不全（3.1%）、胁腹痛（3.7%）、肾功能不全（3.2%）等增加相关（均p < 0.05）。肾切除术与术后肠梗阻（5.3%）、疼痛和头痛（4.8%）、麻痹性肠梗阻（3.6%）等增加相关（均p < 0.05）。
栓塞治疗和肾切除术均有效，但与某些血管平滑肌脂肪瘤相关病症的增加有关。此外，栓塞治疗对肉眼血尿、腹膜后出血和腹部肿块的疗效在干预年后可能会消退。
