利伐沙班、达比加群与肝素在全髋或全膝置换后的抗凝治疗

背景:目前临床上主要使用依诺肝素预防全髋或全膝置换后静脉血栓形成,但其并非百分之百的有效与安全. 目的:系统评价新型口服抗凝药利伐沙班和达比加群与依诺肝素在临床随机对照试验中预防全髋或全膝置换后静脉血栓形成的有效性和安全性. 方法:计算机检索 Pubed、ScienceDirect、Cochrane Library、CBM、CNKI,收集有关利伐沙班、达比加群与依诺肝素在全髋或全膝置换后抗凝治疗有效性和安全性的临床随机对照试验,并评价纳入研究的方法学质量,统计软件用 RevMan5.1.0. 结果与结论:共纳入14个临床随机对照试验,共17212例患者.Meta 分析显示,利伐沙班组总静脉血栓发生率、大静脉血栓及有症状静脉血栓发生率均低于依诺肝素组;利伐沙班和达比加群组深静脉血栓发生率低于依诺肝素组;利伐沙班和达比加群与依诺肝素在出血率方面差异无显著性意义.提示新型口服抗凝药对全髋或全膝置换后深静脉血栓的预防效果优于依诺肝素,且利伐沙班优于达比加群.     

Apixaban and rivaroxaban safety after hip and knee arthroplasty: a meta-analysis

Direct experimental safety comparisons of Xa coagulation factor direct inhibitors, apixaban and rivaroxaban, on their approved therapeutic indications have not been identified. Due to recently raised safety concerns, a meta-analysis was carried out pooling data from studies identified on a Medline and Cochrane Library search in order to better evaluate the safety profile of both drugs. Abstracts from scientific meetings were also searched from 2003 to 2011. Primary and secondary outcome measures were major bleeding and total bleeding, respectively. Relative risks (RRs) were estimated using random effects models and statistical heterogeneity was estimated with I(2) statistics. Of the 160 screened publications, 12 clinical trials were included in which enoxaparin was the active control. For knee arthroplasty, apixaban was associated with significantly fewer major bleeding events (6496 patients, RR 0.56, 95% confidence interval [CI] 0.32-0.96) and fewer total bleeding events (6496 patients, RR 0.81, 95% CI 0.67-0.97). There were no significant differences in the incidence of major bleeding events (5699 patients, RR 1.40, 95% CI 0.56-3.52) or in the incidence of total bleeding events for rivaroxaban (5699 patients, RR 1.09, 95% CI 0.91-1.30). No differences were found when thromboprophylaxis after hip replacement was the case. Apixaban seems to be associated with a lower risk of the incidence of hemorrhagic events after total knee arthroplasty. For hip arthroplasty, no differences were found between the studied drugs.     

The efficacy and safety of apixaban, an oral, direct factor Xa inhibitor, as thromboprophylaxis in patients following total knee replacement.

BACKGROUND: Heparins and warfarin are currently used as venous thromboembolism (VTE) prophylaxis in surgery. Inhibition of factor (F) Xa provides a specific mechanism of anticoagulation and the potential for an improved benefit-risk profile. OBJECTIVES: To evaluate the safety and efficacy of apixaban, a potent, direct, oral inhibitor of FXa, in patients following total knee replacement (TKR), and to investigate dose-response relationships. PATIENTS/METHODS: A total of 1238 patients were randomized to one of six double-blind apixaban doses [5, 10 or 20 mg day(-1) administered as a single (q.d.) or a twice-daily divided dose (b.i.d.)], enoxaparin (30 mg b.i.d.) or open-label warfarin (titrated to an International Normalized Ratio of 1.8-3.0). Treatment lasted 10-14 days, commencing 12-24 h after surgery with apixaban or enoxaparin, and on the evening of surgery with warfarin. The primary efficacy outcome was a composite of VTE (mandatory venography) and all-cause mortality during treatment. The primary safety outcome was major bleeding. RESULTS: A total of 1217 patients were eligible for safety and 856 patients for efficacy analysis. All apixaban groups had lower primary efficacy event rates than either comparator. The primary outcome rate decreased with increasing apixaban dose (P = 0.09 with q.d./b.i.d. regimens combined, P = 0.19 for q.d. and P = 0.13 for b.i.d. dosing).A significant dose-related increase in the incidence of total adjudicated bleeding events was noted in the q.d. (P = 0.01) and b.i.d. (P = 0.02) apixaban groups; there was no difference between q.d. and b.i.d. regimens. CONCLUSIONS: Apixaban in doses of 2.5 mg b.i.d. or 5 mg q.d. has a promising benefit-risk profile compared with the current standards of care following TKR.     

