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During the COVID-19 outbreak, there was a sharp increase in generalized anxiety disorder (GAD). Acupuncture therapy has the advantages of accurate clinical efficacy, safety and reliability, few adverse reactions, and no dependence, and is gradually becoming one of the emerging therapies for treating GAD. We present a study protocol for a randomized clinical trial with the aim of exploring the mechanism of brain plasticity in patients with GAD and evaluate the effectiveness and reliability of acupuncture treatment. Transcranial magnetic stimulation (TMS) will be used to assess cortical excitability in GAD patients and healthy people. Sixty-six GAD patients meeting the inclusion criteria will be randomly divided into two groups: TA group, (treatment with acupuncture and basic western medicine treatment) and SA group (sham acupuncture and basic western medicine treatment). Twenty healthy people will be recruited as the control group (HC). The parameters that will be evaluated are amplitude of motor evoked potentials (MEPs), cortical resting period (CSP), resting motor threshold (RMT), and Hamilton Anxiety Scale (HAMA) score. Secondary results will include blood analysis of γ-aminobutyric acid (GABA), glutamate (Glu), glutamine (Gln), serotonin (5-HT), and brain-derived nerve growth factor (BDNF). Outcomes will be assessed at baseline and after the intervention (week 8). This study protocol is the first clinical trial designed to detect differences in cerebral cortical excitability between healthy subjects and patients with GAD, and the comparison of clinical efficacy and reliability before and after acupuncture intervention is also one of the main contents of the protocol. We hope to find a suitable non-pharmacological alternative treatment for patients with GAD.
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ObjectiveTo draft the Metadata of Evidence from Traditional Chinese Medicine Randomized Controlled Trials for standardizing thedata collection， storage， transmission， exchange， analysis， and evaluation of traditional Chinese medicine （TCM） studies. In addition to the application of conventional systematic review and meta-analysis， this draft will provide strong support for the development of automated systematic review， facilitate the efficient utilization of TCM clinical evidence， and underpin the evidence-based rapid decision-making in TCM. MethodThis study was structured into three stages. During the first stage （pre-research）， suggestions for formulating new standards were proposed based on comprehensive research and demonstration of views obtained from literature investigation and expert interviews. The second stage concentrated on drafting the standard by assembling a working group and crafting a draft solicitation document for metadata standards. At the third stage， feedback was sought from relevant institutions， organizations， and experts and scholars outside the research group via mail or other means to finalize the draft standard. ResultDuring the pre-research stage， a preliminary examination was conducted to assess the characteristics and current status of clinical research metadata standards， and the information was identified regarding the significance of formulating the standard， principles guiding metadata formulation， reference materials， and suggestions for metadata subset establishment. After establishing a working group and drafting the initial version of the standard， opinions from external experts were sought via email. Based on the comments， a third round of revisions was conducted， resulting in the finalization of a draft for the standard. The finalized version of the standard draft comprised 12 sections： preface， introduction， scope， normative reference documents， terms and abbreviations， principles and composition， metadata description method， metadata summary representation， metadata dictionary description， Extensible Markup Language （XML） markup example， JavaScript Object Notation （JSON） markup example， and references. Of these， the section of metadata summary representation/metadata dictionary description contained 6 metadata subsets， involving 20 metadata entities and 141 metadata elements. ConclusionThrough literature research， expert interviews， questionnaire surveys， standard drafting， and opinion solicitation， this study drafts the Metadata of Evidence from Traditional Chinese Medicine Randomized Controlled Trials. This draft plays a crucial role in standardizing TCM clinical research and advancing objective scientific evaluation and effective utilization of TCM.
