The quality of clinical trials with Harpagophytum procumbens

OBJECTIVE: To examine systematically the quality of the clinical trials investigating the effectiveness of Harpagophytum products. METHODS: Literature searches and enquiries to experts identified 20 studies of treatment with various Harpagophytum products (powder, aqueous and ethanolic extracts) for exacerbations of chronic musculoskeletal pain. Eight were open uncontrolled observational studies, one comparing progress under treatment for pain in back, knee and hip pain. Two were open comparisons with conventional treatment, only one of which was randomised. Ten were double-blinded, randomised controlled comparisons, 8 with placebo and 2 with NSAID comparator treatments. Indices of the internal and external validities were examined by reference to a checklist to see how well the studies answered the questions: do Harpagophytum products work and do they work as well as more conventional comparator treatments? RESULTS: The uncontrolled trials, though providing useful preliminary estimates of the possible effect of treating various conditions, could not separate the effects of the Harpagophytum product from whatever placebo effect might have been exerted in the circumstances of the study. The 2 open comparisons were open to performance, detection and/or selection bias. Of the 8 randomised double blinded controlled comparisons with placebo, 6 were marred by lack of transparency, one could not provide definitive evidence from its pre-selected principal outcome measure, and one provided good quality evidence of a dose dependent superiority of effect over placebo, though this was with a product that is not generally available for clinical practice. One of the randomised controlled comparisons with comparator (Doloteffin versus rofecoxib) was intended only as a pilot and studied too few patients for definitive conclusions whereas the other did provide good evidence that the powder, Harpadol is not importantly less effective than the weak NSAID diacerhein. CONCLUSIONS: Evidence of effectiveness of Harpagophytum products is not transferrable from product to product. The results of some studies suggest some effectiveness for some products, but for none of the clinically available products is the quality of evidence totally satisfactory. It is better so far with products that contain at least 50 mg of harpagoside in the daily dosage than with products (which happen to be of ethanolic extraction) that contain less.     

高强度聚焦超声消融治疗（HIFU术）联合补肾活血方治疗子宫腺肌病的临床研究

摘要 目的：探讨高强度聚焦超声消融治疗（HIFU术）联合补肾活血方治疗子宫腺肌病的临床疗效。方法：选取我院2020年3月到2023年3月收治的100例子宫腺肌病患者作为研究对象,应用随机数字表法将其分为观察组与对照组,每组50例。对照组患者采取HIFU术治疗,观察组患者采取HIFU术联合补肾活血方治疗,对比两组患者临床疗效,治疗前后中医证候积分,对比手术前、手术后3个月、6个月的糖类抗原CA125及血红蛋白水平变化,并在治疗3个月后和治疗6个月应用子宫体积、痛经评分、经量评分评价患者远期预后情况。结果：两组临床疗效比较无差异（P>0.05）;治疗前两组患者腰膝酸软、经期腰骶痛、经期腹痛相关中医证候积分对比无明显差异（P＞0.05）,治疗后两组患者腰膝酸软、经期腰骶痛、经期腹痛相关中医证候积分均降低,且观察组低于对照组（P＜0.05）;手术两组患者糖类抗原CA125、Hb水平对比无明显差异（P＞0.05）,术后3个月、6个月两组患者糖类抗原CA125水平降低,观察组低于对照组,Hb水平升高,观察组高于对照组（P＜0.05）;观察组治疗后3个月的子宫体积、痛经评分、经量评分明显低于对照组（P＜0.05）,且治疗6个月后两组患者子宫体积、痛经评分、经量评分均降低,观察组低于对照组（P＜0.05）。结论：对子宫腺肌病患者应用高强度聚焦超声消融术联合补肾活血方治疗可提升其临床治疗效果,减轻患者临床症状,改善患者糖类抗原CA125表达水平,减轻贫血情况,且远期疗效较好,能够进一步改善患者子宫体积、疼痛程度和月经量,值得临床应用推广。     

Effects of clodronate on synovial fluid levels of some inflammatory mediators, after intra-articular administration to patients with synovitis secondary to knee osteoarthritis

Recent studies have outlined the role of bisphosphonates, and particularly clodronate, as potential therapeutic agents for inflammatory and degenerative joint diseases. On this basis, we carried out an open, non comparative pilot trial to evaluate the effects of clodronate on synovial fluid concentration of some inflammatory mediators (prostaglandin E2, leukotriene B4 and tromboxane B2) after intra-articular, repeated administrations in 20 patients (7 males and 13 females) with synovitis secondary to knee osteoarthritis. At the end of the treatment period, statistically significant reductions (p < 0.05) of spontaneous pain and pain on active movement, evaluated by means of a 100 mm visual analogue scale (VAS), were reported. Linear regression analysis showed that the decrease of pain was correlated with the bisphosphonate induced reduction of prostaglandin E2 levels. These results, in spite of the limitation due to the open design of the trial suggest a possible role of bisphosphonates in the treatment of knee osteoarthritis.     