Effect of obesity on outcomes after fondaparinux, enoxaparin, or heparin treatment for acute venous thromboembolism in the Matisse trials

BACKGROUND: Selecting initial anticoagulant dose by patient weight for acute pulmonary embolism and deep vein thrombosis has clinical credibility; however, uncertainty remains regarding how to dose obese patients with newer anticoagulants because outcome data are sparse. OBJECTIVES: To use the Matisse trials' comparison of sc fondaparinux once daily with control heparin therapies (intravenous unfractionated heparin for pulmonary embolism, sc enoxaparin 1 mg/kg b.i.d. for deep vein thrombosis) for initial treatment in order to compare primary outcomes (venous thromboembolism recurrence and major bleeding) in obese patients. PATIENTS AND METHODS: Primary outcomes were compared in subsets composed of patients weighing < or = and > 100 kg and with body mass index (BMI) < 30 and > or = 30 kg/m(2). Medians and ranges for weight and BMI were compared for patients suffering either recurrence or major bleeding. RESULTS: Twenty-two thousand and one patients received fondaparinux and 2217 received enoxaparin or unfractionated heparin. Four hundred and ninety-six patients (11%) weighed > 100 kg and 1216 (28%) had a BMI > or = 30. Treatment groups had similar characteristics. The upper limit in subject weight for recurrence was 166 kg (BMI 58), and for major bleeding 120 kg (BMI 39). The incidences of recurrence and major bleeding were similar for each patient subset of weight and BMI for both fondaparinux and heparin treatment groups. Among patients with a primary outcome, median weights and BMIs were also similar. CONCLUSIONS: The current recommended doses of fondaparinux and heparins for the treatment of venous thromboembolism appear to provide similar protection against recurrence and major bleeding to one another and to obese and non-obese patients.     

Efficacy and safety of bemiparin compared with enoxaparin in the prevention of venous thromboembolism after total knee arthroplasty: a randomized, double-blind clinical trial

Summary.  In this randomized, multicenter, controlled, double-blind, sequential trial, 381 patients undergoing primary total knee replacement were randomly assigned to receive subcutaneous injections of either 3500 IU anti-factor Xa of bemiparin sodium, first dose 6 h after surgery, or 40 mg of enoxaparin, first dose 12 h before surgery, followed by daily doses for 10 ± 2 days, for the prophylaxis of venous thromboembolism. The primary efficacy endpoint was venous thromboembolism up to postoperative day 10 ± 2, defined as deep vein thrombosis detected by mandatory bilateral venography, documented symptomatic deep vein thrombosis and/or documented symptomatic pulmonary embolism. The primary safety endpoint was major bleeding. Eighty-seven percent of all randomized patients (333 of 381 patients) were evaluable for efficacy. The incidence of venous thromboembolism was 32.1% (53 of 165 patients) in the bemiparin group and 36.9% (62 of 168 patients) in the enoxaparin group. The absolute risk difference was 4.8% in favor of bemiparin [95% confidence interval (CI), −15.1% to 5.6%; non-inferiority P -value: 0.02; superiority P -value: 0.36]. The incidence of proximal deep vein thrombosis was 1.8% (three of 165 patients) in the bemiparin group and 4.2% (seven of 168 patients) in the enoxaparin group. Major bleeding occurred in six patients (three in each group). There were no deaths during the study. This trial shows that bemiparin started postoperatively is as effective and safe as enoxaparin started preoperatively in the prevention of venous thromboembolism in patients undergoing total knee replacement.     

