The Clinical Observation Of Qizhi Zhenyuan Capsule In The Treament Of Bone Marrow Depression After Non-Small Cell Lung Cancer Chemotherapy

Background:Lung cancer is one of the most dangerous diseases to mankind and both the morbidity and mortality of which increasingly rose in the world in many countries and metropolises.Clinically,most of the lung cancer patients are advanced when they first visit,which loss the opportunities of radical surgery for the early stage.Chemotherapy is the main therapy for these advanced non-small cell lung cancer patients without surgical treatment.At present,NP,TP,DP,GP are the most commonly used chemotherapy regimens for non-small cell lung cancer.Many advanced non-small cell lung cancer patients have decrudescence in liver reserve function,renal clearance ability and bone marrow reserve function,which lead to the sensitivity of the toxicity of chemotherapy drugs increase and the tolerance of the toxic and side-effects in chemotherapy conspicuously decrease,even the chemotherapy can not be accomplished,evidently affect the quality of life and the survival time.Lots of research results show that The Traditional Chinese Medicine can conspicuously alleviate the toxicity and side-effects of chemotherapy,stabilize the lesions,improve life quality and prolong survival time.In addiction,less toxic and side-effects,higher quality of life and lower cost of therapy would make the traditional chinese medicine therapy more easy to be accepted by the advanced non-small cell lung cancer patients and their family members.Therefore, traditional chinese medicine therapy will bring multifaceted effects like efficacy enhancing and toxicity reducing when combined with chemotherapy.Based on the recognition of etiology and pathogenesis of lung cancer as well as common toxic and side-effects after lung cancer chemotherapy such as bone marrow depression,Jiangsu Hengrui Medical & Pharmaceutical Co.,LTD accords to therapeutic characteristics of TCM oncology,use the method of TCM syndrome differentiation plus disease differentiation, makes Qizhi Zhenyuan Capsule which can strengthening spleen and replenishing qi and nourishing the kidney-yin,to cure toxic and side-effects after lung cancer chemotherapy such as bone marrow depression,alleviate the clinical symptoms and improve quality of life.Purpose:To alleviate the clinical symptoms,decrease toxic and side-effects after chemotherapy and improve quality of life in NSCLC patients receiving Qizhi Zhenyuan Capsule therapy combine with chemotherapy,and to observe the effect and the characteristics of reducing bone marrow depression after chemotherapy,preliminarily determine its safety.Patients and Method:The randomized,double blind,positive drug control trial was performed in 2^ndDept.of oncology of The First Affiliated Hospital of GuangZhou University of Traditional Chinese Medicine. Between December 2006 and March 2008,37 patients with a histologically confirmed diagnosis of NSCLC and reach the deficiency of both lung and spleen diagnosis standard were enrolled.Thereinto,20 patients are in test group(group A),receive Qizhi Zhenyuan Capcule therapy combining with chemotherapy,17 patients are in control group(group B),receive A-L Tonic Capsule combining with chemotherapy.All patients use NP/TP/DP/GP as chemotherapy regimens,repeat once every 3 weeks, 2 courses in total.The primary effect observation indexes are blood analysis,Karnofski performance status(KPS),weight change,score of QOL and symptom improvemen,safety index are hepatic and renal function,blood glucose,vital signs,ect.Result:In different periods,the overall incidences of low leucocyte neutrophil,hemoglobin and platelet amount have no statistical differences between test group and control group.In the improvement of KPS,improvement rate of test group are higher than the control group's in 1^stand 2^ndtherapy course,but the difference has no statistical significance.It proved that,Qizhi Zhenyuan Capcule have better effect than A-L Tonic Capsule in KPS. The trends of body weight are upward in both test group and control group,which was no statistical significance.In the field QOL scoring,there is no statistical significance between test group and control group.But physical improvement in test group is slightly higher than control group.As for the improvement of TCM syndromes,the remarkably effective rate is significant but similar.As the therapy goes on,the long-term remarkable effect of Qizhi Zhenyuan Capcule may be better than A-L Tonic Capsule.During therapy,no severe adverse reaction happened in test group nor control group.Which showed that Qizhi Zhenyuan Capcule and A-L Tonic Capsule has no bad effect in hepatic and renal function,blood glucose, vital signs.The safety evaluation of Qizhi Zhenyuan Capcule is 3. Conclution:Qizhi Zhenyuan Capcule can reduce bone marrow depression, alleviate the clinical symptoms and improve quality of life.