OBJECTIVE:To investigate the distribution of Traditional Chinese Medicine(TCM)constitution among individuals with functional constipation,which would provide insights for developing constitution-targeted prevention and treatment strategies. METHODS:A systematic search was conducted across eight databases(China National Knowledge Infrastructure Database,Wanfang Database,China Science and Technology Journal for Chinese Technical Periodicals,SinoMed,PubMed,Web of Science,Embase,and the Cochrane Library)to identify relevant observational studies assessing Traditional Chinese Medicine(TCM)constitution types among people with functional constipation.The protocol for this review has been registered on International Prospective Register of Systematic Reviews(registration number:CRD42022345996). RESULTS:A total of sixteen cross-sectional studies involving 2976 participants were included in this review.Among functional constipation patients,the proportions of Yin-deficiency,Yang-deficiency,and Qi-deficiency constitution were 27.0%[95%confidence interval(CI)19.9%to 36.7%],25.2%(95%CI 17.5%to 35.0%)and 23.7%(95%CI 15.8%to 34.0%),respectively.Besides,females accounted for a higher percentage of the population with functional constipation in the included studies,and most patients were aged 45 years or older.These findings may reflect the demographic characteristics of the general functional constipation population,where older adults and women are more commonly affected.The impact of gender and age on TCM constitution distribution merits further exploration. CONCLUSION:Our finding revealed that Yin-deficiency,Yang-deficiency,and Qi-deficiency are the predominant TCM constitution types in people with functional constipation.This study suggests that clinicians should focus on patients with these TCM constitution types in the prevention and management of functional constipation.Larger sample sizes and more rigorous methodological designs are needed in future studies.Furthermore,future researches should also focus on developing individualized prevention and treatment strategies based on different TCM constitution types.
Introduction In recent years, guidelines and consensus statements have recommended Chinese patent medicines (CPMs) for the treatment of functional constipation (FC). The latest Chinese Health Care Directory also lists CPMs for FC; however, the supporting evidence remains insufficient. In this study, we aimed to evaluate the effectiveness and safety of CPMs in the treatment of FC using a network-meta-analysis (NMA). Methods We searched for eligible randomized controlled trials (RCTs) published in the databases of PubMed, Cochrane Library, Embase, SinoMed, China National Knowledge Infrastructure, Wanfang, and Chinese Scientific Journals Database. Bayesian NMA and pairwise comparisons were performed to determine the frequency of spontaneous bowel movements, clinical effects, recurrence rate, dyschezia score, and defecation time score. Results A total of 61 studies were included. The methodological quality of the included studies was relatively poor, and the reliability of the synthetic outcomes was low. Our findings indicate that in older individuals, according to the self-established clinical efficacy criteria, Liuwei Anxiao combined with prokinetics demonstrated superior clinical effectiveness compared to prokinetic monotherapy (risk ratio [RR]: 1.46, 95% confidence interval [CI]: 1.17, 1.96), with lower scores for defecation times (mean difference: −0.30, 95% CI: −0.60, −0.02). Dalitong granules combined with prokinetics showed better clinical efficacy than prokinetic monotherapy (RR: 1.59, 95% CI: 1.03, 2.53). In older participants, based on published clinical efficacy criteria, Shouhui Tongbian capsule combined with an osmotic laxative exhibited superior clinical effectiveness compared to osmotic laxative monotherapy (RR: 1.21, 95% CI: 1.00, 1.48). Reported adverse events included stomachache, diarrhea, and nausea. Conclusions Several positive outcomes were observed, including better clinical effects across different criteria and lower defecation frequency scores. However, the quality of the included studies and the conclusions on CPM coverage areas were limited. Future research should include more high-quality studies directly comparing the effects of different CPMs.
