复方阿胶江治疗白细胞减少症的疗效和安全性:系统评价和meta分析。

L U Zhenkai, Tan Chang, Zhi Yingjie, Zhang Xuming, Xie Yanming
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引用次数: 0

摘要

目的:系统评价复方阿胶姜(CEJ)治疗白细胞减少症的安全性和有效性。方法:检索截至2024年7月1日CEJ治疗白细胞减少症的4个英文和4个中文数据库的随机对照试验(RCTs)。两名研究人员独立筛选研究并提取必要的数据。使用Cochrane风险偏倚工具评估方法学质量和偏倚风险。采用RevMan对符合meta分析条件的文章进行分析。结果:共纳入28项rct,受试者2041人,其中实验组1034人,对照组1007人。meta分析显示CEJ治疗肿瘤及免疫性疾病所致白细胞减少的疗效显著(3项rct)[风险比(RR) = 1.17, 95%可信区间(CI) (1.08, 1.27), P= 0.0002, i2 = 35%]。CEJ联合西药治疗在白细胞(WBC)计数(15个RCTs)[平均差异(MD) = 1.12, 95% CI(0.83, 1.42), P< 0.00001, i2 = 88%]、Karnofsky Performance Status (KPS)水平(7个RCTs) [RR = 1.39, 95% CI(1.25, 1.55), P 0.00001, i2 = 36%]和骨髓毒性缓解(11个RCTs) [RR = 0.61, 95% CI(0.54, 0.69), P 0.00001, i2 = 24%]方面均优于单用西药治疗。不良反应主要包括与化疗药物相关的胃肠道和消化反应。结论:CEJ单用或联合西药治疗肿瘤及免疫性疾病所致白细胞减少,可提高白细胞计数,提高临床疗效和生活质量。减轻骨髓毒性所致的白细胞减少,增强化疗疗效的同时降低其毒性,缓解症状。在随机对照试验中未报告明显的不良事件,表明良好的疗效和安全性。推荐评分评估、发展和评价评估显示,CEJ在提高白细胞升高疗效、KPS水平和骨髓抑制毒性方面的证据水平较低。因此,建议开展大规模、高质量、严格的多中心双盲对照试验,加强证据水平。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and safety of Compound E'jiao Jiang for treating leukopenia based: a systematic review and Meta-analysis.

Objective: To systematically assess the safety and effectiveness of Compound E'jiao Jiang (, CEJ) for treating leukopenia.

Methods: Four English and four Chinese databases were searched for randomized controlled trials (RCTs) on CEJ for treating leukopenia up to July 1, 2024. Two researchers independently screened the studies and extracted necessary data. Methodological quality and risk of bias were assessed using the Cochrane risk-of-bias tool. Articles eligible for Meta-analysis were analyzed using RevMan.

Results: A total of 28 RCTs involving 2041 participants were included, with 1034 in the experimental group and 1007 in the control group. The Meta-analysis showed a significant effect of CEJ in treating leukopenia caused by tumor and immune diseases (three RCTs) [risk ratio (RR) = 1.17, 95% confidence interval (CI) (1.08, 1.27), P= 0.0002, I 2 = 35%]. The combination of CEJ and Western Medicine showed superior results in terms of white blood cell (WBC) counts (fifteen RCTs) [mean difference (MD) = 1.12, 95% CI(0.83, 1.42), P< 0.000 01, I 2 = 88%], Karnofsky Performance Status (KPS) levels (seven RCTs) [RR = 1.39, 95% CI(1.25, 1.55), P <0.000 01, I 2 = 36%], and mitigation of bone marrow toxicity (eleven RCTs) [RR = 0.61, 95% CI(0.54, 0.69), P < 0.00001, I 2 = 24%] compared to Western Medicine alone. Adverse events mainly included gastrointestinal and digestive reactions associated with chemotherapy drugs.

Conclusion: CEJ alone or in combination with Western Medicine for treating leukopenia caused by tumor and immune diseases improved WBC counts, clinical efficacy, and quality of life. It also reduced bone marrow toxicity-induced leukopenia, enhanced the efficacy of chemotherapy while reducing its toxicity, and alleviated symptoms. No significant adverse events were reported in the RCTs, indicating favorable efficacy and safety. The Grading of Recommendations Assessment, Development and Evaluation assessment indicated a low level of evidence for CEJ in improving leukocyte elevation efficacy, KPS levels, and myelosuppressive toxicity. Therefore, large-scale, high-quality, rigorous multicenter double-blind controlled trials are recommended to strengthen the evidence level.

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