殊群体的健康状况不容乐观。因此,为成为一个健康的高校教师,首先从自身做起,树立正确的健康意识,克服不良的生活习惯,保持健康的生活方式,进行积极的自我尝试学会调节情绪,维护心理平衡,悦纳自己,积极参与其他社会活动、体育锻炼,寻求多方面支持;其次,学校要定期为教师做体检,特别是政府和社会要全面关注年轻教师的生理、心理健康,和社会应激能力,采取各种针对性的预防干预措施,对预防亚健康状态的发生,防治疾病,提高教师的整体健康水平具有重要的现实意义。 The health status of special groups remains concerning. Therefore, to become a healthy university teacher, one must first start with oneself by establishing proper health awareness, overcoming unhealthy habits, maintaining a healthy lifestyle, actively attempting self-regulation of emotions, preserving psychological balance, accepting oneself, and actively participating in social activities and physical exercise while seeking multifaceted support. Secondly, schools should conduct regular health check-ups for teachers. In particular, the government and society should comprehensively address the physical and mental health of young teachers, as well as their social stress resilience, by implementing targeted preventive interventions. This approach holds significant practical importance for preventing suboptimal health conditions, combating diseases, and improving the overall health level of teachers.
参 考 文 献 References
[1]傅善来. 21 世纪健康新视角.上海:上海科技教育出版社,2000 FU Shan-lai.New Perspective of Twenty-First Century Health. Shanghai:Shanghai Scientific and Technological Education Publishing House,2000 [1] FU Shan-lai. New Perspective of Twenty-First Century Health. Shanghai: Shanghai Scientific and Technological Education Publishing House, 2000
[2]赵瑞芹,宋振峰.亚健康问题的研究进展.国外医学•社会医学分册,2002,19(1):10-13 [2] Zhao Ruiqin, Song Zhenfeng. Research progress on sub-health issues. Foreign Medical Sciences • Social Medicine Edition, 2002, 19(1): 10-13
ZHAO Rui-qin,SONG Zhen-feng.The research progress of sub- health problem.Foreign medicine *\cdot Social Medicine,2002,19(1): 10-13 ZHAO Rui-qin, SONG Zhen-feng. The research progress of sub-health problem. Foreign Medicine *\cdot Social Medicine, 2002, 19(1): 10-13
[3]王文丽,周明,王力,等.亚健康的概念、特点及与慢性疲劳综合征的关系.中华行为医学与脑科学杂志,2010,19(1):91 [3] Wang Wenli, Zhou Ming, Wang Li, et al. The concept, characteristics of sub-health and its relationship with chronic fatigue syndrome. Chinese Journal of Behavioral Medicine and Brain Science, 2010, 19(1): 91
WANG Wen-li,ZHOU Ming,WANG Li,et al.Health concepts, characteristics and the relationship between chronic fatigue syndrome.Chinese Journal of behavioral medicine,2010,19(1):91 WANG Wen-li, ZHOU Ming, WANG Li, et al. Health concepts, characteristics and the relationship between chronic fatigue syndrome. Chinese Journal of Behavioral Medicine, 2010, 19(1): 91
[4]陈国元,刘卫东,杨磊.教师"亚健康"现状及预防对策研究.职业卫生与病伤,2000,15:101-103 [4] CHEN Guo-yuan, LIU Wei-dong, YANG Lei. Research on the current status of "sub-health" among teachers and preventive measures. Occupation and Health, 2000, 15: 101-103
CHEN Guo-yuan,LIU Wei-dong,YANG Lei."sub-health"status and prevention countermeasure research.Occupation health and disease injury,2000,15:101-103 CHEN Guo-yuan, LIU Wei-dong, YANG Lei. "Sub-health" status and prevention countermeasure research. Occupation Health and Disease Injury, 2000, 15: 101-103
[5]朱丽,王声涌,范存欣,等.高校青年教师亚健康危险因素 Logistic回归分析.中国公共卫生,2003,19(5):595-596 [5] ZHU Li, WANG Sheng-yong, FAN Cun-xin, et al. Logistic regression analysis of risk factors for sub-health among young college teachers. Chinese Journal of Public Health, 2003, 19(5): 595-596
ZHU Li,WANG Sheng-yong,FAN Cun-xin,et al.Young college teachers'sub health risk factors for logistic regression analysis. China public health,2003,19(5):595-596 ZHU Li, WANG Sheng-yong, FAN Cun-xin, et al. Young college teachers' sub-health risk factors for logistic regression analysis. China Public Health, 2003, 19(5): 595-596
(收稿日期:2011年10月3日) (Received: October 3, 2011)
中医药治疗小儿遗尿症系统评价 Systematic Review of Traditional Chinese Medicine in Treating Pediatric Enuresis
戎萍 ^(1){ }^{1} ,赵玉生 ^(1){ }^{1} ,马融 ^(1){ }^{1} ,胡思源 ^(1){ }^{1} ,钟成梁 ^(1){ }^{1} ,赵金生 ^(2){ }^{2} RONG Ping ^(1){ }^{1} , ZHAO Yu-sheng ^(1){ }^{1} , MA Rong ^(1){ }^{1} , HU Si-yuan ^(1){ }^{1} , ZHONG Cheng-liang ^(1){ }^{1} , ZHAO Jin-sheng ^(2){ }^{2}( ^(1){ }^{1} 天津中医药大学第一附属医院,天津 300193;^(2){ }^{2} 天津中医药大学,天津 300193) ( ^(1){ }^{1} First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China; ^(2){ }^{2} Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China)
Abstract
摘要:目的:分析中医药治疗小儿遗尿症的疗效。方法:计算机检索1979年至2011年1月20日期间国内各种医学期刊。纳人以小儿遗尿症患者为研究对象、中药或中成药与西药治疗效果的随机对照试验,由 2 名评价者独立提取资料并交叉核对,而后按照Cochrane Handbook 5.0进行质量评估,并运用RevMan 5.0.2软件进行Meta分析。结果:最终纳入 7 个随机对照试验,共 1476 例患儿,Meta分析结果显示,可以认为中医药相对阳性西药对于小儿遗尿症的疾病疗效、中医证候疗效方面有一定的优势,且安全性可靠。结论:尚需更多大样本、高质量的随机对照试验来进一步证实中医药治疗小儿遗尿症的疗效。 Objective: To analyze the efficacy of traditional Chinese medicine (TCM) in treating pediatric enuresis. Methods: Computerized searches were conducted on various domestic medical journals from 1979 to January 20, 2011. Randomized controlled trials (RCTs) comparing the therapeutic effects of TCM or Chinese patent medicines with Western medicine in pediatric enuresis patients were included. Two reviewers independently extracted data and cross-checked the results. Quality assessment was performed according to the Cochrane Handbook 5.0, and Meta-analysis was conducted using RevMan 5.0.2 software. Results: A total of 7 RCTs involving 1,476 children were ultimately included. Meta-analysis results indicated that TCM may have certain advantages over positive Western medicine controls in terms of disease efficacy and TCM syndrome efficacy for pediatric enuresis, with reliable safety. Conclusion: More large-sample, high-quality randomized controlled trials are needed to further confirm the efficacy of TCM in treating pediatric enuresis.
