Abstract
The aim of this meta-analysis was to evaluate the clinical efficacy and safety of tripterygium glycosides in treatment of stage IV diabetic nephropathy. Methods Through searching the PubMed and CNKI databases, the open published clinically controlled trials related to efficacy and safety of tripterygium glycosides in the treatment of stage IV diabetic nephropathy were collected. The pooled total efficacy, 24h urinary protein, serum creatinine and tripterygium glycosides related toxicity were calculated using Stata 11.0 software. Results Fourteen publications including 992 subjects (512 in the experimental group and 480 in the control group) were included in this study. Eight studies reported the total clinical efficacy comparing the experiment and control groups. No significant statistical heterogeneity was found in total efficacy (I(2)=24.9%, p>0.05). Thus, the combined odds ratio (OR) was pooled by fixed effect model. The pooled OR=4.16 with its 95% CI 2.71~6.37 (p<0.05), which indicated the total efficacy in the experiment group, was significant higher than that of control group (p<0.05); Thirteen studies reported the post-treatment 24h urinary protein value. Statistical heterogeneity analysis indicated significant heterogeneity across studies (I(2)=91.1%, p<0.05); that data was pooled by a random effects model. The combined standardized mean difference (SMD) was -1.55 with its 95% I -2.06~1.03, (p<0.05). The results indicated that post-treatment 24h urinary protein in the experiment group was significant lower than that in control group (p<0.05); Ten studies reported the post-treatment serum creatinine. Significant heterogeneity existed across those studies (I(2)=82.3%, p<0.05). Thereafter, the data was pooled by a random effect model. The combined standardized mean difference (SMD) was -0.24 with its 95%CI -0.40~0.09, (p<0.05). The results indicated that the post-treatment serum creatinine in experiment group was significant lower than that of control group (p<0.05); Eight studies reported tripterygium glycoside-associated toxicity such as liver function damage, gastrointestinal reactions and menstrual disorders. With no statistical heterogeneity among the studies, the data was pooled by fixed effect model. The pooled OR=6.42 (95%CI 2.23~18.48, p<0.05). The pooled results showed the tripterygium glycoside- associated toxicity incidence rate was significant higher in the experiment group than that of the control group (p<0.05); There were no publication bias for effect size of total efficacy, 24h urinary protein, and serum creatinine. However, for tripterygium glycoside-related toxicity, the publication bias was significant (t=-3.55, p<0.05). Conclusion The present evidence shows that tripterygium glycosides can improve clinical efficacy, reduce the 24h urinary protein and serum creatinine, but that they increase the tripterygium glycoside-related toxicity in treatment of stage IV diabetic nephropathy.