Sodium hyaluronate in the treatment of osteoarthritis of the ankle: a controlled, randomized, double-blind pilot study

BACKGROUND: Intra-articular injections of hyaluronans have been shown to be safe and effective for the treatment of pain associated with osteoarthritis of the knee. This pilot study was undertaken to gather preliminary data on the efficacy and safety of five weekly intra-articular injections of Hyalgan (sodium hyaluronate; molecular weight, 500 to 730 kDa) as compared with saline solution for the treatment of pain associated with osteoarthritis of the ankle. METHODS: Twenty patients at two test sites were randomized with use of a double-blind (blinded observer), saline solution-controlled, parallel experimental design. Patients were randomized to receive five weekly intra-articular injections of either 1 mL of sodium hyaluronate (10 mg/mL) or 1 mL of phosphate-buffered saline solution into the ankle joint. The primary outcome measurement was the ankle osteoarthritis score. Several secondary outcome measures also were assessed. RESULTS: Significant improvement in the mean ankle osteoarthritis score from baseline was seen at all follow-up visits from one to six months in both the sodium hyaluronate group and the saline solution group (p < 0.0001). In addition, five of nine patients in the sodium hyaluronate group had >30 mm of improvement in this score, compared with one of eight patients in the control group. No withdrawals were directly attributable to the injections of sodium hyaluronate or saline solution, and no severe medication-related adverse events were observed. CONCLUSIONS: The present study suggests that five weekly intra-articular injections of sodium hyaluronate (molecular weight, 500 to 730 kDa) are well tolerated, can provide sustained relief of pain, and can improve function in patients with osteoarthritis of the ankle. These findings are consistent with those of previously published studies involving intra-articular injections of sodium hyaluronate in other joints, but they require confirmation in a large, randomized, saline solution-controlled study.     

Efficacy and safety of intraarticular sodium hyaluronate in knee osteoarthritis. ORTHOVISC Study Group

A prospective, multicenter, randomized, double-blind, controlled trial was conducted in 226 patients with knee osteoarthritis to evaluate the safety and efficacy of intraarticular injections of sodium hyaluronate. Patients were randomized to three weekly injections of 30 mg sodium hyaluronate or physiologic saline (control) and were observed for an additional 25 weeks. In comparison with the control group, among patients who completed at least 15 weeks of the study and whose Western Ontario and McMaster Universities Osteoarthritis Index pain score for the contralateral knee was less than 12 at baseline, sodium hyaluronate injection resulted in improvement in Western Ontario and McMaster Universities Osteoarthritis Index pain score, patient and investigator global assessments, and pain on standing from Weeks 7 to 27. Fifty-eight percent of patients treated with sodium hyaluronate achieved a 5-unit or greater improvement in mean pain score from Weeks 7 through 27, compared with 40% of control patients. In addition, nearly twice as many patients treated with sodium hyaluronate as with saline (30% versus 17%, respectively) achieved a net improvement of at least 7 units. In contrast to treatment with saline, Western Ontario and McMaster Universities Osteoarthritis Index pain score for the contralateral knee was inversely related to the magnitude of improvement after treatment with sodium hyaluronate. Few side effects were attributed to treatment, and no differences between treatment groups were seen in this respect (sodium hyaluronate, nine [8%]; saline, 11 [10%]). The incidence of injection site reactions was low (sodium hyaluronate, 1.2 %; saline, 1.5%). The results indicate that sodium hyaluronate treatment is well tolerated and produces statistically and clinically significant improvement of symptoms in patients with mild to moderate knee osteoarthritis in whom pain in the contralateral knee is relatively modest.     