关键词:中医药;小儿遗尿症;随机对照试验;系统评价 Keywords: Traditional Chinese Medicine; Pediatric Enuresis; Randomized Controlled Trial; Systematic Review
基金资助:儿科中药新药临床评价研究技术平台规范化建设(No.2011ZX09302-006-03) Funding: Standardized Construction of Clinical Evaluation Research Technology Platform for New Pediatric TCM Drugs (No. 2011ZX09302-006-03)
Systematic evaluation of literatures of TCM on nocturnal enuresis in children
RONG Ping ^(1){ }^{1} ,ZHAO Yu-sheng ^(1){ }^{1} ,MA Rong ^(1){ }^{1} ,HU Si-yuan ^(1){ }^{1} ,ZHONG Cheng-liang ^(1){ }^{1} ,ZHAO Jin-sheng ^(2){ }^{2}( ^(1){ }^{1} Affiliated Hospital of Tianjin University of TCM,Tianjin 300193,China;^(2){ }^{2} Tianjin University of TCM,Tianjin 300193,China)
Abstract
Objective:To analysis the curative effect of the traditional Chinese medicine on nocturnal enuresis in children. Methods:To retrieve all sorts of domestic medical journals from 1979 to 2011.1.20 by computer.With these nocturnal enuresis children into in patients as the research object,traditional Chinese medicine and western medicine therapy or Chinese patent Objective: To analyze the curative effect of traditional Chinese medicine on nocturnal enuresis in children. Methods: Retrieve various domestic medical journals from 1979 to January 20, 2011, using computerized searches. With pediatric nocturnal enuresis patients as the research subjects, compare traditional Chinese medicine therapy with Western medicine treatment or Chinese patent..
medicine effect of randomized controlled trials,by two independent evaluators extraction material and cross check,and then according to the Cochrane Handbook 5.0 analyse the quality of these researches,and the RevMan 5.0.2 software Meta to analysis. Results: 7 randomized controlled trials were brought,including 1476 patients,Meta analysis shows that,traditional Chinese medicine for these children has certain advantages in curative effect compared with positive western medicine,and is safety and reliable.Conclusion:More large sample,high quality of randomized controlled trials are needed to further proof the curative effect of traditional Chinese medicine on nocturnal enuresis children. Evaluation of randomized controlled trials on the efficacy of traditional Chinese medicine in treating pediatric enuresis was conducted by two independent reviewers who extracted data and performed cross-verification. The quality of the studies was assessed according to the Cochrane Handbook 5.0, followed by Meta-analysis using RevMan 5.0.2 software. Results: Seven randomized controlled trials involving 1,476 patients were included. Meta-analysis demonstrated that traditional Chinese medicine exhibits certain therapeutic advantages over conventional Western medicine for pediatric enuresis, with proven safety and reliability. Conclusion: Larger-scale, high-quality randomized controlled trials are required to further validate the efficacy of traditional Chinese medicine in treating children with nocturnal enuresis.
Key words:TCM;Nocturnal enuresis in children;Randomized controlled trial;System evaluation Keywords: TCM; Nocturnal enuresis in children; Randomized controlled trial; Systematic review
Fund assistance:Standardization Construction in Clinical Evaluation Research Technology Platform of Chinese Herbal's Fund assistance: Standardization Construction in Clinical Evaluation Research Technology Platform of Chinese Herbal's
New Medicine in Pediatric(No.2011ZX09302-006-03) New Medicine in Pediatrics (No. 2011ZX09302-006-03)
目前国际上广泛接受的2006年国际小儿尿控协会提出的遗尿症定义是, 5 岁以上儿童不能从睡眠中醒来而反复发生无意识排尿行为 ^([1]){ }^{[1]} 。其 5 岁时发病率为 15%-20%15 \%-20 \% ,7岁时发病率为 10%10 \% ,虽然每年以 15%15 \%的比例自然消退,但仍然有 1%-2%1 \%-2 \% 的患儿症状持续到成人,给患儿身心健康带来严重影响。男孩较女孩多见 ^([2]){ }^{[2]} 。一般认为,遗传、睡眠觉醒障碍、抗利尿激素分泌异常、膀胱功能障碍,以及心理因素等,都可能与遗尿症的发病有关。 The internationally widely accepted definition of enuresis proposed by the International Children's Continence Society in 2006 is the repeated involuntary urination during sleep in children over the age of 5 who fail to wake up ^([1]){ }^{[1]} . The incidence rate is 15%-20%15 \%-20 \% at age 5 and 10%10 \% at age 7. Although the condition naturally resolves at a rate of 15%15 \% per year, approximately 1%-2%1 \%-2 \% of affected children continue to experience symptoms into adulthood, significantly impacting their physical and mental health. The condition is more common in boys than girls ^([2]){ }^{[2]} . It is generally believed that factors such as genetics, sleep arousal disorders, abnormal secretion of antidiuretic hormone, bladder dysfunction, and psychological factors may contribute to the onset of enuresis.
