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1.
China Journal of Chinese Materia Medica ; (24): 4569-4574, 2021.
Article in Chinese | WPRIM | ID: wpr-888159

ABSTRACT

Wangbi Tablets are widely used in the treatment of rheumatoid arthritis, knee osteoarthritis and other diseases at pre-sent. Long-term clinical application and research have shown that this drug has a good effect in reducing the pain of related diseases and improving symptoms. Due to the lack of guidance in the instructions and currently no relevant norms to guide the clinical application of Wangbi Tablets, in order to further improve clinicians' understanding of the drug and fully tap the clinical advantages of the drug, the Professional Committee of Orthopedics and Traumatology Drug Research of China Association of Chinese Medicine organized experts in the fields of rheumatism, orthopedics, pharmacy and methodology in Chinese and western medicine to develop expert consensus on Chinese patent medicines in accordance with the relevant requirements of the consensus methodology. Based on full consideration of clinical research evidence and expert experience, the clinical issues were summarized in the consensus, and for those clinical problems supported by evidences, the internationally recognized recommendation evaluation and formulation method GRADE was used to evaluate the evidence and form recommendations; for those clinical issues not supported by evidences, a consensus was reached through the nominal group method to form consensus recommendations. The consensus adopted a concise and clear format to form re-commendations or reach consensus suggestions on the medication regimen, medication characteristics, intervention timing, usage and dosage, course of use and safety issues for the treatment of rheumatoid arthritis and knee osteoarthritis with Wangbi Tablets. It is suggested that its application will better improve the efficacy of Wangbi Tablets in the treatment of rheumatoid arthritis and knee osteoarthritis, at the same time provide a reference for clinicians to use Wangbi Tablets in a standardized, reasonable and safe manner.


Subject(s)
Humans , Arthritis, Rheumatoid/drug therapy , Consensus , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Osteoarthritis, Knee/drug therapy , Tablets
2.
Chinese Journal of Integrated Traditional and Western Medicine ; (12): 673-677, 2015.
Article in Chinese | WPRIM | ID: wpr-237960

ABSTRACT

<p><b>OBJECTIVE</b>To evaluate the short-term efficacy and safety of Bushen Shuji Granule (BSG) in treating ankylosing spondylitis (AS) patients.</p><p><b>METHODS</b>A prospective randomized controlled clinical trial was carried out in 62 active stage AS patients with Shen deficiency Du-channel cold syndrome (SDDCS), who were randomly assigned to the BSG group (treated with BSG) and the control group (treated with Celecoxib Capsule). Twelve weeks consisted of one therapeutic course. Therapeutic effects were evaluated by ASAS20 and ASAS40 (set by Assessments in Ankylosing Spondylitis working group) , BASDA150, Chinese medical (CM) syndrome efficacy evaluation standards. BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath AS Metrology Index (BASMI), scores for spine pain, scores for pain at night, patient global assessment (PGA) , erythrocyte sedimentation rate (ESR) , and C reactive protein (CRP) were observed before and after treatment.</p><p><b>RESULTS</b>After three-month treatment by BSG, ASAS20 standard rate was 63. 33% (19/30 cases) in the BSG group and 66.67% (20/30 cases) in the control group with no significant difference between the two groups (χ2 = 0.073, P > 0.05). The efficacy for CM syndromes was 70.00% (21/30 cases) in the BSG group, higher than that in the control group [40.00% (12/30 cases), χ2 = 5.455, P < 0.05]. Scores for CM syndromes, BASDAI, night pain index, spinal pain index, PGA, CRP were improved in the BSG group (P < 0.05, P < 0.01). The incidence of adverse events in the BSG group was lower than that of the control group.</p><p><b>CONCLUSION</b>BSG based on Shen supplementing, Du-channel strengthening, blood activating, and channels dredging method had good short-term clinical efficacy and safety in treating AS.</p>


Subject(s)
Humans , Asian People , Biomedical Research , Blood Sedimentation , C-Reactive Protein , Drugs, Chinese Herbal , Therapeutic Uses , Pain , Prospective Studies , Safety , Spondylitis, Ankylosing , Drug Therapy
3.
Chinese Journal of Integrated Traditional and Western Medicine ; (12): 1319-1323, 2014.
Article in Chinese | WPRIM | ID: wpr-313029

