Effects of Lycium barbarum polysaccharide on cytokines in adolescents with subthreshold depression:a randomized controlled study

Strong evidence has accumulated to show a correlation between depression symptoms and inflammatory responses.Moreover,anti-inflammatory treatment has shown partial effectiveness in alleviating depression symptoms.Lycium barbarum polysaccharide(LBP),derived from Goji berries,exhibits notable antioxidative and anti-inflammatory properties.In our recent double-blinded randomized placebo-controlled trial,we found that LBP significantly reduced depressive symptoms in adolescents with subthreshold depression.It is presumed that the antidepressant effect of LBP may be associated with its influence on inflammatory cytokines.In the double-blinded randomized controlled trial,we enrolled 29 adolescents with subthreshold depression and randomly divided them into an LBP group and a placebo group.In the LBP group,adolescents were given 300 mg/d LBP.A 6-week follow up was completed by 24 adolescents,comprising 14 adolescents from the LBP group(15.36±2.06 years,3 men and 11 women)and 10 adolescents from the placebo group(14.9±1.6 years,2 men and 8 women).Our results showed that after 6 weeks of treatment,the interleukin-17A level in the LBP group was lower than that in the placebo group.Network analysis showed that LBP reduced the correlations and connectivity between inflammatory factors,which were associated with the improvement in depressive symptoms.These findings suggest that 6-week administration of LBP suppresses the immune response by reducing interleukin-17A level,thereby exerting an antidepressant effect.

Functional and psychosocial effects of pulmonary Daoyin on patients with COPD in China:study protocol of a multicenter randomized controlled trial

BACKGROUND： Chronic obstructive pulmonary disease （COPD） is a major public health problem worldwide. Pulmonary rehabilitation （PR） is an established intervention for the management of patients with COPD. Exercise training is an important part of PR, and its effectiveness in patients with COPD is well established. However, alternative methods of PR training such as Daoyin have not been appropriately studied. Hence, alternative forms of exercise training that require less exercise equipment and no specific training place should be evaluated. This paper describes the study protocol of a clinical trial that aims to determine if pulmonary Daoyin training will improve the exercise capacity and psychosocial function of patients with COPD in China. METHODS AND DESIGN： A multicenter, randomized, controlled trial will be conducted. A total of 464 patients meeting the inclusion criteria will be enrolled into this study with 232 patients in each of the trial group and the control group. Based on patient education, patients in the trial group will receive pulmonary Daoyin and continue with their usual therapy for three months. In the control group, patients will continue with their usual therapy. The primary outcome measures are exercise capacity assessed by the six-minute walking distance test and lung function. Secondary outcomes include dyspnea and quality of life. Measurements will be taken at baseline （month 0） and after the study period （month 3）. DISCUSSION： It is hypothesized that pulmonary Daoyin will have beneficial effects in improving exercise capacity and psychosocial function of patients with stable COPD, and will provide an alternative form of exercise training that is accessible for the large number of people with COPD. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is NCT01482000.

Human umbilical cord mesenchymal stem cells to treat spinal cord injury in the early chronic phase: study protocol for a prospective, multicenter, randomized, placebo-controlled, single-blinded clinical trial

Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019.

A Double-Blind, Randomized, Placebo-Controlled Nutritional Study Using an Insoluble Yeast Beta-Glucan to Improve the Immune Defense System

Purpose: In a placebo-controlled, double-blind, randomized clinical trial, the effect of an insoluble yeast beta-glucan preparation on the incidences of common colds and its effect on common cold symptoms were compared to placebo. Methods: 100 healthy participants with recurring infections were randomly assigned to receive either placebo or yeast beta-glucan (Yestimun?;n = 50 each group) over a period of 26 weeks. The subjects had to document each common cold episode in a diary, and rate 6 predefined infections symptoms on a 3-point rating scale during an infection period, resulting in an infection score. The common cold episodes were confirmed by the investigators. Results: A total of 171 common cold episodes were documented. Of these, 76 were experienced by 38 subjects in the beta-glucan group and 96 were experienced by 48 subjects in the placebo group (p = 0.406). The beta-glucan group had significantly more subjects without incidences of common cold than the placebo group (15.6% vs 2.0%;p = 0.019). During the most intense infection season (first 13 weeks of the study), the beta-glucan group had significantly less infections compared to placebo (p = 0.02). Beta-glucan significantly reduced the typical cold symptoms (“sore throat and/or difficulty swallowing”, “hoarseness and/or cough” and “runny nose”) as opposed to placebo. Conclusion: The present study demonstrates a prophylactic effect of yeast beta-glucan on the occurrence of common colds as opposed to placebo. In addition, when these episodes occurred, they were from the beginning less pronounced and subsided faster.

