Oral Oxymatrine Preparation for Chronic Hepatitis B: A Systematic Review of Randomized Controlled Trials

Objective

To evaluate the efficacy and safety of oral oxymatrine preparation for the treatment of chronic hepatitis B (CHB).

Methods

Randomized controlled trials (RCTs) on oral oxymatrine preparation in treating patients with CHB were retrieved until October 2013 by searching PubMed, the Cochrane Library, Embase and four Chinese databases, irrespective of language and publication status. Data extraction and data analyses were conducted according to the Cochrane standards. The risk of bias for each included trials and the quality of evidence on pre-specified outcomes were assessed. The RevMan software was used for statistical analyses.

Results

Totally 52 RCTs enrolling 5,227 participants were included, of which 51 RCTs were included in meta-analyses. Oral oxymatrine preparation including oxymatrine capsule and oxymatrine tablet were associated with statistically significant effect on the clearance of hepatitis B virus (HBV) DNA, HBV surface antigen and HBV e antigen, and were beneficial to the normalization of serum alanine aminotransferase and aspartate aminotransferase. Nevertheless, the overall methodological quality and the quality of evidence in the included trials were poor. In addition, safety of oral oxymatrine preparation was not confirmed.

Conclusions

Oral oxymatrine preparation showed some potential benefits for patients with CHB. However, the overall quality of evidence was limited and the safety of oral oxymatrine preparation for CHB patients was still unproven. More high quality evidence from rigorously designed RCTs is warranted to support the clinical use of oral oxymatrine preparation for patients with CHB.

     

提高中草药随机对照试验的质量Ⅰ:临床试验设计和方法学

目的:通过对中草药临床随机对照试验的设计及方法学进行质量评价,探讨如何提高中草药临床试验的质量。方法:文献检索2005年7月前发表于Cochrane图书馆的中草药系统评价共11篇,包含167个中草药临床随机对照试验。质量评价方法采用修订版CONSORT声明9项指标以及中草药剂型及质量控制标准指标。结果:所有167个临床试验都含有试验目的、方法、第1结局指标、统计学方法及中药剂型;其中163(97.6%)个临床试验说明了研究对象的纳入标准,只有26(15.6%)个临床试验说明了研究对象的排除标准;只有14(8.4%)个临床试验详细说明了随机序列的产生方法;4(2.4%)个临床试验提及了随机分配隐藏;绝大部分的临床试验(86.8%)属于开放性的,只有13.2%的临床试验采用了盲法设计;只有1个临床试验在试验前进行了样本含量的计算;在中草药剂型方面,45.5%的临床试验使用的是汤剂或中药茶包,只有1个临床试验提及了制剂的质量控制。在167个临床试验中,所有质量评价指标的涉及率只有36.0%。结论:现阶段中草药临床随机对照试验的质量还很低。建议:(1)试验设计者及实施者必须接受正规的临床试验基础知识的培训;(2)推荐采用临床试验设计流程图,逐一解决临床试验过程中的关键问题;(3)在方案正式实施前进行预试验,并根据预试验的结果对临床试验设计方案进行调整;(4)对临床试验设计的最终方案进行注册登记,并预先发表(最好是网上发表)临床试验设计方案;(5)广泛开展国际合作,特别是与对中医药研究感兴趣的国际知名学术研究机构进行合作,以提高中草药临床研究的质量。     

Chinese medicine for treatment of chronic hepatitis B

<正>Contemporary Western medicines approved by the U.S.Food and Drug Administration(FDA) for the treatment of chronic hepatitis B(CHB),although available in China,have high costs,or major side effects and limited effectiveness. Research efforts have focused on looking for natural products as alternative medicines with low cost and good safety for CHB treatment.Chinese medicine(CM) has ancient,time-honored theories about methods of diagnosis and treatment for liver diseases.In recent decades,a large number of clinical trials and pre-clinical studies,which were performed in China and other countries,indicated that CM has potential benefit in several aspects of the treatment of CHB,e.g.,anti-inflammatory, anticancer,antioxidant,immunomodulating,antifibrosis,and antiviral.However,there are many concerns regarding the study design and the quality of clinical trials.Further larger,stringently designed,double-blind,placebo control,randomized clinical trials and long-term follow-up are needed to provide conclusive evidence of their efficacy and safety.Components of CM deserve further study in pre-clinical models of HBV infection and in clinical trials world-wide.     

