Randomized, double-blind, placebo parallel controlled clinical study on the treatment of ureteral calculi with total flavonoids of Desmodium styracifolium
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摘要: 目的 评价广金钱草总黄酮胶囊治疗输尿管结石(湿热蕴结证)的有效性和安全性。方法 采用中央随机、双盲、安慰剂平行对照的研究设计，将2017年12月—2020年1月于湖北省中医院就诊的102例输尿管结石初筛受试者(0.5 cm≤结石直径≤1.0 cm)，根据纳入、排除及剔除标准筛选66例入组，年龄为(44.44±13.38)岁，其中试验组48例，对照组18例。试验组口服广金钱草总黄酮胶囊，1次3粒(0.2 g/粒)，3次/d；对照组口服广金钱草总黄酮胶囊模拟剂，1次3粒，3次/d，给药周期为28 d，若受试者中途结石排出，则停止服药。依据全尿路CT/CTU评价患者排石效果，记录排石时间、腰腹疼痛、尿痛、血尿情况以及泌尿系中医症候评分等。采用SPSS 23.0分析资料数据(χ2检验、t检验、Fisher精确检验)。结果 试验组结石排出25例，有效率为52.08%，对照组结石排出4例，有效率为22.22%，两组差异有统计学意义(P＝0.029)。试验组泌尿系中医症候评分也显著优于对照组(P < 0.05)。试验组共发生4例数、5例次不良事件，分别为左肾积液、口腔溃疡、尿路感染、发热、血白细胞升高，发生率为4/48(8.33%)，对照组为0/18(0)，两组差异无统计学意义。试验组与对照组均无严重不良事件发生。结论 广金钱草总黄酮胶囊治疗输尿管结石疗效肯定，且具有较高的安全性。Abstract: Objective To evaluate the efficacy and safety of total flavonoids of Desmodium styracifolium in the treatment of ureteral calculi.Methods A randomized, double-blind, placebo parallel controlled study design was adopted. A total of 102 patients with ureteral calculi who received treatment in Hubei Provincial Hospital of Traditional Chinese Medicine from December 2017 to January 2020 were screened, and 66 patients were successfully enrolled according to the inclusion and exclusion criteria, whose average age was (44.44±13.38) years. Among them, 48 patients in the experimental group and 18 patients in the control group. Experimental group: oral Desmodium styracifolium flavone capsules test drug, 3 capsules a time (0.2 g/capsule), 3 times a day; Placebo group: oral total flavone capsules placebo, 3 capsules at a time, 3 times a day; Administration period: 28 days, if the subject passes stones during the course, the medication should be stopped. The efficacy of lithecbole was evaluated according to CTU of urinary system. The time of lithecbole, the degree of pain attack, as well as lumbago pain, pain in urination, hematuria and lumbar percussion pain were recorded, and the relief rate was calculated. SPSS 23.0 data analysis (Chi-square test, t-test, Fisher exact test) was used to evaluate the efficacy and safety of Desmodium styracifolium flavone capsules in the treatment of ureteral calculi.Results The number of stone expulsion in the experimental group was 25 cases, with an effective rate of 52.08%, while in the placebo group was 4 cases, with an effective rate of 22.22%. The difference between two groups was statistically significant (P=0.029). The TCM symptom score of the experimental group was also significantly better than that of the placebo group (P < 0.05). There were 4 cases and 5 adverse events in the experimental group, including left kidney effusion, oral ulcer, urinary tract infection, fever, and elevated white blood cells. Incidence of adverse events were experimental group 4/48 (8.33%) and placebo group 0/18 (0), and the difference was not statistically significant. There were no serious adverse events in both two groups.Conclusion Total flavonoids of Desmodium styracifolium have good curative effect and high safety in the treatment of ureteral calculi.
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表 1 病例分布情况
组别 入组例数 完成例数 脱落/例(%) 剔除/例(%) 试验组 48 39 8(16.67) 1(2.08) 对照组 18 12 4(22.22) 2(11.11) 合计 66 51 12(18.18) 3(4.55) 
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表 2 一般资料比较
例(%)，X±S 因素 对照组(18例) 试验组(48例) t/Z P 年龄/岁 43.33±14.33 44.85±13.14 0.418 0.520 身高/cm 171.33±4.55 168.73±6.29 2.207 0.142 体重/kg 67.92±6.73 68.38±9.79 3.388 0.070 中医症候积分 17.50±3.50 17.80±4.10 0.243 0.624 结石直径/cm 5.92±1.31 6.16±1.44 0.042 0.838 高血压 3(16.67) 6(12.50) -0.363 0.716 合并用药 3(16.67) 5(10.42) -0.993 0.321 肾积水 12(66.67) 31(64.58) -0.157 0.875
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表 3 两组主要疗效指标效果比较
组别 有效
/例无效
/例有效率
/%χ2 P 对照组(18例) 4 14 22.22 4.739 0.029 试验组(48例) 25 23 52.08
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表 4 两组次要疗效指标效果比较s
组别 痊愈/例(%) 显效/例(%) 有效/例(%) 无效/例(%) χ2 P 对照组(18例) 1(5.56) 4(22.22) 7(38.89) 6(33.33) 8.408 0.038 试验组(48例) 10(20.83) 19(39.58) 15(31.25) 4(8.33)
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