Purpose:In recent decades, numerous non-invasive tests (NITs) for diagnosing nonalcoholic fatty liver disease (NAFLD) have been developed, however, a comprehensive comparison of their relative diagnostic accuracies is lacking. We aimed to assess and compare the diagnostic accuracy of various NITs for NAFLD using network meta-analysis (NMA). Materials and Methods:We conducted a systematic search in seven databases up to April 2024 to identify studies evaluating the diagnostic values of NITs, with liver biopsy as the gold standard. The participants included patients with suspected or confirmed NAFLD, irrespective of age, sex, ethnicity. Statistical analysis was conducted using R 4.0.3 for Bayesian NMA and STATA 17.0 for pairwise meta-analysis. Sensitivity, specificity, diagnostic odds ratio (DOR), area under the receiver operating characteristic curve (AUC), and superiority index were calculated. Bayesian calculations were performed using the Rstan package, specifying parameters like MCMC chain count, iteration count, and operational cycles. The methodological quality of included studies was assessed using the QUADAS-2 tool. Results:Out of 15,877 studies, 180 were included in the quantitative synthesis, and 102 were used in head-to-head meta-analyses. For diagnosing steatosis stage 1, Hydrogen Magnetic Resonance Spectroscopy (H-MRS, DOR 15,745,657.6, 95% CI 17.2-1,014,063.59) proved to be the most accurate. For significant fibrosis, HRI leading (DOR 80.94, 95% CI 6.46-391.41), For advanced fibrosis, CK-18 showed the highest performance (DOR 102654.16, 95% CI 1.6-134,059.8). For high-risk NASH, Real-Time Elastography showing the highest performance (DOR 18.1, 95% CI 0.7-96.33). Meta-regression analyses suggested that variability in the diagnostic accuracy of NITs for NAFLD may result from differences in study design, thresholds, populations, and performance indicators. Conclusion:We conducted a network meta-analysis to rank the accuracy of these tests. While some results are promising, not all NITs demonstrate substantial accuracy, highlighting the need for validation with larger datasets. Future research should concentrate on studying the thresholds of NITs and enhancing the clarity of methodological reporting.
Liuzijue is an essential nonpharmacological intervention within the comprehensive management strategies for chronic obstructive pulmonary disease (COPD) patients. However, the absence of an animal model for Liuzijue presents methodological limitations in its basic research. This study aimed to apply interventions with kinematic characteristics of Liuzijue to COPD mice, with the objective to explore an animal model of Liuzijue suitable for experimental studies. Forty-eight C57BL/6 mice randomly assigned into six groups to receive interventions mimicking Liuzijue's kinematic features, namely aerobic exercise, pursed-lip breathing and abdominal breathing. Post-intervention, respiratory function, diaphragmatic contractility, and rectus abdominis thickness were assessed. Histological structures of lung tissue, diaphragm, and rectus abdominis were observed using H&E staining. Expression levels of IL-10, INF-γ, and TNF-α in bronchoalveolar lavage fluid, and p65, CasP3, MuRF1, MyoD1, IGF-1, and Hspa5 in the diaphragm and rectus abdominis were measured. The modeling process impaired respiratory function and diaphragmatic contractility in mice. All four stimulation forms effectively improved pulmonary and diaphragmatic function in COPD mice. The thickness of the rectus abdominis was increased by three specified exercise forms. Despite minimal lung tissue structural changes, swimming and abdominal stimulation improved the structure of the rectus abdominis in COPD mice and airway inflammation levels were inhibited. Lastly, the four stimulations regulated the balance of myoprotein synthesis and degradation in the diaphragm and rectus abdominis, although the intervention effects of the four stimulations did not escalate with the complexity of the methods. The exercise stimulation paradigms established by simulating the kinematic characteristics of Liuzijue possess the therapeutic effects of Liuzijue in improving respiratory function, demonstrating first evidence that kinematic-based animal models can bridge traditional Qigong and modern mechanism research. However, the development of an animal model for the application of Liuzijue in basic research still warrants further exploration.