The direct thrombin inhibitor melagatran followed by oral ximelagatran compared with enoxaparin for the prevention of venous thromboembolism after total hip or knee replacement: the EXPRESS study

Summary.  Background : Ximelagatran and its subcutaneous (s.c.) form melagatran are novel direct thrombin inhibitors for the prevention and treatment of thromboembolic disease. Methods : In a double-blind study, 2835 consecutive patients undergoing total hip or knee replacement were randomized to either melagatran/ximelagatran or enoxaparin. Melagatran 2 mg was started immediately before surgery; 3 mg was then administered postoperatively, followed by 24 mg of oral ximelagatran b.i.d. beginning the next day. Enoxaparin 40 mg, administered subcutaneously o.d., was started 12 h before surgery. Both treatments were continued for 8–11 days. The main efficacy outcome measures were major venous thromboembolism (VTE); [proximal deep vein thrombosis (DVT), non-fatal and/or fatal pulmonary embolism (PE), death where PE could not be ruled out], and total VTE (proximal and distal DVT; PE; death from all causes). DVT was detected by mandatory bilateral ascending venography at the end of the treatment period or earlier if clinically suspected. The main safety outcome was bleeding. Results : The rates of major and total VTE were significantly lower in the melagatran/ximelagatran group compared with the enoxaparin group (2.3% vs. 6.3%, P  = 0.0000018; and 20.3% vs. 26.6%, P  < 0.0004, respectively). Fatal bleeding, critical site bleeding and bleeding requiring reoperation did not differ between the two groups. 'Excessive bleeding as judged by the investigator' was more frequent with melagatran/ximelagatran than with enoxaparin. Conclusions : In patients undergoing total hip or knee replacement, preoperatively initiated s.c. melagatran followed by oral ximelagatran was significantly more effective in preventing VTE than preoperatively initiated s.c. enoxaparin.     

疏血通联合依诺肝素治疗髋关节置换术后下肢深静脉血栓的疗效及其对凝血功能的影响

目的探讨疏血通注射液联合依诺肝素预防老年髋关节置换术后下肢深静脉血栓(DVT)形成疗效及对患者凝血功能的影响。方法选取2014年1月至2015年12月于本院接受髋关节置换术治疗的老年患者共80例作为研究对象,按照入院先后顺序分为对照组40例和观察组40例。常规治疗基础上,对照组患者给予依诺肝素治疗,而观察组在对照组基础上联合给予疏血通注射液治疗。术后3周,比较组间DVT发生率、凝血功能指标及不良反应发生情况。结果术后3周,观察组和对照组患者DVT发生率分别为5.0%和20.0%,组间比较差异具有统计学意义(P0.05),且观察组和对照组活化部分凝血活酶时间(APTT)、凝血酶原时间(PT)、凝血酶时间(TT)等凝血功能指标时间组间比较差异均无统计学意义[(27.4±6.5)s vs.(28.5±7.6)s,(12.6±2.7)s vs.(12.8±2.5)s,(18.3±4.0)s vs.(18.1±3.8)s,P0.05]。治疗过程中,无严重不良反应病例,观察组患者不良反应发生率为12.5%,与对照组患者不良反应发生率(10.0%)比较,差异无统计学意义(P0.05)。结论疏血通注射液联合依诺肝素能够有效预防老年髋关节置换术后下肢DVT形成,降低DVT发生率,且对凝血功能无明显影响,不良反应轻微,临床上值得进一步研究。     

Impact of stage 3B chronic kidney disease on thrombosis and bleeding outcomes after orthopedic surgery in patients treated with desirudin or enoxaparin: insights from a randomized trial

