华蟾素注射液治疗中晚期原发性肝癌的统评价和Meta分析

doi:10.5246/jcps.2019.04.027

中国药学(英文版) ›› 2019, Vol. 28 ›› Issue (4): 264-275.DOI: 10.5246/jcps.2019.04.027

• 【药事管理与临床药学专栏】 • 上一篇下一篇

华蟾素注射液治疗中晚期原发性肝癌的统评价和Meta分析

董志勇¹, 邱仙土¹, Stacy A. Kujawa², S.M. Shariful Islam³, 张杰^4*

1. 福建莆田学院附属医院普通外科, 福建莆田 351100
2. 美国西北大学 Feinberg医学院 Robert H. Lurie医学研究中心, 美国芝加哥 60611
3. 澳大利亚墨尔本迪肯大学健康学院, 澳大利亚墨尔本 3280
4. 中国人民解放军联勤保障部队第九八八医院中医科, 河南郑州 450042

收稿日期:2018-11-23 修回日期:2018-12-19 出版日期:2019-04-30 发布日期:2019-03-26
通讯作者: Tel./Fax: +86-371-63858055, E-mail: doctorzhangjie@126.com
基金资助:
Science and Technology Project of Putian University, China (Grant No. 2013035).

Cinobufacini injection for moderate and advanced primary liver cancer: A systematic review and meta-analysis

Zhiyong Dong¹, Xiantu Qiu¹, Stacy A. Kujawa², S.M. Shariful Islam³, Jie Zhang^4*

1. Department of Surgery, the Affiliated Hospital of Putian University, Putian 351100, China
2. Robert H. Lurie Medical Research Center, Feinberg School of Medicine, Northwestern University, Chicago 60611, USA
3. Institute of Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Faculty of Health, Deakin University, Melbourne 3280, Australia
4. Department of TCM, No. 988 Hospital of People’s Liberation Army, Zhengzhou 450042, China

Received:2018-11-23 Revised:2018-12-19 Online:2019-04-30 Published:2019-03-26
Contact: Tel./Fax: +86-371-63858055, E-mail: doctorzhangjie@126.com
Supported by:
Science and Technology Project of Putian University, China (Grant No. 2013035).

摘要/Abstract

摘要：

华蟾素是一种从蟾蜍中提取的化合物,是一种传统的中草药,已被证实在癌症治疗中具有疗效。华蟾素注射液广泛应用于中国中晚期肝癌患者。本研究的目的是明确华蟾素注射液对这类特定患者的影响。在PubMed, EMBASE, CENTRAL和其他四个主要的中国数据库中检索使用华蟾素注射液治疗中晚期肝癌随机对照试验。根据Cochrane协作和RevMan 5.3的建议进行系统评价和Meta-分析。根据Cochrane手册计算风险比(RR)和相应的95％置信区间,使用随机效应模型来统计数据。最后共纳入了11项随机对照试验, 728名患者。所有试验均显示,使用华蟾素注射干预组的总反应率, Karnofsky表现评分(KPS)的总反应率, 1–2年生存率和生活质量均有明显改善。但是6个月生存率和临床受益率各组之间没有统计学差异。本研究发现华蟾素注射液对中晚期肝癌患者的总反应率和1至2年生存率的有益作用。因此我们认为华蟾素注射液治疗中晚期肝癌的疗效可能优于对照组。鉴于大多数试验质量较低,因此需要严格按照CONSORT for TCM设计的更高质量的前瞻性随机试验来进一步验证。

关键词: 华蟾素注射液, 肝癌, Meta-分析, 中草药, 替代疗法

Abstract:

Cinobufacini, a compound extracted from bufo toad, is a traditional Chinese medicine (TCM) that has been shown to have efficacy in cancer treatment. The cinobufacini injection is widely used in patients with moderate and advanced liver cancer in China. In the present study, we aimed to determine the effects of cinobufacini injection for this specific category of patients.A search for randomized control trials (RCTs) using cinobufacini was conducted in the PubMed, EMBASE, CENTRAL, and the other four major Chinese databases. The systematic review was performed according to the recommendations of the Cochrane collaboration, and the RevMan 5.3. software was used for statistical analysis. A random-effects model was used to perform the data. Risk ratios (RR) with corresponding 95% confidence interval were calculated according to Cochrane handbook.A total of 11 RCTs consisting of 728 patients were included. All of the trials demonstrated significantly improved total response rates, total response rates of Karnofsky Performance Score (KPS), 1- to 2-year survival rates, and quality of life in the intervention groups injected with cinobufacini. There was no statistically significant difference between the groups (cinobufacini versus no cinobufacini; cinobufacini plus transcatheter arterial chemoembolization (TACE) versus TACE only) in terms of the 6-month survival rate, clinical benefit rate and clinical benefit rate of KPS. This systematic review demonstrated the beneficial effects of cinobufacini injection in terms of total response rate and the 1- to 2-year survival rate in patients with moderate and advanced liver cancer. The efficacy for the cinobufacini injection group might be better than that of the control group for treatment of moderate and advanced liver cancer. Given that the majority of the trials were of low quality, more high-quality prospective RCTs with strict design in accordance with CONSORT for TCM are needed.

Key words: Cinobufacini injection, Liver cancer, Meta-analysis, Chinese herb medicine, Alternative therapies

中图分类号:

R954

Supporting:

董志勇, 邱仙土, Stacy A. Kujawa, S.M. Shariful Islam, 张杰. 华蟾素注射液治疗中晚期原发性肝癌的统评价和Meta分析[J]. 中国药学(英文版), 2019, 28(4): 264-275.

Zhiyong Dong, Xiantu Qiu, Stacy A. Kujawa, S.M. Shariful Islam, Jie Zhang. Cinobufacini injection for moderate and advanced primary liver cancer: A systematic review and meta-analysis[J]. Journal of Chinese Pharmaceutical Sciences, 2019, 28(4): 264-275.

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华蟾素注射液治疗中晚期原发性肝癌的统评价和Meta分析

Cinobufacini injection for moderate and advanced primary liver cancer: A systematic review and meta-analysis

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