Background: Antibiotic resistance has emerged as a global concern. Xiyanping injection (XYP), a traditional Chinese medicine injection, has been extensively utilized for the treatment of suppurative acute tonsillitis (SAT) in China, exhibiting clinical efficacy. Consequently, there is a need for further evaluation of the potential effectiveness and safety of this treatment. This meta-analysis consolidated data from multiple independent studies to assess the overall treatment efficacy of XYP as adjuvant therapy in patients with SAT.Methods: The search for randomized controlled trials (RCTs) encompassed databases from their inception to 1 April 2024, including the Cochrane Library, PubMed, Embase, SinoMed, CNKI, Wanfang, VIP, and CBM. Data extraction, methodological quality assessment, and meta-analysis were performed independently by two researchers. Review Manager 5.4 was used for data analysis. Various tools were employed for assessment, including forest plots to visualize results, funnel plots to detect publication bias, trial sequential analysis to estimate sample size, and GRADE to evaluate evidence quality.Results: A comprehensive analysis of 32 RCTs involving 4,265 cases was conducted. When compared to conventional treatments (CTs; β-lactams/clindamycin hydrochloride injection/ribavirin) alone, the combination of XYP with CTs demonstrated significant reductions in symptom duration. This included sore throat (MD = −21.08, 95% CI: −24.86 to −17.29, p < 0.00001), disappearance of tonsillar redness and swelling (mean difference [MD] = −20.28, 95% confidence interval [CI]: −30.05 to −10.52, p < 0.0001), tonsil purulent discharge (MD = −22.40, 95% CI: −28.04 to −16.75, p < 0.00001), and normalization of temperature (MD = −19.48, 95% CI: −22.49 to −16.47, p < 0.00001). Furthermore, patients receiving CTs combined with XYP exhibited lower levels of interleukin-6 (MD = −7.64, 95% CI: 8.41 to −6.87, p < 0.00001) and interleukin-8 (MD = −5.23, 95% CI: −5.60 to −4.86, p < 0.00001) than those receiving CTs alone. Additionally, the combination therapy significantly improved the recovery rate (relative risk [RR] = 1.55, 95% CI: 1.37 to 1.77, p < 0.00001), white blood cell count recovery rate (RR = 1.13, 95% CI: 1.04 to 1.23, p = 0.004), and disappearance rate of tonsillar redness and swelling (RR = 0.51, 95% CI: 1.14 to 1.38, p < 0.00001), with no significant increase in adverse events (RR = 0.47, 95% CI: 0.20 to 1.10, p = 0.08).Conclusion: The current systematic review and meta-analysis tentatively suggest that the combination of XYP and CTs yields superior clinical outcomes for patients with SAT compared to CTs alone, with a favorable safety profile. Nonetheless, these findings warrant further confirmation through more rigorous RCTs, given the notable heterogeneity and publication bias observed in the included studies.Systematic Review Registration:https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=296118, identifier CRD42022296118.

目的 研究目前临床工作中使用脉络舒通丸治疗骨外科疾病有效患者的用药方案特征和规律.方法 从全国11家三甲医院医院信息系统(Hospital information system,HIS)数据库中提取使用脉络舒通丸治疗骨外科疾病有效的病例共计2083例,描述其临床联合用药品种,并采用Tabu搜索算法建立复杂网络模型,利用矩阵法展示不同子网络间关系.并进行关联规则分析,尝试寻找骨外科疾病的核心处方以及各类药物之间的相关性.结果 由子结构提取出脉络舒通丸治疗骨外科疾病的中西医结合治疗方案一组,主要包括:脉络舒通丸、头孢类、肝素类、羟乙基淀粉、强骨胶囊.由矩阵展开图得出的常用联合用药10种,主要包括:苯巴比妥、青霉素类、地塞米松、右旋糖酐、红花注射液、曲马多、胰岛素类、庆大霉素、疏血通注射液.结论 除去外科手术常规用药,在使用脉络舒通丸治疗骨外科疾病的过程中可考虑以脉络舒通丸、头孢类、肝素类、羟乙基淀粉、强骨胶囊为用药方案,同时可以考虑联用红花注射液、疏血通注射液等活血中药制剂,预防下肢深静脉血栓形成及缓解肢体肿胀.

