OBJECTIVETo evaluate the clinical efficacy and safety of Huayu Tongbi Recipe (HTR) combined methotrexate (MTX) in treating refractory rheumatoid arthritis (RRA).

METHODSTotally 167 RRA patients were assigned to the treatment group (73 cases) and the control group (94 cases) according to different therapeutic methods. Patients in the treatment group were treated with HTR combined MTX, while those in the control group were treated with leflunomide (LEF) combined MTX. Clinical signs and symptoms, RF, CRP, ESR, disease activity score 28 (DAS28), and safety indicators were compared between the two groups before treatment, at week 12 and 24 after treatment. The efficacy and safety indices were also evaluated.

RESULTSAt week 12 after treatment the total effective rate was 82.2% (60/73 cases) in the treatment group and 79.8% (75/94 cases) in the control group, showing no statistical difference between the two groups (chi2 = 0.15, P > 0.05). At week 24 after treatment the total effective rate was 78.1% (57/73 cases) in the treatment group and 755% (71/94 cases) in the control group, showing no statistical difference between the two groups (chi2 = 0.15, P > 0.05). There was statistical difference in the total effective rate between week 24 and week 12 in the control group (chi2 = 0.49, P < 0.05). Clinical signs and symptoms, RF, CRP, ESR, and DAS28 were significantly improved in the two groups after 12- and 24-week treatment (P < 0.01). There was no statistical difference in the improvement at week 12 after treatment between the two groups (P > 0.05). There was statistical difference in time of morning stiffness, tender joint numbers, swollen joint numbers, patient global assessment, RF, CRP, and DAS28 at week 24 after treatment between the two groups (P < 0.05). Besides, adverse reactions occurred less in the treatment group than in the control group (P < 0.01).

CONCLUSIONThe efficacy of HTR combined MTX was equivalent to that of LEF (10 mg per day) combined MTX, but with more stable therapeutic effects and less adverse reactions.

Antirheumatic Agents ; pharmacology ; therapeutic use ; Arthralgia ; Arthritis, Rheumatoid ; drug therapy ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; pharmacology ; therapeutic use ; Humans ; Isoxazoles ; Methotrexate ; pharmacology ; therapeutic use ; Phytotherapy ; Treatment Outcome

A parallel group double-blind comparative trial was conducted to study the efficacy and safety of risperidone compared with haloperidol. After a one-week wash-out, 35 chronic schizophrenic patients (17 males, 18 females) were randomly assigned to one of two groups for eight weeks of double-blind treatment. The patients' psychopathology was assessed by means of the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) and the Clinical Global Impression (CGI). Safety assessments included the Extrapyramidal Symptom Rating Scale (ESRS), the UKU Side Effect Rating Scale, vital signs, body weight, ECG and laboratory screening. Thirty-two patients completed the trial: there were 3 dropouts in the risperidone group. The results on the PANSS and CGI indicate that the mean changes from baseline on the total PANSS score and on the total BPRS score were comparable in both treatment groups. The number of patients where a clinical improvement at least 20% reduction in baseline score was also similar in both treatment groups. Risperidone caused less extrapyramidal symptoms and less side effects in UKU scale than haloperidol. No significant ECG changes were induced, no relevant changes in blood pressure or clinical laboratory parameters were observed. This study has demonstrated that the combined serotonin 5-HT2 and dopamine-D2 antagonist risperidone is an antipsychotic as potent as haloperidol. Risperidone causes less extrapyramidal symptoms, and is better tolerated than haloperidol.
Adolescent ; Adult ; Chronic Disease ; Comparative Study ; Double-Blind Method ; Female ; Haloperidol/*therapeutic use ; Human ; Isoxazoles/*therapeutic use ; Male ; Middle Age ; Piperidines/*therapeutic use ; Risperidone ; Schizophrenia/*drug therapy

