Comparison of the therapeutic efficacy of TENS versus intra-articular hyaluronic acid injection in patients with knee osteoarthritis: A prospective randomized study

Knee osteoarthritis (OA) is perceived as a major public health problem, and today, various treatment modalities are used to manage this condition. The purpose of this study was to assess and compare the efficacy of transcutaneous electrical nerve stimulation (TENS) and intra-articular hylan G-F 20 (Synvisc; Genzyme Corporation, Ridgefield, NJ) in patients with symptomatic knee OA. A total of 60 patients with primary knee OA were randomized into 2 treatment groups. TENS was applied for 3 weeks in the first group, and in the second group, hylan G-F 20 was injected intra-articularly once a week for 3 weeks. Patients were then followed for 6 months. Disease severity was measured with the Lequesne Index. Efficacy in terms of pain, functional status, and quality of life was assessed through analysis of changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and short Form 36 Health Survey (SF-36) scores. Adverse events were monitored throughout the study. WOMAC pain scores were improved at the first control visit in the TENS group and in the viscosupplementation group; this improvement was statistically significant. WOMAC stiffness scores showed a statistically significant decrease in the TENS group at the first control visit. Stiffness did not decrease during the first month in the second group; however, these patients exhibited improvement during the sixth month after injection. Physical function scores and SF-36 total scores did not change in either group after treatment. Pain relief was observed at the first month and continued throughout the 6-month follow-up period in both groups. Stiffness decreased by the sixth month in both groups. Improvement in WOMAC physical function scores was greater in the intra-articular hylan group than in the TENS group at the end of follow-up; however, quality of life was not improved in either group. These therapies used in combination may alleviate symptoms in patients with OA.     

The efficacy of topical sesame oil in patients with knee osteoarthritis: A randomized double-blinded active-controlled non-inferiority clinical trial

ObjectiveSesame oil is an herbal product that has been used to treat the joints pain in several traditional medicines. In this study, we evaluated the efficacy of topical sesame oil versus diclofenac gel in patients with knee osteoarthritis (OA).MethodsOne hundred and four patients were randomly enrolled in two arms of the trial. Patients were treated by topical sesame oil or diclofenac (three times a day) for 4 weeks. Outcome measures were knee pain via visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire, knee joint’s flexion angle, 8-meter walk test and number of used analgesics. Patients were evaluated at baseline, 2 and then 4 weeks after the intervention.ResultsAt the follow-up visits, sesame oil was not inferior to diclofenac regarding scores of WOMAC pain, 8-meter walk test, and knee flexion angle. Although, its non-inferiority was not proved regarding scores of VAS, WOMAC stiffness, and WOMAC total at the 4^th week. Moreover, sesame oil was not inferior to diclofenac regarding consumed analgesics.ConclusionIt seems that the topical sesame oil was non-inferior to diclofenac gel on the reduction of the knee OA pain and improvement of some indicators of its function.     

Results of the multicenter clinical trial of structum preparation in Russia]

AIM: To study clinical effectiveness and tolerance of structum in patients with osteoarthrosis (OA) of the knee joints (KJ) and hip joints (HJ) in a multicenter open randomised trial. MATERIAL AND METHODS: A 6-month trial of effectiveness and tolerance of structum has been performed in 9 medical centers and included outpatients (males and females) with KJ OA or HJ OA satisfying the OA diagnostic criteria of the American Rheumatology College, having x-ray stage I-III according to Kellgren-Lawrence with manifest pain, a total functional Leken index from 4 to 11, regular intake of non-steroid antiinflammatory drugs (NAID) for 30 days in the last 3 months. Consent was obtained from each patient. 192 patients received structum, 363 matched patients served control. Structum was given per os for 3 weeks in a dose of 1.5 g/day then in a dose 1.0 g/day up to 6 months. The patients continued on NAID. The patients' examination was performed in the beginning of the study, at its months 3 and 6. RESULTS: Leken index in HJ and KJ OA significantly fell after 3 months of structum treatment. Up to month 6 it fell still further (p < 0.05). After 6 months of treatment pain syndrome relieved both at rest and movement, pain at rest disappeared fully in 57% of NJ OA patients and 46% of HJ OA patients, for movement pain it was 17 and 13%, respectively. During the treatment NAID intake was less required in both groups (p < 0.05) while 55% of patients in both groups could discontinue NAID after 6 months of the treatment. Tolerance of the drug was rather good, side effects were mild. CONCLUSION: Structum (chondroitin sulphate) is an effective drug for treatment of KJ and HJ OA: it relieves pain, preserves and improves articular function, allows to reduce or discontinue NAID, is well tolerated.     

