early effectiveness

  • 文章类型: Journal Article
    本研究旨在评估除标准疗法外,贝利木单抗对系统性红斑狼疮(SLE)患者24周的早期有效性和安全性。
    这项回顾性研究是在2020年6月至2022年8月期间对60名患有活动性SLE的成年患者进行的。患者除标准治疗外还接受静脉注射贝利木单抗(n=31;24名女性,7名男性;平均年龄:33.7±14.1岁;范围,18至52岁)或仅标准治疗(n=29;22名女性,7名男性;平均年龄:34.1±13.4岁;范围,19至66岁),为期24周。成果措施,包括安全性和有效性(红斑狼疮中雌激素的安全性国家评估-系统性红斑狼疮疾病活动指数[SELENA-SLEDAI]),生物标志物的变化(双链DNA[脱氧核糖核酸]),血清补体水平,记录免疫球蛋白G(IgG)。记录不良事件。
    两组的基线人口统计学和临床特征相似。贝利木单抗组中更多的患者在第12周和第24周时SELENA-SLEDAI降低≥4分(第12周,77.4%vs.41.4%,p=0.008;第24周,87.1%vs.48.3%,p=0.002)。在第12周时,贝利木单抗组的SELENA-SLEDAI平均评分明显低于标准治疗组。然而,在第24周没有达到显著差异.此外,在第12周和第24周时,belimumab组的血清C3和C4平均水平显著高于标准治疗组.贝利木单抗组中C3水平正常的患者比例高于标准治疗组。此外,belimumab治疗导致IgG水平在第12周和第24周显著下降.在第24周,贝利木单抗组的泼尼松剂量减少率高于标准治疗组。此外,在第12周时,使用贝利木单抗治疗的泼尼松比基线降低50%以上的患者百分比显著高于标准治疗(p=0.002).两组患者的不良事件发生率相似(标准治疗组,44.8%;贝利木单抗组,51.6%)。
    静脉注射贝利木单抗在中国SLE患者治疗早期具有良好的耐受性和显著改善疾病活动性。更重要的是,贝利木单抗治疗最早可能导致泼尼松剂量在第12周迅速减少.
    UNASSIGNED: This study aimed to evaluate the early effectiveness and safety of belimumab in addition to standard therapy in patients with systemic lupus erythematosus (SLE) for 24 weeks.
    UNASSIGNED: This retrospective study was conducted with 60 adult patients with active SLE between June 2020 and August 2022. The patients either received intravenous belimumab in addition to standard therapy (n=31; 24 females, 7 males; mean age: 33.7±14.1 years; range, 18 to 52 years) or only standard therapy (n=29; 22 females, 7 males; mean age: 34.1±13.4 years; range, 19 to 66 years) for 24 weeks. Outcome measures, including safety and effectiveness (Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index [SELENA-SLEDAI]), changes in biomarkers (double-stranded DNA [deoxyribonucleic acid]), serum complement levels, and immunoglobin G (IgG) were recorded. Adverse events were recorded.
    UNASSIGNED: Baseline demographic and clinical characteristics were similar between the two groups. More patients in the belimumab group achieved a reduction of ≥4 points in SELENA-SLEDAI at weeks 12 and 24 (week 12, 77.4% vs. 41.4%, p=0.008; week 24, 87.1% vs. 48.3%, p=0.002). The mean score of SELENA-SLEDAI was significantly lower in the belimumab group compared to the standard therapy group at week 12. However, a significant difference was not reached at week 24. Moreover, mean levels of serum C3 and C4 in the belimumab group were significantly higher than those in the standard therapy group at weeks 12 and 24. A higher proportion of patients in the belimumab group had a normal C3 level than in the standard therapy group. In addition, belimumab treatment resulted in a significant decrease in IgG levels at both weeks 12 and 24. At week 24, the belimumab group had a higher reduction in prednisone dose than the standard therapy group. Furthermore, the percentages of patients with more than 50% reduction in prednisone over baseline were significantly greater for belimumab versus standard therapy at week 12 (p=0.002). The occurrence of adverse events was similar between the two groups (standard therapy group, 44.8%; belimumab group, 51.6%).
    UNASSIGNED: Intravenous belimumab was well tolerated and significantly improved disease activity in Chinese patients with SLE at the early stage of treatment. More importantly, belimumab treatment could result in a rapid reduction in prednisone dose as early as week 12.
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  • 文章类型: Journal Article
    UNASSIGNED: To explore the early effectiveness and influence on cartilage of local injection of multimodal drug cocktail (MDC) during anterior cruciate ligament reconstruction (ACLR).