Summary. Background: Venous thromboembolism (VTE) remains a significant complication of major orthopedic surgery, and chronic kidney disease (CKD) is common among elderly patients undergoing total hip replacement (THR). Objectives: The purpose of this study was to evaluate thrombosis and bleeding outcomes in patients with stage 3B CKD treated with either desirudin or enoxaparin after elective THR. Patients/Methods: This was a post hoc subgroup analysis of a randomized, multicenter, double‐blind study of desirudin vs. enoxaparin in patients undergoing elective THR. Results: Patients received either subcutaneous desirudin 15 mg twice daily or subcutaneous enoxaparin 40 mg once daily. Of the 2078 randomized patients who received study medication, 577 had stage 3B CKD or worse (27.8%), and the proportion of these patients who experienced a major VTE in the enoxaparin treatment group was found to be much higher than in the desirudin treatment group (11.1% vs. 3.4%, model‐adjusted odds ratio 3.52, 95% confidence interval 1.48–8.40, P = 0.004). There was no statistically significant difference between treatment groups in terms of rates of major bleeding, regardless of stage of renal function. Conclusions: CKD has been reported previously to increase the risk of bleeding with anticoagulants, and these findings suggest that CKD may also increase the risk of major VTE for patients treated with enoxaparin, but not for patients treated with desirudin. Clinicians should consider the impact of CKD on the risk of VTE when choosing a prophylaxis agent.     

Gait in the early days after total knee and hip arthroplasty: a comparison

Purpose. To evaluate whether gait after Total Knee Arthroplasty (TKA) is different from gait after Total Hip Arthroplasty (THA) in the early days following surgical intervention.

Method. The gait was studied in water, thus exploiting its buoyancy force. Twenty consecutive patients underwent TKA and twenty consecutive patients underwent THA. The mean age was 70.2 years (SD 6.9). Twenty age-matched volunteers were the control group.

Results. At the beginning TKA and THA patients had the same speed and the same step length. At day 15 there was a speed difference in favour of THA patients (t = - 2.245, df 38, p = 0.031). Likewise, the step length was longer in THA patients (t = -2.293 df 38, p = 0.027). In contrast to TKA patients, THA patients were unbalanced, having a longer stance phase on the non-operated leg and a longer swing on the contralateral one.

Conclusions. Gait strategies were completely different after TKA and THA interventions. TKA patients were balanced over their feet and they appeared more cautious and more concerned about gait quality than moving quickly. By contrast, THA patients were unbalanced, having a longer stance phase on the non-operated leg and a longer swing on the contralateral one. However, their speed gain was higher.     

Gait in the early days after total knee and hip arthroplasty: A comparison

Purpose.?To evaluate whether gait after Total Knee Arthroplasty (TKA) is different from gait after Total Hip Arthroplasty (THA) in the early days following surgical intervention.

Method.?The gait was studied in water, thus exploiting its buoyancy force. Twenty consecutive patients underwent TKA and twenty consecutive patients underwent THA. The mean age was 70.2 years (SD 6.9). Twenty age-matched volunteers were the control group.

Results.?At the beginning TKA and THA patients had the same speed and the same step length. At day 15 there was a speed difference in favour of THA patients (t = ? 2.245, df 38, p = 0.031). Likewise, the step length was longer in THA patients (t = ?2.293 df 38, p = 0.027). In contrast to TKA patients, THA patients were unbalanced, having a longer stance phase on the non-operated leg and a longer swing on the contralateral one.

Conclusions.?Gait strategies were completely different after TKA and THA interventions. TKA patients were balanced over their feet and they appeared more cautious and more concerned about gait quality than moving quickly. By contrast, THA patients were unbalanced, having a longer stance phase on the non-operated leg and a longer swing on the contralateral one. However, their speed gain was higher.     

Post-operative anxiety and depression levels in orthopaedic surgery: a study of 56 patients undergoing hip or knee arthroplasty