Comparison of the time to analgetic and anti-inflammatory effect in the treatment of gouty arthritis with nimesulide and sodium diclofenac

AIM: To compare the time to presentation of the analgetic and anti-inflammatory effects of granulated and tablet nimesulide and sodium diclofenac since the start of therapy for gouty arthritis (GA). MATERIAL AND METHODS: Ninety males with gout were randomized into 3 equal groups. The patients were included in the study by the following criteria: a documented diagnosis of gout (Wallace S. criteria), age over 18 years, acute arthritis for less than 3 weeks, affection of 4 and more joints. For 7 days patients of group 1 received nimesil (200 mg/day), those of group 2--aponil (200 mg/day), group 3 --sodium diclofenac (150 mg/day). Swelling, articular, pain indices were estimated daily for 7 days. RESULTS: Patients of group 1 (nimesil) experienced pain relief on min 20; patients taking nimesulide (aponil) experienced pain attenuation within the first hour. Pain (at rest and movement) and the indices declined faster in group 1 than in group 2 as well as in groups 1 and 2 compared to group 3. Arthritis was arrested in 24 (80%) patients of group 1, 11 (36%) of group 2 and 4 (13%) of group 3. CONCLUSION: Efficacy of nimesulide for arrest of an acute gout attack exceeds that of sodium diclofenac. Granulated nimesulide has advantages over tablets.     

Comparative assessment of the effectiveness and tolerability of lornoxicam 8 mg BID and diclofenac 50 mg TID in adult indian patients with osteoarthritis of the hip or knee: A 4-week, double-blind, randomized, comparative, multicenter study

Background: Reports of cardiovascular adverse events (AEs) associated with the use of cyclooxygenase-2 inhibitors for the treatment of osteoarthritis (OA) have prompted the quest for a better-tolerated NSAID.Objective: The aim of this study was to compare the effectiveness and tolerability of lornoxicam 8 mg BID and diclofenac 50 mg TID in adult Indian patients with OA of the hip or knee.Methods: This 4-week, double-blind, randomized, comparative, multicenter study was undertaken to compare oral lornoxicam and diclofenac in patients with OA. Patients who met the selection criteria were enrolled consecutively from the outpatient clinics of each of the participating hospitals in India. Participants completed the Western Ontario and McMasters Individual Osteoarthritis Index (WOMAC-OA), WOMAC Composite Index (WOMAC-CI) (for pain, stiffness, and physical function), and a 10-cm visual analog scale (VAS) (0-10 where 0 = no pain and 10 = worst possible pain or severe or excruciating pain) at each study visit (weeks 0 [baseline], 2, and 4 [or at early termination]). Patients' and physicians' global assessments of arthritis control were measured at each study visit when laboratory and clinical AEs were also monitored. The primary end points were the WOMAC-OA, the WOMAC-CI, and VAS scores for pain among the patients who completed the study.Results: Of the 273 patients (159 men, 114 women; mean [SD] age, 44.73 [10.72] years; range, 28-68 years) enrolled in the study, 13 (7 in the lornoxicam group and 6 in the diclofenac group) were lost to follow-up and their effectiveness and tolerability results were not included in the study analysis. Over the 4-week study period, both drugs provided significant (P < 0.05) sustained relief of OA symptoms compared with baseline. Compared with baseline, the mean pain score (WOMAC-CI) decreased 90.6% (13.88 [4.47] vs 1.30 [1.49]; P < 0.05) in the lornoxicam group and 88.9% (14.15 [4.56] vs 1.57 [1.49]; P < 0.05) in the diclofenac group after 4 weeks of treatment. After 4 weeks of treatment, the VAS pain score decreased from baseline 83.1% (8.04 [2.70] vs 1.36 [1.43]; P < 0.05) in the lornoxicam group and 79.3% (7.98 [2.98] vs 1.65 [1.47]; P < 0.05) in the diclofenac group. Compared with baseline, the improvement rated at 2 weeks was not significantly different between the 2 groups. Lornoxicam and diclofenac were well tolerated. The rate of mild to moderate adverse gastrointestinal events was not significantly different in the lornoxicam group compared with the diclofenac group (14.6% vs 18.4%). Similarly, overall tolerability between the 2 groups was not significantly different. None of the patients experienced cardiovascular AEs (eg, edema or increased blood pressure).Conclusion: The results of the present study suggest that lornoxicam was comparable to diclofenac in effectiveness and tolerability after 4 weeks of treatment in these adult Indian patients with OA of the hip or knee who completed the study.     

