电针结合雷火灸治疗寒湿型膝骨性关节炎的临床随机对照试验

文题释义：膝骨性关节炎：又称为膝关节增生性关节炎、退行性膝关节炎,是中老年人常见的一种慢性骨关节病,主要病理特点为关节软骨退变、破坏、软骨下骨硬化、关节边缘软骨下骨增生,进而引起滑膜炎症、半月板损伤、游离体形成及关节外组织炎症等一系列病变,临床症状以膝关节的疼痛、肿胀、变形及活动受限为主。白细胞介素6：是由CD4⁺T细胞、巨噬细胞等多种细胞产生的促炎性细胞因子,它能够对多种细胞产生促炎作用,在正常健康人群的血浆中其表达水平较低,在手术、炎症、感染等情况时其表达水平会显著上升。背景：雷火灸疗法及电针疗法均能有效改善膝骨性关节炎的相关症状,同时两种疗法兼具操作简单、廉价、实用性强等优点。目的：观察电针结合雷火灸与塞来昔布胶囊治疗寒湿型膝骨性关节炎的疗效差异。方法：选择2017年6月至2018年12月在广西中医药大学附属瑞康医院就诊的寒湿型膝骨性关节炎患者72例,其中男35例,女37例,采用随机数字表法分为2组：观察组(n=35)进行雷火灸(1次/d)结合电针治疗(1次/d),对照组(n=37)口服塞来昔布胶囊(1次/d),每个疗程14 d,两组均治疗2个疗程,疗程之间休息2 d。治疗前与治疗结束后进行目测类比评分、WOMAC评分、关节液相关炎性指标检测,并评估中医证候疗效有效率,并在治疗结束后进行1个月的随访。试验获得广西中医药大学附属瑞康医院伦理委员会批准,伦理批件号：KY2017-005。结果与结论：①两组试验过程中无严重不良反应发生;②观察组治疗结束后及随访1个月的目测类比评分、WOMAC评分(疼痛、僵硬、功能3项目评分)均较治疗前明显降低(P < 0.05);对照组治疗结束后及随访1个月的目测类比评分、WOMAC评分(疼痛、功能2项目评分)均较治疗前明显降低(P < 0.05);观察组治疗结束后及随访1个月的目测类比评分、WOMAC评分(疼痛、僵硬、功能3项目评分)均低于对照组(P < 0.05);③两组治疗结束后的白细胞介素6、肿瘤坏死因子α水平均较治疗前明显降低(P < 0.05),并且观察组两指标水平低于对照组(P < 0.05);④观察组的治疗总有效率高于对照组(97.1%,81.1%,P < 0.05);⑤结果表明,电针结合雷火灸治疗寒湿型膝骨性关节炎的临床效果明显且不良反应少,其与塞来昔布胶囊相比在疗效持久性方面更具优势。ORCID: 0000-0002-7859-7850(邓凯烽)中国组织工程研究杂志出版内容重点：组织构建;骨细胞;软骨细胞;细胞培养;成纤维细胞;血管内皮细胞;骨质疏松;组织工程     

Chinese herbal recipe versus diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial [ISRCTN70292892]

Background  

Duhuo Jisheng Wan (DJW) is perhaps the best known and most widely used Chinese herbal recipe for arthralgia, but the clinical study to verify its efficacy is lacking. The purpose of this study was to compare the efficacy of DJW versus diclofenac in symptomatic treatment of osteoarthritis (OA) of the knee.     

人工全膝关节置换后是否放置引流管：随机对照试验

BACKGROUND: Total knee arthroplasty had been generally accepted as the final treatment plan, relieving pain and reconstructing function of knee joint. However, whether drainage tube can be used after replacement is still controversial.     

