Frontiers in pharmacology · 2025
Comparative efficacy and safety of Xuebijing injection as adjuvant therapy in sepsis-associated acute kidney injury: a systematic review and meta-analysis.
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Shu Bofei, Zhou Xu, Fan Jing, Yang Can, Deng Wei, Fang Bangjiang, Zhang Huan
Аннотация
BACKGROUND: Xuebijing injection is a standardized traditional Chinese medicine formulation comprising extracts from safflower, red peony, Chuanxiong, Angelica, and Salvia miltiorrhiza. It is clinically employed for the treatment of sepsis and associated complications.
METHODS: This systematic review evaluated the efficacy and safety of Xuebijing injection in treating sepsis-associated acute kidney injury (SA-AKI). Six databases were searched up to 1 September 2024, to identify randomized controlled trials (RCTs) comparing Xuebijing injection combined with conventional therapies versus the same conventional therapies alone. Data from individual RCTs were synthesized by meta-analysis, with effect measures expressed as risk ratios (RRs) or mean differences (MDs) and their 95% confidence intervals (CIs). Trial sequential analysis was used to assess the precision of the effect estimates, and the GRADE system was used to evaluate the quality of evidence.
RESULTS: Eighteen RCTs involving 1,650 patients were included. Meta-analysis demonstrated that, compared with conventional therapies alone, Xuebijing injection combined with conventional therapies significantly reduced 28-day mortality (RR 0.82%, 95% CI 0.69-0.98). It also significantly improved renal function (serum creatinine level: MD -17.55 μmol/L, 95% CI: -23.22 to -11.88; blood urea nitrogen level: MD -1.58 mmol/L, 95% CI -1.83 to -1.32; urine volume: MD 5.83 ml, 95% CI: 3.45-8.21), inflammatory cytokines (tumor necrosis factor-alpha level: MD -29.20 ng/ml, 95% CI: -39.15 to -19.25; interleukin-6 level: MD -25.80 ng/mL, 95% CI: -35.56 to -16.04; interleukin-10 level: MD -8.02 ng/mL, 95% CI: -13.98 to 2.07), and immune function (percentage of CD3+ T cells: MD 10.30%, 95% CI 7.77%-12.84%; percentage of CD3+ T cells: MD 9.57%, 95% CI 3.53%-15.61%; CD4/CD8 ratio: MD 0.27, 95% CI 0.18-0.36). In addition, Xuebijing injection significantly alleviated the severity of SA-AKI as measured by the Acute Physiology and Chronic Health Evaluation II score (MD -3.12, 95% CI: -4.51 to -1.73). Subgroup analyses suggested potential effect modifications based on treatment duration or dosage. All reported adverse reactions were mild.
CONCLUSION: Xuebijing injection may help reduce mortality and improve renal function in patients with SA-AKI. However, the certainty of evidence ranged from moderate to very low, underscoring the need for validation through large-scale, double-blind randomized controlled trials.
METHODS: This systematic review evaluated the efficacy and safety of Xuebijing injection in treating sepsis-associated acute kidney injury (SA-AKI). Six databases were searched up to 1 September 2024, to identify randomized controlled trials (RCTs) comparing Xuebijing injection combined with conventional therapies versus the same conventional therapies alone. Data from individual RCTs were synthesized by meta-analysis, with effect measures expressed as risk ratios (RRs) or mean differences (MDs) and their 95% confidence intervals (CIs). Trial sequential analysis was used to assess the precision of the effect estimates, and the GRADE system was used to evaluate the quality of evidence.
RESULTS: Eighteen RCTs involving 1,650 patients were included. Meta-analysis demonstrated that, compared with conventional therapies alone, Xuebijing injection combined with conventional therapies significantly reduced 28-day mortality (RR 0.82%, 95% CI 0.69-0.98). It also significantly improved renal function (serum creatinine level: MD -17.55 μmol/L, 95% CI: -23.22 to -11.88; blood urea nitrogen level: MD -1.58 mmol/L, 95% CI -1.83 to -1.32; urine volume: MD 5.83 ml, 95% CI: 3.45-8.21), inflammatory cytokines (tumor necrosis factor-alpha level: MD -29.20 ng/ml, 95% CI: -39.15 to -19.25; interleukin-6 level: MD -25.80 ng/mL, 95% CI: -35.56 to -16.04; interleukin-10 level: MD -8.02 ng/mL, 95% CI: -13.98 to 2.07), and immune function (percentage of CD3+ T cells: MD 10.30%, 95% CI 7.77%-12.84%; percentage of CD3+ T cells: MD 9.57%, 95% CI 3.53%-15.61%; CD4/CD8 ratio: MD 0.27, 95% CI 0.18-0.36). In addition, Xuebijing injection significantly alleviated the severity of SA-AKI as measured by the Acute Physiology and Chronic Health Evaluation II score (MD -3.12, 95% CI: -4.51 to -1.73). Subgroup analyses suggested potential effect modifications based on treatment duration or dosage. All reported adverse reactions were mild.
CONCLUSION: Xuebijing injection may help reduce mortality and improve renal function in patients with SA-AKI. However, the certainty of evidence ranged from moderate to very low, underscoring the need for validation through large-scale, double-blind randomized controlled trials.