| ObjectiveSenile Pneumonia is the most common lung infection in old population, notorious with its serious condition and bad prognosis. Morbidity and mortality of Senile Pneumonia are significantly higher than that of pneumonia in young people. Age, underlying disease, hospitalization caused by CAP and malnutrition are major risk factors of Senile Pneumonia. Bacterial infection is the most important pathogens of Senile Pneumonia.Endotoxin produced by Gram-negative bacteria can cause severe inflamm-ation cascade which promote the occurrence of SIRS, even the development of MODS, leading to death of patients. This pathological process is accordant with that of lung heat disease with wind-warm syndrome. "exuberance of heat-toxicity,intermingled phlegm and blood stasis,deficiency of vital qi "is the core pathogenesis of senile pneumonia. Wind-warm and toxicity pathogen are the main pathogenic factor. Heat and toxicity pathogens are always present in the whole course of the disease. The entanglement of exuberance of heat-toxicity,intermingled phlegm and blood stasis,over consumption of qi and fluid is the key factor leading to the extremely dangerous progress of lung heat disease with wind-warm syndrome. In order to reduce the mortality of senile pneumonia, we grasp the core of the pathogenesis of senile pneumonia, follow the principle of "strengthening vital qi to eliminate pathogenic factor", and establish the treatment method of "strengthening vital qi,clearing toxicity,removing blood stasis". The purpose of our research is:â‘ discuss the core of the pathogenesis of senile pneumonia and the treatment method of "strengthening vital qi,removing blood stasis";â‘¡evaluate the efficacy and safety of treatment method of "strengthening vital qi,clearing toxicity,removing blood stasis" in the intervention in elderly pneumonia mortality;â‘¢analyse causes, clinical features and distribution of syndromes, so as to provide clinical evidence for settlement of technical specifications of treatment method of "strengthening vital qi,clearing toxicity,removing blood stasis".MethodsThe main object of the study are hospitalized pneumonia patients who are more than 65 years old. Senile Pneumonia is attributed to "lung heat disease with wind-warm syndrome"in Chinese medicine. Literatures of Chinese medicine are carrier of Chinese medicine theory and clinical experience and the basis for research and clinical application. Through learning literatures and clinical practice, we study the pathogenesis and treatment method of senile pneumonia in the theoretical layer.Clinical research is conducted in five centers and the patients are divided into treatment group and control group according to the principles of randomization, with 154 cases of subjects in each group. The treatment group is interfered with anti-infection treatment and FuZhengJieDuHuaYu particle treatment, while the control group is interfered with anti-infection treatment and placebo. The treatment lasts for one month, death and discharge after cure (or improvement) are the end of the treatment and the time for medication is no longer than 4 weeks.7 days after treatment, symptom score evaluation,chest radiograph,blood routine,blood gas analysis and body temperature are obtained; 14 days after treatment, symptom score evaluation,blood routine,sputum smear, bacterial culture,throat swab to find mycoplasma,blood gas analysis and body temperature, are obtained; 21 days after treatment, evaluation of symptom score, chest radiograph, blood routine, blood gas analysis and body temperature are obtained; 28 days after treatment, evaluation of symptom score, chest radiograph, blood routine, sputum smear, bacterial culture, throat swab to find mycoplasma, blood gas analysis, vital signs, urine and stool routine, liver and kidney function, ECG are obtained. Deaths and adverse events are recorded whenever they occur.This study foucses on statistical analysis of baseline data; 30-day mortality of pneumonia; the cure rate, symptom score, chest X-ray absorption, blood routine, blood gas analysis and temperature changes 1 week and 2 weeks after treatment respectively. Safety evaluation is conducted by record of adverse reactions in patients, and evaluation of blood, urine and stool routine, liver and kidney function, ECG before and after treatment.ResultsThrough literature study, preliminary work and summary of clinical practice, we believe that wind-warm and toxicity pathogen are the major risk factor of senile pneumonia; exuberance of heat-toxicity,intermingled phlegm and blood stasis,deficiency of vital qi are the core pathogenesis. Interfered with "strengthening vital qi,clearing toxicity,removing blood stasis" treatment,which is aimed at the core pathogenesis, therapy combined with westen and Chinese medicine can improve the efficacy of treatment with lower mortality.303 cases of clinical trial subjects were enrolled in this research,17 cases of which are lost and 2 cases are excluded and finally 284 cases are statistically analysed. Clinical trial results show that:1 20 death cases in the treatment group (13.89%),16 death cases in the control group (11.43%) with no statistically significant difference (p>0.05), which may be related to small sample size. But overall mortality rate of the treatment group is lower than 30% to 50%, which is the average mortality rate reported by literature.If the sample size is enlarged, there may be statistical significance between the two groups.2 Four classification level analysis of cure rate lweek after treatment shows no significant statistical difference between the two groups; chi-square test shows efficacy of treatment group is higher than that of control group with