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简介：目的：观察推拿在全髋关节置换术后康复治疗中的临床疗效。方法：将60例患者随机分成治疗组和对照组。治疗组30例进行推拿结合康复治疗，对照组30例进行单纯康复治疗。两组均治疗2星期。分别观察两组患者术后7天、术后2星期、术后6星期的改良人工髋关节Harris量表及汉密尔顿焦虑量表（HamiltonAnxietyRatingScale，HAMA）。结果：Harris量表评分总分，两组组内患者不同时间点多重比较差异有统计学意义（P〈0．05）；术后1天、术后7天及术后6星期两组间比较，差畀均无统计学意义（A，0．05）；术后2星期两组间比较差异有统计学意义（P〈0．05）。HAMA量表两组组内患者不同时间点多重比较差异有统计学意义（P〈0．05）；术后1天两纽间评分无显著性差异（P〉0．05）；术后7天、术后2星期、术后6星期两组间评分均有显著性差异（P〈0．05）。结论：单位时间内，推拿结合康复治疗对全髋关节置换术后患者的疼痛、关节活动范围及焦虑等方面的改善作用优于单纯康复治疗。

简介：AbstractImportance:Recurrent respiratory tract infection (RRTI) is common in children. Inappropriate RRTI treatment will lead to asthma and other diseases, thereby seriously affecting the growth and physical health of children. Immune function modulation can prevent and alleviate childhood RRTI. Yupingfeng (YPF), a patented traditional Chinese medicine (TCM), has immunomodulatory effects and is widely used in China to treat children with RRTI.Objective:To evaluate the safety and efficacy of YPF monotherapy in treating children with RRTI.Methods:This multicenter, randomized, double-blind, double-simulation, noninferiority clinical trial was conducted from January 2015 to August 2017, with an 8-week treatment period and 52-week follow-up after the drug withdrawal. Children aged 2–6 years with RRTI meeting the inclusion and exclusion criteria were enrolled in 13 hospitals in China and divided randomly into three groups (2:2:1 ratio) to receive YPF, pidotimod, or placebo. The primary outcome was the proportion of RRTI returning to normal standard level during the follow-up. The secondary outcomes were reduction in the number of RRTI recurrences, effect on clinical symptoms (in accord with TCM practice), effect per symptom, and safety. The trial was registered at the Chinese Clinical Trials Registry (www.chictr.org.cn) under the unique identifier ChiCTR-IPR-15006847.Results:Three hundred and fifty-one children were enrolled and randomly assigned to 3 groups; 124, 125, and 61 children in the YPF, pidotimod, and placebo groups, respectively, had completed the trial. During the follow-up, the proportion of RRTI returning to normal standard level was 73.13%, 67.15%, and 38.81% with YPF, pidotimod, and placebo, respectively (P < 0.0001). The proportion of cases who returned to normal standard level in the YPF group was 34.32% higher than that in the placebo group. The safety profile did not significantly differ among the groups.Interpretation:YPF granules were noninferior to the active control drug pidotimod oral solution for the treatment of RRTI in children, and were superior to placebo, with a high safety profile.

简介：客观：观察膜dialyzer在临床的维护hemodialysis(MHD)由长期的肾的失败病人使用了的polyethersulfone的安全和功效。方法：从1月到2009年2月，36个病人从加盟上海JiaoTong的新华医院被招募大学医学院。实验被人种的委员会同意，新华医院并且在从病人的权限下面。所有病人被使随机化进polyethersulfone组(足，n=18)并且polysulfone组(PS，n=18)。Hemodialysis被使用Fresenius4008S给控制能力的dialyser和极端净化酸式碳酸盐透析液，超过3.5h每次，三次每星期，由肝磷脂antieoagulation列在后面一个星期，三次完全。在血脲氮(甜面包)的变化，浆液creatinine(Scr)，磷酸盐(P2+)，血红素和白朊层次为功效和安全评估被决定。结果：显著地与不同dialyzers在hemodialysis以后减少的浆液甜面包，Scr和P2+集中，和二个组的减少振幅是相等的(P>0.05)。浆液甜面包和重量的单位的清理率没在二个组之中有重要差别(P>0.05)。浆液P2+的清理率(ml/min)是144.57