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ObjectiveTo observe the clinical efficacy of Shengmaisan combined with polymyxin B in the treatment of carbapenem-resistant gram-negative bacillus infection with sepsis complicated with severe acute respiratory distress syndrome. MethodA total of 90 patients suffering from carbapenem-resistant gram-negative bacillus infection with sepsis complicated with severe acute respiratory distress syndrome were randomly divided into a control group and an observation group， with 45 cases in each group. The control group was treated with polymyxin B， and the observation group was treated with Shengmaisan combined with polymyxin B. The treatment course of both groups was seven days. The infection-related indicators ［white blood cell （WBC） count， procalcitonin （PCT）， neutrophil apolipoprotein （HNL）］， inflammatory factors ［interleukin-6 （IL-6）， serum chemokine ligand 2 （CXCL2）］， and T lymphocyte subpopulations （CD3+， CD4+， CD8+， and CD4+/ CD8+ value）， acute physiological and chronic health Ⅱ （APACHE Ⅱ） score before and after treatment， as well as bacterial clearance rate and 28-day survival rate after treatment were observed. Result① The experiment was completed， and 81 cases were included， including 41 cases in the observation group and 40 cases in the control group. The general data of the two groups were comparable. ② The bacterial clearance rate of the observation group and the control group was 75.6% （31/41） and 52.5% （21/40）， respectively， and the observation group was higher than the control group （χ2=4.7， P<0.05）. ③ The WBC count， PCT， HNL， IL-6， CXCL2， and APACHE Ⅱ scores of the observation group and the control group all decreased after treatment （P<0.05）. Except for the WBC count， the PCT， HNL， IL-6， CXCL2， and APACHE Ⅱ scores of the observation group were lower than those of the control group （P<0.05）. ④ The values of CD3+， CD4+， and CD4+/CD8+ in the observation group were increased after treatment （P<0.05）， and CD8+ was decreased （P<0.05）. In the control group， only CD3+ value was increased （P<0.05）. The values of CD3+， CD4+， and CD4+/CD8+ in the observation group were higher than those in the control group， and the value of CD8+ was lower than that in the control group （P<0.05）. ⑤ The 28-day survival rate in the observation group was higher than that in the control group （χ2=4.3， P<0.05）. ConclusionShengmaisan combined with polymyxin B in the treatment of carbapenem-resistant gram-negative bacillus infection with sepsis complicated with severe acute respiratory distress syndrome can better clear bacteria， control infection， reduce the level of inflammatory factors， regulate the immune state of the body， and improve the short-term prognosis.
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Objective To compare the influence between self-monitoring of blood gluocose(SMBG)combined with digital diabetes management and traditional management mode on the related clinical indexes in the patients with type 2 diabetes mellitus(T2DM).Methods A total of 100 patients with T2DM treated in the endocrinology and metabolism outpatient department of this hospital from January 2022 to June 2022 and meeting the inclusion criteria of this study were successively included.They were divided into the experimental group and control group.The experimental group was managed by SMBG combined with digital diabetes man-agement mode,while the control group adopted the traditional management mode,the outpatient clinic follow up once a month.After 6 months of follow-up,fasting blood glucose,glycosylated hemoglobin(HbA1c),low density lipoprotein cholesterol(LDL-C)and urinary microalbumin/creatinine ratio(UACR)were compared between the two groups.Results The FBG,HbA1c,LDL-C,and UACR of the experimental group decreased after intervention when compared with baseline.Compared with the control group,the FBG[8.7(7.7,9.2)mmol/L vs.10.8(8.8,12.7)mmol/L,Z=-4.660,P＜0.001],HbA1c[6.3％(5.3,7.8)％vs.8.5％(7.2,10.0)％,Z=-5.130,P＜0.001],LDL-C[2.6(1.8,3.1)mmol/L vs.3.3(2.6,4.0)mmol/L,Z=-4.112,P＜0.001],UACR[16.1(3.5,46.5)mg/g vs.58.4(11.9,108.0)mg/g,Z=-2.220,P=0.026]for patients in the expriemental group after intervention were significantly decreased.Conclusion SMBG combined with digital diabetes management model can significantly improve the clinical indicators of patients.
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Objective We conduct a systematic review and meta-analysis to evaluate the efficacy and safety of Suanzaoren decoction for post-stroke insomnia.Methods We conducted a comprehensive literature search,including PubMed,EMbase,CNKI,WanFang Data and so on,from the database creating to September 15th 2023.Our systematic review only included randomized controlled trials(RCTs)concerning with Suanzaoren decoction in treating post-stroke insomnia.Two reviewers independently screened the literature,extracted the data,and assessed the risk of bias for included studies.We used RevMan 5.3 software to perform Meta-analysis.Results A total of 13 RCTs were included,involving 1002 patients.The meta-analysis results showed that the clinical effective rate of the Suanzaoren decoction group was higher than the control group(OR=4.25,95%CI 2.79 to 6.46,P<0.00001).The Suanzaoren decoction group(combined with other treatments)reduced the Pittsburgh sleep quality index(PSQI)score more significantly than the control group(MD=-2.78,95%CI-3.24 to-2.33,P<0.00001).The Suanzaoren Decoction group was better than the control group in reducing the score of the National Institute of Health Stroke Scale(NIHSS)and improving neurological impairment(MD=-1.58,95%CI-1.95 to-1.21,P<0.00001).The incidence of adverse events in Suanzaoren Decoction group was lower than that in the control group(OR=0.38,95%CI 0.20 to 0.71,P=0.003).Conclusion Suanzaoren decoction can enhance the clinical efficacy and improve the degree of neurological defect of post-stroke insomnia patients,Suanzaoren decoction(combined with other treatments)can improve the sleep quality.The incidence of adverse events is lower.However,the efficacy and safety of Suanzaoren decoction for post-stroke insomnia still need to be further verified by more high-quality RCTs.
