宁泌泰胶囊治疗糖尿病尿路感染的临床疗效观察

Clinical observation on efficacy of Ningmitai capsule for treatment of patients with diabetic urinary tract infection

目的：观察宁泌泰胶囊治疗糖尿病尿路感染的临床疗效。方法选择贵州省遵义市第一人民医院和山东省龙口市计划生育服务站收治的100例糖尿病尿路感染患者，在得到受试者知情同意后按随机方法将患者分对照组和试验组。在降糖治疗基础上，试验组65例用宁泌泰胶囊（4粒/次，每粒0.38 g）治疗，对照组35例用三金片（4粒/次，每粒0.29 g）治疗，两组均每日3次，2周为1个疗程。观察两组治疗前后临床疗效、血常规、尿常规、血糖、中段尿细菌培养转阴率和中医证候疗效及不良反应。结果试验组总有效率明显高于对照组〔88.52%（54/61）比70.59%（24/34），P＜0.01〕。两组治疗前尿中红细胞计数（RBC）、白细胞计数（WBC）及血中RBC、WBC、血红蛋白（Hb）、血糖比较差异均无统计学意义（均P＞0.05）。试验组治疗后尿中RBC、WBC均较治疗前降低；对照组RBC较治疗前升高，WBC较治疗前降低，试验组RBC和WBC与对照组比较差异均有统计学意义〔RBC（个/μL）：1.99±0.59比9.11±3.76，WBC（个/μL）：23.09±6.18比63.72±25.76，均P＜0.05〕；对照组治疗后血RBC较治疗前明显降低（×109/L：3.93±0.40比4.02±0.39，P＜0.05）。两组治疗后WBC、Hb及血糖均较治疗前有所降低，但差异均无统计学意义（均P＞0.05）。试验组中段尿细菌培养阳性转阴率较对照组明升高〔80%（4/5）比0（0/2）〕。治疗后两组各项中医证候均有不同程度的改善，试验组改善尿急、尿色黄赤、少腹胀痛的有效率明显高于对照组〔尿急：90.0%（54/60）比61.8%（21/34），尿色黄赤：75.0%（39/52）比47.6%（10/21），少腹胀痛：74.5%（35/47）比70.6%（12/17），P＜0.05或P＜0.01〕，但其他各症状两组比较差异均无统计学意义（均P＞0.05）。结论宁泌泰胶囊治疗糖尿病尿路感染的临床疗效优于三金片，临床观察中未见不良反应发生。

ObjectiveTo explore the clinical efficacy of Ningmitai capsule for treatment of patients with diabetic urinary tract infection.Methods A total of 100 diabetes patients with urinary tract infection from Zunyi First People＇s Hospital in Guizhou Province and Longkou Family Planning Service Station in Shandong Province wereenrolled in the study and randomly divided into control and treatment groups after they were informed and gave consent. With basic therapy to lower blood glucose, 65 cases in the treatment group were treated with Ningmitai capsule（4 granules/time, every grain of 0.38 g）, while another 35 cases of the control group were given Sanjin tablets （4 granules/time, every grain of 0.29 g）, 3 times a dayfor 2 weeks in both groups. Before and after treatment, the clinical effect, blood routine, urine routine, blood glucose, negative conversion ratio of midstream urine bacteria culture and tradition Chinese medicine syndrome curative effect in both groups were observed.Results The total effective rate of treatment group was significantly higher than that of the control group〔88.52%（54/61） vs. 70.59%（24/34）,P〈0.01〕. Before treatment, the differences in red blood cell（RBC） and white blood cell（WBC） count in urine samples as well as RBC, WBC, hemoglobin（Hb） and glucose in blood samples had no statistical significance in the comparisons between the two groups（allP〉0.05）. Compared with those before treatment, after treatment, the urinary RBC and WBC were decreased in treatment group, while in control group WBC was decreased but RBC increased, and in the comparisons of above indexes between the two groups there were statistical significant differences〔RBC（cell/μL）： 1.99±0.59 vs. 9.11±3.76, WBC（cell/μL）： 23.09±6.18 vs. 63.72±25.76, bothP〈0.05〕. The blood RBC was significantly lowered after treatment in control group（×109/L： 3.93±0.40 vs. 4.02±0.39,P〈0.05）. In both groups, after treatment, WBC, Hb and glucose in blood were reduced in comparisons to those before treatment, and no statistical significant differences were found（allP〉0.05）. Negative conversion ratio of midstream urine bacterial culture in treatment group was significantly higher than that in control group〔80%（4/5） vs. 0（0/2）〕. Syndromes of traditional Chinese medicine were ameliorated at different degrees after treatment in both groups. The effectiveness of treatment group on urinary urgency, yellowish turbid urine and swelling pain in lower abdomen were obviously more valid than that of control group〔urinary urgency： 90.0%（54/60） vs. 61.8%（21/34）, yellowish turbid urine： 75.0%（39/52） vs. 47.6%（10/21）, swelling pain in lower abdomen： 74.5%（35/47） vs. 70.6%（12/17）,P〈0.05 orP〈0.01〕, but other symptoms were similar in the two groups（allP〉0.05）.ConclusionThe clinical efficacy of Ningmitai capsule is better than that of Sanjin tablet for treatment of patients with diabetic urinary tract infection, and no adverse reaction has been seen in clinical observation.