Jing-Xian Chen1, Xiao-Heng Shen. 1. Department of Chinese Medicine, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025.
Abstract
OBJECTIVE: To observe the intervention of Qisheng Mixture (QM) on the chemotherapy induced myelosuppression in patients with colorectal cancer. METHODS:One hundred and twenty patients with colorectal cancer at Ruijin Hospital, Shanghai Jiaotong University School of Medicine were randomly assigned to the pure chemotherapy group (as the control group) and the QM + chemotherapy group (as the treatment group), 60 in each group. All patients received FOLFOX4 or XELOX regimen for totally 6 cycles. Patients in the treatment group took QM 150 mL at the end of chemotherapy, once in the morning and once in the evening for 7 successive days, totally 6 therapeutic courses. The total and average dosages of using granulocyte colony stimulating factor (G-CSF) were observed in all patients. The changes of white blood cell (WBC) counts were determined before chemotherapy and after the 6th chemotherapy. The hemoglobin (Hb), red blood cell (RBC), and platelet (PLT) counts were observed before chemotherapy, before the 4th chemotheray, and after the 6th chemotherapy. The clinical symptoms integrals (fatigue, liability to catch cold, aphthous stomatitis, pharyngalgia, pale complexion, poor appetite, vomiting, diarrhea, and so on) and the safety indicators (the functions of the liver and kidney, urine routines) were observed. The grading toxic and adverse reactions, KPS scoring, body weight, and the efficacy of the symptoms integrals were compared between the two groups. RESULTS: During the treatment period the total and average dosages of G-CSF used were larger in the control group than in the treatment group (P<0.01). After treatment the WBC count of the two groups were reduced with statistical difference (P<0.01). The WBC counts were higher in the treatment group than in the control group in the whole therapeutic process except the first chemotherapy (P<0.01, P<0.05). Compared with before treatment in the same group, RBC and PLT were reduced in the two groups before the 4th chemotherapy, RBC, Hb, and PLT were reduced after treatment (P<0.05, P<0.01). Better effects on body weight were obtained in the treatment group than in the control group with statistical difference (P<0.01). Compared with the control group, the clinical symptoms integrals such as fatigue, liability to catch cold, pharyngalgia, pale complexion, poor appetite, vomiting, and diarrhea were reduced (P<0.01). Compared with the control group, the toxic and adverse reactions were reduced in the treatment group before the 4th chemotherapy (P<0.01). CONCLUSIONS:QM could effectively intervene chemotherapy induced myelosuppression in patients with colorectal cancer. It was a safe Chinese medicine compound with lower toxicity.
RCT Entities:
OBJECTIVE: To observe the intervention of Qisheng Mixture (QM) on the chemotherapy induced myelosuppression in patients with colorectal cancer. METHODS: One hundred and twenty patients with colorectal cancer at Ruijin Hospital, Shanghai Jiaotong University School of Medicine were randomly assigned to the pure chemotherapy group (as the control group) and the QM + chemotherapy group (as the treatment group), 60 in each group. All patients received FOLFOX4 or XELOX regimen for totally 6 cycles. Patients in the treatment group took QM 150 mL at the end of chemotherapy, once in the morning and once in the evening for 7 successive days, totally 6 therapeutic courses. The total and average dosages of using granulocyte colony stimulating factor (G-CSF) were observed in all patients. The changes of white blood cell (WBC) counts were determined before chemotherapy and after the 6th chemotherapy. The hemoglobin (Hb), red blood cell (RBC), and platelet (PLT) counts were observed before chemotherapy, before the 4th chemotheray, and after the 6th chemotherapy. The clinical symptoms integrals (fatigue, liability to catch cold, aphthous stomatitis, pharyngalgia, pale complexion, poor appetite, vomiting, diarrhea, and so on) and the safety indicators (the functions of the liver and kidney, urine routines) were observed. The grading toxic and adverse reactions, KPS scoring, body weight, and the efficacy of the symptoms integrals were compared between the two groups. RESULTS: During the treatment period the total and average dosages of G-CSF used were larger in the control group than in the treatment group (P<0.01). After treatment the WBC count of the two groups were reduced with statistical difference (P<0.01). The WBC counts were higher in the treatment group than in the control group in the whole therapeutic process except the first chemotherapy (P<0.01, P<0.05). Compared with before treatment in the same group, RBC and PLT were reduced in the two groups before the 4th chemotherapy, RBC, Hb, and PLT were reduced after treatment (P<0.05, P<0.01). Better effects on body weight were obtained in the treatment group than in the control group with statistical difference (P<0.01). Compared with the control group, the clinical symptoms integrals such as fatigue, liability to catch cold, pharyngalgia, pale complexion, poor appetite, vomiting, and diarrhea were reduced (P<0.01). Compared with the control group, the toxic and adverse reactions were reduced in the treatment group before the 4th chemotherapy (P<0.01). CONCLUSIONS: QM could effectively intervene chemotherapy induced myelosuppression in patients with colorectal cancer. It was a safe Chinese medicine compound with lower toxicity.