Randomised trial of long term effect of acupuncture for shoulder pain

The objective of the study is to compare the efficacy of electro-acupuncture with placebo-acupuncture for the treatment of shoulder pain. This study comprised of a prospective, randomized, placebo controlled trial, with independent evaluator set in a Public primary care clinic in Spain. The participants are patients aged from 25 to 83 years with shoulder pain. Patients were randomly allocated to two treatments over eight weeks, with electro-acupuncture or skin non-penetrating placebo-acupuncture, both able to take diclofenac if needed for intense pain. Primary outcome measure was the difference between groups in pain intensity (visual analogue scale-VAS). Secondary outcomes were differences between groups in pain intensity measured by Lattinen index, in range of motion (goniometer), functional ability (SPADI), quality of life (COOP-WONCA charts), NSAIDS intake, credibility (Borkoveck and Nau scale) and global satisfaction (10 points analogue scale). Assessments were performed before, during and three and six months after treatment. At six month follow-up after treatment the acupuncture group showed a significantly greater improvement in pain intensity compared with the control group [VAS mean difference 2.0 (95% CI 1.2-2.9)]. The acupuncture group had consistently better results in every secondary outcome measure than the control group. Acupuncture is an effective long-term treatment for patients with shoulder pain (from soft tissues lesions) in a primary care setting.     

Experience with glucosamine hydrochloride in the treatment of patients with osteoarthrosis

AIM: To study efficacy and tolerance of glucosamine hydrochloride (GH) in osteoarthrosis (OA). MATERIAL AND METHODS: GH was given to patients of the study group (n = 30) for 2 months in a dose 1200 mg/day, while diclofenak was administered to the patients from the control group (n = 24) in a dose 100 mg/day. Clinical, laboratory activity of the disease was estimated before the study, after it, 3 and 6 months later. Side effects were also studied. The efficacy of GH therapy was estimated according to the Lequesne's index, pain intensity on vision-analogy scale (VAS), doses of non-steroidal anti-inflammatory drugs during the day. RESULTS: A decrease in the Lequesne's index and pain by VAS while walking, requirements of NSAIDs in OA patients were revealed. No unfavorable aftereffects of GH were observed. CONCLUSION: GH relieves pain, improves function of the affected joints, reduces necessity in NSAIDs. The effect persists for 3 months. No side effects were registered.     

Analgesic effectiveness of celecoxib and diclofenac in patients with osteoarthritis of the hip requiring joint replacement surgery: a 12-week, multicenter, randomized, double-blind, parallel-group, double-dummy, noninferiority study