    UNASSIGNED: Between February 2022 and August 2023, patients undergone arthroscopic ACLR using autologous hamstring tendons were selected as the study subjects. Among them, 90 patients met the selection criteria and were randomly divided into 3 groups ( n=30) according to the different injection drugs after ligament reconstruction. There was no significant difference in baseline data such as gender, age, body mass index, surgical side, disease duration, preoperative thigh circumference, and preoperative levels of tumor necrosis factor α (TNF-α), interleukin 6 (IL-6), IL-1, matrix metalloproteinase 3 (MMP-3), MMP-13, and aggrecan (ACAN) in synovial fluid between groups ( P>0.05). After the ligament reconstruction during operation, corresponding MDC (consisting of ropivacaine, tranexamic acid, and betamethasone in group A, and ropivacaine, betamethasone, and saline in group B) or saline (group C) were injected into the joint and tendon site, respectively. The length of hospital stay, postoperative tramadol injection volume, incidence of complications, degree of knee joint swelling and range of motion, visual analogue scale (VAS) score, International Knee Documentation Committee (IKDC) score, Lyshlom score, and Hospital for Special Surgery (HSS) score were recorded and compared between groups. The T2 * values in different cartilage regions were detected by MRI examination and the levels of TNF-α, IL-6, IL-1, MMP-3, MMP-13, and ACAN in synovial fluid were detected by ELISA method.
    UNASSIGNED: The patients in group A, B, and C were followed up (12.53±3.24), (13.14±2.87), and (12.82±3.32) months, respectively. All incisions healed by first intention. Compared with group C, group A and group B had shorter length of hospital stay, less tramadol injection volume, and lower incidence of complications, showing significant differences ( P<0.05); there was no significant difference between group A and group B ( P>0.05). The degree of knee swelling in group A was significantly less than that in group B and group C ( P<0.05), but there was no significant difference between group B and group C ( P>0.05). At 3, 6, 12, 24, and 48 hours after operation, VAS scores of group A and group B were significantly lower than those of group C ( P<0.05); at 72 hours after operation, there was no significant difference among the three groups ( P>0.05). At 3 days, 14 days, and 1 month after operation, the range of motion of knee joint in group A were significantly better than those in group C ( P<0.05), and there was no significant difference between the other groups ( P>0.05). At 1 month after operation, the IKDC score of group A and group B was significantly higher than that of group C ( P<0.05); there was no significant difference among the three groups at other time points ( P>0.05). There was no significant difference in Lyshlom score and HSS score among the three groups at each time point ( P>0.05). At 14 days after operation, the levels of IL-1 and IL-6 in the synovial fluid in groups A and B were significantly lower than those in group C ( P<0.05). There was no significant difference in the levels of TNF-α, MMP-3, MMP-13, and ACAN between groups A and B ( P>0.05). At 1 month after operation, there was no significant difference in the above indicators among the three groups ( P>0.05). At 3, 6, and 12 months after operation, there was no significant difference in the T2 * values of different cartilage regions among the three groups ( P>0.05).
    UNASSIGNED: Injecting MDC (ropivacaine, tranexamic acid, betamethasone) into the joint and tendon site during ACLR can achieve good early effectiveness without significant impact on cartilage.
    UNASSIGNED: 探讨前交叉韧带重建术(anterior cruciate ligament reconstruction,ACLR)中局部注射多模式混合药物(multimodal drug cocktail,MDC)的早期疗效及对软骨的影响。.
    UNASSIGNED: 以2022年2月—2023年8月拟采用自体腘绳肌腱行关节镜下ACLR患者作为研究对象,其中90例符合选择标准纳入研究,根据韧带重建后注射药物不同随机分为3组( n=30)。3组患者性别、年龄、身体质量指数、手术侧别、病程以及术前大腿周径及关节液中TNF-α、IL-6、IL-1、基质金属蛋白酶3(matrix metalloproteinase 3,MMP-3)、MMP-13、聚集蛋白聚糖(aggrecan,ACAN)含量等基线资料比较,差异均无统计学意义( P>0.05)。术中韧带重建后,分别于关节内和取腱处注射对应MDC(A组由罗哌卡因、氨甲环酸、倍他米松组成,B组由罗哌卡因、倍他米松、生理盐水组成)或生理盐水(C组)。比较3组患者住院时间、术后曲马多注射量及并发症发生情况,膝关节肿胀程度及活动度、疼痛视觉模拟评分(VAS)、国际膝关节文献委员会(IKDC)评分、Lyshlom评分以及美国特种外科医院(HSS)评分;MRI检查不同软骨区域T2 *值;ELISA法检测关节液中TNF-α、IL-6、IL-1、MMP-3、MMP-13、ACAN含量。.
    UNASSIGNED: 3组患者均获随访,A、B、C组随访时间分别为(12.53±3.24)、(13.14±2.87)、(12.82±3.32)个月。术后切口均Ⅰ期愈合。A、B组与C组相比,住院时间缩短、曲马多注射量减少、并发症发生率降低,差异均有统计学意义( P<0.05);A、B组间差异均无统计学意义( P>0.05)。术后A组膝关节肿胀程度较B、C组减轻( P<0.05),B、C组间差异无统计学意义( P>0.05)。术后3、6、12、24、48 h时,A、B组VAS评分低于C组( P<0.05);术后72 h时3组间差异均无统计学意义( P>0.05)。术后3 d、14 d、1个月,A组膝关节活动度优于C组( P<0.05),其余组间比较差异无统计学意义( P<0.05)。术后1个月时,A、B组IKDC评分高于C组( P<0.05);其余时间点组间比较差异均无统计学意义( P>0.05)。各时间点Lyshlom评分及HSS评分组间比较差异均无统计学意义( P>0.05)。ELISA检测术后14 d A、B组患膝关节液中IL-1和IL-6含量低于C组( P<0.05),TNF-α、MMP-3、MMP-13、ACAN含量差异均无统计学意义( P>0.05);A、B组上述指标差异均无统计学意义( P>0.05)。术后1个月时,上述各项指标组间比较差异均无统计学意义( P>0.05)。术后3、6、12个月时,3组间各软骨区域T2 *值比较差异均无统计学意义( P>0.05)。.
