| ObjectiveTo observe the therapeutic effects of standard anti-tuberculosis chemotherapy for 6 months and standard anti-tuberculosis drugs combined with immunotherapy for 4 months during treatment,evaluate the effectiveness of early treatment of smear-negative tuberculosis patients and study the cost and cost-effectiveness of the two chemotherapies,in order to provide the basic and scientific evidence of early treatment of smear-negative tuberculosis for using immunotherapy to make the treatment course shorter.Data and Methods(1)Data:The multicenter randomized controlled clinical trial design was applied to investigate the treatment outcome for ealy-diagnosed smear-negative pulmonary tuberculosis patients treated with two different therapies for 6 months.Patients were enrolled according to the study protocol and the enrollment and exclusion criteria.All patients were randomly divided in to cases in test group and control group.Two groups of patients received intensive treatment for 2 months,while after that cases in test group received consolidation treatment for 2 months and cases in control group for 4 months.Cases in test group were treated with a regimen of 2HRZEM15/2HRM15(H:isoniazid,R:rifampicin,Z:pyrazinamide,E:ethambutol,M:mycobacterium vaccae for injection),M is used by 1 time every 2 weeks,6 times,intramuscular injection;cases in control group were treated with a regimen of 2HRZE15/2HR15+2HR.Epidemiology investigation was conducted to collect the participants' characteristics,changes of clinical efficacy and lung lesions in chest X ray,medication fee information at the end of January,February,April and June.And finally establish the relevant databases to make cost-effectivenes analysis.(2)Methods:Two main research methods had been used in the study,which were statistical analysis and pharmaceutical economics evolution method.The statistical analyses include statistic description,t-test,no ninferiority test,Chi-square test,one-way ANOVA and logistic regression analysis.And pharmaceutical economics evalution applied cost-effectiveness analysis,using cost-effectiveness ratio and incremental cost-effectiveness ratio to measure it,and analysis of them was done by SPSS 20.0.Results(1)General comparison:Two chemotherapies of patients have no significant difference in age,gender,education,marital status and occupation.(2)Comparison of effectiveness:Changes in patchy shadows,nodular shadows and voids have no significant difference at the end of January,February,April and June.The effective absorption rate of lesions in chest X-ray in test group is 17.3%,42.7%,60.8%,72.3%at the end of January,February,April and June,respectively,while the control group is 21.4%%,35.3%,53.6%,66.0%,respectively.And the test group is non-inferior to the control group except the end of February.The significant absorption rate of lesions in chest X-ray in test group is 2.0%,4.5%,9.8%,28.3%at the end of January,February,April and June,respectively,while the control group is 0.0%,2.2%,8.0%,22.9%,respectively.And the test group is non-inferior to the control group.(3)Comparison of cost:The mean total cost of the test group is ? 3554.6,which is higher than that of the control group and the difference is significant.(4)Cost-effectiveness analysis:When effect indicator is the effective absorption rate of lung lesions in chest X-ray,CER of cases in test group is lower than cases in control group and the test group is worthyto be adopted.In male the control group is more cost-effective and the test group is worthy to be adopted,while in female the test group is more cost-effective and the test group is worthy to be adopted.When effect indicator is the significant absorption rate of lung lesions in chest X-ray,CER of cases in test group is higher than cases in control group and the test group is worthy to be adopted,and whether in male or female,the test group is more cost-effective and the test is worthy to be adopted.Conclusions(1)The effectiveness of the test group and the control group is almost the same.When the effective absorption of lung lesions in chest X-ray is effect indicator,the test group is non-inferior to the control group at the end of February,April and June.And when the significant absorption of lung lesions in chest X-ray is effect indicator,the test group is non-inferior to the control group at the end of January,February,April and June.(2)The cost in test group is higher than the control group.Though the treatment course in test group is shorter than the control group,the price of the mycobacterium vaccae for injection is expensive and thus the cost of the test group is higher than the control group.(3)Overall the test group is more cost-effective than the control group,especially in female.Whether the effective absorption of lung lesions in chest X-ray or the significant absorption of lung lesions in chest X-ray is effect indicator,the test group is more cost-effective than the control group.When effect indicator is the effective absorption of lung lesions in chest X-ray,the control group is more cost-effective than the test group,while effect indicator becomes the significant absorption of lung lesions in chest X-ray then the result is opposite in male.In female,whether the effective absorption of lung lesions in chest X-ray or the significant absorption of lung lesions in chest X-ray is effect indicator,the test group is more cost-effective than the control group. |
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