Safety of the Xuesaitong injection in China: results from a large-scale multicentre post-marketing surveillance study in a real-world setting.

OBJECTIVE: The safety profile of traditional Chinese medicine injections has emerged as the greatest challenge to their clinical application. The authors aimed to perform a post-marketing surveillance study in a real-world setting to evaluate the safety of the Xuesaitong (XST) injection in China. METHODS: This multi-centre, post-marketing, observational study enrolled patients who received XST injections in 42 centres in China between March 2015 and November 2017. Adverse drug reactions (ADRs) and adverse drug events (ADEs) were collected and evaluated in a post-marketing database. Logistic regression analysis was performed to analyse the risk factors for ADRs. RESULTS: A total of 30,008 consecutive patients with a mean age of 62.29 ± 14.58 years were included in this post-marketing study. The incidences of ADEs and ADRs were 0.5% and 0.33%, respectively. The most common clinical manifestations were damage to skin and appendages (47.66%). There were four new kinds of ADEs found in the present monitoring study. The majority of ADRs were type B (62.62%) and occurred within 24 h after XST injection treatment. No severe ADRs were reported in this analysis. Multivariate logistic regression analysis showed that the hospital level (OR = 0.607; 95% CI = 0.407-0.906; p = .0144), hypertension (OR = 1.979; 95% CI, 1.323-2.959; p = .0009) and solvent type (OR = 2.951; 95% CI, 1.608-5.417; p = .0005) were risk factors for ADR occurrence. CONCLUSION: XST injection is well tolerated and has a favourable safety profile for patients in a real-world setting. This post-marketing study provided further evidence of the safety of XST injections for clinical applications.

[Effect of IL-8 on the Immune Function of Patients with Acute -Lymphoblastic Leukemia and Its Mechanism].

OBJECTIVE: To investigate the effect of interleukin -8 (IL-8) on immune function in acute lymphoblastic leukemia patients and its related mechanisms. METHODS: Forty-five ALL patients were selected from January 2014 to September 2017 in our hospital. Out of them, 32 relieved patients were included in group A, 13 patients did not relieved patients after treatment and were included in the group B. The serum IL-8 level was detected by ELISA.Th1 and Th2 cells were measured by flow cytometry. After Th cells were treated with different concentration of IL-8, the Western blot was used to detect the translation levels of p-STAT3 and JAK in cells. RESULTS: The difference of white blood cell count and clinical risk level between the 2 groups was statistically significant (P<0.05). The serum IL-8 levels in group A and B were significantly higher than that in control group (P<0.05). The serum IL-8 level in group B was significantly higher than that in group A (P<0.05). After treatment, the level of Th1 cells in group B was 6.15%±1.22%, significantly lower than that in group A (P<0.05), and Th2 cell level in group B was 2.76%±0.24%, significantly higher than that in group A (P<0.05); Th1/Th2 in group B was 2.23%±0.09, significantly lower than that in group A (P<0.05). The protein level of p-STAT3 and JAK in the Th cells was lower than that in control group at different levels of IL-8 after treatment (P<0.05). After stimulating Th cells with 20 ng/ml IL-8, the levels of p-STAT3 and JAK protein in cells were lower than those after 10 ng/ml IL-8 treatment (P<0.05). IL-8 level had no significant effect on the protein expression of STAT3 in Th cells (P>0.05). CONCLUSION: IL-8 can interfere the balance of Th1/Th2 through STAT3 signaling pathway, and has effect on the immune function of ALL patients.

[Construction of recombinant GST-RCAS1 fusion gene and its expression in E. Coli].

OBJECTIVE: To construct the recombinant plasmid of RCAS1, to express and purify its fusion protein GST-RCAS1, and to investigate its biological function. METHODS: RCAS1 encoding gene was amplified by RT-PCR from total RNA extract of MCF-7 cells and was ligated with expression plasmid vector pGEX-2T by T4 DNA ligase after digested by the restricted endonucleases BamH I and EcoR I. Then the ligated products were inserted into competence JM109 E. Coli and the positive recombinants were identified by restriction endonuclease digestion assay and DNA sequencing. The GST-RCAS1 fusion protein expression was induced by IPTG in BL21 E. Coli and was purified with GST column and identified by SDS-PAGE and Western blotting with anti-GST monoclonal antibody, anti-RCAS1 (N-18) and anti-RCAS1 (C-20) polyclonal antibody. The apoptosis of activated T cells induced by GST-RCAS1 fusion protein was detected by flow cytometry with Annexin V and propidium iodide (PI) staining. RESULT: A 642 bp product was cloned by RT-PCR and the recombinant plasmid was constructed successfully. The GST-RCAS1 fusion protein was recognized by GST monoclonal antibody and RCAS1(N-18 and C-20) polyclonal antibody. FACS analysis showed that GST-RCAS1 fusion protein induced apoptosis in activated T cells. CONCLUSION: The recombinant plasmid of RCAS1 has been successfully constructed and the GST-RCAS1 fusion protein expressed and purified. The apoptosis inducing effect of GST-RCAS1 fusion protein on activated T cells is demonstrated.