ABSTRACT

<p><b>OBJECTIVE</b>To explore distinctive manifestations of rheumatoid arthritis (RA) patients of cold syndrome and heat syndrome using wrist joints ultrasound.</p><p><b>METHOD</b>s Totally 65 RA patients were syndrome typed as cold syndrome (29 cases, cold-damp blockage syndrome) and heat syndrome (36 cases, damp-heat obstruction syndrome). Grey-scale synovitis, power doppler (PD) signals, tenosynovitis, and bone erosion were observed using wrist ultrasound. Distinctive manifestations of cold syndrome and heat syndrome were analyzed using wrist ultrasound.</p><p><b>RESULTS</b>In RA patients of cold syndrome, the positive rate of synovitis, PD, tenosynovitis, and bone erosion was 51.72%, 20.68%, 51.72%, and 37.93%, respectively, while they were 97.22%, 91.67%, 75.0%, and 63.89%, respectively in RA patients of heat syndrome. Compared with patients of cold syndrome, the positive rate of synovitis, PD, and bone erosion increased in patients of heat syndrome (P < 0.01, P < 0.01, P < 0.05). There was no statistical difference in the positive rate of tenosynovitis between the two groups (P > 0.05). Compared with the cold syndrome group, there was statistical difference in the constituent ratio of synovitis, PD, and bone erosion in the heat syndrome group (P < 0.01, P < 0.01, P < 0.05), but with no statistical difference in the constituent ratio of tenosynovitis (P > 0.05). Results of the ROC curve showed that the sensitivity was 86.1% and the specificity was 62.1% in judging heat syndrome, when the total score of synovitis in two wrists was more than 1.5; the sensitivity was 80.0% and the specificity was 93.1% in judging heat syndrome, when the total score of PD in two wrists was more than 1.5.</p><p><b>CONCLUSIONS</b>Positive rates of synovitis, PD, and bone erosion were significantly higher in RA patients of heat syndrome than those of cold syndrome. Especially serious manifestations were more often seen in RA patients of heat syndrome. The total score of synovitis or PD in the two wrist joints higher than 1.5 was characteristic manifestations of heat syndrome using wrist ultrasound.</p>


Subject(s)
Humans , Arthritis, Rheumatoid , Therapeutics , Hot Temperature , Medicine, Chinese Traditional , ROC Curve , Sensitivity and Specificity , Syndrome , Synovitis , Ultrasonography , Wrist , Diagnostic Imaging , Wrist Joint , Diagnostic Imaging
4.
Chinese Journal of Integrated Traditional and Western Medicine ; (12): 1611-1616, 2013.
Article in Chinese | WPRIM | ID: wpr-231635

ABSTRACT

<p><b>OBJECTIVE</b>To observe the clinical effect and safety of modified Bushen Zhuanggu Recipe (BZR) in treating ankylosing spondylitis (AS).</p><p><b>METHODS</b>Recruited were 96 AS outpatients of Shen deficiency induced cold-dampness syndrome (SDCDS) or Shen deficiency dampness-heat syndrome (SDDHS) at clinics of China-Japan Friendship Hospital from May 2010 to May 2011. They were randomly assigned to the traditional Chinese medicine (TCM) treatment group and the Western medicine (WM) treatment group in the ratio of 1:1. Those in the TCM treatment group were syndrome typed as the SDCDS group (group A, 22 cases, treated by Bushen Zhuanggu Quhan Decoction + WM placebos) and the SDDHS group (group B, 26 cases, treated by Bushen Zhuanggu Qinghua Decoction +WM placebos). Those in the WM treatment group were syndrome typed as SDCDS group (group C, 27 cases, treated by SASP + TCM placebos) and the SDDHS group (group D, 21 cases, treated by SASP +TCM placebos). Totally 12 weeks consisted of one therapeutic course. BAS-G, BASFI, BASDAI, spine pain, pain at night, TCM symptom score, distance between occipital and wall, distance between finger and ground, thoracic activity, spine activity, Schober test, ESR, CRP were observed as the observing indices; ASAS20, ASAS50, ASAS70, BASDAI50, and criteria of TCM were explored for clinical evaluation and safety evaluation.</p><p><b>RESULTS</b>In comparison with the same group before treatment,BAS-G, BASFI, BASDAI, spine pain, pain at night, TCM syndrome score,distance between finger and ground, Schober test, ESR, and CRP were improved after treatment (P < 0.01, P < 0.05). In group A and C, thoracic activity and spine activity were getting better (P < 0.01, P < 0.05). In group B distance between occipital and wall and spine activity were getting better (P < 0.01, P < 0.05). In comparison with group C, BAS-G, BASFI, BASDAI, spine pain, distance between finger and ground,thoracic activity,spine activity, Schober test, ESR, CRP were getting better in group A after treatment (P < 0.01, P < 0.05). In comparison with group D, BASFI, BASDAI, spine pain, pain at night,distance between finger and ground, distance between occipital and wall, spine activity, Schober test, and ESR were getting better in group B after treatment (P < 0.01, P < 0.05). The total effective rate, ASAS20, ASAS50, ASAS70, and BASDAI50 were higher in the TCM treatment group than in the WM treatment group (P < 0.05).</p><p><b>CONCLUSION</b>Modified BZR was more effective than SASP method in relieving clinical symptoms and signs, TCM syndrome scores, and inflammatory activity indicators of AS patients.</p>


