全血献血间隔期调整为3个月对献血不良反应与个体无偿献血行为的影响:一项多中心、回顾性队列研究OA

Objective Some regions in China have lowered the minimum interval for whole blood donation to 3 months through local regulations:Hainan,effective from March 1,2012,allows men to donate at intervals of≥3 months and women at intervals of≥4 months;Shenzhen,effective from November 1,1995,allows whole blood donation at intervals of≥3 months.The aim of this study was to evaluate the impact of shortening the whole blood donation interval on blood donation adverse reactions and donation behavior,thereby providing scientific evidence for policy evaluation and revision of relevant regulations.Methods This was a multicenter,retrospective cohort study based on blood donation registry data from Shenz-hen and Hainan.Data were obtained from the blood information management systems of Hainan Province(1991-2025)and Shenzhen City(2018-2024).Eligible participants were donors aged 18-65 years who had donated whole blood at least twice and met health eligibility criteria.The exposure was defined as a shorter donation interval(whole-blood interval≥3 months and<6 months)and was treated as a time-varying variable.The primary outcome was blood donation adverse reac-tions.Negative binomial regression with person-years as an offset was used to estimate incidence rate ratios for adverse reac-tions.Marginal standardization was used to estimate the adjusted incidence rate difference,and donor-level bootstrap resam-pling was used to estimate the 95%confidence interval of the adjusted incidence rate difference.Non-inferiority was as-sessed by comparing the upper limit of the 95%confidence interval with the prespecified non-inferiority margin of Δ=0.00 070 per person-year.In addition,Andersen-Gill models were used to analyze adverse reaction-free probability for re-current events.Secondary outcomes were donation behavior,including annual repeat donation rate,annual donation fre-quency,mean donation interval,and annual whole-blood donation volume.These were analyzed using logistic regression,negative binomial regression,and linear regression models,respectively,with adjustment for age,sex,region,and donation site.This study was approved by the Ethics Committee of the Institute of Blood Transfusion,Chinese Academy of Medical Sciences(Approval No.2025011)and registered in the Chinese Clinical Trial Registry(ChiCTR2500114968).Results A total of 375 075 repeat whole-blood donors were included,contributing 1 292 748 whole-blood donations.Among them,119 993 had ever donated at a shorter interval and 255 082 had never done so.Over 1 281 842 person-years of follow-up in the dynamic cohort,2 100 blood donation adverse reactions were recorded.The incidence rates of adverse reactions were 1.76 and 1.58 per 1 000 person-years in the ever-short interval and never-short interval groups,respectively.After adjust-ment for age,sex,province,and donation site,the ever-short interval group had a slightly higher adverse reaction rate than the never-short interval group(IRR=1.28,95%CI:1.15-1.41,P<0.001).Marginal standardization showed that the ad-justed incidence rates were 1.73 and 2.21 per 1 000 person-years in the never-short interval and ever-short interval groups,respectively.The adjusted incidence rate difference was 0.000 48 per person-year,with a bootstrap 95%CI of 0.000 26-0.000 69 per person-year;the upper limit of the 95%CI was below the prespecified non-inferiority margin.Andersen-Gill recurrent-event analysis showed that the ever-short interval group had a higher probability of remaining adverse reaction-free.Analysis of donation behavior showed that among donors followed for at least 365 days,the ever-short interval group had a higher annual repeat donation rate than the never-short interval group(74.2%vs 18.3%;adjusted OR=12.5,95%CI:12.3-12.7,P<0.001).They also had a higher annual whole-blood donation rate(adjusted RR=1.98,95%CI:1.97-1.98,P<0.001),a shorter mean whole-blood donation interval(β=-239 days,95%CI:-242 to-237 days,P<0.001),and a higher annual whole-blood donation volume(adjusted RR=2.14,95%CI:2.13-2.15,P<0.001).Con-clusion Based on real-world data from repeat whole-blood donors in Shenzhen and Hainan,lowering the minimum whole blood donation interval to 3 months did not show an absolute increase in blood donation adverse reactions exceeding the pre-specified margin within the scope of this outcome.Shorter whole-blood donation interval behavior was also associated with greater repeat-donation activity,higher annual donation frequency,and higher annual whole-blood donation volume.Given the observational nature of this study and the lack of long-term donor health indicators such as iron status and longitudinal hemoglobin changes,the long-term safety of setting the minimum whole blood donation interval at 3 months requires further evaluation.