    UNASSIGNED: ACLR术中关节内联合取腱处注射MDC(罗哌卡因、氨甲环酸、倍他米松)可获得良好早期疗效,且对软骨无明显影响。.
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  • 文章类型: English Abstract
    UNASSIGNED: To explore the early effectiveness of arthroscopic tri-anchor double-pulley suture-bridge in treatment of medium-size supraspinatus tendon tears.
    UNASSIGNED: Between December 2020 and January 2023, 40 patients with medium-size supraspinatus tendon tears were treated with arthroscopic tri-anchor double-pulley suture-bridge. There were 18 males and 22 females, with an average age of 62.6 years (mean, 45-73 years). Among them, 17 patients had trauma history. The main clinical symptom was shoulder pain with hug resistance test (+). The interval from symptom onset to operation was 10.7 months on average (range, 3-36 months). Visual analogue scale (VAS) score, University of California Los Angeles (UCLA) score, American Shoulder and Elbow Surgeons (ASES) score, and shoulder range of motion (ROM) of forward flexion, abduction, and external rotation were used to evaluate shoulder function. MRI was performed to assess the structural integrity and tension of reattached tendon. Patient satisfactions were calculated at last follow-up.
    UNASSIGNED: All incisions healed by first intention, no complications such as incision infection or nerve injury occurred. All patients were followed up 12-37 months (mean, 18.2 months). At 12 months after operation, VAS score, UCLA score, and ASES score significantly improved when compared with the preoperative scores ( P<0.05). At 3 and 12 months after operation, the ROM of external rotation significantly improved when compared with preoperative one ( P<0.05), and further improved at 12 months after operation ( P<0.05). However, the ROMs of abduction and forward flexion did not improve at 3 months after operation when compared with those before operation ( P>0.05), but significantly improved at 12 months after operation ( P<0.05). Twenty-six patients underwent MRI at 3-6 months, of which 23 patients possessed intact structural integrity, good tendon tension, and tendon healing; 3 patients underwent tendon re-tear. The self-rated satisfaction rate was 92.5% at last follow-up.
    UNASSIGNED: Arthroscopic tri-anchor double-pulley suture-bridge in treatment of medium-size supraspinatus tendon tears can maximize the tendon-bone contact area, obtain satisfied early effectiveness with high satisfaction rate and low incidence of tendon re-tear. However, the function of abduction is limited at 3 months after operation, and patients need to adhere to rehabilitation training to further improve the joint activity.
    UNASSIGNED: 探讨关节镜下三钉双滑轮缝线桥技术修补冈上肌腱中型撕裂的早期疗效。.
    UNASSIGNED: 2020年12月—2023年1月,对40例冈上肌腱中型撕裂患者行关节镜下三钉双滑轮缝线桥技术修补术。男18例,女22例;年龄45~73岁,平均62.6岁。17例有明显外伤史。主要临床症状为肩关节疼痛,抱抬抗阻试验(+)。出现症状至该次入院时间为3~36个月,平均10.7个月。以疼痛视觉模拟评分(VAS)、美国肩肘外科医师协会(ASES)评分、美国加州大学洛杉矶分校(UCLA)评分以及肩关节前屈、外展和外旋活动度,评价肩关节疼痛和功能;术后复查MRI评估冈上肌腱愈合情况;末次随访时统计患者满意度。.
    UNASSIGNED: 术后切口均Ⅰ期愈合,无切口感染、神经损伤等并发症发生。患者均获随访,随访时间12~37个月,平均18.2个月。术后12个月VAS评分、ASES评分、UCLA评分均优于术前( P<0.05)。术后3、12个月肩关节外旋活动度均较术前改善,术后12个月进一步改善,差异均有统计学意义( P<0.05);术后3个月前屈、外展活动度与术前相似( P>0.05),但12个月较术前及术后3个月均改善( P<0.05)。术后3~6个月26例患者行MRI复查,其中23例冈上肌腱愈合良好,3例肌腱再撕裂。末次随访时,患者自评满意率达92.5%。.
    UNASSIGNED: 关节镜下三钉双滑轮缝线桥技术修补冈上肌腱中型撕裂,可以扩大腱-骨接触面积,早期疗效满意、肌腱再撕裂率低,但是存在术后3个月肩关节活动受限,患者需坚持康复训练,以进一步改善关节活动度。.
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  • 文章类型: English Abstract
    UNASSIGNED: To compare the accuracy and effectiveness of orthopaedic robot-assisted minimally invasive surgery versus open surgery for limb osteoid osteoma.
    UNASSIGNED: A clinical data of 36 patients with limb osteoid osteomas admitted between June 2016 and June 2023 was retrospectively analyzed. Among them, 16 patients underwent orthopaedic robot-assisted minimally invasive surgery (robot-assisted surgery group), and 20 patients underwent tumor resection after lotcated by C-arm X-ray fluoroscopy (open surgery group). There was no significant difference between the two groups in the gender, age, lesion site, tumor nidus diameter, and preoperative pain visual analogue scale (VAS) scores ( P>0.05). The operation time, lesion resection time, intraoperative blood loss, intraoperative fluoroscopy frequency, lesion resection accuracy, and postoperative analgesic use frequency were recorded and compared between the two groups. The VAS scores for pain severity were compared preoperatively and at 3 days and 3 months postoperatively.