The effects of leflunomide on clinical parameters and serum levels of IL-6, IL-10, MMP-1 and MMP-3 in patients with resistant rheumatoid arthritis

OBJECTIVE: The purpose of this open pilot study was to assess possible mechanisms of the effects of leflunomide by studying the influence of the drug on the serum levels of MMP-1, MMP-3, IL-10, IL-6 and their possible correlation with clinical disease parameters. PATIENTS AND METHODS: Thirty patients with long standing active rheumatoid arthritis were enrolled in this study. All patients failed at least 5 DMARDs in the past and were on stable treatment for at least 3 months before starting the protocol. The patients received a loading dose of 100 mg for 3 days followed by 20 mg/day thereafter and followed up monthly for 6 months. Disease activity was assessed at baseline, 2 weeks, and every month of therapy thereafter using the following variables: tender joint count, swollen joint count, morning stiffness duration, pain, tiredness, physician's and patient's global assessment, using VAS, ESR and CRP. Clinical effects of the treatment regimen were calculated using the American College of Rheumatology (ACR) criteria for clinical response. Adverse events were recorded. Serum levels of MMP-1, MMP-3, IL-10 and IL-6 were measured before and 3 months after starting the protocol. RESULTS: Except for tiredness, a statistically significant improvement in all clinical and laboratory parameters of disease activity was reached after 3 months. At this time point the ACR-20 response rate was 46.2%. The levels of MMP-1, MMP-3, IL-6 and IL-10 decreased significantly after 3 months. A statistically significant correlation between serum levels of MMP-1, IL-10 and IL-6 and clinical and laboratory parameters was also shown. After 6 months, 16 out of 30 patients withdrew from the study [adverse events (35.4%), lack of efficacy (9.7%), and low compliance (6.4%)]. CONCLUSIONS: Leflunomide was clinically efficacious in this group of long standing resistant RA in an open study "real life" design. These results comply with those reported in previous clinical trials. Serum MMP-1, MMP-3, IL-10 and IL-6 levels decreased significantly. Despite high withdrawal rate, no serious adverse effects were recorded.     

方右旋糖酐40注射液联合甘露醇治疗下肢软组织开放性损伤负压封闭引流术后患者的疗效及对血液流变学的影响

目的:探讨复方右旋糖酐40注射液联合甘露醇治疗下肢软组织开放性损伤负压封闭引流(VSD)术后的治疗效果及对血液流变学的影响,为下肢软组织开放性损伤的治疗提供临床依据。方法:选取下肢软组织开放性损伤VSD术后患者80例,随机分为对照组和观察组各40例,对照组单纯应用甘露醇治疗,观察组应用复方右旋糖酐40注射液及甘露醇治疗,观察两组的临床疗效,比较两组治疗前后国际骨关节炎评分标准(Lequesne指数)、视觉模拟评分法(VAS)、美国食品药品管理局(FDA)皮肤评分、Lysholm膝关节功能评分(Lysholm)、血液流变学的变化以及不良反应发生情况。结果:治疗后,对照组和观察组的总有效率分别为85.00%、97.50%,比较差异具有统计学意义(P<0.05)。治疗后,两组VAS评分和Lequesne指数评分均降低,Lysholm评分及FDA皮肤评分较治疗前显著升高(P<0.05);治疗后,观察组VAS评分和Lequesne指数评分低于对照组,Lysholm评分及FDA皮肤评分高于对照组(P<0.05)。治疗后,两组血细胞比容较治疗前升高,全血比高切黏度、全血比低切黏度、血浆比黏度较治疗前降低(P<0.05);治疗后,观察组血细胞比容高于对照组,全血比高切黏度、全血比低切黏度、血浆比黏度低于对照组(P<0.05)。两组不良反应发生率比较无差异(P>0.05)。结论:复方右旋糖酐40注射液联合甘露醇治疗下肢软组织开放性损伤VSD术后患者疗效确切,可减轻膝关节疼痛,促进皮肤软组织恢复,改善膝关节功能和血液流变学,安全性较好。     