OBJECTIVE: To explore the effects of different analgesia methods after UPPP. METHOD: Ninety cases of patients uvulopalatopharyngoplasty were divided into 3 groups randomly, and 30 cases in each group. The group A was the blank control group without any analgesia measures. The cases in group B were treated with intramuscular injection of parecoxib sodium 40 mg after surgery immediately, and continued injecting 40 mg after 12 hours, 24 hours and 36 hours respectively. 100 mg tramadol replaced 40 mg parecoxib sodium in group C. The VAS scoring was performed after surgery 12, 24, 36, 48, 72, 96 hours in 3 groups, and we observed adverse reaction such as lethargy, nausea, vomiting, dizziness, skin rash and so on. RESULT: The group B and C reduced the pain significantly compared with blank control group. The pain scores in group B were significantly decreased than that in group C (P<. 05). CONCLUSION The analgesic effect of parecoxib sodium after UPPP is significant and better than tramadol. It is worthy to use widely in clinical due to its better effect and less side effect.
Analgesia ; methods ; Analgesics ; therapeutic use ; Humans ; Injections, Intramuscular ; Isoxazoles ; therapeutic use ; Pain Measurement ; Pain, Postoperative ; Palate ; surgery ; Pharynx ; surgery ; Tramadol ; therapeutic use ; Uvula ; surgery

OBJECTIVE: To observe and evaluate the clinical effect of intra-articular injection of parecoxib in patients with early knee osteoarthritis. METHODS: From September 2016 to August 2017, 107 patients with early knee osteoarthritis were treated, including 50 males and 57 females, aged 45 to 64 (51.9±4.2) years. They were divided into basic therapy+oral glucosamine group(group A) 36 cases, oral celecoxib+basic therapy+oral glucosamine group(group B) 36 cases, intra-articular injection of parecoxib+basic therapy+oral glucosamine group(group C) 35 cases. There was no significant difference in gender, age, BMI and clinical stage(Kellgren-Lawrence classification) between the three groups before treatment. VAS score, HSS score and patient satisfaction were compared before and after treatment in the three groups. The levels of inflammatory cytokines in synovial fluid were measured before and after treatment in the three groups. RESULTS: All cases were followed up for(15.2±2.6) months on average. The VAS score and HSS score of each group were improved after treatment(<0.001). There were significant differences in VAS and HSS scores among the three groups after treatment(<0.001). The clinical efficacy of group C was better than that of group A and B(<0.001), group B was better than that of group A(<0.001), and group C had the highest satisfaction(<0.001). After treatment, the concentration of proinflammatory factor TNF-α and IL-6 in the synovial fluid of each group decreased(<0.001) and the concentration of anti-inflammatory factor IL-10 increased(<0.001). After treatment, the concentrations of TNF-α, IL-6 and IL-10 in the synovial fluid of the three groups were significantly different(<0.001). CONCLUSIONS For patients with early knee osteoarthritis, intra-articular injection of parecoxib can significantly improve clinical symptoms and avoid adverse reactions of long-term oral NSAIDs, which is an effective treatment.
Adult ; Aged ; Female ; Humans ; Injections, Intra-Articular ; Isoxazoles ; therapeutic use ; Male ; Middle Aged ; Osteoarthritis, Knee ; drug therapy

OBJECTIVE: To evaluate the perioperative analgesic effects of parecoxib sodium in patients undergoing nasal endoscopic surgery. METHOD: In the randomized, double blind, controlled study, 120 patients undergoing septoplasty were divided into 3 groups (n = 40): A group received parecoxib at a dose of 40 mg by muscle injection 30 min before the operation followed by saline at the same volume every 24 h for 48 h; B group received parecoxib at a dose of 40 mg by muscle injection 30 min before the operation followed by 40 mg every 24 h for 48 h; C group received an equal volume of 0.9% saline at the same time points. Patients were assessed with respect to pain score (VAS), rescue analgesia requirement and the side effects during the operation as well as at 3, 24, 48 h after the surgery. RESULT: Intra-operative as well as the postoperative pain scores were less in the A group and B group than in the.control group. Compared with group A, group B had significantly lower VAS score at 24 h after the operation, however there were no significant difference on other time points. Fewer participants of both the A and B groups required rescue medication after operation. CONCLUSION Administration of parecoxib can provide ideal analgesic effects without serious adverse side effects at the perioperative period for patients who received nasal endoscopic operation. Intramuscular parecoxib (40 mg 30 min before the operation followed 40 mg qd for 48 h) designed as preoperative analgesia mode resulted in sufficient perioperative analgesia that deserves popularization in the clinical works.
Analgesia ; methods ; Double-Blind Method ; Endoscopy ; Humans ; Isoxazoles ; administration & dosage ; therapeutic use ; Nasal Surgical Procedures ; methods ; Pain, Postoperative

