| Objective:Formed in accordance with China’s national conditions of combining traditional Chinese and western medicine in the treatment of recurrent smear-positive pulmonary tuberculosis treatment. Improve the retreatment TB cure rate, reduce the resistance and the risk of multidrug-resistant and extensively drug-resistant. This study intends to improve the retreatment sputum smear-positive pulmonary tuberculosis curative rate and improve the bacterium turns shade rate, improve the quality of life of patients with tuberculosis and reduce the side effects of chemotherapy drugs, so as to lower the risk of drug resistance pulmonary tuberculosis. At the same time, further optimize the combination of traditional Chinese and western medicine treatment of tuberculosis of talent team, improve the overall level of tuberculosis prevention and control of major infectious diseases of traditional Chinese medicine, to eventually achieve the overall goal of TB control lay a solid foundation.Methods:Adopt parallel randomized, double blind, placebo controlled, multicenter clinical study. Research object:14 total number of cases of 812 cases of collaboration for unit, chengdu university of traditional Chinese medicine affiliated hospital is in charge of 58 cases of recurrent smear-positive pulmonary tuberculosis patients. Randomization scheme:using hierarchical (center for layered) block randomized allocation method, the unit to which the data management and statistical analysis of China academy of traditional Chinese medicine clinical basic medical research institute of traditional Chinese medicine clinical evaluation center randomized allocation according to the clinical trial scheme, and through the central random distribution network system to implementation and administration of random allocation, doctors clinical trials for subjects through the network distribution of coding. Control methods:in order to overcome the researchers, the participants and curative effect and safety evaluation of personnel due to psychological factors forming the bias, objective evaluation the curative effect and security of the testing scheme, comparison the clinical trials using a placebo. Blind method:the clinical study with double blind technique, according to the study of syndromes parting preparation.Results:(1) Syndromes curative effect evaluation study shows that:the treatment group and control group in the treatment of 240±14 days, the doctor of traditional Chinese medicine syndrome curative effect evaluation study compared difference is significant (P<0.05).(2) TCM symptom score between two groups of patients at the same time point group comparative evaluation studies showed that the treatment group in the treatment of 90+7 days, lung Yin deficiency syndrome, Yin deficiency fire, qi and Yin deficiency syndrome compared with control group, the differences were statistically significant (P<0.05). The treatment group in the treatment of 150±7 days, lung Yin deficiency syndrome compared with control group, the difference statistically significant (P<0.05), Qi and Yin deficiency syndrome compared with control group, with significant difference statistically significant (P<0.01);Treatment to 150±7 days, the treatment group compared with control group in Yin deficiency syndrome of the fire, there was no statistically significant difference (P>0.05). The treatment group in the treatment of 240±7 days, lung Yin deficiency syndrome compared with control group, the difference statistically significant (P<0.05);Qi and Yin deficiency syndrome compared with control group, with significant difference statistically significant (P<0.01);Treatment to 240±7 days, the treatment group compared with control group in Yin deficiency syndrome of the fire, there was no statistically significant difference (P>0.05).(3) The doctor of traditional Chinese medicine treatment group before and after treatment in patients with symptoms integral research shows that:the treatment group lung Yin deficiency syndrome, Yin deficiency syndrome, qi and Yin deficiency fire three syndrome types in the treatment of 90±7 days, compared to 150±7 days, compared to 240±7 days compared with before treatment, all have significant difference statistically significant (P<0.01)."Treatment to 150±7 days compared with treatment to 90±7 days, three syndrome types were statistically difference (P<0.05);Treatment to 240±7 days compared with treatment to 150±7 days, three syndrome types were significantly significant statistical significance (P<0.01);Treatment to 240±7 days compared with treatment to 150±7 days, three syndrome types were statistically difference (P<0.05).(4) The doctor of traditional Chinese medicine treatment group before and after treatment in patients with symptoms integral research shows that:the treatment group lung Yin deficiency syndrome, Yin deficiency syndrome, qi and Yin deficiency fire three syndrome types in the treatment of 90±7 days, compared to 150±7 days, compared to 240±7 days compared with before treatment, all have significant difference statistically significant (P<0.01);Treatment to 150±7 days compared with treatment to 90±7 days, three syndrome types were statistically difference (P<0.05);Treatment to 240±7 days compared with treatment to 150±7 days, three syndrome types were significantly significant statistical significance (P<0.01);Treatment to 240±7 days compared with treatment to 150±7 days, three syndrome types were statistically difference (P<0.05).(5) Life quality evaluation study shows that the treatment to 150±7 days, physiological function in treatment group was better than control group, the difference was statistically significant (P<0.05);After treatment to 240+7 days, in the physiological function, physiological function, emotional function, social function, mental health and general health, energy, etc. The improvement of the treatment group was significantly superior to the control group, the difference statistically significant (P<0.05).