Background: The hip is the second most common large joint that is affected by osteoarthritis (OA), with prevalence ranging from 3% to 11% in patients aged >/=35 years. OA is often associated with significant pain, disability, and impaired quality of life. Treatment should be tailored according to the level of pain, disability, and handicap. Pharmacologic treatment options for hip OA include acetaminophen (recommended by the European League Against Rheumatism as a first-line treatment), NSAIDs such as diclofenac, and cyclooxygenase-2-selective NSAIDs such as celecoxib. Objective: The purpose of this study was to determine whether celecoxib 200 mg QD is noninferior to diclofenac 50 mg TID in the treatment of OA of the hip. Methods: This was a 12-week, randomized, double-blind, parallel-group, double-dummy, noninferiority study conducted at 40 centers in the United Kingdom. Patients with OA flare at baseline (determined by visual analog scale [VAS] measurement of >/=40 to <90 mm and patient's and physician's global assessments of arthritis ratings of "poor" or "very poor") and awaiting joint replacement surgery were randomized to receive celecoxib QD or diclofenac TID. Patients were excluded if surgery was anticipated within 8 weeks. The United Kingdom National Health Service initiatives on waiting-list times caused a reduction in the number of potential patients available for participation. Therefore, the study protocol was amended such that change from baseline to week 6 (as opposed to week 12) in the patient's assessment of arthritis pain on walking, measured by VAS (0-100 mm), was the primary outcome. Primary analysis was carried out on the evaluable population (subjects with baseline and week 6 arthritis pain on walking VAS scores and no major protocol deviations). Celecoxib was declared noninferior to diclofenac if the upper limit of the 2-sided 95% CI of the treatment difference (celecoxib vs diclofenac) in the mean change from baseline in VAS did not exceed 10 mm. Tolerability was assessed by the documentation of observed and volunteered adverse events (AEs), physical examination findings, sitting blood pressure, and pulse at screening and at the end of the study (week 12 or early withdrawal). Results: A total of 249 patients aged >/=45 years were randomized to treatment. There were 126 patients in the celecoxib group and 123 patients in the diclofenac group. One patient in the celecoxib group did not receive any treatment and was excluded from analysis. Additionally, 54 patients in the celecoxib group and 45 patients in the diclofenac group discontinued treatment due to AEs and/or lack of treatment effectiveness. Therefore, 71 patients in the celecoxib group and 78 patients in the diclofenac group completed the study. No significant differences in demographic characteristics were observed between treatment groups. The mean (SD) age was 64.0 (9.0) years, 53.9% (76/141) of the patients were men and 46.1% (65/141) were women, and 99.3% (140/141) were white. At weeks 6 and 12, the patient's assessment of arthritis pain on walking (VAS) improved in both groups (-20.0 [23.6] mm in the celecoxib group and This work was presented in poster form at the European Federation of the International Association for the Study of Pain Chapters 5th Congress, September 13-16, 2006, Istanbul, Turkey. Accepted for publication November 28, 2007. -35 [27.0] mm in the diclofenac group [mean treatment difference, 14.4 mm; 95% CI, 6.1 to 22.7]). However, treatment differences in change from baseline favored diclofenac at week 6 (14.4 mm; 95% CI, 6.1 to 22.7) and week 12 (12.2 mm; 95% CI, 2.2 to 22.1). A post hoc analysis, performed after unblinding due to an imbalance in the numbers of patients previously receiving NSAIDs, found a greater treatment difference at week 6 between celecoxib and diclofenac in arthritis pain, favoring diclofenac, in previous nonusers of NSAIDs (n = 49, 18.6 mm; 95% CI, 4.5 to 32.8) compared with previous NSAID users (n = 92, 9.5 mm; 95% CI, -0.4 to 19.3). Celecoxib and diclofenac were generally well tolerated. A similar proportion of patients in both treatment groups experienced AEs (all causality): 67/125 of celecoxib-treated patients (53.6%) compared with 66/123 of diclofenac-treated patients (53.7%). Conclusion: This study did not demonstrate nonin-feriority of celecoxib 200 mg QD to diclofenac 50 mg TID in treating arthritis pain in patients with OA of the hip requiring joint replacement.     

Effects of nimesulide on pain and on synovial fluid concentrations of substance P, interleukin-6 and interleukin-8 in patients with knee osteoarthritis: comparison with celecoxib

OBJECTIVE: This study was designed to investigate the analgesic effects of nimesulide and celecoxib in patients with knee osteoarthritis (OA). In patients with joint effusion, the effects of these non-steroidal anti-inflammatory drugs (NSAIDs) on synovial fluid concentrations of substance P (SP), interleukin (IL)-6 and IL-8 also were evaluated. METHODS: Patients were randomly assigned either nimesulide (100 mg twice a day) or celecoxib (200 mg once a day) for 2 weeks. The intensity of joint pain was assessed with a 100-mm visual analogue scale (VAS). Furthermore, patients completed questions about analgesic efficacy and overall tolerability of the treatments on a five-point categorical scale. Synovial fluid samples were drawn at baseline, 30 min after the first drug intake (day 1), and 30 min after the last drug intake (day 14). RESULTS: We enrolled 44 patients, 20 of whom had a joint effusion. In this group, the effects of nimesulide were more marked than for celecoxib, with evidence of a faster onset of the analgesic action. Both after a single or repeated administration, nimesulide significantly reduced the synovial fluid concentrations of SP and IL-6. Celecoxib, on the other hand, did not change the concentrations of SP and significantly reduced the levels of IL-6 only on day 14. None of the drugs affected IL-8. Both drugs were generally well tolerated. CONCLUSIONS: These results provide evidence that nimesulide is an effective agent for the symptomatic treatment of OA. The effect on inflammatory pain mediators is consistent with the fast analgesic action of this NSAID.     

