Administration, Oral ; Anti-Inflammatory Agents, Non-Steroidal ; adverse effects ; Female ; Hematuria ; chemically induced ; Humans ; Infant ; Male ; Sulfonamides ; adverse effects

Aged ; Antihypertensive Agents ; adverse effects ; Endothelin-1 ; antagonists & inhibitors ; drug effects ; Face ; pathology ; Female ; Humans ; Hypertension, Pulmonary ; drug therapy ; Sulfonamides ; adverse effects ; Telangiectasis ; chemically induced ; diagnosis

PURPOSE: Non-steroidal anti-inflammatory drugs (NSAID) are frequently used in oral surgical procedures in dentistry. The evaluation of the frequency of sister chromatid exchange (SCE) is accepted as a reliable cytogenetic method to assess the genotoxic effects of environmental factors. MATERIALS AND METHODS: In this study, the genotoxic effects of various NSAIDs were assessed in 30 patients to who they were administered following encluosed third molar surgery using SCE analysis before and after the operation. The frequency of SCE was evaluated before the operation and after 3 days of etodolac, nimesulid and naproxen use. RESULTS: There was no statistically significant difference in the frequency of SCE between the preoperative and postoperative states in patients given etodolac, nimesulid or naproxen sodium. CONCLUSION: Short term use of selective and non-selective NSAIDs was not associated with a significant genotoxic effect that could be detected using the SCE method in peripheric lymphocytes.
Adult ; Anti-Inflammatory Agents, Non-Steroidal/*adverse effects ; Etodolac/adverse effects ; Female ; Humans ; Male ; Molar, Third/*surgery ; Mutagenicity Tests ; Naproxen/adverse effects ; Prospective Studies ; Sister Chromatid Exchange/*drug effects ; Sulfonamides/adverse effects

OBJECTIVETo observe the rate of efficacy and adverse drug reaction of non-steroidal anti-inflammatory drugs (NSAIDs) in the population with osteoarthritis and rheumatoid arthritis, based on available clinical data.

METHODSUsing Meta analysis to evaluate the data of effect and safety profile of NSAIDs from 19 articles on randomized clinical trials published from 1990 to 2001 in Chinese journals. The total number of patients enrolled for evaluation on rates of effectiveness and adverse drug reaction were 1 732 and 2 925, respectively.

RESULTSData on the effect and safety were comparatively heterogeneous among different kinds of NSAIDs. The effective rates (95% CI) were as follows: nabunetone, 66.7% (61.9% - 71.4%); meloxicam, 68.4% (59.2% - 77.6%); naproxen, 64.5% (59.8% - 69.1%); nimesulide, 79.8% (75.7% - 84.0%); ibuprofen, 77.2% (70.7% - 83.8%); diclofenac, 77.1% (69.2% - 85.0%); oxaprozin, 65.8% (59.5% - 72.0%). Rates of adverse drug reaction (95% CI) were as follows: nabunetone, 16.3% (12.5% - 20.0%); meloxicam, 10.2% (4.2% - 16.2%); naproxen, 29.2% (24.8% - 33.6%); nimesulide, 20.2% (16.0% - 24.3%); ibuprofen, 16.7% (14.7% - 18.8%); diclofenac, 19.3% (11.9% - 26.7%); oxaprozin, 12.7% (8.9% - 16.7%) respectively.

CONCLUSIONThe rates of effect and adverse reaction on patients having osteoarthritis and rheumatoid arthritis with NSAIDs treatment would largely depend on the drugs being used. Within 2 - 8 weeks of treatment, the effective rate and rate of adverse drug reaction with commonly used NSAIDs as nabumeton, meloxicam, etc., were 59.2% - 85.0% and 4.2% - 33.6%, respectively.

Anti-Inflammatory Agents, Non-Steroidal ; adverse effects ; therapeutic use ; Arthritis, Rheumatoid ; drug therapy ; Butanones ; adverse effects ; therapeutic use ; China ; Diclofenac ; adverse effects ; therapeutic use ; Humans ; Ibuprofen ; adverse effects ; therapeutic use ; Naproxen ; adverse effects ; therapeutic use ; Osteoarthritis ; drug therapy ; Propionates ; adverse effects ; therapeutic use ; Randomized Controlled Trials as Topic ; Sulfonamides ; adverse effects ; therapeutic use ; Thiazines ; adverse effects ; therapeutic use ; Thiazoles ; adverse effects ; therapeutic use

BACKGROUNDA novel anti-rheumatic drug, T-614, has been shown to have an anti-inflammatory effect and to improve abnormal immunological findings in rheumatoid arthritis (RA). To assess the safety and efficacy of T-614 versus placebo in patients with active RA we conducted a 24-week clinical study in 280 Chinese patients.