简介：因为输精管切除术的不可避免的复杂并发症，这研究被承担与一个微型外科的方法与没有解剖刀输精管切除术(NSV)相比植入进管腔的一台nonobstructiveintravas设备(IVD)估计男消毒的功效和安全。IVD被分成二种类型：而，IVD-B让一条尾巴使用了修理到管deferens(固定翅膀)IVD--A不做。multicenter未来的使随机化的控制临床的审判在中国被进行。学习由寻求输精管切除术的1459个男志愿者组成随机被分到IVD--一(n=487)，IVD-B(n=485)或NSV(n=487)组并且经历了操作。包括的后续在3rd-6th和12th手术后的月。对这些题目的评价包含了常规物理考试(包括的将军和andrological考试)和精液分析。subjects’；搭挡们也经历了监视因为由月刊的怀孕关于月经会见，如果必要，尿测试。处于怀孕率没有重要差别(0.65%为IVD--一，0为IVD-B并且0.21%为NSV)在三个组之中(P>；0.05)。在12th手术后的月分别地在三个组是零，0.9%和1.7%。在结论，IVD男消毒展出长期的不利事件的低风险并且被发现作为一个男消毒方法有效，类似于NSV技术。IVD男消毒被期望是一个新奇避孕方法。

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简介：摘要ObjectiveTo identify the effects of rTMS intervention on PSCI patients and its potential neural correlates to behavioral improvements.MethodsWe recruited 34 PSCI patients for 20 sessions of 10 Hz rTMS or no-stim control treatments over the left dorsal lateral prefrontal cortex (DLPFC). Cognitive function was evaluated with the Montreal Cognitive Assessment Scale, Victoria Stroop Test, Rivermead Behavior Memory Test, and Activities of Daily Living (ADL) assessed with the Modified Barthel Index. 14 patients received functional MRI scan, a useful non-invasive technique of determining how structurally segregated and functionally specialized brain areas were interconnected, which was reflected by blood oxygenation level-dependent signals. The amplitude of low-frequency fluctuation (ALFF) and functional connectivity (FC) were applied as the analytical approaches, which were used to measure the resting-state brain activity and functional connection.ResultsrTMS improved cognitive functions and ADLs for PSCI patients relative to patients who received no-stim control treatment. The cognitive improvements correlated to increased ALFF of the left medial prefrontal cortex, and increased FC of right medial prefrontal cortex and right ventral anterior cingulate cortex.Conclusions10 Hz rTMS at DLPFC could improve cognitive function and quality of life for PSCI patients, which is associated with an altered frontal cortical activity.

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简介：AbstractObjective:To investigate the effect of early versus late amniotomy after induction of labor (IOL) with vaginally administered misoprostol.Methods:This randomized clinical trial was conducted at the Department of Obstetrics and Gynecology, Menoufia University, from May 2019 to March 2020, and included 120 nulliparous women at term (≥ 37 weeks’ gestation) undergoing IOL. Computer-generated randomization was used to randomize the participants into either the early amniotomy group (3 cm cervical dilatation; n = 60) or the late amniotomy group (7 cm cervical dilatation; n = 60). All participants received misoprostol (25 µg) vaginally to induce labor. The primary outcome was the induction-to-delivery interval, defined as the time from the initiation of IOL to the time of delivery.Results:Women in the early amniotomy group had a shorter duration of labor (12.60 ± 5.36 h) than those in the late amniotomy group (16.67 ± 7.26 h). The mean time from rupture of the fetal membrane to delivery was significantly shorter in the late (2.51 ± 0.36 h) than in the early amniotomy group (3.1 ± 0.89 h). There was no statistically significant difference between the groups in terms of maternal complications (fever, nausea, vomiting, and uterine hyperstimulation) or neonatal complications (meconium-stained liquor, APGAR score <7 at 1 and 5 min, and neonatal intensive care unit admission).Conclusions:IOL using vaginally administered misoprostol followed by early amniotomy was accompanied by a shorter duration of labor and decreased use of oxytocin. There was no significant difference between the early and late amniotomy groups in terms of the rate of cesarean section or maternal and neonatal complications.

