ObjectiveTo evaluate the efficacy and toxicity of TEC and CEF regimen in preoperative chemotherapy for patients with breast cancer. MethodsA total of one hundred breast cancer patients undergoing preoperative chemotherapy were divided into TEC group (n=50) and CEF group (n=50) by the pairgroup method and received surgical therapy after three courses of chemotherapy. The efficacy and toxicity of preoperative chemotherapy of patients in two groups were analyzed. ResultsFour patients with stage ⅢB breast cancer quit from CEF group after two courses of treatment because of the worse satisfaction. Clinical complete remission (cCR) was 7 cases, clinic partial remission (cPR) was 34 cases, stable disease (SD) was 9 cases, therefore, the remission rate (RR) was 82.0% (41/50), and reduction rate of tumor was 64.0% (32/50) in TEC group. cCR was 2 cases, cPR was 32 cases, SD was 12 cases, thus the RR was 680% (34/50), and reduction rate of tumor was 40.0% (20/50) in CEF group. The clinical efficacy and reduction rate of tumor of patients in TEC group were significantly superior than those in CEF group (Plt;0.05). The negative conversion ratio of lymph nodes were 54.1% (20/37) and 57.1% (20/35) in TEC group and CEF group, which was not statistically different (Plt;0.05). The occurrence of hair loss and leukopenia of patients in TEC group were significantly higher than those in CEF group (Plt;0.05), while the differences in thrombocytopenia, low concentration of hemoglobin, nausea, vomiting, diarrhea, cardiac toxicity, and neurotoxicity were not significant (Pgt;0.05). ConclusionTEC regimen is better than CEF regimen in the efficacy and safety of neo-adjuant therapy for patients with breast cancer, and well tolerated.
Acute pharyngitis belongs to the category of "acute throat impediment" in traditional Chinese medicine (TCM), which has a high incidence and is easy to recur. In clinical practice of TCM, Chinese patent medicines with the effects of clearing heat and detoxifying, reducing swelling and relieving pain are widely used in the treatment of acute pharyngitis. These medicines have the advantages of definite efficacy, low side effects, and low risk of developing drug resistance. However, at present, there are no standardized clinical diagnostic and therapeutic evaluation norms for acute pharyngitis in TCM, which has hindered the application of TCM in the prevention and treatment of acute pharyngitis and the development of new TCM preparations. Therefore, the China Association of Chinese Medicine initiated this expert consensus, which was led the formulation by Xiyuan Hospital, China Academy of Chinese Medical Sciences. This expert consensus integrates the current best evidence and extensive clinical expert experience from the front line, covering seven aspects: applicable scope, diagnosis in both Chinese and Western medicine, syndrome classification and evaluation scales, basis for efficacy evaluation, and time for efficacy evaluation. It has formed 8 types of TCM syndromes for acute pharyngitis, as well as the diagnostic criteria, syndrome classification and evaluation scales, evaluation basis for efficacy, and scoring standards for syndromes and diseases. This expert consensus can be used to standardize the diagnosis of the TCM syndromes of acute pharyngitis, as well as the core indicators and evaluation methods for syndrome and disease efficacy, with the aim of providing references for clinical practice and scientific research on acute pharyngitis.