Recent clinical trials of acupuncture in the west: Responses from the practitioners

In the West,hundreds of randomized controlled trials（RCTs）have been performed testing acupuncture.They include two types：those that compare acupuncture to other therapies,usual care or no treatment（pragmatic trials）,and those that have placebo controls（efficacy trials）.Acupuncture has generally performed well against other therapies or no treatment,but until recently,the evidence from placebo controlled trials has been considered equivocal or contradictory.A recent series of large RCTs,mostly performed in Germany and also in the US have included both pragmatic and placebo comparisons.The evidence poises a conundrum for the profession of acupuncture.This essay first describes the two types of RCTs used to examine acupuncture and examine the results of two recent large RCTs for chronic low back pain as representative examples of recent large studies.The essay then presents the most common Euro-American acupuncture professions＇ interpretation of these results.Western responses have included：（1）methodological weaknesses; （2）inappropriateness of placebo controls; （3）questions as to whether acupuncture placebo controls are＂inert＂; （4）rejection of evidence-based medicine epistemology; （5）discrepancy between acupuncture performed in RCTs with real world acupuncture; （6）enhanced placebo effects of acupuncture; and（7）needs to re-evaluate acupuncture theory.The authors do not necessarily agree with all of these responses; they are presented in an attempt to foster critical discussion.The paper also looks at recent neuroimaging experiments on acupuncture that may point to some worthwhile new avenues of investigation.Finally,the Euro-American health care policy consequences of these recent RCTs are discussed.     

中医药治疗支气管哮喘缓解期的系统评价

目的:系统评价中医药治疗支气管哮喘缓解期的疗效与安全性。方法:计算机检索Cochrane图书馆、Medline、中国生物医学文献数据库(CBM)、中国学术期刊全文数据库(CNKI)和中国中医文献检索系统数据库,采用Cochrane Handbook评价体系对文献进行分析,采用Revman 5.0软件进行Meta分析。结果:纳入3项随机对照试验,包括2项中医药与西医药对照的试验和1项中西医结合与西医药对照的试验。合并后,中医治疗组临床疗效优于西医对照组(P<0.0001),中西医结合组未见明显优势(P=0.17);中医药治疗组中医证候疗效优于对照组(P=0.02);中医药组喘息、咳嗽和哮鸣音疗效与对照组无显著差异(P=0.12,P=0.25,P=0.91);中医药治疗可以显著提高FEV1%(P=0.001),对PEF25无明显影响(P=0.13);中医药治疗可以显著降低嗜酸性粒细胞(EOS)(P<0.00001);中医药治疗未见明显不良反应报道。结论:中医药单用或与西医药联合应用治疗支气管哮喘缓解期有一定的疗效,亦无明显的毒副作用报道。但由于所纳入试验方法学质量低下等原因,其潜在的疗效及安全性还需严格设计的高质...     

提高中草药随机对照试验的质量Ⅲ:中草药的质量控制

目的:通过对中草药临床随机对照试验中有关中草药质量控制的方法进行分析评价,探讨如何实施中草药临床试验的药物质量控制。方法:文献检索2005年7月前发表于Cochrane图书馆的中草药系统评价共11篇,包含167个中草药临床随机对照试验,实证分析中草药临床试验中有关中草药质量控制的方法。结果:在纳入分析的167个中草药临床随机对照试验中,所采用的中草药制剂类型共有11种,其中只有1个临床随机对照试验提及中药的质量控制方法。结论:在中草药临床随机对照试验过程中,中草药的质量控制是一个非常薄弱的环节。建议:在中草药临床随机对照试验过程中,必须提高中草药的质量控制意识及建立中草药质量控制的技术平台,整合包括中药材生产质量管理规范(Good Agricultural Practice,GAP)、药物生产质量管理规范(Good Manufacturing Practice,GMP)、药物临床试验质量管理规范(Good ClinicalPractice,GCP)以及中药指纹图谱等技术,建立系统控制临床试验药物的质量控制体系。     