目的 以奇正消痛贴膏(1.8 g和1.2 g规格)为例,通过调研医生和患者了解不同规格中药外用贴剂临床应用病种、部位、敷贴数量等现状.方法 以来自全国28个省份开具过奇正消痛贴膏处方的医生及使用过该贴剂的患者为调研对象,采用横断面研究设计,整群抽样法,自行设计调查问卷,进行访问并收集资料.利用Epidata3.1录入数据,应用SPSS26.0统计软件进行分析.结果 共调查医生346人,患者255人.医生反馈1.8 g、1.2 g规格奇正消痛贴膏临床主要用于腰肌劳损/下腰痛(96.3%、94.5%)、肩周炎(95.0%、94.1%)、颈椎病/落枕(94.9%、91.7%)、急慢性扭挫伤或软组织损伤(92.5%、94.2%)、骨质增生/骨关节炎(93.6%、89.2%)、陈旧性伤痛(92.3%、88.6%)、跌打瘀痛(84.2%、85.8%)、骨骼肌肉疼痛(74.7%、88.6%)、风湿及类风湿疼痛(71.8%、84.2%)、骨折术后恢复期(61.5%、66.9%)的治疗.患者反馈的奇正消痛贴膏应用病种与医生反馈一致.奇正消痛贴膏治疗部位主要为颈(95.7%、97.3%)、肩(95.0%、96.2%)、腰(94.0%、92.9%)、背(89.1%、91.7%)、膝(86.6%、78.5%)、腕(80.3%、71.8%)、踝(78.5%、72.2%)、肘(75.7%、74.6%).治疗时普遍使用1贴/次,但1.2 g规格在肩部(46.6%)、背部(42.4%)、腰部(48.3%)多用2贴/次.1.2 g规格在四肢关节部位或局限性病灶推荐使用率略高于躯干部位病灶,1.8 g规格在躯干部位病灶推荐使用率略高于四肢关节部位或局限性病灶.结论 奇正消痛贴膏(1.8 g、1.2 g规格)临床主要用于骨骼肌肉系统疾病,2种规格贴膏均适宜于四肢关节部位和躯干部位应用,可有效缓解疼痛、肿胀、功能障碍,具有一定应用基础及可及性;且医生更倾向在颈、肩、腰、背等躯干部位使用1.8 g规格贴膏,以满足该类患者精准用药需求.
To identify the active constituents, core targets, immunomodulatory functions and potential mechanisms of Dizhi pill (DZP) in the treatment of myopia. The active constituents and drug targets of DZP were searched in the TCMSP, Herb databases and correlational studies. The targets of myopia were searched in the TTD, Genecards, OMIM and Drugbank databases. Gene expression profile data of GSE136701 were downloaded from the GEO database and subjected to WGCNA and DEG analysis to screen for significant modules and targets of myopia. Intersectional targets of myopia and DZP and core targets of myopia were analyzed through the String database. The GO and KEGG enrichment analyses of the interested targets were conducted. Cibersort algorithm was used for immune infiltration analysis to investigate the immunomodulatory functions of DZP on myopia. Autodock was used to dock the important targets and active constituents. Eight targets (STAT3, PIK3CA, PIK3R1, MAPK1, MAPK3, HSP90AA1, MIP, and LGSN) and 5 active constituents (Quercetin, Beta-sitosterol, Diincarvilone A, Ferulic acid methyl ester, and Naringenin) were identified from DZP. In pathways identified by the GO and KEGG enrichment analyses, "ATP metabolic process" and "AGE-RAGE diabetes complication signaling" pathways were closely related to the mechanisms of DZP in the treatment of myopia. Molecular docking showed that both the intersectional targets and core targets of myopia could bind stably and spontaneously with the active constituents of DZP. This study suggested that the mechanisms of DZP in the treatment of myopia were related to active constituents: Quercetin, Beta-sitosterol, Diincarvilone A, Ferulic acid methyl ester and Naringenin, intersectional targets: STAT3, PIK3CA, PIK3R1, MAPK1, MAPK3, and HSP90AA1, core targets of myopia: MIP and LGSN, AGE-RAGE signaling pathway, positive regulation of ATP metabolic process pathway and immunomodulatory functions.
