Randomized Noninferiority Trial of a Liberalized Diet Versus the Neutropenic Diet in Hematopoietic Stem-Cell Transplant Patients and Patients With Acute Leukemia.

Recent studies suggest that a more liberalized diet (LD) might be safe.

最近的研究表明，更宽松的饮食（LD）可能是安全的。

However, those studies lacked robust designs to demonstrate noninferiority and did not address whether an LD improves caloric intake or nutritional status.

然而，这些研究缺乏强有力的证据来证明非劣效性，并且没有解决低剂量（LD）是否改善了热量摄入或营养状况的问题。

This trial aimed to determine whether the rate of major infections in LD patients was noninferior to that in ND patients and whether an LD improved caloric intake and nutritional status.

本试验旨在确定低剂量（LD）患者的主要感染率是否不劣于无剂量（ND）患者，并且低剂量是否改善了热量摄入和营养状况。

Methods

In this phase III noninferiority trial, patients were randomly assigned to either an ND or LD, containing fresh fruits and vegetables.

在这项III期非劣效试验中，患者被随机分配到接受新鲜水果和蔬菜的ND或LD治疗组。

The primary end point was the development of any major infection during neutropenia.

主要终点是在中性粒细胞减少期间发展出任何主要感染。

The noninferiority margin was set at a difference of ≤10% in the major infection rate.

非劣效界值设定为在主要感染率上的差异≤10%。

Results

The trial was halted at the second interim analysis after enrolling 214 evaluable patients, because of the LD arm's major infection rate surpassing the predefined stopping boundary.

在招募了214名可评估患者后，由于LD组的主要感染率超过了预设的停止界限，该试验在第二次中期分析时被停止。

In the LD arm, major infections occurred in 31.4% of patients compared with 20.2% of patients in the ND arm, a difference of 11.2% ([95% CI, -0.4 to 22.9]; P = .58).

在LD组中，31.4%的患者发生了主要感染，而在ND组中这一比例为20.2%，差异为11.2%（95% 置信区间，-0.4至22.9；P = .58）。

Furthermore, the caloric intake in the LD arm was not improved and nearly two thirds of patients on both diets reported critical nutritional problems.

此外，LD组的热量摄入并未改善，近三分之二的患者报告了严重的营养问题。

There was no advantage in symptoms, quality of life, or survival for the LD arm.

低剂量组在症状、生活质量或生存方面没有优势。

Conclusions

These findings suggest that LD is not a safe alternative to ND in HSCT patients and patients with AL because of increased infection risk without nutritional or other benefit.

这些发现表明，对于造血干细胞移植（HSCT）患者和急性白血病（AL）患者来说，低剂量（LD）并非高剂量（ND）的安全替代方案，因为感染风险增加，而没有营养或其他益处。

Further dietary strategies are needed to improve nutrition without compromising safety.

需要进一步的饮食策略来改善营养状况，同时不损害安全性。