Objective To assess effectiveness and safety in rheumatoid arthritis （RA）patients treated with the indigenous leflunomide in comparison with Airohua produced by Cinkate Corp. Methods A double blind and double dummy randomized controlled trial was conducted in the outpatient clinic of rheumatology. Fifty-six Chinese RA patients were divided into two groups who received either indigenous Leflunomide or Airohua of 20 mg daily and the two matching placebo tablets of Airohua or indigenous Leflunomide with the constant dose of Oxaprozin （0.4 g, qd） in the first 6 weeks. Clinical and laboratory data were collected every 6 weeks during 24 weeks of follow-up. Results This study showed that the patients of both groups significantly improved on main variables except erythrocyte sedimentation rate （EXR） at the 12th week . The variables such as ESR, and the level of c-reaction protein in both groups at 24th week showed no statistical difference compared with those at the baseline. There were also no statistical difference in the clinical characteristics and laboratory findings between the two groups at the 12th week and 24th week （P 〉0. 05）. The effcacy of Airohua（37% ） was lower than that of indigenous Leflunomide（64% ） at the 12th week （P 〈0. 05 ） and slightly better than indigenous Leflunomide group at the 24 week （81.5% vs 77.3% , （ P 〉0. 05）. The administration of Airohua and indigenous leflunomide presented a similar pattern and frequency of adverse events. Serious adverse events such as interstitial pneumonitis, pulmonary infiltration, and liver impairment etc. were not reported in either group. Conclusions The study shows that the indigenous Leflunomide has a superior therapeutic effect. Its efficacy and safety are similar to Airohua in the treatment of acfive RA patients in China.
Objective To assess the effectivess and safety of Shenkang capsule in the treatment of chronic glomerulonephritis （Qiyinliangxu Syndrome）. Methods A double blind, double dummy and randomized controlled method was adopted. A total of 96 patients were randomized to the treatment group （Shenkang capsule, 2 capsules, twice a day） and the control group （Shenyankang capsule, 2 capsules, twice a day）. The therapeutic course for both groups was 2 months. Results All the results were analyzed on the basis of retention-to-treat（ITT） and per-protocol-population （PP）. For effect of chronic glomerulonephritis in the treatment group, the clinical control rates were 12.86% （9/70） with ITT analysis and 14. 75% （9/61） with PP analysis; the good improvement rates were 12. 86% （9/70） with ITT analysis and 14. 75% （9/61） with PP analysis; the total effective rates were 48. 58% （34/70） and 55.73% （34/61）. In the control group, the clinical control rates were 4. 17% （1/24） with ITT analysis and 5.00% （1/20） with PP analysis respectively; the good improvement rates were 4. 17% （1/24） with ITT analysis and 5.00% （1/20） with PP analysis respectively; the total effective rates were 45. 83% （11/24） with ITT analysis and 55.00% （11/20） with PP analysis. There was no statistical difference between the two groups （P〉0.05）. For Qiyinliangxu syndrome improvement, in the treatment group, the clinical control rate and good improvement rate were 18. 57% （13/70） with ITT analysis and 21.31% （13/61） with PP analysis respectively; the total effective rates were 81.43% （57/70） with ITT analysis and 93. 44% （57/61） with PP analysis respectively; In the control group, the clinical control rate and good improvement rate were 20. 84% （ 5/24 ） with ITT analysis and 25.00% （5/20 ） with PP analysis respectively; the total effective rates were 75. 00% （18/24） with ITT analysis and 85. 00% （17/20） with PP analysis respectively. The results showed no statistical difference between the two groups （P 〉0. 05）. No adverse effects were found. Conclusions No statistical difference was detected between Shengkang capsule and Shenyan capsule groups. No obvious toxic adverse effects were found.