    UNASSIGNED: Compared with the open surgery group, the robot-assisted surgery group had a longer operation time, less intraoperative blood loss, less fluoroscopy frequency, less postoperative analgesic use frequency, and higher lesion resection accuracy ( P<0.05). There was no significant difference in lesion resection time ( P>0.05). All patients were followed up after surgery, with a follow-up period of 3-24 months (median, 12 months) in the two groups. No postoperative complication such as wound infection or fracture occurred in either group during follow-up. No tumor recurrence was observed during follow-up. The VAS scores significantly improved in both groups at 3 days and 3 months after surgery when compared with preoperative value ( P<0.05). The VAS score at 3 days after surgery was significantly lower in robot-assisted surgery group than that in open surgery group ( P<0.05). However, there was no significant difference in VAS scores at 3 months between the two groups ( P>0.05).
    UNASSIGNED: Compared with open surgery, robot-assisted resection of limb osteoid osteomas has longer operation time, but the accuracy of lesion resection improve, intraoperative blood loss reduce, and early postoperative pain is lighter. It has the advantages of precision and minimally invasive surgery.
    UNASSIGNED: 比较骨科机器人辅助微创手术与开放手术切除肢体骨样骨瘤的准确性与疗效。.
    UNASSIGNED: 回顾分析2016年6月—2023年6月收治的36例肢体骨样骨瘤患者临床资料,其中16例选择骨科机器人辅助微创切除瘤巢手术(机器人手术组),20例采用常规C臂X线机透视定位后切除肿瘤(开放手术组)。两组患者性别、年龄、病灶部位、瘤巢直径以及术前疼痛视觉模拟评分(VAS)等基线资料比较,差异均无统计学意义( P>0.05)。记录并比较两组手术时间、病灶切除时间、术中出血量、术中透视次数、病灶切除准确度、术后止痛药使用次数,以及术前及术后3 d、3个月疼痛程度(VAS评分)。.
    UNASSIGNED: 与开放手术组相比,机器人手术组手术时间延长,但术中出血量、透视次数及术后止痛药使用次数均减少,病灶切除准确度提高,差异均有统计学意义( P<0.05);病灶切除时间差异无统计学意义( P>0.05)。两组患者术后均获随访,随访时间均为3~24个月,中位时间均为12个月。术后两组均无切口感染、骨折等并发症发生。随访期间均无肿瘤复发。两组患者术后3 d、3个月时VAS 评分均较术前改善( P<0.05);术后3 d机器人手术组VAS评分较开放手术组更低( P<0.05),但术后3个月VAS评分组间差异无统计学意义( P>0.05)。.
    UNASSIGNED: 与开放手术相比,骨科机器人辅助下切除肢体骨样骨瘤虽然手术时间延长,但病灶切除准确度提高、术中出血量减少、术后早期疼痛程度更轻,具有精准、微创优势。.
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  • 文章类型: English Abstract
    UNASSIGNED: To investigate the early effectiveness of arthroscopic repair of supraspinatus tendon tears with douple-pulley suture-bridge.
    UNASSIGNED: The clinical data of 38 patients with supraspinatus tendon tears who met the selection criteria between September 2020 and July 2022 were retrospectively analyzed, and all of them were treated with arthroscopic double-pulley suture-bridge technique. There were 15 males and 23 females, aged from 43 to 77 years, with an average of 61.5 years. There were 15 cases of left shoulder and 23 cases of right shoulder. Seven cases had a history of trauma, and the other 31 cases had no obvious inducement. The main clinical symptoms of the patient were pain in lifting the shoulder joint and hug resistance test (+). The time from onset of symptoms to admission ranged from 6 to 19 months, with an average of 10.3 months. Flexion, abduction, and external rotation of the shoulder were recorded before operation and at 3 and 12 months after operation. Pain and function of the shoulder were evaluated by visual analogue scale (VAS) score, University of California Los Angeles (UCLA) shoulder score, and American Society of Shoulder and Elbow Surgeons (ASES) score before operation and at 12 months after operation. Tendon healing, tendon continuity, and tension were evaluated by MRI at 3-6 months after operation, and patient\'s satisfaction was evaluated at last follow-up.
    UNASSIGNED: All the incisions healed by first intention, and there was no complication such as incision infection or nerve injury. All patients were followed up 12-34 months, with an average of 23.3 months. VAS score, UCLA shoulder score, and ASES score at 12 months after operation were significantly better than those before operation ( P<0.05). The external rotation range of shoulder joint significantly improved at 3 and 12 months after operation ( P<0.05), and it further improved at 12 months after operation when compared with 3 months after operation ( P<0.05). There was no significant difference in the range of flexion and abduction at 3 months after operation when compared with those before operation ( P>0.05), but the range of flexion and abduction at 12 months after operation significantly improved when compared with those before operation and at 3 months after operation ( P<0.05). MRI reexamination was performed in 28 patients at 3-6 months after operation. Among them, 25 patients had intact supraspinatus tendon structure, good tension, and tendon healing, and 3 patients had type 1 retear. The remaining 10 patients refused to undergo MRI reexamination because of the satisfactory effectiveness. At last follow-up, 29 patients (76.3%) were very satisfied with the results, 6 (15.7%) were satisfied, and 3 (7.8%) were not satisfied.