关节镜手术在膝关节骨性关节炎患者中的综合应用价值

目的:研究关节镜手术在膝关节骨性关节炎患者中的综合应用,为膝关节骨性关节炎的临床治疗提供依据。方法:选取50例单膝关节骨性关节炎患者,行常规关节镜手术,术后注射透明质酸钠并指导患者进行康复训练。在关节镜手术前后对患者进行LKSS评分,评定患者膝关节功能;对患膝的屈肌、伸肌力进行等速测定;在术前及术后2周测定外周血及患膝关节液IL-6、TNF-α、MMP-3表达水平。结果:与术前相比,患者术后LKSS评分及关节活动度均显著提高(P0.05),关节功能得到较好的恢复;患膝伸肌PT、STW及TAE值均得到显著提高(P0.05),屈肌PT、STW及TAE值无统计学意义;患者外周血及关节液中IL-6、TNF-α及MMP-3表达水平均显著降低(P0.05)。结论:采用关节镜手术治疗骨性关节炎可明显降低机体的炎症状态,改善关节的功能,增加患膝的伸肌力。     

Evaluation of putative CSF biomarkers in paediatric spinal muscular atrophy (SMA) patients before and during treatment with nusinersen

Spinal muscular atrophy (SMA) is a genetic neurodegenerative disorder leading to immobilization and premature death. Currently, three alternative therapeutic options are available. Therefore, biomarkers that might reflect or predict the clinical course of the individual patient with treatment are of great potential use. Currently, the antisense oligonucleotide nusinersen is the prevalent and longest validated therapy for SMA. We analysed CSF candidate biomarkers for degenerative CNS processes (namely phosphorylated heavy chain (pNf-H), light-chain neurofilaments (NfL), total tau protein (T-Tau), neurogranin, β-secretase BACE-1 and alpha-synuclein) in 193 CSF samples of 44 paediatric SMA types 1, 2 and 3 patients before and under nusinersen treatment and related them to standardized clinical outcome scores in a single-centre pilot study. pNf-H and NfL correlated with disease severity and activity, emphasizing their relevance as marker of neuronal loss and clinical outcome. T-Tau was significantly correlated with motor function scores in SMA type 1 making it an interesting marker for treatment response. Additionally, baseline T-Tau levels were elevated in most SMA patients possibly reflecting the extension of neuronal degeneration in paediatric-onset SMA. Further investigations of these CSF proteins might be beneficial for paediatric SMA subtypes and treatment modalities as an indicator for clinical outcome and should be analysed in larger cohorts.     

UKA与TKA治疗膝关节内侧单间室骨性关节炎的临床对比

目的:探究膝关节单髁置换术(UKA)与全膝关节置换术(TKA)治疗膝关节内侧单间室骨性关节炎的临床治疗效果。方法:将2011年4月-2015年7月期间因膝关节单间室骨性关节炎入院接受治疗的89例患者纳入本研究,随机分为研究组和对照组,研究组44例,行UKA手术,对照组45例,采用TKA手术方式治疗。对两组患者进行术后随访,对比临床治疗效果。结果:两组术前均有明显膝关节疼痛,术后膝关节疼痛均明显改善,组间差别无显著统计学意义(X2=1.323,P=0.2500.05);术后膝关节屈曲角度、HSS评分相对于术前均显著改善,研究组术后膝关节屈曲角度(111.2±18.8)度高于对照组的(98.6±14.7)度,差异有统计学意义(P0.05);HSS评分(87.6±13.7)分高于对照组的(73.2±16.8)分,差异有统计学意义(P0.05);研究组膝关节屈曲至90度时间比对照组短,数据差异有统计学差异(t=-2.303,P=0.0240.05)。结论:膝关节内侧单间室骨性关节炎采用UKA与TKA均能取得一定临床效果,减轻患者痛苦,改善膝关节功能,但UKA临床疗效较好,手术创伤较小,术后恢复较快。     

The Modified painDETECT Questionnaire for Patients with Hip or Knee Osteoarthritis: Translation into Dutch,Cross-Cultural Adaptation and Reliability Assessment