Trial characteristics and treatment effect estimates in randomized controlled trials of Chinese herbal medicine: A meta-epidemiological study

Background:Previously published meta-epidemiological studies focused on Western medicine have identified some trial characteristics that impact the treatment effect of randomized controlled trials(RCTs).Nevertheless,it remains unclear if similar associations exist in RCTs on Chinese herbal medicine(CHM).Further,Chinese medicine-related characteristics have not been explored yet.Objective:To investigate trial characteristics related to treatment effect estimates on CHM RCTs.Search strategy:This meta-epidemiological study searched 5 databases for systematic reviews on CHM treatment published between January 2011 and July 2021.Inclusion criteria:An eligible systematic review should only include RCTs of CHM and conduct at least one meta-analysis.Data extraction and analysis:Two reviewers independently conducted data extraction on general characteristics of systematic reviews,meta-analyses and included RCTs.They also assessed the risk of bias of RCTs using the Cochrane risk of bias tool.A two-step approach was used for data analyses.The ratio of odds ratios(ROR) and difference in standardized mean differences (dSMD) with 95%confidence interval (CI) were applied to present the difference in effect estimates for binary and continuous outcomes,respectively.Results:Ninety-one systematic reviews,comprising 1338 RCTs were identified.For binary outcomes,RCTs incorporated with syndrome differentiation (ROR:1.23;95%CI:[1.07,1.39]),adopting Chinese medicine formula (ROR:1.19;95%CI:[1.03,1.34]),with low risk of bias on incomplete outcome data (ROR:1.29;95%CI:[1.06,1.52]) and selective outcome reporting (ROR:1.12;95%CI:[1.01,1.24]),as well as a trial size≥100 (ROR:1.23;95%CI:[1.04,1.42]) preferred to show larger effect estimates.As for continuous outcomes,RCTs with Chinese medicine diagnostic criteria (dSMD:0.23;95%CI:[0.06,0.41]),judged as high/unclear risk of bias on allocation concealment (dSMD:-0.70;95%CI:[-0.99,-0.42]),with low risk of bias on incomplete outcome data (dSMD:0.30;95%CI:[0.18,0.43]),conducted at a single center (dSMD:-0.33;95%CI:[-0.61,-0.05]),not using intention-to-treat analysis (dSMD:-0.75;95%CI:[-1.43,-0.07]),and without funding support (dSMD:-0.22;95%CI:[-0.41,-0.02]) tended to show larger effect estimates.Conclusion:This study provides empirical evidence for the development of a specific critical appraisal tool for risk of bias assessments on CHM RCTs.

Stochastic resonance whole body vibration reduces musculoskeletal pain:A randomized controlled trial

AIM:To examined the effects of stochastic resonance whole-body vibration training on musculoskeletal pain in young healthy individuals.METHODS:Participants were 43 undergraduate students of a Swiss University.The study was designed as a randomized controlled trial(RCT)with randomized group allocation.The RCT consisted of two groups each given 12 training sessions during four weeks with either 5 Hz-Training frequency(training condition)or 1.5 Hz Training frequency(control condition).Outcome was current musculoskeletal pain assessed in the evening on each day during the four week training period.RESULTS:Multilevel regression analysis showed musculoskeletal pain was significantly decreased in the training condition whereas there was no change in the control condition(B=-0.023,SE=0.010,P=0.021).Decrease in current musculoskeletal pain over four weeks was linear.CONCLUSION:Stochastic resonance whole-body vibration reduced musculoskeletal pain in young healthy individuals.Stochastic resonance vibration and not any other exercise component within training caused pain reduction.