目的 了解初中生膳食矿物质和维生素摄入状况,分析饮食行为与近视之间的关系.方法 采用整群抽样法,选取2018年7月至2019年3月北京市郊区某中学的所有初中生,应用24 h膳食回顾调查表及自编"1周内饮食行为问卷"进行膳食调查,采用NCCW营养软件分析矿物质和维生素摄入情况,采用全国通用的E字标准视力表对初中生进行视力检查.结果 本次共调查181名初中生,其中女生92人(50.8%),男生89人(49.2%).年龄10~16岁,平均(13.06±0.96)岁.蛋类、粗粮及大豆制品的食用情况不佳,能坚持一周内食用5~6次粗粮的初中生只有20人(11.0%).24h膳食回顾调查NCCW软件分析结果发现,该校初中生膳食矿物质的摄入中仅磷的摄入量男、女生均达到推荐摄入量的90%以上,其余矿物质和维生素摄入整体不足,其中钙的摄入量处于严重不足情况,摄入量仅为推荐摄入量的23.50%、26.62%.近视筛查发现,该校56.7%的初中生处于重度近视范围,其中女生左眼近视程度高于男生(P<0.05).不同程度近视随着矿物质和维生素摄入量不同出现差异,钙的摄入量在重度近视学生中要高于轻度及中度近视,差异有统计学意义(P<0.05).结论 该校初中生矿物质和维生素摄入量不足,其中矿物质钙与近视程度存在一定联系,建议家长及学校应在学生饮食上做到科学膳食均衡搭配,从饮食方面降低青少年近视发生风险.
Review question / Objective: To evaluate the effectiveness and safety of Chinese patent medicine in treatment of functional constipation by using the Network Meta-Analysis. 1. Types of participants: participants diagnosed as functional constipation according to Rome III, Rome IV or other published criteria or guidelines. No limitation on types of FC, age, sex, and nation. Children and pregnant women were excluded. Participants who had other constipation-related diseases including irritable bowel syndrome, functional defecation disorders and opioid-induced constipation were excluded. 2 Types of Interventions. Chinese patent medicine which have been registered with the approval batch number beginning with “Z,” approved by Chinese National Medical Product Administration (NMPA), used alone or in combination with Polyethylene Glycol, Lactulose, Bisacodyl, Prucalopride Succinate, probiotic, or Mosapride which recommended by latest clinical guidelines released by authorized organizations. The dosage, formulation, and route of administration of Chinese patent medicine were not limited. 3 Types of control. Registered Chinese patent medicines used alone, Polyethylene Glycol, Lactulose, Bisacodyl, Prucalopride Succinate, probiotic, Mosapride which recommended by latest clinical guidelines released by authorized organizations or placebo were eligible. 4 Types of outcomes. Primary outcomes were the clinical effect, score of dyschezia and defecation time. Secondary outcomes were adverse events and recurrence rate. 5 Types of study design. Parallel randomized controlled trials (RCTs) were included. Conference abstracts were excluded if full articles were not available.
BackgroundMalignant pleural effusion (MPE) is a common complication in patients with advanced lung cancer that can severely compromise the quality of life and limit life expectancy. Randomized controlled trials (RCTs) have shown that Chinese herbal injections (CHIs) may be beneficial in improving quality of life. This network meta-analysis (NMA) aims to explore several CHIs used for lung cancer patients with MPE.MethodsSeven databases were systematically searched for eligible RCTs from inception to November 2021. The primary outcome was the clinical effective rate. Secondary outcomes were the improvement rate of Karnofsky performance status (KPS) score and incidence of adverse events (AEs). The Cochrane risk of bias 2 tool was used to assess the quality of included studies. Data analysis was performed using STATA 16.0 and R software 4.1.0. Both pairwise meta-analysis and Bayesian NMA were conducted. Competing interventions were ranked using the surface under the cumulative ranking (SUCRA) probabilities. Evidence grading was evaluated using the Confidence in Network Meta-Analysis online software (https://cinema.ispm.unibe.ch/).ResultsA total of 44 studies involving 2,573 patients were included. The combined Huachansu injection (HCS) with intrapleural cisplatin (cis-diamminedichloro-platinum, DDP) had the highest probability of improving the clinical effective rate (SUCRA, 84.33%). The Kangai injection (KA) combined with DDP had the most improvement rate of KPS score (SUCRA, 80.82%), while the Fufangkushen injection (FFKS) alone was more likely to reduce AEs including gastrointestinal reactions (SUCRA, 89.92%), leukopenia (SUCRA, 91.85%), and chest pain (SUCRA, 98.17%). FFKS combined with DDP ranked the best in reducing the incidence of fever (SUCRA, 75.45%).ConclusionsOur NMA showed that CHIs alone or combined with DDP could improve clinical effectiveness and quality of life and reduce AEs, compared to DDP alone. HSC and KA, combined with DDP, may be the most effective considering clinical effective rate and improvement of KPS score, respectively. FFKS, either used alone or in combination therapy with DDP, may be the best in reducing AEs. However, high-quality RCTs with larger sample sizes are needed to further support the evidence.Systematic review registrationPROSPERO https://www.crd.york.ac.uk/prospero/, identifier CRD42021285275.