There is a growing amount of evidence that alteration in pain processing by the peripheral and central nervous system play a role in osteoarthritis pain, leading to neuropathic-like symptoms. It is essential to identify knee and hip osteoarthritis patients with a neuropathic pain profile in order to offer such patients education and additional treatment options besides conventional pain treatment. The painDETECT Questionnaire is a self-report questionnaire developed to discriminate between nociceptive and neuropathic pain. This questionnaire was modified to fit patients suffering from knee osteoarthritis. The aim of this study was to translate and cross-culturally adapt the modified painDETECT Questionnaire to the Dutch language and to provide a modified version to fit patients with hip osteoarthritis. Reliability for internal consistency, repeatability and floor and ceiling effects were subsequently assessed. A total of 278 patients were included in the reliability study and 123 patients in the repeatability analysis. The Dutch modified painDETECT Questionnaire shows good internal consistency and small relative measurement errors, represented by a good intraclass correlation coefficient. Absolute measurement error, represented by the Standard Error of Measurement, was acceptable. However, a measurement bias might be present when it comes to repeatability. To our knowledge, this study is the first to provide a Dutch modified painDETECT Questionnaire to fit hip and knee osteoarthritis patients and to assess internal consistency, reliability and agreement. International guidelines were followed in the translation process and this study has ample sample size with an adequate time interval for repeatability. Based on this study, the Dutch modified painDETECT Questionnaire seems to be fit as a discriminative tool to identify knee and hip osteoarthritis patients with a neuropathic pain profile. Whether it is also suitable as an evaluative tool to record changes over time or after an intervention remains open to further investigation.     

温针灸联合塞来昔布胶囊对膝骨关节炎患者骨代谢指标和血清IL-6、IL-17、IL-18水平的影响

摘要 目的：观察温针灸联合塞来昔布胶囊对膝骨关节炎（KOA）患者骨代谢指标和血清白介素-6（IL-6）、白介素-17（IL-17）、白介素-18（IL-18）水平的影响。方法：纳入我院2017年4月~2020年12月间针灸科接收的KOA患者80例,将患者采用信封抽签法分为对照组和研究组,各为40例。对照组给予塞来昔布胶囊进行治疗,研究组给予温针灸联合塞来昔布胶囊进行治疗,均连续治疗8周。观察两组疗效、骨代谢指标[骨保护素（OPG）、降钙素（CT）、骨钙素（BGP）]、炎性因子、量表评分[视觉模拟评分法（VAS）、骨关节炎指数评分表（WOMAC）、Lysholm膝关节评分]等情况,记录治疗期间的不良反应发生率。结果：研究组的临床总有效率高于对照组（P<0.05）。研究组治疗8周后VAS、WOMAC较对照组低,Lysholm膝关节评分较对照组高（P<0.05）。研究组治疗8周后血清OPG、BGP较对照组高（P<0.05）。两组血清CT水平治疗8周后对比差异无统计学意义（P>0.05）。研究组治疗8周后血清IL-6、IL-17、IL-18较对照组低（P<0.05）。两组不良反应总发生率组间对比差异无统计学意义（P>0.05）。结论：温针灸联合塞来昔布胶囊治疗KOA患者,可有效减轻疼痛,促进膝关节功能恢复,同时还可抑制炎症因子,改善骨代谢指标,优化治疗效果。     

Infrapatellar fat pad-derived mesenchymal stromal cell product for treatment of knee osteoarthritis: a first-in-human study with evaluation of the potency marker

Background aimsInfrapatellar fat pad-derived mesenchymal stromal cells (IFP-MSCs) have not yet been used in a human clinical trial. In this open-label phase 1 study, patients with knee osteoarthritis (OA) received a single intra-articular injection of autologous IFP-MSCs. Safety was assessed through physical examination of the knee joint, vital signs, laboratory tests and adverse events. Efficacy was evaluated with regard to pain and function using questionnaires, x-ray and magnetic resonance imaging (MRI). Indoleamine-2,3-dioxygenase (IDO) expression in IFP-MSCs primed with interferon gamma was used as an in vitro potency measurement in investigating the correlations of clinical outcomes.MethodsTwelve patients with symptomatic knee OA were recruited. IFP adipose tissue was harvested from each patient's knee through surgical excision for IFP-MSC manufacturing. Cryopreserved IFP-MSCs (5 × 10⁷ cells) were injected into the knee joint immediately after thawing.ResultsNo significant adverse events were observed. Patients who received IFP-MSCs exhibited clinically significant pain and functional improvement at 48-week follow-up. The MRI Osteoarthritis Knee Score average was also significantly reduced from 100.2 before injection to 85.0 at 48 weeks after injection. The IDO expression of the primed IFP-MSCs of the 12 patients was correlated with clinical outcomes after injection.ConclusionsA single intra-articular injection of IFP-MSCs appears to be a safe therapy for treating knee OA and may improve disease symptoms. IDO measurement of primed IFP-MSCs has potential as a potency marker of MSC products for immunomodulatory therapy.     

