| Objective: To discuss whether qigefang(QGF)decoction can prolong disease free survival(DFS)compared the traditional Chinese medicine(TCM)group with control group.To discuss whether it can reduce relapse-metastasis rate,increase disease-free survival rate.To discuss whether it can improve clinical symptoms and improve the quality of life of patients.To discuss whether it can increase Karnofsky(KPS)score and body weight of patients with stage I-III esophageal carcinoma after radical resection.To provide clinical evidence for traditional Chinese medicine in the treatment of esophageal cancer.Methods: This experiment was a prospective cohort study,which collected a total of 332 cases in the department of thoracic surgery at the Fourth Affiliated Hospital of Hebei Medical University from December 2011 to December 2014.Patients were divided into two groups according to whether using QGF decoction.The TCM group was 128 cases,and the control group was 204 cases(including TCM group lost 2 patients and control group lost 3patients,because the phone was wrong or shut down).All the patients were the I-III stage after radical resection,in which the I stage patients were not grant chemotherapy,and II-III stage patients were grant 4 cycles chemotherapy of paclitaxel combined with platinum-based after radical resection.After then all the patients were take pate in the experiment.It took the QGF decoction as exposure factor according to the design of prospective cohort studies.The patients accepting the QGF decoction were divided into Chinese medicine cohort(TCM group)and the others were divided into control cohort(control group).The patients used QGF decoction 3 weeks in stage I patients afteroperation,and in stage II-III patients after the end of 4 cycles chemotherapy in TCM group.The patients take the QGF decoction a total of 1 years or to disease recurrence and metastasis with a daily dose.The control group was not treated with QGF.All patients were followed up to relapse and metastasis recurrence after operation,with the quality of life questionnaire survey,KPS score and weight before and after the treatment and observation for 3 months.Results:1 It was found that the average DFS was 22.09±1.40 months in TCM group and 14.21±1.04 months in the control group after the treatment observation.The DFS in TCM group was significantly longer than that in the control group.The difference was statistically significant(P<0.05)by Wilcoxon rank sum test.2 After treatment,the result showed that 12 cases were relapse and metastasis,and 116 cases were no relapse and metastasis in the past 1 year in the TCM group.1-year relapse-metastasis rate was 9.38% and the disease-free survival rate was 90.62% in the TCM group.38 cases were relapse and metastasis,and 90 cases were no relapse and metastasis in the past 2 years in the TCM group.2-year relapse-metastasis rate was 29.69% and the diseasefree survival rate was 70.31% in the TCM group.In the control group,the result showed that 40 cases were relapse and metastasis,and 164 cases were no relapse and metastasis in the past 1 years.1-year relapse-metastasis rate was19.61% and the disease-free survival rate was 80.39% in the control group.76 cases were relapse and metastasis,and 128 cases were no relapse and metastasis in the past 2 years.2-year relapse and metastasis rate was 37.25%and the disease-free survival rate was 62.75% in the control group.The difference was statistically significant in the 1-year relapse-metastasis rate by using chi square test between two groups(P<0.05).The relapse-metastasis rate in TCM group was significantly lower than in the control group.However,the 2-year relapse-metastasis rate in TCM group was lower than in the control group,but there was no significant difference between the two groups(P>0.05).3 To evaluate the quality of life of patients with QLQ-C30,there was significant improvement in general health,physical function,role function,social function,fatigue,nausea and vomiting,pain,constipation,diarrhea and loss of appetite comparing in TCM group before and after treatment(P<0.05).However,there was no significant improvement in emotional function,cognitive function and shortness of breath,insomnia,economic difficulties comparing in TCM group before and after treatment(P>0.05).The quality of life in the control group was improved,but the scores of all functions,symptoms,individual items and overall health status were not statistically significant(P>0.05)comparing in control group before and after treatment.Comparing with two groups,the TCM group was more serious than the control group in the loss of appetite before treatment,and the difference was statistically significant(P<0.05).The others were no significant differences(P>0.05)before treatment.There was significant difference in the overall health status,physical function,fatigue and nausea and vomiting between the two groups after treatment(P<0.05).The quality of life in the TCM group was better than that in the control group after treatment.To evaluate the quality of life of patients with QLQ-OES18,there was significant improvement in dysphagia,eating,reflux,obstruction,pain,dry mouth,loss of appetite comparing in TCM group before and after treatment(P<0.05).However,there was no significant improvement in swallowing saliva,cough and speech function(P>0.05)comparing in TCM group before and after treatment.There was no significant difference in all functional and symptom domains in the control group before and after treatment(P>0.05).Comparison between the two groups before treatment,the difference in TCM group was statistically significant in the dysphagia and dry mouth than that in the control group(P<0.05).The difference was statistically significant in the aspects of reflux,obstruction symptoms between the two groups after treatment(P<0.05).The quality of life was better in TCM group than in the control group.4 After treatment,the result showed that 49 cases were improved,54 cases were steadied,and 25 cases were deterioration in TCM group of KPS score,respectively accounted for 38.28%,42.19% and 19.53%.The improve-ment and stability rate was 80.47%.48 cases were improved,92 cases were steadied,64 cases were deterioration in control group,respectively accounted for 23.53%,45.10% and 31.37%.The improvement and stability rate were68.63%.Comparing two groups of patients,the KPS score improvement was better in TCM group than in the control group.The difference was statistical significance by chi-square test(P<0.05).5 About weight of patients,41 cases were increase with accounting for32.03%,53 cases were stable with accounting for 41.41%,34 cases were decrease with accounting for 26.56% in TCM group.63 cases were increased,60 cases were stabled,81 cases were decreased,respectively accounted for30.88%,29.41% and 39.71% in control group.Improvement and stability rate was 73.44% in TCM group compered with 59.41% in control group.The difference has statistical significance by chi-square test(P<0.05).6 In the aspect of safety index evaluation,1 patient has liver function damage(aspartate aminotransferase increased)1 level,which may be caused by taking statins drugs in the TCM group.1 patient has proteinuria 1+,which may be associated with diabetic nephropathy in control group.There was no significant correlation with the test drug safety indicators of two groups of patients in the observation period.It suggested that QGF was safe and no obvious side effects.Conclusions: These results demonstrate that QGF can prolong DFS of the esophageal squamous cell carcinoma patients with stage I-III after radical resection.It can reduce disease relapse-metastasis rate and increase diseasefree survival rate.It can improve symptoms and the quality of life,increase KPS score and body weight.It is worthy of clinical application and use safety. |
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