(6) Thl/Th2 cytokines related evaluation studies showed that IL-2 treatment group in the treatment of 90±7 days, compared to 240±7 days compared with the control, the differences were statistically significant (P<0.05); Treatment group in the treatment of 150 ±7 days compared with control group, with significant difference (P<0.01).IFN-y treatment group in the treatment of 90±7 days,150±7 days,240±7 days compared with control group, the differences were statistically significant (P<0.05). TGF-β treatment group in the treatment of 90±7 days,240±7 days compared with control group, the differences were statistically significant (P<0.05); Treatment group compared with control group in the treatment of 150± days, TGF-β no statistical difference (P>0.05).IL-4 comparing the treatment group compared with control group in the treatment of 90 ±7 days, no statistical difference (P> 0.05); Treatment group in the treatment of 150± 7 days, compared to 240±7 days compared with control group, the differences were statistically significant (P<0.05).IL-5 in the treatment of 90±7 days,150± days for the treatment group compared with the control group were statistically significant (P<0.05); The treatment group in the treatment of 240± days compared with control group, there was no statistically significant difference (P>0.05). IL-6 in the treatment of 90±7 days, compared to 150± days, compared to 240± days treatment group compared with the control group had no statistical significance (P>0.05).IL-10 in the treatment of 90±7 days, compared to 150± days, compared to 240± days in treatment group were statistically significant compared with the control group (P<0.05).(7) Rate of phlegm germ feminine changed evaluation studies have suggested that the treatment of 30 ± 7 days, the treatment group sputum bacteria turn rate of sputum bacterium turns shade rate compared with control group, two groups have statistical difference (P<0.05);To treat 60±7 days, the treatment group sputum bacteria turn rate of sputum bacterium turns shade rate compared with control group, two groups have statistically significant difference (P<0.01);Treatment to 90±7 days, the treatment group sputum bacteria turn rate of sputum bacterium turns shade rate compared with control group, two groups have no statistical difference (P>0.05).(8) Mycobacterium tuberculosis culture and drug sensitive test analysis showed that the group, the treatment group on case in 5 cases,20 patients with culture positive, drug sensitivity,15 cases of control group on case 4 cases,17 were culture positive, including 13 cases of drug sensitivity;Treatment to 90±7 days in treatment group and control group were smear-positive 0 cases, treatment group culture positive in 1 case, drug sensitive 0 cases, control group culture positive 4 cases, drug sensitive 0 cases;Treatment to 240± 7 days in treatment group and control group were smear-positive 0 cases, treatment group culture positive 0 cases, control group culture positive in 1 case, drug sensitive 0 cases.(9) Lung CT lesions before and after the treatment situation is:to treat 240 ±7 days and into the group, the treatment group compared with control group the chest CT lesions absorption, two groups have statistical difference (P<0.05).(10) Lung CT before and after treatment, empty change situation is:the treatment of 240 ±7 days and into the group, the treatment group compared with control group chest CT empty, two groups have statistical difference (P<0.05).(11) Safety index in the treatment of 30±7 days for evaluation studies have suggested that the treatment group and control group 30±7 days for the WBC, HGB comparison was statistically significant (P<0.05); Treatment group and control group 30±7 days PLT is a significant statistical significance (P<0.01). Treatment group and control group in January ALT, ALP comparison was statistically significant (P<0.05); AST, TBIL, GGT, propagated to treat 30±7 days compared with control group (P>0.05), there was no statistically significant difference. Treatment group and control group 30±7 days for UREA and CREA, UA comparison, no statistical significance (P>0.05).(12) Safety index to treat 60±7 days evaluation studies have suggested that the treatment group and control group of 60 ±7 days for the WBC comparison was statistically significant (P< 0.05); Treatment group and control group of 60±7 days for RBC, PLT, HGB is no statistical significance (P>0.05). Treatment group and control group of 60±7 days for ALT compared with control group, the difference was statistically significant (P<0.05); AST, ALP, GGT is significant statistical significance (P<0.01); TBIL, propagated to treat 60±7 days compared with control group, there was no statistically significant difference (P>0.05). Treatment group and control group of 60±7 days for UA comparison, the difference was statistically difference (P<0.05); UREA and CREA compared with control group, no statistical significance (P>0.05).(13) Evaluation of treatment to 90±7 days safety index study:treatment group and control group 90±7 days the WBC is a significant statistical significance (P<0.01); RBC, PLT, HGB is no statistical significance (P>0.05). Treatment group and control group 90±7 days ALT, AST, ALP comparisons, with significant difference statistically significant (P<0.01); TBIL, GGT, propagated treatment to 90± 7 days compared with control group, there was no statistically significant difference (P>0.05). Treatment group and control group 90±7 days compared UA, statistically significant difference (P<0.05); UREA and CREA compared with control group, no statistical significance (P>0.05).