A Pilot Clinical Study of Hyperacute Serum Treatment in Osteoarthritic Knee Joint: Cytokine Changes and Clinical Effects

The serum fraction of platelet-rich fibrin (hyperacute serum) has been shown to improve cartilage cell proliferation in in vitro osteoarthritic knee joint models. We hypothesize that hyperacute serum may be a potential regenerative therapeutic for osteoarthritic knees. In this study, the cytokine milieu at the synovial fluid of osteoarthritic knee joints exposed to hyperacute serum intraarticular injections was investigated. Patients with knee osteoarthritis received three injections of autologous hyperacute serum; synovial fluid was harvested before each injection and clinical monitoring was followed-up for 6 months. Forty osteoarthritic-related cytokines, growth factors and structural proteins from synovial fluid were quantified and analysed by Multivariate Factor Analysis. Hyperacute serum provided symptomatic relief regarding pain and joint stability for OA patients. Both patients “with” and “without effusion knees” had improved VAS, KOOS and Lysholm-Tegner scores 6 months after of hyperacute serum treatment. Synovial fluid analysis revealed two main clusters of proteins reacting together as a group, showing strong and significant correlations with their fluctuation patterns after hyperacute serum treatment. In conclusion, hyperacute serum has a positive effect in alleviating symptoms of osteoarthritic knees. Moreover, identified protein clusters may allow the prediction of protein expression, reducing the number of investigated proteins in future studies.     

关节镜手术联合胫骨高位截骨治疗内侧膝关节骨关节炎的临床研究

目的:观察关节镜手术联合胫骨高位截骨(HTO)治疗内侧膝关节骨关节炎(KOA)的临床疗效。方法:本研究为回顾性研究,将2018年2月~2020年9月间在我院接受治疗的内侧KOA患者63根据手术方式的不同分为A组和B组,分别为30例和33例。A组进行HTO手术,B组进行关节镜手术联合HTO治疗。术前、术后6周、术后12周采用美国纽约特种外科医院(HSS)评分、视觉模拟量表(VAS)评分评价两组患者膝关节功能、疼痛情况。采用36项简明健康状况调查表(SF-36)评价两组患者术前与术后12周的生活质量变化情况。记录两组术后并发症发生情况。术前、术后12周采用MB-Ruler软件测量两组患者机械胫骨近端内侧角(mMPTA)、解剖股胫角(aFTA)。结果:术后6周、术后12周,B组HSS评分高于A组,VAS评分低于A组(P<0.05)。术后12周,B组SF-36量表各维度评分高于A组(P<0.05)。术后3周,B组mMPTA、aFTA小于A组(P<0.05)。两组术后并发症发生率组间对比无差异(P>0.05)。结论:相对于单纯的HTO手术,关节镜手术联合HTO治疗内侧KOA患者,可有效促进膝关节功能改善,减轻疼痛症状,调整下肢力线,近期疗效肯定。     

Relationships between biomarkers of cartilage, bone, synovial metabolism and knee pain provide insights into the origins of pain in early knee osteoarthritis

Introduction

We tested the hypothesis that there exist relationships between the onset of early stage radiographically defined knee osteoarthritis (OA), pain and changes in biomarkers of joint metabolism.

Methods

Using Kellgren-Lawrence (K/L) grading early radiographic knee OA (K/L 2) was detected in 16 of 46 patients. These grades (K/L 1 is no OA and K/L 2 is early OA) were divided into two groups according to the presence or absence of persistent knee pain. Sera (s) and urines (u) were analysed with biomarkers for cartilage collagen cleavage (sC2C and uCTX-II) and synthesis (sCPII), bone resorption (uNTx) and synovitis (hyaluronic acid: sHA).

