| ObjectiveThis study aimed to analyze the efficacy and safety of TCM combined with prednisone and leflunomide in the treatment of lupus nephritis,and focus on the literature published nearly 10 years to study the present situation of integrative medicine in the treatment of lupus nephritis by Bibliometric analysis。MethodsFirst,we conducted a retrospective study of TCM combined with prednisone and leflunomide in the active lupus nephritis patients visited the department of Nephrology in our hospital from 2009 to 2016.It demanded that the course last for not less than 6 months.At last,32 patients were included,and all patients’ gender,age,course of disease,pathology,history,medication status,TCM syndromes were recorded at baseline.The levels of urinary protein,urinary erythrocyte count,Scr,ALB,complement C3,anti-ds-DNA,TCM syndromes were recorded during the treatment period;The primary indicator was complete remission and total effective rate and would recorded in the 3rd,6th and 12th months,the second indicator were recurrence rates,the study was performed until December 2016,and the adverse reactions observed during the study.Second,Retrieve the literature published in the VIP "Chinese Technology Journal Net Database"(full version)、CNKI、CBM、WanFang data "China Science Periodical Database" about clinical research of integrative medicine in the treatment of lupus nephritis in 2007-2016,and descriptive analysis the data,such as number of articles,the sample size,treatment,efficacy,TCM syndromes,prescription composition,gathered in the literature.Results1.Retrospective analysisA total of 32 patients were enrolled in the study,with an average age of 33.97±12.41 years,median duration of disease of 46.1(11-68.7)months.Among them,26 patients were female and 6 were male,6 had hypertension and 14 had CTX or MMF ineffective or recurrence before;In the renal pathological category,18 cases were class Ⅳ or Ⅳ + Ⅴ,5 cases class Ⅲ,3 cases class II and 6 cases no renal biopsy.Finally,in the 3rd,6th,12th month,the complete remission rate was 3.13%,21.88%,31.26%respectively,the total effective rate was 50%,90.63%,84.39%respectively,and the TCM syndrome effective rate was 84.38%,93.75%and 96.55%respectively.The level of 24h urinary protein,erythrocyte count,Scr,ALB,complement C3,anti-ds DNA,TCM syndrome scores,SLEDAI scores improved significantly(P<0.05);The observation time ranged from 6 to 56 months,average(21.53±13.75)months,renal flare were observed in 2 patients,systemic flare were observed in 1 patients,the recurrence rate was 10.34%,time to flare was ranged from 9 to 14 months,average(12±2.65)months.Adverse events,included infection(25%),elevated liver enzymes(3.13%),leukopenia(3.13%),herpes zoster(3.13%),diarrhea(3.13%)and irregular menstruation(3.13%),were mild and disappeared after treatment,and infection is mainly upper respiratory tract infection(15.63%).The most common TCM syndrome was spleen and kidney qi/yang deficiency syndrome,and the most common empirical was blood stasis syndrome,followed by damp-heat syndrome,and blood stasis medicine,heat dampness medicine use the most in the study.2.Bibliometric analysisA total of 93 clinical studies were included,there were 11(11.83%)of the non-control group,8(8.6%)of the non-randomized controls,3(3.23%)of false randomized and 71(76.34%)of the randomized control trials.Among 71 RCTs,12 of them described specific randomized methods,only one was blinded,randomly hidden and the sample size estimation was not clear.In the sample size,3(3.23%)of the studies’ sample size were more than 100 cases and 56(60.22%)were 59-99 cases,the rest 34(36.53%)less than 50 cases;As for western medicine treatment,53(56.99%)studies were prednisone with CTX,the rest were prednisone alone and immunosuppressive agents alone,prednisone or with immunosuppressive agents;As for the integrative medicine treatment,91(97.85%)studies were treated with Chinese medicine or traditional Chinese medicine decoction on the basis of western medicine treatment,and self-made prescription accounted for 37.63%.All the studies gave a treatment for 0.5 to 24 months,average 5.86 months;The effective criteria were different in most studies,80(86.02%)studies reported the total effective rate in the range of 74%-100%,and 92.96%of randomized controlled trial suggested that the total effective of the treatment group was significantly better than that of the control group.Overall,the combination of traditional Chinese and western medicine in the treatment of lupus nephritis was superior to that of western medicine alone,but the quality of the literature was low.ConclusionChinese medicine combined with prednisone and leflunomide in the treatment of active lupus nephritis is a promise therapy,with low recurrence rate and nice tolerance.Bibliometric analysis suggested that the efficacy of combined traditional Chinese with prednisone and immunosuppressive agents was better,but the quality of all the literature is low,the evidence is not strong. |
PDF Full Text Request