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Abstract：
Background and Objective: Severe pneumonia is a critical respiratory disease with high mortality. There is insufficient evidence on the efficacy and safety of traditional Chinese medicine (TCM) adjuvant therapy for severe pneumonia. This study aims to identify, describe, assess, and summarize the currently available high-quality design evidence on TCM adjuvant therapy for severe pneumonia to identify evidence gaps using the evidence mapping approach. Methods: Systematic searches were performed on English and Chinese online databases (PubMed, EMBASE, Cochrane Library, Web of Science, CNKI, WanFang Data, CQVIP, and SinoMed) to identify papers from inception until August 2023 for inclusion into the review. Randomized controlled trials (RCTs), systematic reviews (SRs), and meta-analyses concerning TCM adjuvant therapy for severe pneumonia or its complications in adults were included. The risk of bias in RCTs was evaluated by using the Cochrane Handbook ROB tool. The Assessment of Multiple Systematic Reviews 2 (AMSTAR-2), the Risk of Bias in Systematic Review (ROBIS) tool, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system were used to assess the methodological quality, risk of bias, and evidence quality of SRs or meta-analyses, respectively. Then, a bubble plot was designed to visually display information in four dimensions. Results: A total of 354 RCTs and 17 SRs or meta-analyses met the inclusion criteria. The published RCTs had several flaws, such as unreasonable design, limited sample size, insufficient attention to non-drug therapy studies and syndrome differentiation, improper selection or use of outcome indicators, and failure to provide high-quality evidence. Sixteen SRs or meta-analyses of methodological quality scored \"Critically Low\" confidence. Twelve SRs or meta-analyses were rated as \"High Risk.\" Most outcomes were rated as \"Low\" evidence quality. We found that TCM combined with conventional treatment could improve the clinical total effective rate and the TCM syndromes efficacy. The combined approach could also shorten mechanical ventilation time, infection control time, and length of hospital and ICU stay; significantly reduce temperature, respiratory rate, heart rate, white blood cell counts, levels of C-reactive protein, procalcitonin, blood inflammatory factors, bacteriological response, and D-dimer; decrease CPIS, APACHE II score, and PSI score; improve pulmonary imaging features, arterial blood gas indicators (including arterial oxygen pressure, arterial oxygen saturation, and oxygen index), and lung function (including forced vital capacity and forced expiratory volume in the first second) for severe pneumonia compared with conventional treatment only (p < 0.05). There was no significant difference in adverse reactions and incidence of adverse events (p > 0.05). In addition, compared with conventional treatment only, most SRs or meta-analyses concluded that TCM combined with conventional treatment was \"Beneficial\" or \"Probably beneficial.\" Conclusion: TCM combined with conventional treatment had advantages in efficacy, clinical signs, laboratory results, and life quality outcomes of severe pneumonia, with no difference in safety outcomes compared with conventional treatment only. QingJin Huatan decoction is the most promising target, and Xuanbai Chengqi decoction has a \"Probably beneficial\" conclusion. XueBiJing injection and TanReQing injection are two commonly used Chinese herbal injections for treating severe pneumonia, and both are \"Probably beneficial.\" However, there was a need for multicenter RCTs with large sample sizes and high methodological quality in the future. In addition, the methodological design and quality of SRs or meta-analyses should be improved to form high-quality, evidence-based medical evidence and provide evidence for the effectiveness and safety of TCM adjuvant therapy for severe pneumonia.
摘要：
背景与目的：重症肺炎是一种危重的呼吸系统疾病，死亡率高。中医药辅助治疗重症肺炎的有效性和安全性证据不足。本研究旨在确定,描述，评估,并总结目前已有的关于重症肺炎中医辅助治疗的高质量设计证据，利用证据图谱方法找出证据缺口。方法：在中英文在线数据库（PubMed，EMBASE,科克伦图书馆,WebofScience,CNKI,万方数据,CQVIP,和SinoMed)确定从成立到2023年8月的论文，以纳入评论。随机对照试验（RCT），系统评价(SRs)，纳入了有关成人重症肺炎或其并发症的中医辅助治疗的荟萃分析。使用Cochrane手册ROB工具评估RCT中的偏倚风险。多重系统评价2(AMSTAR-2)，系统评价中的偏差风险(ROBIS)工具，和建议评估的分级，开发和评估(GRADE)系统用于评估方法学质量，偏见的风险，和SR或荟萃分析的证据质量，分别。然后，气泡图被设计为在四个维度上直观地显示信息。结果：共有354项RCT和17项SR或meta分析符合纳入标准。出版的RCT有几个缺陷，如不合理的设计，样本量有限，对非药物治疗研究和辨证分型重视不够，结果指标选择或使用不当，未能提供高质量的证据。16个SRs或方法学质量的荟萃分析评分为“极低”信心。12份SR或荟萃分析被评为“高风险”。大多数结果被评为“低”证据质量。我们发现中医结合常规治疗可以提高临床总有效率和中医证候疗效。联合方法还可以缩短机械通气时间，感染控制时间,以及住院时间和ICU住院时间；显着降低温度，呼吸频率,心率,白细胞计数,C反应蛋白水平,降钙素原,血液炎症因子，细菌学反应，和D-二聚体；降低CPIS，APACHEII得分,和PSI评分；改善肺部影像学特征，动脉血气指标（包括动脉血氧压，动脉血氧饱和度,和氧指数)，与常规治疗相比，重症肺炎的肺功能（包括第1秒的用力肺活量和用力呼气量）（p<0.05）。不良反应和不良事件发生率差异无统计学意义(p>0.05)。此外,与仅常规治疗相比，大多数SR或荟萃分析得出结论，中医与常规治疗相结合是“有益的”或“可能有益的”。结论:中医结合常规治疗在疗效上具有优势,临床体征,实验室结果,和重症肺炎的生活质量结果，与常规治疗相比，安全性结局无差异。清金化痰汤是最有前途的靶点，宣白承气汤有“可能有益”的结论。血必净注射液和痰热清注射液是治疗重症肺炎的两种常用中药注射剂,两者都是\"可能有益的。\"然而,未来需要大样本量和高方法学质量的多中心随机对照试验.此外,应改进SR或荟萃分析的方法设计和质量，以形成高质量的，循证医学证据,为中医辅助治疗重症肺炎的有效性和安全性提供依据。
