| ObjectiveTo observe the influences of nourishing spleen and kidney and blood-activating paste on malnutrition in maintenance hemodialysis (MHD) patients, and to investigate the healing effect and safety of the paste,in order to provide the reference for traditional Chinese medicine (TCM) on undernourished MHD patients.MethodsThe non-randomized contrast Clinical Trial was adapt, to observe the effects of nourishing spleen and kidney and blood-activating paste on malnutrition in MHD patients. All of the MHD patients were from the hemodialysis center of guangdong hospital of TCM. According to the inclusion and exclusion standard,37 patients were incorporated. According to patients whether take the paste, to divided into two groups:treatment group and control group. All the patients were given maintenance hemodialysis, basis of conventional medicine, and dietary guidance. In addition, the treatment group take the paste,3 months for a period of treatment. Observe and record the situation before and after treatment, including anthropometric arameters (BMI, TSF, MAC, MAMC), laboratory examination(Hb, Alb, PA, PCR), SGA score, clinic sign change, safety observation index (hepatic function, plasma lipids, ion etc.). Analysis and evaluate the clinical efficacy and safety of the paste. Using SPSS 17.0 package to do the data statistic analysis. Measurement data was formularized by ((?)±S), using matching t-test and independent sample t-test. P<0.05 was refered to a statistical significance. Results1 A total of 36 cases accessed to the final statistical analysis, each 18 cases for treatment group and control group, while 1 case exited.2 Two groups of patients were comparable in age, gender, age, dialysis age, primary disease, etc. There was no significant statistical difference among them (P> 0.05).3 Comparison of anthropometric index:After treatment, BMI,TSF in treatment group increased, and the differences were significant (P<0.05), and MAC,MAMC were no significant differences before treatment (P>0.05). TSF in control group increased compared with before treatment, and the difference was significant (P<0.05), and MAMC,BMI,MAC were no significant differences before treatment (P>0.05). There wwere no significant differences between treatment group and control group (P>0.05).4 Comparison of laboratory examination indicators:After treatment, Hb, Alb, PA, PCR in treatment group increased, and the differences were significant (P<0.05). Hb, PCR in control group increased, and the differences were significant (P<0.05), Alb, PA were no significant difference (P>0.05). Hb,Alb,PCR in treatment group were higher than that in control group (P<0.05), PA was no significant differences between two groups (P>0.05).5 Comparison of SGA score:After treatment, SGA score in treatment group and control group were both improved (P<0.05). SGA score in treatment group was better comparised with control group (p<0.05). And there were no difference by grading malnutrition according to SGA score.6 The change of clinic symptoms:Compared with the control group, the clinical symptoms of the treatment group were obviously improved, especially weariness, short breath and lazy to talk, eating a little or not feel like eating, abdominal fullness and distention, constipated etc. And the clinical symptoms of the treatment group were almost stable, but some clinical symptoms of the control group were aggravated.7 Safety index:before and after the treatment, the hepatic function (ALT, AST), plasma lipids (TC, TG, LDL-C),ion (k, Ca, P) between the two groups had no significantly changes (P>0.05).Conclusion1 The influence of the nourishing spleen and kidney and blood-activating paste on malnutrition in MHD patients was brought about mainly by the following factors:Firstly, it has greatly raised the level of Alb,Hb,PCR; secondly, it has greatly improved SGA score; thirdly, it has improved the clinical symptoms. In a word, this paste can improve the malnutrition in MHD patients to some extent.2 No adverse event were observed during the clinical observation.3 It's a exploratory study, with a small sample and a short course of treatment, the outcome measures are not accurate.
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