目的 对复方丹参喷雾剂/气雾剂治疗冠心病心绞痛的有效性和安全性进行系统评价.方法 系统检索中国知网、万方数据、维普网、中国生物医学文献数据库、Cochrane Library、PubMed、Embase、Web of Science,自建库至 2021年5月5日的数据.筛选出复方丹参喷雾剂/气雾剂治疗冠心病心绞痛的随机对照试验进行Meta分析,使用TSA软件对冠心病心绞痛显效率结局指标的样本量进行预测,运用推荐分级评估、发展和评价(GRADE)证据评价方法对纳入的结局指标进行质量评价.结果 共纳入9项研究,总样本量为1113例,试验组702例,对照组411例.Meta分析结果显示,复方丹参喷雾剂/气雾剂单用的治疗效果优于复方丹参片;联合硝酸酯类药物治疗冠心病心绞痛在提高冠心病心绞痛显效率、心电图显效率以及药品不良反应发生率与单用硝酸酯类药物无显著差异,但在稳定斑块(降低低密度脂蛋白、血清总胆固醇、血小板黏附率变化)方面优于单用硝酸酯类药物.不良反应主要为鼻咽部不适,可自行缓解,未发生严重不良反应.结论 复方丹参喷雾剂/气雾剂治疗冠心病心绞痛有良好的临床疗效和安全性.

This study systematically sorted out the evidence data of the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM) of Reyanning Mixture in the treatment of acute upper respiratory tract infection(heat-toxin attacking lung syndrome) with the qualitative and quantitative evaluation methods adopted. Based on evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, pharmacoeconomics, and health technology evalua-tion(HTA), the clinical value of Reyanning Mixture was evaluated using multi-criteria decision analysis(MCDA) model, Chinese patent medicine clinical evidence, and value evaluation software(CSC v2.0). The SRS monitoring data, Meta-analysis, and other safety evidence showed that the main adverse reactions of Reyanning Mixture were nausea, diarrhea, and rash, and no serious adverse reactions were found. The pharmacovigilance system was sound, and the system was perfect. There was no recall, notification, or interview for unqualified products. Based on the existing research, the evidence was sufficient, and the risk was controllable. Hence, its safety was grade A. Meta-analysis showed that in the treatment of acute upper respiratory tract infection, Reyanning Mixture combined with Amoxicillin Capsules was better than Amoxicillin Capsules alone in shortening the complete fever relief time and improving the cure rate. Besides, it was superior to Shuanghuanglian Granules in shortening the complete fever relief time, cough relief time, nasal congestion relief time, and pharyngeal congestion relief time. The Meta-analysis was conducted based on AMSTAR standard, and its ove-rall quality was proved good. The evidence quality in GRADE system evaluation was medium and low. The quality of evidence was medium, and the clinical value was obvious. Hence, its effectiveness was grade A. The results of pharmacoeconomic research showed that compared with Amoxicillin Capsules, Reyanning Mixture alone or in combination with Amoxicillin Capsules had cost-effectiveness advantages in the treatment of acute upper respiratory tract infection, and the results were stable in sensitivity analysis. According to the CASP economic evaluation checklist, the research problems were clear and the results were reliable. As revealed by the comprehensive evaluation, the evidence quality was sufficient and the result was clear. Its economy was grade B. Reyanning Mixture had multiple therapeutic targets like anti-virus, anti-bacteria, antipyresis, and anti-cough, with good clinical innovation. There were many innovative initiatives in ensuring drug supply, especially at the grass roots, drug safety, and effectiveness, and also multiple innovative contributions to production technology, quality control, scientific and technological research and development, and enterprise management and marketing. Therefore, its innovation was grade B. The dosage form of Reyanning was mixture, which made it convenient for storage and transportation. The usage was easy to be mastered and accepted by doctors and nurses, exhibiting good suitability for clinicians, nurses, pharmacists, and patients who received this drug and basically meeting the needs of clinical medication. The suitability was grade B. The average daily cost of this drug was 8.082 yuan, and the price was low. The treatment cost accounted for a small proportion of the annual disposable income of urban and rural residents, indicating that it was affordable. Reyanning Mixture was available in 31 provinces, cities and autonomous regions, covering 6 910 hospitals. The allocation of hospitals at all levels was more than 50%. There was no shortage or supply restriction of medicinal material resources. The annual production capacity was sufficient to meet the supply demand, so its accessibility was grade A. Reyanning Mixture, sourced from "pneumonia Ⅲ", has been subjected to a real-world study of its clinical application, with 4 367 cases involved, and the characteristic of TCM was grade B. The comprehensive evaluation results demonstrated that the clinical value score of Reyanning Mixture in the treatment of acute upper respiratory tract infection(heat-toxin attacking lung syndrome) was 0.80, making it rated class A. According to the Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021), it is recommended to convert it into the relevant policy results of basic clinical medication management according to the procedures.

