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.
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.
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.
截至2002年8月,有关妊娠子痫及高血压的临床证据如下:预防: ①抗血小板药物:1个系统评价发现,对可能发生先兆子痫的孕妇使用抗血小板药物(主要是阿司匹林)与使用安慰剂或不治疗相比,在降低发生先兆子痫的危险、减少胎儿死亡和早产方面有统计学意义,在其他重要结局上无统计学意义.随后的1个小样本随机对照试验(RCT)也得出相似的结论.该系统评价还发现,无证据表明使用阿司匹林会比安慰剂增加孕妇或胎儿出血的危险. ②补钙(用于高危孕妇或钙摄入不足的孕妇):1个系统评价发现,给孕妇补钙(2 g/d)与使用安慰剂相比,在降低先兆子痫的发病危险及减少胎儿出生时体重不足 2 500 g方面有统计学意义,但对降低死产、住院期间围产儿死亡、减少剖腹产或早产没有统计学意义. ③补镁 : 1个系统评价发现,尚无充足证据证明补镁对有发生先兆子痫或其并发症危险的孕妇有效. ④其它药物干预:两个RCT比较了使用阿替洛伟或硝酸甘油与安慰剂,但由于纳入的病例数太少不能得出可靠结论. ⑤限制盐的摄入: 1个系统评价的有限证据表明,低盐饮食与正常饮食相比,在降低孕妇先兆子痫的发生率方面无统计学差异. ⑥ Vit C和Vit E:在高危孕妇中进行的1个RCT中,有限的证据显示,使用Vit C和Vit E与安慰剂相比,前者可明显减少先兆子痫的发生率,但是,我们不能对其疗效得出可靠结论,也无足够证据证明Vit C和Vit E对其它临床指标有影响. ⑦夜间服用月见草油或鱼油:我们找到6个关于服用月见草油和鱼油的RCT,但其样本量都太小,不能得出可靠的结论.治疗: ①积极治疗与姑息疗法对首发严重先兆子痫孕妇的疗效比较:纳入两个小样本RCT的1篇系统评价发现,无证据表明积极治疗对严重先兆子痫孕妇比姑息疗法更能减少死产率或围产儿死亡率.相反,与姑息疗法相比,积极治疗增加了新生儿进入重症监护病房的比例和发生坏死性小肠结肠炎及呼吸窘迫的危险.与姑息疗法相比,无充足证据表明积极治疗对母亲有效. ②降压药用于治疗轻、中度高血压:两个系统评价发现,使用降压药与安慰剂、不用降压药或另外一种降压药比较,前者能明显减少发展为严重高血压的危险,但是对先兆子痫和围产儿死亡无明显效果.该系统评价发现,在妊娠期使用血管紧张素转换酶抑制剂与胎儿发生肾衰有关,还发现使用β受体阻滞剂会增加孕龄过小的危险. ③降压药用于治疗妊娠期重度高血压(尽管在药物的最佳选择方案上尚无足够的证据):在患有孕期重度高血压需要立即采取治疗的孕妇中做的1个系统评价和1个RCT中,无证据表明用不同的降压药控制血压在疗效上有差异.由于这些研究的样本量太小,尚不能得出关于不同药物之间相互关系的进一步结论. ④抗氧化剂用于治疗严重的先兆子痫:1个RCT发现,无足够证据表明,在治疗严重先兆子痫的疗效方面,Vit E、Vit C和别嘌呤醇联用与安慰剂相比有差异. ⑤卧床休息对出现蛋白尿的孕期高血压患者的作用:1个系统评价发现,无足够证据表明卧床休息与常规住院活动相比,前者对出现蛋白尿的孕期高血压患者更有效. ⑥卧床休息/住院治疗:我们没有找到关于住院、卧床休息或日间观察与门诊观察或住院但不限制活动相比较的充足证据. ⑦严重先兆子痫患者无痛分娩麻醉方式的选择:1个RCT发现,严重先兆子痫患者进行无痛分娩时,与静脉麻醉相比,硬膜外麻醉能明显降低平均疼痛指数,但这种差异的临床重要性不清楚. ⑧无蛋白尿的妊娠高血压患者的住院治疗:1个系统评价发现,住院治疗与门诊治疗相比,两者在主要临床结局上无统计学差异. ⑨硫酸镁用于治疗子痫(其疗效优于其它抗惊厥药):多个系统评价发现,对于子痫患者,硫酸镁比较苯妥英钠、地西泮或抗自主神经合剂(冬眠合剂)能明显减少子痫的进一步发作.所有系统评价都显示,使用硫酸镁有降低孕产妇死亡率的趋势,尽管其差异没有统计学意义. ⑩扩张血容量用于治疗严重先兆子痫:1个系统评价发现,无足够证据表明是否扩容治疗对严重先兆子痫患者在疗效上有差异.B11严重先兆子痫患者预防性使用硫酸镁:1个系统评价和1个大样本RCT发现,对于严重先兆子痫患者,与使用安慰剂相比,预防性给予硫酸镁可以使发生子痫的危险减半.但是这些试验中无证据表明,患有严重先兆子痫的孕妇使用硫酸镁和安慰剂,其胎儿在死产率或围产期死亡率方面有统计学差异.据报道,有1/4的孕妇会出现轻微的不良反应,主要是面部潮红. B12严重先兆子痫患者预防性使用地西泮:1个系统评价发现,无足够证据表明,在严重先兆子痫的孕妇中使用地西泮与不用抗惊厥药物治疗有差异.