BACKGROUND:Ulcerative colitis (UC), a chronic inflammatory bowel disease, is characterized by abdominal pain, diarrhea, and mucopurulent bloody stool. In recent years, the incidence and prevalence of UC have been increasing consistently. Five-flavor Sophora falvescens enteric-coated capsule (FSEC), a licensed Chinese patent medicine, was specifically used to treat UC. This review was aimed to assess the effectiveness and safety of FSEC for the treatment of UC.METHODS:Six electronic databases were searched from inception to March 2021. Randomized clinical trials (RCTs) comparing FSEC or FSEC plus conventional Western medicine with conventional Western medicine in participants with UC were included. Two authors screened all references, assessed the risk of bias, and extracted data independently. Binary data were presented as risk ratios (RRs) with 95% confidence intervals (CIs) and metric data as mean difference (MD) with 95% CI. The overall certainty of the evidence was assessed by GRADE.RESULTS:We included 15 RCTs (1194 participants, 763 in the FSEC group and 431 in the control group). The treatment duration ranged from 42 to 64 days. Twelve trials compared FSEC with conventional Western medicine, and two trials compared FSEC plus conventional medicine with conventional medicine. Another trial compared FSEC plus mesalazine with compound glutamine enteric capsules plus mesalazine. FSEC showed a higher clinical effective rate (improved clinical symptoms, colonoscopy results, and stools) (RR 1.12, 95% CI 1.05 to 1.20; 729 participants; 8 trials; low-quality evidence) as well as the effective rate of traditional Chinese medicine (TCM) syndromes (RR 1.10, 95% CI 1.01 to 1.20; 452 participants; 5 trials; low-quality evidence) compared to mesalazine. There was no significant difference in the adverse events between FSEC and control groups.CONCLUSIONS:FSEC may show effectiveness in UC treatment compared to conventional medicine, and the use of FSEC may not increase the risk of adverse events. Due to the limited number of clinical trials and low methodological quality of the included trials, our findings must be interpreted with discretion.
目的 研制中医药个体预后与诊断预测模型研究报告规范(TRIPOD-TCM),为中医药临床预测模型研究者提供报告规范和建议.方法 对个体预后与诊断预测模型研究报告规范(TRIPOD)中的条目逐一解读,结合中医药研究特点,初步提出TRIPOD-TCM基本框架和相关条目;采用德尔菲法对专家进行两轮调研,每轮调研后,对专家意见进行整合并修订TRIPOD-TCM,形成最终TRIPOD-TCM清单.结果 对TRIPOD清单中14项条目应用于中医药领域时进行修订(包括条目1、2、3a、3b、4b、5b、5c、6a、10a、13b、13c、18、19b、20),对17项条目进行语言和举例的表述修订,6项条目维持原状.最终TRIPOD-TCM清单共包含6个方面22项条目的37项子条目.结论 初步研制的TRIPOD-TCM可用于支持研究者撰写出详细透明的中医药个体预后与诊断预测模型报告,提高中医药个体诊断与预后预测模型研究的报告规范.
