Objective: To observe the effect of Jianpi Yiqi Huoxue Decoction on the patients with Hand-foot Syndrome caused by spleen deficiency and blood stasis.Methods: Clinical cases meeting the inclusion requirements were collected and randomly divided into 2 groups.Finally,31 effective cases were included in each group.The observation group was given Jianpi Yiqi Huoxue Decoction orally and fumigated,and the control group was given vitamin B6 orally and fumigated with warm water.After observing for 42 consecutive days,the grade of Hand-foot syndrome,the grade of local symptoms of Hand-foot syndrome(numbness,skin dryness,skin erythema,pain),Karlscher score,TCM syndrome score of spleen deficiency and blood stasis,safety indexes,and the occurrence of adverse reactions were compared between the two groups.Results:1.Baseline data: Patients in the two groups were comparable in gender,age,disease type,chemotherapy regimen,pre-treatment Hand-foot syndrome and local symptom grade,Karlske score,and TCM syndrome score(P > 0.05).2.Comparison of efficacy of Hand-foot syndrome: both groups were degraded after treatment.The observation group: 14 cases were cured,11 cases were effective,and the effective rate was 80.65%,while in the control group,5 cases were cured,10 cases were effective,and the effective rate was 48.39%.And the effect in the observation group was better(P < 0.05).3.Comparison of the efficacy of Hand-foot syndrome's local symptoms:after treatment,the effective rates of the observation group were: numbness74.19%,skin dryness 87.10%,erythema 77.42%,pain 84.62%;In the control group,they were numbness 58.06%,dryness 51.61%,erythema38.71% and pain 45.83%.The curative effect of observation group was better than the other(P < 0.05).4.Karlscher score: After treatment,it is increased compared with before in the observation group(P < 0.05),while there was no statistical significance in the control group(P > 0.05).In the observation group,14 cases were elevated and 15 cases were stable.In the control group,6 cases were elevated and 18 cases were stable.The observation group had better curative effect(P < 0.05).5.TCM syndrome score: After treatment,it is decreased in both groups.In the observation group,9 cases were significantly effective,17 cases were effective,and the total effective rate was 83.87%.In the control group,2 cases were significantly effective,11 cases were effective,and the total effective rate was 41.94%.The effect in the observation group was better(P< 0.05).6.The first remission time of Hand-foot syndrome: the time of observation group was significantly earlier than that of control group(P < 0.05).Conclusion:1.Jianpi Yiqi Huoxue Decoction can effectively reduce the grade of Hand-foot syndrome,and can also reduce the grade of numbness,skin dryness,skin erythema and pain.2.Jianpi Yiqi Huoxue Decoction can improve patients' quality of life.3.Jianpi Yiqi Huoxue Decoction can relieve symptoms related to spleen deficiency and blood stasis.4.The first remission time of patients with the Jianpi Yiqi Huoxue Decoction was earlier than that of vitamin B6 combined with warm water fumigation group.5.Jianpi Yiqi Huoxue Decoction is safe to take orally and fumigated with no special adverse reactions. |