目的:旨在应用医院信息系统电子医疗数据开展真实世界脉络舒通丸对胃肠功能影响的临床安全性研究,为脉络舒通丸的临床安全应用提供参考.方法:提取我国14家三甲医院电子医疗数据,按照年龄±5岁、性别相同、入院病情相似的原则,匹配后得到共5086例数据,应用GBM倾向性评分法平衡混杂因素,使用2种Logistic回归方法对比分析真实世界中脉络舒通丸是否对患者胃肠功能具有显著影响.将使用脉络舒通丸后立即停药,并且在用药1～3 d后使用护胃药物,但排除联合使用有胃肠刺激性的药物、既往有慢性胃肠道疾病病史患者作为疑似发生胃肠道不良反应的患者.结果:运用倾向性评分平衡混杂因素后,使用Logistic回归的方法对处理后的数据进行分析,结果显示未观察到使用脉络舒通丸对胃肠功能产生显著影响.结论:该研究为脉络舒通丸的安全性研究提供了证据,但鉴于倾向性评分法有其局限性,无法实现对未知混杂因素的平衡,尚需多种安全性研究证据,为脉络舒通丸在临床安全应用方面提供证据.

目的 应用医院信息医疗系统电子数据开展真实世界脉络舒通丸对肝功能指标影响的安全性临床研究.方法 基于全国14家大型三级甲等医院的医疗电子数据库,将服用脉络舒通丸患者作为脉络舒通丸组,未服用脉络舒通丸者作为对照组,以性别相同、年龄±5岁为匹配条件,按照1:1比例分组后2组均为2387例,以用药后肝功能指标[碱性磷酸酶(alkaline phosphatase,ALP)、丙氨酸氨基转移酶(alanine transaminase,ALT)、天冬氨酸氨基转移酶(aspartate transaminase,AST)、谷氨酞转移酶(gamma-glutamyl transferase,GGT)、总胆红素(total bilirubin,TBIL)]作为结局评价指标,通过倾向性评分方法控制研究中存在的混杂因素,采用3种统计学方法进行安全性分析.结果 筛选出12个影响程度较高的混杂.因素,加权平衡了全部的混杂因素,3种统计学方法得到的结果均为P＞0.05,两组差异不具有统计学意义.结论 不能认为脉络舒通丸导致肝功能指标异常变化,但鉴于倾向性评分法仅能控制已知潜在混杂因素,无法实现对未知混杂因素的平衡,不排除存在未知偏倚可能,需开展相关前瞻性主动监测进一步获得其临床安全性证据,从而指导脉络舒通丸的安全、科学、合理用药.

