Efficacy and safety of combination therapy of Shenfu injection and postresuscitation bundle in patients with return of spontaneous circulation after in-hospital cardiac arrest: A randomized, assessor-blinded, controlled trial
Critical Care Medicine Oct 04, 2017
Zhang Q, et al. - This study assessed the efficacy as well as the safety of combined therapy of Shenfu injection and postresuscitation care bundle in patients with return of spontaneous circulation after in-hospital cardiac arrest. Findings revealed that these patients had improved clinical outcomes as a result of combined treatment with Shenfu injection plus conventional postresuscitation care bundle.
Methods
- A prospective, randomized, controlled clinical study was performed in 50 hospitals in China, including adult patients who had experienced in-hospital cardiac arrest between 2012 and 2015.
- Based on the standardized postresuscitation care bundle treatment, researchers randomized patients to a Shenfu injection group (Shenfu injection + postresuscitation care bundle) or control group (postresuscitation care bundle) for 14 days or until hospital discharge.
- In the Shenfu injection group, 100 mL Shenfu injection was additionally administered via continuous IV infusion, bid.
- 28-day survival after randomization was the primary outcome and, 90-day survival as well as the duration of mechanical ventilation and the hospital stay and the total cost of hospitalization were the secondary outcomes.
Results
- Data reported that out of 1,022 patients enrolled, a total of 978 patients were allocated to the two groups: the control (n = 486) and Shenfu injection (n = 492) groups.
- The Shenfu injection group versus the control group (30.1%) had a significantly greater 28-day survival rate (42.7%).
- Also, researchers observed that the Shenfu injection group had a significantly higher survival rate at 90 days (39.6%) than the control group (25.9%).
- Findings demonstrated that, compared with patients in the control group, patients in the Shenfu injection group had lower risks of 28-day mortality (hazard ratio, 0.61; 95% CI, 0.43Â0.89; p = 0.009) and 90-day mortality (hazard ratio, 0.55; 95% CI, 0.38Â0.79; p = 0.002).
- Compared with the control group, the duration of mechanical ventilation (8.6 ± 3.2 vs 12.7 ± 7.9 d; p < 0.001) and the hospital stay (8.7 ± 5.9 vs 13.2 ± 8.1 d; p < 0.001) were significantly less in the Shenfu injection group.
- In addition, researchers found that irreversible brain damage was the main cause of death in both groups.
- Data revealed that no serious drug-related adverse event was recorded.
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