Hypothenar fat pad flap vs conventional open release in primary carpal tunnel syndrome:A randomized controlled trial

AIM To compared outcomes between the hypothenar fat pad flap(HTFPF) and conventional open carpal tunnel release(COR) in primary carpal tunnel syndrome(CTS). METHODS Forty-five patients(49 hands) were enrolled into the study from January 2014 to March 2016, 8 patients were excluded. Randomization was conducted in 37 patients(41 hands) by computer generated(Block of four randomization) into COR and HTFPF group. Nerve conduction study(NCS) included distal sensory latency(DSL), distal motor latency(DML), sensory amplitude (S-amp), motor amplitude(M-amp) and sensory nerve conduction velocity(SCV) were examined at 6 and 12 wk after CTR. Levine score, grip and pinch strength, pain [visual analog scale(VAS)], 2-point discrimination(2-PD), Semmes-Weinstein monofilament test(SWM), Phalen test and Tinel's sign were evaluated in order to compare treatment outcomes.RESULTS The COR group, 19 patients(20 hands) mean age 50.4 years. The HTFPF group, 20 patients(21 hands) mean age 53.3 years. Finally 33 patients(36 hands) were analysed, 5 patients were loss follow-up, 17 hands in COR and 19 hands in HTFPF group. NCS revealed significant difference of DSL in HTFPF group at 6 wk(P < 0.05) compared with the COR group. S-amp was significant improved postoperatively in both groups(P < 0.05) but not significant difference between two groups. No significant difference of DML, M-amp and SCV postoperatively in both groups and between two groups. Levine score, pain(VAS), grip and pinch strength, 2-PD, SWM, Phalen test and Tinel's sign were improved postoperatively in both groups, but there was no significant difference between two groups.CONCLUSION There is no advantage outcome in primary CTS for having additional HTFPF procedure in CTR. COR is still the standard treatment. Nevertheless, improvement of DSL and S-amp could be observed at 6 wk postoperatively.

Bias-Variation Dilemma Challenges Clinical Trials: Inherent Limitations of Randomized Controlled Trials and Meta-Analyses Comparing Hernia Therapies

Purpose:Evaluation of hernia therapies according to the current rules of Evidence Based Medicine is widely reduced to results of RCTs or meta-analyses. RCTs have been accepted as a most important tool to confirm a superior effect of an intervention. Unfortunately, in hernia surgery, comparisons of RCTs and correspondingly their use in meta-analyses, are not, surprisingly often, able to confirm any significant impact of a specific procedure due to intrinsic restrictions in a multi-causal setting with its web of influences. Methods:Based on our own experiences of clinical studies in surgery, the present article outlines several situations, with their respective reasons, which argue the severe limitations of RCTs and meta-analysis to define an optimum treatment. Results:Meta-analyses accumulate the variations of each trial, which then may cover any clear causal relationship. RCTs usually are dealing with subgroups of standard patients thus excluding the majority of our patients. Low statistical power of current cohort sizes restricts the analysis of subgroups or of effects with low incidences. Simple comparisons of means frequently are hampered by nonlinear relationships to outcome. The relevance of a specific variable is difficult to separate from other influences. The limited surveillance period of studies ignores a delayed change in outcome. Randomization cannot guarantee a standardized patient’s condition. All the arguments have to be considered as a crucial and fundamental consequence of the bias-variance dilemma or principle of uncertainty in medicine, and underline the many limitations of RCTs to evaluate any specific impact of hernia therapies on e.g. infection, pain or recurrence. Conclusions: Many surgical issues cannot be and should not be investigated by RCTs, in particular, if a marked patients’ heterogeneity has to be considered or the low incidences of the outcome readout cannot be addressed with sufficient statistical power without getting lost in the variation mire. Registries with their non-restricted data-acquisition should be regarded as reliable alternatives for postoperative outcome quality surveillance studies.

Study design in evidence-based surgery:What is the role of case-control studies?

Randomized controlled trials(RCTs) are the gold standard in terms of study design, however, in the surgical setting conducting RCTs can often be unethical or logistically impossible. Case-control studies should become the major study design used in surgical research when RCTs are unable to be conducted and definitely replacing case series which offer little insight into surgical outcomes and disease processes.