简介：AbstractBackground:As a non-invasive and effective diagnostic method for small intestinal bacterial overgrowth (SIBO), wild-use of breath test (BT) has demonstrated a high comorbidity rate in patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and SIBO. Patients overlapping with SIBO respond better to rifaximin therapy than those with IBS-D only. Gut microbiota plays a critical role in both of these two diseases. We aimed to determine the microbial difference between IBS-D overlapping with/without SIBO, and to study the underlying mechanism of its sensitivity to rifaximin.Methods:Patients with IBS-D were categorized as BT-negative (IBSN) and BT-positive (IBSP). Healthy volunteers (BT-negative) were enrolled as healthy control. The patients were clinically evaluated before and after rifaximin treatment (0.4 g bid, 4 weeks). Blood, intestine, and stool samples were collected for cytokine assessment and gut microbial analyses.Results:Clinical complaints and microbial abundance were significantly higher in IBSP than in IBSN. In contrast, severe systemic inflammation and more active bacterial invasion function that were associated with enrichment of opportunistic pathogens were seen in IBSN. The symptoms of IBSP patients were relieved in different degrees after therapy, but the symptoms of IBSN rarely changed. We also found that the presence of IBSN-enriched genera (Enterobacter and Enterococcus) are unaffected by rifaximin therapy.Conclusions:IBS-D patients overlapping with SIBO showed noticeably different fecal microbial composition and function compared with IBS-D only. The better response to rifaximin in those comorbid patients might associate with their different gut microbiota, which suggests that BT is necessary before IBS-D diagnosis and use of rifaximin.Registration:Chinese Clinical Trial Registry, ChiCTR1800017911.

简介：AbstractBackground:Nitinol-containing devices are widely used in clinical practice. However, there are concerns about nickel release after nitinol-containing device implantation. This study aimed to compare the efficacy and safety of a parylene-coated occluder vs. a traditional nitinol-containing device for atrial septal defect (ASD).Methods:One-hundred-and-eight patients with ASD were prospectively enrolled and randomly assigned to either the trial group to receive a parylene-coated occluder (n = 54) or the control group to receive a traditional occluder (n = 54). The plugging success rate at 6 months after device implantation and the pre- and post-implantation serum nickel levels were compared between the two groups. A non-inferiority design was used to prove that the therapeutic effect of the parylene-coated device was non-inferior to that of the traditional device. The Cochran-Mantel-Haenszel chi-squared test with adjustment for central effects was used for the comparison between groups.Results:At 6 months after implantation, successful ASD closure was achieved in 52 of 53 patients (98.11%) in both the trial and control groups (95% confidence interval (CI): [-4.90, 5.16]) based on per-protocol set analysis. The absolute value of the lower limit of the 95% CI was 4.90%, which was less than the specified non-inferiority margin of 8%. No deaths or severe complications occurred during 6 months of follow-up. The serum nickel levels were significantly increased at 2 weeks and reached the maximum value at 1 month after implantation in the control group (P < 0.05 vs. baseline). In the trial group, there was no significant difference in the serum nickel level before vs. after device implantation (P > 0.05).Conclusions:The efficacy of a parylene-coated ASD occluder is non-inferior to that of a traditional uncoated ASD occluder. The parylene-coated occluder prevents nickel release after device implantation and may be an alternative for ASD, especially in patients with a nickel allergy.