Objective  To investigate the presence and rates of anxiety and depression in postsurgical patients.
Methods  The Hospital Anxiety and Depression Scale was used to measure anxiety and depression levels. Patients completed the questionnaire on the day prior to surgery, then on each post-operative day up to and including their day of discharge. Statistical analysis using logistic regression was performed to determine whether any variables were risk factors for developing anxiety or depression. Fifty-six patients undergoing lower limb arthroplasty agreed to take part.
Results  Post-operatively 17 patients became anxious prior to discharge. No variables were significant predictors of anxiety. Post-operatively 28 subjects (50%) became depressed at some point prior to discharge. Females were more likely to become depressed than males odds ratio (OR) = 3.48 [95% confidence interval (CI) 1.01–11.88]. Those who had had a previous lower limb arthroplasty were more likely to develop post-operative depression, OR = 3.92 (95% CI 1.05–14.6). Site of operation was not found to be significant, OR = 0.67 (95% CI 0.20–2.22). Age and anaesthetic method were not predictive of depression. The mean time point for development of depression was 2.43 days (SD = 1.40 days) and the time of deepest depression was 2.93 days (SD = 1.72 days). The mean length of depression was 1.93 days (SD = 1.21 days). The mean length of stay for depressed patients was 5 days (SD = 1.72), compared with 4 days for the non-depressed patients (SD = 1.62 days).
Conclusion  The results suggest that post-operative depression does occur in orthopaedic surgery. The prevalence may be higher than that reported in other surgical specialities. These findings emphasize the need for evaluation of patients' psychiatric state post-operatively.     

The novel association between red complex of oral microbe and body mass index in healthy Japanese: a population based cross-sectional study

Microbiota has been thought to be one of important environmental factors for obesity or Type 2 diabetes mellitus. Among oral microbe, Porphyromonas gingivalis, Treponema denticola and Tannellera forsythia are known as risk factors, so called red complex, for periodontitis. Red complex could also be a risk factor for obesity. However, recent study indicated that obesity was not improved by periodontal therapy. Thus, we performed a cross sectional study to reveal the association of oral microbe with body mass index in a healthy population. Healthy individuals were randomly recruited. The infections of oral microbe were identified by Taqman polymerase chain reaction. The relationships between number of red complex and body mass index or waist circumference were analyzed. Two hundred and twenty-two apparently healthy Japanese were enrolled. BMI and waist circumference as well as age, periodontitis, number of brushing teeth were significantly associated with the number of red complex after adjusting covariance. The effect size of body mass index or waist circumference was 0.023 (p = 0.028) or 0.024 (p = 0.024), respectively. Body mass index and waist circumference were independently associated with the number of red complex among apparently healthy Japanese. The current observation implies the possibility that oral microbe was associated with obesity in healthy population.     

Comparison of efficacy and safety of different tourniquet applications in total knee arthroplasty: a network meta-analysis of randomized controlled trials

ObjectiveTotal knee replacement (TKA) is an effective way to treat teratogenic and disabling knee diseases such as advanced osteoarthritis. Tourniquets are often used in TKA to reduce bleeding and to get a better visualization of the surgical field, while it is related to safety concerns. We did this network meta-analysis to comprehensively compare the efficacy and safety of various tourniquet application strategies.MethodPubMed, Embase, Cochrane Library, CNKI, and WanFang Database were systematically searched from January 1990 to May 2020. A network meta-analysis with a frequentist framework was done to assess the relative efficacy and safety by comparing seven clinical important endpoints.Results38 eligible studies that assessed 3007 participants who underwent TKA were included in this network meta-analysis. Tourniquet inflation before osteotomy then deflation after wound closure effectively reduce perioperative bleeding (WMD compared with control group −234.66, 95% CI [–409.19 to −60.13]), while shortening the operation time (WMD −8.98, 95%CI [–14.07 to −3.88]) and reducing postoperative complications, including DVT (OR −0.58, 95%CI [–1.19 to 0.03]) and minor wound complications (OR −1.38, 95%CI [–3.00 to 0.25]). No difference was found in the late postoperative knee pain and function outcomes.ConclusionsUsing tourniquets during the entire operation can effectively reduce blood loss, but it also can cause many safety problems, including DVTs, wound oozing, delayed healing, and serious wound complications. Tourniquet inflation before osteotomy then deflation after wound closure effectively can reduce perioperative bleeding while shortening the operation time and reducing postoperative complications, so it could be the ideal tourniquet application strategy in TKA.

Key messages

• This is the first study that comprehensively compared different tourniquet application strategies to evaluate their impact on postoperative recovery following TKA, and five clinically important endpoints were assessed in this study: perioperative blood loss, operation time, postoperative pain and function, and complications.
• We conclude that tourniquet inflation before osteotomy then deflation after wound closure could be the ideal tourniquet application strategy in TKA.