Tolerability of a Proprietary Larch Arabinogalactan Extract: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Healthy Subjects

In a placebo-controlled, double-blind, randomized clinical trial, the tolerability of a proprietary larch arabinogalactan preparation (ResistAidTM) was investigated. METHODS: 199 healthy participants were randomly assigned to receive either placebo (n = 98) or an arabinogalactan preparation (n = 101) over a period of 12 weeks. As safety parameters the total number of adverse events, changes in various biochemical and laboratory parameters as well as the global evaluation of tolerability by investigator and subjects compared to placebo were evaluated. RESULTS: In total 16 adverse events were observed in 16 subjects, with no difference between the arabinogalactan and the placebo group (p = 0.935). There were no differences in the mean changes of the measured biochemical and laboratory parameters. The tolerability of the arabinogalactan extract was rated as “very good” or “good” by the investigators for 99% of the subjects and by 98% subjects in self-assessment with no statistical differences to placebo. CONCLUSION: The measured parameters as well as the evaluation of the tolerability by the investigators and the subjects demonstrate a very good tolerance profile of the proprietary arabinogalactan extract with no differences to placebo when taken for 12 weeks.

耳穴压丸联合耳穴揿针疗法治疗儿童青少年近视的多中心随机对照研究

目的 观察耳穴压丸联合耳穴揿针疗法对儿童青少年近视的临床疗效和安全性。方法 纳入2021年7月—2022年10月中国中医科学院眼科医院等6家医院诊治的低度近视和近视前期患儿156例(156只眼),随机分为试验组和对照组,每组78例(78只眼)。对照组予健康宣教+足矫配镜(近视前期患儿只予健康宣教);试验组在对照组的基础上联合耳穴压丸+耳穴揿针治疗。分别于治疗前、治疗后6周、12周和24周检测受试者的裸眼远视力(UCDVA)、等效球镜度(SE)、眼轴(AL)和全身症状评分,并进行统计分析。结果 2组患儿治疗前的UCDVA、SE、AL和全身症状评分比较,差异均无统计学意义(P>0.05)。(1)UCDVA:治疗前后比较,试验组各时间节点UCDVA较治疗前比较,差异均无统计学意义(P>0.05)。对照组治疗后12周和24周UCDVA均较治疗前降低,差异均有与统计学意义(Z12_(周)=3.495,Z24_(周)=3.950,均P=0.000)。2组间比较,试验组治疗后6周、12周和24周UCDVA均高于对照组,差异均有统计学意义(Z6_(周)=2.655,P=0.008;Z12_(周)=3.441,P=0.001;Z24_(周)=2.933,P=0.003)。(2)SE:治疗前后比较,试验组治疗后12周和24周SE均较治疗前升高,差异均有统计学意义(t12_(周)=2.349,P=0.020;t24_(周)=3.643,P=0.000)。对照组治疗后各时间节点SE均较治疗前升高,差异均有统计学意义(t6_(周)=5.861、t12_(周)=7.640、t24_(周)=9.845,均P=0.000)。2组间比较,试验组治疗后6周、12周和24周SE均低于对照组,差异均有统计学意义(t6_(周)=3.392,P=0.001;t12_(周)=3.468,P=0.001;t24_(周)=3.968,P=0.000)。2组治疗后24周与治疗前的SE差值比较,差异有统计学意义(t=4.529,P=0.000)。(3)AL:2组AL治疗后各时间节点与治疗前的比较及组间比较,差异均无统计学意义(P>0.05)。2组间差值比较,试验组治疗后24周与治疗前的AL差值低于对照组,差异有统计学意义(t=2.035,P=0.044)。(4)全身症状评分:治疗前后比较,试验组治疗后6周、12周和24周全身症状评分均较治疗前降低,差异均有统计学意义(Z6_(周)=5.358、Z12_(周)=5.690、Z24_(周)=5.886,均P=0.000)。对照组治疗后6周、12周全身症状评分均较治疗前降低,差异均有统计学意义(Z6_(周)=4.411, P=0.000;Z12_(周)=3.259, P=0.001)。2组间比较,试验组治疗后12周和24周的全身症状评分均低于对照组,差异均有统计学意义(Z12_(周)=1.999, P=0.046;Z24_(周)=3.093, P=0.002)。(5)不良反应及依从性:2组均无不良反应发生;2组依从性比较,差异无统计学意义(P>0.05)。结论耳穴压丸联合耳穴揿针疗法具有防控儿童青少年近视进展作用,能够控制屈光度增加、延缓眼轴增长度、稳定视力、改善全身症状体征,安全性高,依从性好,值得推广应用。