简介：AbstractBackground:Treatment of coronary bifurcation lesions remains challenging; a simple strategy has been preferred as of late, but the disadvantage is ostium stenosis or even occlusion of the side branch (SB). Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported. This prospective, multicenter, randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon (PEB) compared with regular balloon angioplasty (BA) in the treatment of non-left main coronary artery bifurcation lesions.Methods:Between December 2014 and November 2015, a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers. Patients were randomly allocated at a 1:1 ratio to a PEB group (n = 113) and a BA group (n = 109). The primary efficacy endpoint was angiographic target lesion stenosis at 9 months. Secondary efficacy and safety endpoints included target lesion revascularization, target vessel revascularization, target lesion failure, major adverse cardiac and cerebral events (MACCEs), all-cause death, cardiac death, non-fatal myocardial infarction, and thrombosis in target lesions. The main analyses performed in this clinical trial included case shedding analysis, base-value equilibrium analysis, effectiveness analysis, and safety analysis. SAS version 9.4 was used for the statistical analyses.Results:At the 9-month angiographic follow-up, the difference in the primary efficacy endpoint of target lesion stenosis between the PEB (28.7% ± 18.7%) and BA groups (40.0% ± 19.0%) was -11.3% (95% confidence interval: -16.3% to -6.3%, Psuperiority <0.0001) in the intention-to-treat analysis, and similar results were recorded in the per-protocol analysis, demonstrating the superiority of PEB to BA. Late lumen loss was significantly lower in the PEB group than in the BA group (-0.06 ± 0.32 vs. 0.18 ± 0.34 mm, P < 0.0001). For intention-to-treat, there were no significant differences between PEB and BA in the 9-month percentages of MACCEs (0.9% vs. 3.7%, P = 0.16) or non-fatal myocardial infarctions (0 vs. 0.9%, P = 0.49). There were no clinical events of target lesion revascularization, target vessel revascularization, target lesion failure, all-cause death, cardiac death or target lesion thrombosis in either group.Conclusions:In de novo non-left main coronary artery bifurcations treated with provisional T stenting, SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis.Trial registration:ClinicalTrials.gov, NCT02325817; https://clinicaltrials.gov

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简介：AbstractBackground:Preliminary studies have indicated that Shexiang Baoxin Pill (MUSKARDIA) has a coronary artery dilation effect and increases the coronary blood flow, relieving the symptoms of angina. This study aimed to evaluate the benefit of MUSKARDIA on patients with stable coronary artery disease (CAD) and diabetes mellitus (DM).Methods:This was a subgroup analysis of a multicenter, randomized, placebo-controlled phase IV trial. CAD patients with a medical history of DM or baseline fasting blood glucose (FBG) ≥7.0 mmol/L were grouped according to the treatment (standard therapy plus MUSKARDIA or placebo). The primary outcome was major adverse cardiovascular events (MACEs), which was the composite outcome of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. The secondary outcome was the composite outcome of all-cause death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina or heart failure, and coronary angioplasty.Results:MACEs occurred in 2.6% (9/340) and 4.8% (18/376) of patients in the MUSKARDIA and placebo groups, respectively (P = 0.192). Secondary composite outcome was significantly less frequent with MUSKARDIA than with placebo (15.3% [52/340] vs. 22.6% [85/376], P = 0.017). Risk of MACEs (hazard ratio [HR] = 0.69, 95% confidence interval [CI]: 0.31-1.57) was comparable between two groups. In patients with uncontrolled DM (≥4 measurements of FBG ≥7 mmol/L in five times of follow-up), the risk of secondary outcome was significantly lower with MUSKARDIA (5/83, 6.0%) than with placebo (15/91, 16.5%) (HR= 0.35, 95%CI: 0.13-0.95).Conclusion:As an add-on to standard therapy, MUSKARDIA shows a trend of reduced MACEs in patients with stable CAD and DM. Furthermore, MUSKARDIA may reduce the frequency of all-cause death, hospitalization, and coronary angioplasty in this population, especially in those with uncontrolled DM.Trial Registration:ChiCTR.org.cn, ChiCTR-TRC-12003513

