Xiang W, Guo Y L, Zhang J Y, Zheng T, Zhang C H
Department of Urology, Wuhan 1st Hospital, Wuhan 430000, China.
Zhonghua Wai Ke Za Zhi. 2018 Oct 1;56(10):776-780. doi: 10.3760/cma.j.issn.0529-5815.2018.10.015.
To observe the clinical efficacy of Ningmitai capsules, a traditional Chinese medicine using for clearing heat and dampness, in the treatment of residual fragments and postoperative complications following lithotripsy for upper urinary stones. During October 2016 and March 2018, patients from Wuhan 1 Hospital, Wuhan 2 Hospital, Wuhan 3 Hospital, and Wuhan Puai Hospital having upper urinary residual fragments following minimally-invasive stone treatment were randomly assigned to control group and Ningmitai group with a proportion of 1∶3. The patients in control group were treated with antibiotics or sodium diclofenac suppository on demand, while patients in Ningmitai group took additional Ningmitai capsule orally (4 capsules per time, 3 times per day). The observation was started when a patient was enrolled in this study and continued for a maximum of 12 weeks or until stone-free status. During the observation, the stone expulsion time, stone-free time, stone-free rate were observed, and the difference in curative effect between the two groups on postoperative complications such as pain and infection were compared. Statistical analysis was done using -test or χ test by GraphPad Prism 5 software. Totally 269 cases enrolled in this study. Eighty-six patients were from Wuhan 1 Hospital, 69 patients from Wuhan 2 Hospital, 58 patients from Wuhan 3 Hospital, 56 patients from Wuhan Puai Hospital, respectively. There were 66 cases in control group and 203 cases in Ningmitai group. The residual fragments expulsion time in Ningmitai group was significantly earlier than that in control group ((4.5±0.4) days . (7.5±1.3) days, =2.877, =0.004), the residual fragments clearance time in Ningmitai group was significantly shorter than that in control group ((13.6±1.0) days .(25.6±3.8) days, =4.252, =0.000), and the stone-free rate within 4 weeks post operation in Ningmitai group was significantly higher than control group (91.6% . 68.2%, χ=22.57, =0.000). After 12 weeks of treatment, the total effective rate of control group was 89.4%, and the total effective rate of Ningmitai group was 99.5%, with statistically significant difference (χ=17.65, =0.000). The proportion of caregivers that offered analgesia in Ningmitai group was significantly lower than that in control group (16.3% . 30.3%, χ=6.212, =0.013), the recovery rate of routine urinalysis following 4 weeks' treatment was significantly higher in Ningmitai group than that in control group (88.2% .71.2%, χ=10.67, =0.001). No obvious adverse effects were observed in both groups. Ningmitai capsule can facilitate the stone passage and increase the stone-free rate in the treatment of residual fragments and postoperative complications of upper urinary stones. It is also helpful for the prevention and treatment of postoperative pain, infection and other complications.
为观察清热利湿类中药宁泌泰胶囊治疗上尿路结石碎石术后残余结石及术后并发症的临床疗效。2016年10月至2018年3月，选取武汉市第一医院、武汉市第二医院、武汉市第三医院及武汉市普爱医院微创取石术后存在上尿路残余结石的患者，按照1∶3的比例随机分为对照组和宁泌泰组。对照组按需使用抗生素或双氯芬酸钠栓治疗，宁泌泰组在此基础上加用宁泌泰胶囊口服（每次4粒，每日3次）。研究从患者入组开始观察，最长持续12周或直至结石清除。观察期间，记录结石排出时间、结石清除时间、结石清除率，并比较两组术后疼痛、感染等并发症的疗效差异。采用GraphPad Prism 5软件进行t检验或χ²检验。本研究共纳入269例患者，分别来自武汉市第一医院86例、武汉市第二医院69例、武汉市第三医院58例、武汉市普爱医院56例。其中对照组66例，宁泌泰组203例。宁泌泰组残余结石排出时间明显早于对照组（（4.5±0.4）天 比（7.5±1.3）天，t =2.877，P =0.004），残余结石清除时间明显短于对照组（（13.6±1.0）天 比（25.6±3.8）天，t =4.252，P =0.000），术后4周内结石清除率明显高于对照组（91.6% 比68.2%，χ²=22.57，P =0.000）。治疗12周后，对照组总有效率为89.4%，宁泌泰组总有效率为99.5%，差异有统计学意义（χ²=17.65，P =0.000）。宁泌泰组使用镇痛药物的比例明显低于对照组（16.3% 比30.3%，χ²=6.212，P =0.013），治疗4周后尿常规恢复正常的比例明显高于对照组（88.2% 比71.2%，χ²=10.67，P =0.001）。两组均未观察到明显不良反应。宁泌泰胶囊可促进上尿路结石碎石术后残余结石排出，提高结石清除率，有助于预防和治疗术后疼痛、感染等并发症。
