| Objective:To observe the clinical efficacy and safety of Mai Wei Yangfei decoction in the treatment of Qi and Yin deficiency syndrome of idiopathic pulmonary fibrosis(IPF)with basic theory and method of traditional Chinese medicine(TCM).Methods:According to the single arm clinical trial method,26 cases of IPF patients with Qi and Yin deficiency in the stable period were included.Finally,6 cases fell out,and 20 patients of IPF finished the clinical trial.The treatment prescription was oral Mai Wei Yangfei decoction and the course of medication was three months.Before treatment,one month and three months after treatment,the scores of TCM syndromes,lung function,the scores of St George's respiratory questionnaire(SGRQ),the 6-minute walking distance(6MWD),and the blood oxygen saturation(SpO2%)were used to assess the clinical efficacy of Mai Wei Yangfei decoction in the treatment of IPF patients.Meanwhile,the blood routine,liver and kidney function were used to evaluate the safety of Mawei Yangfei decoction in the treatment of IPF.Results:1.The symptom score of TCM:The total symptom score of treatment after one month and three months(15.63±6.86 and 13.10±7.08)were significantly lower than before treatment(26.84±9.69)(P<0.05).The gasp of symptom score of treatment after one month and three months(2.84±1.81 and 2.84±1.58)were significantly lower than those before treatment(4.58±2.25)(P<0.05).The short breath of symptoms scores of treatment after one month and three months(2.84±1.06 and 3.00±2.00)were significantly lower than those before treatment(5.21 ±2.35)(P<0.05).The cough of symptoms scores of treatment after one month and three months(3.47±2.01 and 2.21 ± 1.69)were significantly lower than those before treatment(5.68 ± 3.21)(P<0.05).2.Functional index:There was no statistical significance about FEV1 between before treatment(2.04±0.59L)and after treatment(1.99±0.51L)(P>0.05).The drop value of FEV1 was about 50ml,and the rate of decline was about 2.5%.There was no statistical significance about FVC between before treatment(2.44±0.70L)and after treatment(2.29±0.57L)(P>0.05).The drop value of FVC was about 150ml,and the rate of decline was about 6.1%.There was no statistical significance about DLCO SB between before treatment(3.61 ±0.97mml/min/kpa)and after treatment(3.49±1.25mml/min/kpa)(P>0.05).The drop value of DLCO SB was about 120mml/min/kpa,and the rate of decline was about 3.3%.3.The scores of SGRQ:The scores of SGRQ of treatment after one month and three months(28.38±9.34 and 24.58±14.34)were significantly lower than those before treatment(42.08±14.57)(P<0.01).4.The blood oxygen saturation and 6MWD:The numerical value of 6MWD of treatment after three months(437.12±98.74m)was higher than before treatment(369.28±95.83m)(P<0.05).There was no statistical significance about SpO2%between before treatment(90.79±5.86%)and after treatment(88.00±11.62%)(P>0.05).5.Acute exacerbation times:No acute aggravation was found in 20 patients with IPF.6.Combined use of drugs:In addition to medication of complications such as hypertension and diabetes,5 patients used N-acetylcysteine.7.Safety analysis:Before and after treatment,there was no significant difference in blood routine,liver and kidney function related indexes(P>0.05),and there were no adverse reaction of liver and kidney damage in all patient.Conclusion:Mai Wei Yangfei decoction can significantly relieve the clinical symptoms,the quality of life,increase exercise tolerance,and it has good safety.Whether the rate of lung function decline in IPF patients can be delayed requires high quality and large sample randomized controlled trials to verify. |
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