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中药(康艾注射液)辅助治疗肝癌患者的疗效和安全性的Meta 分析。

Efficacy and safety of Chinese patent medicine (Kang-ai injection) as an adjuvant in the treatment of patients with hepatocellular carcinoma: a meta-analysis.

机构信息

Department of Critical Care Medicine, Weifang People's Hospital, Weifang, China.

Infection Control Office, Weifang People's Hospital, Weifang, China.

出版信息

Pharm Biol. 2021 Dec;59(1):472-483. doi: 10.1080/13880209.2021.1915340.

Abstract

CONTEXT

Kang-ai injection (KAI) is an authorized herbal medicine used in cancer treatment. However, its clinical efficacy in hepatocellular carcinoma (HCC) has not been investigated thoroughly.

OBJECTIVE

To systematically evaluate the efficacy and safety of KAI in patients with HCC.

MATERIALS AND METHODS

The Web of Science, PubMed, Cochrane Library, EMBASE, CBM, CNKI, VIP and Wanfang databases were systematically searched (date range: inception to December 2020) using the key terms 'Kang-ai injection' and 'hepatocellular carcinoma'. The current analysis included controlled clinical trials that compared the efficacy and safety of the combination of KAI and conventional treatment (CT) with CT alone for HCC. The current study estimated the pooled risk ratio (RR) with 95% confidence intervals (CI).

RESULTS

Data pertaining to 35 trials with 2501 HCC patients were analysed. The results revealed that the combination of KAI and CT was associated with significantly superior objective response rate (RR = 1.57, 95% CI = 1.43-1.73), disease control rate (RR = 1.18, 95% CI = 1.10-1.26), and quality of life (RR = 2.40, 95% CI = 1.79-3.23), compared to CT alone. The administration of KAI significantly alleviated most of the adverse effects caused by CT, including nausea and vomiting, liver damage, peripheral neurotoxicity, fever, abdominal pain, alopecia, increased bilirubin levels, leukopoenia, and reduction in haemoglobin levels ( < 0.05, for all).

CONCLUSIONS

The current meta-analysis indicates that a combination of CT and KAI could be more effective in improving the clinical efficacy of the treatment of HCC, compared to CT alone.

摘要

背景

康艾注射液(KAI)是一种用于癌症治疗的已授权草药药物。然而,其在肝细胞癌(HCC)中的临床疗效尚未得到充分研究。

目的

系统评估 KAI 在 HCC 患者中的疗效和安全性。

材料和方法

通过关键词“Kang-ai 注射液”和“肝细胞癌”,系统地在 Web of Science、PubMed、Cochrane 图书馆、EMBASE、CBM、CNKI、VIP 和万方数据库中进行了搜索(检索日期范围:从创建到 2020 年 12 月)。目前的分析包括比较 KAI 联合常规治疗(CT)与 CT 单药治疗 HCC 的疗效和安全性的对照临床试验。目前的研究使用 95%置信区间(CI)估计汇总风险比(RR)。

结果

分析了 35 项试验共 2501 例 HCC 患者的数据。结果表明,与 CT 单药治疗相比,KAI 联合 CT 治疗的客观缓解率(RR = 1.57,95%CI = 1.43-1.73)、疾病控制率(RR = 1.18,95%CI = 1.10-1.26)和生活质量(RR = 2.40,95%CI = 1.79-3.23)均显著提高。与 CT 单药治疗相比,KAI 的应用显著减轻了 CT 引起的大多数不良反应,包括恶心和呕吐、肝损伤、周围神经毒性、发热、腹痛、脱发、胆红素水平升高、白细胞减少和血红蛋白水平降低(均 < 0.05)。

结论

目前的荟萃分析表明,与 CT 单药治疗相比,CT 联合 KAI 治疗可能更有效地提高 HCC 治疗的临床疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/625e/8081330/43d361aec1ba/IPHB_A_1915340_F0001_C.jpg

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