| 1 Objective?To evaluate the efficacy and safety of traditional Chinese medicine in the treatment of idiopathic pulmonary fibrosis?According to the results of evaluation,to provide evidence for clinical application of Chinese medicine in the treatment of this disease2 MethodAccording to the research methods of Cochrane system,4 Chinese databases and 2 English databases were retrieved,and those were CNKI?CBM?Wanfang Database?VIP?Pubmed and Embase.We collected the clinical trials of traditional Chinese medicine in the treatment of idiopathic pulmonary fibrosis systematically,and these literature were screened according to the inclusion and exclusion criteria.The methodological quality of the included studies was assessed according to the bias risk assessment tool of the Cochrane collaboration network,.We extracted the relevant information,analyzed some of the outcome indicators using Revman5.3,and these relevant outcome indicators were explained and discussed.3 ResultsThis systematic review includes 33 studies,according to the different intervention measures,we divide them into 4 subgroups:the combination of traditional Chinese medicine and hormone versus hormone,Chinese medicine versus hormone control group,Chinese medicine versus N-acetylcysteine,and Chinese medicine versus placebo group.Observe indicators are:survival rate,clinical efficacy,lung imaging(CT and X-ray),lung fimction(DLCO,TLC,FVC,VC,FEV1,FEV1%,FEV1/FVC),adverse reactions,PaO2,quality of life,the 6 minute walk test,dyspnea score,cytokines,blood rheology,the cost of treatment.The main results are as follows:Survival rate:only 1 studies reported the survival rate.The results showed that 1 and 3 years survival rate of two groups were similar,but the 5 year survival rate was higher in the group of Chinese medicine combined with hormone(95%CI 1.12-7.75,P=0.03).Clinical efficieicy.27 studies reported this indicator.The results showed that the combination of traditional Chinese medicine and hormone performed better than hormone only in the overall clinical efficacy(95%CI[1.11,1.56],P=0.002).Traditional Chinese medicine showed no difference with hormone in the overall clinical efficacy(95%CI[0.99,128],P= 0.06).Meta analysis showed no significant difference between the traditional Chiese medicine and N-acetylcysteine in improving the clinical curative effect(95%CI[0.95,1.38],P=0.16).Pulmonary imaging:CT:The subgroup of traditional Chinese medicine combined with glucocorticoid versus glucocorticoid included 3 studies,and the Meta analysis results showed no differences between the two groups.The 2 RCTs which compared traditional Chinese medicine with hormone showed no difference in the final results.The X-ray:Traditional Chinese medicine combined with hormone versus hormone subgroup included 2 studies,and Meta analysis showed no statistical difference between the two groups.Pulmonary function:21 RCTs reported the diffusion capacity of carbon monoxide(DLCO).Results showed that the combination of traditional Chinese medicine with hormone performed better in improving DLCO(95%CI[0.25,0.79],P=0.0002);no difference were demonstrated between traditional Chinese medicine and hormone in DLCO(95%CI[,-0.43,0.33],P=0.79).There was no significant difference between traditional Chinese medicine and the NAC in improving this indicator(95%CI[-0.34,1.07],P=0.31).19 RCTs reported total lung capacity(TLC).Meta analysis showed that the Chinese medicine combined with hormone was better than hormone only in improving TLC(95%CI[0.17,0.79],P=0.002);traditional Chinese medicine and hormone showed no significant difference in the improvement of TLC(95%CI[-021,0.24],P=0.91);Traditioinal Chinese medicine and N-acetylcysteine showed no difference raising in TLC(95%CI[-0.58,0.28],P=0.50).12 RCTs reported VC.Meta analysis results showed a better efficacy of traditional Chinese medicine combined with hormone in improving VC(95%CI[0.31,1.48],P=0.003);ther.was no difference between traditional Chinese medicine and hormone(95%CI[-0.11,0.33],P=0.33);and the traditional Chinese medicine and N-acetylcysteine performed similarly(95%CI[-0.49,0.37],P=0.79).The 7 original studies reported FVC.The results showed that the combination of traditional Chinese medicine was better in improving FVC(95%CI[0.43,1.36],P=0.0002)2 RCTs reported FEV1,the results showed that Chinese medicine combined with hormone is better than the use of hormones in the improvement of FEV1(MD=0.61,95%CI[0.52,0.71],P<0.00001).5 RCTs reported FEV1%,and Chinese medicine combined with hormone performed better than the hormone only in improving FEV1%(SMD=0.52,95%CI[0.18,0.86],P=0.003).4 studies reported the outcome of FEV1/FVC,and the results showed no significant differences between the traditional Chinese medicine and hormone in improving FEV1/FVC.PaO2:20 RCTs reported PaO2.Final results showed that traditional Chinese medicine combined with hormone can improve arterial oxygen pressure better than hormone only;and the only use of traditional Chinese medicine also showed better effect than hormones,but the grasp degree is low(95%CI[0.23,0.61],P<0.0001).Quality of life:8 RCTs reportd the quality of life.The results showed no statistical difference between Chinese herb combined with hormone and hormone alone in improving the quality of life(95%CI[-0.60,0.40],P=0.69),and the traditional Chinese medicine only and hormone had no significant difference(95%CI[0.96,1.66],P=0.04).But as part of the original study was not accurate enough in assessing the scores,the reliability is low.Adverse reaction:12 RCTs observed the safety,of which 7 studies reported adverse reactions.Results showed that the adverse reaction of using traditional Chinese medicine group was significantly lower than the control group.4 ConclusionChinese medicine can improve the clinical curative effect of idiopathic pulmonary fibrosis patients,especially in the impovement of lung function,and there is a huge potential to increase the partial pressure of arterial oxygen,but for the limitations of this systematic review,it is still unable to draw a certain positive conclusion,and more multi-center,large sample randomized controlled clinical trials are needed to provide more relevant evidence.The current methods of TCM clinical trials is generally low,and there is an urgent need to improve the methods of clinical trial's design and implementaion.Chinese medicine treatment of idiopathic pulmonary fibrosis should be based on the syndrome differentiation and prescribe accordingly in order to ensure its clinical efficacy.In clinical research of traditional Chinese medicine,there should includ the evaluation of standard of the quality of life,and moreworks are needed to standardize the observation of the life quality to avoid waste of resources. |
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