METHODSIn a multicenter, randomized, double blind, placebo controlled study, 280 patients were randomly assigned to receive placebo (n = 95) or T-614 at 50 mg (n = 93) or 25 mg (n = 92) daily. Active disease was defined by 4 of the following 5 criteria: >or= 5 tender joints, >or= 3 swollen joints, morning stiffness lasting for >or= 60 minutes, and Westergren erythrocyte sedimentation rate (ESR) >or= 28 mm/h, the assessment of pain at the rest by patient as moderate or severe. Clinical and laboratory parameters were analyzed at baseline, 2, 4, 6, 12, 18 and 24 weeks. The primary efficacy variable at week 24 was the American College of Rheumatology (ACR) response rate using the intent-to-treat population.

RESULTSThe ACR response rate was significantly higher in the T-614 treatment group compared with the placebo group within 8 weeks after the initiation of treatment. After 24 weeks, the 25 mg/d and 50 mg/d dosage groups and the placebo group showed 39.13%, 61.29% and 24.21% in ACR20 and 23.91%, 31.18% and 7.37% in ACR50, respectively. A time-response in ACR response was observed, with clear superiority for the 25 mg/d and 50 mg/d dosage groups compared to placebo (P < 0.0001), and the 50 mg/d dose compared to the 25 mg/d dose (P < 0.05) when using the ACR response analyses after 24 weeks. ESR and c-reactive protein (CRP) were significantly different in the treatment groups after 24 weeks. The incidence of adverse events (AEs) was not significantly higher with T-614 than with placebo, but upper abdominal discomfort, leucopenia, elevated serum alanine aminotransferase (sALT), skin rash and/or pruritus were more common in the 50 mg and 25 mg dosage groups.

CONCLUSIONT-614, a new slow-acting drug, is effective in treatment of rheumatoid arthritis and is well tolerated.

Adult ; Aged ; Antirheumatic Agents ; therapeutic use ; Arthritis, Rheumatoid ; drug therapy ; Benzopyrans ; adverse effects ; therapeutic use ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Sulfonamides ; adverse effects ; therapeutic use

Anti-Inflammatory Agents, Non-Steroidal ; adverse effects ; Chemical and Drug Induced Liver Injury ; etiology ; Humans ; Liver Failure, Acute ; chemically induced ; Sulfonamides ; adverse effects

BACKGROUNDTamsulosin hydrochloride can significantly improve benign prostatic hyperplasia (BPH) symptoms after the first dose and achieve long-term efficacy in European and American populations; however, the corresponding studies from China are rarely seen. The purpose of this study was to evaluate the long-term efficacy and safety of tamsulosin hydrochloride 0.2 mg once daily in patients with lower urinary tract symptoms (LUTS) suggestive of BPH in China.

METHODSChinese patients with LUTS suggestive of BPH were enrolled in a 4-week placebo run-in period and subsequent 60-week open-label study. Tamsulosin hydrochloride 0.2 mg was administered daily during the period of the study. The efficacy and safety parameters were evaluated at the end of treatment period I (0 - 12 weeks) and period II (13 - 60 weeks). The BPH patients were divided into tamsulosin monotherapy group and combination therapy group which received concomitant medication of finasteride 5 mg once daily after the evaluation at the end of treatment period I.

RESULTSA total of 113 patients were recruited to the study. Eighty-two patients received tamsulosin monotherapy and twenty-nine received combination therapy during the treatment period II. Tamsulosin hydrochloride produced a great improvement in mean maximum urinary flow rate (Q(max)) (1.7 ml/s, 3 ml/s) and a significant decrease in mean international prostate symptom score (IPSS) (4.1, 6.4) after 12-week and 60-week treatments, respectively. At the end of treatment period II, there were significant improvement in IPSS, quality of life (QOL) score, Q(max) and average flow rate (Q(ave)) for combination therapy group compared with the treatment period I (all P < 0.05). No serious adverse events (SAE) were recorded during the study.

CONCLUSIONLong-term tamsulosin hydrochloride therapy is a safe, effective and well-tolerated method for the treatment for LUTS suggestive of BPH in China.

Adrenergic alpha-1 Receptor Antagonists ; adverse effects ; therapeutic use ; Aged ; China ; Humans ; Male ; Middle Aged ; Placebos ; Prostatic Hyperplasia ; drug therapy ; Prostatism ; drug therapy ; Sulfonamides ; adverse effects ; therapeutic use

BACKGROUNDPharmacological therapy has been considered as the first-line treatment for patients with uncomplicated benign prostatic hyperplasia (BPH). The aim of this study was to evaluate the efficacy and safety of tamsulosin compared with a placebo for treating BPH.

