| Objective:To evaluate clinical efficacy and safety of Majie Recipe through treating AECOPD out-patient, objectively analyze the application value of Majie Recipe in AECOPD treatment, promote the practicability transformation of proved recipe of our department and provide previous preparation and data support for research and development of new traditional Chinese medicine.Methods:use stochastic contrast method, select 102 AEOPD patients (46 patients in control group,56 patients in treatment group), use Majie Recipe on the basis of using standard treatment of Western medicine in treatment group, using standard treatment of Western medicine in control group, observe traditional Chinese medicine symptom integral, sputum change condition, CAT score, laboratory test, comprehensive efficacy evaluation and other indicators.Results:1 comparability analysis:before the treatment, the general information (age, sex, smoking history), general condition (systolic blood pressure, diastolic blood pressure, respiration, heart rate, body temperature, BMI), severity of patient's condition (course of disease, CAT score, total symptom score of traditional Chinese medicine, acute attack time, mMRC score) difference have no statistical significance (P>0.05), the two groups were comparable.2. Syndrome analysis of traditional Chinese medicine:the two groups can make significant improvement of traditional Chinese medicine symptom, make TCM symptom scores (including cough, sputum, breath, wheezing, main symptom score, secondary symptom score, aggregate score of TCM syndrome) decrease significantly (P<0.05), but curative effect of treatment group is superior to the control group (P< 0.05), especially in sputum change (quality, color, quantity of sputum), the treatment group is significantly better than the control group (P<0.05). In TCM syndrome efficacy evaluation respect, the total efficiency of treatment group is 85.71%, the total efficiency of the control group is 65.21%, the treatment group is significantly higher than the control group (P<0.05).3. CAT score analysis:before and after treatment, each index of treatment group has significant improvement (P<0.01). In addition to housework, trip indicators, other indicators and CAT score of the control group have significant decrease (P<0.05) In addition to two symptoms chest tightness, climbing stairs, other indexes in treatment group are superior to those in control group (P<0.05).4. Analysis of index of laboratory examination:two groups can make the WBC, N% improve significantly (P<0.05), but there is no significant difference in comparison among groups (P>0.05). PH, PaCO2 and PaO2 of patients in both groups are improved significantly (P<0.05), the treatment group is superior to the control group (P<0.05).5. Comprehensive therapeutic evaluation:the total effective rate of the treatment group is 82.14%, the total effective rate of the control group is 67.39%, and the treatment is significantly higher than the control group (P<0.05).6. Safety assessment:after treatment, intra-group comparison of blood routine examination, liver and kidney function, ECG and urine routine testing of patients in both groups have no significant findings (P> 0.05), which shows that both of the two treatment options have no significant effect on blood routine examination, liver and kidney function, ECG.Conclusion:1. The study confirmed that the use of Majie Recipe on the basis of using standard treatment of Western medicine is superior to the control group including cough, sputum, breath, wheezing and other main symptom scores, and is helpful to relieve abdominal distention, spontaneous sweating, breathe hard and other secondary symptom score. In TCM syndrome efficacy evaluation and aggregate score of TCM syndrome respect,the treatment group have obvious advantage.2. The study confirmed that Majie Recipe in sputum change (quality, color, quantity of sputum) have obvious effect. The use of Majie Recipe on the basis of using standard treatment of Western medicine is superior to the control group including promoting sputum dilution, changing sputum color, increasing excreting sputum and other aspect.3. In this study, the CAT score was selected as the evaluation index of AECOPD efficacy. A number of studies have shown that CAT score and SGRQ score have good correlation, and CAT score is more simple and easy to operate. Research results show, The use of Majie Recipe on the basis of using standard treatment of Western medicine is superior to the control group in relieving cough, sputum, CAT score and other index. In the improvement of chest tightness, climbing, the treatment group have no obvious advantage.4. In laboratory tests, the treatment group was not better than the control group in the WBC?N% improve significantly. Inference reason, traditional Chinese medicine is at a disadvantage in terms of anti-infection, although a number of studies have confirmed some traditional Chinese Medicine in the Majie Recipe has the function of inhibiting bacteria, and the observation time is short, and it has a certain influence on the experimental research. In addition, the treatment group was superior to the control group in improving the blood gas analysis index. This may be related to the treatment group in the treatment of respiratory difficulties. In animal experiments, there was no clear increase in the anti-hypoxia ability of the animal model.5. On the analysis of the comprehensive curative effect, the treatment group was significantly better than the control group.6. Synthesizing acute toxicity test, long term toxicity test and clinical safety outcomes in this study, Majie Recipe is safety and reliability... |
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