Subject(s)
Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Young Adult , Drugs, Chinese Herbal , Therapeutic Uses , Medicine, Chinese Traditional , Phytotherapy , Spondylitis, Ankylosing , Diagnosis , Drug Therapy , Treatment Outcome
5.
China Journal of Chinese Materia Medica ; (24): 4076-4078, 2013.
Article in Chinese | WPRIM | ID: wpr-287636

ABSTRACT

<p><b>OBJECTIVE</b>To optimize formulas of Quban gel.</p><p><b>METHOD</b>The U6 (6(2) x 3) uniform design was adopted to optimize gel formulas, with rheological parameters, such as viscosity and yield value in room temperature, viscosity and yield value in average temperature of skin, thixlotropy.</p><p><b>RESULT</b>The optimum proportion of matrix was made of 1.0 g carbomer 940, 5 mL glycerin and pH value 5-6.</p><p><b>CONCLUSION</b>The regression model for gel matrix quality and gel rheological parameters was established to directly reflect the impacting effect of various factors, and provide certain preference basis for the screening of gel matrix formulas. Quban gel prepared by the method was evenly distributed, moderately viscous and highly thixotropic</p>


Subject(s)
Chemistry, Pharmaceutical , Methods , Drugs, Chinese Herbal , Chemistry , Gels , Quality Control , Regression Analysis , Viscosity
6.
Chinese Journal of Integrated Traditional and Western Medicine ; (12): 614-618, 2013.
Article in Chinese | WPRIM | ID: wpr-287501

ABSTRACT

<p><b>OBJECTIVE</b>To evaluate the clinical efficacy and safety of bushen quhan zhiwang decoction (BQZD) combined methotrexate (MTX) in treating rheumatoid arthritis (RA).</p><p><b>METHODS</b>A prospective, randomized controlled study was carried out. RA patients of Shen deficiency and cold invading syndrome in the treatment group (120 cases) were treated with BQZD and MTX (10 mg/week), while those in the control group (120 cases) were treated with MTX (10 mg/week) alone. The therapeutic course for all was 24 weeks. The efficacy and safety indices were evaluated at the baseline and 24 weeks after treatment, including clinical signs and symptoms, condition assessment, Health Assessment Questionnaire (HAQ), disease activity index 28 (DAS28), laboratory parameters of erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), safety indicators, and Chinese medical syndrome integrals.</p><p><b>RESULTS</b>The total effective rate was 80. 0% in the treatment group, better than that of the control group (66.7%), showing statistical difference (P <0.01). In the two groups significant improvement of clinical signs and symptoms, ESR, CRP, visual analogue scale (VAS) by both physicians and patients, HAQ, DAS28, and Chinese medical syndrome integrals after treatment were shown (P <0.01). Better effects were obtained in the treatment group in lessening tender joint numbers and swollen joint numbers, VAS by both physicians and patients, DAS28, and Chinese medical syndrome integrals (P < 0.05). Besides, adverse reactions occurred less in the treatment group than in the control group (P < 0.05).</p><p><b>CONCLUSIONS</b>BQZD had roles in relieving symptoms, improving joint functions, signs, ESR, and CRP. It was an effective herb for RA patients of Shen deficiency and cold invading syndrome. It could enhance the efficacy and reduce adverse reactions of MTX through synergistic effects with MTX.</p>


Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Arthritis, Rheumatoid , Diagnosis , Drug Therapy , Drug Therapy, Combination , Drugs, Chinese Herbal , Therapeutic Uses , Medicine, Chinese Traditional , Methotrexate , Therapeutic Uses , Prospective Studies , Treatment Outcome
7.
Chinese Journal of Integrated Traditional and Western Medicine ; (12): 257-260, 2012.
Article in Chinese | WPRIM | ID: wpr-252565

ABSTRACT

<p><b>OBJECTIVE</b>To explore the effects of Bushen Shuji Granule (BSG) on inhibiting the interleukin 6 (IL-6) level in the synovial fluid sample of fibroblast cells from the ankylosing spondylitis (AS) patients.</p><p><b>METHODS</b>Using serum pharmacologic method, the IL-6 level in the culture fluid sample of fibroblast cells was observed by ELISA method with different concentrations of medicated serum containing BSG. The IL-6 level at the mRNA level was detected using reverse transcriptase-polymerase chain reaction (RT-PCR). The vehicle serum and sulfasalazine (SSZ) serum were taken as controls.</p><p><b>RESULTS</b>Results of ELISA showed the IL-6 level in the AS group was more than that in the vehicle serum group with obvious statistical difference. BSG could obviously inhibited the IL-6 level, showing statistical difference when compared with the vehicle serum group. Besides, obvious dose-dependent correlation existed between BSG and its inhibition on fibroblast proliferation. And the IL-6 level at the mRNA level in the AS group was higher than that in the vehicle serum group, showing statistical difference by semi-quantitative analysis.</p><p><b>CONCLUSION</b>BSG could play its clinical role of anti-inflammation and anti-fibrosis through inhibiting the IL-6 level in the culture fluid sample of fibroblast cells.</p>


Subject(s)
Animals , Female , Humans , Male , Rats , Cell Line , Drugs, Chinese Herbal , Pharmacology , Fibroblasts , Bodily Secretions , Interleukin-6 , Metabolism , RNA, Messenger , Genetics , Rats, Sprague-Dawley , Spondylitis, Ankylosing , Synovial Fluid , Metabolism , Synovial Membrane
8.
Chinese Journal of Integrated Traditional and Western Medicine ; (12): 398-401, 2012.
Article in Chinese | WPRIM | ID: wpr-252502

ABSTRACT

<p><b>OBJECTIVE</b>To study the acute toxicity of the water extracts (ERWE) and 60% ethanol extracts (EREE) from different processed products of Radix Polygalae (crude Radix Polygalae, licorice, and honey processed Radix Polygalae), thus providing scientific evidence for toxicity study of Radix Polygalae and its safe clinical application.</p><p><b>METHODS</b>The ERWE and EREE were prepared from different processed products of Radix Polygalae. Their contents of saponins were respectively determined. The poisoning condition and death of the mice administered with ERWE and EREE by gastrogavage were observed within fourteen days. The modified Karber's method was used to calculate LD50 and 95% confidence interval (CI).</p><p><b>RESULTS</b>The EREE of licorice processed Radix Polygalae had the maximum toxicity with highest content of saponins, while the ERWE of honey processed Radix Polygalae had the minimum toxicity with lowest content of saponins.</p><p><b>CONCLUSIONS</b>Different processing methods have effects on the contents of saponins in Radix Polygalae. The experiment showed that the toxicity of Radix Polygalae is in direct proportion to the content of saponins. The higher the saponins contents, the higher the toxicity.</p>


Subject(s)
Animals , Female , Male , Mice , Lethal Dose 50 , Mice, Inbred Strains , Plant Extracts , Toxicity , Polygala , Saponins , Toxicity , Toxicity Tests, Acute
9.
China Journal of Orthopaedics and Traumatology ; (12): 387-391, 2011.
Article in Chinese | WPRIM | ID: wpr-351729