    UNASSIGNED: Arthroscopic double-pulley suture-bridge technique can achieve the effect of suture bridge operation, reduce the cost of operation and the risk of type 2 retear, and the early effectiveness is satisfactory, but the shoulder joint movement is limited within 3 months after operation.
    UNASSIGNED: 探讨关节镜下双滑轮缝线桥修补冈上肌腱撕裂的早期疗效。.
    UNASSIGNED: 回顾分析2020年9月—2022年7月收治且符合选择标准的38例冈上肌腱撕裂患者,均采用关节镜下双滑轮缝线桥修补。其中男15例,女23例;年龄43~77岁,平均61.5岁。左肩15例,右肩23例。7例有外伤史,余31例无明显诱因。患者主要临床症状为肩关节上举疼痛,抱抬抗阻试验(+)。出现症状至入院时间6~19个月,平均10.3个月。记录术前及术后3、12个月肩关节前屈、外展和外旋活动度;术前及术后12个月采用疼痛视觉模拟评分(VAS)、美国加州大学洛杉矶分校(UCLA)肩关节评分和美国肩肘外科医师协会(ASES)评分评价肩关节疼痛及功能。术后3~6个月MRI评估肌腱愈合情况、肌腱连续性和张力,末次随访时统计患者满意度。.
    UNASSIGNED: 术后切口均Ⅰ期愈合,无切口感染、神经损伤等并发症发生。38例患者均获随访,随访时间12~34个月,平均23.3个月。术后12个月VAS评分、UCLA肩关节评分及ASES评分均优于术前( P<0.05)。术后3、12个月肩关节外旋活动度均较术前明显改善,术后12个月较3个月时进一步改善,差异均有统计学意义( P<0.05)。术后3个月肩关节前屈和外展活动度与术前比较差异无统计学意义( P>0.05);但术后12个月较术前及术后3个月均明显改善( P<0.05)。术后3~6个月28例患者行MRI复查,其中25例冈上肌腱结构完整、张力良好、肌腱愈合,3例发生1型再撕裂;余10例患者对疗效满意拒绝再次MRI检查。末次随访时,患者对疗效非常满意29例(76.3%)、满意6例(15.7%)、不满意3例(7.8%)。.
    UNASSIGNED: 关节镜下双滑轮缝线桥技术可以实现缝线桥手术效果,降低手术费用和2型再撕裂发生率,早期临床疗效满意,但术后3个月内肩关节活动受限。.
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  • 文章类型: English Abstract
    UNASSIGNED: To evaluate the early effectiveness of a new minimally invasive plate in the treatment of varus-type ankle arthritis.
    UNASSIGNED: A clinical data of 15 patients with varus-type ankle arthritis who met the selection criteria between March 2021 and October 2021 were retrospectively analyzed. All the patients were treated with medial open-wedge supramalleolar osteotomy and fibular osteotomy. The osteotomies were fixed with the new minimally invasive plate. There were 7 males and 8 females with an average age of 49.8 years (range, 16-71 years). The causes of ankle arthritis included post-fracture deformity in 1 case, sprain in 8 cases, and acquired clubfoot in 1 case; and 5 cases were without obvious factors. The disease duration ranged from 1 to 12 years, with an average of 4.1 years. Comparisons were made between pre-operation and the last follow-up in the Takakura staging, the American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, foot function index (FFI), visual analogue scale (VAS) score, tibial anterior surface angle (TAS), tibial lateral surface angle (TLS), and talar tilt (TT).
    UNASSIGNED: All incisions healed by first intention. All patients were followed up 7-18 months (mean, 12.8 months). At last follow-up, the AOFAS ankle-hindfoot score, FFI, VAS score, and Takakura staging significantly improved when compared with the preoperative ones ( P<0.05). X-ray films showed that the osteotomy healed at 3 months after operation. At last follow-up, TAS significantly increased and TT decreased when compared with the preoperative ones ( P<0.05), and the difference in TLS between pre- and post-operation was not significant ( P>0.05). Complications included 1 case of intraoperative screw breakage and 2 cases of nerve injury of the affected foot. None of the patients complained of significant discomfort at the plate placement during follow-up, and no loosening of the internal fixator occurred. Eleven patients were very satisfied with the effeectiveness, while 4 were relatively satisfied.
    UNASSIGNED: The new minimally invasive plate for the varus-type ankle arthritis has good early effectiveness in relieving ankle pain, correcting deformity, improving limb alignment and ankle function, and reducing the incidence of postoperative incisional complications.
    UNASSIGNED: 探讨新型微创接骨板治疗内翻型踝关节炎的早期疗效。.
