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1、CAG Position Statement:Hip fracture and proton pump inhibitor therapy -a 2013 updateCAG 的立场声明： 髋部骨折和质子泵抑制剂治疗- 2013 年更新 Health Canada have recently provided an information update on proton pump inhibitor (PPI) therapy and risk of fracture in April 2013 (1) stating “Several scientific studies suggest
2、that PPI therapy may be associated with a small increased risk for fractures of the hip, wrist, or spine related to osteoporosis, adisease resulting in the weakening of bones. The risk of fracture was higher in patients who received multiple daily doses of PPIs and therapy for a year or longer. Addi
3、tional risk factors for osteoporosis,such as age, gender and the presence of other health conditions, may also contribute to the increased risk of fractures. At Health Canadas request, manufacturers of all PPIs marketed in Canada have updated the drug labels for their products to include information
4、 on this risk.”加拿大卫生部最近提供了一个质子泵抑制剂(PPI)治疗的信息更新，在2013年 4 月的骨折风险(1)说明“一些科学研究表明， PPI 治疗可能是一个小的风险增 加髋部、腕部骨折，或脊柱相关疾病的骨质疏松症，导致骨骼弱化。骨折风险较 高的患者接受 PPI 治疗多每天服用一年或更长时间。骨质疏松症的其他危险因素， 如年龄，性别和其他健康状况的存在，也有助于增加骨折的风险。在加拿大卫生 部的要求，所有在加拿大销售的厂家有 PPIs 更新他们的产品包括信息风险的药 物标签。”The Canadian Association of Gastroenterology prov
5、ided a position statement on PPI therapy and risk ofhip fracture in 2008 (2) and we have updated this in light of the recent Health Canada statement. Large administrative databases are a useful tool to assess possible benefit or harms of health care interventions but given that billions of associati
6、ons can be measured with these databases then highly statistically significant findings will inevitably occur by chance. Added to this problem is that any association may simply be due to confounding factors and not due to the health care intervention causing the disease (e.g. a database study may f
7、ind that steroid inhaler therapy increases the risk of lung cancer but this may simply due to smokers are more likely to have lung disease (and be given steroid inhalers) and smoking causes lung cancer). Associations between health care interventions and risk of harm are therefore being reported alm
8、ost every week and it is therefore very difficult for the clinician to know what associations that are likely to be causal and what are likely to be spurious. There is no simple answer to this problem as epidemiological data can never prove or disprove a hypothesis. Hill (3) has described nine facto
9、rs that make an association more likely to be causal. We have previously evaluated he evidence for PPI therapy and risk of fracture according to the most important of these factors namely strength of the association, biological plausibility, specificity, consistency of the association, and evidence
10、of a dose response relationship (4). We have conducted an updated systematic review evaluating PPI therapy and risk of fracture that will be submitted to a peer reviewed journal and have used these data to assess CAG position on the use of PPI therapy and risk of fracture.加拿大胃肠病学协会提供的PPI治疗和髋骨折风险的立场声
11、明2008 (2),我们 已经更新了在最近的加拿大健康声明的光。大型管理数据库是一个有用的工具， 以评估可能的好处或损害的医疗干预措施，但考虑到这些数据库可以测量的数十 亿协会，然后有高度统计学意义的结果将不可避免地发生的机会。添加到这个问 题是任何关联可能是由于混杂因素并不是由于医疗干预引起疾病(如数据库的研 究可以发现，激素吸入治疗会增加患肺癌的风险，但这可能只是由于吸烟者更容 易得肺病(并给予类固醇吸入剂)吸烟导致肺癌)。因此，健康护理干预和风险 的危害之间的关联，因此，几乎每周都有报道，因此非常困难的临床医生知道什 么协会，很可能是因果关系，什么是可能的虚假。有没有简单的回答这个问题的
12、 流行病学数据无法证实或证伪的假说。山(3)有九个因素，使一个关联更可能 是因果关系。之前我们已经对PPI治疗和根据这些最重要的因素，即关联强度的 生物合理性，特异性骨折风险评估证据，协会的一致性，并有剂量反应关系(4)。我们进行了一项最新的系统性综述评估PPI治疗和骨折的危险，将提交给同行评 审的期刊，用这些数据来评估CAG位置对PPI治疗与骨折危险性的使用。Strength of the associationThere has been a wealth of data published since the 2008 CAG position statement on PPI ther
13、apy and hip fracture risk. Our systematic review identified 13 case control studies (5-17) evaluating 1,101,595 participants. PPI use was associated with fracture with an odds ratio (OR) = 1.21 (95% confidence intervals (CI) 1.07 to 1.38). There were also 12 cohort studies (18-29) evaluating 834,442
14、 participants over 3,712,891 patient years of follow up. Overall these cohort studies suggested PPI therapy was associated with an increased risk of fracture (relative risk (RR) = 1.30; 95% CI = 1.13 to 1.49). Overall the data therefore suggest that PPI therapy may increase the risk of fracture alth
15、ough the effect is very modest and any association may be due to confounding factors. Studies usually did adjust for some confounding factors but data available from databases is limited and residual confounding cannot be excluded. 关联强度有丰富的自2008 CAG的立场声明PPI治疗和髋部骨折的风险发表的数据。我们 的系统的审查确定了 13个病例对照研究(5-17
16、)评价1101595名。PPI的使用与 骨折相关的比值比(或)=1.21(95%置信区间(CI)为1.07至1.38)。也有12 个队列研究(18-29岁)评估834442名病人超过3712891年的随访。总的来说这 些队列研究表明PPI治疗的患者骨折风险增加(相对危险度(RR)为1.30； 95% 可信区间为1.13至1.49)。总体而言，数据表明，PPI治疗可能增加骨折的风险， 虽然效果很谦虚，任何关联可能是由于混杂因素。研究通常对一些混杂因素进行 调整，但从数据库中获得的数据是有限的，不能排除残留的混杂因素。Biological plausibilityThe association between PPI therapy and fracture risk would be strengthened if a biologically plausible mechanism could explain the association. The original paper that highlighted concerns rega
