| Objective To observe the clinical effects of TCM therapy of supplementing qi and nourishing yin in treating idiopathic pulmonary fibrosis (IPF).Method 44 IPF patients with qi and yin deficiency syndrome were retrospectively collected from MINO Chinese Medical Clinic in Singapore from January 2007 to September 2011. All patients were treated with TCM therapy of supplementing qi and nourishing yin. According to the course of treatment, they were divided into group A (21 patients, the course of treatment≤6 months) and group B (23 patients, the course of treatment> 6 months). After treated for 6 months, 12 months,24 month and 36 months, changes in KL-6,6 minute walk test (6 minute walk distance, (6MWD), the minimum value of arterial oxygen saturation (SPO2), Borg dyspnea score), high resolution CT (HRCT, ground glass score (GGO) and fibrosis score (FS)) were compared between the two groups, while the clinical effects of traditional Chinese medicine were evaluated.Result①The total effective rates of TCM therapy were respectively 84.09% in the 6th month, 79.55% in the 12th month,43.18% in the 24th month and 31.82% in the 36th month, with significant difference among the four time points, P=0.000; the clinical effects in the 6th month and 12th month were superior to those in the 24th month and 36th month, P=0.000, while there was no significant difference between the clinical effects in the 6th month and those in the 12th month, as well as between those in the 24th month and in the 36th month, P>0.05. There was no significant difference in the clinical effects in the 6th month between group A and group B. The effective rate was 66.67% in group A and 91.30% in group B while in the 12th month, with significant difference between the two groups, Z=-2.001, P=0.045.②After receiving TCM treatment, KL-6, Borg scores and HRCT scores were decreased to varying degrees, and 6MWD and the minimum value of SPO2 were increased in 6-minute walk test. In group A, Borg scores and GGO of HRCT in the 6th month were lower than their baseline values, with significant difference, P=0.024 and P=0.022, while there was no significant difference in k1-6,6MWD, Borg scores, the minimum value of SPO2 and HRCT scores in the 12th month as compared to their baseline values, P>0.05. In group B, GGO of HRCT in the 6th month were lower than the baseline value, with significant difference, P=0.026; At the 12th month,24th month and 36th month, KL-6,6MWD, Borg scores, the lowest SPO2 and HRCT scores were lower than their baseline values, with significant difference, P<0.05. There was no significant difference in 6MWD between any two of the four time points, P>0.05.③KL-6 levels returned to normal in a total of 10 patients (4 patients in group A and 6 patients in group B) during the treatment and in the follow-up visit, with no significant difference between the two groups, P=0.582. After the treatment, KL-6 levels of the 4 patients in group A were increased in various degree, while in group B,2 patients showed an increase in KL-6 levels after treatment and 2 patients showed an increase in KL-6 levels during the treatment, while 2 patients showed no increase in KL-6 levels after treatment. Univariate analysis demonstrated that whether KL-6 levels can return to normal or not after TCM treatment is associated with the baseline value:KL-6 levels of 805.80±478.22 U/mL with a median of 622.00 U/mL could return to normal, while KL-6 levels of 1424.79±1000.14 U/mL with a median of 1095.00 U/mL could not return to normal, t=-2.707, P=0.011. A multivariate logistic regression analysis demonstrated whether KL-6 levels can return to normal or not after TCM treatment is only associated with gender (man or female),P=0.028.④During the treatment, Borg scores were decreased and the minimum value of SPO2 was increased. In group B, there were significant difference in Borg scores and the minimum value of SPO2 in the 12th month,24th month and 36th month, as compared to their baseline values, P<0.05.⑤At the 6th month, GGO was decreased significantly in both two groups, P<0.05, but FS showed no significant decrease, P>0.05. There were significant difference in HRCT scores (GGO and FS) in the 12th month,24th month and 36th month in group B, as compared to the baseline values, P<0.05, while HRCT scores in group A showed no significant difference between the 12th month and the baseline value, P>0.05.⑥The cause of death were respiratory failure, lung infections and heart and lung failure while four deaths occurred in group A and two deaths occurred in group B, with no significant difference, c2=0.313, P=0.576. Univariate analysis showed that the clinical effects of 12-months, the duration of treatment, KL-6 levels,6MWD, FS and acute exacerbation of IPF (yes/no) were associated with death (yes/no), P<0.05.⑦A total of 15 cases of acute exacerbation of IPF occurred in group A while 24 occurred in group B, with no significant difference between the two groups, c2=2.679, P=0.262. Univariate analysis showed that age and the the clinical effects of 12-months were associated with acute exacerbation of IPF (yes/no), P<0.05.Conclusion TCM therapy of supplementing qi and nourishing yin can relieve dyspnea and decrease KL-6 level and HRCT scores in IPF patients with qi and yin deficiency syndrome, but it has not showed effects in reducing the mortality and the incidence of acute exacerbation of IPF. We suggest extending the course of the TCM treatment to more than 12 months in patients who have showed improvement after treated with TCM therapy. It is necessary to further expand the sample size and to extend the follow-up time to evaluate the value of TCM therapy in improving the prognosis of IPF.
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