ABSTRACT

<p><b>OBJECTIVE</b>In order to investigate the roles of metalloproteinase in inflammatory bone destruction in ankylosing spondylitis (AS), and analyze the mechanism of preventing inflammatory bone destruction of Bushen Qiangdu decoction (BSQDD) in AS cases. Comparisons were made on the expressions of matrix metalloproteinase 9 (MMP-9) and tissue inhibitor of metalloproteinase 1 (TIMP-1) by peripheral blood mononuclear cells (PBMC) between AS patients and healthy controls. The effect of BSQDD was investigated on the expression and of MMP-9 and TIMP-1 produced by PBMC in AS patients.</p><p><b>METHODS</b>From March 2005 to March 2006, 30 active AS cases of Kidney-asthenia, Du-cold and blood-stasis syndrome were selected as patients group in the China-Japan Friendship Hospital. There are 27 male patients and 3 female patients. The age range is from 16 to 45, averaging (30.8 +/- 8.8) years. Disease duration is from 0.5 to 10 years. Cases received three-month BSQDD treatment were considered as the treatment group. Twenty healthy persons were included in the control group. Serum and PBMC were separated. The PBMC were stimulated by PHA and PMA, and the supernatant was collected. The mRNA expression of MMP-9 and TIMP-1 in PBMC was analyzed by RT-PCR. The content of MMP-9 and TIMP-1 in serum and culture supernatant of PBMC were detected by ELISA.</p><p><b>RESULTS</b>Compared with health control group, the serum concentration of MMP-9 and TIMP-1 in patients group before treatment increased (P<0.01, P<0.05), but the level of MMP-9 and TIMP-1 in the serum of patients after treatment decreased compared with pre-treatment cases (P<0.05). Furthermore,compared with health control group, PBMC of patients group before treatment expressed higher levels of MMP-9 and TIMP-1 both on transcript level and at protein level (P<0.01, P<0.05), and the expression levels of MMP-9 and TIMP-1 in PBMC in patients after treatment both on transcript level and at protein level was down-regulated compared with pre-treatment (P<0.01, P<0.05).</p><p><b>CONCLUSION</b>PBMC of AS patients had a higher potential capacity for MMP-9 and TIMP-1. BSQDD possibly prevented inflammatory bone destruction of AS through inhibiting production of MMP-9 and TIMP-1 produced by PBMC.</p>


Subject(s)
Adolescent , Adult , Female , Humans , Male , Middle Aged , Young Adult , Case-Control Studies , Drugs, Chinese Herbal , Pharmacology , Therapeutic Uses , Gene Expression Regulation , Leukocytes, Mononuclear , Metabolism , Matrix Metalloproteinase 9 , Blood , Genetics , RNA, Messenger , Genetics , Metabolism , Retrospective Studies , Spondylitis, Ankylosing , Blood , Drug Therapy , Genetics , Metabolism , Tissue Inhibitor of Metalloproteinase-1 , Blood , Genetics
10.
Chinese Journal of Integrated Traditional and Western Medicine ; (12): 471-475, 2011.
Article in Chinese | WPRIM | ID: wpr-260961

ABSTRACT

<p><b>OBJECTIVE</b>To observe the therapeutic effect of Bushen Qiangdu Recipe (BSQDR) on osteoporosis and bone loss in patients with ankylosing spondylitis (AS).</p><p><b>METHODS</b>Patients with AS were randomly assigned to two groups. The 288 patients in the treatment group received BSQDR (consisting of cibotii rhizoma, antler, prepared rehmannia root, epimedium herb, rhizoma drynariae, teasel root, eucommia bark, pangolin scales, etc., one dose daily, taken in two portions, once in the morning and once in the evening). The 72 patients in the control group received SIDSM and sulfasalazine. The therapeutic course for both was six months. Clinical symptoms, pillow distance from the wall, hand distance from the ground, jaw distance from the handle, chest mobility, Schober test, spinal mobility and other signs of disease activity indices (ESR and CRP) were observed in patients before and after treatment. The bone mineral density (BMD) testing was performed in the lumbar spine, the femur, the forearm, and the heels, etc. Osteocalcin (BGP), calcitonin, parathyroid hormone (PTH), etc. bone metabolic indices were detected.</p><p><b>RESULTS</b>BASFI, BASDAI, the overall assessment, the spinal pain, pillow distance from the wall, hand distance from the ground, jaw distance from the handle, chest mobility, Schober test, spinal mobility, and so on were all improved to some extent when compared with before treatment in the treatment group (P<0.05). The ESR and CRP decreased to various degrees, showing statistical significance when compared with before treatment (P <0.01). BGP increased and PTH decreased, showing statistical difference when compared with before treatment (P<0.05). The BMD in patients' lumbar spine, femoral neck, Ward's triangle, femoral trochanter increased to various degrees. The calcaneal intensity index, blood uric acid (BUA) and SOS values also increased more than before treatment, showing statistical significance (P<0.05). Long-term oral administration of BSQDR was safe, with no obvious adverse reaction.</p><p><b>CONCLUSIONS</b>BSQDR showed significant effect in treatment of AS. It could regulate the bone metabolic level in patients, attenuate the immune inflammatory response, improve the spine and joint activities functions, increase bone formation, reduce bone resorption, thereby, enhancing the BMD, showing significant therapeutic effect on osteoporosis in AS patients.</p>


