May 11, 2010 — 根據發表於5月10日內科醫學誌(Archives of Internal Medicine)的「Women's Health Initiative (WHI)」研究結果，使用質子幫浦抑制劑 (PPIs)與髖骨骨折無關，但是與臨床脊椎骨折、前臂或腕骨折、停經婦女的整體骨折略有關係。這篇描述此項前瞻分析的文章，是內科醫學誌有關PPIs，主題為「少則得(Less Is More)」的系列報告之一。
西雅圖華盛頓大學藥學博士Shelly L. Gray等人寫道，PPI藥物與骨質疏鬆骨折的關聯在各研究結果中並不一致，我們檢視使用PPI和骨骼方面(骨折、骨密度[BMD])之結果的關聯。
研究世代包括161,806名停經婦女、年紀50-79歲，沒有髖骨骨折病史，參與「WHI Observational Study and Clinical Trials」研究，研究者分析平均追蹤7.8 ± 1.6年間130,487名婦女的完整資訊，在開始時與第3年的個人訪談中，從藥品容器直接獲得所用的藥物資訊。初級結果是自我報告的髖骨(判定)骨折、臨床脊椎骨折、 前臂或腕骨折、整體骨折。此外，測量3年時的BMD變化作為子樣本(3處測密度位置)。
國家心臟肺臟與血液研究中心支持本研究。研究作者、Andrea Z. LaCroix博士宣告和Pfizer、Procter Gamble與 Sanofi-Aventis的各種財務關係。
Katz醫師是Health Management Associates的獨立顧問。
PPI Use Not Linked With Hip Fractures, but Modestly With Other Types of Fractures
By Laurie Barclay, MD
Medscape Medical News
May 11, 2010 — Use of proton pump inhibitors (PPIs) is not associated with hip fractures but is modestly associated with clinical spine fractures, forearm or wrist fractures, and total fractures in postmenopausal women, according to the results of a study from the Women's Health Initiative (WHI) reported in the May 10 issue of the Archives of Internal Medicine. The article describing this prospective analysis is part of a series about PPIs in the Archives of Internal Medicine entitled "Less Is More."
"...PPI medications have been inconsistently shown to be associated with osteoporotic fractures," write Shelly L. Gray, PharmD, MS, from the University of Washington, Seattle, and colleagues. "We examined the association of PPI use with bone outcomes (fracture, bone mineral density [BMD])."
The study cohort consisted of 161,806 postmenopausal women aged 50 to 79 years, without a history of hip fracture, who participated in the WHI Observational Study and Clinical Trials. The investigators analyzed data from 130,487 women with complete information during mean follow-up of 7.8 ± 1.6 years. During in-person interviews at baseline and at year 3, medication information was taken directly from drug containers. Primary endpoints were self-reported hip (adjudicated) fractures, clinical spine fractures, forearm or wrist fractures, and total fractures. In addition, 3-year change in BMD was determined for a subsample (3 densitometry sites).
There were 1500 hip fractures, 4881 forearm or wrist fractures, 2315 clinical spine fractures, and 21,247 total fractures identified during 1,005,126 person-years of follow-up. For current PPI use, multivariate-adjusted hazard ratios were 1.00 (95% confidence interval [CI], 0.71 - 1.40) for hip fracture, 1.47 (95% CI, 1.18 - 1.82) for clinical spine fracture, 1.26 (95% CI, 1.05 - 1.51) for forearm or wrist fracture, and 1.25 (95% CI, 1.15 - 1.36) for total fractures. PPI users and nonusers had similar baseline BMD measurements.
"Use of PPIs was associated with only a marginal effect on 3-year BMD change at the hip (P=.05) but not at other sites," the study authors write. "Use of PPIs was not associated with hip fractures but was modestly associated with clinical spine, forearm or wrist, and total fractures."
Limitations of this study include more chronic health conditions and risk factors for fractures in users of PPIs, possible residual or unmeasured confounding, lack of information on PPI dose, reliance on self-report of nonhip clinical fractures, and lack of spine radiographs.
Editorial: Risk Modest but Morbidity Increased
In an accompanying editorial, Mitchell H. Katz, MD, from the San Francisco Department of Public Health, San Francisco, California, describes this study as well as the others described in the series, "Less Is More."
"With a sample of 130,487 postmenopausal women and extensive follow-up (7.8 years), they [Gray et al.] found that PPIs were associated with an increased rate of spine, lower arm, and total fractures," Dr. Katz writes. "The increases in risk were modest (eg, the hazard ratio for total fractures was 1.25 [95% CI, 1.15-1.36]), but increases of common conditions due to commonly used medications add up to a lot of morbidity on a population level."
The National Heart, Lung, and Blood Institute of Health supported this study. Study author Andrea Z. LaCroix, PhD, has disclosed various financial relationships with Pfizer, Procter & Gamble, and Sanofi-Aventis.
Dr. Katz is an independent consultant for Health Management Associates.
