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榄香烯对接受化疗的癌症患者的临床获益与风险:一项系统评价和荟萃分析

Clinical benefit and risk of elemene in cancer patients undergoing chemotherapy: a systematic review and meta-analysis.

作者信息

Pan Yanhong, Wan Panting, Zhang Li, Wang Cuirong, Wang Yijun

机构信息

Department of Pharmacy, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.

Jiangsu Key Laboratory for Pharmacology and Safety Evaluation of Chinese Materia Medica, School of Pharmacy, Nanjing University of Chinese Medicine, Nanjing, China.

出版信息

Front Pharmacol. 2023 Aug 2;14:1185987. doi: 10.3389/fphar.2023.1185987. eCollection 2023.

Abstract

Elemene injection and oral emulsion, known as elemene, have been utilized have been used in adjuvant therapy for cancer patients in China for more than 20 years. In order to evaluate the efficacy and potential risks of the treatments in cancer patients undergoing chemotherapy, a system review and meta-analysis were conducted. Additionally, the factors that may influence the outcomes were also explored. A comprehensive search was conducted across various databases including PubMed, Cochrane Library, Web of Science, EMBASE, CKNI, Wan Fang, and VIP databases. Meta-regression, subgroup, and sensitivity analyses were conducted to explore the heterogeneity. GRADE system and TSA were used to assess the strength of evidence and robustness of the results. The pooled data showed that combination with elemene could improve the response rate (RR:1.48, 95%CI:1.38-1.60, < 0.00001), disease control rate (RR:1.20, 95%CI:1.15-1.25, < 0.00001), the rate of quality-of-life improvement and stability (WMD:1.31, 95% CI:1.12-1.53, = 0.0006), immune function (CD4/CD8: WMD:0.33, 95% CI:0.24-0.42, < 0.00001), survival rate (1-year, RR:1.34, 95% CI:1.15-1.56, = 0.0002; 2-year, RR:1.57, 95% CI:1.14-2.16, = 0.006), and decrease the prevalence of most chemotherapy-induced side effects, especially leukopenia (Ⅲ-Ⅳ) (RR:0.46, 95% CI:0.35-0.61, < 0.00001), thrombocytopenia (RR:0.86, 95% CI:0.78-0.95, = 0.003), and hemoglobin reduction (RR:0.83, 95% CI:0.73-0.95, = 0.007). However, the administration of elemene has been found to significantly increase the incidence of phlebitis in patients undergoing chemotherapy (RR:3.41, 95% CI:1.47-7.93, = 0.004). Meta-regression and subgroup analyses discovered that the outcomes were rarely influenced by CR, CT, and dosage of elemene (DE) but the cycle number of elemene (CNE) and TT were the main sources of heterogeneity. As the treatment time and the number of cycles increased, the efficacy of the elemene combination decreased across various aspects. Thus, shorter duration and fewer cycles are recommended.

摘要

榄香烯注射液和口服乳剂,即榄香烯,在中国已用于癌症患者的辅助治疗20多年。为了评估其在接受化疗的癌症患者中的治疗效果和潜在风险,进行了一项系统评价和荟萃分析。此外,还探讨了可能影响治疗结果的因素。在包括PubMed、Cochrane图书馆、科学网、EMBASE、中国知网、万方数据库和维普数据库在内的多个数据库中进行了全面检索。进行了Meta回归、亚组分析和敏感性分析以探讨异质性。采用GRADE系统和TSA评估证据强度和结果的稳健性。汇总数据显示,联合使用榄香烯可提高缓解率(RR:1.48,95%CI:1.38 - 1.60,P < 0.00001)、疾病控制率(RR:1.20,95%CI:1.15 - 1.25,P < 0.00001)、生活质量改善和稳定率(WMD:1.31,95%CI:1.12 - 1.53,P = 0.0006)、免疫功能(CD4/CD8:WMD:0.33,95%CI:0.24 - 0.42,P < 0.00001)、生存率(1年,RR:1.34,95%CI:1.15 - 1.56,P = 0.0002;2年,RR:1.57,95%CI:1.14 - 2.16,P = 0.006),并降低大多数化疗引起的副作用的发生率,尤其是白细胞减少(Ⅲ - Ⅳ级)(RR:0.46,95%CI:0.35 - 0.61,P < 0.00001)、血小板减少(RR:0.86,95%CI:0.78 - 0.95,P = 0.003)和血红蛋白降低(RR:0.83,95%CI:0.73 - 0.95,P = 0.007)。然而,已发现使用榄香烯会显著增加接受化疗患者的静脉炎发生率(RR:3.41,95%CI:1.47 - 7.93,P = 0.004)。Meta回归和亚组分析发现,治疗结果很少受榄香烯的CR、CT和剂量(DE)影响,但榄香烯的周期数(CNE)和TT是异质性的主要来源。随着治疗时间和周期数的增加,榄香烯联合治疗在各方面的疗效均下降。因此,建议缩短治疗时间和减少周期数。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a4d3/10436211/a124228b5cfe/fphar-14-1185987-g001.jpg

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