Subject(s)
Adult , Female , Humans , Male , Middle Aged , Young Adult , Bone Density , Bone Resorption , Drug Therapy , Drugs, Chinese Herbal , Therapeutic Uses , Osteoporosis , Drug Therapy , Metabolism , Phytotherapy , Spondylitis, Ankylosing , Drug Therapy , Metabolism
11.
Chinese journal of integrative medicine ; (12): 458-461, 2009.
Article in English | WPRIM | ID: wpr-344963

ABSTRACT

<p><b>OBJECTIVE</b>To observe the therapeutic efficacy and safety of Gubitong Recipe (, GBT) in treating osteoarthritis (OA) of knee joint.</p><p><b>METHODS</b>Ninety patients with knee osteoarthritis were equally assigned, according to a randomizing digital table, to the treatment group and the control group. The treatment group was treated with GBT Decoction one dose every day and the control group with glucosamine sulfate 500 mg thrice a day, respectively, for eight successive weeks. Besides, diclofenac sodium could be given as supplementary dugs with the dosage used recorded if necessary. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, an index reflecting the degree of joint pain, stiffness, and dysfunction) in patients was assessed before and after treatment, and the patients' symptoms were evaluated by visual analogue scale (VAS) as well. Moreover, erythrocyte sedimentation rate (ESR), blood C-reactive protein (CRP), blood and urinary routine tests, liver and kidney function examination, and the adverse reaction that occurred during the treatment period were observed.</p><p><b>RESULTS</b>WOMAC index and integral VAS value were lowered in both groups after treatment, showing significant statistical difference as compared with before treatment (P<0.05), but the decrement of WOMAC index in the treatment group was more significant than that in the control group (P<0.05). ESR and CRP levels remained unchanged in all patients, and the proportion and mean dosage of diclofenac sodium used were similar in the two groups. No evident adverse reaction occurred during the treatment period.</p><p><b>CONCLUSION</b>GBT is an effective and safe recipe for the treatment of osteoarthritis of knee joint, which could alleviate the joint pain, stiffness, and dysfunction.</p>


Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Blood Sedimentation , C-Reactive Protein , Diclofenac , Therapeutic Uses , Drugs, Chinese Herbal , Therapeutic Uses , Medicine, Chinese Traditional , Osteoarthritis, Knee , Blood , Drug Therapy , Pain Measurement
12.
Chinese Medical Journal ; (24): 1518-1523, 2008.
Article in English | WPRIM | ID: wpr-293967