     

Effective exercise intervention period for improving body function or activity in patients with knee osteoarthritis undergoing total knee arthroplasty: a systematic review and meta-analysis

Background

Various systematic reviews and/or meta-analyses examining the effects of pre- or postoperative exercise on body function or activity in patients undergoing total knee arthroplasty (TKA) have been published. However, the interventional period needed to at least improve outcomes is unknown.

Limitations in activities in patients with osteoarthritis of the hip or knee: The relationship with body functions,comorbidity and cognitive functioning

Purpose. To determine the relationship between body functions, comorbidity and cognitive functioning on the one side and limitations in activities on the other, in elderly patients with osteoarthritis (OA) of the hip or knee.

Method. A cross-sectional cohort study was conducted in which 288 patients with hip or knee OA were included. Patients were recruited from rehabilitation centres and hospitals (Departments of Orthopedics, Rheumatology or Rehabilitation). Apart from demographic and clinical data, information about limitations in activities, body functions (pain, muscle strength, range of joint motion), comorbidity and cognitive functioning was collected by questionnaires and tests. Statistical analyses included univariate and stepwise multivariate regression analysis.

Results. Self-reported limitations in activities (Western Ontario and McMaster Universities Osteoarthritis Index) were significantly associated with pain, muscle strength knee extension, range of motion (ROM) hip flexion and morbidity count. Performance-based limitations in activities (timed walking test) were significantly associated with ROM (knee flexion, hip flexion and knee extension), muscle strength hip abduction, pain, cognitive functioning and age.

Conclusions. Self-reported limitations in activities in hip or knee OA are largely dependent on pain and to a lesser extent on range of joint motion, muscle strength and comorbidity. Performance-based limitations in activities are largely dependent on range of joint motion and muscle strength, and to a lesser extent on pain, cognitive functioning and other factors. These findings point to the role of body functions in limitations in activities in OA of the hip or knee. Although less important, comorbidity and cognitive functioning play a role as well.     

Causal association pathways between fetuin-A and kidney function: a mediation analysis

ObjectiveBody mass index (BMI), uric acid, diabetes mellitus, and hypertension are risk factors for reduced kidney function and are associated with fetuin-A levels, but their causal pathways remain unclear. The objective of this study was to investigate this knowledge gap.MethodsA repeated cross-sectional design was used to assess causal pathway effects of fetuin-A on the estimated glomerular filtration rate (eGFR), which is mediated through BMI, uric acid, diabetes mellitus, and hypertension.ResultsAmong 2305 participants, the mean eGFR at baseline decreased from 98.7 ± 23.6 mL/minute/1.73 m² in 2009 to 92.4 ± 22.9 mL/minute/1.73 m² in 2014. Fetuin-A was significantly associated with eGFR , suggesting that increasing fetuin-A levels predict a decrease in eGFR. Additionally, the indirect effect of fetuin-A on eGFR, as assessed through BMI, was also significant. The effects of fetuin-A on eGFR through other mediation pathways showed variable results.ConclusionsOur study revealed a possible role of fetuin-A in the etiology of declining renal function through mediating body mass index, uric acid, diabetes mellitus, and hypertension via complex causal pathways. Further studies to clarify these mediated effects are recommended.     

The effect of prehabilitation on the range of motion and functional outcomes in patients following the total knee or hip arthroplasty: A pilot randomized trial

Objective: The study investigated the effect of prehabilitation on the quality of life and function in patients having total knee replacement (TKR)/total hip replacement (THR). Methods: A pilot randomized controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis was conducted. Sixty-four people undergoing elective lower-limb arthroplasty were included. Prehabilitation included one-hour twice-weekly sessions for at least three and a maximum of four weeks prior to surgery. Control participants did not complete any pre-surgical programs. Health utility and quality of life as measured by the EQ-5D-3L and the patient-specific functional scale were the primary outcomes measured before allocation and eight weeks post-operatively. Results: No between-group differences were evident in health utility (main effect of the group ?0.04 (95% Confidence Interval [CI] ?0.16 to 0.08, p = 0.50) or patient-specific functional scale (main effect of the group ?0.59 (95% CI ?1.8 to 0.6, p = 0.73), but the group-by-joint interaction effects for the timed up and go (TUG) (7.6 (95% CI ?0.9 to 16.1, p = 0.08)) and the EQ-5D VAS (?18.3 (95% CI ?41.1 to 4.5), p = 0.11) were larger. Prehabilitation participants’ knee flexion improved by 12.6 degrees (95% CI 5.2–20, p = 0.001). Conclusions: Prehabilitation improved knee flexion, but this did not translate into improved functional mobility or quality of life.     