截至2002年7月,急性心肌梗塞(acute myocardial infarction,AMI)治疗的临床证据如下:(1)改善AMI预后的证据:①血管紧张素转换酶抑制剂(ACEI):1篇概述和1个(AMI 36 h到14 d内接受治疗的患者)系统评价发现,血管紧张素转换酶抑制剂和安慰剂相比,患者30 d后的死亡率明显减少;血管紧张素转换酶抑制剂和安慰剂相比,显著增加了持续低血压和肾功能不全.血管紧张素转换酶抑制剂是提供给每一位存在AMI的患者,还是仅提供给有心衰征象的患者,目前尚无定论.②阿司匹林:1个系统评价发现,阿司匹林与安慰剂相比,能明显减少1个月时的死亡率、非致死性再梗塞以及非致死性中风.③β受体阻滞剂:2个系统评价和1个后来的RCT发现,在AMI数小时内给予β受体阻滞剂与对照比较,显著减少死亡率和再梗塞率.溶栓治疗的RCT发现,美托洛尔的及时使用与延后使用相比,明显减少患者6 d后再梗塞率以及复发的胸痛,但使用该药6 d和1年间的死亡率没有显著差异.1个研究比较了在近期有心肌梗塞并且左室射血分数小于40%,或者基本没有接受溶栓治疗的患者中使用卡维地洛与安慰剂的RCT发现,尽管单独的死亡率和复发性非致死性AMI在卡维地洛组中明显较低,但1.3年后各种原因的死亡率以及由于心血管事件住院的联合终点并没有差异.④钙离子拮抗剂:9个RCT发现,在AMI头几天范围内,二氢吡啶和维拉帕米与安慰剂相比并不降低死亡率.1个左心衰的RCT发现有限的证据表明,在AMI的头几天给予硝苯地平与安慰剂比较可能会增加死亡率.⑤糖蛋白Ⅱb/Ⅲ a拮抗剂:2个大型的RCT发现,在AMI患者中联合使用半剂溶栓剂和阿昔单抗与使用全剂量的溶栓剂相比,并没有减少1个月时的死亡率,但可预防非致死性的心血管事件;用阿昔单抗联合治疗增加了出血并发症,特别是颅外的出血.3个RCT发现,尽管加用阿昔单抗增加了出血的危险,但将阿昔单抗加到AMI患者最初的冠脉成型术或者支架中的益处仍有争议.⑥溶栓之外的硝酸盐制剂:2个溶栓时期使用硝酸盐与安慰剂的RCT发现,死亡率没有显著差异.⑦没有溶栓时的硝酸盐制剂:1个在溶栓时代前所做试验的系统评价发现,硝酸盐较安慰剂显著降低AMI患者的死亡率.⑧早期的经皮腔内冠状动脉成形术与溶栓比较(在专业中心完成):2个系统评价发现,早期的经皮腔内冠状动脉成形术与早期的溶栓相比明显降低了急性心肌梗塞患者的死亡率以及30 d的再梗塞率.在非专业中心开展的有关比较经皮腔内冠状动脉成形术与溶栓的试验结果尚不清楚.⑨溶栓:1篇研究对象为AMI患者以及最初的心电图上存在ST段上抬或者束支传导阻滞的患者的试验的概述发现,及时的溶栓治疗(症状发作后的6 h内或许到12 h或者更长)与安慰剂比较显著降低短期内的死亡率;溶栓与对照相比明显增加了中风和大出血的危险.不同类型的溶栓剂之间相互比较的RCT的Meta分析发现,死亡率没有显著差异.(2)AMI继发心源性休克的预后证据:①早期侵入性的心脏血管重建:1个以AMI 48 h内发生心源性休克患者为研究对象的RCT发现,早期侵入性的心脏血管重建与最初的单独药物治疗相比显著降低了6～12 d后的死亡率.1个样本含量较小的RCT也得出了相似的结果,但差异并不显著.②主动脉内的球囊反搏术:1个在AMI后的心源性休克患者中将主动脉内的球囊反搏术加溶栓与单用溶栓作比较的RCT摘要发现,6个月后的死亡率没有显著差异.③1个来自比较溶栓与不溶栓的RCT的AMI后心源性休克患者的亚组分析发现,21 d后的死亡率没有显著差异.④在心脏移植、早期心脏手术、正性肌力药和血管扩张剂、肺动脉插管及左心室支持系统方面,尚未发现有关这些干预措施效果的RCT证据.