    UNASSIGNED: 回顾性分析2021年3月—10月符合选择标准的15例内翻型踝关节炎患者临床资料。患者均行内侧撑开踝上截骨术联合腓骨截骨,采用新型微创接骨板固定截骨。男7例,女8例;年龄16~71岁,平均49.8岁。踝关节炎病因:骨折后畸形愈合1例,扭伤8例,后天马蹄足1例,无明显诱因5例。病程1~12年,平均4.1年。比较手术前后Takakura分期、美国矫形足踝协会(AOFAS)踝-后足评分、足部功能指数(FFI)、疼痛视觉模拟评分(VAS)以及胫骨远端关节面正位角(tibial anterior surface angle,TAS)、距骨倾斜角(talar tilt,TT)、胫骨远端关节面侧位角(tibial lateral surface angle,TLS)。.
    UNASSIGNED: 术后切口均Ⅰ期愈合。患者均获随访,随访时间7~18个月,平均12.8个月。末次随访时,AOFAS踝-后足评分、FFI、VAS评分及Takakura分期均较术前改善( P<0.05)。X线片复查示术后3个月随访时截骨均愈合;末次随访时TAS较术前增大、TT减小,差异均有统计学意义( P<0.05),而TLS与术前比较差异无统计学意义( P>0.05)。并发症包括1例术中螺钉断裂,2例患足神经损伤。随访期间患者均未诉放置钢板处明显不适,无内固定物松动发生。患者自评满意度达非常满意11例,比较满意4例。.
    UNASSIGNED: 新型微创接骨板用于治疗内翻型踝关节炎具有良好早期疗效,可缓解踝关节疼痛,矫正畸形,改善下肢力线及踝关节功能,且术后切口并发症发生率较低。.
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  • 文章类型: Journal Article
    2020年,日本批准了5%的溴化软皮溴铵(ECCLOCK®)凝胶(以下简称软皮溴铵)用于原发性腋窝多汗症的局部治疗。一项关于软皮溴的III期研究证明了软皮溴的有效性和安全性;然而,没有研究在开始治疗后<6周评估其早期疗效。因此,为了评估软皮溴的早期有效性,我们进行了2周,单中心,探索性,prospective,日本原发性腋窝多汗症患者的观察性研究。年龄≥20岁且在基线时满足多汗症疾病严重程度量表(HDSS)评分为3或4的患者符合研究条件。有效性的主要终点是2周研究期间HDSS评分为1、2、3或4的患者比例的变化。在纳入完整分析集(FAS)的80名患者中,女性比男性多(93.8%vs.6.3%),平均年龄(±标准差[SD])为33.3±9.4岁。在FAS中,在第7天,HDSS评分为1或2分的患者比例为55.0%,与基线相比,第3天之后观察到有统计学意义的变化(p<0.05).在第7天,平均HDSS评分(±SD)从基线值3.5±0.5显著降低至2.4±0.9(p<0.001)。连续2天实现HDSS评分为1或2的软皮溴铵治疗的中位期为6天(95%置信区间,4-8).安全性分析集中对92名患者进行了安全性评估,在2周的研究期间未报告不良事件.这些结果表明,对于HDSS评分为3或4的患者,在用索皮溴铵治疗1周之后,大约50%的患者可以实现HDSS评分为1或2,这对于患者来说是临床上显著的改善。
    In 2020, 5% sofpironium bromide (ECCLOCK® ) gel (hereinafter referred to as sofpironium) was approved in Japan for the topical treatment of primary axillary hyperhidrosis. A phase III study of sofpironium demonstrated the efficacy and safety of sofpironium; however, no study has assessed its early efficacy at <6 weeks after starting treatment. Therefore, to assess the earlier effectiveness of sofpironium, we conducted a 2-week, single-center, exploratory, prospective, observational study in Japanese patients with primary axillary hyperhidrosis. Patients aged ≥20 years and satisfying with a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 at baseline were eligible for the study. The primary endpoint for the effectiveness was change in the proportion of patients with a HDSS score of 1, 2, 3, or 4 during the 2-week study period. In 80 patients included in the full analysis set (FAS), there were more women than men (93.8% vs. 6.3%), and the mean age (±standard deviation [SD]) was 33.3 ± 9.4 years. In the FAS, the proportion of patients with a HDSS score of 1 or 2 was 55.0% on day 7, and statistically significant changes were observed after day 3 compared to baseline (p < 0.05). Mean HDSS scores (±SD) were significantly decreased from baseline value of 3.5 ± 0.5 to 2.4 ± 0.9 on day 7 (p < 0.001). The median period for sofpironium treatment to achieve a HDSS score of 1 or 2 for a continuous 2 days was 6 days (95% confidence interval, 4-8). Safety was evaluated in 92 patients in the safety analysis set, and no adverse events were reported during the study period of 2 weeks. These results suggest that after 1-week treatment with sofpironium for patients with a HDSS score of 3 or 4, approximately 50% of the patients can achieve a HDSS score of 1 or 2, which is a clinically significant improvement for the patients.
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  • 文章类型: Journal Article
    OBJECTIVE: To estimate the early effectivenss of computer navigation-assisted total knee arthroplasty (TKA) by comparing with traditional TKA.