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Objective This study aims to summarize and evaluate clinical evidence of randomized controlled trial(RCT)of Chinese patent medicine published in 2021 and providing reasonable suggestions.Methods The collection literatures of Evidence Database System of TCM(EVDS)was main source,and CNKI,Wan Fang Data,VIP,SinoMed,Cochrane Library,PubMed,and EMbase databases were supplement.Obtaining the RCT of Chinese patent medicine published in 2021,and to analyze and evaluate their characteristics and methodological quality.Results 2215 RCTs of Chinese patent medicine(2206 in Chinese/9 in English)were included,which involving 237,379 patients,26 types of diseases,and 750 types of proprietary Chinese medicines(619 types of oral Chinese patent medicine,91 types of Chinese injections,and 40 types of topical Chinese patent medicine).The circulatory system diseases,respiratory system diseases and neurological diseases was highlight research area.The most number of diseases were ischemic Stroke,coronary heart disease,and angina pectoris.The sample size between 30 and 8,000 cases,and the case sources were mainly single-center.Methodologically,the implementation of allocation concealment and blinding remained unappreciated.Conclusion The number of RCTs publication increased in 2021 compared with 2020,more studies pay attention to neurological disease research,and quality control and standardized management during study design and implementation still need to be improved.
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BACKGROUND:With the variation of disease treatment modes and the in-depth research on senile osteoporosis in recent years,increasing studies have confirmed that traditional Chinese medicine has a significant effect on the prevention and treatment of senile osteoporosis. OBJECTIVE:To investigate the effect of Yishen Gushu Formula on bone metabolic markers in patients with osteoporosis of kidney deficiency and blood stasis type. METHODS:102 patients with senile osteoporosis of kidney deficiency and blood stasis type who were treated at Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine from July 2020 to March 2022 were enrolled,including 32 males and 70 females,aged 71-93 years.All patients were randomly divided into two groups,with 51 patients in each group.The control group was treated with calcium carbonate D3 granules and sodium alendronate tablets,while the treatment group was treated with Yishen Gushu Formula beyond the control group.Treatments in each group lasted 3 months.Bone mineral density of the L1-4 lumbar vertebrae and left femoral neck,visual analog scale score,and serum levels of osteocalcin,osteopontin,type Ⅰ collagen cross-linked C-terminal peptide and tartrate resistant acid phosphatase were measured before and 3 months after treatment.Traditional Chinese medicine syndrome score and therapeutic efficiency were also assessed. RESULTS AND CONCLUSION:After 3 months of treatment,the bone mineral density of the lumbar vertebrae(L1-4)and left femoral neck was significantly increased in both two groups(P<0.05),and the bone mineral density of the lumbar vertebrae(L1-4)and left femoral neck was significantly higher in the treatment group than the control group(P<0.05).The visual analog scale scores of both groups after 3 months of treatment were lower than those before treatment(P<0.05),and the visual analog scores of the treatment group after 3 months of treatment were lower than those of the control group(P<0.05).After 3 months of treatment,the serum levels of osteocalcin,osteopontin,type Ⅰ collagen cross-linked C-terminal peptide and tartrate resistant acid phosphatase were significantly improved in both two groups,while compared with the control group,the serum levels of osteocalcin and osteopontin were significantly higher(P<0.05)and the serum levels of type Ⅰ collagen cross-linked C-terminal peptide and tartrate resistant acid phosphatase were significantly lower in the treatment group(P<0.05).After 3 months of treatment,the Traditional Chinese medicine syndrome scores were decreased in both two groups,while the Traditional Chinese medicine syndrome scores in the treatment group were lower than those in the control group.After 3 months of treatment,no significant adverse reactions occurred in both groups.The total effective rate was 88.2%and 70.6%in the treatment and control groups respectively,and there was a significant difference between the two groups(P<0.05).To conclude,Yishen Gushu Formula combined with anti-osteoporosis drugs can significantly improve the clinical symptoms of patients with senile osteoporosis of kidney deficiency and blood stasis type and prevent disease progression by regulating bone metabolism,increasing bone mineral density,and relieving pain.