中医药辨证治疗亚实性肺结节的实用性随机对照研究

目的探讨中医药在亚实性肺结节(SSN)中的治疗效果。方法纳入SSN患者254例,分为中药组102例与随访组152例,随访组根据指南推荐定期复查,中药组给予中药辨证治疗24周,对比两组患者治疗前后SSN直径、数目、中医症状积分并评价总体疗效,记录不良反应发生情况及安全性指标。结果中药组治疗有效率(16.7%)显著高于随访组(2.6%)(P<0.01)。与本组治疗前相比,中药组SSN直径、数目无显著变化,乏力、小便黄赤症状积分及中医症状总分均显著降低(P<0.05);随访组SSN直径显著增大(P<0.01)、数目显著增多(P<0.01)。组间对比显示:治疗后随访组SSN直径增大程度显著高于中药组(P<0.05),乏力、情志抑郁、小便黄赤症状积分及中医症状总分显著高于中药组(P<0.05或P<0.01)。结论中医药治疗SSN临床疗效明确,能降低SSN恶性风险,改善SSN患者临床症状且安全可行,可进一步研究和应用。

眼压控制后青光眼患者球后血流动力学改变及揿针疗效观察

目的观察眼压控制后青光眼患者球后血流动力学改变及揿针对其球后血流动力学的影响。方法采用前瞻性、多中心、随机对照临床研究,从各中心选取192例眼压控制后青光眼患者,随机分为揿针组及安慰针组,分别予以揿针、安慰针治疗。比较两组患者治疗前、治疗后2月及4月的眼压、BCVA、眼动脉(OA)、视网膜中央动脉(CRA)以及睫状后短动脉(SPCA)的收缩期峰值流速(PSV)、舒张期峰值流速(EDV)、阻力指数(RI)。结果治疗前两组间眼压、BCVA、OA、CRA、SPCA相关血流动力学指标无差异(P>0.05),治疗后2月及4月,揿针组BCVA与治疗前比较无差异(P>0.05),然而,安慰针组BCVA却明显降低(P<0.05);治疗后2月及4月,揿针组及安慰针组IOP较治疗前无统计学差异(P>0.05);与治疗前比较,治疗后2月及4月揿针组OA、CRA、SPCA的PSV与EDV有所提高(P<0.05),RI均有所下降(P<0.05);然而,治疗后2月,安慰针组RI较治疗前无改善,且治疗4月后仍进一步升高(P<0.05),治疗后2月及4月,安慰针组PSV与EDV有所下降(P<0.05)。结论眼压控制后青光眼患者存在球后血流动力学障碍,揿针改善眼压控制后青光眼患者视力,可能是通过改善球后血流动力学改变引起的。

白苓止痛方治疗慢性紧张性头痛的随机对照研究

目的基于祛湿化痰、缓急止痛法观察白苓止痛方对慢性紧张性头痛(CTTH)(痰湿内蕴型)患者的影响。方法根据临床资料,选择2022年1—12月就诊于吉林省中医药科学院的72名符合标准患者,采用随机数字表法分为两组,各36例。治疗组给予盐酸乙哌立松片+白苓止痛方,对照组给予盐酸乙哌立松片,治疗4周后,分别对两组患者的疼痛程度、每月发作次数、每次头痛持续时间、总的疼痛评分,以及汉密尔顿焦虑量表(HAMA)和汉密尔顿抑郁量表(HAMD)评分进行比较。结果69例患者完成了本项研究,治疗组35例,对照组34例。治疗后,治疗组总有效率(94.29%)高于对照组(52.94%,P<0.01);疼痛程度、每月发作次数、每次头痛持续时间、总的疼痛评分,以及HAMA和HAMD评分均低于对照组(P<0.01);两组患者的不良反应发生率比较,差异无统计学意义(P>0.05)。结论应用白苓止痛方能明显改善CTTH(痰湿内蕴型)患者的疼痛程度,降低其发作频率,缩短其持续时间,且安全性较佳。