This study systematically evaluated the efficacy and safety of Ganshuang Granules in the treatment of liver injury, so as to provide a new choice for patients with liver injury. CNKI, Wanfang, VIP, SinoMed, Cochrane Library, PubMed, EMbase, and Web of Science were systematically searched for the randomized controlled trial(RCT) of Ganshuang Granules in the treatment of liver injury. RevMan 5.4 was employed to perform the Meta-analysis of the included RCT according to the Cochrane Handbook 5.1. A total of 3 005 patients were included in 38 RCTs, including 1 536 patients in the observation group and 1 469 in the control group. The results of Meta-analysis showed that Ganshuang Granules combined with conventional therapy was superior to the therapy in the control group in reducing alanine aminotransferase(ALT)(MD=-24.12, 95%CI[-32.17,-16.07], P<0.000 01), aspartate aminotransferase(AST)(MD=-23.24, 95%CI[-29.70,-16.78], P<0.000 01), total bilirubin(TBiL)(MD=-12.42, 95%CI[-14.62,-10.22], P<0.000 01), and gamma-glutamyl transpeptidase(GGT)(MD=-21.32, 95%CI[-33.61,-9.03], P=0.000 7). Compared with the control group, the observation group had witnessed a significant increase in albumin(ALB)(MD=4.94, 95%CI[4.44, 5.45], P<0.000 01). No significant adverse reactions were observed. According to the available data, Ganshuang Granules combined with conventional therapy can effectively recover the levels of ALT, AST, TBiL, GGT, and ALB in patients with liver injury. Nevertheless, high-quality RCT is still needed to further verify the findings of this study.

This study aimed to provide researchers with a better understanding of the research status, progress and problems of Chinese medicine-induced kidney injury. The mapping knowledge domain(MKD) was chosen to visualize the research process, hotspots,and frontiers, thus providing a reference for follow-up research. The relevant articles were retrieved from China National Knowledge Infrastructure(CNKI) from its inception to November 20, 2020, and 683 were finally included for visualization, with a knowledge map covering the keywords, research institutions and authors plotted by Cite Space. Since 2006, the annual number of published articles regarding Chinese medicine-induced kidney injury has steadily declined. The top five keywords sorted by frequency of co-occurrence were tubulointerstitial nephritis(TIN), aristolochic acid(AA), Akebiae Caulis, experimental research, and descriptive research. Akebiae Caulis appeared at the highest frequency of co-occurrence among Chinese medicines and exhibited the highest burst intensity. The burst ended in 2020, when the Chinese medicine with the highest burst intensity changed to Tripterygii wilfordii and its preparations. It could be seen that Akebiae Caulis was the hotspot in the research of Chinese medicine-induced kidney injury, and T. wilfordii became the research frontier. The current research has mainly focused on " organic anion transporters" and " metabolomics". The decline in articles about Chinese medicine-induced kidney injury was attributed to the reduced clinical case reports after the in-depth study of Chinese medicine-induced kidney injury. However, more clinical studies need to be conducted based on the concept and method of pharmacovigilance to construct a pharmacovigilance system of Chinese medicine for actively and passively monitoring and collecting the clinical cases with Chinese medicine-induced kidney injury, figuring out the incidence and characteristics of adverse reactions caused by Chinese medicine, and carrying out comprehensive and multi-dimensional safety research.

目的 基于真实世界医疗电子数据库,探索脉络舒通丸治疗周围血管疾病的疗效.方法 基于全国14家大型三级甲等医院的医疗电子数据库,以周围血管疾病的患者为研究对象,将服用脉络舒通丸患者作为脉络舒通丸组,未服用脉络舒通丸患者作为对照组,以性别、年龄±5岁且入院病情相同为匹配条件,按照1:1比例匹配,匹配后两组均为293例,以用药疗效为结局评价指标,通过倾向性评分方法控制本研究中存在的混杂因素,采用x2检验、单变量的Logistic回归、不带协变量的倾向评分加权Logistic回归、带协变量的倾向评分加权Logistic回归进行疗效分析.结果 脉络舒通丸组有效290例(98.98％),无效3例(1.02％);对照组有效269例(91.81％),无效24例(8.19％),两组治疗结局比较差异有统计学意义(x2值=15.53,P＜0.001).采用倾向性评分方法筛选出27个影响程度较高的混杂因素,加权平衡了其中14个混杂因素,4种统计学方法得到的结果均显示两组差异有统计学意义(P＜0.001),脉络舒通丸组的治疗结果优于对照组.结论 脉络舒通丸对周围血管疾病有良好的临床治疗效果.