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OBJECTIVE:At present,there are various surgical repair strategies for the lateral stability of chronic ankle instability after the injury of the lateral collateral ligament of the ankle,but the specific repair strategy to maximize the recovery of lateral stability of the ankle still lacks of evidence-based medical evidence.Based on this,for the first time,this paper systematically evaluated the effects of four popular repair strategies to restore the lateral stability of chronic ankle instability using the network meta-analysis method. METHODS:Computer retrieval was conducted on CNKI,WanFang,VIP,PubMed,Embase,Web of Science and Cochrane Library.The retrieval time was from the establishment of each database to December 2022.The randomized controlled trials or clinical controlled trials on different repair strategies to recover chronic ankle instability after injury of the lateral ligament of the ankle were included.The literature was screened and extracted.The literature quality was evaluated and data were analyzed using RevMan 5.4,R4.2 and Stata 14.2 software. RESULTS:Twelve studies(including 10 randomized controlled trials and 2 cohort studies)were included.A total of 673 patients with chronic ankle instability were involved in 4 repair strategies.The observation indicators were:anterior talar translation distance and talar tilt angle of ankle joint stress X-ray film(hereinafter referred to as anterior talar translation distance and talar tilt angle).The results of network meta-analysis showed that:(1)In terms of anterior talar translation distance,the sequence of reticular meta-analysis results from inferior to superior was anatomical repair>anatomical repair + enhancement of inferior extensor retinaculum>internal brake anatomical reconstruction>autologous/allogeneic tendon anatomical reconstruction.(2)In terms of talar tilt angle,the sorting results of reticular meta-analysis from inferior to superior were as follows:anatomical repair>anatomical repair + inferior extensor retinaculum enhancement>internal brace anatomical reconstruction>autologous/allogeneic tendon anatomical reconstruction. CONCLUSION:Anatomical reconstruction strategy of autologous/allogeneic tendon is the first in improving anterior talar translation distance and talar tilt angle,suggesting that this strategy may have the best effect in restoring the stability of chronic joint instability after injury of the lateral ligament of ankle,but more large sample,multicenter,double-blind randomized controlled trials are still needed in the future to further confirm.
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OBJECTIVE:Exercise intervention is one of the main treatments for fibromyalgia,but there is no consistent conclusion on the choice of different exercise modalities.In this article,a network Meta-analysis was used to comprehensively and quantitatively evaluate the effects of different exercise modalities on fibromyalgia syndrome. METHODS:PubMed,EMbase,Scoups,The Cochrane Library,Web of Science,CNKI,WanFang Database,and China Biomedical Literature Database were searched for relevant literature,with a search timeframe from the establishment of each database to June 2023.The outcome indicators included five continuous variables,including fibromyalgia impact questionnaire-revised(FIQ)scores,visual analogue scale(VAS)scores,quality of life,quality of sleep,and depression.The Cochrane Risk of Bias Assessment Tool was used to evaluate the quality of the included literature.RevMan 5.4 software was used to perform effect sizes,subgroup analyses,and sensitivity analyses of the data.Stata 17 software was used to perform reticulation and network Meta-analysis of the data. RESULTS:A total of 13 articles with 14 randomized controlled trials were finally included.The overall methodological quality of the literature was high.The results of traditional Meta-analysis showed that,compared with the control group,exercise therapy significantly improved the FIQ score[standardized mean difference(SMD)=-0.67,95％confidence interval(CI):-0.83 to-0.50,P<0.01],VAS score(SMD=-0.72,95％CI:-0.90 to-0.54,P<0.01),quality of life(SMD=1.03,95％CI:0.45 to 1.61,P=0.000 5),sleep quality(SMD=-0.62,95％CI:-0.98 to-0.25,P=0.001),and depression(SMD=-0.63,95％CI:-1.09 to-0.18,P=0.007).Network Meta-analysis showed that the probability of optimal intervention effect of exercise modalities on FIQ scores was ranked as:mind-body exercise(86.5)>resistance exercise(70.5)>aerobic exercise(41.7);the probability of optimal intervention effect of exercise modalities on VAS scores was ranked as:resistance exercise(85.3)>mind-body exercise(74.3)>aerobic exercise(34.5). CONCLUSION:Exercise therapy significantly improves FIQ scores,VAS scores,quality of life,sleep quality,and depression in patients with fibromyalgia syndrome.Mind-body exercise and resistance exercise are the most effective exercise modalities to reduce FIQ scores and VAS scores in patients with fibromyalgia syndrome.
