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.
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.
ObjectiveTo analyze the clinical characteristics and evaluate the effect and safety of anti-vascular endothelial growth factor (VEGF) therapy in retinopathy of prematurity (ROP) in Sichuan province. MethodsA retrospective study. From January 2013 to January 2022, 156 patients (306 eyes) with ROP who received intravitreal anti-VEGF therapy for the first time in the Department of Ophthalmology, West China Hospital of Sichuan University were selected. According to the type of anti-VEGF drugs, the children were divided into intravitreal injection of ranibizumab (IVR) group and intravitreal injection of conbercept (IVC) group; IVC group was divided into hospital group and referral group according to the different paths of patients. After treatment, the patients were followed up until the disease degenerated (vascular degeneration or complete retinal vascularization) or were hospitalized again for at least 6 months. If the disease recurred or progressed, the patients were re-admitted to the hospital and received anti-VEGF drug treatment, laser treatment or surgical treatment according to the severity of the disease. Clinical data of these children was collected, including general clinical characteristics: gender, gestational age at birth (GA), birth weight (BW), history of oxygen inhalation; pathological condition: ROP stage, zone, whether there were plus lesions; treatment: treatment time, postmenstrual gestational age at the time of the first anti-VEGF drug treatment; prognosis: re-treat or not, time of re-treatment, mode of re-treatment; adverse events: corneal edema, lens opacity, endophthalmitis, retinal injury, and treatment-related systemic adverse reactions. The measurement data between groups were compared by t test, and the count data were compared by χ2 test or rank sum test. ResultsOf the 306 eyes of 156 children with ROP, 74 were male (47.44%, 74/156) and 82 were female (52.56%, 82/156). Each included child had a history of oxygen inhalation at birth. The GA was (28.43±2.19) (23.86-36.57) weeks, BW was (1 129±335) (510-2 600) g, and the postmenstrual gestational age was (39.80±3.04) (31.71-49.71) weeks at the time of the first anti-VEGF drug treatment. All patients were diagnosed as type 1 ROP, including 26 eyes (8.50%, 26/306) of aggressive ROP (A-ROP), 39 eyes (12.74%, 39/306) of zone Ⅰ lesions, and 241 eyes (78.76%, 241/306) of zone Ⅱ lesions. The children were treated with intravitreal injection of anti-VEGF drugs within 72 hours after diagnosis. Among them, 134 eyes (43.79%, 134/306) of 68 patients were treated with IVR, and 172 eyes (56.21%, 172/306) of 88 patients were treated with IVC. In IVC group, 67 eyes of 34 patients (38.95%, 67/172) were in the hospital group and 105 eyes of 54 patients (61.05%, 105/172) were in the referral group. 279 eyes (91.18%, 279/306) were improved after one treatment, 15 eyes (4.90%, 15/306) were improved after two treatments, and 12 eyes (3.92%, 12/306) were improved after three treatments. The one-time cure rate of IVR group was lower than that of IVC group, but the difference was not statistically significant (χ2=1.665, P=0.197). In different ROP categories, IVC showed better therapeutic effect in A-ROP, and its one-time cure rate was higher than that in IVR group, with statistically significant difference (χ2=7.797, P<0.05). In the hospital group of IVC group, the GA, BW and the postmenstrual gestational age at first time of anti-VEGF drug treatment were lower than those in the referral group, and the difference was statistically significant (t=－2.485, －2.940, －3.796; P<0.05). The one-time cure rate of the hospital group and the referral group were 94.94%, 92.38%, respectively. The one-time cure rate of the hospital group was slightly higher than that of the referral group, but the difference was not statistically significant (χ2=0.171, P=0.679). In this study, there were no ocular and systemic adverse reactions related to drug or intravitreal injection in children after treatment. ConclusionsCompared with the characteristics of ROP in developed countries, the GA, BW and postmenstrual gestational age of the children in Sichuan province are higher. Both IVR and IVC can treat ROP safely and effectively. There is no significant difference between the two drugs in the overall one-time cure effect of ROP, but IVC performed better in the treatment of A-ROP in this study.
Objective To develop a preliminary "pulmonary nodule symptom scale" based on the Delphi method, providing a tailored, standardized, normalized, and promotable symptomatic evaluation tool for the efficacy assessment of pulmonary nodule patients treated with traditional Chinese medicine or integrated traditional Chinese and Western medicine interventions. Methods A preliminary pool of scale items was formed through literature review, interviews with doctors and patients, and reference to guidelines and consensus on pulmonary nodules and patient-reported outcome (PRO) scales related to lung cancer. Two rounds of expert consultation were conducted using the Delphi method. Based on the concentration and variation indicators of expert evaluations, and considering experts’ suggestions for specific item deletions and modifications, a core group meeting was held to screen and refine the scale items. Results Invitations were sent to 54 experts, with 51 accepting the consultation. The active coefficient for the first round of consultation was 94.4%, and for the second round, it was 100%. The average authority coefficient for the 51 experts was 0.896. The Kendall’s coefficient of concordance and the average coefficient of variation for the first and second rounds of consultation were 0.215 (P<0.001) and (0.34±0.07), 0.162 (P<0.001) and (0.24±0.05), respectively. Through two rounds of Delphi expert consultation, a preliminary "pulmonary nodule symptom scale" covering 17 items across four dimensions - respiratory symptoms, systemic manifestations, psychological state, and overall assessment - was formed. Conclusion The experts participating in this Delphi consultation had high authority and enthusiasm, and they have a good level of acceptance and consistency for the preliminary "pulmonary nodule symptom scale". Subsequent empirical research will be conducted on a large sample cohort of pulmonary nodule patients to verify the scale’s stability and effectiveness.