去氨加压素(DDAVP,弥凝)作为治疗遗尿症的首选西药,其疗效肯定,但治疗后仅有 30%30 \% 的患者完全有效,且停药复发率高,价格昂贵,需要限制水分的摄入等限制,影响了药物的推广和疗效 ^([3]){ }^{[3]} 。相对西药,中医药治疗小儿遗尿症历史悠久,报道取得较好的效果,且复发率较低,不良反应少。但因中医临床研究对方法学的重视仍不够,临床试验的规范性较差,对中医药临床疗效缺乏客观、科学的评价,影响了研究结论的推广和国外医学的承认。鉴于此,本研究按照系统评价的方法,比较中药、中成药与西药治疗小儿遗尿症的有效性和安全性。 Desmopressin (DDAVP, Minirin), as the first-line Western medication for treating enuresis, has confirmed efficacy. However, only 30%30 \% of patients achieve complete effectiveness after treatment, and the recurrence rate after discontinuation is high. Additionally, its high cost, the need for fluid intake restrictions, and other limitations hinder its widespread use and therapeutic outcomes ^([3]){ }^{[3]} . In contrast, traditional Chinese medicine (TCM) has a long history of treating pediatric enuresis, with reported better outcomes, lower recurrence rates, and fewer adverse effects. However, due to insufficient attention to methodology in TCM clinical research, poor standardization of clinical trials, and a lack of objective and scientific evaluation of TCM's clinical efficacy, the promotion of research findings and recognition by international medical communities are limited. Given this, this study systematically evaluates the effectiveness and safety of Chinese herbal medicine and proprietary Chinese medicines compared to Western medications in treating pediatric enuresis.
资料与方法 Materials and Methods
1.研究对象 检索中国生物医学文献数据库 (1979年1月-2011年1月)、中国知网(1979年1月- 2011年1月)、维普数据库(1989年1月-2011年1月)和万方数字化期刊群(1998年1月-2011年1月)上的中医药治疗小儿遗尿症的所有的随机对照试验或半随机对照试验或自称是随机对照试验。所有检索均截至2011年1月20日。 1. Study Subjects
All randomized controlled trials (RCTs), quasi-randomized controlled trials, or self-proclaimed RCTs on TCM treatment for pediatric enuresis were retrieved from the Chinese Biomedical Literature Database (January 1979–January 2011), China National Knowledge Infrastructure (January 1979–January 2011), VIP Database (January 1989–January 2011), and Wanfang Digital Journal Database (January 1998–January 2011). All searches were conducted up to January 20, 2011.
2.纳入标准(1)文献的内容提示有中医药治疗小儿遗尿症的临床研究报道;(2)文献中的分组法出现 "随机"、"对照"的字样,无论其是否使用盲法;(3)试验组均采用中药或中成药治疗,不合并使用其他治疗方法;对照组采用弥凝或盐酸甲氯芬酯或安慰剂治疗;(4)研究对象只有 1 个治疗组和 1 个对照组;(5)主要结局指标是有效事件的发生率。 2. Inclusion Criteria
(1) The literature must report clinical research on TCM treatment for pediatric enuresis.
(2) The grouping method in the literature must mention "randomized" or "controlled," regardless of whether blinding was used.
(3) The treatment group must use Chinese herbal medicine or proprietary Chinese medicines without combining other therapies, while the control group must use Minirin, meclofenoxate hydrochloride, or a placebo.
(4) The study must include only one treatment group and one control group.
(5) The primary outcome measure must be the incidence of effective events.
3.排除标准(1)疗效评定未详细公布治疗结果 3. Exclusion criteria (1) Studies that did not provide detailed treatment outcomes for efficacy evaluation;
者;(2)无明确的西医或中医诊断标准者。 (2) Studies lacking clear Western or traditional Chinese medicine diagnostic criteria.
4.质量评价 根据Cochrane Reviewer's Handbook 5.0.2评价标准,分别按分配序列的产生、隐蔽分组、盲法、失访和意向性分析情况评估每个 RCT 的质量,将每项分为"恰当"、"不恰当"、"不清楚" 3 个等级以 AA 、 BB 、 CC 来进行判定。意见不一致时通过和第 3 位评价者讨论决定。 4. Quality assessment According to the Cochrane Reviewer's Handbook 5.0.2 evaluation criteria, the quality of each RCT was assessed based on the generation of allocation sequences, concealment of allocation, blinding, loss to follow-up, and intention-to-treat analysis. Each item was categorized into three levels: "adequate," "inadequate," or "unclear," represented by AA , BB , and CC , respectively. Discrepancies were resolved through discussion with a third evaluator.
5.研究方法 5. Research methods
5.1 疗效指标的选择 在中医药治疗小儿遗尿症的研究中,主要采用临床疗效、中医证候疗效作为疗效判定指标,根据国家或行业公认的疗效判定标准一般将其分为治愈、显效、有效、无效 4 级。将等级资料合并为二分类资料,即试验组治愈、显效、有效合并为有效进行统计分析。 5.1 Selection of Efficacy Indicators
In studies on traditional Chinese medicine (TCM) for treating pediatric enuresis, clinical efficacy and TCM syndrome efficacy are primarily used as evaluation criteria. Based on nationally or industry-recognized standards, efficacy is generally classified into four levels: cured, markedly effective, effective, and ineffective. Ordinal data are combined into binary data, where cured, markedly effective, and effective outcomes in the experimental group are merged as "effective" for statistical analysis.
5.2 统计软件及其数据分析 采用Cochrane协作网提供的RevMan 5.0.2软件进行数据分析。计数资料用优势比 (OR)(O R) ,计量资料采用加权均数差 (WMD),两者均以 95%95 \% CI表示。采用 chi^(2)\chi^{2} 检验分析,显著性水平设定为 alpha=0.01\alpha=0.01 。 5.2 Statistical Software and Data Analysis
Data analysis was performed using RevMan 5.0.2 software provided by the Cochrane Collaboration. Dichotomous data were expressed as odds ratios (OR), while continuous data were presented as weighted mean differences (WMD), both with 95% confidence intervals (CI). Heterogeneity was assessed using the I² test, with the significance level set at P < 0.05.
