| PurposeThe cl ini cal effi cacy and therapeut ic safety of Chi nes e herbal medi cine in the treat ment of thy roid nodule(TN)were sy stem atical ly evaluated by using Meta-an alys is meth od,and the cli ni cal efficacy of self-prepared Li Qi Xi ao Ying decocti on in the treat ment of th yroid nodule pati ents wit h qi stagnat ion and phl egm coagulati on was observed to provide strong ev idence for the cl inical treatment of TN.cMethod(1)For Meta-analys is,comput er netwo rks were searched for Chi nes e databases such as Chi na Kn owl edge Network Dat abas e(C NKI),Wanfang Database(WANFANGDATA),and Wi pu full-t ext journal database and Engl ish lit erat ure network s such as Pubm ed,Web of Science,and Coch rane Library to coll ect the lit erat ure of randomi zed cont rol led cl inical studi es of Chi nes e herbal medi cine for TN.Meta-an al ys is of the literature was perform ed us ing Rev Man 5.3soft ware,and ris k bias as ses smen t was used for each study literature incl uded in the analysi s to evaluate the study qualit y of th e incl uded study literatu re.(2)For cl in ical obs ervat ion,40 pati ent s wi th thy roid nodul es wh o met the incl us ion and exclusi on cri teria were randoml y div id ed int o an observat io n group and a con trol group.The obs ervat ion group was treated wi th self-prepared Li Qi Xi ao Ying decoct ion,while th e cont rol grou p was treat ed wit h Wu Hai Ying Liu Wan for 3 month s.The size of thyroi d nodules,the sy mpt om scores before and aft er treatmen t,the levels of TSH,FT3 and FT4 were evaluated us ing SPSS2 1.0 soft ware,and the advers e effects were obs erved in both groups before and after treatment.Res ult s1 Meta-a nalysis1.1 Literature search resul tsA to tal of 241 lit erat ure arti cles were ret rieved,26 of which met the cri teria,al l of wh ich were publ ished cl ini cal research lit erat ure on the treatment of TN wit h a tot al sampl e size of 2279 cas es,incl uding1144 cas es in the treatment group(or ob servat ion group(o r experi men tal group))and 11 35 cas es in the cont ro l group(o r comparison grou p).23 of the 26 art icles inv ol ved total effi ciency,13inv ol ved advers e effect s,13 invo lved Chinese medi cin e evidence score,21 nodule diamet ers,14 TSH,10 FT4,11 FT3,3 vit am in D,and5 nodul e vol um es.1.2 Meta-analysi s res ults(1)Treat men t effi cacy analysi s:(1)Total effecti ve rat e:the total effect ive rat e of the treatment group was 81.79%(610/688),and the tot al effecti ve rat e of the co ntrol group was 50.00%(435/679),and the tot al effect of the co mbined compari son was stat ist icall y signi ficant(Z=10.40,P=0.00001<0.05),wi th its 95%Cl confi dence int erval at 4.59(3.45-6.12).It sugges ted that the overall effect ive rat e of therapeut ic int erventions in the treatment group was bett er than that in the control group,which indicated that TCM treat ment of TN has bett er cl inical efficacy.(ii)TCM evidence points:The res ul ts of the heterogeneity test of TCM evidence poi nt s between the treatmen t grou p and the control group(P=0.00001<0.1,I~2=88%)showed that there was greater heterogeneity between the lit erat ure.(3)Nodule size:the heterogeneity of nodule diam eter and nodule volum e aft er treatment was great er in the treat ment and control groups,and sens it ivity an alysi s and subgroup analysi s showed greater heterogenei ty at bot h types of groupi ng,tot al sample size and basel ine level.(4)Thyroi d ho rm on e(TSH)and vit am in D:Among the14 papers usi ng TSH indicat ors,the heterogeneity of TSH level s,FT3level s,FT4 levels,and tot al vit amin D aft er treat ment was greater in the treatment and control groups in each stu dy li terature.(2)Treat men t safet y analysi s:The res ul ts of the test fo r heterogeneity of adv ers e event s in the treatment and cont rol groups(P=0.24>0.1,I~2=25%),the rat e of ad vers e events in the treat ment group was 5.06%(30/593)and the tot al effect ive rate in the control group was 13.06%(76/582),an d the tot al effect of the combined comparison was stat ist icall y sig ni ficant(Z=4.78,P=0.00 001<0.05).(3)Analy si s of the applicat ion of Chinese herbal medi cines:am on g the 73 Chin ese herbal medi cines incl uded in the literatu re,Xia Ku Cao,an anti-swelli ng and dis pers io n medi cine,was used the mos t frequently,up to 18 tim es;fo ll owed by Chai Hu,a liver detoxi ficati on medi cine,us ed 17 ti mes;and Han Xia,a medi cine to dis pers e and res ol ve phlegm,used 16 times.(4)Ev aluation of the qual ity of literature studi es:fro m the scatt er plo ts of pub li cation bias detecti on for the indicat ors of overal l treatmen t effi ciency and advers e event rat e in the treatment and cont rol grou ps,there was so me as ym metry,so the lit erat ure incl uded in thi s stu dy may have so me publi cat ion bias in the indicat ors.2 Cli nica l obs ervationIn the ob servat ion group,the su bject s treated wi th the Chi nes e herbal medi cine self-form ul at ed Li Qi Xi ao Yi ng decoct ion showed signi ficant improvement in thyroi d nodule size,Qi stagnat ion and phlegm coagu lati on sympt om score,TSH,before and aft er treat ment compared wit h the con trol group,wi th a lower incidence of advers e reacti ons and a high er treatment safety.Fin ding s1.Chinese herb al medici ne is effecti ve,safe an d has few side effects in th e treat ment of TN,but fu rther ran domi zed cont rol led tri als wi th large samples,compreh ens iv e and sys temat ic,are needed for furth er study.2.Chi nes e herbal medici ne is effect ive and safe in the treatment of qi-s tag nant phl egm-coagulat ed thy roi d nodules. |
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