| Idiopathic pulmonary fibrosis (IPF) is a world-refractory, fatal disease; neither Chinese medicine nor western medicine has any effective treatments. Our previous animal studies has preliminary proofed, the Fuzheng tixie souluo formula based on the prescription of insects drugs has some therapeutic effect in the intervention of pulmonary fibrosis in rats. Based on the results of preliminary animal study, this research intends to observe the clinical efficacy of insect drugs tracking network-vessels in treating patients with IPF and provide scientific basis for clinical use of insect drugs in the treatment of pulmonary fibrosis through the Randomized controlled study. Fuzheng tixie souluo formula was made by adding insect drugs tracking network-vessels to the basic formula of supplementing Qi, dissolving phlegm and activating blood. The symptoms, signs, laboratory tests and ST. George’s Chest questionnaire items will be collected before and after the study as measures of efficacy.Objective:This study is a clinical curative effect observation about Fuzheng tixie souluo formula of the IPF patients.Method-Using randomized controlled clinical trial,66 cases included in the standard of IPF patients were randomly divided into two groups.All patients came from the outpatient of respiratory in Dong Zhi Men hospital attached to Beijing university of Chinese medicine、International medical department and Chao yang district Traditional Chinese hospital in the period of August 2013 to March 2015.32 cases in the treatment group(receive Fuzheng tixie souluo formula) and the 34 cases in the control group (receive the placebo) in the research of 3 months. Then analyzed the main symptoms, signs, secondary symptoms, laboratory tests (Sp02, pulmonary function and pulmonary CT), st. George’s Chest questionnaire items and CPR scoring before and after the treatment.The database of the pulmonary fibrosis was established with the Microsoft Access 2003 and statistically analysed with the application of SPSS17.0 software.Results:1. In the clinical research part,30 cases in the treatment group and 31 cases in the control group were retained. Two groups of gender, age, course of the disease and disease classification has no statistical significance before treatment. They were comparable in the two groups.2. Comprehensive therapeutic effect:After treatment for 3 months,1 case had marked effect,22 cases effectively and 7 cases were invalid and the total effective rate 76.67% in the treatment group.The control group has no markedly effective, effective 7 cases,24 cases ineffective, and the total effective rate was 22.58%. There has statistical difference in the two groups (p<0.05) Traditional Chinese medicine of Fuzheng tixie souluo formula in improving IPF patients with clinical symptoms, the remission of the disease and to maintain stable disease has a certain role.3. Syndrome of traditional Chinese Medicine effect:After treatment for 3 months,1 case had marked effect,23 cases effectively and 6 cases were invalid and the total effective rate 80% in the treatment group.The control group has no markedly effective, effective 9 cases,22 cases ineffective, and the total effective rate was 30%. the difference was statistically significant (p<0.05) The Fuzheng tixie souluo formula in improving clinical symptoms of IPF patients has an obvious effect than the control group.Treatment group in improving the shortness of breath, wheezing, cough, expectoration is obvious,the control group only improved in terms of cough, expectoration4. Pulmonary function effect:Diffusion capacity of the lung for carbon monoxide (DLCO) had statistical significance before and after treatment in the treatment group. And compared with the control group with statistical significance (P< 0.05). In total lung capacity (TLC) the treatment group had a tendency to improve, but there was no significant difference between before and treatment, there was a decline in the control group.But there was no significant difference between the two groups. In terms of Vital Capacity (VC), two groups have a downward trend, but the treatment group decreased than the control group, compared two groups had no statistical significance (P> 0.05).5. HRCT effect:The HRCT results showed there was no significant difference between groups(P>0.05).6. Quality of life:Compared before and after treating, the treatment group in terms of symptoms, the condition of limited activities, psychological had statistical significance (P< 0.05), The control group compared with before treatment, there was no significant difference. the difference was statistically significant (p<0.05).Compared between the two ways was statistically significant (P< 0.05). In raising the quality of life, Fuzheng tixie souluo formula is better than the placebo group.7. The effect of dyspnea:Compared before and after treating, On the dyspnea treatment group had significant difference (P< 0.05), there was no significant difference in the control group.Chinese traditional medicine of Fuzheng tixie souluo formula on dyspnea has a certain improving effect.8. Adverse drug reactions monitoring:Before and after the treatment, compared with the function of liver and kidney, blood routine, electrocardiogram (ecg), routine urine and so on, the two groups had no significant difference (P> 0.05). Confirmed the safety of the Fuzheng tixie souluo formulaConclusions:The results show Fuzheng tixie souluo formula treatment of IPF had certain curative effect, it can significantly reduce the clinical symptoms of the patients, increase patients exercise endurance, and improve the quality of life. It also can improve DLCO, and delay the decline of TLC and VC. But the effect is not obvious in improving pulmonary HRCT. |
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