Results

sCPII decreased and sC2C/sCPII, uCTX-II/sCPII and sHA increased with onset of OA (K/L 2 versus K/L 1) irrespective of joint pain. In contrast, sC2C and uCTX-II remained unchanged in early OA patients. Of the patients with K/L grades 1 and 2 sC2C, sCPII, sHA, uNTX and uCTX-II were all significantly increased in patients with knee pain independent of grade. Among the K/L grade 2 subjects, only uCTX-II and uCTX-II/sCPII were increased in those with knee pain. In grade 1 patients both sC2C and sCPII were increased in those with knee pain. No such grade specific changes were seen for the other biomarkers including sHA.

Conclusions

These results suggest that changes in cartilage matrix turnover detected by molecular biomarkers may reflect early changes in cartilage structure that account directly or indirectly for knee pain. Also K/L grade 1 patients with knee pain exhibit biomarker features of early OA.     

Therapeutic application of ultrasound: contrast-enhanced thrombolysis in acute ST-elevation myocardial infarction; the Sonolysis study

Contrast enhancement by microbubble infusion has proven its applicability in the field of diagnostic ultrasound. Recent studies also indicate a therapeutic effect of the combined use of ultrasound and microbubbles. Results from animal studies demonstrate that diagnostic ultrasound in combination with intravenous microbubbles can dissolve thrombi. So far, this effect has never been tested in patients with an acute ST-elevation myocardial infarction (STEMI). We recently launched a pilot study in acute STEMI patients to assess safety, feasibility and efficacy of the treatment in this patient group with transthoracic three-dimensional diagnostic ultrasound and intravenous microbubbles immediately after prehospital thrombolysis, but prior to primary percutaneous coronary intervention.     

膝周神经射频热凝治疗顽固性膝骨关节炎疼痛的临床效果

目的:探讨膝周神经射频热凝治疗顽固性膝骨关节炎疼痛的疗效。方法:收集2013年1月至2014年1月,我院收治的顽固性膝骨关节炎疼痛患者62例,随机分为观察组与对照组,各31例。观察组予以膝周神经射频热凝联合关节腔内注射玻璃酸钠治疗,对照组单纯行关节腔内玻璃酸钠注射治疗,比较两组的临床疗效。结果:观察组治疗后VAS评分及OKS评分均显著低于对照组(P0.05);两组均未见明显并发症。结论:膝周神经射频热凝辅助治疗顽固性膝关节炎疼痛疗效显著,创伤较小,可促进关节功能的康复,值得推广应用。     

康复训练联合超激光对全膝关节置换术患者术后疼痛、膝关节功能和生活质量的影响

目的:探讨康复训练联合超激光对全膝关节置换术(TKA)患者术后疼痛、膝关节功能和生活质量的影响。方法:选取2016年1月-2017年9月期间在青海省人民医院疼痛科行TKA术式的患者73例为研究对象。根据随机数字表法将患者分为对照组(n=36)和研究组(n=37),对照组患者术后给予康复训练,研究组在对照组基础上联合超激光进行治疗,两组均治疗6周。比较治疗前、治疗6周后(治疗后)两组患者膝关节功能状况、疼痛程度、膝关节屈曲度和伸展度,同时随访3个月,观察两组患者生活质量情况。结果:两组患者治疗后视觉模拟疼痛量表(VAS)评分均较治疗前降低,且研究组低于对照组(P0.05)。两组患者治疗后膝关节伸展度、屈曲度、美国特种外科医院(HSS)评分均较治疗前升高,且研究组高于对照组(P0.05)。随访3个月,两组患者的生理功能(PF)、生理职能(RF)、躯体疼痛(BP)、总体健康(GH)、活力(VT)、社会功能(SF)、情感职能(RE)以及心理健康(MH)等评分较治疗前均升高,且研究组高于对照组(P0.05)。结论:TKA患者给予康复训练联合超激光治疗效果较好,可显著改善患者膝关节功能,减轻患者疼痛,提高患者生活质量。     

