脑出血急性期甘露醇治疗作用的临床评估

目的：正确评估脑出血急性期甘露醇的治疗作用。方法：使用脑室内压监测法对１０例基底节区脑出血急性期患者进行甘露醇降颅压作用的连续监测。结果：甘露醇降颅压作用时间开始于用药后１１．７０±５．１０分钟，达最强降压作用时间为２２．５０±７．５０分钟，最强降颅压持续时间为２７．００±９．００分钟，药效作用时间范围５８．１２～１７０．０２分钟；用药后颅压降低程度为４２．４３％；９０％患者出现用药后的反跳作用。结论：本结果与有关甘露醇药理作用的某些专著记载结果相差较大，也说明其对脑出血患者降颅压作用的临床价值有限。     

Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial

Introduction and hypothesis

Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months.

Methods

ESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment.

Results

The final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized.

Conclusions

We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making.

     

Management of Early Node‐Positive Breast Cancer in Australia: A Multicentre Study

To examine practice patterns for breast cancer patients with limited sentinel node (SN) disease in light of the ACOSOG Z0011 results. Retrospective analysis of patients with T1‐2 breast cancer and positive sentinel lymph node biopsy (SLNB) admitted between January 2009 and December 2012. Patient demographics, tumor characteristics, and treatments were recorded. Eight hundred positive SLNBs were identified. A total of 452 (56.5%) proceeded to completion axillary lymph node dissection (cALND). cALND rate decreased from 65.1% to 49.7% from 2009–2010 to 2011–2012. cALND was performed for micrometastasis or isolated tumor cells in 39.3% in 2009–2010 and 22.2% in 2011–2012, whereas for macrometastases the rates were 83.1% and 68.6%, respectively. cALND rates diminished for both Z0011‐eligible and ‐ineligible patients. The ACOSOG Z0011 trial presentation and publication coincided with a reduction in cALND for breast cancer with limited nodal disease. There appears equipoise regarding management of macrometastatic SN disease.