Effects and Safety of Intra-Articular Sodium Hyaluronate Injection for the Treatment of Ankle Osteoarthritis: A Prospective Clinical Trial

Various nonoperative treatments have been implemented to reduce pain and improve the quality of life in patients with ankle osteoarthritis. Among these treatments, intra-articular hyaluronate injection has proven efficacy and safety in patients with knee osteoarthritis. The purpose of this study was to evaluate the efficacy and complications of hyaluronate injection using various clinical scoring systems. This study included 37 patients with unilateral ankle osteoarthritis (grade 2 or 3 according to the Takakura classification) who did not respond to previous pharmacological treatment. 3 weekly hyaluronate injections (2 mL Hyruan Plus®) were administered. The efficacy of intra-articular hyaluronate injection was evaluated on the basis of patient-reported foot and ankle clinical assessment at a mean follow-up of 13.8 ± 8.3 (range 6-33) months. Ankle Osteoarthritis Scale scores for pain and disability, American Orthopedic Foot and Ankle Society ankle-hindfoot scores, and visual analog scale for pain significantly improved at the final follow-up compared to that before intra-articular hyaluronate injection (p ≤ .05). When patients were dichotomized according to age, sex, body mass index, symptom duration, and Takakura classification, all these factors were not related to clinical outcomes. This study suggests that 3 weekly intra-articular hyaluronate injections can be performed safely to reduce pain and improve function without serious complications in patients with early or intermediate-grade ankle osteoarthritis when patients inadequately respond to medication. Larger controlled studies are needed to clarify the effects of hyaluronate injection and identify patients who can benefit most from hyaluronate injection.     

膝关节手术后注射透明质酸钠效果观察

目的　探讨膝关节术后关节腔内注射透明质酸钠的效果。方法　 1998年 1月～ 2 0 0 1年 2月 ,对关节镜手术 134例于手术结束时 ,以及膝关节开放手术 91例于术后 2 4小时拔引流管时 ,分别在关节腔内注射透明质酸钠 4ml(用药组 ) ;术后第 5天抽出关节积液 ,再注入透明质酸钠注射液 2 ml;每周 1次 ,连续 5周为一个疗程 ,根据病情注射 1～ 2个疗程 ,观察各时间点疼痛 VAS评分和达到最大无痛活动度的时间。与同期手术未用药的 85例进行比较。结果　用药组术后各时间点的疼痛程度评分均低于未用药组 ,关节镜手术用药组术后达最大无痛活动度所需的时间为 3天 ,未用药组为 5天 ;膝关节开放手术用药组达最大无痛活动度的时间为 6天 ,未用药组为 9天。结论　膝关节手术后关节腔内注射透明质酸钠能有效止痛 ,并有助于关节功能恢复     

臭氧联合玻璃酸钠治疗膝骨性关节炎的疗效观察

[目的]观察医用臭氧(O3)联合玻璃酸钠(SH)治疗膝骨性关节炎的临床疗效。[方法]选择120例膝骨性关节炎患者,随机分为A、B、C三组,每组40例。其中A组第1周关节腔内注射15ml(35ug/ml)的医用臭氧,第2周注射玻璃酸钠25mg,第3周注射15ml(35ug/ml)的医用臭氧;B组关节腔内注射15ml/周的医用臭氧,每周1次,连续3次为1疗程;C组关节腔内注射玻璃酸钠25mg/周,每周1次,连续5次为1疗程,比较三组病例治疗前及治疗后1、2、3个月VAS值和治疗效果。[结果]三组患者治疗后VAS评分与治疗前相比均有降低(P0.01),在治疗后的第1、2、3个月同一时点,A组疼痛缓解最明显,VAS评分三组相比差异有统计学意义(P0.05,P0.01)。A组膝关节功能的优良率要高于对照组,差异有统计学意义(P0.05和P0.01)。全部患者未见明显的不良反应和副作用。[结论]医用臭氧联合玻璃酸钠治疗膝骨性关节炎能有效解除关节疼痛,改善关节活动度,临床疗效优于臭氧、玻璃酸钠单独应用。是一种治疗膝骨性关节炎的优势方法。     

Oral treatment of oligozoospermia with testosterone-undecanoate: results of a double-blind-placebo-controlled trial