5.3 异质性检验 无临床异质性测量结果采用固定效应模型( P > 0.1P>0.1 或 I^(2) < 50%\mathrm{I}^{2}<50 \% );若异质性明显,查找原因,去除对研究影响较大的研究后进行比较;若未找出临床和方法学异质性,则采用随机效应模型进行合并分析,并谨慎解释研究结果。 5.3 Heterogeneity Test
For measurement outcomes without clinical heterogeneity, a fixed-effects model ( P > 0.1P>0.1 or I^(2) < 50%\mathrm{I}^{2}<50 \% ) was used. If significant heterogeneity was observed, potential causes were investigated, and studies with substantial influence were excluded before comparison. If no clinical or methodological heterogeneity was identified, a random-effects model was employed for pooled analysis, with results interpreted cautiously.
5.4 发表性偏倚检测 对潜在的发表偏倚采用 "漏斗图"进行分析。 5.4 Publication Bias Detection
Potential publication bias was analyzed using a "funnel plot."
结果 Results
1.文献概况 11篇符合纳人标准的文献中排除 2篇未详细公布治疗结果的文献、 2 篇没有明确诊断标准的文献。得到采用随机对照方法,符合研究标准的中医药治疗小儿遗尿症的临床研究共 7 篇。 7 篇文献中有 1 篇将遗尿患儿分为了功能性、器质性、原发性、继发性,其余 6 篇文献的研究对象均为原发性小儿遗尿症患儿。有2篇文献自行设置了计分方法,按分数的高低对遗尿患儿的病情进行了轻、中、重度的分级,有 1 篇文献只对患儿的病情进行了分级,但未 1. Literature Overview
Among the 11 articles meeting the inclusion criteria, 2 were excluded due to insufficiently detailed treatment outcomes, and 2 lacked clear diagnostic standards. A total of 7 clinical studies using randomized controlled methods and meeting the research criteria for traditional Chinese medicine treatment of pediatric enuresis were identified. Among these 7 articles, 1 classified enuretic children into functional, organic, primary, and secondary types, while the remaining 6 focused solely on primary pediatric enuresis. Two articles established their own scoring methods to grade the severity of enuresis (mild, moderate, or severe) based on scores, and 1 article graded the severity of the condition without specifying the method.
描述分级方法。 Description of grading methods.
1.1 患者情况 见表1。7篇文献共纳入 1476 例病人;年龄 4 岁以上;病程 3 个月 -10 年不等,其中 3 篇未提及, 1 篇描述不清;有 5 篇文献对研究对象的基线进行了描述,另外 2 篇未提及;诊断标准不统一;有 2篇文献详细说明了纳入标准, 2 篇文献制定了排除标准,其余文献未提及。 1.1 Patient Characteristics See Table 1. A total of 1,476 patients were included across 7 studies; all participants were aged 4 years or older; disease duration ranged from 3 months to 10 years (3 studies did not report this information, while 1 provided unclear descriptions); 5 studies described baseline characteristics of participants, while 2 did not mention them; diagnostic criteria were inconsistent; 2 studies specified inclusion criteria in detail, 2 established exclusion criteria, and the remaining studies did not mention these criteria.
1.2 干预措施 见表2。所有文献对照组均为阳性西药对照,无安慰剂组。其中试验组有 2 篇采用中成药治疗, 5 篇采用中药自拟方治疗;对照组 2 篇采用弥凝治疗, 5 篇采用盐酸甲氯芬酯治疗。 1.2 Interventions See Table 2. All control groups in the literature used positive Western medicine controls, with no placebo groups. Among them, the experimental group included 2 studies using Chinese patent medicines and 5 studies using self-formulated Chinese herbal prescriptions; the control group included 2 studies using Minirin treatment and 5 studies using Meclofenoxate Hydrochloride treatment.
1.3 结局指标 7篇文献均选用有效事件发生率作为结局指标,所采用的疗效判断标准以自拟标准最多。另有 2 篇文献还采用了遗尿次数等作为评价指标。 1.3 Outcome Measures
All seven studies selected the incidence of effective events as the outcome measure, with most using self-developed criteria for efficacy evaluation. Additionally, two studies also adopted metrics such as the frequency of bedwetting as evaluation indicators.
1.4 纳入文献质量 见表3。7篇文献对于隐蔽分组、盲法、失访和意向性分析均未描述,只有 2 篇 1.4 Quality of Included Literature See Table 3. None of the 7 articles described allocation concealment, blinding, loss to follow-up, or intention-to-treat analysis, with only 2 articles mentioning...
文献既描述了随机序列的产生,又设立了盲法, 1 篇文献仅限定了盲法。实行随机对照试验的整体质量偏低。 The literature describes both the generation of random sequences and the establishment of blinding, with one study only specifying blinding. The overall quality of the implemented randomized controlled trials is relatively low.
2.疗效及安全性分析 2. Efficacy and Safety Analysis
2.1 小儿遗尿宁颗粒组与盐酸甲氯芬酯组对照 2 篇文献均报道了两组治疗肾气不足型小儿遗尿症的疾病有效率及中医证候有效率,各研究间无统计学异质性差异( P=0.63,I^(2)=0%P=0.63, \mathrm{I}^{2}=0 \% )及( P=0.29,I^(2)=11%P=0.29, \mathrm{I}^{2}=11 \% ),故采用固定效应模型进行Meta分析。图1-图2结果显示,与单纯盐酸甲氯芬酯治疗组相比,小儿遗尿宁颗粒对肾气不足型小儿遗尿症的治疗效果不劣于对照药盐酸甲氯芬酯胶囊:OR=1.28,95%CI[0.80,2.06],P=0.30O R=1.28,95 \% \mathrm{CI}[0.80,2.06], P=0.30 。 2.1 Comparison between Xiaoer Yiniaoning Granule Group and Meclofenoxate Hydrochloride Group
Both included studies reported the disease efficacy rate and TCM syndrome efficacy rate for treating enuresis in children with kidney qi deficiency. No statistical heterogeneity was observed among the studies ( P=0.63,I^(2)=0%P=0.63, \mathrm{I}^{2}=0 \% and P=0.29,I^(2)=11%P=0.29, \mathrm{I}^{2}=11 \% ), so a fixed-effects model was used for Meta-analysis. Figures 1–2 show that, compared with the meclofenoxate hydrochloride monotherapy group, Xiaoer Yiniaoning Granule demonstrated non-inferior efficacy in treating enuresis in children with kidney qi deficiency relative to the control drug meclofenoxate hydrochloride capsules: OR=1.28,95%CI[0.80,2.06],P=0.30O R=1.28,95 \% \mathrm{CI}[0.80,2.06], P=0.30 .
