Abstract:

Objective To evaluate the treatment effect of Shenqi Eleven Granules on treating leukopenia caused by antituberculosis drugs.Methods A total of 158 patients who were complicated by leukopenia after first standard anti-TB drug treatment were collected from Tuberculosis Prevention and Control Agency, Xuchang City, He’nan Province from September 2015 to February 2017. According to the table of random number, patients were divided into two groups: taking Shenqi Eleven Flavor Granule for “A group”(n=79) and taking Leucogen for B group (n=79). Peripheral blood leukocyte count, main symptoms associated with leucopenia, and adverse drug reactions were observed and recorded.Results The total effective rate of leukopenia (94.44% (68/72)) and WBC in peripheral blood (5.12±0.76)×10 ⁹/L) in A group were significantly higher than those in B group (72.97% (54/74), (4.09±1.02)×10 ⁹/L) (χ ²=10.14, P=0.021; t=4.38, P=0.017). The WBC of peripheral blood in group A and B after treatment were significantly higher than that before treatment ((3.26±1.02)×10 ⁹/L and (3.18±0.82)×10 ⁹/L)) (t=5.79, P=0.010; t=4.15, P=0.018). Dizziness (8.33% (6/72), 9.46% (7/74)), low fever (2.78% (2/72), 2.70% (2/74)), weakness (5.56% (4/72), 4.05% (3/74)) in both groups were than those before treatment (27.78% (20/72), 28.38% (21/74); 15.28% (11/72), 16.22% (12/74)); 40.28% (29/72), 41.89% (31/74)) (χ ²=12.34, P=0.008; χ ²=12.09, P=0.008; χ ²=8.83, P=0.011;χ ²=8.16,P=0.010; χ ²=17.26, P=0.020; χ ²=18.09, P=0.020). However, there was no significant difference between the two groups in the improvement of the main symptoms such as dizziness, fever and fatigue (χ ²=1.43, P=0.437; χ ²=2.62, P=0.406; χ ²=1.95, P=0.410). The incidence of ADR in group A was not significantly different from that in group B (83.33% (60/72)) compared with 86.49% (64/74) in group B (χ ²=3.03, P=0.382). Conclusion Shenqi Eleven Flavor Granules has a better clinic effect on leukopenia caused by anti-tuberculosis drugs and higher safety.

Key words: Antitubercular agents, Drug toxicity, Leukopenia, Drug evaluation, Shenqi eleven granules