Self-help treatment for insomnia: a randomized controlled trial

STUDY OBJECTIVES: Insomnia is a prevalent health complaint that often remains untreated. Several interventions are efficacious but they are not widely available. This study evaluated the efficacy of a self-help behavioral intervention for insomnia. DESIGN: The study used a 2 (conditions; self-help treatment, no treatment control) x 3 (assessments; pretreatment, posttreatment, 6-month follow-up) mixed factorial design. SETTING: This study was part of a larger epidemiologic study conducted with a randomly selected sample of 2001 adults of the province of Quebec in Canada. PARTICIPANTS: One-hundred ninety-two adults (n = 127 women, 65 men; mean age, 46 years) with insomnia, selected from a larger community-based epidemiologic sample, were randomly assigned to self-help treatment (n = 96) or no-treatment control (n = 96). INTERVENTIONS: The self-help intervention included 6 educational booklets mailed weekly to participants and providing information about insomnia, healthy sleep practices, and behavioral sleep scheduling and cognitive strategies. MEASUREMENTS AND RESULTS: Participants completed sleep diaries and questionnaires at pretreatment, posttreatment, and 6-month follow-up. Significant but modest improvements were obtained on subjective sleep parameters for treatment but not control participants. Treated participants averaged nightly gains of 21 minutes of sleep and a reduction of 20 minutes of wakefulness, with a corresponding increase of 4% in sleep efficiency. Improvements were also obtained on measures of insomnia severity (Insomnia Severity Index) and of sleep quality (Pittsburgh Sleep Quality Index), and those changes were maintained at follow-up. CONCLUSIONS: A self-help behavioral intervention was effective in alleviating a broad range of insomnia symptomatology in a community sample. Self-help may be a promising approach to make effective intervention more widely available.     

Olanzapine versus lithium in the acute treatment of bipolar mania: a double-blind, randomized, controlled trial

BACKGROUND: This multicenter, double-blind, randomized, controlled study conducted in China examined the efficacy and safety of olanzapine versus lithium in the treatment of patients with bipolar manic/mixed episodes. METHODS: Patients with bipolar manic or mixed episode (DSM-IV criteria) and Young Mania Rating Scale (YMRS) score> or =20 at screening received olanzapine (5-20 mg/day, n=69) or lithium carbonate (600-1800 mg/day, n=71) for 4 weeks. The primary outcome was mean change from baseline in Clinical Global Impressions-Bipolar Version Overall Severity of Illness (CGI-BP) score. Secondary efficacy measures included YMRS, Brief Psychiatric Rating Scale (BPRS), and Montgomery-Asberg Depression Rating Scale (MADRS) scores. Safety was also assessed. RESULTS: A significantly greater mean change was observed in olanzapine versus lithium patients in CGI-BP (Overall Severity) (P=0.009), YMRS (P=0.013), BPRS (P=0.032), and CGI-BP (Severity of Mania) (P=0.012) scores. More olanzapine than lithium patients experienced at least one adverse event possibly related to study drug (P=0.038). More olanzapine patients had a clinically significant weight increase (> or =7% of baseline weight) compared to lithium patients (P=0.009). More olanzapine patients completed the study than lithium patients, although this difference was not statistically significant (olz, 91.3%; lith, 78.9%; P=0.057). LIMITATIONS: No placebo arm was included; however both treatments have previously been reported to be more effective than placebo. CONCLUSIONS: These results suggest that olanzapine has superior efficacy to lithium in the acute treatment of patients with bipolar mania over a 4-week period. However, adverse events were experienced by a greater number of olanzapine patients than lithium patients.     

Post-operative GnRH analogue treatment after conservative surgery for symptomatic endometriosis stage III-IV: a randomized controlled trial.

BACKGROUND: In order to decrease endometriosis recurrence after surgical therapy, it has been proposed to use a post-surgical oestrogen-lowering medical treatment. Results from previous trials on this topic are contradictory. METHODS: A total of 89 women were randomized, by computer-generated list, after laparoscopic conservative surgery for symptomatic endometriosis stage III-IV to receive monthly i.m. injections of gonadotrophin-releasing hormone (GnRH) analogue, leuprolide acetate depot (3.75 mg) for 3 months (n = 44) or to an expectant management (n = 45). All patients were followed up every 6 months for evaluation of pain symptoms, fertility and objective disease recurrence. RESULTS: During the follow-up, which ranged from 6-36 months, five (33%) of the 15 women who wanted children and who were allocated the GnRH analogue and six (40%) of the 15 given no treatment became pregnant (not significant). Moderate/severe pelvic pain recurred during the follow-up in 10 (23%) of the women allocated the GnRH analogue and 11 (24%) of those allocated no treatment; the cumulative pain recurrence rates at 18 months were 23 and 29% respectively (not significant). Four women (9%) treated with GnRH analogue and four women (9%) who received no treatment had objective disease recurrence as demonstrated by gynaecological examination and/or pelvic ultrasonography. CONCLUSIONS: This study does not support the routine post-operative use of a 3 month course of GnRH analogue in women with symptomatic endometriosis stage III-IV.     

