Safety of compound Qinghuang powder in patients with myelodysplastic syndromes / 国际中医中药杂志

ABSTRACT

Objective To evaluate the safety of compound Qinghuang powder for myelodysplastic syndromes(MDS). Methods A total of108 patients with MDSwere collected, 60 patients were treated with Qinghuang powder(Qinghuang powder group)and 48 with compound Qinghuang powder(compound Qinghuang group). The treatment time of 3 months was as one course, and all the patients were treated for more than one course. The patients who developed adverse reactions in the Qinghuang powder group changed to receive compound Qinghuang powder. The adverse reactions were recorded during the treatment. Results The overall incidence of adverse reactions in the compound Qinghuang powder group was significantly lower than that in the Qinghuang powder group(18.75% vs. 41.7%; χ2=6.492, P<0.05). None in the compound Qinghuang powder group and 3 patients in the compound Qinghuang powder group developed moderate to severe adverse reactions. The incidences of various adverse reactions in the compound Qinghuang powder group were lower than those in the Qinghuang powder group, especially, lower limb swelling (4.17%vs. 25%;χ2=9.205, P<0.05) epigastric discomfort(18.75% vs. 41.67%; χ2=6.492, P<0.05). Twenty patients who developed adverse reactions in the Qinghuang powder group changed to receive compound Qinghuang powder. Among them, 5 patients (25%) maintained adverse reactions. The various adverse reactions after changing to compound Qinghuang powder were decreased, especially, facial swelling (10% vs. 30%; χ2=2.50, P<0.05), leg swelling (5%vs. 45%;χ2=8.533, P<0.05), and abdominal pain and diarrhea(10%vs. 30%;χ2=2.50, P<0.05). No patient developed liver or kidney dysfunction after the treatment with Qinghuang powder or Compound Qinghuang powder. Conclusion Compound Qinghuang powder is safer than Qinghuang powder in the treatment of MDS.