蒿秦化斑优化方治疗多形性日光疹的临床研究

目的应用多中心、双盲、安慰剂随机的研究方法对蒿秦化斑优化方治疗多形性日光疹(PLE)的临床疗效及安全性进行评价。方法依据诊断、纳入及排除标准,将126例于首都医科大学附属北京中医医院、北京中医医院顺义医院、北京回民医院皮肤科门诊就诊的多形性日光疹患者,采用2∶1比例随机分为治疗组与对照组,治疗组84例口服蒿秦化斑优化方颗粒,对照组42例口服安慰剂。每周观察1次,连续观察4周后进行疗效评价。比较2组治疗前后湿疹面积及严重程度指数(EASI)评分(红斑、丘疹、表皮剥脱、渗出/结痂、苔藓化和受累面积);中医主要临床证候评分(瘙痒、心烦、口渴、小便黄和大便干);皮肤病生活质量指数(DLQI)量表、健康状况调查问卷(SF-36)及安全性指标进行疗效判定。结果治疗4周后,治疗组愈显率(76.92%)及总有效率(94.87%)均较对照组提高(P<0.001);EASI评分较对照组明显下降(P<0.001),其中红斑、丘疹、受累面积均较对照组明显改善(P<0.05)。治疗组治疗4周后中医证候评分总分较对照组明显下降(P<0.05)。治疗4周后治疗组患者生理机能、生理职能、躯体疼痛、社会功能、情感职能评分较对照组提高(P<0.05),DLQI评分较对照组明显降低(P<0.05)。2组患者治疗前后安全性指标未出现异常,无不良事件发生。结论口服蒿秦化斑优化方可有效改善PLE患者临床症状和体征及生活质量,且无明显不良反应。

针灸联合经颅直流电刺激治疗脑卒中伴认知障碍的随机对照试验

目的:观察针灸联合经颅直流电刺激(tDCS)治疗脑卒中后血管性认知障碍的疗效及对同型半胱氨酸(Hcy)、神经元特异性烯醇化酶(NSE)和脑源性神经营养因子(BDNF)水平的影响。方法:选取2021年11月至2022年11月陕西省人民医院康复医学科收治的缺血性脑卒中伴认知障碍患者102例作为研究对象,按照随机数字表法随机分为针刺联合组(34例,脱落2例)、tDCS联合组(34例,脱落1例)和西药组(34例),进行为期4周的治疗。结果:治疗后,针灸联合组的蒙特利尔认知评分、洛文斯坦因作业疗法认知评定(LOTCA)评分、巴塞尔(Barthel)指数评分和血清BDNF均明显升高(P<0.05),且高于其他2组;针灸联合组和tDCS组的行为记忆测验评分均显著提高(P<0.05),且优于西药组;治疗后,3组的血清Hcy和NSE水平均明显降低,且针灸联合组明显低于其他2组(P<0.05)。结论:针灸联合tDCS治疗能显著改善脑卒中伴认知障碍患者的认知功能,提高日常活动能力和生命质量。

循证护理在重症脑卒中患者呼吸机相关性肺炎中的应用

目的分析循证护理在重症脑卒中患者呼吸机相关性肺炎中的应用效果。方法随机选取2021年1月-2023年1月丰县人民医院急诊监护室收治的90例重症脑卒中合并呼吸机相关性肺炎患者为研究对象,按随机数表法分为对照组与观察组,每组45例。对照组采用常规护理,观察组采用循证护理。分析比较两组生活质量等指标。结果与对照组相比,观察组患者生活质量、舒适度评分较高,差异有统计学意义(P均<0.05)。观察组护理满意度(100.00%)高于对照组,差异有统计学意义(χ^(2)=11.250,P<0.05)。结论在重症脑卒中呼吸机相关性肺炎患者中采用循证护理的效果较好。

Efficiency and safety of acupuncture for women with premature ovarian insufficiency:study protocol for a randomized controlled trial

Acupuncture has been widely used as an alternative and complementary therapy for premature ovarian insufficiency(POI)in China.However,research to date has not shown that acupuncture is effective for POI compared with hormone replacement therapy(HRT).We will conduct a randomized,controlled,and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on POI.Seventy-six patients with POI will be randomly assigned to two groups.The treatment group will receive twenty-eight one-hour sessions of acupuncture treatments,and the control group will receive 12-week HRT.The whole study will consist of a 12-week treatment plan and a 12-week follow-up session.The primary outcome is measured by changes in serum anti-Müllerian hormone and follicle-stimulating hormone(FSH)levels at weeks 12 and 24.Secondary outcome measures include estradiol,luteinizing hormone(LH),LH/FSH ratio,Kupperman index,and menstrual condition.This trial is expected to clarify whether or not acupuncture is effective and safe for POI compared with HRT.

