平衡晶体液（施他宁）与生理盐水治疗糖尿病酮症酸中毒的比较：一项采用历史对照的前瞻性干预试验。

Balanced crystalloid (Sterofundin) vs. normal saline for diabetic ketoacidosis: a prospective intervention trial with historical controls.

作者信息

Bharti D, Selvam S, Sharma N, Dutta P, Pannu A K

机构信息

Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Nehru Hospital, Chandigarh 160012, India.

Department of Endocrinology, Postgraduate Institute of Medical Education and Research, Nehru Hospital Extension, Chandigarh 160012, India.

出版信息

QJM. 2025 Feb 1;118(2):79-86. doi: 10.1093/qjmed/hcae169.

DOI:10.1093/qjmed/hcae169

PMID:39180713

Abstract

BACKGROUND

Fluid therapy with normal saline (NS) in diabetic ketoacidosis (DKA) can cause hyperchloremic acidosis and delay DKA resolution. Balanced crystalloids may address this concern, though results with Ringer lactate and Plasma-Lyte have been mixed.

AIM

This study aimed to compare the effectiveness of Sterofundin (SF) vs. NS in the management of DKA.

METHODS

A prospective, intervention trial with historical controls was conducted at the Postgraduate Institute of Medical Education and Research, Chandigarh, India. Patients aged 13 years or older with DKA were enrolled. The primary outcome was the time taken to DKA resolution, with a predefined superiority margin of a one-fourth reduction in resolution time. Secondary outcomes included total intravenous fluid and short-acting regular insulin requirements, the need for 0.45% saline, hospital stay duration and in-hospital mortality.

RESULTS

A total of 150 patients (mean age 36.8 years, 56.7% males) were included, with 75 receiving SF (intervention group) and 75 receiving NS (historical control group). The SF group showed a significantly shorter mean time to DKA resolution (13.8 ± 6.0 h) compared to the NS group (18.1 ± 5.5 h; P < 0.001). SF patients required less total intravenous fluid (4500 vs. 6000 ml; P = 0.004), less insulin (98 units vs. 112 units; P = 0.017) and had a lower need for 0.45% saline (8% vs. 74.3%; P < 0.001). Patients receiving SF had shorter hospital stays (4 [interquartile range, IQR 3-5] days vs. 4 [IQR 4-6] days; P = 0.020). Mortality rates were similar between the groups (SF: 9.3%, NS: 8.1%; P = 0.791).

CONCLUSION

SF may be a superior alternative to NS for fluid therapy in DKA.

摘要

背景

糖尿病酮症酸中毒（DKA）患者使用生理盐水（NS）进行液体治疗可导致高氯性酸中毒并延缓DKA的缓解。平衡晶体液可能解决这一问题，不过乳酸林格液和聚明胶肽液的治疗效果不一。

目的

本研究旨在比较舒泰得（SF）与NS治疗DKA的有效性。

方法

在印度昌迪加尔的医学教育与研究研究生院进行了一项采用历史对照的前瞻性干预试验。纳入年龄在13岁及以上的DKA患者。主要结局为DKA缓解所需时间，预定义的优效性界值为缓解时间缩短四分之一。次要结局包括静脉补液总量、短效正规胰岛素需求量、0.45%盐水的使用需求、住院时间和院内死亡率。

结果

共纳入150例患者（平均年龄36.8岁，56.7%为男性），其中75例接受SF治疗（干预组），75例接受NS治疗（历史对照组）。与NS组（18.1±5.5小时）相比，SF组DKA缓解的平均时间显著缩短（13.8±6.0小时；P<0.001）。接受SF治疗的患者静脉补液总量更少（4500 vs. 6000毫升；P=0.004），胰岛素用量更少（98单位 vs. 112单位；P=0.017），0.45%盐水的使用需求更低（8% vs. 74.3%；P<0.001）。接受SF治疗的患者住院时间更短（4[四分位间距，IQR 3-5]天 vs. 4[IQR 4-6]天；P=0.020）。两组死亡率相似（SF组：9.3%，NS组：8.1%；P=0.791）。