Objective To evaluate the effectiveness and safety of reduced glutathione in the treatment of acute renal failure. Methods Twenty-three patients with acute renal failure were divided into the treatment group (n=10) and the control group (n=13) by simple randomisation. Patients in the treatment group received intravenous reduced glutathione 1200 mg daily. Patients in the control group were not treated with reduced glutathione. The therapeutic course for both groups was 4 weeks. Serum creatinine and urea nitrogen were determined before treatment as well as at the end of each of the 4 weeks. Proximal and distal renal tubular functions were evaluated at the end of the treatment. The time when clinical symptoms were improved was recorded and adverse drug reactions were monitored. Results The durations of nausea and vomiting as well as the oliguria stage were shorter in the treatment group than in the control group. The serum creatinine level in the treatment group decreased more markedly than that in the control group. At the end of the treatment, the renal tubular function was better in the treatment group than in the control group. Conclusion Reduced glutathione contributes to the early recovery of renal function in patients with acute renal failure. However, more high-quality and large-scale randomized controlled trials are needed.
目的 探讨鱼胆汁对兔肾脏的影响及其机制。 方法 将实验新西兰大耳白兔随机分为灌胃组（GP组，n=19）与静脉注射组（VI组，n=15），根据体重分别按3 mL/kg、0.3 mL/kg的剂量通过灌胃或耳缘静脉注射方式给予鱼胆汁。采集鱼胆汁处理前与处理后1～5 h的血标本，测定肾功能、酸碱平衡及电解质指标，记录GP组每个采样点前20 min尿量及鱼胆汁处理前、处理后5 h的尿常规。鱼胆汁处理后5 h处死动物取肾做病理学检查。 结果 给予一定量鱼胆汁后5 h内，两组兔血肌酐（Scr）、尿素氮、K+呈升高趋势（P均＜0.05），而血HCO3?浓度呈下降趋势（P＜0.05），其中VI组兔Scr、血K+改变早于GP组。GP组记录尿量明显下降，尿pH值升高，蛋白定量试验、隐血试验结果均呈阳性。两组兔肾组织病理检查均显示肾小球血管充盈，少量中性粒细胞浸润；肾小管水肿及间质充血，部分有局灶性出血，肾间质损伤较肾小球更为严重。 结论 无论经由消化道还是血管给予实验兔鱼胆汁均可导致急性肾功能损伤，与鱼胆汁造成急性肾实质损伤、特别是肾小管间质损伤有关。
Objective To assess the effectiveness and safety of Fushenqudu capsules in the treatment of chronic renal failure. Methods The double blind, double dummy and randomized controlled method was adopted. One hundred and thirty one patients were randomized to the trial group (n=88, Fushenqudu capsule, 4 capsules, qid) and the control group (n =43, Shenshuaining capsules, 4 capsules, qid). The therapeutic duration for both groups was 8 weeks. Results The results were analyzed on the basis of intention-to-treat. For effectiveness of treatment, the markedly effective rate was 27.3% (24/88); the total effective rate was 67.0% (59/88) in the treatment group; the markedly effective rate was 25.6% (11/43), the total effective rate was 58.1% (25/43) in the control group. There was no statistical difference between the two groups (Pgt;0.05). For effectiveness of Pishenqixu syndrome, the markedly effective rate was 48.9% (43/88) and 53.3% (23/43) respectively in the trial and control groups. No statistically significant difference was tested between the two groups (Pgt;0.05). Mild adverse effects occurred in two groups. When a smaller dose or termination of the drug were applied, the symptoms went. The tolerance was good when the patients took the medicine regularly. Conclusions Fushenqudu capsules have the same clinical effect as Shenshuaining capsule with a little toxic adverse effects.
Objective To assess the effectiveness and safety of prulifloxacin in the treatment of urinary tract infection. Methods The double-blind, double dummy and randomized controlled method was adopted. One hundred and forty-four patients were randomized to the treatment group (prulifloxacin , 4 tablets, bid) and the control group (levofloxacin, 4 tablets, bid). The randomization code was produced by computer. The treatment duration for both groups was from 7 to 10 days. Results Data were analyzed on the basis of full analysis sets (FAS) and per-protocol (PP) analysis. The total improvement rates of the trial and control groups were 85.07% and 88.52% respectively by FAS analysis, and 90.48% and 91.53% respectively by PP analysis. There was no significant difference between the two groups in improvement rates (Pgt;0.05). Bacterial negative rates in the trial and control groups were 93.75% and 93.88% respectively by FAS analysis and 97.83% and 97.87% respectively by PP analysis. The results showed no statistical significance difference between the two groups in bacterial negative rates (Pgt;0.05). The adverse events in the prulifloxacin and levofloxacin groups were 2.80% and 5.60% respectively. Conclusion Prulifloxacin has the same clinical effectiveness as levofloxacin with a few toxic adverse effects in the treatment of urinary tract infection.