截止至2002年6月,有关阑尾炎治疗的临床证据如下:①辅助性抗生素治疗:1项RCT和1项回顾性RCT发现,经阑尾切除术的复杂性和单纯性阑尾炎的成人和儿童,预防性使用抗生素可显著减少伤口感染和腹腔内脓肿.②辅助性抗生素治疗(儿童复杂性阑尾炎):1项系统评价的亚组分析发现,使用抗生素可显著减少伤口感染.③辅助性抗生素治疗(儿童单纯性阑尾炎):1项系统评价的亚组分析发现,使用抗生素不减少伤口感染.1项儿童单纯性阑尾炎的回顾性RCT发现,预防性使用抗生素不能减少伤口感染,但该RCT的样本量太小,不能排除有临床差别.④抗生素治疗和手术:1项成人疑诊阑尾炎的RCT发现,与手术治疗比较,抗生素保守治疗可减少治疗开始后12 h到10 d的疼痛和吗啡的使用.但采取抗生素保守治疗的患者有35%在1年内再次因急性阑尾炎入院,并行阑尾切除术.⑤腹腔镜手术和开腹手术(成人):1项系统评价发现,腹腔镜手术可以减少伤口的感染,减轻手术后第1天的疼痛,减少住院时间以及恢复工作的时间,但增加手术后腹腔内脓肿的发生.⑥腹腔镜手术和开腹手术(儿童):1项系统评价发现,腹腔镜手术可以减少伤口的感染,减少住院时间,但不能减轻手术后第1天的疼痛,不能减少恢复的时间和腹腔内脓肿的发生.⑦开腹手术和不治疗:无RCT证据.⑧开腹阑尾切除术中对残端的内翻处理:1项RCT发现,两次包埋和单纯结扎比较,不能减少伤口的感染、住院时间和腹腔内脓肿的发生.
ObjectiveTo discuss the effect of Cabrol in treatment of Stanford type A aortic dissection.MethodsThe clinical data of patients whom were diagnosed with type A aortic dissection of Stanford in our hospital from January 2013 to January 2018 were retrospectively analyzed. All of 40 patients underwent Cabrol surgical procedure. There were 31 males and 9 females aged 26–75 (48.8±3.3) years. The surgical treatment effect of the patients was evaluated, mainly including the aortic index, the changes in cardiac function before and after operation, and the postoperative follow-up.ResultsAll the 40 patients completed the operation successfully. The diameter of ascending aorta and aortic sinus in postoperative patients were smaller than those before operation (P<0.05). Postoperative left ventricular ejection fraction and cardiac output increased, central venous pressure and left ventricular end-diastolic dimension decreased, and cardiac function indexes were significantly different from those before the operation (P<0.05). Seven patients suffered complications in postoperative follow-up including one stenting leakage, three neurological diseases and three acute renal failure. Two patients died postoperatively.ConclusionCabrol’s operation is effective in the treatment of Stanford type A aortic dissection, which can significantly improve the cardiac function of patients, simplify the anastomosis of coronary artery ostia and decrease amount of bleeding.
Objective To compare endoscopic sinius surgery plus middle meatus fenestration with endoscopic sinius surgery plus middle and inferior meatus fenestration for fungus ball maxillary sinusitis. Methods Applying a prospective randomized controlled trial, 80 patients with fungal ball maxillary sinusitis from January, 2010 to March, 2011 were collected and then divided into two groups, including experiment (40 cases) and control groups (40 cases). The trial group received endoscopic sinius surgery plus middle and inferior meatus fenestration, which the control group received endoscopic sinius surgery plus middle meatus fenestration. Then a follow-up was conducted from the end of surgery to February 28th, 2013. All patients took subjective and objective assessment before and after the surgery, including VAS, SNOT-20, Lund-Mackay CT system scores and Lund-Kennedy endoscopic mucosal score. Results with the trial group was superior to the control group in VAS score, SNOT rating and Lund-Kennedy mucosa score 6 months, 1 year, and 2 years after surgery (Plt;0.01). Lund-Mackay CT score of the control group was significantly higher than the trial group after 1 year of surgery (Plt;0.01). According to the Haikou standard to assess the efficacy of surgery, we found that the total effectiveness rate of the trial group (100.0%; recovery: 36 cases; improved: 4 cases) was higher than that of the control group (87.5%; recovery: 28 cases; improved: 4 cases), with a significant difference (P=0.021). Conclusion Endoscopic sinius surgery plus middle and inferior meatus fenestration with a lower reoccurrence rate is superior to endoscopic sinius surgery plus middle meatus fenestration for fungus ball maxillary sinusitis in clinical efficacy.