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OBJECTIVE:At present,there are a variety of treatment methods for scoliosis using specific exercise therapy,but there is a lack of comparison of efficacy between different specific exercise therapy.This article compared the effectiveness of different specific exercise therapies to treat adolescent idiopathic scoliosis through a network meta-analysis. METHODS:Domestic and foreign electronic databases of relevant studies were searched for randomized controlled trials of specific exercise therapy for adolescent idiopathic scoliosis.Search time was from January 2000 to July 2023.The literature was screened by two reviewers using RevMan 5.4 and Stata 16.0 software to extract data and assess the bias risk of of inclusion studies. RESULTS:(1)This article includes 20 randomized controlled trials with 1 377 patients.Of them,12 studies involved Schroth therapy;2 studies involved BSPTS therapy,and 6 studies involved SEAS therapy.(2)The network meta-analysis indicated that in terms of improving Cobb angle and reducing trunk rotation angle in scoliosis patients,the BSPTS therapy group and Schroth therapy group were better than the conventional control group[WMD=-4.60,95%CI(-8.37,-0.82),P<0.05;WMD=-3.37,95%CI(-4.98,-1.75),P<0.05;WMD=-3.20,95%CI(-5.50,-0.90),P<0.05;WMD=-2.13,95%CI(-3.16,-1.09),P<0.05].The Schroth therapy group performed better than the conventional control group effective in improving the International Society for Scoliosis Research-22 Questionnaire quality of life score[WMD=1.41,95%CI(0.07,2.75),P<0.05]. CONCLUSION:Given the current evidence,BSPTS therapy group and Schroth therapy group were better than the conventional control group in improving Cobb angle and reducing trunk rotation angle.In the comparison of different specific exercise therapies,BSPTS therapy can be preferred to improve Cobb angle and reduce trunk rotation angle in adolescent idiopathic scoliosis patients.In addition,Schroth therapy may be the best treatment to improve the quality of life of adolescent idiopathic scoliosis patients.Limited by the quantity and quality of the included studies,the above conclusions should be interpreted with caution and need more high-quality studies to further validation.
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Objective To evaluate the efficacy and safety of budesonide combined with pulmonary surfactant(PS)in the treatment of meconium aspiration syndrome(MAS)in neonates.Methods PubMed,Cochrane Central Register of Controlled Trials(Central),Embase,Web of Science,SinoMed,VIP,WanFang Data and CNKI databases were electronically searched to collect randomized controlled trials(RCTs)of budesonide combined with PS in the treatment of neonatal MAS from inception to September 2,2023.Two researchers independently screened literature,extracted data and assessed the risk of bias of the included studies,meta-analyses were performed by using the RevMan 5.4 software.Results A total of 6 RCTs involving 544 patients were included.The results of meta-analysis showed that compared with PS group,budesonide combined with PS group had higher overall effective rate(RR=1.29,95％CI 1.17 to 1.41,P＜0.001),shorter hospital stay(MD=-6.35,95％CI-9.25 to-3.46,P＜0.001)and shorter time of oxygen inhalation(MD=-1.61,95％CI-2.23 to-0.98,P＜0.001),shorter the duration of ventilator use(MD=-26.46,95％CI-35.98 to-16.95,P＜0.001),improved the blood gas analysis indexes at each time after treatment(P＜0.05);In terms of safety,the incidence of total complications and adverse reactions in budesonide combined with PS group was significantly lower(RR=0.35,95％CI 0.25 to 0.47,P＜0.001).Subgroup analysis showed that the incidence of persistent pulmonary hypertension of the newborn(PPHN)in the budesonide combined with PS group was decreased(RR=0.38,95％CI 0.19 to 0.74,P=0.004),and the incidence of pneumorrhagia was decreased(RR=0.26,95％CI 0.10 to 0.69,P=0.007),and the difference was statistically significant;the incidence of heart failure and sepsis was not statistically significant compared with the PS group(P＞0.05).Conclusion Current evidence shows that budesonide combined with PS in the treatment of neonatal meconium aspiration syndrome can improve the symptoms and signs of MAS children,improve the blood gas analysis index,accelerate disease rehabilitation,shorten the course of the disease,can help reduce the risk of complications and PPHN,pneumorrhagia,and doesn't increase the incidence of heart failure,sepsis.Due to the limited quantity of the included studies,more high-quality and large-sample RCTs are needed to further validate the above conclusions.
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Objective To systematically review the efficacy and safety of denosemab and zoledronic acid in patients with solid tumors bone metastases and multiple myeloma.Methods Pubmed,Embase,Cochrane Library,Web of Science,CNKI,WanFang Data and VIP databases were electronically searched for randomized controlled trials(RCTs)related to denosemab and zoledronic acid in the solid tumors bone metastases and multiple myeloma from inception to November 21,2023.Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies,and Meta-analysis was performed by using RevMan 5.3 software.Results A total of 5 RCTs,involving 8 957 patients were included.The results of Meta-analysis showed that denosumab was effective in delaying the time to first bone-related event(SRE)(HR=0.85,95％CI 0.80 to 0.92,P＜0.001)and the time to first and subsequent SRE time(HR=0.87,95％CI 0.79 to 0.96,P=0.004)were superior to zoledronic acid.Denosumab had lower incidence of nephrotoxicity(RR=0.70,95％CI 0.58 to 0.85,P＜0.001),acute phase response(RR=0.46,95％CI 0.40 to 0.51,P＜0.001),anemia(RR=0.91,95％CI 0.85 to 0.98,P=0.008)and appetite decreased/anorexia(RR=0.89,95％CI 0.81 to 0.98,P=0.02),but the incidence of hypocalcemia was higher(RR=1.72,95％CI 1.49 to 1.99,P＜0.001).There were no significant differences between denosumab and zoledronic acid in terms of overall survival,time to disease progression,incidence of adverse events and serious adverse events(P＞0.05).Conclusion Current evidence shows that compared with zoledronic acid,denosemab can significantly delay SREs induced by solid tumors bone metastases and multiple myeloma.In terms of safety,the risk of denosemab-induced nephrotoxicity,acute phase reactions,anemia and decreased appetite/anorexia are lower,but the risk of denosemab-induced hypocalcemia is higher.
