| Objective This study was to evaluate the efficacy and safety of the TCM stepped therapy of Qingre Zhixue Granules combined with Tripterygium Wilfordii and tanshinone IIA sodium injection for he-maturia and proteinuria in children with HSPN,and to observe the function of the phased Chinese medicine treatment on improving the indicators of urine radioimmunoassay,blood coagulation,humoral im-munity and cell-mediated immunityMethods 32 children with HSPN who were hospitalized in the 5 research centers and met the inclusion criteria,were enrolled in this study and all randomized through the central randomization system according to the ratio of 2:1.All the children were divided into 2 groups randomly,19 cases in TCM treatment group and 13 cases in western medicine control group. According to the severity of disease,The TCM treated group were divided into TCM group 1 (severe group) group and TCM group 2 (mild group),and treated hierarchically by the TCM stepped therapy of Qingre Zhixue Granules combine with Tripterygium Wilfordii and tanshinone IIA sodium inj ection;the western medicine control group were into western medicine control group 1 (severe group) group and western medicine control group 2 (mild group),treated hie-rarchically by prednisolone, dipyridamole and the bend heparin calcium injecttion.The total period of treatment last 12 weeks.The 2nd,the 4th, the 8th and the 12th weekend were chosen as the main observation points in total trial.We would observe the change of clinical symptoms and laboratory in-dicators for evaluating the efficacy and safety before and after treatment.Results (1) Proteinuria efficacy:At the 2nd,the 4th, the 8th and the 12th weekend,2 therapies all can reduce the urine protein in the child-ren with HSPN,and showed no significant differences (p> 0.05).The rate of the TCM treated group was 68.42%,94.44%,93.75%,100% in the cure and significant efficacy at the 2nd,the 4th, the 8th and the 12th weekend,the control rates was 15.59%,44.44%,43.75%,44.44% respectively;The rate of the western medicine control group was 38.46%、 91.67%、100%,100% in the cure and significant efficacy at the 2nd,the 4th, the 8th and the 12th weekend,the control rates was 7.69%、25.00%、 45.45%、88.89% respectively. Comparison of the severity classification: at the 2nd,the 4th, the 8th weekend of treatment, there were no significant differences (p> 0.05) in efficacy between TCM treatd group 1 and western medicine group 1, and between TCM group 1 and western medicine group 2; because of the small sample size, Western medicine group 1 and Western medicine group 2 cannot be compared at the 2nd,the 4th, the 8th and the 12th weekend, the TCM groups and control groups can not be compared at the 12th weekend. (2) Hematuria efficacy:Two groups won’t differrence significantly (p> 0.05) at the 2nd,the 4th,the 8th weekend,The TCM treated group showed significantly better cure and significant efficacy than the western medicine control group at and the 12th weekend(/?< 0.05). The rate of the TCM treated group was 31.58%、33.33%、56.25%、70% in the cure and significant efficacy at the 2nd,the 4th, the 8th and the 12th weekend,the effctive rates was 42.11%、38.89%、68.75%,90.00% respectively; The rate of the western medicine control group was 23.08%、25.00%、36.36%,33.33% in the cure and significant efficacy at the 2nd,the 4th, the 8th and the 12th weekend,the effective rates was 23.08%、25.00%、36.36%,33.33% respectively. Comparison of the severity classification:at the 2nd,the 4th, the 8th weekend of treatment, there were no significant differences (p>0.05) in efficacy between TCM treatd group 1 and western medicine group 1, and between TCM group 1 and western medicine group 2; because of the small sample size, Western medicine group 1 and Western medicine group 2 cannot be compared at the 2nd,the 4th, the 8th and the 12th weekend, the TCM groups and control groups can not be compared at the 12 th weekend. (3) The efficacy of Each type in the TCM treated group couldn’t be compared due to the small amount of cases. (4) TCM treatment group showed better curative effect for blood coagulation of than western medicine group.(5)Two therapies all can improve the indi-cators of URI, humoral immunity and cell-mediated immunity,but didn’t show significant differences. (6) The security didn’t show significant differences in two groups(p>0.05).Conclusion (1)The TCM stepped therapy of Qingre Zhixue Gra-nules combine with Tripterygium Wilfordii and tanshinone IIA sodium injection was significant superior for proteinuria and hematuria in children with HSPN without serious side effects,and showed beter efficacy in proteinuria than hematuria.(2)Both 2 therapies are effective treatment options for HSPN,and the TCM treatment was superior to the western medicine treatment in urinary protein clearance time;at the 12th weekend, the efficacy of the TCM group of hematuria is superior to Western medicine group, with the advantages of fast onset time and better efficacy;(3)This TCM stepped therapy can improve the indi-cators of URI, coagulation and IgA in humoral immunity in children with HSPN effectively. It should be noted that this study is a part of the project of the national "the 12th Five-year Plan" issue, because of the limited time leading to a small sample size, so that only preliminary conclusions can be made which need to be tested by the study with a larger sample size that would have done. |
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