Curative Effect Evaluation And Preliminary Study Of Differential Treatment For70Cases Of Secondary Pulmonary Tuberculosis In Initial Treatment Treated With Combination Therapy Of Li Kongding’s Empirical Anti-tuberculosis Formula And Fixed-dose Combinati

Purpose:To observe the clinical efficacy of combination therapy of Li Kongding’s empirical anti-tuberculosis formula and fixed-dose combination(FDC) for secondary pulmonary tuberculosis in initial six-month treatment,judging TCM syndromes and physical changes in the course of treatment, assessing the advantages of the combination therapy of Li Kongding’s empirical anti-tuberculosis formula and FDC,and establish the foundation for future treatment of multidrug-resistant tuberculosis and drug development.Methods:140cases of secondary pulmonary tuberculosis in initial treatment, diagnosed and met the inclusion criteria, were collected by two centers for disease control and prevention in Mianyang,Sichuan province from June2012to February2013. All patients were randomly assigned to the experimental group(70cases) and the control group(70cases). The experimental group were treated with combination therapy of Li Kongding’s empirical anti-tuberculosis formula and FDC.The control group were treated with chemotherapy of FDC-2HRZE/4HR.The two groups of patients were score determined with clinical symptoms,syndromes and TCM constitution.After6months of treatment,observing symptoms and physical changes combined with chest radiography, sputum smear result, liver and kidney function, blood uric acid and other indicators and using statistical software SPSS17.0to analyze data,and so to evaluate the clinical efficacy of Li Kongding’s empirical anti-tuberculosis formula and its effect to TCM syndromes along with constitution.Results:In all the140cases of secondary pulmonary tuberculosis in initial treatment,the type of lung Yin deficiency accounted for53cases(37.9%),syndrome of deficiency of both qi and yin accounted for42cases (30%),syndrome of hyperactivity of fire due to yin deficiency accounted for39cases(27.6%),blood stasis syndrome accounted for5cases(3.6%) and syndrome of deficiency of both yin and yang accounted for1case(0.7%).TCM constitution:yin deficiency accounted for45cases (32.1%),Qi deficiency accounted for27cases (19.3%),dampness-heat constitution accounted for26cases (18.6%), constitution of qi stagnation accounted for15cases (10.7%), mild physical accounted for13cases (9.3%), blood stasis accounted for8cases(5.7%),yang-insufficiency constitution accounted for5cases (3.6%),Phlegm-dampness constitution accounted for1case (0.7%).Curative effect of TCM syndrome comparison:The total effective rate of the experimental group was98.6%, compared to the control group (95.7%) there was no significant difference.The cure rate of the experimental group was67.1%,which was significantly higher than the control group (28.6%)(p<0.05).Symptom score of the experimental group with syndrome of hyperactivity of fire due to yin deficiency was lower than that of the control group at the end of one-month treatment(p<0.05). Symptom score of the experimental group with syndrome of deficiency of both qi and yin was lower than that of the control group at the end of one and three month treatment(p<0.05).Symptom score between the two group with syndrome of lung Yin deficiency has no significant difference at the end of one, three and six month treatment(p>0.05).Changes of TCM constitution:At the end of three-month treatment,the proportion of cases with mild constitution in the experimental group was higher than that of the control group(31.4%to7.1%)(p<0.05),the proportion of cases with Qi deficiency constitution in the experimental group was lower than that of the control group(15.7%to35.7%)(p<0.05), the proportion of cases with yang-insufficiency constitution in the experimental group was higher than that of the control group(12.9%to2.9%)(p<0.05).At the end of six-month treatment,the proportion of cases with mild constitution in the experimental group was higher than that of the control group (54.3%to22.9%)(p<0.05),the proportion of cases with Qi deficiency and Yin deficiency constitution in the experimental group was lower than that of the control group(p<0.05), the proportion of cases with yang-insufficiency constitution in the experimental group was higher than that of the control group(20%to4.3%)(p<0.05).Chest imaging (X-ray or CT) result:At the end of six-month treatment,lesions absorption rate of the treatment group was significantly higher than that of the control group(72.8%to41.4%)(p<0.05),the cavity change rate of the treatment group was no significantly different to that of the control group(82.1%to82.6%)(p>0.05). Sputum examination results:At the end of two and five and six-month treatment, all the cases were smear-negative,there was no significant difference between the two groups(p>0.05).Side effects of laboratory parameters:At the end of three and six-month treatment,blood uric acid elevated degree of the treatment group was significantly lower than that of the control group(p<0.05).At the end of one and three-month treatment, abnormal ALT of the treatment group was no significantly different to that of the control group(p>0.05). At the end of one-month treatment, abnormal AST of the treatment group was significantly different to that of the control group(p<0.05).Conclusion:Combination therapy of Li Kongding’s empirical anti-tuberculosis formula and fixed-dose combination(FDC) for secondary pulmonary tuberculosis in initial six-month treatment has curative effect,and it is superior than FDC used only on improving TCM syndrome and constitution regulating,and that with its lower side effects,it has promotional clinical value and great significance to drug resistance reseach.