OBJECTIVETo evaluate the efficacy and safety of leflunomide in comparison with methotrexate (MTX) on patients with rheumatoid arthritis (RA) in China.

METHODSFive hundred and sixty-six patients with active rheumatoid arthritis were randomly assigned to receive leflunomide at 20 mg once daily or MTX at 15 mg once weekly in a controlled trial. Five hundred and four patients completed the 12-week treatment and some patients continued the treatment for 24 weeks.

RESULTSBoth leflunomide and MTX could improve the symptoms, signs, and joint function, but there were no changes in X-ray observations of patients with rheumatoid arthritis. In the leflunomide group, the overall rates of effectiveness at 12 weeks and 24 weeks were 86.94% and 92.31% respectively; the rates of remarkable improvement were 64.95% and 79.81% respectively. In the MTX group, the overall rates of effectiveness at 12 weeks and 24 weeks were 84.04% and 83.15% respectively; the rates of remarkable improvement were 56.81% and 75.28% respectively. According to intent-to-treat analysis, the ACR 20% response rates at 12 weeks and 24 weeks in the leflunomide group were 62.54% and 67.18% respectively, compared with 60.08% and 61.32% respectively in MTX group. No statistical differences were shown in the efficacy between the two groups (P > 0.05). The adverse events in the leflunomide group were gastrointestinal symptoms, skin rash, alopecia, nervous system symptoms, decreased leukocyte count, and elevation of alanine aminotransferase (ALT). Most of these side effects were mild and transient. The incidence of adverse events in the leflunomide group was 16.84%, significantly lower than that in MTX group (28.17%, P = 0.002).

CONCLUSIONSLeflunomide is effective in the treatment of RA with less adverse events than MTX. Its efficacy is similar to MTX, but the incidence of adverse events and the rate of withdrawal due to adverse events were lower in the leflunomide group than in MTX group.

Antirheumatic Agents ; adverse effects ; therapeutic use ; Arthritis, Rheumatoid ; drug therapy ; Female ; Growth Inhibitors ; adverse effects ; therapeutic use ; Humans ; Immunosuppressive Agents ; adverse effects ; therapeutic use ; Isoxazoles ; adverse effects ; therapeutic use ; Male ; Methotrexate ; adverse effects ; therapeutic use ; Middle Aged

FK778 is a synthetic malononitrilamide (MNA) that has been demonstrated to have both both immunosuppressive and anti-proliferative activities. The MNAs inhibit both T-cell and B-cell function by blocking de novo pyrimidine synthesis, through blockade of the pivotal mitochondrial enzyme dihyroorotic acid dehydrogenase (DHODH), and the inhibition of tyrosine kinase activity. FK778 has been demonstrated to prevent acute allograft rejection in multiple experimental transplant models in rodents, dogs and primates and to be effective in the rat model of chronic renal allograft rejection. In addition, FK778 has been shown to prevent vascular remodeling after mechanical intimal injury via a mechanism which may be related to tyrosine kinase inhibitory activity in vascular smooth muscle cells. Another intriguing activity of the MNA family is the ability to block replication of members of the Herpes virus family with in vitro evidence that of efficacy against cytomegalovirus (CMV) and polyoma virus, important pathogens in the transplant recipient. FK778 is currently being explored in a number of trials in solid organ transplant recipients.
Animals ; Clinical Trials, Phase I ; Humans ; Immunosuppressive Agents/*therapeutic use ; Isoxazoles/*therapeutic use ; Nitriles/chemical synthesis ; *Organ Transplantation ; Randomized Controlled Trials ; Treatment Outcome

Adolescent ; Adult ; Arthritis, Reactive ; drug therapy ; Drug Combinations ; Female ; Glomerulonephritis, IGA ; drug therapy ; Humans ; Isoxazoles ; therapeutic use ; Male ; Methylprednisolone ; therapeutic use ; Young Adult

OBJECTIVEThe observe the clinical effect of leflunomide (LEF) and total glucosides of Paeony (TGP) on rheumatoid arthritis (RA) and their influences on laboratory findings.