普瑞巴林与加巴喷丁治疗带状疱疹后遗神经痛Meta分析

目的对已有的普瑞巴林(PGB)与加巴喷丁(GBP)对带状疱疹后遗神经痛(Postherpetic neuralgia,PHN)疗效对比的临床试验进行Meta分析,以期更全面地了解普瑞巴林与加巴喷丁在治疗PHN的疗效,包括对疼痛的控制效果、对健康和生存质量的改善状况以及不良反应发生情况等方面的区别。方法在中国知网、万方数据库、维普数据库、中国生物医学文献服务系统、PubMed、EMBASE、Cochrane Library和Web of Science数据库检索普瑞巴林与加巴喷丁用于PHN患者疗效对比的临床随机对照试验(Randomized controlled trials,RCTs)和队列研究(Cohort study)相关文献。按纳入标准对文献进行筛选,对所纳入研究的数据进行提取,并用Cochrane偏倚风险评估工具和NOS量表分别对RCT研究和队列研究进行质量评价,采用Revman5.3软件进行Meta分析。结果共纳入16篇随机对照试验,3篇队列研究。Meta分析研究结果显示:与加巴喷丁相比,普瑞巴林更能有效地降低平均疼痛评分,疼痛评分较基线下降≥50%的天数更多,治疗后的有效例数更多。同时,普瑞巴林嗜睡的不良反应发生例数较加巴喷丁少。结论与加巴喷丁相比,普瑞巴林对PHN治疗的疗效更好,健康状况更佳,安全性更高。但由于现有文献数量的局限性,仍有待高质量头对头的RCT研究来进一步证实普瑞巴林相比于加巴喷丁在治疗PHN中的优势。

清肝利肠方敷脐治疗酒精性肝硬化腹水湿热水停证45例随机对照研究

目的 观察清肝利肠方敷脐治疗酒精性肝硬化腹水湿热水停证的临床疗效。方法 选取2019年3月—2019年12月期间在首都医科大学附属北京佑安医院门诊及病房就诊治疗的酒精性肝硬化腹水患者50例,借助SAS统计软件,治疗组与对照组按照1∶1比例随机分组,盲底密封,交临床试验负责单位妥善保存,根据随机数码表列出的流水号进行治疗分配。治疗组和对照组各有2例失访,对照组另有1例因病情需要,进行腹腔穿刺后放腹水治疗,最后纳入统计共45例。将45例酒精性肝硬化腹水湿热水停证患者随机分为治疗组23例和对照组22例,两组患者均给予西医对症基础治疗,对照组在基础治疗上加安慰剂敷脐治疗,治疗组在基础治疗上给予清肝利肠方敷脐治疗,两组患者均神阙穴敷贴治疗10 h/d。连续治疗4周后,观察比较两组患者总体疗效、中医证候疗效、中医证候积分、体质量、腹围、腹水量变化及安全性。结果 治疗后治疗组总有效率82.6%(19/23)优于对照组72.7%,差异无统计学意义(P>0.05)。治疗后治疗组中医证候总有效率95.7%(22/23)优于对照组72.7%(16/22),差异有统计学意义(P<0.05)。治疗后两组患者中医证候积分均较治疗前降低,差异有统计学意义(P<0.05);且治疗组中医证候积分较对照组明显降低,差异有统计学意义(P<0.05)。治疗后两组患者体质量、腹围变化情况较治疗前降低,差异有统计学意义(P<0.05);且治疗组体质量、腹围变化低于对照组,差异有统计学意义(P<0.05)。两组患者治疗前后腹水严重程度比较,差异无统计学意义(P>0.05)。两组患者不良反应发生率比较,差异无统计学意义(P>0.05)。结论 中药敷脐治疗是辅助治疗肝硬化腹水的中医特色疗法之一,该疗法有助于酒精性肝硬化腹水的治疗,能够明显改善中医证候,提高患者满意度,增加治疗依从性。