【摘要】 目的 探讨盐酸丁咯地尔对主观性耳鸣的治疗效果。 方法 将2006年1月-2008年1月收治的91例患者随机分为丁咯地尔组（治疗组）和维生素B1组（对照组），治疗组46例58只耳，对照组45例52只耳，分别以丁咯地尔及维生素B1治疗1个月后，对两组患者耳鸣治疗有效率进行χ2检验。 结果 治疗组有效17例，显效16例，无效12例，加重1例，有效率71.7%（33/46）；对照组有效12例，显效7例，无效25例，加重1例，有效率42.2%（19/45）。两组比较有统计学意义(Plt;0.05）。 结论 丁咯地尔对缓解耳鸣有一定作用。【Abstract】 Objective To investigate the clinical effect of buflomedil hydrochlorideis on tinnitus. Methods A randomized, doubled-blind, and controlled clinical trials was conducted from January 2006 to January 2008. Ninty-one patients were divided into two groups randomly: the treatment group and controlled group (placebo group). After being evaluated by tinnitus questionnaire, the two groups were treated with buflomedil hydrochloride and vitamine B1 respectively. One month after treatment, the efficacy of the two groups was observed. The data was analyzed by χ2 test. Results The efficacy was 71.7% in the treatment group and 42.2% in the controlled group, with a significant difference between the two groups (Plt;0.05). Conclusion Buflomedil hydrochloride is effective on tinnitus.
Objective To assess the effect and safety of Dalitong Granule in the treatment of the Piman syndrome (functional dyspepsia). Method The double-blind, double-dummy and randomized controlled method was adopted. 120 patients were randomized to the treatment group (n=90, Dalitong Granule 6 g, tid) and the control group (n=30, treated with cisapride 5 mg, tid). The therapeutic course for both groups was 2 weeks. Results All the results were analyzed on the basis of intention-to-treat and per-protocol population. In the treatment group, the markedly effective rates were 62.37% and 64.45% respectively. The effective rates were 99.55% and 96-67% respectively. In the control group, the markedly effective rates were 58-08% and 60.00% respectively. The effective rates were 90.33% and 93.33% respectively. There was no significant difference between two groups (Pgt;0.05). For effects on Piman syndrome, in the treatment group, the markedly effective rates were 53.76% and 55.56% respectively. The effective rates were 86.02% and 88.89% respectively. In the control group, the markedly effective rates were 48.38% and 50.00% respectively. The effective rates were 80.64% and 83.33% respectively. The results showed no statistical significance difference between two groups (Pgt;0.05). For effects on gastric emptying function (PP population), in the treatment group, the markedly effective rate and effective rate were 72.42% and 79.32%. In the control group those were 64.28% and 64.28%. There was no significant difference between the two groups (Pgt;0.05). ITT and PP analysis revealed similar results. No adverse effect was found in the observation. Conclusions Dalitong granule has the same clinical effect as cisapride with no obvious toxic-adverse effects.
Objective To assess the effectiveness and safety of Jiuweirougan granule in the treatment of chronic hepatitis with hepatic fibrosis. Methods A double-blind, double dummy and randomized controlled method was adopted. Forty-six patients were selected by using the inclusion and exclusion criteria and were randomizedly allocated to the treatment group (n=23, Jiuweirougan 10 g, twice a day) and the control group (n=23, treated with Biejiaruangan 4 pills, three times a day). The duration of treatment for both groups lasted for 6 months. Results Two patients in the treatment group dropped out halfway through the study, while one patient in the control group was withdrawal for irregular treatment. Analysis according to intention-to-treat (ITT) and per-protocol (PP) was conducted. In the treatment group, the effective rates of TCM (Traditional Chinese Medicine) on the syndrome were 82.61% (19/23) (ITT) and 90.48% (19/21) (PP), while in the control group, there were 86.96% (20/23) (ITT) and 86.36% (19/20) (PP). There was no significant difference between the two groups (P＞0.05). The improvement rate of serum parameters in the treatment group such as hyaluronic acid (HA), type Ⅲ procollagen (PCⅢ), type Ⅳ collagewn (CⅣ) and laminin (LN) were 28.57% (6/21), 23.81% (5/21), 28.57% (6/21) and 4.76% (1/21), respectively, while in control group, the rates were 36.37% (8/22),13.64% (3/22), 36.37% (8/22) and 9.09% (2/22), respectively. No significant difference was seen between the two groups (P＞0.05). ITT and PP analysis revealed similar results. No obvious adverse effects were noted. Conclusion Jiuweirougan granule may improve chronic hepatitis with fibrosis, and its effect is equal to that of Biejiaruangan. No obvious toxic-adverse effects were seen.
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.