Short-term effectiveness of ultrasound therapy in knee osteoarthritis

This randomized, placebo-controlled, double-blind study was designed to investigate the short-term efficacy of ultrasound therapy in 90 patients with knee osteoarthritis (OA). Patients were randomly assigned to three groups: group 1 received continuous ultrasound, group 2 received pulsed ultrasound, and group 3 received a 'sham' (placebo) ultrasound for 5 min each session. All treatments were applied once a day for 5 days a week for 2 weeks, i.e. a total treatment duration of 10 days. Compared with baseline, significant improvements were observed in the visual analogue scale pain scores and the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) scores in all three groups. The reductions in pain and WOMAC scores were significantly higher in patients treated with pulsed ultrasound than in the placebo group. In conclusion, pulsed ultrasound therapy is a safe and effective treatment modality in patients with knee OA. Further research is required to investigate the long-term efficacy of pulsed ultrasound therapy in knee OA.     

The Effect of Therapeutic Ultrasound on Pain and Physical Function in Patients with Knee Osteoarthritis

Osteoartritis (OA) is one of the most frequent causes of pain, loss of function and disability in adults. The prevalence of OA is expected to increase substantially in the future. Knee OA is the most common subset of OA. Therapeutic ultrasound (US) is one of several physical therapy modalities suggested for the management of pain and loss of function due to OA. The purpose of our study was to investigate the efficacy of US therapy in reducing pain and functional loss and improving the quality of life in patients with knee OA in comparison to sham US therapy. The study involved 62 patients. The patients were randomly divided into two groups. The patients in group 1 (n = 30) were administered 1 W/cm², 1 MHz continuous US, and the patients in group 2 (n = 32) were administered sham US. The US treatment was applied for 8 min to each knee, 16 min in total, 5 d a wk, for a total of 10 sessions during 2 wk. The patients were evaluated immediately after treatment and 1 mo after therapy according to the visual analog scale (VAS), night pain, range of motion, morning stiffness, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne and Short Form-36 (SF-36) scales and 6 min walking distance. Improvement in pain and joint functions was observed in both groups according to the evaluation immediately after treatment and at 1 mo after the therapy. According to the evaluation results immediately after treatment, there was significant improvement in all pain scales (VAS, WOMAC, Lequesne, SF-36), morning stiffness and 6 min walking distance in patients receiving real US treatment (p < 0.05), but only in some pain scales (VAS, WOMAC) and functions in the group receiving sham US (p < 0.05). Significantly better improvement was observed in some pain scales (SF-36), functions (WOMAC, SF-36) and 6 min walking distance in the real US group. At 1 mo after therapy, no significant difference was observed between groups except for improvement in night pain in the real US group. In conclusion, US therapy has been found to be effective in reducing pain and improving physical function in the short term, but this positive effect was not persistent in the long term. However, we believe that the results of our study may contribute to ongoing research for the treatment of patients with knee OA, and further systematic investigation on larger patient populations may delineate the role of US in knee OA treatment.     

Efficacy and safety of lornoxicam compared with placebo and diclofenac in acute sciatica/lumbo‐sciatica: an analysis from a randomised,double‐blind,multicentre, parallel‐group study

Aim: The efficacy and safety of oral lornoxicam (LNX) as early treatment of acute sciatica/lumbo‐sciatica was compared with placebo and diclofenac in a 5‐day double‐blind, randomised study. Methods: Male or female patients (n = 171) aged 18–70 years with acute sciatica or lumbo‐sciatica [acute sciatica defined as typical radiation of pain along the sciatic nerve (including radiating pain below the knee) and worsening of pain as defined by Lasegue’s leg‐raising test (< 60°) within 72 h and previous attack ceased > 3 months previously; lumbo‐sciatica defined as symptoms of sciatica with concurrent lumbar pain and a predefined minimum pain score]. The dosage of study treatment was 8–24 mg/day LNX, 100–150 mg/day diclofenac or placebo. The primary end‐point was the difference in pain intensity difference from baseline to 6 h (PID_{0–6 h}) after the first dose of study treatment. Secondary end‐points were pain relief, the cumulative sums of pain intensity difference and total pain relief on day 1 and on days 2–4. Results: In total, 164 patients completed the study. Significant differences in PID between LNX and placebo were seen in the time interval 3–8 h after the first dose including PID_{0–6 h} (p = 0.015). Secondary end‐points favoured LNX vs. placebo, but in general were not significantly different. LNX and diclofenac had similar analgesic effect. Incidence and severity of adverse events were comparable for the three treatments; overall tolerability was rated as very good/good by 93% of the patients. Conclusion: These data indicate that the analgesic efficacy of LNX is superior to placebo and similar to diclofenac in acute sciatica/lumbo‐sciatica.     