针灸治疗中风偏瘫的荟萃分析

目的：评价针灸治疗中风偏瘫的疗效与安全性。方法：通过对中国生4物医学资料库及手工查阅，选出以针灸为干预措施来治疗中风偏瘫的随机对照试验，进行研究方法的质量评估及提取有效数据进行随机效应模型的Meta-分析。结果：共9篇文章进入研究，发现针灸治疗对恢复中风偏瘫患者的偏瘫侧上下肢体的肌力及降低神经功能缺损程度评分指标可能优于西医一般的对症治疗。结论：可以初步认为，针灸治疗中风偏瘫有疗效，但由于尚缺乏高质量的随机对照研究支持，针灸治疗中风偏瘫的疗效尚不能作最后结论，需进一步的高质量的临床随机对照研究证实。     

针灸治疗糖尿病胃轻瘫随机对照试验文献质量评价

目的对针灸治疗糖尿病胃轻瘫随机对照试验文献质量进行分析,为进一步的临床试验研究提供参考。方法检索近30年针灸治疗糖尿病胃轻瘫临床研究文献,采用循证医学的原则及评价方法,制定临床文献评价及信息采集表,对纳入文献进行分析和评价。结果检索到符合纳入标准的临床对照试验文献21篇,在样本量估算、疾病诊断标准及疗效判定标准、盲法和分配隐藏、随机化实施、随访及病例脱失剔除情况、结局指标选择、安全性观察、结论推导等方面存在一些问题。结论针灸治疗糖尿病胃轻瘫的临床研究文献存在样本量较少、研究方法实施不严谨、结局指标选取不统一的缺点,尚不能得出针灸优于其他疗法的确切结论,故有必要进一步做多中心、大样本及高质量的临床试验研究。     

Syndrome Pattern and Its Application in Parallel Randomized Controlled Trials

Syndrome pattern (SP) is a core concept of Chinese medicine (CM) and is used to diagnose and treat patients based on an overall analysis of symptoms and signs. This study aimed to systematically review randomized controlled trials (RCTs) using the SP concept and to demonstrate how the SP concept could be applied to the study design of parallel RCTs, considering a gold standard of clinical research. After conducting a brief systematic review by way of a PubMed search, we analyzed how the SP concept was applied to the design of RCT in a CM herbal medicine trial. We then formulated possible research questions, applied the SP concept to answer the research questions, and suggested possible RCT designs to be used for conducting future trials. Fourteen RCTs were included in our systematic review, and three key points of the SP concept were formulated for the design of parallel RCTs: the time point of SP diagnosis between before and after randomization; the relationship between the international classification of diseases (ICD) and SP for the inclusion of target population; and the proper diagnostic method of SP. In this study, we formulated three possible research questions and then suggested perspectives for five possible RCT models arrived at using SP concepts. Future trials applying SP concept to RCTs should overcome the shortcomings of past SP trials, moving CM forward from experience-based to evidence-based medicine.     

提高中草药随机对照试验的质量Ⅳ:采用修改后的CONSORT条目评价临床随机对照试验报告的质量

目的:以Cochrane图书馆中有关中草药治疗2型糖尿病系统评价中的66个临床随机对照试验为基础,分析在中草药临床随机对照试验研究报告中存在的问题,以及如何提高临床随机对照试验报告的质量。方法:文献检索2005年7月前发表于Cochrane图书馆的纳入随机对照试验最多的系统评价—中草药治疗2型糖尿病系统评价,共包含66个临床随机对照试验。以原有的CONSORT条目为基础,增加有关中医药方面的5项内容,即中医证型、组方依据、复方组成、制剂类型及质量控制。修订后的CONSORT评估表共包含63项条目,并以此为标准评估66篇临床随机对照试验报告的质量。结果:按修改后的CONSORT条目,66篇临床随机对照试验的总体报告率为19%~44%,中位数32%(标准差8%)。结论:中草药临床随机对照试验报告的总体质量较低。建议:以CONSORT条目为基础,进行中草药临床随机对照试验报告规范化的研究。同时建议中医药类杂志的编辑要求作者按照规范格式发表临床研究报告。     

