ABSTRACT
Objective To analyze the blood arsenic concentration and the safety of compound Qinghuang powder(compound QHP)in patients with myelodysplastic syndrome(MDS).Methods A total of 45 MDS patients received treatment with compound QHP (the treatment group, n=45). The concentration of blood arsenic in different time was determined by atomic fluorescence spectrometry. The clinical safety of compound QHP was evaluated by analyzing the symptoms of adverse reaction and organ function. The comparison were MDS patients with Qinghuang powder (QHP group, n=47) and healthy people. Results There was no significant difference of the blood arsenic concentration between the treatment group and the healthy control group (P=0.450),while after the treatment for 1 month those concentrations significantly increased (P=0.000). There were no significant difference between the blood arsenic concentration after treatment for 1, 3, and 6 months (P=0.240). The incidence of adverse reaction in the treatment group was significantly lower than that in QHP group(χ2=4.720, P=0.030). The incidence of adverse reactions in the digestive tract was significantly lower in the treatment group than that in QHP group (χ2=4.650, P=0.034). The blood arsenic concentration of patients with abdominal pain diarrhea was significantly lower than those without abdominal pain diarrhea (P=0.020). Before treatment in the compound QHP group, there were 21 cases with increased myocardial enzymes, 10 cases with abnormal liver function and 4 cases with renal dysfunction, respectively. After treatment at 6th month, these indicators returned to normal with 7 cases of myocardial enzymes, 6 cases of liver function and 1 case of renal function, respectively. There was no new case with abnormal myocardial enzymes, liver function and renal dysfunction, respectively. Conclusions Arsenic could be absorbed in the digestive tract into blood in MDS patients after treatment with arsenic-containing compound QHP, and the blood arsenic concentration remained stable during the course of treatment. The adverse reactions were mainly mild gastrointestinal symptoms, but no heart, liver or renal function damage was observed. The incidence of abdominal pain diarrhea in patients treated with compound QHP was significantly lower than that with QHP.
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.