肾康宁胶囊联合用药治疗肾阳虚证导致排尿功能障碍的临床研究

吴瑞艳 胡光 崔淑华 张悦 王芳 张宁

摘要 目的：评价肾康宁胶囊联合用药治疗肾阳虚证患者的临床疗效和安全性。方法：选取2018年5月至2018年10月间黑龙江中医药大学附属第二医院等收治的肾阳虚型患者360例作为研究对象，以区组随机法均分为对照组、联合观察组和葡萄糖酸锌组，每组120例，并给予对应方案进行治疗。记录3组患者在治疗前、治疗4周后、治疗8周后的夜尿量、尿频（日尿）次数、尿失禁现象、尿急次数，進行中医证候的量化评分，评估3组的临床总有效率及单项症状的消失率、生命质量和不良反应等。结果：3组患者在治疗后其夜尿、尿失禁、尿频、尿急的中医证候量化积分均优于治疗前（P<0.01）。患者的总有效率如下：治疗4周后分别为联合观察组74.34%、葡萄糖酸锌组59.32%、对照组56.25%，治疗8周后分别为联合观察组92.92%、葡萄糖酸锌组77.12%、对照组63.39%。结论：肾康宁胶囊联合用药治疗肾阳虚排尿疾病患者疗效显著，可以明显减少夜尿和日尿次数，改善尿失禁、尿频、尿急症状，提高患者生命质量，且安全可靠。

关键词 肾阳虚;肾康宁胶囊;南瓜籽花粉;葡萄糖酸锌;尿频;尿急;尿失禁

Clinical Study of Shenkangning Capsule Combined with Medication in the Treatment of Urinary Dysfunction Caused by Renal Yang Deficiency Syndrome

WU Ruiyan1，HU Guang1，CUI Shuhua1，ZHANG Yue1，WANG Fang1，ZHANG Ning2

（1 Letai Pharmaceutical Co.，Ltd.，Harbin 150525，China; 2 Heilongjiang University of Traditional Chinese Medicine，Harbin 150040，China）

Abstract Objective：To evaluate the clinical efficacy and safety of Shenkangning Capsule in the treatment of kidney yang deficiency syndrome.Methods：A total of 360 patients with kidney yang deficiency in the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine from May 2018 to October 2018 were selected as the research objects and were randomly divided into 3 groups：a control group，a combined treatment group and a zinc gluconate group.The 3 groups were given the corresponding plan for treatment.The nocturnal urine volume，frequency（daily urine），urinary incontinence and urgency were recorded before treatment，4 weeks after treatment and 8 weeks after treatment.The quantitative score of traditional Chinese medicine（TCM）syndrome was performed，and the clinical total effective rate，disappearance rate of single symptom，quality of life and adverse reactions of the 3 groups were evaluated.Results：After treatment，the scores of TCM syndrome of nocturia，urinary incontinence，frequency of urination and urgency in 3 groups were better than those before treatment（P<0.01）.The total effective rates were as follows：74.34% in the combined treatment group，59.32% in the zinc gluconate group and 56.25% in the control group after 4 weeks of treatment，and 92.92% in the combined treatment group，77.12% in the zinc gluconate group and 63.39% in the control group after 8 weeks of treatment.Conclusion：Shenkangning Capsule combined with medication in the treatment of urinary disease with kidney yang deficiency has significant curative effect，can significantly reduce the number of night urine and daily urine，improve the symptoms of urinary incontinence，frequency and urgency，improve the quality of life of patients，which is safe and reliable.

Keywords Shenyang deficiency; Shenkangning Capsule; Pumpkin seed pollen; Zinc gluconate; Urinary frequency; Urinary urgency; Urinary incontinence

中图分类号：R242;R256文献标识码：Adoi：10.3969/j.issn.1673-7202.2021.06.021

肾阳虚多素体阳虚，或年高命门火衰，久病伤阳，它脏累及于肾，或因房事太过，日久损及肾阳。临床表现为：有夜尿多、尿频、尿急、尿失禁、腰膝酸软、倦怠乏力、气短自汗、阳痿早泄、畏寒肢冷等排尿异常等症状[1-9]。特征是病程长、病情极易反复。严重的影响患者生命质量，给患者家庭及社会带来了沉重的经济负担。本研究对比分析了7家医院收治的360例肾阳虚患者在给与肾康宁胶囊等药物干预后的临床疗效。现报道如下。

1 资料与方法

1.1 一般资料 选取2018年5月至2018年10月间黑龙江中医药大学附属第二医院、哈尔滨市中医医院、黑龙江省电力医院、大庆市人民医院、佳木斯市中医院、鹤岗市人民医院、牡丹江医学院附属红旗医院7家医院收治的肾阳虚型患者360例作为研究对象，以区组随机法均分为对照组、联合观察组和葡萄糖酸锌组，每组120例。……