下腰背部疼痛的针刺随机对照试验的临床定性评估

背景：很多随机对照试验和系统综述得出了针刺对下腰背部疼痛无效的结论并且认为针刺和安慰性针刺对于下腰背部疼痛的治疗疗效并没有区别。目的：本研究是从临床的角度,特别是从专业针灸医师的角度来评估近年来发表的有关针刺治疗下腰背部疼痛的随机对照试验和系统综述的价值。数据来源和搜集：对Cochrane图书馆、PubMed／MEDLINE、EMBASE进行检索,检索的时间范围是从2007年1月至2010年1月。本研究共纳入18个用英语写作的关于针刺治疗下腰背部疼痛或者针刺作为治疗手段之一的随机对照试验。评估方法：临床定性批评性价值评估是本文的研究特点。运用临床基本技能和知识以及统计学概念,建立5个价值评估标准对被纳入的随机对照试验和系统综述的质量和可靠性进行价值评估。这种评估方法与随机对照试验中的纳入和排除标准评估很相似。通过使用这种评估方法,尽管随机对照试验和系统综述有较完善的内部有效性,它们之中的不足之处、局限性和错误就会暴露出来。结果：下腰背部疼痛的研究使用了很多种定义。纳入的18个研究中,16个（80％）随机对照试验中没有使用医学诊断;所有的随机对照试验没有使用客观的测量方法去判断研究的结果。由于使用了多种治疗方法或多个治疗师参与治疗,使这些随机对照试验产生了很大的变异;10个（55％）试验运用了针刺联合其他治疗的方法,其中6个（33％）试验使用了非甾体抗炎药或镇痛剂。由于没有使用医学诊断,所有的试验的外部有效性均不可靠。所有这些被纳入的随机对照试验和系统综述都没有使用logistic回归的方法去解决研究中的异质性问题。结论：所有被纳入的随机对照试验在应用本研究设定的价值评估标准衡量时,都不能完全符合这些标准。这些随机对照试验的主要问题在于没有正确的医学诊断和没有客观的测量方法去判断治疗效果,导致了纳入及排除标准制定的不正确,配对的不恰当和数据进入统计分析前记录的不精确。由于治疗效果测量的主观性,随机对照试验和以随机对照试验为基础的系统综述就出现了过于泛化或是含有交叉结论的偏倚估算。此外,在治疗过程中产生的众多变量是很难控制和估算的,这种不确定因素影响了随机对照试验结论的可靠性。基于上述原因,在将来的随机对照试验和系统综述中应该考虑在随机分配之前建立一个恰当的医学诊断和设立一个与临床相关的客观的结局测量方法。     

Standards for reporting randomized controlled trials in medical informatics: a systematic review of CONSORT adherence in RCTs on clinical decision support

Introduction

The Consolidated Standards for Reporting Trials (CONSORT) were published to standardize reporting and improve the quality of clinical trials. The objective of this study is to assess CONSORT adherence in randomized clinical trials (RCT) of disease specific clinical decision support (CDS).

Methods

A systematic search was conducted of the Medline, EMBASE, and Cochrane databases. RCTs on CDS were assessed against CONSORT guidelines and the Jadad score.

Result

32 of 3784 papers identified in the primary search were included in the final review. 181 702 patients and 7315 physicians participated in the selected trials. Most trials were performed in primary care (22), including 897 general practitioner offices. RCTs assessing CDS for asthma (4), diabetes (4), and hyperlipidemia (3) were the most common. Thirteen CDS systems (40%) were implemented in electronic medical records, and 14 (43%) provided automatic alerts. CONSORT and Jadad scores were generally low; the mean CONSORT score was 30.75 (95% CI 27.0 to 34.5), median score 32, range 21–38. Fourteen trials (43%) did not clearly define the study objective, and 11 studies (34%) did not include a sample size calculation. Outcome measures were adequately identified and defined in 23 (71%) trials; adverse events or side effects were not reported in 20 trials (62%). Thirteen trials (40%) were of superior quality according to the Jadad score (≥3 points). Six trials (18%) reported on long-term implementation of CDS.

Conclusion

The overall quality of reporting RCTs was low. There is a need to develop standards for reporting RCTs in medical informatics.     