30 patients with normogonadotrophic oligozoospermia from 1-20 mill/ml (group A) and 30 men with a sperm density from 210-40,0 mill/ml (group B) from the andrologic laboratory of the University Clinic for Gynecology and Obstetrics, Graz, Austria were treated with a 120 mg testosteron-undecanoate per os for 100 days. One randomized half of the patients received a placebo in a double blind manner. Conventional spermiograms were supplemented by extended morphologic analysis and motility determinations by laser-Doppler-spectroscopy. Statistical evaluation of data revealed no differences between verum and placebo group before treatment. After therapy significantly higher levels of testosterone could be observed in the verum group. Statistical calculations of differences between spermiogram parameters before treatment, after treatment and six weeks thereafter revealed significant improvements of sperm morphology in group A and B as well as significantly lower numbers of spermatozoa with head-deformations. A reduction of tail deformities could be observed at the control spermiogram six weeks after end of treatment. Besides improvements of sperm morphology, enhancements of sperm density could be observed in the verum group; sperm motility remained generally unchanged. During the duration of the trial four pregnancies (1 abortion) occurred in the placebo group, six females became pregnant in the verum group: five belonged to group A (1 x gemini), one pregnancy occurred in group B.     

Onset of spinal block is more rapid with isobaric than hyperbaric bupivacaine

PURPOSE: To compare isobaric with hyperbaric 9.75 mg bupivacaine injected intrathecally, and to evaluate the effects of subsequent injection of lidocaine 2% into the epidural space. METHODS: Patients in group 1 (n = 30) received isobaric 9.75 mg bupivacaine and in group 2 (n = 30) hyperbaric 9.75 mg bupivacaine injected into the subarachnoid space in a combined spinal-epidural technique. They were undergoing urological, gynecological, orthopedic, gastro-intestinal or vascular surgery. Using a double blind technique, the followings parameters were measured: cutaneous analgesia to pinprick, motor blockade, time for two segment regression, time for complete regression of the motor block, quality of anesthesia. In 12 patients the effect of epidural injections of 3 ml lidocaine 2% was observed. RESULTS: Motor and sensory block developed more rapidly (five minutes) in the isobaric group (P<0.05). Maximum upper level (T7+/-2), two-segment regression (52 min in both groups), motor recovery (160 vs. 157 min), and quality of anesthesia did not differ between the two groups. Thirty nine epidural injections of 3 ml lidocaine 2% were given in 12 patients 10 min after spinal injection, 28 were in the hyperbaric group (P<0.05). Twenty six of the epidural injections produced an increase in sensory block of 0 or 1 dermatome, and 13, of 2 or more. CONCLUSION: The block developed more rapidly in the isobaric group, but both isobaric and hyperbaric 9.75 mg bupivacaine produced adequate upper levels of analgesia for surgery. The effect of epidural injections of 3 ml lidocaine 2% was usually minimal.     

Myocardial Preservation with Nifedipine: A Comparative Study at Normothermia

Sixty-four dogs were placed on normothermic total cardiopulmonary bypass, and global ischemia was induced for 1 hour during which continuous infusions (240 ml per hour) (N = 39) or bolus injections (150 to 200 ml every 30 minutes) (N = 23) into the proximal aortic root were performed. The control groups (N = 26) had infusion or injection of normal saline solution, normal saline solution + 25 mEq/L of potassium chloride, or Normosol-R pH 7.4. The cardioplegic solution (N = 15) contained 25 mEq/L of potassium chloride in Normosol-R pH 7.4, 0.25 mg/ml of lidocaine, 500 mg/dl of glucose, and 1.8 μ;/ml of insulin. The nifedipine group (N = 23) had infusion or injection of 0.167 to 0.2 μ;g/ml of nifedipine in saline solution, Normosol-R pH 7.4, or the cardioplegic solution.Left ventricular performance was assessed by phasic and mean measurements of left ventricular peak and end-diastolic pressures and its first derivative, left and right atrial pressures, and ascending aortic blood flow. Calculations of stroke work index and total peripheral resistance were performed. Morphological examinations, and light and electron microscopic examinations of heart slices were done. The results demonstrated a consistent superiority of the nifedipine group in terms of performance after bypass compared with the cardioplegic or control group. Normal preischemic stroke work indices and Sarnoff curves were present 2 hours after bypass for the nifedipine-treated groups. The cardioplegic solution was ineffective when given continuously but gave modest protection when given as a bolus injection. It is concluded that the concept of the efficacy of calcium blockade during ischemia and the initial reperfusion period for enhanced myocardial protection is valid.     