Study or Subgroup
Experimental
Control
Weight
Odds Ratio M-H,Fixed,95\%Cl Odds Ratio M-H, Fixed, 95% CI
图1 小儿遗尿宁颗粒与盐酸甲氯芬酯对照疾病疗效森林图 Figure 1 Forest plot comparing disease efficacy between Xiaoer Yiniaoning Granules and Meclofenoxate Hydrochloride
表1 纳入各研究患儿的基本情况 Table 1 Basic characteristics of children included in each study
纳入研究 Included studies
男/总(例) Male/Total (cases)
年龄(岁) Age (years)
病程 Course of disease
诊断标准 Diagnostic criteria
万力生等(2004年)^([4]){ }^{[4]} Wan Lisheng et al. (2004) ^([4]){ }^{[4]}
155/300 155/300
5-14 5-14
未描述 Not described
国家中医药管理局《中医病证诊断疗效标准》(1994年) Diagnostic and Therapeutic Criteria of Traditional Chinese Medicine Diseases and Syndromes (1994) by the State Administration of Traditional Chinese Medicine
苏文等(2010年)^([5]){ }^{[5]} Su Wen et al. (2010) ^([5]){ }^{[5]}
51/90 51/90
5-17 5-17
6个月-10年 6 months - 10 years
国家中医药管理局《中医病证诊断疗效标准》(1994年) Diagnostic and Therapeutic Efficacy Standards of Traditional Chinese Medicine Diseases and Syndromes (1994) by the State Administration of Traditional Chinese Medicine
易竞阳等(2007年)^([6]){ }^{[6]} Yi Jingyang et al. (2007) ^([6]){ }^{[6]}
69/90 69/90
5-15 5-15
未描述 Not described
国家中医药管理局《中医病证诊断疗效标准》(1994年) Diagnostic and Therapeutic Efficacy Criteria for Traditional Chinese Medicine Diseases and Syndromes (1994) by the State Administration of Traditional Chinese Medicine
胡思源等(2008年)^([7]){ }^{[7]} Hu Siyuan et al. (2008) ^([7]){ }^{[7]}
且在改善肾气不足型小儿遗尿症中医证候的总有效率方面具有优势:OR=1.52,95%CI[1.00,2.29]O R=1.52,95 \% \mathrm{CI}[1.00,2.29] , P=0.05P=0.05 。 Moreover, it has advantages in improving the total effective rate of traditional Chinese medicine syndromes for enuresis in children with kidney qi deficiency: OR=1.52,95%CI[1.00,2.29]O R=1.52,95 \% \mathrm{CI}[1.00,2.29] , P=0.05P=0.05 .
图2 小儿遗尿宁颗粒与盐酸甲氯芬酯对照中医证候疗效森林图 Figure 2 Forest plot comparing the efficacy of Xiao'er Yiniaoning Granules with Meclofenoxate Hydrochloride on traditional Chinese medicine syndromes
有 1 篇文献对安全性进行了描述,试验组 342 例及对照组 114 例中,共有发生不良事件者 9 例,试验组 6 例,对照组 3 例,两组不良事件发生率均为 2.63%2.63 \% 。其中对照组发生 1 例治疗后ALT异常加重, 1 例疗后 ALT异常,经研究者判断可能与试验用药有关;试验组发生 5 例上感、 1 例腹痛,对照组发生 1 例发热,经研究者判断均与试验药物无关。试验组无药物不良反应,对照组不良反应发生率为 1.75%1.75 \% 。两组不良事件及不良反应比较差异无统计学意义。两组用药前后生命体征指标及其差值的组间比较,差异也均无统计学意义。 One study documented safety outcomes, reporting a total of 9 adverse events among 342 cases in the experimental group and 114 cases in the control group (6 in the experimental group and 3 in the control group), with both groups showing an adverse event incidence rate of 2.63%2.63 \% . In the control group, one case exhibited aggravated abnormal ALT levels post-treatment, and another showed abnormal ALT levels after treatment, which investigators deemed potentially related to the trial medication. The experimental group reported 5 cases of upper respiratory infections and 1 case of abdominal pain, while the control group had 1 case of fever—all judged by investigators as unrelated to the trial drugs. No adverse drug reactions occurred in the experimental group, whereas the control group had an adverse reaction rate of 1.75%1.75 \% . No statistically significant differences were observed between the two groups in adverse events or adverse reactions. Similarly, comparisons of vital signs before and after treatment, as well as intergroup differences, showed no statistical significance.
2.2 自拟中药汤剂、自拟中药片组与盐酸甲氯芬酯组对照 3 篇文献设立了自拟中药汤剂组与盐酸甲氯芬酯组进行对照,评价治疗遗尿症的总有效率,各研究间无统计学异质性差异( P=0.65,I^(2)=0%P=0.65, \mathrm{I}^{2}=0 \% ),故采用固定效应模型进行Meta分析。图3结果显示,与盐酸甲氯芬酯相比,自拟中药组在治疗遗尿症的总有效率方面更显著:OR=4.93,95%CI[3.15,7.72]O R=4.93,95 \% \mathrm{CI}[3.15,7.72], P < 0.00001P<0.00001 。 2.2 Comparison of Customized Herbal Decoction, Customized Herbal Tablet Groups, and Meclofenoxate Hydrochloride Group
Three studies compared customized herbal decoction groups with meclofenoxate hydrochloride groups to evaluate the total effective rate in treating enuresis. No statistical heterogeneity was observed among the studies ( P=0.65,I^(2)=0%P=0.65, \mathrm{I}^{2}=0 \% ), so a fixed-effects model was used for meta-analysis. Figure 3 results indicate that the customized herbal group demonstrated significantly higher total effectiveness in treating enuresis compared to meclofenoxate hydrochloride: OR=4.93,95%CI[3.15,7.72]O R=4.93,95 \% \mathrm{CI}[3.15,7.72] , P < 0.00001P<0.00001 .