ObjectiveTo evaluate the effectiveness and safety of Linggui Zhugan decoction (LZD) as an adjunct treatment of premature contraction in patients with coronary heart disease.MethodsPubMed, Embase, Web of Science, ClinicalTrials.gov Cochrane Library, Chinese Knowledge Infrastructure, Wanfang database, Sino Med, and VIP database were searched from inception until July 2022. Two reviewers independently selected randomized controlled trials assessing the effectiveness of LZD combined with conventional antiarrhythmic drugs in treating premature contraction in patients with coronary heart disease compared to conventional antiarrhythmic drugs only. The clinical effectiveness was considered as the primary outcome, and the times of premature junctional beats in 24 h after treatment along with adverse reactions were considered secondary outcomes. The Cochrane risk of bias 2 tool was used for the risk of bias assessment. Meta-analysis was conducted using RevMan 5.4.1. and RStudio software.ResultsA total of 14 studies including 1,236 participants were included. The primary outcome indicated that, compared with antiarrhythmic drugs alone (especially β receptor blockers), the combination of LZD and conventional antiarrhythmic drugs resulted in higher clinical effectiveness (RR = 1.29, 95% CI: [1.22,1.36]) and lower number of premature junctional beats in 24 h (MD = −71.14, 95% CI: [−76.23, −66.06]) at end-of-intervention. The differences in adverse reactions (RR = 0.42, 95%CI: [0.15, 1.14], p = 0.09) were not significant. The risk of bias was marginally high among the studies. Funnel plot and Harbord’s test (t = 1.63, p = 0.1346) indicated no existence of publication bias.ConclusionThe current evidence shows that LZD can increase the effectiveness of conventional antiarrhythmic drugs for treating premature contraction in patients with coronary heart disease. However, the results should be interpreted with caution because of the high overall risk of bias. Future studies with appropriate randomization and double-blind methods are warranted to confirm these findings.Systematic review registration[https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=296628], identifier [CRD42022296628].
Objective. To evaluate the effectiveness and safety of Chinese patent medicine for mild-to-moderate active ulcerative colitis (UC) using network meta-analysis (NMA). Methods. We systematically searched PubMed, Cochrane library, Embase, Sino-Med, China National Knowledge Infrastructure (CNKI), Wanfang, and Chinese Scientific Journal Database (VIP) databases to October, 2020. We included randomized controlled trials (RCTs) on Chinese patent medicine for mild-to-moderate active UC. The main analysis was complemented by network subanalyses and standard pairwise comparisons. Statistical heterogeneity, inconsistencies, and ranking probability were also evaluated. Results. The databases search identified 3222 citations, of which 33 RCTs involving 2971 patients met the inclusion criteria. A total of 15 Chinese patent medicines were analyzed. The overall quality of the included studies was low. Pairwise meta-analysis showed that Chinese patent medicine was superior to Mesalazine in improving disappearances of clinical symptoms, recurrence rate, and Mayo score. Based on decreases in adverse events, results from NMA showed that Xilei powder plus Mesalazine was more effective than other drugs. Other NMA results indicated that Danshen freeze-dried powder plus Mesalazine (RR: 0.13; 95% CI, 0.02–0.78) and Kangfuxin lotion plus Mesalazine (RR: 0.24; 95% CI, 0.07–0.57) were superior to Mesalazine in decreasing recurrence rate. Another NMA result indicated that Kangfuxin lotion plus Mesalazine (RR: 0.00; 95% CI, 0.00–0.02) and Zhi Kang capsule plus Mesalazine (RR: 0.00; 95% CI, 0.00–0.02) were superior to Mesalazine in increasing the disappearance of tenesmus. Conclusion. In the probability sorting, Xilei powder combined with Mesalazine ranked first for having the fewest adverse events, Maintaining Intestines Antidiarrheal Pills combined with Mesalazine ranked first for having the lowest recurrence rate, Xilei powder combined with Mesalazine ranked first for improving disappearance rate of mucopurulent bloody stool/abdominal pain, and Kangfuxin lotion combined with Mesalazine ranked first for improving the disappearance rate of diarrhea/tenesmus. However, there is a lack of direct comparisons among Chinese patent medicines for UC. More multiarm RCTs are needed in the future to provide direct comparative evidence.