简介：摘要PurposeTo evaluate the efficacy and safety of radial extracorporeal shock wave therapy (rESWT) according to total number of pulses on hamstring muscle spasticity in children with spastic type cerebral palsy (CP)．MethodsThis study is a randomized controlled trial consisting of thirteen patients with spastic CP, 9 males and 4 females, aged 5 to 14 years (mean age 9.2). Twenty-five spastic hamstring muscles were divided in four groups. Group I: 500 pulses, Group II: 1，000 pulses, Group III: 1，500 pulses, and Group IV: 2，000 pulses. Australian Spasticity Assessment Scale (ASAS) was measured at four different time points (pre-ESWT, post-ESWT, 2 weeks post-ESWT, and 4 weeks post-ESWT)．ResultsAll four groups showed improvement in ASAS relative to pre-treatment, although only significant in Group III (1，500 pulses). There were no statistically significant differences in ASAS between all four groups in pre-ESWT [|2(2)＝3.907, P＝0.272], immediately post-ESWT [|2(2)＝1.250, P＝0.741], 2 weeks post-ESWT vs pre-ESWT [|2(2)＝3.367, P＝0.338], and 4 weeks post-ESWT vs pre-ESWT [|2(2)＝1.566, P＝0.667]．ConclusionThe effect of rESWT on spastic hamstring in children with spastic CP is not dependent on the number of pulses.

简介：AbstractObjective:Various techniques are proposed for changing fetal presentation. We aimed to assess the effect of BL67 point stimulation on correcting breech presentation and natural delivery in women at 36-38 gestational weeks.Methods:A parallel single blinded randomized clinical trial was conducted on 72 eligible pregnant women with breech presentation at the 36 weeks of pregnancy. The subjects were divided into two groups - intervention (n = 36) and control groups (n = 36) by block randomization method. The intervention group stimulated the BL67 point by self-administration for 20 min once a day for 2 weeks. Finally, the appearance of cephalic presentation and rate of vaginal delivery was compared between the groups (n1 = n2 = 32) using the Chi-square test and multivariate logistic regression.Results:The correction of breech to cephalic presentation occurred in 53.1% of patients in the intervention group. The adjusted relative risk (RR) for fetal correction from breech to cephalic was 1.80 (RR = 1.80, 95% confidence interval [CI], 1.13-5.17). It was shown that the stimulation of the BL67 point increased the correction of breech to cephalic presentation. In addition, the rate of vaginal delivery increased by >4-fold (RR = 4.16, 95% CI, 2.54-6.82) by correction to cephalic presentation. Moreover, 65.6% of mothers in intervention group and 90.6% in the control group underwent cesarean section.Conclusions:The stimulation of the BL67 point is a safe, inexpensive, and effective method that can be self-administered at home for fetal correction from breech to cephalic presentation in women with breech presentations during 36-38 gestational weeks. This promotes uncomplicated natural childbirth.

简介：AbstractBackground:The Shexiang Baoxin Pill (MUSKARDIA) has been used for treating coronary artery disease (CAD) and angina for more than 30 years in China. Nevertheless, methodologically sound trials on the use of MUSKARDIA in CAD patients are scarce. The aim of the study is to determine the effects of MUSKARDIA as an add-on to optimal medical therapy (OMT) in patients with stable CAD.Methods:A total of 2674 participants with stable CAD from 97 hospitals in China were randomized 1:1 to a MUSKARDIA or placebo group for 24 months. Both groups received OMT according to local tertiary hospital protocols. The primary outcome was the occurrence of a major adverse cardiovascular event (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal stroke. Secondary outcomes included all-cause mortality, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or heart failure, peripheral revascularization, angina stability and angina frequency.Results:In all, 99.7% of the patients were treated with aspirin and 93.0% with statin. After 2 years of treatment, the occurrence of MACEs was reduced by 26.9% in the MUSKARDIA group (MUSKARDIA: 1.9% vs. placebo: 2.6%; odds ratio = 0.80; 95% confidence interval: 0.45-1.07; P = 0.2869). Angina frequency was significantly reduced in the MUSKARDIA group at 18 months (P = 0.0362). Other secondary endpoints were similar between the two groups. The rates of adverse events were also similar between the two groups (MUSKARDIA: 17.7% vs. placebo: 17.4%, P = 0.8785).Conclusions:As an add-on to OMT, MUSKARDIA is safe and significantly reduces angina frequency in patients with stable CAD. Moreover, the use of MUSKARDIA is associated with a trend toward reduced MACEs in patients with stable CAD. The results suggest that MUSKARDIA can be used to manage patients with CAD.Trial registration:chictr.org.cn, No. ChiCTR-TRC-12003513

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