METHODSEighty patients with RA were randomly divided into 2 groups, 40 in each group: the treated group treated with TGP and leflunomide, and the control group treated with LEF alone, the therapeutic course for both groups was 12 weeks. Clinical effect after treatment, changes of symptoms and physical signs before and after treatment were observed and the relative laboratory indexes were detected as well.

RESULTSThe total effective rate in the treated group was higher than that in the control group (97.5% vs 85.0%, P < 0.05). The clinical and laboratory indexes in the treated group were improved significantly after treatment (P < 0.05, P < 0.01), with the improvement superior to those in the control group (P < 0.05, P < 0.01) respectively. There was no significant difference in adverse reaction between the two groups.

CONCLUSIONCombined application of TGP and LEF is superior to using of LEF alone in treating RA, owing to its quicker initiating action and less adverse reaction.

Adolescent ; Adult ; Aged ; Arthritis, Rheumatoid ; drug therapy ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Glucosides ; therapeutic use ; Humans ; Isoxazoles ; therapeutic use ; Male ; Middle Aged ; Paeonia ; chemistry ; Phytotherapy ; Treatment Outcome

OBJECTIVETo evaluate the efficacy and safety of the combined therapy with leflunomide and methotrexate in the patients with juvenile rheumatoid arthritis (JRA).

METHODSForty patients with active polyarthritis JRA were divided into 2 groups. Group 1 (n = 21) received leflunomide tablet (1 mg/(kg x day) on days 1 - 3; then [(0.2 - 0.4) mg/kg per day] plus methotrexate (0.3 mg/kg i.v. every two weeks till clinical remission, then oral tablet 0.2 mg/kg weekly). Group 2 received the same doses of methotrexate in the same way. Permitted concomitant drugs included stable doses of NSAIDs and a low dose of prednisone during the course of treatments. The clinical assessments included the number of tender and swollen joints, tender articular index, swollen articular index, general articular function score, parents and physician's evaluation score, erythrocyte sedimentation rate, serum C-reactive protein and rheumatoid factor. Drug safety was assessed by observing the reaction of mucous membrane, skin, gastrointestinal tract, nervous system, hematologic changes, liver and renal function. Statistical comparison between two groups was performed by using analysis of variance, t test and chi(2) test.

RESULTSEfficacy and safety was assessed at 12th and 26th week. Average improvement rate of leflunomide plus methotrexate group at 12th week and 26th week was respectively 39.6% and 71.9%; while that of control group was 27.5% and 49.5%, i.e., there was significant difference between the two groups (P < 0.01). Average remission rate of leflunomide plus methotrexate group at 12th week and 26th week was respectively 4.76% and 38.10%; while that of control group (methotrexate only) was respectively 0, 0. The clinical improvement in the group treated with leflunomide plus methotrexate was significantly greater than control group (P < 0.01). There was no significant difference (9.5% v 5.3%) in occurrence rate of side effects between the two groups. Side effects included leucocytopenia and raised aminotransferase. They were mostly mild and tolerable.

CONCLUSIONThe effect of the leflunomide and methotrexate therapy in patients with active JRA was better than methotrexate alone. The combination therapy with leflunomide and methotrexate was safe and well tolerated.

Adolescent ; Arthritis, Juvenile ; drug therapy ; metabolism ; Child ; Child, Preschool ; Drug Therapy, Combination ; Female ; Humans ; Immunosuppressive Agents ; administration & dosage ; adverse effects ; therapeutic use ; Infant ; Isoxazoles ; administration & dosage ; adverse effects ; therapeutic use ; Male ; Methotrexate ; administration & dosage ; adverse effects ; therapeutic use ; Treatment Outcome