| Objective:The efficacy and safety of supplementing qi and nourishing yin combined with chemotherapy and chemotherapy alone in the treatment of adult acute leukemia(AL)were compared by meta-analysis,so as to provide evidence-based basis for the treatment of adult AL with integrated Chinese and Western medicine.Methods : In this study,through systematic evaluation and meta-analysis,the objective remission rate,total survival time and the effective rate of TCM syndrome improvement were used as the main outcome indicators to comprehensively compare the efficacy and safety of TCM decoction with the efficacy of supplementing qi and nourishing yin,TCM injection combined with chemotherapy and chemotherapy alone in the treatment of adult AL.Randomized controlled trials(RCTs)were retrieved from Cochrane Library,Pub Med,Embase,China Knowledge Resource Database(CNKI),China Academic Journal Database(Wanfang Data),Chinese Science and Technology Periodical Database(VIP)and China Key Conference Papers Full-text Database.The retrieval time was from the establishment of the database to October 31,2020.Two reviewers independently completed the screening,and the quality of the included literature was evaluated.Finally,Rev Man 5.3 software was used for statistical analysis.Results:1.A total of 18 RCTs and 1356 patients were included,with sample sizes ranging from 40 to 120.Among them,672 patients in the Yiqi Yangyin TCM combined with chemotherapy group(experimental group)and 664 patients in the chemotherapy group(control group)were included.Among them,the intervention measures in eight studies were Shenmai injection,and the remaining 10 studies were Chinese herbal decoctions.The age span of patients included in the study was large,distributed between 35-71 years old.The treatment cycle was different,with the shortest of 7 days and the longest of 8 weeks.The quality of included studies was evaluated according to the Cochrane bias risk assessment tool,which were all at high risk of bias.According to the modified Jadad scale,2 articles scored 4 points and 16 articles scored 3 points.2.Meta-analysis results showed that in terms of main outcome indicators,the combined treatment group(n=627)improved the objective remission rate compared with the chemotherapy group(n =595)[RR1.21,95 % CI(1.13,1.29)].There were only two references on survival time.Since the data were not specific,no Meta-analysis was conducted.There was no significant difference in the effective rate of TCM syndrome improvement between the combined treatment group(n = 60)and the chemotherapy group(n=60)[RR 1.87,95 % CI(0.88,3.98)].In terms of secondary outcome indicators,the WBC in peripheral blood of the combined treatment group(n = 350)was higher than that of the chemotherapy group(n = 328)[MD0.80,95%CI(-0.18,1.78)] and2.HGB [MD7.51,95%CI(-1.01,16.02)],PLT [MD10.77,95 % CI(-0.49,22.04)],the results were not statistically significant.In terms of safety indicators,the combined treatment group(n = 252)reduced liver damage [ RR 0.29,95 % CI(0.19,0.46)] and renal damage [RR0.50,95%CI(0.31,0.81)] compared with the simple chemotherapy group(n=225).The combined treatment group(n=126)reduced cardiac damage compared with chemotherapy alone group(n=121)[ RR 0.43,95%CI(0.23,0.81)].The combined treatment group(n=194)reduced gastrointestinal reactions compared with chemotherapy alone group(n=189)[RR 0.61,95%CI(0.48,0.76)],and the combined treatment group(n =228)reduced the incidence of infection compared with chemotherapy alone group(n = 228)[ RR 0.55,95 % CI(0.43,0.70)].3.Subgroup analysis was carried out according to the dosage form,age and disease stage of traditional Chinese medicine.The results showed that the objective remission rate of non-elderly group [RR 2.98,95%CI(2.02,4.39)] and the objective remission rate of elderly group [RR 1.54,95% CI(1.05,2.26)] were statistically significant.8 Shenmai injection group(traditional Chinese medicine injection)objective remission rate[RR 1.09,95%CI(1.00,1.19)]results were not statistically significant,9 traditional Chinese medicine decoction group objective remission rate [RR 1.32,95%CI(1.20,1.46)] results were statistically significant.The objective remission rates of 2 relapsed and refractory groups [RR 1.72,95%CI(1.15,2.57)] and 16 newly treated groups [RR1.18,95%CI(1.10,1.26)] were statistically significant.4.In the included RCT studies,blind method and distribution concealment were not implemented,so the sensitivity analysis of grouping concealment and blind method was not carried out.17 studies reported the objective remission rate,and the publication bias test was carried out with this index.All data were symmetrical and concentrated in the funnel plot,so it was considered that there was no publication bias in the literature of this study.5.Through the manual statistics of the intervention of traditional Chinese medicine included in the literature,the frequency of traditional Chinese medicine from high to low is astragalus,licorice,asparagus,radix Pseudostellariae,habitat,Codonopsis,Ligustri Lucidi,wolfberry..Conclusions:Meta-analysis results showed that the efficacy of supplementing qi and nourishing yin combined with chemotherapy in the treatment of adult AL was better than that of chemotherapy alone,and the side effects of chemotherapy could be reduced.But for improving TCM symptoms,improve peripheral blood WBC,HGB,PLT no statistical significance.The curative effect of traditional Chinese medicine decoction of tonifying qi and nourishing yin in the treatment of adult AL is clear,and it is recommended to apply large doses of astragalus membranaceus,licorice,radix Pseudostellariae,Codonopsis,asparagi,habitat,Fructus Ligustri Lucidi and Fructus Lycii on the basis of syndrome differentiation.However,due to the methodological quality of the selected literature is medium,the sample size is small,the implementation of most blind methods is not clear,the case of shedding and the reasons are mostly not mentioned,and the intervention of traditional Chinese medicine prescription is inconsistent with the drug taste,dose,course of treatment,dosage form and so on,resulting in unable to draw a clear conclusion.In the future,a large number of rigorous,multi-center and large-scale random experimental studies are still needed. |
PDF Full Text Request