Synovial response to intraarticular injections of hyaluronate in frozen shoulder: a quantitative assessment with dynamic magnetic resonance imaging

To clarify the response of frozen shoulder (FS) to intraarticular injections of high-molecular-weight sodium hyaluronate (HA), a mixture of 2.5ml of HA and 1.5ml of 1% lidocaine was injected into the glenohumeral joint of 11 patients with FS, 8 of whom received five weekly injections. The patients were assessed using the Japanese Orthopaedic Association shoulder score (JOA score) before the first injection, 1 week after the first injection, and 1 week after the final injection. Following each clinical evaluation, the patients underwent dynamic magnetic resonance imaging enhanced with Gd-DTPA, and the coefficient of enhancement (CE) in the glenohumeral synovium was calculated, with the examiners blinded to the clinical information. The JOA score tended to be greater and the CE smaller after injection than before injection. The changes in the CE following both single and repeated injections were negatively correlated with changes in the JOA score. Thus, clinical improvement in patients with FS was associated with a decrease in the CE. Because the CE depends on the degree of synovitis, the therapeutic effect of intraarticular HA injection for FS results, at least in part, from suppression of synovitis in the glenohumeral joint through an antiinflammatory effect.     

A型肉毒毒素治疗梨状肌综合征的临床观察

目的探讨使用A型肉毒毒素治疗梨状肌综合征的临床效果。方法25例保守治疗无效的梨状肌综合征患者随机分为两组。A组患者13例,梨状肌内注射0．25％布比卡因3ml加5mg曲安奈德,B组12例,梨状肌内注射0．25％佰比卡因3ml加5mg曲安奈德和100U的A型肉毒毒素。记录两组患者注射治疗前、治疗后2周、1、2和3月的VAS以及不良反应。结果A组治疗后各时点的VAS明显低于治疗前（P〈0．05）,治疗后3月的VAS高于治疗后2周、1和2月（P〈0．05）。B组治疗后各时点的VAS明显低于治疗前（P〈o．05）,治疗后1、2和3月的VAS明显低于治疗后2周（P〈0．05）。治疗后1、2和3月的VASB组均显著低于A组（P〈0．05）。B组中有2例患者在注射治疗后1周患侧下肢表现为轻微软弱无力,2周后逐步缓解。结论梨状肌内联合注射A型肉毒毒素、皮质激素和局麻药是较好的治疗梨状肌综合征的疗法,具有疗效佳、维持时间长、不良反应少等优点。     

透明质酸钠预防屈肌腱粘连的临床研究

目的　评价透明质酸钠预防术后屈肌腱粘连的临床效果。方法　 1998年～ 1999年对 47例屈肌腱手术者 ,于肌腱损伤修复部鞘内或局部分别注入两种透明质酸钠凝胶制剂。 A组注入透明质酸钠 I号 ,2 0 m g/ 2 ml,17例 ;B组注入透明质酸钠 号 ,2 0 mg/ 2 ml,16例 ;C组除不用透明质酸钠外 ,其它治疗与 A、B组相同 ,14例。于术后 1、2和 3个月测定相关部位的功能、疼痛和肿胀等情况 ,按关节功能和握拳功能评价透明质酸钠预防粘连的效果。结果　 47例经 1～ 3个月随访 ,A组优良率为 6 4.71% ,B组为 6 8.75 % ,C组为 42 .86 % ,A及 B组与 C组比较有统计学意义 (P<0 .0 5 ) ;各组均未见明显毒副作用。结论　两种透明质酸钠凝胶均有明显抑制术后屈肌腱粘连形成的作用 ,且使用安全方便     

