| Objective：With the prevalence of diabetes mellitus growing, diagnosisand treatment of the two most common acute complications ofdiabetes—diabetic ketosis and diabetic ketoacidosis—are still the focus ofattention. Because diabetes ketosis will not only cause a range of unwellsymptoms, but when it develops to diabetic ketoacidosis, diabetes ketosiswould endanger the life safety. Therefore the early definite diagnosis andtimely treatment of diabetic ketosis and ketoacidosis are the goals of generalscholars to strive. Research has shown that, testing beta-hydroxybutyric acidin blood is more accurate than testing acetacetic acid, and more conducive tothe diagnosis and treatment. But due to conditions restriction and lacking ofawareness, many medical institutions usually apply the method of testingacetacetic acid in urine to diagnose diseases and judge curative effect.Therefore, this clinical trial is aimed at obtaining the correlation of urineketone and blood ketone by observing the results of them on diabetic ketosisand diabetic ketoacidosis treatment process, so as to guide the treatment.Methods:1Study Participants:①I n accordance with WHO diagnostic criteria for diabetes mellitus in1999；②B etween the ages of18to80years old；③Random blood sugar is greaterthan or equal to13.9mmol/L，and the detection result of beta-hydroxybutyricacid is greater than or equal to0.6mmol/L.2Exclusion Participants:Exclusion of gestational diabetes， diabetes in pregnancy and secondarydiabetes.3Intervention Measures:①F luid infusion and its speed: Fluid infusion ofthe first day is10%of the weight, and in the first4hours we should supply the fluid accounted for aquarter to one third of the all day’s amount. Serious patients need to add1000ml liquid in the first hour and two-thirds fluid of the all day’s amount inthe first8to12hours.②Application of small dose of insulin: Add0.1u/kg/hinsulin in physiological saline at the start of the treatment, and continueintravenous infusion. We should review once blood sugar, blood ketone andurine ketone per hour during intravenous injection. If the decrease of bloodglucose level is less than the original30%or no significant decline after twoto four hours injection, we can double the insulin dose. When blood glucosedowns to about13.9mmol/L, we start using5%glucose solution addedinsulin (according to the proportion of a unit insulin with three to four gramsof glucose) to the intravenous drip, and continue to review once blood sugar,blood ketone and urine ketone every hour. Adjust the dose of insulindepending on blood sugar. Keep blood sugar at about10mmol/L, until thedetection result of blood ketone is less than0.6mmol/L.4Data collection:Before treatment, we need measuring once blood sugar, blood ketone andurine ketone (including two methods of urine ketone test strips and ketonebody powder). From every one hour after the start of treatment we shouldreview one times of blood sugar, blood ketone and urine ketone, until theblood ketone numerical value falls below0.6mmol/L. After one hour,measuring blood glucose, blood ketone and urine ketone one more time.5Statistical analysis:Application SPSS13.0statistical software, the result is represented by mean±standard deviation （x±s）.Application SAS9.1.3statistical software forstatistical analysis, there is no difference between the detection results ofblood ketone method and urine ketone method. If we wonder whether thereare differences between the positive rate obtained by blood ketone method andurine ketone method respectively, we should use McNemar X2to test（P＜0.001）. Then fill the data into a bidirectional orderly R*C table, andaccording to different attributes use the method of Spearman rank correlation analysis, or the same properties use the Kappa consistency test method. Whenthe detection results of blood ketone, urine ketone test strips and ketone bodypowder is used to reflect the condition of diabetic ketoacidosis, the results canbe identified as the same attributes. When the above three results are used toindicate different substances, the results can be identified as differentattributes. In the Spearman rank correlation analysis, when P value is less than0.05, correlation coefficient rs has statistical significance: rs is less than orequal to0.4for the weak correlation, rs greater than0.4and less than or equalto0.7for moderate correlation, rs greater than0.7for strong correlation. InKappa consistency test, when the human factors play a role, we need to applyweighting Kappa coefficients and its hypothesis testing. Because there areartificial intervention measures in this research, so the human factors play arole. In the bilateral hypothesis test, when P value is less than0.05, Kappacoefficient is statistically significant. Kappa value of consistent stand for:0to0.20for low consistency (slight),0.20to0.40for general consistency (fair),0.40to0.60for medium consistency (moderate),0.60to0.80for highconsistency (substantial) and0.80to1are almost identical (almost perfect).Results:1paired t-test results: Detection