ABSTRACT

<p><b>BACKGROUND</b>As a kind of sirolimus-eluting stent (SES) made in China, Firebird SES is more effective than bare metal stent (BMS) and not inferior to Cypher SES for short coronary lesions in terms of reduction of restenosis and revascularization. However, Firebird SES does not show any benefits in patients with a very long coronary lesion (VLCL). The present study was undertaken to evaluate the safety and efficacy of Firebird SES for VLCL by comparison of Cypher SES and BMS.</p><p><b>METHODS</b>In this prospective, nonrandomized and comparative study, eligible patients with de novo coronary lesion (> or = 30 mm) between January 2005 and June 2006 were allocated into Firebird SES group, Cypher SES group or BMS group. They were subjected to an angiographic follow-up of 6 months and a clinical follow-up of 12 months. The primary endpoints constitute the in-stent and in-segment restenosis rates at 6 months. The secondary endpoint was defined as a major adverse cardiovascular event (MACE) that was a 12-month combined endpoint of all-cause deaths, reinfarction or in-stent thrombosis, and target-lesion revascularization. The 12-month in-stent thrombosis was also evaluated to address the safety of Firebird SES implantation exceptionally.</p><p><b>RESULTS</b>A total of 468 patients were assessed for eligibility. Of 113 patients who were finally included according to the prior inclusion and exclusion criteria, 39 (41 lesions) were treated with Firebird SES, 37 (39 lesions) with Cypher SES, and 37 (37 lesions) with BMS. There were no significant differences in the baseline characteristics between the three groups; but there were longer lesions, more frequent use of overlapping stent in the Firebird SES group and the Cypher SES group. Angiographic follow-up showed that the rates of binary stenosis were similar between the Firebird SES group and the Cypher SES group (in-segment: 14.6% vs 12.8%, relative risk (RR) 1.14, P = 0.81; in-stent: 9.8% vs 10.3%, RR 0.95, P = 0.94), and significantly lower than those in the BMS group (in-segment: vs. 36.1%, RR 0.41 or 0.36, P = 0.04 or 0.03, respectively; in-stent: vs 30.6%, RR 0.32 or 0.34, P = 0.03 or 0.04, respectively). The total MACE rate up to 12 months was also similar in both SES groups (7.7% vs 5.4%, P = 1.000), and significantly lower than that in the BMS group (27.0%, P = 0.034 or 0.024, respectively). The in-stent thrombosis rate in the follow-up period was 2.6% in the Firebird SES group, not higher in the Cypher SES and BMS groups (2.7% and 2.7%, respectively, P = 1.000).</p><p><b>CONCLUSIONS</b>In the treatment of VLCL, Firebird SES would be safer and more effective than BMS. Firebird SES may be not inferior to Cypher SES in terms of restenosis and MACE.</p>


Subject(s)
Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Angioplasty, Balloon, Coronary , Coronary Angiography , Coronary Artery Disease , Therapeutics , Coronary Restenosis , Therapeutics , Drug-Eluting Stents , Metals , Prospective Studies , Sirolimus , Stents
13.
Chinese Journal of Integrated Traditional and Western Medicine ; (12): 1077-1081, 2005.
Article in Chinese | WPRIM | ID: wpr-331783

ABSTRACT

<p><b>OBJECTIVE</b>To analyze the symptomatic factors of rheumatoid arthritis (RA), and to explore the correlations between these factors and the efficacy of TCM herbal and western medicinal therapies.</p><p><b>METHODS</b>Four hundred and thirteen patients with confirmed diagnosis as active RA came from 9 clinical centers were randomly divided into the Western medicine (WM) treated group (n=204) and the traditional herbal medicine (CM) treated group (n=209). The scheme of WM therapy included administration of voltaren extended action tablet, methotrexate and sulfasalazine. That of CM therapy included basic treatment and medication by syndrome differentiation. Eighteen items of often seen symptoms of the patients were collected before and after treatment. The therapeutic effect was evaluated by the American College of Rheumatology 20% improvement (ACR 20) and all data were analyzed using SAS 8.2 statistical software package. The category of symptoms was analyzed by factor analysis. The correlation of changes of various common factors with the therapeutic efficacy were analyzed by one-way ANOVA test.</p><p><b>RESULTS</b>Four common factors were obtained from the 18 items of symptoms, which could better reflect respectively the local status of arthritis, and symptoms of Cold-syndrome, Asthenia-syndrome and Heat-syndrome in traditional Chinese medicine (TCM). Both CM and WM therapies showed consistent effect on the common factors that reflects the state of RA, but CM therapy showed superior effect on the common factors to improve Asthenia-syndrome to that of WM therapy.</p><p><b>CONCLUSION</b>Factor analysis could be used to categorize and study the important factor symptoms in the syndrome differentiation of TCM, and the results of factor analysis were in accord with the category of TCM syndrome differentiation. The exploration on the correlation of common factor and therapeutic efficacy could better exhibit the characteristics of TCM efficacy.</p>


Subject(s)
Adult , Female , Humans , Male , Middle Aged , Arthritis, Rheumatoid , Drug Therapy , Diagnosis, Differential , Drug Therapy, Combination , Drugs, Chinese Herbal , Therapeutic Uses , Factor Analysis, Statistical , Medicine, Chinese Traditional , Methotrexate , Therapeutic Uses , Phytotherapy , Sulfasalazine , Therapeutic Uses
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