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.
截至2001年10月,有关治疗急性心房纤颤的临床证据如下:①尚未发现急性心房纤颤转律前使用阿司匹林、肝素或华法林预防血栓的RCT.②未发现有关对急性心房纤颤患者使用直流电复律的RCT.让急性心房纤颤和血流动力学障碍的患者作直流电复律的RCT可能有悖于伦理.③ 3个RCT发现,对于急性心房纤颤的患者使用地高辛和安慰剂转律之间没有明显差异.④两个RCT发现,与安慰剂相比,使用地高辛可在短期内明显降低急性心房纤颤患者的心室率.⑤ 1个RCT发现,与安慰剂相比,静脉使用硫氮卓酮(一种钙通道阻滞剂)能明显降低急性心房纤颤患者的心率.⑥ 1个RCT发现,与地高辛相比,静脉使用硫氮卓酮能在5 min内明显降低急性心房纤颤和心房扑动患者的心率.⑦有1个小样本RCT显示,与安慰剂相比,静脉使用噻吗洛尔(一种β受体阻滞剂)可在20 min内明显降低心室率,同时发现其对心房纤颤发作持续时间不详的患者转律的增加不显著.⑧两个RCT发现,与安慰剂相比,静脉使用维拉帕米(一种钙通道阻滞剂)可明显减慢心房纤颤和心房扑动患者的心率.⑨ 1个RCT发现,静脉使用维拉帕米和静脉使用硫氮卓酮相比,对于心房纤颤和心房扑动患者心率的控制以及收缩功能的影响并无显著差异,但维拉帕米可致一些人出现低血压.
Objective To discuss shortterm effect of rotating hinge knee prosthesis. Methods From July 2002 to April 2005, 17 cases of severe knee joint deformity and instability received rotating hinge knee prosthesis for total knee arthroplasty. There were 8 males and 9 females, aging from 41 to 79 years. The left joints were involved in 10 cases and right joint in 7 cases. All patients were admitted because of pain. The course of disease was from 1 to 7 years. There were 10 cases of osteoarthritis，5 cases of rheumatoid arthritis，1 case of traumatic arthritis after operation of left femur fracture，and 1 case of traumatic arthritis with injury of anterior cruciate ligament, meniscus medialis and medial collateral ligament after operation of left fracture of tibial plateau. According to HSS(hospital for special surgery) scoring system，the preoperative score was 36 to 58 with an average of 48.6. The preoperative flexed motion range of articulation was 21° to 80° with an average of 57.4°. Results All patients were followed up from 7 months to 3 years with an average of 23.6 months. There were no complications of thrombogenesis of veins of lower extremity, pulmonary embolism, palsy of peroneal nerve, fracture, and breakage of extended knee structure. Infection occurred in 1 case at 3 months postoperatively，the prosthesis was dislodged，antibiotic-impregnated cement was filed with knee joint，twostage arthroplasty was expected. At the last follow-up,the HSS score was 78 to 98 with an average of 91.1 in 16 patients. The flexed motion range of articulation was 75° to 100° with an average of 852° at 2 weeks postoperatively. The flexed motionrange of articular was 85° to 123° with an average of 1083° at the last followup. There were significant differences in HSS score and motion range of articular between preoperation and thelast follow-up (P＜0.05). Conclusion The short-term outcome of rotating hinge knee prosthesis is good and a long term followup is necessary.
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.
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.
Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.
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.
(1)子宫肌瘤的单独药物治疗:①单独应用促性腺激素释放激素类似物:RCT发现,与安慰剂相比,GnRHa(gonadorelin analogues)可改善子宫肌瘤的症状,但副作用较大.其中1个研究表明,与安慰剂相比,达菲林在治疗12周时能明显增加闭经;另1个系统性回顾研究显示,无充分证据证实达菲林和布舍瑞林疗效的优劣.1个RCT发现,达菲林高剂量治疗较低剂量治疗在治疗16周时显著增加闭经.两个RCT发现,达菲林与安慰剂相比,在治疗16周后能显著减少骨密度,但治疗停止6个月后,骨密度可以回升到治疗前水平.两个RCT发现,与安慰剂和布舍瑞林相比,达菲林引起的潮热显著增加.②GnRHa联合雌/孕激素:1个小样本RCT比较了GnRHa+雌/孕激素和GnRHa+孕酮改善子宫肌瘤症状的效果的差异,但这些证据很不充分.③GnRHa+孕酮:1小样本RCT发现,与单独使用醋酸亮丙瑞林治疗相比,醋酸亮丙瑞林加孕酮能显著减少出血过多.两个小样本RCT发现,与单独应用GnRHa相比,GnRHa+孕酮能显著减少潮热.④GnRHa+7-甲异炔诺酮:小样本RCT发现,在子宫、子宫肌瘤大小及症状改善方面,单独使用GnRHa和GnRHa+7-甲异炔诺酮比较,无显著差异.⑤非类固醇抗炎药物:两个小样本RCT发现,无充分证据显示非类固醇抗炎药物对子宫肌瘤引起的月经过多有效果.⑥孕三烯酮、左炔诺孕酮宫内系统、米非司酮:无RCT.(2)子宫肌瘤的手术前药物治疗:GnRHa:1项系统回顾研究和1个RCT发现,与安慰剂或不治疗相比,术前使用GnRH-a 3个月以上能增加患者血红蛋白和红细胞压积,减轻子宫和盆腔症状及术中出血.术前应用GnRHa后,更适合经阴道而不是经腹子宫切除.然而术前用药妇女往往会有低雌激素所带来的副效应.(3)子宫肌瘤的手术治疗效果:①经腹子宫切除:无RCT.但一致认为子宫切除对改善子宫肌瘤症状有效.②腹腔镜协助下经阴道子宫切除:无RCT比较此方法与其他方法的长期效果.1个小样本RCT发现,仅有限的证据表明此种方法比经腹子宫切除恢复快、术后疼痛轻.③腹腔镜下肌瘤切除(对比经腹肌瘤切除):1项RCT表明,前者比后者的术后疼痛轻、恢复快.④热球子宫内膜切除术:无RCT比较此方法与非手术治疗及子宫切除之间的效果.有1个RCT比较了术前应用GnRHa,且子宫肌瘤小于孕12周子宫大小的病例中此方法与滚珠子宫内膜去除方法.在子宫切除率、闭经率、流血图表估计得分或治疗12个月时的血红蛋白方面,二者没有差别.与滚珠子宫内膜去除相比,热球子宫内膜去除术减少了操作时间及术中并发症.据报道,大约有1/3的妇女不十分满意滚珠子宫内膜去除术和热球子宫内膜去除术二者中的任何一种方法.