目的 运用病例对照研究探讨中医药治疗与糖尿病视网膜病变发生的相关性,为该病的防治提供依据.方法 应用病例对照研究设计,在北京4家医院收集研究对象,以2型糖尿病合并视网膜病变的患者为病例组,以2型糖尿病不合并视网膜病变的患者为对照组,病例与对照以1:4的比例按照年龄、性别匹配研究对象.自行设计调查问卷,采用一对一调查的方式收集资料,应用Epi-Data 3.1软件录入数据,采用条件logistic回归的方法,应用SPSS 22.0软件分析中医药(治疗糖尿病或相关并发症为目的)与糖尿病视网膜病变患病的相关性.结果 病例组共纳入72例2型糖尿病合并视网膜病变的患者,对照组纳入236例2型糖尿病患者.病例组男性36人、女性36人,平均年龄(62.3±10.0)岁,病程[13(6,19)]年;对照组男性112人、女性124人,平均年龄(61.5±9.6)岁,病程[10(5,15)]年.单因素条件logistic回归分析显示病例组与对照组既往接受中医药治疗比例分别为52.8%和33.5%,差异有统计学意义(OR=2.505,95%CI:1.412-4.443).调整病程后,多因素条件logistic回归分析显示病例组与对照组既往接受中医药治疗比例差异有统计学意义(OR=2.296,95%CI:1.269-4.156).结论 中医药治疗与2型糖尿病患者是否合并视网膜病变具有相关性,有糖尿病视网膜病变的患者接受过中医药治疗的比例高且中医药治疗的平均时间较长,但鉴于病例对照研究的局限性,尚需要进一步前瞻性的研究设计结果加以证实.
Objective: Traditional Chinese medicines (TCMs) are efficacious against ulcerative colitis (UC). In recent years, the number of randomized clinical trials (RCTs) of TCM has increased. Thus, it is very important to summarize the basic characteristics, quality, and types of TCM interventions in published RCTs. This scoping review was performed to systematically identify and describe the current situations about RCTs of TCMs for treating UC. Hope to express the focus and specifics of nowadays research in TCM interventions in RCTs and evaluate their common disadvantages exposed to help advance in TCM researching. Materials and Methods: A scoping review was conducted according to the PRISMA extension for scoping reviews. We searched two English databases and four Chinese databases from the date of establishment of each database to January 2020. Data from RCTs focusing on any TCM treatment for patients with UC were extracted and evaluated. Selection and characterization were performed by two independent reviewers using predefined forms. All discrepancies were resolved by consensus discussion with a third reviewer. Microsoft Excel 2010 was used to extract the following data from the included studies: (1) basic information of the included studies including research ID, article title, publication language, journal, year of publication, and funding information; (2) patient information including gender, age, disease course, disease stage, severity, sample size; and (3) information on intervention measures, types of intervention measures, drug dosage forms, and treatment courses. Results: The search identified 2225 RCTs published between 1987 and 2020. These studies covered 36 provinces in China. The time frame of the RCTs was <28 days in approximately one-third of the RCTs (647, 29.08%). Only one RCT was published in English. Nearly three-quarters of RCTs (1665, 74.83%) did not report the severity of the disease. Three types of interventions were included in the RCTs: pharmacotherapy (2028, 91.15%), nonpharmacotherapy (57, 2.56%), and a combination of the two (140, 6.29%). The administration modes of the intervention groups were evaluated. Drug therapy involved 12 types of TCM dosage forms, which were decoctions, troches, powders, capsules, granules, pills, suppositories, ointments, injections, gels, oral liquids, and substitute tea according to the frequency of use. Nondrug intervention measures involved 10 treatment options, namely, acupuncture, moxibustion, hemospasia, auricular point, acupoint catgut embedding, acupoint injection, scrapping, tuina, acupoint application, and five-tone therapy according to the frequency of use. Most studies included in this review were low in quality. This underscores the need for improvement in the quality of trial methodology in TCM RCTs.