CONSORT 和 STRICTA 标准对针刺治疗偏头痛的随机对照试验报告质量的评价

目的:采用CONSORT和STRICTA标准对针刺治疗偏头痛随机对照试验的报告质量进行评价。方法:以中文和英文为语种限制,系统检索Cochrane图书馆临床对照试验数据库、PubMed、OVID、Med-line、EBSCO、EMbase、中国生物医学文献数据库、中文科技期刊全文数据库、中文学术期刊全文数据库、万方数据库共10个数据库,手工检索所有中文针灸杂志、中医药核心期刊及已纳入文献的参考文献。对筛选出的针刺治疗偏头痛的随机对照试验文献,采用国际公认的CONSORT声明和报告针刺临床试验中干预措施的国际标准(STRICTA)进行报告质量的评价。结果:根据CONSORT条目,在纳入的针刺治疗偏头痛的95篇报告中,53篇(55.8%)描述了各组的基线情况和临床特征;34篇(35.8%)提及产生随机分配序列的方法;仅有11篇(11.6%)分配方案隐藏充分;15篇(15.8%)采用盲法的文献中只有7篇采用双盲;13篇(13.7%)提及样本含量的计算。根据STRICTA条目,在95篇文献中有41篇(43.2%)报道了针刺深度,49篇(51.6%)报道了针刺反应,69篇(72.6%)报道了刺激方式,79篇(83.2%...     

Evidence base of randomized controlled trials and guideline recommendations of patent Traditional Chinese Medicines for uncomplicated acute lower respiratory tract infections in adults

OBJECTIVE

To compare clinical practice guideline recommendations on the use of oral patent Traditional Chinese Medicines (PTCMs) for uncomplicated acute lower respiratory tract infections (ALRTIs) in adults with the existing evidence using results of a systematic review of randomized controlled trials (RCTs).

Survey and practice of reporting quality of randomized controlled clinical trials on traditional Chinese medicine

Evidence obtained from randomized controlled trials （RCTs） has been generally accepted as the gold standard in the evaluation of clinical effectiveness. Readers need to understand the trial design, implementation, results, analysis and interpretation, so as to fully Jnderstand the results of RCTs. Thus, the investigators of RCTs have to report these items in a complete, accurate and clear manner. Since 1998, we have conducted several evaluations on the reporting quality of RCTs published in Chinese journals on traditional Chinese medicine （TCM） and results have shown that there is an urgent need for higher quality RCTs on TCM.     

提高中草药随机对照试验的质量Ⅱ:对照组设计

目的:如何选择对照组是临床随机对照试验设计的关键环节之一。通过对Cochrane图书馆发表的关于中草药治疗2型糖尿病系统评价中所包含的66个临床试验进行对照组设计的评价分析,探讨如何提高中草药临床试验中对照组设计的质量。方法:文献检索2005年7月前发表于Cochrane图书馆且纳入临床试验最多的系统评价——中草药治疗2型糖尿病系统评价中的66个临床试验,分析中草药临床随机对照试验在对照组设计方面存在的问题。结果:在66个临床试验中,所采用的对照组包括安慰剂组、阳性药物组及空白对照组等,但在临床试验设计中则并未说明对照组的选择理由;其中27个临床试验采用中、西药结合与西药疗效的比较;24个临床试验采用中药与西药疗效的比较;5个临床试验采用中药与安慰剂疗效的比较;3个临床试验比较了中、西药结合与西药合安慰剂治疗的疗效;3个临床试验比较了中、西药结合与其他中药治疗的疗效;中药治疗组与空白对照组比较、中药合安慰剂治疗与西药合安慰剂治疗的比较则各为1个临床试验;另有1个临床试验采用了中药分别与中、西药结合,西药以及安慰剂的比较;有1个试验则采用了中药分别与西药及中、西药结合的比较。结论:基于不同的临床试验目的选择对照组是进行对照组设计的根本依据。建议:(1)研究者与设计者必须正确理解对照组选择的重要意义;(2)对照组的选择必须以试验设计目的为基础;(3)选择阳性药物对照组必须有充足的证据证明该阳性药物的疗效,同时必须遵照推荐方法使用阳性药物;(4)必须确保安慰剂所含成分为惰性成分,对所研究疾病无任何治疗作用,且在色、泽、味、形等方面尽可能与试验药物一致;(5)空白对照组的选择必须充分考虑伦理道德因素,且不会因为非盲法评估而对结局评估产生任何偏倚;(6)在对慢性、稳定性疾病进行的研究中,交叉对照试验常较随机对照试验更为适宜。     

