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The Therapeutic Efficacy and Safety of Compound Kushen Injection Combined with Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma: An Update Systematic Review and Meta-Analysis.

Ma X, Li RS, Wang J, Huang YQ, Li PY, Wang J, Su HB, Wang RL, Zhang YM, Liu HH, Zhang CE, Ma ZJ, Wang JB, Zhao YL, Xiao XH - Front Pharmacol (2016)

Bottom Line: A safety analysis indicated that AEs (including nausea/vomiting, fever, hepatalgia, increased transaminase, increased bilirubin and leukopenia) were reduced for the combination treatment compared to TACE alone.The 3-year SR was not improved.The combination therapy resulted in a reduction in AEs.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacy, 302 Military Hospital of People's Liberation ArmyBeijing, China; Pharmacy College, Chengdu University of Traditional Chinese MedicineChengdu, China.

ABSTRACT

Background: Compound Kushen Injection (CKI) is a Chinese patent medicine approved by the China Food and Drug Administration for the treatment of various types of solid tumors. CKI, combined with transarterial chemoembolization (TACE), is believed to increase the therapeutic efficacy of unresectable hepatocellular carcinoma (HCC). We report an updated and extended meta-analysis with detailed outcomes of both the efficacy and adverse events (AEs) of CKI combined with TACE therapy.

Materials and methods: Electronic databases, including PubMed, Embase, the Cochrane Library, the Chinese Biomedical Database (CBM), Wanfang, the VIP medicine information system (VMIS) and the China National Knowledge Infrastructure (CNKI), were examined for relevant articles before November 13, 2015. An odds ratio (OR) was used to estimate tumor response (TR), Karnofsky Performance Scale (KPS) improvement, Child-Pugh (CP) improvement, survival rate (SR) and AEs. A publication bias and a subgroup analysis were also assessed.

Results: Eighteen studies, with a total of 1,338 HCC patients who met the criteria for the meta-analysis, were included. TR, KPS improvement and CP improvement were significantly enhanced for the combination therapy compared to TACE alone (OR = 1.84, 95% CI: [1.46, 2.33], P < 0.00001; OR = 2.37, 95% CI: [1.76, 3.18], P < 0.00001; OR = 1.81, 95% CI: [1.08, 3.03], P = 0.02, respectively). The combination therapy was associated with an improvement in 1-year and 2-year SRs but not an improved 3-year SR (OR = 2.40; 95% CI: [1.59, 3.62], P < 0.0001; OR = 2.49, 95% CI: [1.24, 5.00], P = 0.01; OR = 2.49, 95% CI: [0.94, 6.61], P = 0.07, respectively). A safety analysis indicated that AEs (including nausea/vomiting, fever, hepatalgia, increased transaminase, increased bilirubin and leukopenia) were reduced for the combination treatment compared to TACE alone.

Conclusion: The combination treatment of TACE and CKI was associated with improved TR, KPS and CP improvement and improved 1- and 2-year SRs in patients with unresectable HCC. The 3-year SR was not improved. The combination therapy resulted in a reduction in AEs. The findings of this study should be interpreted with caution because of the small sample size and study limitations.

No MeSH data available.


Related in: MedlinePlus

Funnel plot for the publication bias.(A) Funnel plot of the TR; (B) Funnel plot of KPS improvement.
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Figure 7: Funnel plot for the publication bias.(A) Funnel plot of the TR; (B) Funnel plot of KPS improvement.

Mentions: A funnel plot was used to express the publication bias. There were 17 trials (Huang et al., 2006; Yang, 2006; Chen et al., 2007; Cao et al., 2009; Deng et al., 2009; Wang and Chen, 2009; Yu et al., 2009; Tong, 2010; Xu et al., 2010; Yu and Kang, 2010; Wang et al., 2011; Zhang and Tian, 2011; Zuo et al., 2011; Han et al., 2012; Li et al., 2013; Sun, 2014; Tian, 2014) included in the funnel plot of the TR, and no significant asymmetry was observed (Figure 7A). The funnel plot of KPS improvement was used to measure publication bias. The funnel plot indicated that there was no asymmetry in KPS improvement (Figure 7B).