目的:评价脉络舒通丸治疗骨外科疾病的临床疗效,为临床实践提供参考.方法:基于全国20家三级甲等医院信息管理系统,选取主要诊断为骨外科疾病的患者为研究对象,其中筛选出使用脉络舒通丸治疗骨外科疾病的患者1604例作为试验组,并与试验组年龄正负3岁、性别相同、入院病情相近为条件,1:1匹配未使用脉络舒通丸的骨外科疾病患者作为对照组,采用倾向性评分法平衡2组间的混杂因素,并通过Logistic回归方法比较2组间治疗骨外科疾病疗效的差异.结果:单因素分析得出,使用脉络舒通丸的骨外科疾病患者治疗有效率与未使用该药患者的治疗有效率比较差异有统计学意义(P<0.05),苯巴比妥、右旋糖酐、冠状动脉粥样硬化性心脏病是该人群使用脉络舒通丸治疗骨外科疾病疗效评价的主要混杂因素,单因变量Logistic回归、倾向性评分加权的Logistic回归以及带协变量调整的倾向性评分加权Logistic回归的回归系数均大于0,其中单因变量Logistic回归与带协变量调整的倾向性评分加权Logistic回归得P值小于0.05.结论:基于现有数据可以认为,使用脉络舒通丸有助于骨外科疾病的治疗,这可为临床实践提供一定的参考依据,但仍需设计前瞻性试验进一步验证.

目的 了解脉络舒通丸治疗骨外科疾病的临床联合用药特征,挖掘其规律.方法 提取来自全国14家大型三甲医院信息系统中2006～2016年使用过脉络舒通丸至少1次的骨外科疾病患者信息,共3173例,描述临床联合用药特征.结果 使用脉络舒通丸的骨外科疾病患者平均年龄为(42.74+ 16.33)岁,男女比例为2.54∶1,18～45岁的患者居多(46.14％).联合用药中,脉络舒通丸合并1种中药用药频数最高的为红花注射液(9.77％);合并1种西药用药最常为苯巴比妥(6.4％).关联规则显示联合1种中药合并1种西药常为仙灵骨葆胶囊和头孢唑林(9.39％);联合1种中药合并2种西药多为仙灵骨葆胶囊、头孢唑林、苯巴比妥(8.54％);联合1种中药合并3种西药常为仙灵骨葆胶囊、头孢唑林、苯巴比妥、肌苷(4.92％).结论 本研究探索了真实世界中脉络舒通丸治疗骨外科疾病的联合用药特征,脉络舒通丸常合并活血化瘀类、补肾壮骨类、健脾通便类中药联合应用,常与镇静止痛类、抗菌类、抗炎症类、抑酸护胃类西药联合应用.为其在骨外科疾病的临床联合用药提供参考依据,但仍需在证据级别更高的临床研究中作进一步的验证.

目的:为解刺五加注射液治疗冠心病的临床应用情况,提取医院信息采集系统中使用刺五加注射液冠心病患者的数据,挖掘其用药特征及规律,为规范刺五加注射液的临床合理应用提供参考.方法:选取来自全国18家大型三甲医院信息系统中使用过刺五加注射液至少1次并患有冠心病的患者信息,使用频数统计方法描述患者的临床用药特征,采用关联规则数据挖掘方法分析联合用药特征.结果:患有冠心病并使用刺五加注射液患者的平均年龄(69.41±10.53)岁,45岁以上的患者占98.62％,男女比例为1:1.614;冠心病患者常合并高血压、高脂血症、糖尿病等疾病,治疗冠心病时刺五加注射液常与单硝酸异山梨酯、美托洛尔、硝苯地平、硝酸异山梨酯、乙酰水杨酸等药物联合使用.结论:基于对真实世界临床用药特征的解析,研究发现刺五加注射液的使用人群为中老年人群,常联合抗心肌缺血类、抗栓类、降糖降脂类药物使用,联合用药数据挖掘的结果符合冠心病诊疗指南,为其治疗冠心病的临床合理用药提供了重要的参考依据.