In vivo contact areas of the knee in patients with patellar subluxation

OBJECTIVE: Ex vivo studies have suggested that cartilage contact areas and pressure are of high clinical relevance in the etiology of osteoarthritis in patients with patellar subluxation. The aims of this study were therefore to validate in vivo measurements of contact areas with 3D open magnetic resonance imaging (MRI), and to study knee joint contact areas in patients with patellar subluxation at different angles of knee flexion in comparison with healthy subjects. METHODS: 3D-MRI data sets of 12 healthy volunteers and eight patients with patellar subluxation were acquired using a standard clinical (1.5 T) and an open (0.2 T) MRI scanner. We compared femoro-patellar and femoro-tibial contact areas obtained with two different sequences from open MRI [dual-echo-steady-state (DESS) and fast-low-angle-shot (FLASH) sequences] with those derived from standard clinical 1.5 T MRI. We then analyzed differences in joint contact areas between healthy subjects and patients with patellar subluxation at 0 degree, 30 degrees, and 90 degrees of knee flexion using open MRI. RESULTS: The correlation of the size of contact areas from open MRI with standard clinical MRI data ranged from r = 0.52 to 0.92. Open-MRI DESS displayed a smaller overestimation of joint contact areas (+21% in the femoro-patellar, +12% in the medial femoro-tibial, and +19% in the lateral femoro-tibial compartment) than FLASH (+40%, +37%, +30%, respectively). The femoro-patellar contact areas in patients were significantly reduced in comparison with healthy subjects (-47% at 0 degree, -56% at 30 degrees, and -42% at 90 degrees of flexion; all p < 0.01), whereas no significant difference was observed in femoro-tibial contact areas. CONCLUSIONS: Open MRI allows one to quantify joint contact areas of the knee with reasonable accuracy, if an adequate pulse sequence is applied. The technique permits one to clearly identify differences between patients with patellar subluxation and healthy subjects at different flexion angles, demonstrating a significant reduction and lateralization of contact areas in patients. In the future, application of this in vivo technique is of particular interest for monitoring the efficacy of different types of surgical and conservative treatment options for patellar subluxation.     

Treatment of Osteoarthritis of the Knee with a Combination of Autologous Conditioned Serum and Physiotherapy: A Two-Year Observational Study

Background

Autologous conditioned serum (ACS) is an autologous blood product that has shown efficacy against knee osteoarthritis (OA) in randomized controlled trials. However, there are few reports of its effectiveness in everyday practice. Here, we report clinical efficacy results from a two-year prospective observational study of patients with highly symptomatic knee OA who received ACS in conjunction with physiotherapy.

Methods

118 patients with unilateral knee OA (Kellgren-Lawrence grades I–IV), who were candidates for surgery but instead chose conservative treatment, were treated with a combination of four intra-articular injections of ACS (2 mL each) once weekly over four weeks and subsequent physiotherapy applied 4 weeks after ACS injection. Main endpoints of the study were pain (Numeric Rating Scale [NRS]) assessed at 0, 3, 6, 12 and 24 months, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) global score, assessed at 0 and 24 months. The effect size (Cohen’s d) was calculated for pain and WOMAC outcomes, with effect sizes >0.8 considered large.

Results

By 3 months, there were significant improvements in pain (NRS) from baseline (-63.0%, p<0.001), which were maintained over 24 months. Mean WOMAC global score was reduced at 24 months compared to baseline (-56.9%, p<0.001), as were WOMAC subscores of pain (-86.0%, p<0.001) and function (-51.3%, p<0.001). Effect sizes for pain (>5) and WOMAC improvement (8.0–13.6) were very large. Only one patient received total knee joint replacement during the study. Clinical improvement did not correlate with gender, age, Kellgren-Lawrence grade, or body mass index.

Conclusions

Treatment with ACS and physiotherapy produced a rapid decline in pain, which was sustained for the entire two years of the study. This was accompanied by a large improvement in WOMAC scores at two years. These results confirm that ACS combined with physiotherapy is an effective treatment for OA of the knee.     

双切口双侧钢板治疗SchazkerV, VI型骨折的疗效分析

目的：探讨双切口双侧钢板法与传统手术治疗SchazkerV、VI 型骨折的临床疗效及安全性。方法：回顾性分析2007 年6 月 -2012 年6 月在我院行手术治疗的50 例SchazkerV、VI型骨折患者的病历资料,根据手术方法不同将患者分为治疗组及对照组。 治疗组25 例采用双切口双侧钢板治疗,对照组25 例采用锁定钢板内固定治疗。观察并比较两组的临床疗效及膝关节功能评分 变化。结果：治疗组住院时间、TPA、PSA、并发症发生率均低于对照组,差异有统计学意义(t=-2.889、-2.220、-2.377、4.348,P<0.05); 治疗后两组Rasmussen 分级优良率均高于治疗前(P<0.05),治疗组优良率高于对照组(P<0.05)。结论：采用双切口双钢板内固定术 治疗SchatzkerV、VI型胫骨平台骨折患者的临床疗效明显优于传统手术方法,可以显著降低术后并发症的发生率及住院时间。