有 1 篇文献对安全性进行描述,治疗组病人在治疗过程中无不良反应, 118 例病人服用中药遗尿灵片 One study described safety outcomes, noting no adverse reactions in the treatment group during the trial. A total of 118 patients were administered the Chinese herbal preparation Yiniaoling tablets.
图3 自拟中药与盐酸甲氯芬酯对照疾病疗效森林图 Figure 3 Forest Plot Comparing Disease Efficacy Between Customized Herbal Preparations and Meclofenoxate Hydrochloride
后,有不同程度的食欲增强( 37.11%37.11 \% ),说明此药有帮助消化,健脾壮身之功能。 Afterwards, there was varying degrees of increased appetite ( 37.11%37.11 \% ), indicating that this medication aids digestion and strengthens the spleen and body.
2.3 自拟中药汤剂组与弥凝组对照 2 篇文献设立了自拟中药汤剂组与弥凝组进行对照,评价治疗遗尿症的总有效率,各研究间无统计学异质性差异 ( P=0.20,I^(2)=39%P=0.20, \mathrm{I}^{2}=39 \% ),故采用固定效应模型进行Meta分析。图4结果显示, 2 个月的疗程结束后,与弥凝相比,自拟中药组在治疗遗尿症的总有效率方面并无显著优势:OR=0.59,95%CI[0.22,1.59],P=0.30O R=0.59,95 \% \mathrm{CI}[0.22,1.59], P=0.30 。 2.3 Comparison Between Self-Prepared Herbal Decoction Group and Desmopressin Group
Two studies compared the self-prepared herbal decoction group with the desmopressin group to evaluate the total effective rate in treating enuresis. There was no statistical heterogeneity among the studies ( P=0.20,I^(2)=39%P=0.20, \mathrm{I}^{2}=39 \% ), so a fixed-effects model was used for the meta-analysis. Figure 4 shows that after a 2-month treatment period, the self-prepared herbal group did not demonstrate a significant advantage over desmopressin in terms of the total effective rate for treating enuresis: OR=0.59,95%CI[0.22,1.59],P=0.30O R=0.59,95 \% \mathrm{CI}[0.22,1.59], P=0.30 .
图4 自拟中药与弥凝对照疾病疗效森林图 Figure 4 Forest Plot Comparing the Efficacy of Self-Prepared Herbal Decoction and Desmopressin
有 1 篇文献在停药后半年对两组的疗效进行了比较,经统计学分析,得出温肾止遗组与弥凝组比较,有显著性差异( P < 0.01P<0.01 ),这表明温肾止遗组的远期疗效优于弥凝组。 One study compared the efficacy of the two groups six months after discontinuation of treatment. Statistical analysis revealed a significant difference between the Kidney-Warming and Enuresis-Stopping group and the desmopressin group ( P < 0.01P<0.01 ), indicating that the long-term efficacy of the Kidney-Warming and Enuresis-Stopping group was superior to that of the desmopressin group.
3.发表性偏倚 纳入研究的各组文献均低于5篇,所以无法描绘"漏斗图"进行发表性偏倚的描述 ^([11]){ }^{[11]} ,但不排除纳入研究存在发表性偏倚的可能。 3. Publication bias Since the number of studies included in each group was fewer than 5, it was impossible to construct a "funnel plot" to assess publication bias ^([11]){ }^{[11]} . However, the possibility of publication bias in the included studies cannot be ruled out.
讨论 Discussion
综上所述,笔者可以认为中医药相对阳性西药对于小儿遗尿症的疾病疗效、中医证候疗效方面有一定的优势,且安全可靠。但是Meta分析也有其局限性,它是把己有的研究报告被动的接受下来,Meta分析的研究者不可能控制他人研究的质量,因此难以保障其真实性,在解释结论时须慎重。就本研究而言,影响结论真实性的原因主要有以下几点。 In summary, the author concludes that traditional Chinese medicine (TCM) demonstrates certain advantages over positive Western medicine in terms of disease efficacy and TCM syndrome efficacy for pediatric enuresis, with reliable safety. However, Meta-analysis also has its limitations—it passively accepts existing research reports, and Meta-analysis researchers cannot control the quality of others' studies, making it difficult to ensure authenticity. Therefore, conclusions should be interpreted with caution. For this study, the main factors affecting the authenticity of the conclusions include the following:
1.纳人文献质量低 一个说服力强、论证强度高的Meta分析的结论决定于是否有高质量的随机对照临床试验。而本研究对纳人分析的7篇文献总体上质量偏低。这些文献在研究方案设计上存在着很多不足,如缺乏样本含量的估算、随机化的可信度和质 1. Low quality of included literature The persuasiveness and strength of a Meta-analysis depend on the availability of high-quality randomized controlled clinical trials. However, the overall quality of the 7 studies included in this analysis was relatively low. These studies exhibited many shortcomings in research design, such as lack of sample size estimation, questionable randomization credibility, and quality control issues.
量令人质疑、未采用盲法等等,在之前的讨论中己详细阐述。因此我们不能排除治疗组与对照组之间疗效的明显差异可能与试验的方法学质量低下有关。 The questionable sample size, lack of blinding, and other issues have been discussed in detail earlier. Therefore, we cannot rule out the possibility that the significant difference in efficacy between the treatment and control groups may be related to the low methodological quality of the trials.