    METHODS: The clinical data of 89 patients (100 knees) underwent primary TKA between October 2017 and July 2018 were analyzed retrospectively, including 44 patients (50 knees) who completed the TKA under the computer-assisted navigation system as the navigation group and 45 patients (50 knees) treated with traditional TKA as the control group. There was no significant difference between the two groups ( P>0.05) in gender, age, body mass index, diagnosis, side, disease duration, Kellgren-Lawrence classification of osteoarthritis, and preoperative American Hospital for Special Surgery (HSS) score, range of motion (ROM), hip-knee-ankle angle (HKA) deviation. The operation time, incision length, difference in hemoglobin before and after operation, postoperative hospital stay, and the complications were recorded and compared between the two groups. The HSS score, ROM, and joint forgetting score (FJS-12) were used to evaluate knee joint function in all patients. Unilateral patients also underwent postoperative time of up and go test and short physical performance battery (SPPB) test. At 1 day after operation, the HKA, mechanical lateral distal femoral angle (mLDFA), mechanical medial proximal tibial angle (mMPTA), sagittal femoral component angle (sFCA), and sagittal tibial component angle (sTCA) were measured and calculated the difference between the above index and the target value (deviation); and the joint line convergence angle (JLCA) was also measured.
    RESULTS: The operations of the two groups were successfully completed, and the incisions healed by first intention. The operation time and incision length of the navigation group were longer than those of the control group ( P<0.05); the difference in difference of hemoglobin before and after the operation and the postoperative hospital stay between groups was not significant ( P>0.05). Patients in the two groups were followed up 27-40 months, with an average of 33.6 months. Posterior tibial vein thrombosis occurred in 1 case in each of the two groups, and 1 case in the control group experienced repeated knee joint swelling. The HSS scores of the two groups gradually increased after operation ( P<0.05); HSS scores in the navigation group at 1 and 2 years after operation, and knee ROM and FJS-12 scores at 2 years were significantly higher than those in the control group ( P<0.05). There was no significant difference in the postoperative time of up and go test and SPPB results between the two groups at 7 days after operation ( P>0.05); the postoperative time of up and go test of the navigation group was shorter than that of the control group at 2 years ( t=-2.226, P=0.029), but there was no significant difference in SPPB ( t=0.429, P=0.669). X-ray film measurement at 1 day after operation showed that the deviation of HKA after TKA in the navigation group was smaller than that of the control group ( t=-7.392, P=0.000); among them, the HKA deviations of 50 knees (100%) in the navigation group and 36 knees (72%) in the control group were less than 3°, showing significant difference between the two groups ( χ 2=16.279, P=0.000). The JLCA and the deviations of mLDFA, mMPTA, sFCA, and sTCA in the navigation group were smaller than those in the control group ( P<0.05).
    CONCLUSIONS: Compared with traditional TKA, computer navigation-assisted TKA can obtain more accurate prosthesis implantation position and lower limb force line and better early effectiveness. But there is a certain learning curve, and the operation time and incision length would be extended in the early stage of technology application.
    UNASSIGNED: 通过与传统人工全膝关节置换术(total knee arthroplasty,TKA)比较,探讨计算机导航辅助 TKA 的早期疗效。.
    UNASSIGNED: 回顾分析 2017 年 10 月—2018 年 7 月于计算机导航辅助系统下行初次 TKA 的 44 例(50 膝)患者(导航组)临床资料,并与同期行传统 TKA 的 45 例(50 膝)患者(对照组)进行比较。两组患者性别、年龄、身体质量指数、病变类型、侧别、病程、骨关节炎 Kellgren-Lawrence 分级以及术前美国特种外科医院(HSS)评分、膝关节活动度(range of motion,ROM)、髋-膝-踝角(hip-knee-ankle angle,HKA)偏移等一般资料比较,差异均无统计学意义( P>0.05),具有可比性。记录并比较两组手术时间、切口长度、手术前后血红蛋白差值、术后住院时间,以及并发症发生情况。所有患者采用 HSS 评分、ROM、关节遗忘评分(FJS-12)评价膝关节功能恢复情况,单侧患者同时行术后计时起走测试、简易躯体能力测试(SPPB)。于术后 1 d X 线片测量 HKA、机械轴股骨远端外侧角(mechanical lateral distal femoral angle,mLDFA)、机械轴胫骨近端内侧角(mechanical medial proximal tibial angle,mMPTA)、矢状面股骨组件角(sagittal femoral component angle,sFCA),矢状面胫骨组件角(sagittal tibial component angle,sTCA),计算上述指标与目标值差值(指标偏移);测量膝关节线汇聚角(joint line convergence angle,JLCA)。.
    UNASSIGNED: 两组手术均顺利完成,术后切口均Ⅰ期愈合。导航组手术时间及切口长度均长于对照组( P<0.05);手术前后血红蛋白差值及术后住院时间比较,差异均无统计学意义( P>0.05)。两组患者均获随访,随访时间 27~40 个月,平均 33.6 个月。两组各 1 例术后发生胫后静脉血栓形成,对照组 1 例发生膝关节反复肿胀。两组术后 HSS 评分随时间延长逐渐升高( P<0.05);术后 1、2 年导航组 HSS 评分以及 2 年时膝关节 ROM 及 FJS-12 评分均高于对照组( P<0.05)。术后 7 d 两组计时起走测试及 SPPB 结果比较,差异均无统计学意义( P>0.05);术后 2 年,导航组计时起走测试较对照组缩短( t=–2.226, P=0.029),SPPB 比较差异无统计学意义( t=0.429, P=0.669)。术后 1 d X 线片测量示导航组 HKA 偏移小于对照组( t=–7.392, P=0.000);其中导航组 50 膝(100%)HKA 偏移均≤3°、对照组 36 膝(72%)≤3°,差异有统计学意义( χ 2=16.279, P=0.000)。导航组 mLDFA 偏移、mMPTA 偏移、sFCA 偏移、sTCA 偏移及 JLCA 均小于对照组( P<0.05)。.
