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Polygonum multiflorum (PM) is a well‐known Chinese herbal medicine that has been reported to induce inflammation‐associated idiosyncratic liver injury. This study aimed to identify the genetic basis of susceptibility to PM‐drug‐induced liver injury (PM‐DILI) and to develop biological markers for predicting the risk of PM‐DILI in humans. The major histocompatibility complex (MHC) regions of 11 patients with PM‐DILI were sequenced, and all human leukocyte antigen (HLA)–type frequencies were compared to the Han‐MHC database. An independent replication study that included 15 patients with PM‐DILI, 33 patients with other DILI, and 99 population controls was performed to validate the candidate allele by HLA‐B PCR sequence‐based typing. A prospective cohort study that included 72 outpatients receiving PM for 4 weeks was designed to determine the influence of the risk allele on PM‐DILI. In the pilot study, the frequency of HLA‐B*35:01 was 45.4% in PM‐DILI patients compared with 2.7% in the Han Chinese population (odds ratio [OR], 30.4; 95% confidence interval [CI], 11.7‐77.8; P = 1.9 × 10−10). In the independent replication study and combined analyses, a logistic regression model confirmed that HLA‐B*35:01 is a high‐risk allele of PM‐DILI (PM‐DILI versus other DILI, OR, 86.5; 95% CI, 14.2‐527.8, P = 1.0 × 10−6; and PM‐DILI versus population controls, OR, 143.9; 95% CI, 30.1‐687.5, P = 4.8 × 10−10). In the prospective cohort study, an asymptomatic increase in transaminase levels was diagnosed in 6 patients, representing a significantly higher incidence (relative risk, 8.0; 95% CI, 1.9‐33.2; P < 0.02) in the HLA‐B*35:01 carriers (37.5%) than in the noncarriers (4.7%). Conclusion: The HLA‐B*35:01 allele is a genetic risk factor for PM‐DILI and a potential biomarker for predicting PM‐DILI in humans.

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.

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