2.中医证型不明确 辨证论治是中医学理论体系的主要特点之一,是认识疾病和处理疾病的基本原则。中药不同于西药,需要在通过辨证思维得出证候诊断的基础上来处理疾病。而本研究纳入的 7 篇文献只有 3 篇明确了中医证型,从而使疗效的确切性有所降低,往往以偏概全。 2. Unclear TCM Syndrome Patterns
Syndrome differentiation and treatment is one of the main characteristics of TCM theory and a fundamental principle in understanding and managing diseases. Unlike Western medicine, TCM requires a diagnosis based on syndrome differentiation before treating a disease. Among the seven studies included in this review, only three clearly defined TCM syndrome patterns, which reduces the reliability of the efficacy results and often leads to overgeneralization.
3.中药复方加减治疗问题 根据中医独特的理论体系和治疗特点,中医药辨证论治原则是强调治疗的个体化。7篇文献中只有3篇采用了中成药,其它 4 篇都是在原方为主的基础上有不同程度的加减变化,因此中药复方与对照的疗效差异可能与辨证与否有关。 3. Issues with Modified TCM Herbal Formulas
According to the unique theoretical system and treatment principles of TCM, syndrome differentiation emphasizes individualized treatment. Among the seven studies, only three used proprietary Chinese medicines, while the other four employed varying degrees of modifications to the original formulas. Thus, the difference in efficacy between TCM herbal formulas and the control group may be related to whether syndrome differentiation was applied.
4.文献的真实可靠性 本次研究纳人的 7 篇文献仅有 2 篇在个别疗效判断方面报导了阴性结果,大多治疗组有效率远高于对照组,其真实性值得怀疑。一方面是因为可能存在发表性偏倚,阳性结果的研究更容易发表,另一方面也不能排除极个别作者为了某种原因篡改试验数据,将阴性结果改为阳性。作为医学工作者应当尊重事实,通过科学、正当的途径为广大患者谋求最好的治疗方法。 4. Reliability of the Literature
Among the seven studies included in this review, only two reported negative results in certain efficacy assessments, while the majority showed significantly higher effectiveness rates in the treatment group compared to the control group, raising doubts about their authenticity. On one hand, this could be due to publication bias, as studies with positive results are more likely to be published. On the other hand, it cannot be ruled out that a few authors may have altered trial data for certain reasons, converting negative results into positive ones. As medical professionals, we should respect facts and seek the best treatment methods for patients through scientific and ethical means.
上述问题影响了本研究Meta分析的真实性和可靠性。同时也提醒我们,在中医药循证医学逐步发展的时代,我们应提高研究人员的中医临床水平、科研素质及道德素质,学习和运用现代科技手段进行多学科参与的中医临床试验,依据循证医学的原则,结合中医辨证论治的特色,多采用RCT设计进行国际认可的、高质量的前瞻性、大样本、多中心、双盲、随机对照的临床研究,并撰写高质量的论文,以期提供可靠的证据,尤其是对重大疾病的辨证论治综合治疗方的有效性评价。这应成为中医临床科研的主流。 The aforementioned issues have affected the authenticity and reliability of the meta-analysis in this study. At the same time, they remind us that in the era of gradual development of evidence-based medicine in traditional Chinese medicine (TCM), we should enhance the clinical proficiency, research capabilities, and ethical standards of researchers. It is essential to learn and apply modern technological methods to conduct multidisciplinary TCM clinical trials. Following the principles of evidence-based medicine and integrating the characteristics of TCM syndrome differentiation and treatment, we should prioritize RCT designs for internationally recognized, high-quality prospective, large-sample, multicenter, double-blind, randomized controlled clinical studies. Additionally, high-quality papers should be written to provide reliable evidence, particularly for evaluating the effectiveness of comprehensive TCM treatment approaches for major diseases based on syndrome differentiation. This should become the mainstream of clinical research in TCM.
参 考 文 献 References
[1]Neveus T,von Gontard A,Hoebeke P,et al.The standardization of lower urinary tract function in children and adolescents:report from the Standardization Committee of the International Children's Continence Society.J Urol,2006,176:314-324 [1] Neveus T, von Gontard A, Hoebeke P, et al. The standardization of lower urinary tract function in children and adolescents: report from the Standardization Committee of the International Children's Continence Society. J Urol, 2006, 176: 314–324.
[2]汪春华.儿童遗尿症的临床研究进展.医学综述,2008,14(8): 1234-1235 [2] Wang Chunhua. Clinical research progress on enuresis in children. Medical Recapitulate, 2008, 14(8): 1234–1235.
WANG Chun-hua.Clinical research progress of treating enuresis in children.Medical Review,2008,14(8):1234-1235 WANG Chun-hua. Clinical research progress of treating enuresis in children. Medical Review, 2008, 14(8): 1234-1235
[3]Glazener C M,Evans J H.Desmo pressin for nocturnal enuresis in children.Cochrane Database Syst Rev,2002:3:CDOO2112 [3] Glazener C M, Evans J H. Desmopressin for nocturnal enuresis in children. Cochrane Database Syst Rev, 2002: 3: CD002112
[4]万力生,范红霞.温肾止遗合剂治疗小儿遗尿症的临床观察.中医药学刊,2004,22(10):1885-1886 [4] WAN Li-sheng, FAN Hong-xia. Clinical observation of Wenshen Zhiyi Mixture in treating enuresis in children. Journal of Traditional Chinese Medicine, 2004, 22(10): 1885-1886
WAN Li-sheng,FAN Hong-xia.The clinical observation with Wenshen Zhiyi Mixture in treating enuresis in children.Chinese Archives of TCM,2004,22(10):1885-1886 WAN Li-sheng, FAN Hong-xia. The clinical observation with Wenshen Zhiyi Mixture in treating enuresis in children. Chinese Archives of TCM, 2004, 22(10): 1885-1886