significant difference (p=0.042). The results show that anti-infection treatment combined with traditional Chinese medicine, to some certain extent, can improve clinical efficacy in the treatment of senile pneumonia.3 Cough symptom score in treatment group can be obviously improved 1 week and 2 weeks after treatment with statistical significance compared with that of control group (p <0.05); other symptoms (cough, fever, chest pain, shortness of breath, disinclination to talk, breathe, dry mouth, dry stool, etc.) are significantly different before and after treatment, but between the two groups had no significant difference (p>0.05). The treatment method of "strengthening vital qi,clearing toxicity,removing blood stasis" can relieve sputum in the first week after treatment; Symptoms such as breathing, shortness of breath and disinclination to talk can be significantly improved 2 weeks after treatment; but the time when cough, chest pain, malaise, fatigue, dry mouth, dry stools and other symptoms are effectively improved after treatment is uncertain.4 WBC and neutrophil percentage have decreased in both groups with no significant difference (P>0.05).There may be some advantages for the treatment method of "strengthening vital qi,clearing toxicity,removing blood stasis" to reduce white blood cells and neutrophils, but there is no significant difference between the two groups.5 As treatment time passes, blood oxygen gradually increases and carbon dioxide partial pressure decreases in both groups; partial pressure of carbon dioxide of treatment group compared with the control group decreased significantly 1 week after treatment (P=0.039); but there was no significant difference of the elevated blood oxygen pressure compared between the groups (P>0.05).6 57 patients were with fever before they are enrolled, K-S test of their body tempera-ture 4 hours after taking the medicine shows the four sets of data are normally distributed (P> 0.05). Of the four time points between the two groups for differences between groups t-test, each time point were not significantly different (P>0.05). However, changes in body temperature curve show body temperature decrease in treatment group is slightly greater than that in the control group, which indicates real-time effect of decreasing body temperature with the use of the treatment method of "strengthening vital qi,clearing toxicity,removing blood stasis".7 Imaging data of this group of senile pneumonia has the following characteristics:â‘ lesions are most common in lower lung field;â‘¡lesions manifest with blurred, disorder, grid-like shadow, the shadow of spots or patchy, usually the area of lesion is extensive;â‘¢bronchial pneumonia is the most common lesion;â‘£usually associated with pleural effusion, emphysema, atelectasis, etc. Chest X-ray shows a degree of absorption and progress of the lesion, but there was no significant difference between the two groups after treatment (P> 0.05). Dissipation and absorption of inflammation in senile pneumonia usually takes 2 to 3 months and this research focuses on 10 to 14 days, thus this study did not clearly reflect the difference between the two groups.8 The safety of the treatment method of "strengthening vital qi,clearing toxicity, removing blood stasis" is certain, there are only two cases of adverse reactions in 144 cases of treatment group, with an adverse reaction rate of 1.39%; there are three cases of adverse reactions in 140 cases of control group, with an occurance rate of 2.14%; there is no statistically significant difference between the two groups(P>0.05). There are no adverse events or serious adverse events leading to loss of subjects in both groups.Conclusion1 Exuberance of heat-toxicity,intermingled phlegm and blood stasis,deficiency of vital qi is the core of the pathogenesis of senile pneumonia and the treatment method of "strengthen-ing vital qi,clearing toxicity,removing blood stasis" is an effective treatment in senile pneumo-ma;2 The treatment method of "strengthening vital qi,clearing toxicity,removing blood stasis" can significantly improve the cure rate of pneumonia two weeks after treatment; improve sputum and other individual symptom score; and has effect in the early stage to relieve cough, shortness of breath, disinclination to talk and breathing, indicating that the treatment method can effectively improve part of clinical symptoms in senile pneumonia;3 The treatment method of "strengthening vital qi,clearing toxicity,removing blood stasis" can improve part of the laboratory parameters in senile pneumonia, such as WBC, neutrophils and other inflammatory markers; increase blood oxygen partial pressure, reduce carbon dioxide partial pressure,and improve ventilation to certain extent;4 The treatment method of "strengthening vital qi,clearing toxicity,removing blood stasis" probably cures senile pneumonia by interfering with key factors in its pathological process, such as heat,toxicity,phlegm,blood stasis, deficiency";5 The treatment method of "strengthening vital qi,clearing toxicity,removing blood stasis" aimed at the core pathogenesis can improve the treatment effectiveness of pneumonia in the elderly, which to a certain extent, reveals the inherent regularity of pneumonia in the elderly;6 The fact that there is no significant statistical difference of mortality decrease between two groups may be related to the small sample size, thus sample size needs to be expanded in further study.7 The treatment method of "strengthening vital qi,clearing toxicity,removing blood stasis" has relatively higher safety in the treatment of senile pneumonia and can be applied extensively. |
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