Objective To analyze the substitution mechanism of surrogate endpoints for traditional Chinese medicine (TCM) clinical efficacy evaluation of chronic heart failure (CHF). Methods To obtain data from the occurrence of surrogate endpoints and cardiogenic death of patients with CHF in 7 hospitals. The causal relationship between surrogate endpoints and cardiogenic mortality was inferred by the Bayesian network model, and the interaction among surrogate endpoints was analyzed by non-conditional logistic regression model. Results A total of 2 961 patients with CHF were included. The results of Bayesian network causal inference showed that cardiogenic mortality had a causal relationship with the surrogate endpoints including NYHA classification (P=0.46), amino-terminal pro-B-type natriuretic peptide (NT-proBNP) (P=0.24), left ventricular ejaculation fraction (LVEF) (P=0.19), and hemoglobin (HB) (P=0.11); non-conditional logistic regression analysis showed that NYHA classification had interaction with NT-proBNP, LVEF, and HB prior to and after adjusting confounders. Conclusions The substitution capability of surrogate endpoints for TCM clinical efficacy evaluation of CHF for cardiogenic mortality are NYHA classification, NT-proBNP, LVEF, and HB in turn, and there is a multiplicative interaction between the main surrogate endpoint NYHA classification and the secondary surrogate endpoints including NT-proBNP, LVEF, and HB, suggesting that when the two surrogate endpoints with interaction exist at the same time, it can enhance the substitution capability of surrogate endpoints for cardiogenic mortality.
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.
The prominent feature and form of clinical diagnosis and treatment of traditional Chinese medicine is individualization, which has generated difficulty for clinical evaluation and has restricted the production of high-level evidence for traditional Chinese medicine for a long time. Based on the complexity and dynamics of individualized information under the characteristics of time and space, this paper references the theory of space-time of system science to analyze the individualized data of diagnosis and treatment of traditional Chinese medicine and summarizes the concept of the long time course for clinical evaluation. Based on the concept of the long time course, this paper starts with the origin of clinical evaluation, which is the construction of clinical problem elements named PICO, introduces dynamic evaluation factors, explores the construction of individualized dynamic evaluation method of traditional Chinese medicine, and provides demonstration and examples for the design and implementation of individualized clinical research in future.
To evaluate the cl inical results of less invasive stabil ization system (LISS) for femur supercondylar and intercondylar fractures. Methods From March 2004 to November 2005, 47 patients with 49 intercondylar and supercondylar fractures were treated. Of all the patients, there were 34 males and 13 females with an average of 39.7 years (range 19-56 years). The locations were left side in 21 cases and right side in 28 cases. Fracture was caused by traffic accident in 31 cases, fall ing in 8 cases, violence in 6 cases and others in 2 cases. Forty-nine fractures included 14 intercondylar fractures, 21supercondylar fractures and 14 intercondylar and supercondylar fractures; 32 closed fractures and 17 open fractures. According to the AO typing, there were 6 type 33-A1, 8 type 33-A2 , 10 type 33-A3, 7 type 33-C1, 3 type 33-C2 and 15 type 33-C3. The disease course was 30 minutes to 6 days. Articular surface reduction was first performed, then the LISS plate was inserted via two incisions and locking screws were used later. Results The average operation time was 126 minutes (range 48-248 minutes). The blood loss was 180 mL(range 60-1 200 mL). The average follow-up time was 18.6 months (range 12-23 months). There were 4 patients with AP angular deformity and 5 patients with lateral angular deformity (range 2-5°). External rotation deformity was presented in 2 patients. There were no plate breakage, screw loosen and fixation failure. Average bone union time was 5.6 months (range 3-8 months) without infection case. Six cases were treated with il iac bone transplantation for delayed union. Conclusion LISS is one kind of effective treatment to femoral intercondylar and supercondylar fractures.
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.
(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.