Combine Traditional Chinese And Western Medicine Treatment Of Secondary Pulmonary Tuberculosis Treated First Scheme Of Clinical And Experimental Research

ObjectiveTo objectively evaluate the therapeutic effect and safety of regimen of integrated traditional Chinese and western medicine in treating untreated secondary pulmonary tuberculosis; partially expound the basic efficacy of integration of traditional Chinese and western medicine in treating untreated secondary pulmonary tuberculosis, and initially explore its correlated mechanism of action, and provide scientific evidences for clinical application of TCM in preventing and treating pulmonary tuberculosis.MethodsClinical trialStudy design:applied research design of multicenter, large sample, and randomized controlled. Object of study:randomly assigned310cases of untreated secondary pulmonary tuberculosis to control group and experimental group by applying computer central stochastic system, and carried out stratified random based on results of sputum smear (smear-negative/smear-positive=1:1). Interventions:the control group was treated by chemotherapy with2HRZE/4HR; while the experimental group was treated by integrated chemotherapy with2HRZE/4HR and herbal treatment on the basis of syndrome differentiation.Observation index:TCM symptoms integral, sputum smears, chest X-rays, SF-36scales in measuring QOL, and symptoms of adverse drug reactions, Routine blood indexes, liver and kidney function indexes, fasting plasma glucose (FPG), and blood uric acid (BUA).Experimental studyChanges of T-cell subsets (CD3, CD4. CD8) and Th1/Th2(IL-2,IFN-γ, IL-4, IL-6, IL-10, TNF-α) of untreated secondary tuberculosis pulmonary patients before and after the treatment were tested by flow cytometry. The effect of combined application of Shuang Bai Kou Fu Ye (Shuangbai Oral Liquid,双百口服液) and HR on BCG induced lung injury mice was observed by pathological morphology method. The anti-fatigue effect of Shuang Bai Kou Fu Ye was evaluated by mice weight loading swimming test. The effect of Shuang Bai Kou Fu Ye on ALT, AST in serum, and content of CYP2E1, MDA, SOD, and GSH-Px in hepatic tissue was observed by rat liver injury model induced by combination of Isoniazid and Rifampicin.ResultsClinical trialThe determination results of global clinical efficacy assessment of TCM syndromes shown that total effective rate of control group is90.5%, cure rate is13.8%; and those of experimental group is99.3%and51.1%respectively.1month later, the negative-inverted rate of sputum bacteria of control group was59.3%, and that of experimental group was87.8%; while for that of2month later, the deffrence was not statistical significant between two groups.1month treatment later, the patients’ proportion of control group with lesion obsorption shown by chest-X rays was52.6%, and that of experimental group was85.6%. While6months later, that of control group and experimental group was52.6%and85.6%respectively. The results of SF-36 scales shown that physical functioning, role-physical, general health, vitality, role-emotional, mental health of patients in experimental group were better than control group. During the treatment, the incidence of continuous gastrointestinal reaction of patients in control patients was48.3%, and that of experimental group was7.9%. The main influence of antituberculous chemotherapy drugs on blood routine test was PLT and WBC reduction. The portion of patients in control group with PLT lower than normal value was12.38±3.85%, and that of experimental group was6.35±4.16%; while for WBC, the rate of two groups were12.93±2.44%and4.45±1.78%respectively. The highest portion of patients in control group with ALT higher than normal value was29.3%, and that of experimental group was16.5%; while that of AST was17.2%and11.5%respectively. Both regimens had no significant effect on kidney function index, and minor effect on FPG. Afer the treatment, the BUA of both groups increased significantly, however, as ending of the intensive treatment, the BUA gradually reduced to normal range.Experimental studyThere were minor changes of T-cell subsets of untreated secondary pulmonary tuberculosis before and after the treatment. Before the treatment, the portion of patients with less counts than normal value of CD4+, CD8+T-lymphocyte was relatively higher, while6months after the treatment, the portion was relatively reduced. Compared the experimental group with control group, the defference was not statistical significant. Before the treatment, the function of Thl was reduced, manifested by lower content of IL-2and IFN-y in blood serum than post-treatment. After the treatment, IL-2of both groups increased first and decreased then, and the increasing range of experimental group was larger than control group. IFN-y of experimental group also increased first and decreased then, but no significant change for control group. The content of TNF-a in both groups were reducing gradually during the treatment, and the range of experimental group was larger than control group. Before the treatment, the function of Th2cells was hyperactive, manifested by higher level of IL-4, IL-6, and IL-10in blood serum than post-treatment. After the treatment, the content of IL-4, IL-6, IL-10in blood serum reduced significantly, but compared two groups, the difference was not statistical significant. Combined application of Shuang Bai Kou Fu Ye, Isoniazid, and Rifampicin could relieve lung inflammatory injury of BCG induced lung injury model mice, reduce the generation of epithelioid cell granuloma, and promote the repair of lung tissue injury. Shuang Bai Kou Fu Ye could significantly prolong the swimming time of wight loading mice, and had effect of anti-fatigue. Combined application of Shuang Bai Kou Fu Ye, Isoniazid, and Rifampicin could resist rising of ALT and AST caused by Isoniazid, and Rifampicin, reduce content of CYP2E1and MDA in hepatic tissue, stabilize content of SOD, and increase content of GSH-Px.ConclusionThe regimen of integrated traditional Chinese and western medicine treatment for untreated secondary pulmonary tuberculosis is effective and safe. The advantages manifest in effectively reducing toxicity and side effects, and reinforcing anti-tuberculosis effect of chemotherapy drugs with combined application of herbal treatment on basis of syndrome differentiation and anti-tuberculosis chemotherapy drugs. The action of toxicity-reducing and effect-reiforcing of regimen of integrated traditional Chinese and western medicine treatment may be related with reinforcing immune function, activating cytoimmunity related to anti-tubercle bacillus, relieving the inflammation of lung tissue, reducing the generation of epithelioid cell granuloma, promoting the repair of lung tissue injury, improving exercise tolerance and effect of anti-fatigue, inhibiting cytochrome CYP2E1, and enhancing antioxidant capacity of hepatic tissue.