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Objective To assess the safety of paliperidone palmitate(PP)injection versus other antipsychotic drugs long-acting injections(LAIs)in the treatment of schizophrenia.Methods PubMed,Web of Science,Embase,Cochrane Library,PsycINFO,CNKI,SinoMed,VIP and WanFang Data databases were searched to collect randomized controlled trials(RCTs)on PP injection versus other antipsychotic drugs LAIs in the treatment of schizophrenia from the inception to April 30,2023.Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies.Meta-analysis was then performed using RevMan 5.2 software.Results A total of 12 RCTs involving 4 368 patients were included.The results of Meta-analysis showed that there was no significant difference in clinical efficacy between PP injection treated group and risperidone LAIs treated group(P＞0.05),no significant difference was found for positive and negative syndrome scale(PANSS)overall score changes between PP injection treated group and other antipsychotic drugs LAIs treated group(P＞0.05).Compared with other antipsychotic LAIs treated groups,PP injection treated group had a significantly higher rate of total withdrawls(RR=1.14,95％CI 1.06 to 1.24,P＜0.01)and the incidence of adverse reactions of abnormal injection site(RR=2.08,95％CI 1.03 to 4.22,P=0.04).Conclusion Current evidence indicates that PP injection didn't show significant difference in efficacy outcomes,while may increase the incidence of some adverse reactions when compared with other antipsychotic drugs LAIs for schizophrenic.However,due to the limitations of the quantity and quality of the included studies,the above conclusions still need to be validated by more high-quality studies.
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Objective:To compare the short-term efficacy and the safety of microwave ablation (MWA) and radiofrequency ablation (RFA) in the treatment of benign thyroid nodules (BTNs).Methods:This prospective randomized controlled trial, performed from December 2019 to September 2021, included 36 patients with solid or predominantly solid BTNs who met the eligibility criteria and provided written informed consent at the Nanjing sub-center (Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine). Patients were assigned to either the MWA group or the RFA group (18 patients in each group) at a ratio of 1∶1 using a block randomization design and allocation concealment using sealed envelope randomization. The independent-sample t-test and χ2 test were used to compare the volume reduction rates (VRRs), effective rates (VRRs≥50%), cosmetic scores, and complication rates at 1, 3, and 6 months after treatment between the two groups. Results:The clinical characteristics of the two groups of patients were comparable. After ablation, the nodule volume was significantly reduced in both groups. At 1, 3, and 6 months, there was no significant difference in the volume between the two groups (all P>0.05). At 3 months, the RFA group had a larger VRRs than that in the MWA group (62.08%±12.46% vs. 46.90%±23.16%, t=-2.45, P=0.021). However, at 1 and 6 months, no statistical significance was observed (both P>0.05). No significant difference was observed in the effective rates at the last follow-up (14/18 vs. 18/18, P=0.104). However, the RFA group had a lower cosmetic score than that in the MWA group (1.78±0.43 vs. 2.17±0.51, t=-2.47, P=0.019). There was no statistically significant difference in the complication rates between the two groups (all P>0.05). Conclusions:Both MWA and RFA were effective and safe treatments for BTNs, with no significant differences in short-term efficacy and safety. In addition, the RFA group showed slightly more favorable outcomes than the MWA group in terms of cosmetic improvement.
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Objective:To observe the effects of warming triple needling plus Chinese medication on inflammatory responses and daily functioning ability in patients with knee osteoarthritis(KOA)due to wind-cold-dampness Bi-impediment. Methods:A total of 101 patients with KOA due to wind-cold-dampness Bi-impediment were divided into an acupuncture-medication group and a Chinese medication group using the random number table method.Fifty cases in the Chinese medication group took oral Fang Feng Xi Bi Tang for treatment,and 51 cases in the acupuncture-medication group received additional warming triple needling therapy.The symptom score of traditional Chinese medicine(TCM),inflammatory factor levels,and motor function of the knee joint were compared before and after treatment.The clinical efficacy was also compared between the two groups after treatment. Results:Three cases in the acupuncture-medication group and 2 cases in the Chinese medication group dropped out during the study,and the two groups each had 48 cases being included in statistical analysis ultimately.The total effective rate was 95.8%in the acupuncture-medication group,higher than 79.2%in the Chinese medication group,and the between-group difference was statistically significant(P<0.05).After treatment,the TCM symptom score dropped in both groups(P<0.05)and was lower in the acupuncture-medication group than in the Chinese medication group(P<0.05).The levels of interleukin(IL)-6,tumor necrosis factor(TNF)-α,and IL-1β dropped after the intervention in both groups(P<0.05)and were lower in the acupuncture-medication group than in the Chinese medication group(P<0.05).The scores of knee pain intensity,knee joint stiffness,and diurnal functioning decreased after treatment in the two groups(P<0.05)and were lower in the acupuncture-medication group than in the Chinese medication group(P<0.05). Conclusion:Warming triple needling plus Fang Feng Xi Bi Tang can reduce inflammatory responses,improve daily functioning ability,and enhance the quality of life in patients with KOA due to wind-cold-dampness Bi-impediment.
