Data Sheet 4_XueBiJing injection reduced mortality in sepsis patients with diabetes.pdf

IntroductionSepsis patients with diabetes are at a high clinical risk. It is well reported that XueBiJing injection has good clinical benefit in sepsis individuals. However, there is no relevant report about the efficacy and safety of XBJ in sepsis patients with comorbid diabetes.
MethodsData of two large randomized controlled clinical trials (XBJ-SAP (ChiCTR-TRC-13003534) and EXIT-SEP (NCT0323874)) were combined, and post hoc analyses were performed. Sepsis patients with diabetes were further divided into the XBJ-treated group and placebo group based on inclusion and exclusion criteria. The primary (28-day mortality) and secondary outcomes (mortality in the ICU and in the post-randomization hospital, acute physiology, and chronic health evaluation II (APACHE II) score and sequential organ failure assessment (SOFA) score) were compared between the XBJ treatment and placebo groups in sepsis patients with the diabetes status at baseline. Moreover, the occurrence of adverse events (AEs) was also assessed.
ResultsAt the study baseline, a total of 378 sepsis patients (227 men [60.0%] and 151 women [40.0%]; mean [SD] age, 60.3 [11.1] years) were considered to have diabetes, of which 177 received XBJ and 201 received placebo administration. Among these sepsis patients with diabetes, the mortality at 28 days was significantly lower in the XBJ group than in the placebo group (29 of 173 patients [16.8%] vs. 56 of 198 patients [28.3%], P = 0.01), and the absolute risk difference was 11.5% (95% CI, 3.1%–19.9%). Furthermore, there was no difference in the overall incidence of adverse events (AEs) when XBJ was used (24.4% [42 of 172 patients] vs. 27.7% [54 of 195 patients].
DiscussionThe present study underscores the pivotal role of XBJ in modulating the immune response among sepsis patients suffering from diabetes mellitus, exploring the positive effects of XBJ on sepsis patients with diabetes mellitus. The efficacy and safety of XBJ compared with those of the placebo were consistent with the overall trial findings, demonstrating that XBJ is efficacious in sepsis patients with diabetes and suggesting that there is no need for special safety precautions.
Trial Registration IdentifierChiCTR-TRC-13003534 and NCT0323874.

引言 合并糖尿病的脓毒症患者临床风险较高。已有研究证实，血必净注射液(XueBiJing injection)对脓毒症患者具有良好的临床获益，但目前尚无关于血必净（XBJ）在合并糖尿病的脓毒症患者中疗效与安全性的相关报道。
方法 合并两项大型随机对照临床试验（XBJ-SAP（ChiCTR-TRC-13003534）与EXIT-SEP（NCT0323874））的数据，开展事后分析。依据纳入排除标准，将合并糖尿病的脓毒症患者进一步分为血必净治疗组与安慰剂组。以基线合并糖尿病状态的脓毒症患者为研究对象，比较两组的主要结局指标（28天死亡率）与次要结局指标（ICU死亡率、随机化后住院死亡率、急性生理学与慢性健康状况评分系统Ⅱ（APACHE Ⅱ）评分及序贯器官衰竭评估（SOFA）评分），同时评估不良事件（AEs）的发生情况。
结果 研究基线时，共纳入378例合并糖尿病的脓毒症患者（男性227例，占60.0%；女性151例，占40.0%；平均年龄[标准差]为60.3[11.1]岁），其中177例接受血必净治疗，201例接受安慰剂给药。在该群体中，血必净组28天死亡率显著低于安慰剂组（173例患者中29例[16.8%] vs 198例患者中56例[28.3%]，P=0.01），绝对风险差为11.5%（95%置信区间3.1%~19.9%）。此外，两组不良事件总发生率无显著差异（血必净组：172例患者中42例[24.4%]；安慰剂组：195例患者中54例[27.7%]）。
讨论 本研究凸显了血必净在调节合并糖尿病脓毒症患者免疫反应中的关键作用，探讨了血必净对该类患者的积极治疗效果。血必净与安慰剂的疗效及安全性与整体试验结果一致，证实血必净对合并糖尿病的脓毒症患者具有临床疗效，且无需采取特殊安全防护措施。
试验注册编号 ChiCTR-TRC-13003534与NCT0323874。