Structum (chondroitin sulfate)--a new agent for the treatment of osteoarthrosis]

AIM: To study efficiency and tolerance of Structum in gonarthrosis patients as well as duration of its effect after discontinuation. MATERIALS AND METHODS: 100 patients with femorotibial gonarthrosis aged 45 years and older entered an open randomised trial. They had knee joint arthrosis satisfying diagnostic criteria OA ACR at stage II-III according to Kellgren-Lawrence with pain syndrome. Walking pain intensity was > or = 30 mm by the visual analogue scale (VAS), Leken total functional index > or = 4 and < or = 11. Antiinflammatory drugs (AI) were regularly taken for 30 days for the 3 pretreatment months. 50 patients of the study group received Structum and ibuprofen (1200 mg/day) for 6 months. 50 patients of the control group received ibuprofen only. The two groups were followed up for 3 months. Clinical examination was made monthly. RESULTS: There were significant differences between the groups by the Leken's index (p < 0.005), VAS, pain, daily AI drug requirement. Structum proved more effective. Tolerance was good. Side effects were observed only in two patients (diarrhea and nausea). In the control group, side effects made 15 patients to discontinue the treatment. CONCLUSION: Structum is a new effective drug against gonarthrosis which reduces pain, improves joint function. It is well tolerated and allows to diminish the dose of AI drugs. The response to Structum persisted for 3 months after the treatment.     

Oxaprozin versus diclofenac sodium in the treatment of ankylosing spondylitis

The efficacy and tolerance of 1200 mg/day oxaprozin and 100 mg/day diclofenac sodium were compared in 40 patients with ankylosing spondylitis in a 6-week open study. Overall improvement was seen in the patients in both treatment groups. Oxaprozin-treated patients showed significant improvement in spontaneous pain of the vertebral spine and in morning stiffness after 6 weeks' treatment. There were no statistically significant differences between the treatment groups. Therapy was discontinued in 10 patients; five treated with oxaprozin (three because of intolerance and two because of worsening of symptoms) and five taking diclofenac sodium (four because of intolerance and one because of worsening of symptoms). Five (25%) oxaprozin-treated patients and six (30%) diclofenac sodium-treated patients had side-effects, with gastro-intestinal disturbances and dizziness reported most frequently. There were no statistically significant differences between the groups in the frequency of side-effects. These results indicate that oxaprozin is a promising therapeutic agent for ankylosing spondylitis.     