The Therapeutic Efficacy and Safety of Compound Kushen Injection Combined with Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma: An Update Systematic Review and Meta-Analysis.

Ma X, Li RS, Wang J, Huang YQ, Li PY, Wang J, Su HB, Wang RL, Zhang YM, Liu HH, Zhang CE, Ma ZJ, Wang JB, Zhao YL, Xiao XH - Front Pharmacol (2016)

Funnel plot for the publication bias.(A) Funnel plot of the TR; (B) Funnel plot of KPS improvement.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4814457&req=5

Figure 7: Funnel plot for the publication bias.(A) Funnel plot of the TR; (B) Funnel plot of KPS improvement.
Mentions: A funnel plot was used to express the publication bias. There were 17 trials (Huang et al., 2006; Yang, 2006; Chen et al., 2007; Cao et al., 2009; Deng et al., 2009; Wang and Chen, 2009; Yu et al., 2009; Tong, 2010; Xu et al., 2010; Yu and Kang, 2010; Wang et al., 2011; Zhang and Tian, 2011; Zuo et al., 2011; Han et al., 2012; Li et al., 2013; Sun, 2014; Tian, 2014) included in the funnel plot of the TR, and no significant asymmetry was observed (Figure 7A). The funnel plot of KPS improvement was used to measure publication bias. The funnel plot indicated that there was no asymmetry in KPS improvement (Figure 7B).

Bottom Line: A safety analysis indicated that AEs (including nausea/vomiting, fever, hepatalgia, increased transaminase, increased bilirubin and leukopenia) were reduced for the combination treatment compared to TACE alone.The 3-year SR was not improved.The combination therapy resulted in a reduction in AEs.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacy, 302 Military Hospital of People's Liberation ArmyBeijing, China; Pharmacy College, Chengdu University of Traditional Chinese MedicineChengdu, China.

ABSTRACT

Background: Compound Kushen Injection (CKI) is a Chinese patent medicine approved by the China Food and Drug Administration for the treatment of various types of solid tumors. CKI, combined with transarterial chemoembolization (TACE), is believed to increase the therapeutic efficacy of unresectable hepatocellular carcinoma (HCC). We report an updated and extended meta-analysis with detailed outcomes of both the efficacy and adverse events (AEs) of CKI combined with TACE therapy.

Materials and methods: Electronic databases, including PubMed, Embase, the Cochrane Library, the Chinese Biomedical Database (CBM), Wanfang, the VIP medicine information system (VMIS) and the China National Knowledge Infrastructure (CNKI), were examined for relevant articles before November 13, 2015. An odds ratio (OR) was used to estimate tumor response (TR), Karnofsky Performance Scale (KPS) improvement, Child-Pugh (CP) improvement, survival rate (SR) and AEs. A publication bias and a subgroup analysis were also assessed.

Results: Eighteen studies, with a total of 1,338 HCC patients who met the criteria for the meta-analysis, were included. TR, KPS improvement and CP improvement were significantly enhanced for the combination therapy compared to TACE alone (OR = 1.84, 95% CI: [1.46, 2.33], P < 0.00001; OR = 2.37, 95% CI: [1.76, 3.18], P < 0.00001; OR = 1.81, 95% CI: [1.08, 3.03], P = 0.02, respectively). The combination therapy was associated with an improvement in 1-year and 2-year SRs but not an improved 3-year SR (OR = 2.40; 95% CI: [1.59, 3.62], P < 0.0001; OR = 2.49, 95% CI: [1.24, 5.00], P = 0.01; OR = 2.49, 95% CI: [0.94, 6.61], P = 0.07, respectively). A safety analysis indicated that AEs (including nausea/vomiting, fever, hepatalgia, increased transaminase, increased bilirubin and leukopenia) were reduced for the combination treatment compared to TACE alone.

Conclusion: The combination treatment of TACE and CKI was associated with improved TR, KPS and CP improvement and improved 1- and 2-year SRs in patients with unresectable HCC. The 3-year SR was not improved. The combination therapy resulted in a reduction in AEs. The findings of this study should be interpreted with caution because of the small sample size and study limitations.

No MeSH data available.


Related in: MedlinePlus