Viscosupplementation (hyaluronans) in the treatment of ankle osteoarthritis

This pilot study was undertaken to gather preliminary data on the efficacy and safety of viscosupplementation with sodium hyaluronate versus phosphate-buffered saline control for pain associated with osteoarthritis (OA) of the ankle. Results suggest that five weekly intra-articular injections of sodium hyaluronate in patients who have OA of the ankle are well tolerated, can provide sustained relief of pain, and improve ankle function. These findings are consistent with previously published studies using intra-articular injections of sodium hyaluronate in other articular joints but require confirmation in a large, randomized, saline-controlled study. If confirmed, these findings would provide a valuable nonoperative treatment option for patients who have OA of the ankle.     

Efficacy and safety of propiverine in SCI-patients suffering from detrusor hyperreflexia--a double-blind, placebo-controlled clinical trial

AIMS OF THE STUDY: The aim of this double-blind, randomised, prospective, multicentre trial was to evaluate the efficacy of propiverine in patients suffering from detrusor hyperreflexia caused by spinal cord injury in comparison to placebo. STUDY DESIGN: The treatment period of 14 days comprised visits at baseline (V1) and after 14 days treatment (V2). Fifteen mg propiverine t.i.d. or placebo t.i.d. were administered as medication. The following efficacy parameters were adopted: the urodynamic parameters maximal cystometric bladder capacity, bladder volume on onset of the first as well as duration and amplitude of the maximum detrusor contraction, bladder compliance and residual urine, and subjective assessment of efficacy by physicians. For the evaluation of the safety of propiverine the incidence rate of adverse events by directly questioning as well as laboratory parameters were investigated. For biometrical evaluation t-test for independent groups was applied. RESULTS: One hundred and thirteen patients were investigated. The maximal cystometric bladder capacity increased significantly in the propiverine group, on average by 104 ml (V1: 262+/-132 ml. V2: 366+/-143 ml, P<0.001). The changes in bladder capacity during the first contraction and the maximum detrusor contraction in the verum group were both statistically significant. The bladder compliance documented a more pronounced increase under propiverine in comparison to placebo. Residual urine increased by 37+/-71 ml in the propiverine group, significantly more than in the placebo group (P=0.01). Sixty-three per cent of the patients expressed subjectively an improvement under propiverine in comparison with 23% of the placebo group. Expected anticholinergic adverse events occurred: dryness of the mouth (37% in the verum and 8% in the placebo group), accommodation disorders (28% and 2% respectively). Nausea, constipation, headache, dizziness, tiredness and palpitations were reported in almost comparable incidence rates between 3 and 13% in both treatment groups. Eight drop-outs were registered in the propiverine group (five due to adverse events) and three in the placebo group (one due to adverse events). The laboratory parameters revealed no changes. CONCLUSION: Propiverine proved its efficacy in detrusor hyperreflexia with regard to the urodynamic parameters of the maximal cystometric bladder capacity and detrusor contractility. Anticholinergic adverse events such as dryness of the mouth and accommodation disorders were considered being tolerable. The increase in residual urine reflects the therapeutically desired effect of detrusor relaxation because the majority of patients normally practise intermittent catheterisation for bladder emptying.     

Safety and efficacy of intra-articular sodium hyaluronate (Hyalgan) in a randomized, double-blind study for osteoarthritis of the ankle