补肾祛寒通络法治疗膝骨关节炎:随机对照

背景:骨关节炎属中医学“骨痹”范畴,多因肝肾不足、气血亏损、损伤和感受风寒湿邪所致,肾虚寒凝型为骨关节炎的常见证型。目的:观察补肾祛寒通络法治疗肾虚寒凝型膝骨关节炎的临床疗效。设计:随机对照临床实验。单位:广东省东莞市石龙人民医院中医科。对象:于2005-06/2006-07本院风湿专科和骨科门诊及住院的肾虚寒凝型膝骨关节炎患者,以最有可能在实验中获益的患者为目标,纳入88例。采用单纯随机分组方法,分为实验组44例,男21例,女23例,年龄42～70岁,平均(62±8)岁,平均病程(34±18)个月;对照组44例,男24例,女20例,年龄40～69岁,平均(61±7)岁,平均病程(34±16)个月。方法:实验组采用补肾祛寒通络中药内服及中药外洗。补肾祛寒通络中药:胡桃肉12g,补骨脂12g,炒杜仲12g,熟地15g,大茴香9g,络石藤15g,制川乌9g,三七6g,蜈蚣3g,鸡血藤15g。外洗方:透骨草40g,当归15g,苏木15g,生大黄15g,生南星10g,乳香10g,没药10g,冰片3g。(内服,以37℃温开水100mL冲服,1剂/d。外洗以100℃开水500mL溶化,待水温降至35℃时外洗双膝部,1剂/次,2次/d)。对照组采用硫酸葡萄糖胺(商品名维骨力胶囊,每个胶囊含硫酸葡萄糖胺晶体314mg,相当于含硫酸葡萄糖胺250mg),2粒/次,3次/d。吡罗昔康(商品名炎痛喜康片)口服,20mg/次,1次/d。2组疗程均为12周。参照WOMAC骨关节炎指数及骨关节炎临床疗效判定标准,比较两组疗效。主要观察指标:两组WOMAC疼痛积分、僵硬积分、生理功能积分、总积分和临床疗效。结果:88例患者全部进入结果分析。①实验组和对照组治疗后患者的WOMAC疼痛指数、关节僵硬指数、生理功能指数、总指数评分均较治疗前有显著降低,差异有显著性意义(实验组:4.95±2.46,11.39±4.10;0.70±0.88,1.57±1.42;13.16±5.71,31.16±10.08;18.82±7.96,44.11±13.29;对照组:6.64±1.81,11.59±3.07;0.68±0.86,1.52±1.34;14.25±3.99,31.89±8.49;21.57±5.35,45.00±10.73;P<0.05)。②治疗后实验组WOMAC疼痛指数低于对照组,差异有显著性意义(P<0.05),两组WOMAC关节僵硬、生理功能指数评分值比较差异无显著性意义(P>0.05),其余各指标差异无显著性意义(P>0.05)。③实验组总有效率93.2%,对照组总有效率95.5%,两组比较无显著意义(P>0.05)。④对照组实验过程中,有3例患者出现胃肠道反应,坚持用药症状未加剧;实验组未见不良反应。结论:补肾祛寒通络法中药内服加外洗治疗肾虚寒凝型膝骨关节炎可取得满意疗效,止痛效果尤佳。     

Effectiveness of platelet-rich plasma in the treatment of moderate knee osteoarthritis: a randomized prospective study

[Purpose] To assess the effects of different numbers of platelet-rich plasma (PRP) applications on pain and physical function in grade 3 knee osteoarthritis (OA). [Subjects and Methods] A total of 102 patients with grade 3 knee OA were randomly divided into three groups: Group 1 received a single injection of PRP, Group 2 received two injections of PRP two weeks apart, Group 3 received three injections of PRP at 2-weeks intervals. All patients were evaluated with a visual analog scale (VAS), the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the Timed-Up and Go test (TUG) before the treatment and at 1, 3 and 6 months after the treatment. [Results] Ninety-eight patients (15 males, 83 females) completed the study. The mean ages of the patients were 53.5±6.6, 54.9±5.3, and 55.1±5.6 years in Group 1, Group 2, and Group 3, respectively. Statistically significant improvements were noted in all of the evaluated measures in all of the groups. The mean differences of Group 1-Group 2 and Group 1-Group 3 WOMAC total, WOMAC pain, WOMAC stiffness, and WOMAC function scores were statistically significant. [Conclusion] PRP is an effective treatment for functional status and pain in moderate knee osteoarthritis and a minimum of two injections is appropriate.Key words: Platelet-rich plasma effectiveness, Moderate, Knee osteoarthritis     

替扎尼定与非甾体抗炎药联合治疗急性痉挛性疼痛的临床研究

目的:替扎尼定是具有解痉作用的α2肾上腺能受体激动剂,并具有一定的胃肠道保护作用,适用于单一治疗或与非甾体消炎药(NSAIDs)联合治疗急性痉挛性疼痛。通过替扎尼定和非甾体类抗炎药物的联合应用,临床观察和评估联合用药能否增强疗效和增加安全性。方法:急性痉挛性疼痛70例,随机分为两组,一组服用替扎尼定2mg,bid 双氯芬酸50mg,bid,一组服用双氯芬酸50mg,bid 安慰剂2mg,bid。观察药物疗效和不良反应。结果:联用组的总有效率为70%,胃肠道不良反应发生率为12%,中枢神经系统不良反应发生率为18%;单用组的总有效率为56%,胃肠道不良反应发生率为32%,中枢神经系统不良反应发生率为10%。结论:替扎尼定和非甾体类药物联用具有更好的疗效以及更高的药物耐受性。     

Bromelain as an adjunctive treatment for moderate-to-severe osteoarthritis of the knee: a randomized placebo-controlled pilot study