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Objective:To observe the effect of Tongguan Liqiao(opening orifices)needling plus tongue pressure resistance feedback training in treating post-stroke deglutition disorders. Methods:A prospective randomized controlled trial was conducted.A total of 120 patients with post-stroke deglutition disorders were divided into a control group and an observation group using the random number table method,with 60 cases in each group.Both groups were treated with routine treatments.The control group was treated with additional tongue pressure resistance feedback training,and the observation group was treated with additional Tongguan Liqiao needling based on the same intervention in the control group.After 4 weeks of treatment,the clinical efficacy was evaluated,and the complications that occurred during treatment were summarized.The FUJISHIMA Ichiro food intake level scale(FILS)and the swallowing quality of life questionnaire(SWAL-QOL)were scored before treatment and after 4 weeks of treatment. Results:The total effective rate of the observation group was higher than that of the control group(P<0.05).After 4 weeks of treatment,the FILS and SWAL-QOL scores in both groups were higher than those before treatment,and the scores in the observation group were higher than those in the control group(P<0.05).There was no statistical difference in the complication occurrence between the two groups(P>0.05). Conclusion:On the basis of routine treatments,Tongguan Liqiao needling plus tongue pressure resistance feedback training has a better effect in the treatment of post-stroke deglutition disorders.This method can effectively improve the swallowing function of patients,improve the quality of life,and is safe.
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Objective:To observe the effect of electroacupuncture(EA)combined with routine language and motor training on limb and language function,depression,and serum brain injury markers in patients with ischemic stroke. Methods:A total of 86 patients with ischemic stroke were selected and divided into an observation group and a control group using the random drawing method,with 43 cases in each group.Both groups received routine stroke treatments.The control group was additionally treated with routine language and motor training,and the observation group was additionally treated with EA treatment on the basis of the intervention of the control group.Changes in the limb function score,language function score,depression score,and brain injury marker protein were compared between the two groups,and the treatment safety of the two groups was evaluated. Results:The Fugl-Meyer assessment scale scores of both groups were higher than those before treatment(P<0.05),and the Fugl-Meyer assessment scale score of limb function of the observation group was higher than that of the control group(P<0.05).The language function score of the observation group was higher than that of the control group after treatment(P<0.05).The Montgomery-Asberg depression rating scale(MADRS)scores of the observation group were lower than those of the control group after treatment(P<0.05).The levels of brain injury markers heart-type fatty acid-binding protein(H-FABP),glial fibrillary acidic protein(GFAP),and annexin a7(ANXA7)of the observation group were lower than those of the control group(P<0.05).The incidence rate of adverse reactions in the two groups was 14.0%and 9.3%,respectively,with no statistically significant difference between the groups(P>0.05). Conclusion:EA combined with language and motor training is effective in the treatment of ischemic stroke.It can promote the recovery of limb motor function and language function,inhibit the occurrence of depression,and reduce the levels of brain injury markers,with good safety.
الملخص
Objective:To observe the efficacy of using electroacupuncture(EA)plus stuck-needle lifting method to treat intractable facial paralysis based on the myofascial theory. Methods:Ninety patients with intractable facial paralysis were divided into a control group and an observation group using the random number table method,with 45 cases in each group.The control group was given conventional EA treatment,and the observation group received EA plus the stuck-needle lifting method based on the myofascial theory for 4 consecutive weeks,6 sessions each week.The electromyographic results,modified Portmann scale(MPS)score,facial nerve function index(FNFI),and total effective rate were compared. Results:There were no significant differences in the MPS and FNFI scores between the two groups before treatment(P>0.05).After treatment,the total effective rate and FNFI and MPS scores were notably higher in the observation group than in the control group(P<0.05).There were no significant differences in the electromyographic readings between the two groups before the intervention(P>0.05).After the intervention,the observation group had a shorter blink reflex R1 latency and a higher facial nerve compound muscle action potential compared with the control group,and the between-group differences were statistically significant(P<0.05). Conclusion:EA plus stuck-needle lifting method based on the myofascial theory can enhance treatment efficacy for intractable facial paralysis.