Evidence-based medicine advocates to support clinical decision-making with the best evidence, which is useful to objectively evaluate the clinical efficacy of traditional Chinese medicine and optimize clinical diagnosis and treatment. However, significant individualized characteristics identified from syndrome differentiation and treatment are incompatible with evidence-based clinical decision-making, which highlights population-level evidence, to some extent. In recent years, a number of new methods and technologies have been introduced into individualized clinical efficacy evaluation research of traditional Chinese medicine to assist managing and processing complex and multivariate information. These methods and technologies share similarities with evidence-based medicine, and are expected to link the clinical practice of traditional Chinese medicine with evidence-based clinical decision-making. They will guide the development of evidence-based clinical decision-making in traditional Chinese medicine.
ObjectiveTo observe the efficacy of intravitreal injection of conbercept (IVC) combined with subthreshold micropulse laser photocoagulation (SMLP) in the treatment of diabetic macular edema (DME). MethodsA randomized controlled trial. From December 2020 to January 2022, 100 patients (100 eyes) with DME diagnosed by examination in Shanxi Aier Eye Hospital were included in the study. The patients were randomly divided into IVC group (50 eyes) and IVC+SMLP group (50 eyes). All the eyes were treated with IVC once a month for 3 times, and the eyes in IVC+SMLP group were treated with SMLP within 2 weeks after IVC. All affected eyes were examined by best corrected visual acuity (BCVA), which was statistically converted to logarithm of the minimum angle of resolution (logMAR) visual acuity. The central macular thickness (CMT) was measured by optical coherence tomography. Before the treatment, the logMAR BCVA of patients in IVC group and IVC+SMLP group were 0.56±0.04 and 0.55±0.03, respectively. The CMT were (437.36±11.35) μm and (434.58±10.88) μm, respectively. There was no significant difference in logMAR BCVA and CMT between the two groups (t= 0.476, 1.027; P＞0.05). The patients were followed up for 12 months after treatment. The times of IVC and the changes of BCVA and CMT were compared between the two groups. Independent sample t-test was used to compare the logMAR BCVA, CMT and times of IVC between groups. ResultsAfter 12 months treatment, the logMAR BCVA of IVC group and IVC+SMLP group were (241.63±29.79) μm and (240.47±30.46) μm, respectively. Compared with those before treatment, 12 months after treatment, the BCVA of the two groups increased significantly (t=7.014, 5.608; P＜0.001), while CMT decreased significantly (t=8.126, 6.013; P＜0.001). There was no significant difference in BCVA and CMT between the two groups (t=0.835, 0.764; P＞0.05). The number of IVC in IVC group and IVC+SMLP group were (8.15±2.04) times and (5.91±1.80) times, respectively, and the difference was statistically significant (t=5.210, P＜0.001). ConclusionsBoth IVC+SMLP and IVC alone can effectively reduce CMT and increase BCVA in patients with DME. Combination therapy can reduce the number of IVC.
With the advancement of modern research in traditional Chinese medicine (TCM), evidence regarding the clinical efficacy and mechanisms of action of TCM has rapidly accumulated. However, due to a lack of methodological safeguards, the disconnection between clinical and basic research in TCM has become increasingly prominent, making it difficult to form an evidence chain that supports the scientific value of TCM in a manner that is "clear and understandable". Therefore, it is necessary to develop methods for the translation and integration of clinical and basic research evidence oriented towards clinical value, to form a reliable evidence chain that can further discover patterns, confirm efficacy, and highlight advantages. This article discusses the construction and evaluation methods of the evidence chain for the efficacy of TCM, aiming to provide theoretical and methodological references for related work.