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Prolonged effect of calcium supplementation on risk of colorectal adenomas in a randomized trial.

机译:在一项随机试验中,补钙对结直肠腺瘤风险的延长作用。

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BACKGROUND: Calcium supplementation has been shown to decrease the risk of recurrence of colorectal adenomas in randomized trials. However, the duration of this protective effect after cessation of active supplementation is not known. METHODS: In the Calcium Polyp Prevention Study, 930 subjects with a previous colorectal adenoma were randomly assigned from November 1988 through April 1992 to receive placebo or 1200 mg of elemental calcium daily for 4 years. The Calcium Follow-up Study was an observational phase of the trial that tracked adenoma occurrence for an average of 7 years after the end of randomized treatment and gathered information regarding the use of medications, vitamins, and supplements during that time. We obtained follow-up information for 822 subjects, 597 of whom underwent at least one colonoscopy after the end of study treatment and are included in this analysis. Generalized linear models were used to compute relative risks (RRs) and 95% confidence intervals (CIs) for the effect of randomized calcium treatment on risk of adenoma recurrence during the first 5 years after study treatment ended and during the subsequent 5 years. Statistical tests were two-sided. RESULTS: During the first 5 years after randomized treatment ended, subjects in the calcium group still had a substantially and statistically significantly lower risk of any adenoma than those in the placebo group (31.5% versus 43.2%; adjusted RR = 0.63, 95% CI = 0.46 to 0.87, P = .005) and a smaller and not statistically significant reduction in risk of advanced adenomas (adjusted RR = 0.85, 95% CI = 0.43 to 1.69, P = .65). However, the randomized treatment was not associated with the risk of any type of polyp during the next 5 years. The findings were broadly similar when the analysis was restricted to subjects who did not report use of any calcium supplements after the treatment phase of the trial ended. CONCLUSION: The protective effect of calcium supplementation on risk of colorectal adenoma recurrence extends up to 5 years after cessation of active treatment, even in the absence of continued supplementation.
机译:背景:在随机试验中,已证明补充钙可降低结直肠腺瘤复发的风险。但是,停止主动补充后这种保护作用的持续时间未知。方法:在钙息肉预防研究中,从1988年11月至1992年4月,随机分配了930名患有大肠腺瘤的受试者,每天接受安慰剂或1200 mg元素钙,持续4年。钙随访研究是该试验的观察阶段,该试验追踪随机治疗结束后平均7年内腺瘤的发生情况,并收集有关这段时间内使用药物,维生素和补充剂的信息。我们获得了822名受试者的随访信息,其中597名受试者在研究治疗结束后接受了至少一次结肠镜检查,并纳入了该分析。在研究治疗结束后的前5年和随后的5年中,使用广义线性模型计算随机风险钙对腺瘤复发风险的影响的相对风险(RRs)和95%置信区间(CIs)。统计检验是双面的。结果:在随机治疗结束后的头5年内,与安慰剂组相比,钙组的受试者患腺瘤的风险仍显着降低,且具有统计学意义(分别为31.5%和43.2%;调整后的RR = 0.63,95%CI) = 0.46至0.87,P = .005)和较小的,无统计学意义的晚期腺瘤风险降低(调整后RR = 0.85,95%CI = 0.43至1.69,P = .65)。但是,在接下来的5年中,随机治疗与任何类型的息肉风险无关。当分析仅限于在试验的治疗阶段结束后未报告使用任何钙补充剂的受试者时,这些发现大致相似。结论:补充钙对大肠腺瘤复发风险的保护作用在停止积极治疗后可延长至5年,即使​​在没有继续补充的情况下也是如此。

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