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CN31-1366/R
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上海市普陀区高血压患者社区随机对照试验评价
Evaluation on a community-based randomized controlled trial in hypertension outpatients in Putuo District of Shanghai

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DOI:
作者:
陈科[1]，马建红[1]，吴雯静[1]，邓海巨[1]，李新建[2]，厉曙光[3]
CHEN K，MA JH，WU WJ，DENG HJ，LI XJ，LI SG
作者单位:
[1]上海市普陀区疾病预防控制中心 [2]上海市疾病预防控制中心 [3]复旦大学公共卫生学院
[1]CDC of Putuo District, Shanghai 200333, CHINA [2]CDC of Shanghai, Shanghai 200336, CHINA [3]School of Public Health, Fudan University, Shanghai 200032, CHINA
关键词:
高血压、社区、干预、评价、重复测量
hypertension, community, intervention, evaluation, repeated measure
摘要:
【目的】 评价上海市普陀区高血压患者社区干预项目的主要指标，为后续评价、外区平行项目、上海市总体项目提供参考与反馈。 【方法】 预设Power=0.8，按纳入、排除标准采用多阶段混合抽样配合随机化分组形成干预组与对照组各200（人），总计400（人）。由经市、区两级培训的社区卫生服务中心人员使用校准的测量工具与仪器在一年内完成三次知-信-行指标、三次物理指标、两次生化指标的采集，以及六次基于自我效能理论的授课、讲座、互动形式的干预。 【结果】 干预人数：基础阶段200（人），强化阶段平均每次现场175（人）、事后23人，干预组失访2人未计入。项目结束时样本量为：干预组198（人）、对照组196（人）。基线时一般情况在组间分布均衡（P>0.05），评估指标在组间分布不全均衡（α=0.05）。三次测量的知晓度、收缩压、舒张压、腹围等指标的变化趋势及其在组间的差异有统计学意义（P<0.01）。干预前后各指标变化的方向、幅度、组间分布（P<0.05）：知晓度上升且干预组更多；收缩压、舒张压下降且干预组更多；干预组腹围下降明显而对照组轻微上升；两组血糖、血钾、高密度脂蛋白、总胆固醇等生化指标变动的均数差异仅在0.2以内；肌酐上升且对照组幅度大；尿酸上升且干预组幅度明显大。经相关系数阵列筛选及回归参数估计发现腹围降幅能影响舒张压降幅、舒张压升幅能影响血糖升幅。 【结论】 一般情况、向均数回归、评估指标基线偏性等经验混杂得到消除。在统计学上观察到干预对血压、腹围下降有作用；腹围下降对舒张压下降有作用：腹围每多降1（cm）可使舒张压多下降0.132（mmHg），腹围下降引起的DBP改变在两组DBP降幅差异中占38.8%的作用；舒张压上升对血糖上升的作用有待于进一步明确；两组肾功能有变化，但差异无临床意义，具体原因有待后续食物频率表分析；知晓度的提高可能是干预效应的中间环节，但未观察到剂量-反应关系，故有待进一步明确。
【Objective】 To evaluate principle variables of a community intervention program for hypertension outpatients in Putuo District of Shanghai thus to provide reference and feedback to out-district parallel projects and also the mother project. 【Methods】 Prospective Power was set to 0.8. According to I/O rules, trial and control group were formed with 200 patients on each (400 patients in total) by a multistage mixed sampling method with randomized grouping. Fully trained community medicate personals were responsible for a total of 3 times KAPs, 3 times physical examinations, 2 times biochemical tests, 6 times self-efficacy based interventions via pre-adjusted tools and apparatus. 【Results】 Patients went through intervention: 200 in basic stage; 175 in session and 23 after session of enhanced stage; 2 lost not in counting. Final sample sizes were 198 under trial and 196 under control. Two groups at baseline showed balance in general variables (P>0.05). Evaluation variables showed partial balance between groups (α=0.05). The trends of 3 times measured KNS, SBP, DBP, ABC were confirmed with statistics and the trends were different between groups (P<0.01). Changes before-after trial in direction, margin and those differences between groups (P<0.05): KNS rose in both groups and more in trial group. Both SBP and DBP dropped (the former more); trial group ABC dropped obviously while raised a little in control group; Two groups’ mean value of changes in glucose, potassium, HDL and total cholesterol differed within 0.2 from each other; creatinine and uric acid went up (control: higher Cr; trial: higher UA). Using correlation matrix and regression estimates, we found that DBP dropping level could be altered by ABC; GLU rising level could be altered by DBP. 【Conclusion】 Experienced confounding factors like general conditions, regression-to-mean effect and baseline evaluation variable bias were cleared. At statistical level we observed intervention had taken effect on blood pressure and abdominal circumference; ABC had effect on DBP: DBP dropped 0.132 (mmHg) more after 1 (cm) more dropping of ABC which contributed to 38.8% of ΔΔDBP between groups; the effect of DBP on glucose was left to further study. Two groups had changes in renal function but showed no clinical difference, which was left to further analysis on food frequency tables. The raise of KNS might be a way of how intervention effect took place but still needed further study because of no dose-reaction observed here.

 

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