目的 了解真实世界脉络舒通丸对肾功能指标时影响.方法 基于集成数据仓库,提取全国14家三甲医院医疗电子数据库中2006～2016年服用脉络舒通丸(脉络舒通丸组)和未服用脉络舒通丸患者(对照组)的病例数据,以性别相同、年龄±5岁为匹配条件,按照1:1比例匹配,匹配后2组均为2395例,以用药后对肾功能指标[肌酐(Cr)、尿素氮(BUN)]的影响为结局评价指标,通过倾向性评分方法控制本研究中存在的混杂因素,采用4种统计学方法进行安全性分析.结果 采用倾向性评分方法加权平衡了11个的混杂因素,4种统计学方法得到的结果均P>0.05,脉络舒通丸组和对照组相比,导致肾功能指标异常变化的可能性相同,2组差异无统计学意义,真实世界使用脉络舒通丸对患者肾功能指标不具有直接影响.结论 本研究数据没有发现脉络舒通丸会对肾功能指标产生显著影响,但用药仍需谨慎.

目的 探讨真实世界中注射用灯盏花素临床发生过敏反应的可能影响因素.方法 采用回顾性巢式病例对照研究设计,处方序列对称分析方法.基于医院信息管理系统(HIS)集成数据仓库,纳入其中37家三级甲等医院HIS中使用注射用灯盏花素后出现疑似过敏反应的患者,采集患者的入院信息、疾病诊断、医嘱、治疗结局等数据构建数据库.结局为疑似过敏的病例为病例组,根据一定条件在同一队列研究中的结局为非过敏的病例为对照组.可疑过敏反应变量为合并疾病(频数前10位)、合并用药(频数前10位)、住院天数分段、疗程分段、用药剂量分段.采用Logistic回归方法,探讨患者合并疾病、合并用药、用药单次剂量及日剂量、用药疗程、住院天数与疑似过敏反应发生的相关性.结果 最终病例组纳入270例,对照组纳入1350例.合并疾病中腰椎间盘脱出、肺部感染的回归系数分别为0.29363912、0.14228938(P ＜0.05),合并用药中氯化钾、奥美拉唑的回归系数分别为0.13004015、0.08152833(P ＜0.05),单次剂量＞50mg回归系数为0.09793825(P＜0.05),系数为正表明该变量为"是",或取此水平时相对于对照组来说发生不良反应的可能性大,为疑似过敏反应发生的影响因素.结论 合并腰椎间盘脱出、肺部感染,联用氯化钾、奥美拉唑,单次剂量＞50mg为使用注射用灯盏花素发生疑似过敏反应的可能影响因素.

现代中西药联合用药中,中医药一直有着其不可或缺的作用,对疾病有着不可替代的疗效,为了证明中药的精准定位,研究者应当采用多维度的设计,解决不同阶段不同需求的问题.本文以上市后药品注射用丹参多酚酸盐疗效评价精准定位为例,对四维度疗效评价及机制研究设计思路予以介绍,探索中医药在重大疾病治疗中不可或缺的治疗价值.首先,从HIS真实世界数据分析中发现了注射用丹参多酚酸盐常与阿司匹林联合使用治疗冠心病心绞痛,然后使用系统评价对注射用丹参多酚酸盐常与阿司匹林联合使用治疗冠心病心绞痛的疗效进行了验证,进一步采用网络药理学探索其疗效机制,发现二者联合用药对冠心病心绞痛的治疗有着共同的信号通路,有疗效增强和相加作用.最后,在前期3个维度的研究基础上,采用PRCT优效性试验设计,以血栓弹力图的检测作为客观评价指标,以验证注射用丹参多酚酸盐与阿司匹林联合用药治疗冠心病心绞痛的疗效.以期本范例为中药药品上市后疗效评价精准定位提供范例,供临床科研工作者参考和借鉴.