BACKGROUND: Osteoarthritis (OA) of the knee is the most prevalent joint disorder. Previous studies suggest that bromelain, a pineapple extract, may be a safer alternative/adjunctive treatment for knee OA than current conventional treatment. AIM: To assess the efficacy of bromelain in treating OA of the knee. DESIGN: Randomized, double-blind placebo-controlled trial. METHODS: Subjects (n = 47) with a confirmed diagnosis of moderate to severe knee OA were randomized to 12 weeks of bromelain 800 mg/day or placebo, with a 4-week follow-up. Knee (pain, stiffness and function) and quality-of-life symptoms were reported monthly in the WOMAC and SF36 questionnaires, respectively. Adverse events were also recorded. The primary outcome measure was the change in total WOMAC score from baseline to the end of treatment at week 12. Longitudinal models were used to evaluate outcome. RESULTS: Thirty-one patients completed the trial (14 bromelain, 17 placebo). No statistically significant differences were observed between groups for the primary outcome (coefficient 11.16, p = 0.27, 95%CI -8.86 to 31.18), nor the WOMAC subscales or SF36. Both treatment groups showed clinically relevant improvement in the WOMAC disability subscale only. Adverse events were generally mild in nature. DISCUSSION: This study suggests that bromelain is not efficacious as an adjunctive treatment of moderate to severe OA, but its limitations support the need for a follow-up study.     

Periarthritis of the shoulder joint: variants of the course and treatment with artrofoon

AIM: To compare efficacy of shoulder joint periarthritis (SJP) treatment with artrofoon vs non-steroid anti-inflammatory drugs (NSAID). MATERIAL AND METHODS: SJP patients of the study group (12 males, 18 females, mean age 59.4 +/- 8.9 years, the disease duration 6.5 +/- 3.8 years) received artrofoon (1 tablet 8 times a day for 3 months, in improvement of the condition the dose was reduced to 4 tablets a day). Patients of the control group (11 males, 19 females, mean age 58.3 +/- 9.6 years, the disease duration 5.1 +/- 4.1 years) were given NSAID (primarily diclofenac in a dose 100 mg/day with subsequent dose reduction in improvement). All the patients were examined on the day of the treatment start, 2 weeks, 1 and 3 months later. The examination protocol included general examination, measurement of blood pressure, body mass, height, pain at rest and exercise, motility of the shoulder joint, subjective and objective efficacy and tolerance of the drugs. Total blood count, biochemical blood analysis, urine test, ECG, x-ray, ultrasound investigation of the joint were performed before and after therapy. RESULTS: The majority of the patients from both groups experienced nocturnal pain relief, artrofoon relived also pain at the joint movement. Significant objective and subjective responses were registered in 15 and 14, partial response--in 10 and 12 patients of the study group, respectively, no response--in 5 and 4 patients, respectively. In the controls, the above degree of the response was in 9 and 12, 18 and 16, 3 and 2 patients, respectively. Negative effects of the treatments were not seen. CONCLUSION: SJP treatment with artrofoon is effective. It relieves pain, improves motility of the joint, normalizes mental and somatic status of the patients.     

DOUBLE-BLIND STUDY COMPARING THE LONG-TERM EFFICACY OF THE COX-2 INHIBITOR NIMESULIDE AND NAPROXEN IN PATIENTS WITH OSTEOARTHRITIS

This double-blind one-year study compares the long-term efficacy and safety of nimesulide with naproxen in patients with osteoarthritis (OA) of the knee or hip. Patients were randomised to nimesulide 100 mg twice daily (n=183) or naproxen 250 mg morning, 500 mg evening (n=187). The primary efficacy variable was change in pain intensity (WOMAC A scale) at 6 months. Nimesulide tablets showed at least equivalent efficacy to naproxen tablets in reducing pain intensity at 6 and 12 months (nimesulide -22.5% at 6 and 12 months; naproxen -22.4% at 6 months, -19.9% at 12 months; non-inferiority proven). At 6 months the investigator assessed efficacy as ‘good’ or ‘excellent’ in 59.3% of nimesulide and 56.4% of naproxen-treated patients, with corresponding values for patient assessment of 57% and 52.7%. Both treatments were well tolerated, with fewer related gastrointestinal adverse events reported with nimesulide (77 cases, 47.5%) than with naproxen (96 cases, 54.5%). This study shows nimesulide to be as effective as naproxen in the long-term treatment of OA and to be associated with fewer gastrointestinal side-effects.