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2024/2/20 17:52:46  阅读:43 发布者:

论文出处:10.1097/CM9.0000000000002868

01 研究背景部分

Arterial stiffening increases with age and blood pressure and is associated with cardiovascular disease (CVD), but the relationship between blood pressure lowering and arterial stiffening is still uncertain, especially in older people.  This study aimed to evaluate the effect of intensive blood pressure treatment on the progression of arterial stiffness and risk of CVD in older patients with hypertension.

02 论文方法部分解析一

The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial was a multicenter, randomized, controlled trial performed at 42 clinical centers throughout China, and 8511 patients aged 6080 years with essential hypertension were enrolled and randomly assigned to systolic blood pressure (SBP) target of 110 mmHg to <130 mmHg (intensive treatment) or 130 mmHg to <150 mmHg (standard treatment).     

STEP trial 是一个多中心随机对照临床试验,中国42家中心参与,供851160-80岁原发高血压患者入组,被随机分配到2个组别,一组强化降压,收缩压目标值110-130毫米汞柱,另一组常规降压,收缩压目标值130-150毫米汞柱。

这句话本身没有问题,但有点无厘头。

论文方法部分,需要描述的是你这个研究怎么做的,为何莫名其妙地说起了STEP trial

在我阅读了这篇论文的全文,发现了答案:STEP trial是一个大型的临床试验,主要结果早在2012年就发表在了NEJM 上面。

这篇论文,用的是STEP trial的“边角料”,做的一个二级分析。这一层关系,你必须让读者知道,改成:

This study is a posthoc analysis of the Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial, in which 8511 patients aged 6080 years with essential hypertension were randomized to an intensive treatment group (systolic blood pressure target of 110-129 mmHg versus a standard treatment group (target of 130-149 mmHg).

03 论文方法部分解析二

Patients underwent repeated examinations of the brachial-ankle pulse wave velocity (baPWV) and ankle-brachial index (ABI) at baseline, and the arterial stiffness was evaluated at the 3-year follow-up.A total of 5339 patients who had twice repeated measurements were included in this study.

   

2句话说的有点啰嗦,可以总结成:STEP trial 里面,动脉硬度2个指标,基线和3年随访都有数据的5339名患者,被纳入了本研究。

做一下修改,可以写成:

5339 patients with brachial-ankle pulse wave velocity (baPWV) and ankle-brachial index (ABI) at both the baseline and 3-year follow-up were included in the analysis.

04 论文方法部分解析三

Changes in arterial stiffness between the intensive and standard treatment groups were analyzed using a multivariate linear regression model.

用多因素线性回归模型分析了强化降压和标准降压组之间动脉硬度的变化。这话含义不明!!!

变化change”指的是动脉硬度在3年随访以后和基线相比,增高或者降低了多少,2组之间动脉硬度可以有差异,3年以后和基线相比的变化也可以有差异,唯一不可以有、没法理解的就是作者所谓的“Changes in arterial stiffness between the 2 groups - 之间动脉硬度的变化”。

05 论文方法部分解析四

The Cox proportional hazard regression model was used to evaluate the effect of intensive treatment on primary CVD outcomes.

COX 比例风险回归模型评价强化降压对心血管疾病的影响。

文字上没有毛病,但内容有点奇怪!强化降压对心血管疾病的影响,换句话说,强化降压和常规降压2个组别心血管疾病的发病率有没有差别,是STEP trial的核心结果,早就发表了,和这一篇论文没有关系!

这篇论文作者关心的是-强化降压和动脉硬度之间的关系,这一点,从标题中就可以看出。顺着这条思路下来,STEP trial 已经报道,强化降压组心血管疾病发病率降低,这篇论文预计强化降压组动脉硬度增幅减少,应当做的分析是:心血管疾病和动脉硬度增加幅度之间的关联,而不是什么强化降压对心血管疾病的影响。

06 论文摘要结果部分解析

The changes in baPWV were 61.5 cm/s (95% confidence interval [CI]: 49.873.2 cm/s) in the intensive treatment group and 98.4 cm/s (95% CI: 86.7110.1 cm/s) in the standard treatment group (P <0.001).

强化降压和标准降压2个组别脉搏波传递速度,也就是动脉硬度的指标的变化,3年随访和基线相比,强化降压组每秒61.5厘米,标准降压组每秒98.4厘米,P <0.001

Intensive treatment significantly delayed the progression of arterial stiffness, with an annual change of 23.1 cm·s1·year1 vs. 36.7 cm·s1·year1 of baPWV in the intensive and standard treatment groups, respectively.

强化降压显著延缓了动脉硬度的进展,脉搏波传递速度每年变化,强化降压组每秒23.1厘米,标准降压对照组每秒36.7厘米。

第一和第二句话,单独看没有问题,放在一起,非常奇怪!第一句话没有特别强调两组间差别相比那个更高,但给出了p值,第二句话特别说了两个组别对比的结果,而且是因果关系,但没有p值支持。大老婆不给钱,小老婆给。这个不对。

During a median follow-up period of 3.36 years, primary CVD outcomes occurred in 77 (2.9%) patients in the intensive treatment group compared with 93 (3.5%) in the standard treatment group.

 中位数3.36年的随访中,primary CVD 发生比例,强化降压组2.9%,标准降压对照组3.5%

这里有两个问题。

句子给出了两个组别发生CVD患者人数,分别是77人和93人,但整个摘要中没有两个组别患者的总数,没有分母,交代份子干什么?

强化降压组2.9%,标准降压对照组3.5%,这两个百分比的差别是否有统计学意义?应当有个说法,必须给出p值。

Intensive treatment resulted in a significantly lower CVD risk in patients aged 7080 years or with SBP <140 mmHg.   

论文摘要结果部分,到这里结束。你仔细品味一下,是不是少了点什么?少了对方法部分第4句话的交代。那句话是这么说的:Changes in arterial stiffness between the intensive and standard treatment groups were analyzed using a multivariate linear regression model.

 方法里说了你对什么指标用什么方法进行了分析,结果里就必须交代。这是讲故事的一个基本守则,你不可以言而无信,始乱终弃!

07

内容组织写作小结

声明

01

STEP trial 是一个很牛掰的试验,其主要结果2021年发表在 NEJM 上面,之前也有二次分析的结果发在 Hypertension 这样的学科顶级杂志上面。这篇论文,如果写的更好,完全可以发在更好的期刊上面。

想法

02

STEP trial 是否能够做得更好?能,用cluster randomization,中国医大一附院孙英贤。

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