BACKGROUND: The potential benefit of hyaluronans in alleviating pain associated with osteoarthritis (OA) in joints other than the knee is of increasing interest. This double-blind, randomized, controlled study examined the safety and efficacy of intraarticular sodium hyaluronate (Hyalgan) in the treatment of pain associated with ankle OA. MATERIALS AND METHODS: Thirty consecutive patients with ankle OA documented by X-ray were randomized to treatment with five weekly injections of either sodium hyaluronate 2 mL (HYL) or phosphate-buffered saline 2 mL (control) in the tibiotalar joint. The primary endpoint was pain on movement and weightbearing using the Ankle Osteoarthritis Scale (AOS) 3 months after injection (a 100-mm visual analog scale [VAS]). Additional measures included the Western Ontario and McMaster Universities (WOMAC) OA Index and patient global assessment through 6 months; the Short Form-12 (SF-12) Health Survey at 3 months and 6 months; and all reported adverse events (AEs). RESULTS: The study groups differed only in age, baseline WOMAC pain, and AOS total scores; 80% of the HYL and 73% of the control patients completed the study. At Month 3, the primary endpoint of the study, the HYL group demonstrated a significantly greater improvement from baseline in AOS total score than did the control group (HYL: -17.4 +/- 5.0 mm; Control: -5.1 +/- 4.0 mm; p = 0.0407). The incidence of AEs was low, with no significant differences between the groups. There were no post-injection flares. CONCLUSION: Our study suggests that sodium hyaluronate may be a safe and effective option for pain associated with ankle OA, although larger studies are needed.     

A randomized, controlled parallel-group trial on efficacy and safety of iron sucrose (Venofer) vs iron gluconate (Ferrlecit) in haemodialysis patients treated with rHuEpo.

BACKGROUND: The objectives of the present trial were to compare the efficacy and safety of two i.v. iron preparations with respect to haemoglobin levels, iron status and recombinant human erythropoetin (rHuEpo) dosage requirements in stable, rHuEpo-treated haemodialysis patients (maintenance phase of iron treatment) over 6 months. METHODS: A total of 59 patients were randomized and assigned to one of two treatment groups and 55 patients were analysed (iron sucrose n=27; iron gluconate n=28). Iron sucrose was administered in a dose of 250 mg iron diluted in 100 ml normal saline given over 60 min once per month, while 62.5 mg iron as iron gluconate was given once per week in a slow push injection (5 min). RESULTS: --Efficacy parameters: Haemoglobin levels could be maintained from baseline to endpoint in both groups. There were, however, more patients in the iron sucrose group than in the iron gluconate group for whom treatment was discontinued because their haemoglobin values exceeded 12.5 g/dl or ferritin values exceeded 1000 ng/ml (five vs two and three vs one patient, respectively). Transferrin saturation and serum ferritin increased significantly in both groups (+255.7 ng/ml with iron sucrose and +278.5 ng/ml with iron gluconate), while rHuEpo dosage did not change significantly throughout the study. --Safety parameters: There were a total of 174 infusions of iron sucrose and 720 injections of iron gluconate during the trial; all of them were well tolerated. In particular, we did not observe anaphylactoid reactions or any events suggestive of iron toxicity such as hypotension, dizziness, or nausea. CONCLUSIONS: High doses of iron sucrose (Venofer((R)) at a dose of 250 mg/month) was equally effective in maintaining haemoglobin and equally well tolerated as low doses of iron gluconate (Ferrlecit((R)) at a dose of 62.5 mg once per week) in stable, rHuEpo treated haemodialysis patients.     

Treatment of adhesive capsulitis with intra-articular hyaluronate: A systematic review

Sodium hyaluronate injection into the glenohumeral joint is a treatment option in the management of adhesive capsulitis of the shoulder. We hypothesized that a systematic review would demonstrate that intra-articular sodium hyaluronate injections would result in significant improvements in passive range-of-motion, shoulder and general clinical outcome measures, and pain scales at short- and mid-term follow-up. Multiple medical databases were searched for levels I-IV evidence with a priori defined specific inclusion and exclusion study criteria. Clinical outcome measures used included Constant score, VAS pain scores, Cho functional scores, JOA scores, and range-of-motion measurements. Seven studies were included (four Level I and three Level IV; 292 subjects, 297 shoulders). Mean subject age was 59.1 years and mean pre-treatment duration of symptoms was 7.3 months. 140 subjects underwent one or multiple hyaluronate injections (120 glenohumeral joint; 20 subacromial bursa). Clinical follow-up was mean 9.0 weeks. Sodium hyaluronate injection into the glenohumeral joint has significantly improved shoulder range-of-motion, constant scores, and pain at short-term follow-up following treatment of adhesive capsulitis. Isolated intra-articular hyaluronate injection has significantly better constant scores than control. Isolated intra-articular hyaluronate injection has equivalent clinical outcomes and range-of-motion compared to intra-articular corticosteroid injection. Intra-articular hyaluronate injection was safe, with no reported complications within the studies in this review. Sodium hyaluronate injection into the glenohumeral joint is a safe, effective treatment in the management of adhesive capsulitis of the shoulder. Short-term evidence indicates that clinical outcomes are better than control and equivalent to intra-articular corticosteroid injection.     