中医药治疗非小细胞肺癌临床随机对照试验文献评价

目的:评价中医药治疗非小细胞肺癌(NSCLC)临床随机对照试验(RCTs)文献的质量。方法:根据Cochrane中心指南,机检和手检相结合检索1997年1月至2006年12月国内生物医学期刊发表的有关中医药治疗NSCLC的RCTs文献,按照临床流行病学原理及临床试验的统一标准(CONSORT声明),收集所有文献的信息,进行描述性分析和一致性检验。结果:共纳入RCTs文献124篇。其中37篇报告了纳入标准,占29.84%;13篇有排除标准,占10.48%;37篇有明确的中医证候分类,占29.84%;无1篇文献交代样本含量估算情况;24篇报告了随机分配方法,占19.35%;8篇有随机隐藏的简单描述,占6.45%;85篇有基线资料的描述,占68.55%;3篇运用了盲法,占2.42%;77篇有统计学方法描述,占62.10%;6篇文献涉及到知情同意,占4.84%;88篇记录了不良反应,占70.97%;38篇对治疗后病例进行随访,占30.65%。结论:中医药治疗NSCLC的RCTs质量还不够高,有待进一步提高。主要表现为随机分组方法没有说明或应用错误,随机分配隐藏没有得到足够重视,盲法使用过低,受试者的纳入排除标准未充分报告,中医证候分类亟需规范统一,组间基线资料统计不全,样本量低且没有具体的估算方法,疗效评价标准不够统一,忽视依从性、病例脱落、随访情况的分析和伦理规范。     

针灸研究中组间症状积分的定量比较与组内分级定性法利弊的探讨

近年来,在中医针灸随机对照临床试验（randomized controlled trial,RCT）中恰当地应用统计学方法日益受到重视。基于假设检验的统计推断是临床试验与循证医学的基础,根据临床试验设计的基本统计原则,本文探讨了中西方文献中针灸RCT设计与分析方法学的差异。国内针刺临床试验多采用3级或4级定性法进行临床统计分析,而国外的临床试验则多采用组间症状积分的定量比较。本文以针刺治疗疼痛的临床试验为例,讨论了两种分析方法的利弊。我们认为两种方法可以兼用,但应以定量分析方法为主,分级定性法为辅,以取各自方法的所长。本文的目的是希望通过提出问题来抛砖引玉,以期引起更多的学术讨论,从而提高中医针灸临床研究的科学性和严谨性。     

Methodological quality and reporting of ethical requirements in phase III cancer trials

BACKGROUND: The approval of a research ethics committee (REC) and obtaining informed consent from patients (ICP) could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials. METHOD: Methodological quality (Jadad score) and ethical quality (Berdeu score) were assessed for all randomised controlled trials (RCTs) published in 10 international journals between 1999 and 2001 (n = 231). RESULTS: The mean Jadad score was 9.86 +/- 1.117. The methodological quality was poor in 75 RCTs (Jadad score <9). The mean Berdeu score was 0.42 +/- 0.133. The mean ethical quality score for poor methodological quality RCTs (n = 75) was 0.39 +/- 0.133; it was 0.43 +/- 0.133 for good (n = 156) methodological quality RCTs (p = 0.07). There was improvement in ethical quality according to the year of commencement of the trials (p < 0.001). There was no correlation between methodological quality and the number of participating patients (R2 = 0.003, p = 0.78), between ethical quality and the number of participating patients (R2 = 0.003, p = 0.76 ), or between ethical quality and methodological quality (R2 = 0.012, p = 0.1). ICP and REC approval were not obtained for 21 and 77 trials respectively. CONCLUSION: The association between methodological quality and the reporting of ethical requirements probably reflects the respect shown for patients during the whole research process. These results suggest that closer attention to the conduct of clinical research, as well as the reporting of its ethical aspects, is needed.     

痰热清注射液治疗急性气管-支气管炎随机对照试验的系统综述及文献质量评价

目的：系统综述痰热清注射液治疗急性气管-支气管炎的临床疗效及安全性,分析随机对照试验报告的质量。方法：采用系统综述的方法,利用Jadad计分表及CONSORT for TCM评价纳入文献的质量;纳入的文献按不同治疗策略进行分层,评价其临床结果。结果：符合纳入标准的文献共10篇。其中2篇有纳入标准,4篇有排除标准,无1篇文献对样本量估算以及随机化相关细节进行说明,无1篇文献应用盲法设计。仅报道2例与痰热清注射液可能有关的不良事件。结论：①纳入的随机对照试验文献存在未充分说明随机方法、纳入标准、排除标准,未进行样本量估算及盲法设计等不足,尚不能对痰热清注射液治疗急性气管-支气管炎的临床疗效提供确切的循证依据。②痰热清注射液有可能引发变态反应的风险,需加以防范,过敏体质者应慎用。