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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

Forest plot of the SR in patients treated with CKI + TACE therapy and TACE alone.(A) Forest plot of the 1-year SR; (B) Forest plot of the 2-year SR; (C) Forest plot of the 3-year SR. I2 and P are the criterion for the heterogeneity test, ♢ pooled OR, –□– OR and 95% CI.
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Figure 6: Forest plot of the SR in patients treated with CKI + TACE therapy and TACE alone.(A) Forest plot of the 1-year SR; (B) Forest plot of the 2-year SR; (C) Forest plot of the 3-year SR. I2 and P are the criterion for the heterogeneity test, ♢ pooled OR, –□– OR and 95% CI.

Mentions: Six trials (Huang et al., 2006; Yang, 2006; Chen et al., 2007; Wang and Chen, 2009; Yu et al., 2009; Xu et al., 2010; Qu et al., 2011) with 433 patients were identified using the 1-year SR outcome. CKI combined with TACE therapy improved the 1-year SR in patients with unresectable HCC compared to TACE alone (OR = 2.40; 95% CI: 1.59, 3.62; P < 0.0001) (Figure 6A). No heterogeneity (P = 0.96, I2 = 0%) was noted among these studies. Three trials (Chen et al., 2007; Wang and Chen, 2009; Qu et al., 2011) reported the 2-year SR. A fixed-effect model demonstrated that CKI combined with TACE therapy significantly improved the 2-year SR (OR = 2.49, 95% CI: 1.24, 5.00; P = 0.01). No statistically significant heterogeneity (P = 0.53, I2 = 0%) was observed among individual trials (Figure 6B). There was no difference between CKI combined with TACE therapy and TACE treatment alone in 3-year SR (based on two studies) (Wang and Chen, 2009; Qu et al., 2011) (OR = 2.49, 95% CI: 0.94, 6.61; P = 0.07). No heterogeneity (P = 0.88, I2 = 0%) was noted. The fixed-effect model was used in the analysis (Figure 6C).


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)

Forest plot of the SR in patients treated with CKI + TACE therapy and TACE alone.(A) Forest plot of the 1-year SR; (B) Forest plot of the 2-year SR; (C) Forest plot of the 3-year SR. I2 and P are the criterion for the heterogeneity test, ♢ pooled OR, –□– OR and 95% CI.
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Figure 6: Forest plot of the SR in patients treated with CKI + TACE therapy and TACE alone.(A) Forest plot of the 1-year SR; (B) Forest plot of the 2-year SR; (C) Forest plot of the 3-year SR. I2 and P are the criterion for the heterogeneity test, ♢ pooled OR, –□– OR and 95% CI.
Mentions: Six trials (Huang et al., 2006; Yang, 2006; Chen et al., 2007; Wang and Chen, 2009; Yu et al., 2009; Xu et al., 2010; Qu et al., 2011) with 433 patients were identified using the 1-year SR outcome. CKI combined with TACE therapy improved the 1-year SR in patients with unresectable HCC compared to TACE alone (OR = 2.40; 95% CI: 1.59, 3.62; P < 0.0001) (Figure 6A). No heterogeneity (P = 0.96, I2 = 0%) was noted among these studies. Three trials (Chen et al., 2007; Wang and Chen, 2009; Qu et al., 2011) reported the 2-year SR. A fixed-effect model demonstrated that CKI combined with TACE therapy significantly improved the 2-year SR (OR = 2.49, 95% CI: 1.24, 5.00; P = 0.01). No statistically significant heterogeneity (P = 0.53, I2 = 0%) was observed among individual trials (Figure 6B). There was no difference between CKI combined with TACE therapy and TACE treatment alone in 3-year SR (based on two studies) (Wang and Chen, 2009; Qu et al., 2011) (OR = 2.49, 95% CI: 0.94, 6.61; P = 0.07). No heterogeneity (P = 0.88, I2 = 0%) was noted. The fixed-effect model was used in the analysis (Figure 6C).

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