Objective:To evaluate the clinical effectiveness and safety of Jiuwei-Zhuhuang San plus amoxilcillin sodium and sulbactam sodium in the treatment of bacterial pneumonia in children. Methods:A total of 120 patients with bacterial pneumonia in children from 1 year to 14 years old were randomly divided into the study group ( n=90) and the control group ( n=30) with ratio 3 to 1, the random sequence created by SAS software. Both groups were treated with amoxilcillin sodium for basic treatment, the observation group was treated with Jiuwei-Zhuhuang San. Both groups were treated for 1 week and followed up for 1 week. The cough frequency, clinical effective rate, symptoms and signs score, Traditonal Chinese medicine (TCM) pattern scores and adverse event rate were observed. Results:Eighteen cases were dropped and eliminated in the observation group, and 4 cases were dropped and eliminated in the control group, so 72 of observation group and 26 of control group were analyzed. After treatment, the clinical effective rate of the observation group was 27.8% (20/72), and the control group was 0% (0/26), where the difference was significant ( χ2=7.445, P=0.006). The difference of TCM syndrome score before and after treatment in the observation group (-16.8 ± 8.2 vs. -11.0 ± 5.8, t=-3.858) was lower than that of the control group ( P<0.01). There was significant difference between the two groups ( Z=-2.347, P= 0.019) in the TCM syndrome. The cough frequency of the observation group was 41.7% (30/72), and the control group was 26.9% (7/26). There wasn’t any significant differences in the cough frequency between two groups ( P>0.05). There was no statistical difference in symptoms and signs score or adverse event rate between two groups ( P>0.05). Conclusion:On the basis of amoxicillin sodium and sulbactam sodium, combined use of Jiuwei-Zhuhuang San can improve the clinical effectiveness of children with bacterial pneumonia.
目的 系统梳理中药制剂治疗溃疡性结肠炎(UC)随机对照试验(RCT)的方法学和临床特征,为深入进行荟萃分析以及为临床试验核心指标集的构建提供参考.方法 计算机检索中国知网、维普数据库、万方数据知识服务平台、中国生物医学文献服务系统、PubMed、Cochrane Library从建库至2020年6月6日收录的中药治疗UC的RCT,进行资料提取,分析其方法学质量和临床特征.结果 共检索到中药制剂治疗UC的文献11527篇,最终纳入406篇,包括35485例受试者.单中心临床试验占比最高(332/406,81.8%),35.5% (144/406)的试验报告了详细的随机方法,4.9% (20/406)的试验实施了盲法.干预措施共261种,包含中成药21种,有3种方药的RCT研究超过10项.汤剂是最常见的中药剂型,给药途径多见口服、灌肠或二者结合,82.0%(214/261)的干预措施仅有1项随机对照试验.临床综合疗效是受关注最多的结局指标.结论 中药制剂治疗UC的RCT研究大多数干预方案RCT证据不足,同时需要关注对于缓解期患者的药物干预及卫生经济学、生命质量、安全性指标等结局指标的报道.
Background Traditional Chinese Medicine (TCM) has been a proposed treatment option for ulcerative colitis (UC), however it has been difficult to understand the breadth and depth of evidence as various Chinese medicine therapies may produce effects differently. The aim of this evidence mapping is to visually understand the available evidence in the use of TCM in the treatment of UC, and to identify gaps in evidence to inform priorities of future research. Methods A systematic electronic literature search of six databases were performed to identify systematic reviews (SRs) on different Chinese medicine therapies in the treatment in UC. Methodological quality of the included SRs was assessed using AMSTAR 2. Results The mapping was based on 73 SRs, which included nine interventions that met eligibility criteria. The quality of the included SRs was very low. The diseases stages of patients with UC varied greatly, from active to remission, to non-acute outbreak, to not reported. The results mostly favored the method of intervention. Oral administration combined with enema was the most widely used route of administration in secondary research. Conclusion Based on the current evidence, the treatment of UC with TCM can only be recommended cautiously. A majority of included SRs did not report the location of the disease, the disease classification, and the route of administration of the intervention. Further research is needed on the effectiveness of Chinese medicine alone in the treatment of UC. The effectiveness of combined Chinese and conventional medicine combined with different routes of administration cannot be confirmed. Attention should be paid to the methodological quality of the systematic review. Unifies the outcome indicators used in the evaluation of effectiveness.