results by blood ketone method along with thetreatment time in the course of treatment. D-values of former and latteroutcome are both positive, and the mean of d-values has statisticalsignificance（P＜0.001）.2McNemar X2test results:The two test methods of blood ketone and urine ketone test strips are notconsistent, and the differences of the inconsistent parts have statisticalsignificance(P＜0.0001); The two test methods of blood ketone and ketonebody powder are not consistent, and the differences of the inconsistent partshave statistical significance (P＜0.0001).3The analysis results of Spearman rank:3.1The comparison of blood ketone method and urine ketone test stripsmethod: When random blood ketone is greater than or equal to0.6mmol/L as well as less than or equal to3.0mmol/L, the two have high correlation（rs=0.72868）, rshas statistical significance（P＜0.0001）.3.2The comparison of blood ketone method and ketone body powder method:When random blood ketone is greater than or equal to0.6mmol/L as well asless than or equal to3.0mmol/L, the two have high correlation（rs=0.76628）,rshas statistical significance（P＜0.0001）.3.3Determination results of urine ketone test strips change with treatmenttime after the start of treatment: Determination results of urine ketone teststrips and treatment time have medium correlation（rs=0.60698）, rshasstatistical significance（P＜0.0001）; When random blood ketone is greaterthan3mmol/L or between2mmol/L to3mmol/L, the two have highcorrelation, and the correlation become highest in the first three hours after thestart of treatment（the value of rsis0.74604，0.80017respectively）, rshasstatistical significance（P＜0.0001）; When random blood ketone is between1mmol/L to2mmol/L, the two have medium correlation（rs=0.62202）, rshasstatistical significance（P＜0.0001）; When random blood ketone is between0.6mmol/L to1mmol/L, the two have low correlation（rs=0.3483）, rshasstatistical significance（P＜0.0001）.3.4Determination results of ketone body powder change with treatment timeafter the start of treatment: the correlation between ketone body powder andtreatment time is low（rs=0.40735）, rs has statistical significance（P<0.0001）;When random blood ketone is greater than3mmol/L or between2mmol/L to3mmol/L, the two have medium correlation, and the correlation becomehighest in the first three hours after the start of treatment（the value of rsis0.66599，0.55347respectively）, rshas statistical significance（P＜0.005）;When random blood ketone is between0.6mmol/L to2mmol/L, the two havelow correlation（rs=0.16717）, rshas statistical significance（P＜0.005）.4The results of Kappa consistency test:4.1The comparison of blood ketone method and urine ketone test stripsmethod: Before treatment, the two have medium consistency (WeightingKappa=0.559), Kappa coefficient has statistical significance（P＜0.0001）; When random blood ketone is greater than or equal to0.6mmol/L and lessthan or equal to3.0mmol/L, the two have high consistency (WeightingKappa=0.6811), and Kappa coefficient has statistical significanc（eP＜0.0001When random blood ketone is greater than3.0mmol/L, the consistency isextremely low (Weighting Kappa=0.0304), and Kappa coefficient has nostatistical significance（P=0.8668）; After treatment, the two have generalconsistency（Weighting Kappa=0.2039）, but Kappa coefficient has statisticalsignificance （P＜0.0001）.4.2The comparison of blood ketone method and ketone body powder method:Before treatment, the two have medium consistency (WeightingKappa=0.4458), and Kappa coefficient has statistical significance （P＜0.0001）; When random blood ketone is greater than or equal to0.6mmol/Land less than or equal to3.0mmol/L, the two have high consistency(Weighting Kappa=0.7092), and Kappa coefficient has statistical significance（P＜0.0001）; When random blood ketone is greater than3.0mmol/L, theconsistency is extremely low (Weighting Kappa=-0.5283), and Kappacoefficient has statistical significance（P=0.0053<0.05）; After treatment, thetwo have general consistency （Weighting Kappa=0.3785）, but Kappacoefficient has statistical significance （P＜0.0001）.4.3The comparison of urine ketone test strips method and ketone bodypowder method: In the whole treatment, the two have high consistency(Weighting Kappa=0.6029), and Kappa coefficient has statistical significance（P＜0.0001）.Conclusion:1In the treatment of diabetic ketosis and diabetic ketoacidosis, thepositive rate of diagnosis of blood ketone method is better than that of urineketone method. When random blood ketone is less than or equal to3.0mmol/L, urine ketone method could replace blood ketone method for the earlydiagnosis of disease.2After the start treatment of diabetic ketosis and diabetic ketoacidosis,beta-hydroxybutyric acid concentration in blood is declining gradually. The concentration of acetacetic acid has a trend that first increased or unchangedthen decreased. Especially in the first3hours of treatment, when randomblood ketone is greater than or equal to2.0mmol/L, this trend is moreobvious．... |
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