(14) Evaluation of treatment to 120±7 days safety index study:treatment group and control group 120 ±7 days PLT is a significant statistical significance (P<0.01); Treatment group and control group 120±7 days the WBC, RBC, HGB is no statistical significance (P>0.05). Treatment group and control group 120± days ALT, AST, ALP, GGT, the difference was statistically significant (P<0.05); TBIL, propagated treatment to 120±7 days compared with control group, there was no statistically significant difference (P>0.05). Treatment group and control group 120±7 days UA comparison, the difference was statistically difference (P<0.05); UREA and CREA compared with control group, no statistical significance (P>0.05).(15) Evaluation of treatment to 150±7 days safety index study:treatment group and control group 150 ±7 days PLT is a significant statistical significance (P<0.01); The WBC treatment compared to 150±7 days, statistically significant difference (P<0.05); Treatment group and control group 150±7 days, RBC, HGB is no statistical significance (P>0.05). Treatment group and control group 150±7 days ALP comparisons, the difference was statistically significant (P<0.05); ALT, AST, TBIL, GGT, propagated treatment to 150±7 days compared with control group, there was no statistically significant difference (P>0.05). Treatment group and control group 150±7 days for UREA and CREA, UA compared with control group, there was no statistically significant difference (P>0.05).(16) Evaluation of treatment to 180±7 days safety index study:treatment group and control group 180±7 days PLT is a significant statistical significance (P<0.01); Treatment group and control group 180±7 days the WBC, RBC, HGB is no statistical significance (P>0.05). Treatment group ALP treatment to 180±7 days compared with control group, the difference was statistionally significant(P<0.05);ALT;AST, GGT, TBIL,propagated treatment to 180± 7 days compared with control group, there was no statistically significant difference (P>0.05). Treatment group and control group 180±7 days for UREA and CREA, UA compared with control group, there is no statistical significance (P>0.05).(17) Evaluation of treatment to 210± days safety index study:treatment group an d control group 210± days PLT differences significant statistical significance (P<0. 01); Treatment group and control group 210±7 days the WBC, RBC, HGB is no statistical significance (P>0.05). Treatment group and control group 210±7 days ALT, AST, ALP, G GT, TBIL, propagated comparison, there was no statistically significant difference (P>0. 05). Treatment group and control group 210 ±7 days UREA comparison, the difference was statistically difference (P<0.05); CREA, UA compared with control group, no statistical significance (P>0.05).(18) Evaluation of treatment to 240±7 days safety index study:treatment group and control group 240±7 days PLT diff was statistically significant (P<0.05); Treatment group and control group 240±7 days the WBC, RBC, HGB is no statistical significance (P>0.05). Treatment group and control group 210±7 days ALT, AST, ALP, GGT, TBIL, propagated comparison, there was no statistically significant difference (P>0.05). Treatment group and control group 240±7 days for UREA and CREA, UA compared with control group, there is no statistical significance (P>0.05).(19) Cases in the group and fall off the crowd analysis and evaluation research shows that: the treatment group into the group of 29 cases, control group into the group of 29 cases, the treatment group off 4 cases, control group falls off in 5 cases. Fall off in the two groups were compared (P= 1.00), P>0.05, have no statistical difference.(20) Patients medication compliance evaluation study shows that two groups of patients with eight time medication rate over 99%, two groups of comparison, there were no statistically significant difference (P>0.05).Conclusions:(1) Granule infusion of Chinese medicine treatment group patients with simulation agent control reduce the chest CT before and after treatment in patients with lesions and empty change situation, have certain advantages, at the same time, sputum culture and drug susceptibility test also found that the treatment group can reduce the positive cases.(2) Granule infusion of Chinese medicine treatment group patients with syndrome of traditional Chinese medicine efficacy evaluation, evaluation of TCM symptom score and quality of life is better than that of patients with infusion of simulate particles and the control group;Because TB are chronic wasting disease, Chinese medicine granule infusion of the treatment group can improve the patients quality of life, reduce chemotherapy drugs on the body of the secondary attack and multiple hazards.(3) Granule infusion of Chinese medicine treatment group patients with liver enzyme to detoxify, increase efficiency and follow-up of patients with self-conscious symptom improvement and strengthen the resistance to acid bacillus staining smear Yin turn rate simulation agent were better than the control group patients.(4) Granule infusion of Chinese medicine treatment group patients Thl/Th2 cytokines related evaluation, part of the index is superior to the analog control group, and the motherland medicine "treatment based on syndrome differentiation is card use is" to the "supporting", from the perspective of exploration to enhance the body’s immune function, activation and fight n/med tuberculosis bacili related to cellular immunity, but there are still many indicators granule infusion of Chinese medicine treatment group patients is not superior to analog control patients, related immunology still need large sample, the further research to clarify.(5) Granule infusion of Chinese medicine treatment group cure rate is better than that of analog agent infusion of the control group in patients.(6) Nourishing yin and moisturizing lung formula particles, nourishing yin to lessen fire formula particles and double hundred formula granules curative effect, easy to use, easy to promote.
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