ABSTRACT
Objective To prepare quality control material of β2-microglobulin (β2 MG),then evaluate the quality of it.Methods The quality control material of β2-MG was prepared with pooled serum from patients.Then according to Guidance on Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing and ISO Guide 35,the homogeneity and stability of it was evaluated.Results According to the result of homogeneity test,there was no statistically significant difference between within groups and between-groups (F=0.699,2.091,all P＞0.05) for 2 levels of quality control materi al.What was more,the stability test showed that it could stabilize for at least 5 days at 25 ℃ (t=-1.76,-2.64,all P＞ 0.05),28 days at 4 ℃ (t=-1.86,-2.44,all P＞0.05),4 months at-20 ℃ (t=0.26,-2.68,allP＞0.05),and 1 yearat -80℃ (t=-0.96,0.01,all P＞0.05).Conclusion Quality control material of β2-MG has simple preparation.The homogeneity and stability of it meets the standard requirements.
ABSTRACT
<p><b>OBJECTIVE</b>To observe the clinical effect of self-formulated Tongdatang serial recipe (TDT) in treating antipsychotic drug-induced galactorrhea-amenorrhea syndrome (GAS).</p><p><b>METHODS</b>One hundred female schizophrenic patients with antipsychotic drug-induced GAS were selected and equally assigned to the treatment group and the control group at random. Both received antipsychotic drug-therapy, but combined with TDT and placebo respectively. The efficacy was evaluated by determining prolactin level before, 4 and 8 weeks after treatment.</p><p><b>RESULTS</b>The treatment course was completed in 96% of patients. Therapeutic efficacy on the 49 patients of the treatment group was cured in 31 (63.3%), markedly effective in 11 (22.4%), effective in 4 (8.2%) and ineffective in 3 (6.1%), with total effective rate of 93.9%, while in 47 patients of the control group, the corresponding cases (%) was 0, 3 (6.4%) , 7 (14.9%) and 37 (78.7%), respectively, with the total effective rate of 21.3%. Prolactin levels in the two groups were insignificantly different before treatment, it reduced in the treatment group after treatment (P < 0.01), and the decrement in the treatment group was more significant than that in the control group (P < 0.05).</p><p><b>CONCLUSION</b>Satisfactory effect could achieved by using TDT for treatment of antipsychotic drug-induced GAS.</p>