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.
The characteristics of traditional Chinese medicine (TCM) practice include treatment based on syndrome differentiation and holism, which determines it is difficult to reflect the individualized therapeutic evaluation and overall regulation of TCM through traditional randomized controlled trials, which is based on quantitative evaluation. The implementation of N-of-1 trials will provide opportunities for quantitative evaluation of individualized therapeutic evaluation of TCM. Using mixed methods research, such as exploratory sequence design, interpretive sequence design or convergent design can provide abundant data to individualized therapeutic evaluation of TCM in different aspects, which may reflect holism and humanities characteristics of TCM in individual level.
Objectives To assess the clinical effectiveness of non-penetrating trabecular surgery versus trabeculectomy for open angle glaucoma. Methods We searched the Cochrane Central Register of Controlled Trials (issue 2, 2007), MEDLINE (1966 to May 2008), EMbase (1980 to May 2008), and CMB-disk (1979 to May 2008). We also hand searched relevant journals and conference proceedings. Data were extracted by two reviewers independently using an extraction form. The Cochrane Collaboration’s RevMan 5.0 software was used for statistical analysis. Results Three RCTs involving 127 participants (144 eyes) with previously untreated open angle glaucoma were included. Meta-analysis showed that compared with non-penetrating trabecular surgery, trabeculectomy increased the proportion of patients with reduced postoperative intraocular pressure (WMD2.78, 95%CI 1.41 to 4.15), improved the operation success rate (RR 0.53, 95%CI 0.37 to 0.77), and reduced the use of postoperative antiglaucoma medication (WMD 0.96, 95%CI 0.84 to 1.08). Non-penetrating trabecular surgery reduced the incidence of postoperative complications (RR 17.00, 95%CI 8.36 to 26.00). Conclusion Since the sample sizes of the included trials are relatively small, and the two procedures are also related to progressive visual field loss and optic disk damage, more well-designed large-scale RCTs are required.
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.
Objective To compare the therapeutic effect of cannulated screws fixation at different time points through different reduction methods on the heal ing of displaced femoral neck fractures. Methods From January 1997 to September 2007, 240 patients with displaced femoral neck fracture were treated, including 121 males and 119 females aged 22-79 years old (average 56 years old). All cases were fresh and close fractures. According to the fractured part, there were 133cases of subcapital fracture, 64 of transcervical fracture and 43 of basal fracture. According to Garden classification, there were 105 cases of type III and 135 of type IV. Cannulated screws fixation was performed on all the patients, and the time from injury to operation was 6 hours to 7 days. Fifty-five cases received closed reduction and 59 cases received l imited open reduction as emergency treatment, while 65 cases received closed reduction and 61 cases received l imited open reduction as selective operation. Different groups were compared in terms of the heal ing rate of fracture, the excellent and good rate of reduction as well as the excellent and good rate of fixation. Results There was no significant difference between the closed reduction and the l imited open reduction in terms of operation time and bleeding volume (P gt; 0.05). Postoperatively, all wounds healed by first intention, no infection was observed, avascular necrosis of femoral head occurred in 44 cases, and the rate of avascular necrosis of femoral head in the l imited open reduction at emergency group was less than that of other 3 groups (P lt; 0.01). All the patients were followed up for 12-72 months (average 38 months), 193 cases got fracture heal ing at 10-23 months after operation (average 14 months). For the closed reduction as emergency operation group, the l imited open reduction as emergency operation group, the closed reduction as selective operation group, and the l imited open reduction as selective operation group, the heal ing rate of fracture was 74.55%, 91.53%, 69.23% and 86.89%, respectively; the excellent and good rate of reduction was 73.73%, 94.92%,70.77% and 91.80%, respectively; the excellent and good rate of fixation was 76.36%, 93.22%, 73.85% and 88.52%, respectively. The heal ing rate of fracture, the excellent and good rate of reduction as well as the excellent and good rate of fixation in the l imited open groups were higher than that of the closed reduction groups (Plt; 0.01), and there was no significant difference between the emergency operation groups and the selective operational groups (Pgt; 0.05). Conclusion The reduction methods have significant influences on the heal ing of fractures after cannulated screws fixation of the displaced femoral neck fracture, and the operation time has no obvious effect on fracture heal ing.