METHODSThe randomized placebo-controlled trials (RCT) of tamsulosin for the treatment of BPH from all over the world were searched. PubMed, Ovid, ScienceDirect, EBSCO, CBM, and CNKI were searched, as well as a manual search of four Chinese journals: Chinese Journal of Andrology, National Journal of Andrology, Chinese Journal of Urology, and Journal of Clinical Urology was also performed. Two reviewers independently screened the studies for eligibility, evaluated the quality and extracted the data from the eligible studies, with confirmation by cross-checking. Divergences of opinions were settled by discussion. Meta-analysis was processed by Rev Man 5.0 software, fail-safe number was performed by SAS8.0 software.

RESULTSSeven RCTs involving 2455 men met the inclusion criteria. The basic characteristics of patients were comparable in all the studies. Comparing three common criteria: international prostate symptom score (IPSS)/Boyarsky symptom score, maximum flow rate (MFR), quality of life (QOL), tamsulosin was better than placebo at improving IPSS and MFR, with no significant difference in the QOL. Adverse events of tamsulosin also showed no significant difference from the placebo group (Z=1.62, P=0.10, OR=1.22, 95% CI 0.96-1.54).

CONCLUSIONSTamsulosin is better than placebo at improving IPSS and MFR. Adverse events of tamsuloisn show no significant difference compared with placebo. More high quality trials with larger samples and longer follow-up are proposed.

Antineoplastic Agents ; adverse effects ; therapeutic use ; Humans ; Male ; Prostatic Hyperplasia ; drug therapy ; Randomized Controlled Trials as Topic ; Sulfonamides ; adverse effects ; therapeutic use

We report a case of anterior ischemic optic neuropathy associated with udenafil. A 54-year-old male presented with an acute onset visual field defect of the right eye after udenafil use. Examination revealed a relative afferent pupillary defect and a swollen disc. Automated visual fields revealed an enlarged blind spot and a narrowed visual field. Fluorescein angiography revealed both an inferior choroidal filling delay and an inferior sector filling delay of the optic disc in the arteriovenous phase as well as diffuse leakage of the optic disc in the late phase. Optical coherent tomography revealed increased thickness of the retinal nerve fiber layer, especially in the area of the inferior disc. The patient was counseled to discontinue the use of udenafil and to monitor his blood pressure regularly. The disc swelling was resolved with residual optic atrophy one month after discontinuing the use of udenafil.
Acute Disease ; Choroid/*pathology ; Humans ; Male ; Middle Aged ; Optic Neuropathy, Ischemic/*chemically induced/diagnosis ; Phosphodiesterase 5 Inhibitors/adverse effects ; Pyrimidines/*adverse effects ; Sulfonamides/*adverse effects ; Tomography, Optical Coherence ; Visual Fields

Objective: To study the safety and efficacy of Bushen Daozhuo Granules (BDG) in the treatment of type Ⅲ prostatitis. METHODS: This multicenter randomized controlled clinical trial included 478 patients with type Ⅲ prostatitis, 290 in the trial group and 188 as controls, the former treated with BDG at 200 ml bid and the latter with tamsulosin hydrochloride sustainedrelease capsules at 0.2 mg qd, both for 4 weeks. Before treatment, after 4 weeks of medication, and at 4 weeks after drug withdrawal, we obtained the NIH Chronic Prostatitis Symptom Index (NIHCPSI) scores and compared the safety and effectiveness rate between the two groups of patients. RESULTS: Compared with the baseline, the NIHCPSI score was markedly decreased in the control group after 4 weeks of medication (21.42 ± 4.02 vs 15.67 ± 3.65, P < 0.05) but showed no statistically significant difference from that at 4 weeks after drug withdrawal (19.03 ± 3.86) (P>0.05), while the NIHCPSI score in the trial group was remarkably lower than the baseline both after 4 weeks of medication and at 4 weeks after drug withdrawal (10.92 ± 2.06 and 12.91 ± 2.64 vs 21.58 ± 3.67, P < 0.05). The trial group exhibited both a higher rate of total effectiveness and safety than the control (P < 0.05). CONCLUSIONS BDG is safe and effective for the treatment of type Ⅲ prostatitis.
Capsules ; Chronic Disease ; Delayed-Action Preparations ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Humans ; Male ; Prostatitis ; drug therapy ; pathology ; Sulfonamides ; adverse effects ; therapeutic use ; Tamsulosin ; Treatment Outcome ; Urological Agents ; adverse effects ; therapeutic use