Pitfalls of repeat subureteral bovine collagen injections for the endoscopic treatment of vesicoureteral reflux

PURPOSE: Collagen has been used for the endoscopic subureteral treatment of vesicoureteral reflux since the late 1980s. We evaluated the long-term efficacy of repeat subureteral glutaraldehyde bovine cross-linked collagen injections for the endoscopic management of vesicoureteral reflux. MATERIALS AND METHODS: We prospectively evaluated 14 girls and 2 boys (21 ureteral units) 6 months to 16 years old (median age 6 years). In all patients initial treatment failed or reflux recurred after a single subureteral collagen injection and injection was repeated. Patients were followed with voiding cystography. Reflux-free periods after each injection and reflux grade were documented. RESULTS: All patients were treated twice with subureteral bovine collagen injection. Mean injected collagen volume of injections 1 and 2 was 1. 5 ml. (range 0.7 to 3.0) and 1.6 ml. (range 1.0 to 2.3), respectively, at a concentration of 35 mg./ml. In all but 4 cases reflux disappeared after injection 2. Mean followup was 11 months (range 1 to 41) after treatment 2. However in 10 patients (13 ureteral units) treatment failed or reflux recurred a mean of 10 months after injection 2. The reflux-free period after injection 2 was prolonged compared to that after injection 1 (p <0.05). CONCLUSIONS: Our results suggest that repeat endoscopic subureteral bovine collagen injections prolong the reflux-free period but remain ineffective at long-term followup for correcting vesicoureteral reflux.     

透明质酸钠治疗颞颌关节退行性关节病临床随机对照研究

目的　通过临床随机对照研究检验透明质酸钠治疗颞颌关节退行性关节病的效果及不良反应 ,为该病治疗寻找新的手段。方法　应用临床随机对照方法将患者分成治疗组与对照组 ,治疗组应用透明质酸钠 ,对照组应用醋酸强的松龙 ,均行颞颌关节上腔注射 ,每周 1次 ,每次剂量分别为 6 m g和 12 .5 mg,3～ 4次为一个疗程 ,治疗前、后观察临床症状及监测关节滑液中白细胞介素 - 6 (IL- 6 )水平及蛋白总量的变化。共纳入患者 6 7例 ,失访 4例 ;6 3例中 ,男 12例 ,女 5 1例。滑膜炎 14例 ,不可复性盘前移位 2 1例 ,骨关节炎 2 8例 ;治疗组 35例 ,对照组2 8例。结果　两种药物均可有效缓解颞颌关节退行性关节病的临床症状 ,治疗组显效率 5 1.43% ,有效率 45 .71% ,无效率 2 .86 % ;对照组显效率 39.2 9% ,有效率 42 .86 % ,无效率 17.86 %。两种药物均可显著降低关节滑液内 IL- 6的含量 ,但治疗组降低幅度更大。透明质酸钠注射后疼痛发生率 37.1% ,一过性患侧开牙合及咀嚼无力发生率8.6 % ;强的松龙注射后疼痛发生率 5 0 %。结论　应用透明质酸钠治疗颞颌关节退行性关节病疗效明显 ,无严重不良反应 ,有效率及 IL- 6减少幅度优于强的松龙 ,可作为皮质激素的替代用药在临床推广使用。     

Sodium hyaluronate in the treatment of hallux rigidus. A single-blind, randomized study