Day 5 versus day 3 embryo transfer: a controlled randomized trial

Blastocyst transfer has been suggested to improve implantation rate without affecting pregnancy rate. The aim of this study was to compare the pregnancy and implantation rates of day 3 and 5 transfers in a prospective randomized manner. Patients with four or more zygotes were randomly allocated on day 1 to either day 3 or 5 transfers. Fertilization was achieved through regular IVF or intracytoplasmic sperm injection. Zygotes were kept in Medicult IVF medium for day 3 transfers and transferred into G1.2 and G2.2 on day 1 and 3 respectively for day 5 transfers. The morphologically best two or three embryos or blastocysts were chosen for transfer in both groups. Overall pregnancy rates per embryo transfer were the same (39%) in day 3 and 5 transfers. Implantation rates were 21 and 24% for day 3 and 5 transfers respectively. The pregnancy and implantation rates for day 5 transfers were significantly affected by the availability of at least one blastocyst to transfer and the number of zygotes. The number of good quality embryos on day 3 also significantly affected pregnancy and implantation rates on day 5 transfers. Multiple gestation rate, number of abortions and ongoing pregnancies were similar in both groups. In conclusion, day 3 and 5 transfer had similar pregnancy, implantation and twinning rates. Currently, day 5 transfers have no advantages over day 3 transfers.     

全膝关节置换后系统康复的随机对照

背景：国内外对人工全膝关节置换后的康复有较多的研究,但往往局限于一种康复方法。 目的：分析系统康复对人工全膝关节置换后康复进程的影响。 方法：选择行单侧人工全膝关节置换的50例骨性关节炎患者,随机分为两组,干预组置换前给予康复指导,置换后由康复治疗师给予康复锻炼,同时行CPM锻炼和冷敷,对照组给予传统CPM锻炼。 结果与结论：干预组置换后24 h~6 d疼痛目测类比评分均低于对照组(P < 0.05),置换后2 d~6周时膝关节活动度高于对照组(P < 0.05),置换后2,6周时HSS评分高于对照组(P < 0.05),两组均无局部切口并发症发生。说明人工全膝关节置换后系统康复可加快康复进程,减轻患者疼痛,改善关节活动度,且不会增加并发症。     

Cognitive behavior therapy versus supportive therapy in social phobia: a randomized controlled trial

BACKGROUND: The efficacy of cognitive behaviour therapy (CBT) in social phobia has been demonstrated in several controlled trials and meta-analyses, but no comparison of CBT with supportive therapy (ST) can be found in the literature. METHOD: The aim of the trial was to study the effectiveness of CBT versus ST carried out 'as usual'. Sixty-seven DSM-4 social phobic patients (89% generalized subtype, most with avoidant personality) were randomly allocated into two groups. Group 1 (CBT) received 8 1-hour sessions of individual cognitive therapy (CT) for 6 weeks, followed by 6 2-hour sessions of social skills training (SST) in group weekly. Group 2 received ST for 12 weeks (6 half-hour sessions), then the patients were switched to CBT. All patients agreed not to take any medication during the whole trial. In group 1, 29 patients reached week 6, 27 reached week 12, and 24 weeks 36 and 60 (endpoint). In group 2, 29 patients reached week 6, 28 reached weeks 12 and 18, 26 week 24, and 23 reached weeks 48 and 72 (endpoint). RESULTS: At week 6, after CT, group 1 was better than group 2 on the main social phobia measure. At week 12, after SST, group 1 was better than group 2 on most of the measures and demonstrated a significantly higher rate of responders. This finding was replicated after switching group 2 to CBT. Sustained improvement was observed in both groups at follow-up. Compliance with abstinence from medication increased over time. CONCLUSIONS: CBT was more effective than ST and demonstrated long-lasting effects. This may suggest that social phobia management requires more than a simple and inexpensive psychological intervention.     