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ObjectiveTo explore the effect of Dingkundan on Qi stagnation and blood stasis syndrome in patients with chronic obstructive pulmonary disease （COPD） at a stable phase. MethodA randomized controlled clinical design method was adopted， and 60 patients who were diagnosed with Qi stagnation and blood stasis syndrome in COPD at a stable phase in the outpatient and inpatient departments of the respiratory department of Guang' anmen Hospital of China Academy of Chinese Medical Sciences from June 2019 to December 2019 were divided into observation group and control group according to 1∶1. During the study period， there was no dropout， loss of follow-up， or exclusion between the two groups. On the basis of both groups receiving traditional Chinese medicine （TCM） lung rehabilitation training， the observation group took Dingkundan 7 g/time orally， twice a day. The control group received oral administration of the same specification of Dingkundan starch simulator of 7 g/time， twice a day. Both groups have a treatment period of 12 weeks. The COPD Assessment Test （CAT）， modified Medical Research Council （mMRC）， fatigue scale-14 （FS-14）， self-rating anxiety scale （SAS）， self-rating depression scale （SDS）， 6-minute walk distance （6MWD）， and pulmonary function before and after treatment were evaluated. ResultAfter treatment， both groups showed improvements in CAT， mMRC， FS-14， SAS scores， and 6MWD （P<0.05）. The observation group also showed improvements in SDS scores and lung function indicators （P<0.05）. Compared with the control group after treatment， the observation group showed more significant improvement in CAT， FS-14， SAS， SDS scores， and 6MWD （P<0.05）. ConclusionDingkundan has a clear therapeutic effect on Qi stagnation and blood stasis syndrome in patients with COPD at a stable phase. It can reduce symptom burden， enhance exercise capacity， and improve psychological status and has the potential to improve lung function.
الملخص
ObjectiveTo evaluate the clinical effectiveness and safety of acupuncture with manipulation for lumbar disc herniation in remission period. MethodsOne hundred and four patients with lumbar disc herniation in remission were randomly divided into a treatment group and a control group， with 52 cases in each group. Treatment group applied acupuncture with manipulation of pointing， pulling， and shaking. Acupoints were selected as lumbar Jiaji （EX-B2， bilateral）， Ashi point， Shenshu （BL 23， bilateral）， Huantiao （GB 30， bilateral）， Weizhong （BL 40， opposite side of the affected area）， Chengshan （BL 57， opposite side of the affected area）. The control group applied lumbar traction plus acupoint ultrasonic pulse penetration therapy （acupoints selection same as the treatment group）； 20 minutes each time， 3 times a week， a total of 3 weeks for both groups. The primary outcome was the improvement rate of lumbar disc herniation symptoms and signs， which was calculated at 1 week of treatment， 3 weeks of treatment， 1 month follow-up， and 3 months follow-up， respectively； the secondary outcome were the Japanese Orthopaedic Association （JOA） scores， Visual Analogue Scale （VAS） scores， and Oswestry Disability Index （ODI） scores （including ODI total scores， sitting scores and standing scores）， which were evaluated before treatment， 1 week of treatment， 3 weeks of treatment， 1 month follow-up， and 3 months follow-up； clinical effectiveness was assessed at 3 months follow-up； and the occurrence of adverse events in the participants， as well as blood routine， urine routine， stool routine， and electrocardiograms before and after the treatment were recorded to evaluate safety. ResultsTwo patients from each group fell out， and 50 patients of each group were included in the outcome analysis ultimately. The scores of lumbar disc herniation symptoms and signs improved more in the treatment group than in the control group at 1 week of treatment， 3 weeks of treatment， 1 month follow-up and 3 months follow-up （P＜0.01）. The JOA scores of participants in both groups at 1 week of treatment， 3 weeks of treatment， 1 month follow-up and 3 months follow-up were higher than those before treatment in the same group， and the VAS scores， ODI total scores， ODI sitting scores and standing scores were significantly lower than those before treatment in the same group （P＜0.05）， and the JOA scores of patients in the treatment group were higher than those of the control group at all time points， and the VAS scores， ODI total scores， ODI sitting scores and standing score were lower than those of the control group （P＜0.05）. At the 3 months follow-up， the excellent rate of the treatment group was 70.00% （35/50） better than that of the control group， which was 50.00% （25/50） （P＜0.05）. There were no abnormalities in blood， urine， stool routines and electrocardiograms before and after treatment in both groups， and no adverse events occurred. ConclusionAcupuncture with manipulation of pointing， pulling， and shaking for treating patients with lumbar disc herniation in remission has a better safety on pain relief and improving quality of life， and the effectiveness is better than lumbar traction plus acupoint ultrasonic pulse penetration therapy.