Compliance with clinical guidelines and adherence to antiretroviral therapy among patients living with HIV

Objective: Evaluation of provider compliance with antiretroviral (ARV) treatment guidelines and patient adherence to ARVs is important for HIV care quality assessment; however, there are few current real-world data for guideline compliance and ARV adherence in the US. This study evaluated provider compliance with US Department of Health and Human Services (DHHS) guidelines and patient adherence to ARVs in a US population of patients with HIV.

Methods: This was a retrospective claims study of adults with HIV-1 receiving ARV treatment between January 2010–December 2014. Follow-up began at first ARV treatment and ended at health plan disenrollment or study end. ARV regimens for treatment-naïve patients were categorized as “preferred/recommended”, “alternative”, or “non-preferred/recommended/alternative” according to DHHS guidelines. ARV adherence was evaluated using proportion of days covered (PDC) and medication possession ratio (MPR).

Results: The analysis included 25,320 patients (84.4% male, mean age 45.3 years) and 39,071 regimens. Preferred/recommended regimens were most common during each study year, but the proportion of non-preferred/recommended/alternative regimens was substantial (15.9–20.6%). Only 53.6% of patients had optimal adherence by PDC ≥0.95, and 57.9% by MPR ≥0.95. Guideline non-compliance and sub-optimal adherence were more prevalent among female vs male patients (22.6% vs 14.8% [in 2014] and 65.9% vs 53.7%, respectively).

Conclusions: Provider non-compliance with DHHS guidelines and sub-optimal ARV adherence among patients with HIV remain common in real-world practice, particularly for female patients. Healthcare providers should follow the latest clinical guidelines to ensure that patients receive recommended therapy, and address non-adherence when selecting ARV regimens.     

从脾论治慢性肾脏病的生物学基础探讨

脾为后天之源,肾为先天之本,以后天滋先天,使从脾论治成为中医临床治疗慢性肾脏病(CKD)的经典方法。现代医学研究发现人体内最庞大的“器官”——肠道菌群与“脾”的功能非常密切。目前研究发现肠道菌群紊乱是加速CKD进展的重要环节,基于脾肾互根互用的中医原理,收集、整理肠道菌群与CKD代谢功能、免疫应答及肾脏损伤关联的文献,从肠道菌群与机体功能代谢和内环境稳态的角度进行探讨,认识到运用中医药可通过干预肠道菌群的丰度、结构和代谢功能,维持肠道微生态的平衡,从而达到调节肾脏代谢和免疫应答的作用,提出肠道菌群是从脾论治慢性肾脏病的重要生物学基础。     

辛开苦降法治疗慢性肾小球肾炎初探

辛开苦降法为中医临床常用治法。本文通过探析辛开苦降法的源流和内涵,总结辛开苦降法在慢性肾小球肾炎治疗中的临床应用。辛开苦降法以苦辛之药配伍应用,具有燮理阴阳、平调寒热、调运气机、清利湿热、清化瘀热之功。慢性肾小球肾炎以本虚标实、虚实夹杂为病机特点,以机体阴阳失衡、肺脾肾三脏亏虚为本,以气机不调与湿热、瘀血阻滞为标。辛开苦降法可调补肺脾肾三脏之虚平燮阴阳,又可调运气机以清湿热、化瘀热,颇合慢性肾小球肾炎的病机特点。辛开苦降法在慢性肾脏病中的应用,为慢性肾小球肾炎的临床治疗提供了新的思路与方法,最后附典型病案1则加以说明。     

Symptom improvement in dry eye subjects following intranasal tear neurostimulation: Results of two studies utilizing a controlled adverse environment

PurposeTo evaluate the safety and effectiveness of the intranasal tear neurostimulator (ITN) in improving dry eye symptoms assessed in a controlled adverse environment (CAE®).MethodsStudy 1: Multicenter, subject-masked, randomized-sequence, crossover design. Single intranasal (active) and extranasal (control) ITN administration during CAE exposure. Study 2: Single-arm, open-label design. Intranasal ITN administration ≥2 times/day for 45 days, CAE assessment at days 0 and 45. In both studies, upon CAE entry, and every 5 min thereafter, subjects assessed eye dryness score (visual analog scale, 0–100 mm; EDS-VAS), and ocular discomfort score (ODS; Ora Calibra™, 0–4), for ≈2 h. Study 1: when ODS was ≥3 at 2 consecutive timepoints, subjects applied ITN intranasally or extranasally for ≈3 min, and again when achieving the same ODS criteria in randomized sequence. Study 2: days 0 and 45, ITN was applied for ≈3 min employing the same ODS criteria as Study 1.ResultsStudy 1: Significantly greater pre- to post-application reductions in mean [SEM] EDS (−16.5 [1.7] vs −3.1 [1.7], P < 0.0001) and ODS (−0.93 [0.08] vs −0.34 [0.08], P < 0.0001; n = 143) with intranasal vs extranasal stimulation. Study 2: On day 0 (n = 52) and day 45 (n = 48), significant pre- to post-application reductions in mean [SEM] EDS (−15.9 [2.7] and −15.2 [2.4]; P < 0.0001), and ODS (−1.3 [0.2] and −1.3 [0.1]; P < 0.0001). Few device-related adverse events were reported, none serious.ConclusionsAcute symptom relief is significant with the ITN and remains undiminished after daily use.     

Invasive breast cancer over four decades reveals persisting poor metastatic outcomes in treatment resistant subgroup – the “ATRESS” phenomenon

BackgroundMajor advances in breast cancer treatment have led to a reducuction in mortality. However, there are still women who are not cured. We hypothesize there is a sub-group of women with treatment-resistant cancers causing early death.MethodsBetween 1975 and 2006, 5392 women with invasive breast cancer underwent surgery at Guy’s Hospital, London. Data on patient demographics, tumour characteristics, treatment regimens, local recurrence, secondary metastasis, and death were prospectively recorded. We considered four time periods (1975–1982, 1983–1990, 1991–1998, 1999–2006). Risks and time to event analysis were performed with Cox proportional hazards model and Kaplan-Meier estimation.ResultsUnadjusted hazard ratios for developing metastasis and overall mortality relative to the 1975–1982 cohort decreased steadily to 0.23 and 0.63, respectively in 1999–2006. However, metastasis-free interval shortened, with the proportion of women developing metastasis ≤5 years increasing from 73.9% to 83.0%. Furthermore, median post-metastatic survival decreased from 1.49 years to 0.94 years. Applying our risk criteria identified the presence of ±200 patients in each cohort who developed metastasis early and died within a much shorter time frame.ConclusionsAdvances in treatment have decreased the risk of metastasis and improved survival in women with invasive breast cancer over the last 40 years. Despite this, a subpopulation with shorter metastasis-free and post-metastatic survival who are unresponsive to available treatment remains. This may be due to the ATRESS phenomenon (adjuvant therapy-related shortening of survival) secondary to preselection inherent in adjuvant therapy, successful treatment of less malignant tumour cells and treatment-induced resistance in the remaining tumour clones.