Gabapentin for the treatment of menopausal hot flashes: a randomized controlled trial

OBJECTIVE: To compare the effectiveness and tolerability of gabapentin with placebo for the treatment of hot flashes in women who enter menopause naturally. DESIGN: A randomized, double-blind, placebo-controlled trial was conducted across the greater Toronto area between March 2004 and April 2006 in the community and primary care settings. Eligible participants were 200 women in natural menopause, aged 45 to 65 years, having at least 14 hot flashes per week. Study participants were randomized to receive gabapentin 300 mg oral capsules or placebo three times daily for 4 weeks. The primary outcome measure was the mean percentage change from baseline to week 4 in daily hot flash score, determined from participant diaries. Secondary outcome measures included changes in weekly mean hot flash scores and frequencies, quality of life, and adverse events. RESULTS: Of the 197 participants, 193 (98%) completed the study. Analysis was by intention to treat. Hot flash scores decreased by 51% (95% CI: 43%-58%) in the gabapentin group, compared with 26% (95% CI: 18%-35%) on placebo, from baseline to week 4. This twofold improvement was statistically significant (P < 0.001). The Menopause-Specific Quality-of-Life vasomotor score decreased by 1.7 (95% CI: 1.3-2.1; P < 0.001) in the gabapentin group. These women reported greater dizziness (18%), unsteadiness (14%), and drowsiness (12%) at week 1 compared with those taking placebo; however, these symptoms improved by week 2 and returned to baseline levels by week 4. CONCLUSIONS: Gabapentin at 900 mg/day is an effective and well-tolerated treatment for hot flashes.     

Effectiveness of diclofenac versus paracetamol in knee osteoarthritis: a randomised controlled trial in primary care

Background

The effectiveness of diclofenac versus paracetamol in primary care patients with pain caused by knee osteoarthritis is unclear.

Aim

To assess the effectiveness of diclofenac compared with paracetamol over a period of 2, 4, and 12 weeks in patients with knee osteoarthritis.

Design and setting

Randomised controlled trial in general practice.

Method

There were 104 patients included in the study, they were aged ≥45 years consulting their GP with knee pain caused by knee osteoarthritis. Patients were randomly allocated to diclofenac (n = 52) or paracetamol (n = 52) for at least 2 weeks. Primary outcomes were daily knee pain severity, and knee pain and function measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS).

Results

Over a period of 2- and 4-weeks follow-up, no significant difference in daily knee pain was found between the patient groups: estimated differences of 0.5 (95% CI = −0.2 to 1.3) and −0.2 (95% CI = −1.0 to 0.7), respectively. Over the 12-weeks follow-up, no significant differences were found between both groups for KOOS pain: estimated difference of −2.8 (95% CI = −10.7 to 5.1) and KOOS function of −2.7 (−10.6 to 5.0).

Conclusion

Over a period of 2- and 4-weeks follow-up no significant difference in daily measured knee pain severity was found between primary care patients with knee osteoarthritis taking paracetamol or diclofenac. Also, over a period of 12-weeks follow-up no significant differences were found regarding KOOS pain and KOOS function between both groups. Patients more frequently reported minor adverse events after taking diclofenac (64%) than paracetamol (46%).     

Management of miscarriage: a randomized controlled trial of expectant management versus surgical evacuation

BACKGROUND: In many countries, surgical uterine evacuation is the standard treatment for women with a miscarriage, but expectant management has been advocated as an alternative. The choice between the two options cannot be based on published evidence alone, because randomized clinical trials are scarce while generalizability of findings to patients with a strong preference for either management options is unclear. METHODS: In a randomized controlled trial, the complications and efficacy of either expectant or surgical management for miscarriages were compared, and the results in patients who refused randomization and were managed according to their own preference were studied. In total, 122 patients were randomized and 305 were managed according to their choice. RESULTS: No differences were found in the number of emergency curettages and complications between expectant and surgical management. Efficacy at 6 weeks was 30/64 (47%) in women allocated to expectant management, and 55/58 (95%) in women allocated to surgical evacuation. After 7 days, 37% of expectantly managed women had a spontaneous complete miscarriage. After 6 weeks, intention-to-treat analysis including cross-overs showed similar effectiveness (92% versus 100%). Results in the preference groups were comparable with those in the randomized groups. CONCLUSION: In our experience a waiting period of 7 days after diagnosis may prevent 37% of surgical procedures.     