BACKGROUND: The purpose of this study was to evaluate the effectiveness and safety of intra-articular sodium hyaluronate (Ostenil)mini) compared to intra-articular triamcinolone acetonide (Trigon depot) in the treatment of painful hallux rigidus. METHODS: Thirty-seven patients (ages 40 to 80 years) with painful early stage hallux rigidus were enrolled in the study. One group received an intra-articular injection with 1.0 ml sodium hyaluronate (SH); the other received an intra-articular injection of 1.0 ml triamcinolone acetonide (TA). Patients were evaluated on days 0, 14, 28, 56 and 84. Effectiveness was measured using the following parameters: joint pain at rest or on palpation (VAS), with passive motion, and gait pain; AOFAS hallux metatarsophalangeal score; use of analgesics and global assessment of the treatment by the patient and investigator. Safety was evaluated by the outcome of tolerance to treatment and observation of adverse events. Statistical analyses were performed using the Chi-square test, Mann-Whitney U test, Wilcoxon test and Friedman test. RESULTS: Thirty-seven patients (40 feet) were evaluated. Pain at rest or with palpation and pain on passive mobilization decreased significantly in both treatment groups in comparison to baseline (p<0.01), but no significant between-group differences were observed (p>0.05). Gait pain improved substantially in the sodium hyaluronate group with significant differences compared to the triamcinolone group at days 28 and 56 (p<0.05). The AOFAS total score improved significantly in the SH group compared to the TA group (p<0.05). This was mainly due to improvements in the pain subscale. No between-group differences were seen regarding the use of analgesics. Global assessment of treatment by patients was good in both groups, and there was a significant between-group difference favoring SH when areas under the curves (AUC) were calculated (p < 0.05). Tolerance was good in both groups. Adverse events occurred in three patients. CONCLUSIONS: Intra-articular injections of sodium hyaluronate are effective and safe in decreasing hallux rigidus pain. The AOFAS scores in the SH group were significantly better than in the TA group.     

关节内注射富血小板血浆对膝关节软骨退行性变的治疗作用

目的富血小板血浆(platelet-rich plasma,PRP)能促进软骨细胞增殖和修复软骨缺损,通过比较膝关节退行性变患者关节内注射PRP及透明质酸钠的疗效,分析PRP治疗关节软骨退行性变的安全性和可行性。方法于2010年1月-6月收治的膝关节软骨退行性变患者中,选择符合标准的30例30膝患者纳入研究。根据注射药物不同,将患者随机分为PRP组(试验组)和透明质酸钠组(对照组),每组各15例。两组患者性别、年龄、体重指数、Kellgren-Lawrence分级等一般资料比较,差异均无统计学意义(P>0.05),具有可比性。试验组患者抽取自体静脉血制备PRP后,于关节腔内均匀注射3.5 mL PRP;对照组注射2 mL透明质酸钠。每3周注射1次,3次为一疗程。记录两组患者注射后不良反应发生情况,并采用国际膝关节文献委员会(IKDC)评分、美国西部Ontario与McMaster大学骨关节炎指数(WOMAC)评分及Lequesne指数评定关节功能。结果两组患者均获随访6个月。两组治疗后IKDC评分、WOMAC评分及Lequesne指数与治疗前比较,差异均有统计学意义(P<0.05);试验组治疗后3、4、6个月间比较,差异均无统计学意义(P>0.05);对照组治疗后6个月各评价指标较3、4个月差,但差异有统计学意义(P<0.05)。治疗后3个月及4个月,两组IKDC评分、WOMAC评分及Lequesne指数比较,差异无统计学意义(P>0.05);6个月时,试验组各指标均优于对照组(P<0.05)。试验组患者12例31次出现不良反应,对照组12例30次;两组不良反应起始时间、终止时间及持续时间比较,差异均无统计学意义(P>0.05)。结论关节内注射PRP治疗关节软骨退行性变安全,可缓解疼痛、肿胀等症状,提高患者生活质量,但需要大样本长期随访观察进一步验证其安全性和远期疗效。