[5]苏文,胡爱霞,徐辉甫,等.遗尿方治疗肾阳虚型小儿遗尿临床观察.湖北中医杂志,2010,32(2):54-55 [5] Su Wen, Hu Aixia, Xu Huifu, et al. Clinical observation of Yinao Fang in treating children with enuresis of kidney-yang deficiency type. Hubei Journal of Traditional Chinese Medicine, 2010, 32(2): 54-55
SU Wen,HU Ai-xia,XU Hui-fu,et al.The clinical observation with Yi Niao Fang in treating enuresis in children of Shenyang Xu.Hubei Journal of TCM,2010,32(2):54-55 Su Wen, Hu Aixia, Xu Huifu, et al. The clinical observation with Yi Niao Fang in treating enuresis in children of Shenyang Xu. Hubei Journal of TCM, 2010, 32(2): 54-55
[6]易竞阳,俞惠英.鸡肠散治疗小儿遗尿临床观察.甘肃中医, 2007,20(11):38 [6] Yi Jingyang, Yu Huiying. Clinical observation of Jichang San in treating children with enuresis. Gansu Journal of Traditional Chinese Medicine, 2007, 20(11): 38
YI Jing-yang,YU Hui-ying.The clinical observation with Ji Chang San in treating enuresis in children.Gansu Journal of TCM, 2007,20(11):38 Yi Jingyang, Yu Huiying. The clinical observation with Ji Chang San in treating enuresis in children. Gansu Journal of TCM, 2007, 20(11): 38
[7]胡思源,马融,刘小凡,等.小儿遗尿颗粒与盐酸甲氯芬酯胶囊对照治疗肾气不足型小儿遗尿症III期临床试验.临床药理学, 2008,13(1):107-111 [7] Hu Siyuan, Ma Rong, Liu Xiaofan, et al. Phase III clinical trial of Xiaoer Yiniao Granules versus meclofenoxate hydrochloride capsules in treating enuresis in children with kidney qi deficiency syndrome. Clinical Pharmacology, 2008, 13(1): 107-111
HU Si-yuan,MA Rong,LIU Xiao-fan,et al.III children phase of clinical trial with Xiaoer Yiniao Keli in treating enuresis in children of Shen Qi Bu Zu against to meclofenoxate hydrochloride capsules. Clinical Pharmacology,2008,13(1):107-111 Hu Siyuan, Ma Rong, Liu Xiaofan, et al. Phase III clinical trial of Xiaoer Yiniao Granules versus meclofenoxate hydrochloride capsules in treating enuresis in children with kidney qi deficiency syndrome. Clinical Pharmacology, 2008, 13(1): 107-111
[8]张雪荣,肖飞,向希雄,等.小儿遗尿宁颗粒治疗肾气不足型小儿遗尿症 96 例临床试验。中国中西医结合儿科学,2009,1(5): 478-480 [8] Zhang Xuerong, Xiao Fei, Xiang Xixiong, et al. Clinical trial of Xiaoer Yiniao Ning Granules in treating 96 cases of enuresis in children with kidney qi deficiency syndrome. Chinese Journal of Integrated Traditional and Western Medicine in Pediatrics, 2009, 1(5): 478-480
ZHANG Xue-rong,XIAO Fei,XIANG Xi-xiong,et al.Clinical research on the Yiniaoning granule in the treatment of the deficiency of Kidney-Qi in child enuresis.China Integrated Traditional Chinese and Western Medicine in Pediatrics,2009,1(5): 478-480 Zhang Xuerong, Xiao Fei, Xiang Xixiong, et al. Clinical trial of Xiaoer Yiniao Ning Granules in treating 96 cases of enuresis in children with kidney qi deficiency syndrome. Chinese Journal of Integrated Traditional and Western Medicine in Pediatrics, 2009, 1(5): 478-480
[9]李荫昆.益肾健脾汤治疗小儿遗尿.云南中医中药杂志,1998, 19(4):28-29 [9] Li Yinkun. Treating enuresis in children with Yishen Jianpi Decoction. Yunnan Journal of Traditional Chinese Medicine and Materia Medica, 1998, 19(4): 28-29
LI Yin-kun.Treating enuresis in children with Yi shen jian pi tang. Yunnan Journal of TCM and Materia Medica,1998,19(4):28-29 LI Yin-kun. Treating enuresis in children with Yi shen jian pi tang. Yunnan Journal of TCM and Materia Medica, 1998, 19(4): 28-29
[10]朱长君,董浚华,魏履霜.中药遗尿灵片治疗遗尿症的临床研究.中药新药与临床药理,1994,5(1):18-20 [10] Zhu Changjun, Dong Junhua, Wei Lvshuang. Clinical research on Chinese medicine Yi Niao Ling Pian for treating enuresis. Traditional Chinese Drug Research & Clinical Pharmacology, 1994, 5(1): 18-20
ZHU Chang-jun,DONG Jun-hua,Wei Lv-shuang.The clinical research of Chinese medicine Yi Niao Ling Pian in treating enuresis in children.Traditional Chinese Drug Research \&Clinical Pharmacology,1994,5(1):18-20 ZHU Chang-jun, DONG Jun-hua, Wei Lv-shuang. The clinical research of Chinese medicine Yi Niao Ling Pian in treating enuresis in children. Traditional Chinese Drug Research & Clinical Pharmacology, 1994, 5(1): 18-20
[11]王家良.临床流行病学—临床科研设计、衡量与评价.2版.上海:上海科学技术出版社,2001:53 [11] Wang Jialiang. Clinical Epidemiology—Design, Measurement, and Evaluation in Clinical Research. 2nd ed. Shanghai: Shanghai Scientific & Technical Publishers, 2001: 53
WANG Jia-liang.Clinical Epidemiology-Clinical Research Design,Measure and Evaluation.2nd edition.Shanghai:Shanghai Science and Technology Publishing House,2001:53 WANG Jia-liang. Clinical Epidemiology—Clinical Research Design, Measurement and Evaluation. 2nd edition. Shanghai: Shanghai Science and Technology Publishing House, 2001: 53
(收稿日期:2011年9月15日) (Received: September 15, 2011)
通讯作者:胡思源,天津市南开区鞍山西道314号天津中医药大学第一附属医院药理基地,邮编:300193,电话:022-27432275 Corresponding author: Husiyuan, Pharmacology Base, First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, 314 Anshan West Road, Nankai District, Tianjin, 300193, China. Tel: 022-27432275
E-mail:husiyuan1963@sina.com E-mail: husiyuan1963@sina.com
注:Qd:每日1次;Bid:每日2次;Tid:每日3次。 Note: Qd: Once daily; Bid: Twice daily; Tid: Three times daily.
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