The limited use of a tourniquet during total knee arthroplasty: A randomized controlled trial

BackgroundTotal knee arthroplasty (TKA) is commonly performed using a tourniquet. However, some studies have reported that several complications were associated with the use of a tourniquet in TKA. In this study we investigate whether the limited use of a tourniquet in TKA would reduce complications and facilitate postoperative recovery.MethodsSixty patients were randomly divided into two groups (30 cases/group): group A using the tourniquet throughout the surgical procedure, and group B using the tourniquet starting from the cementation to the completion of the procedure. Operation time, total measured blood loss, and incidence of complications were all recorded.ResultsThere was no significant difference in operation time, total measured blood loss, and hemoglobin concentration between the two groups. Incidence of postoperative complications in group B was significantly decreased in comparison to that in group A. The limb circumference at 10 cm above the superior patellar pole or below the inferior patellar pole and the pain score in group B were significantly decreased compared with that in group A at any time point. Range of motion in group B was significantly increased at three and 5 days postoperatively in comparison to that in group A.ConclusionsThe limited use of a tourniquet in TKA provides the benefit of decreased limb swelling and knee joint pain while not compromising the operation time or blood loss and recovery.Level of evidenceLevel I (Therapeutic).Trial registration numberNCT02102581.     

骨关节炎患者全膝关节置换：多中心的随机对照

背景：年龄在60岁以上存在关节疼痛、功能障碍和关节畸形的骨关节炎患者均可以考虑行全膝关节置换。 目的：比较传统全膝关节置换、微创全膝置换和避开股四头肌的微创全膝置换后早期膝关节功能恢复情况的差异。 方法：选择北京301医院、山东省立医院、山东省交通医院获得随访的120例骨关节炎患者,其中42例接受常规全膝关节置换,42例接受微创全膝关节置换,36例接受避开股四头肌的微创全膝关节置换。所有患者置换后第2,6,12周进行膝关节HSS评分及关节活动度检测。 结果与结论：微创全膝关节置换组及避开股四头肌的微创全膝关节置换组较常规全膝关节置换组手术时间长(P < 0.01),出血量少(P < 0.01);两微创手术组间差异无显著性意义(P > 0.05)。置换后2周微创全膝关节置换组及避开股四头肌的微创全膝关节置换组关节活动度、HSS评分均优于常规全膝关节置换组(P < 0.01),两微创组间关节活动度差异无显著性意义(P > 0.05),但避开股四头肌的微创全膝关节置换组HSS评分优于微创全膝关节置换组(P < 0.01);置换后6,12周3组HSS评分及关节活动度差异无显著意义(P > 0.05)。提示避开股四头肌的微创全膝关节置换与微创全膝关节置换以及常规全膝关节置换相比,手术损伤较小,术后疼痛程度更轻,术后能早期进行康复锻炼。     

针刀与针灸治疗膝骨关节炎疗效比较的Meta分析

背景：针刀和针灸是临床上治疗膝骨关节炎的常用疗法,但其临床疗效差异尚缺乏系统的评价。 目的：系统评价针刀与针灸治疗膝骨关节炎的疗效差异。 方法：计算机检索中国知网(CNKI)、维普数据库(VIP)、万方数据库(WANFANG DATA)、PubMed和Cochrane临床对照试验中心注册库(2011年第3期),所有数据库检索时间从建库到2011-09-15。纳入治疗组采用针刀疗法、对照组采用针灸的随机对照试验,由两名评价者独立提取资料和评价文献质量后采用RevMan5.1软件进行Meta分析。 结果与结论：共纳入8个随机对照试验,涉及654例患者。Meta分析结果显示针刀治疗膝骨关节炎的近期总有效率和治愈率均优于针灸,其合并的OR值及95%CI分别为：OR=4.27,95%CI(2.32-7.85);OR=3.01,95%CI (1.77-5.14)。针刀治疗膝骨关节炎近期疗效优于针灸。但纳入试验方法学质量不高,且均未报道不良事件,建议开展高质量的随机对照试验加以验证。