Efficacy and safety of prolonged-release hyaluronic acid derivative vaginal application in the postpartum period: a prospective randomised clinical trial

IntroductionIn puerperium, the hypoestrogenic state induced by delivery and subsequently sustained by lactation may lead to vaginal dryness, burning, and itching sensation, contributing to the onset of sexual dysfunction.Material and methodsThis was a prospective, randomized, controlled, open-label study (NCT04560283) for evaluating the effects of application of a prolonged-release hyaluronic acid derivative vaginal gel in restoring sexual function during the postpartum period. Eighty-five patients were randomized to apply prolonged-release Hydeal-D 0.2% vaginal gel (Fidia Farmaceutici, Abano Terme, Italy; n = 43) every three days for 12 consecutive weeks or expectant management (n = 42).ResultsWomen undergoing treatment had a more elevate increase in Female Sexual Function Index (FSFI) total score (+15.1 ± 11.9 vs +6.5 ± 8.9, p < 0.001) and a higher decrease in vaginal pH (−1.2 ± 0.7 vs −0.2 ± 1.1; p < 0.001). Moreover, the proportion of vaginal smears with maturation index (VMI) >65 was significantly higher in patients treated (80.6% vs 35.3%; p = 0.004). Edinburgh Postnatal Depression Scale (EPDS) decreased significantly in both groups with no inter-group difference (p = 0.459). Only two cases (4.8%) of moderate vaginal burning sensation were reported in patients undergoing local vaginal therapy.ConclusionsThe results of our study demonstrated that hyaluronic acid derivative vaginal gel (Hydeal-D) was able to improve sexual function of puerperal women in the short-term treatment.

KEY MESSAGE

• In the puerperium, the hypoestrogenic state induced by delivery and subsequently sustained by lactation may lead to vaginal dryness, burning, and itching sensation, contributing to the onset of sexual dysfunction.
• Hydeal-D is a prolonged-release hyaluronic acid derivative characterised by elevated resistance to enzymatic breakdown. During puerperium, its local application may improve the vaginal microenvironment by ensuring a better migration and proliferation of cells involved in local tissue repair.
• Among puerperal women, Hydeal-D vaginal gel causes a significant improvement of sexual function, including desire, arousal, and lubrification, compared to expectant management. Furthermore, it leads to a decrease in vaginal pH and an increase of the trophic status of vaginal epithelium.

     

祛伤灵一方预防髋部骨折术后下肢深静脉栓塞的临床观察

目的：验证中药汤剂祛伤灵一方预防髋部骨折术后下肢深静脉栓塞发生的疗效、探讨用药的安全性。 方法：将80例患者随机分两组,治疗组口服中药汤剂祛伤灵一方,每日一剂分两次服;对照组口服利伐沙班片,10mg每次每天1次,观察两组术前、术后第7、14天患肢肿胀情况,检测术后血清凝血酶原时间、活化部分凝血活酶时间和D一二聚体水平（第7、14天）,检查是否发生静脉血栓（术后第7天）。 结果：1,深静脉血栓发生率比较：用药后第7天两组DVT发生率比较,差异无显著性差异(P＞0．05);2,两组实验室检查指标比较（凝血酶原时间、活化部分凝血活酶时间和D一二聚体）：两组用药后7天和第14天血浆指标浓度变化比较,差异无显著性差异(P>0．05);3,血肿和瘀斑的发生率：两组患者治疗全过程中发生率无显著性差异(P>0．05) 结论：祛伤灵一方可以取得与对照组利伐沙班组相当的预防深静脉栓塞的作用,并且两组在用药安全方面没有显著性差异。