The Study On N-of-1Trails For Diabetic Retinopathy By Qiming Granule

Object:Study on efficacy of Qiming Granules on diabetic retinopathy in N-of-1trialsMethods:according to the method of N-of-1trials, we enrolled DR patients met the inclusion criteria, and took the general condition, visual acuity, fundus examination and TCM syndrome integral investigation, filled in Case Report Form (CRF) including general subjective symptoms, tongue and pulse, the stages of DR and relevant laboratory biochemical index and so on. We examined visual acuity using ETDRS visual chart, the fundus examination was through fundus photographs or ophthalmoscope, and the TCM syndrome integral was according to TCM Syndromes scale questionnaire. After each on-medication session we assessed the visual acuity, fundus, efficacy of TCM syndrome and total curative effects, washout period lasted a week, there were2times alternate medication. Finally we entered the case report data into database and analyzed statistically.Result:①According to the N-of-1trials, comprehensive assessment of efficacy showed Qiming granules was better than simulated herbs(P<0.05);②In the N-of-1trials, the difference of therapeutic effect of fundus between Qiming granules and simulated herbs was not statistically significant (P>0.05), but there were some trendy choosing Qiming granules;③In the N-of-1trials, compared the therapeutic effect of visual acuity between Qiming granules and simulated herbs, it was not statistically significant (P>0.05);④the proportion of terminal herb mix choosing Qiming Granules is57.6%, showing there was a certain effect of Qiming Granules;⑤No adverse events occurred during this study.Conclusion:①In the short time efficacy assessment of the N-of-1trials, Qiming Granules had a certain effect on visual acuity, fundus changes, and whole TCM syndrome;②N-of-1trials was be suitable for DR study, and it was beneficial to patients choosing suitable treatment schemes;③Qiming Granules was safty in clinical use. and there was no obvious adverse reaction.