    UNASSIGNED: 与传统 TKA 相比,计算机导航辅助 TKA 的假体植入位置和下肢力线重建更精确,可获得更好的早期疗效;但存在一定学习曲线,应用早期手术时间与切口长度均延长。.
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  • 文章类型: Journal Article
    UNASSIGNED: To compare the early effectiveness and safety of simultaneous bilateral and staged bilateral unicompartmental knee arthroplasty (UKA) in treatment of anteromedial compartment osteoarthritis.
    UNASSIGNED: The clinical data of 31 patients with bilateral anteromedial compartment osteoarthritis who underwent bilateral UKAs between January 2015 and January 2017 was retrospectively analyzed. Of them, 17 patients were treated with simultaneous bilateral UKAs (simultaneous group) and 14 patients with staged bilateral UKAs (staged group). There was no significant difference in gender, age, body mass index, osteoarthritis grading, and preoperative hip-knee-ankle angle, knee society score (KSS), visual analogue scale (VAS) score, and range of motion (ROM) of knee between the two groups ( P>0.05). The operation time, blood loss, hospitalization stay, minimum hemoglobin value during 10 days after operation, and hospitalization cost were recorded. The staged group was compared by the sum of two operations. The effectiveness was evaluated by KSS score, VAS score, ROM at 3, 6, 12 months after operation, and patient satisfaction scores were recorded at 12 months after operation.
    UNASSIGNED: The operation time, hospitalization stay, and hospitalization cost of the simultaneous group were significantly lower than those of the staged group ( P<0.05). There was no significant difference in blood loss and the minimum hemoglobin value during 10 days after operation between the two groups ( P>0.05). Superficial infection occurred in 1 side of 1 case (7.1%) in staged group. Postoperative delirium occurred in 1 case (5.9%) in simultaneous group. There was no significant difference in incidence of postoperative complications between the two groups ( P=1.000). Patients in both groups were followed up 12-32 months (mean, 24.7 months). There was no significant difference in KSS score between the two groups at 3 months after operation ( t=0.896, P=0.392). KSS scores were significanly higher in simultaneous group than in staged group at 6 and 12 months after operation ( P<0.05). There was no significant difference in ROM and VAS scores between the two groups at 3, 6, and 12 months after operation ( P>0.05). At 12 months after operation, the patient satisfaction scores were significantly higher in simultaneous group than in staged group ( P<0.05). X-ray films showed no loosening of the prosthesis in the two groups.
    UNASSIGNED: Simultaneous bilateral UKAs has the same security as staged bilateral UKAs. Meanwhile knee function recovery was better, hospitalization stay and hospitalization cost reduced, and patient satisfaction was higher in simultaneous bilateral UKAs.
    UNASSIGNED: 比较同期和分期人工单髁关节置换(unicompartmental knee arthroplasty,UKA)治疗双膝前内侧骨关节炎的早期疗效及安全性。.
    UNASSIGNED: 回顾性分析 2015 年 1 月—2017 年 1 月完成双侧 UKA 的 31 例双膝前内侧骨关节炎患者临床资料。其中,17 例行同期双膝 UKA(同期组),14 例行分期 UKA(分期组)。两组患者性别、年龄、体质量指数、骨关节炎分级以及术前髋-膝-踝角、膝关节学会评分系统(KSS)评分、疼痛视觉模拟评分(VAS)、膝关节活动度等一般资料比较,差异均无统计学意义( P>0.05)。记录手术时间、出血量、住院时间、术后 10 d 内血红蛋白最低值及住院费用,分期组以两次手术总和进行比较。术后 3、6、12 个月,采用 KSS 评分、VAS 评分、膝关节活动度评价手术疗效,并记录术后 12 个月患者满意度评分。.
    UNASSIGNED: 同期组手术时间、住院时间及住院费用均低于分期组( P<0.05),两组出血量及术后 10 d 内血红蛋白最低值比较差异无统计学意义( P>0.05)。术后分期组 1 例(7.1%)1侧膝关节切口出现浅表感染,同期组 1 例(5.9%)出现谵妄,两组术后并发症发生率比较差异无统计学意义( P=1.000)。两组患者均获随访,随访时间 12~32 个月,平均 24.7 个月。两组术后 3 个月 KSS 评分比较差异无统计学意义( t=0.896, P=0.392),术后 6、12 个月同期组 KSS 评分明显高于分期组,差异有统计学意义( P<0.05)。两组术后 3、6、12 个月膝关节活动度、VAS 评分比较差异均无统计学意义( P>0.05)。术后 12 个月同期组患者满意度评分明显高于分期组,差异有统计学意义( t=2.959, P=0.006)。X 线片复查示假体均无松动。.
    UNASSIGNED: 同期双侧 UKA 安全性与分期手术相似,但膝关节功能恢复更好、住院时间及手术费用均减少,患者满意度更高。.
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