Objective To investigate the advances and clinical efficacy evaluation method on neoadjuvant chemotherapy in patients with gastric cancer. Methods Literatures on the advances and clinical efficacy evaluation method on neoadjuvant chemotherapy in patients with gastric cancer were reviewed and analyzed. The agreement between computed tomography (CT), endoscopic ultrasound (EUS), magnetic resonance imaging (MRI) and positron emission tomography (PET) and the results of histopathology and survival was analyzed.Results CT and EUS were the method of efficacy evaluation commonly used at present, but the evaluation indexes and criteria were controversial, and the criteria for solid tumors seemed to be not feasible for gastric cancer. Diffusionweighted imaging (DWI) method needed more investigation, while PET held advantage in early selection of patients without response accurately.Conclusion There is no uniform standard for clinical efficacy evaluation yet, so an integration of diverse imaging methods may be the best choice to improve the accuracy of neoadjuvant chemotherapy in patients with gastric cancer.
至2002年6月,有关上呼吸道感染治疗的临床证据如下:①止痛剂/抗炎药用于缓解症状:1个系统评价发现与安慰剂比较止痛剂或抗炎药在1～5 d时显著减轻咽喉炎症状;1个RCT发现在服用抗生素的急性鼻窦炎患者,激素鼻喷剂较安慰剂明显改善症状,持续21 d.②抗生素用于预防β溶血链球菌咽炎的少见并发症:1个系统评价发现抗生素可预防β溶血链球菌咽炎的非化脓性并发症,但在工业化国家该并发症少见.③抗生素能缩短流感嗜血杆菌、卡他莫拉菌或肺炎链球菌感染的康复时间,在少部分患者中其上呼吸道感染由流感嗜血杆菌,卡他莫拉菌或肺炎链球菌引起.1个RCT发现抗生素较安慰剂明显增加这些患者在5 d时的康复.但目前尚无简捷的方法将此亚组患者从众多鼻咽培养阴性的患者中甄别出来.④抗生素缩短急性支气管炎、咽喉炎和鼻窦炎的康复时间:系统评价发现抗生素能轻度改善症状.与安慰剂比较,使用抗生素常出现副作用(恶心、呕吐、头痛、皮疹、阴道炎).⑤抗生素在感冒患者中的作用:2个系统评价发现,在患感冒6～14 d时使用抗生素在治愈率或全身改善方面与安慰剂没有差异.⑥抗组胺药用于流涕和喷嚏:1个系统评价发现,使用抗组胺药2 d后流涕和喷嚏明显减轻,但临床获益较小.⑦β受体激动剂缩短成人支气管高反应性、喘息或气流受限患者咳嗽的持续时间:1个系统评价发现,与安慰剂或红霉素比较,在7 d时β受体激动剂可减轻成人咳嗽症状,但亚组分析表明此种获益仅限于伴有支气管高反应性、喘息或气流受限者.β受体激动剂明显增加手抖、震颤和神经过敏的发生比例.儿童中进行的2个小样本RCTs发现在7 d时咳嗽症状在β受体激动剂和安慰剂间没有显著差异.但是,这些RCTs规模太小,故不能检出临床上重要的差异.⑧减充血剂用于充血症状的长期缓解:1个系统评价发现,无证据支持数天中反复使用减充血剂.1个病例对照研究发现,有微弱证据支持去甲麻黄碱可能增加出血性中风的风险.⑨减充血剂用于充血症状的短期缓解:1个系统评价发现,与安慰剂比较单剂减充血剂显著减轻鼻充血,持续3～10h.⑩紫锥花属用于预防:1个系统评价发现与不干预比较,紫锥花属显著减少一次感染发作的人数,但与安慰剂比较,无有效证据支持紫锥花属的作用.(11)紫锥花属制剂:2个系统评价发现有限证据支持紫锥花属的某些制剂在改善症状方面优于安慰剂,但我们未发现有效证据支持任何特定产品的疗效.(12)蒸汽吸入:1个系统评价发现,无证据支持蒸汽吸入的作用.(13)维生素C:1个系统评价发现与安慰剂比较维生素C可轻度缩短感冒症状持续时间,但该作用较小且可能是发表偏倚.(14)锌(鼻内锌胶或锭剂):2个RCTs发现,与安慰剂比较鼻内锌胶缩短感冒症状的平均持续时间,但仅有1个RCT发现差异有显著性.2个系统评价发现,与安慰剂比较葡萄糖酸锌或醋酸盐锌锭剂在7d时减轻症状的持续.