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.
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.
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.
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.
Objective To compare the clinical efficacy and safety of thrombolysis with anticoagulation therapy for patients with acute sub-massive pulmonary thromboembolism. Methods The clinical data of 84 patients with acute sub-massive pulmonary thromboembolism were analyzed retrospectively, mainly focusing on the in-hospital efficacy and safety of thrombolysis and/ or anticoagulation. The efficacy was evaluated based on 6 grades: cured, markedly improved, improved, not changed, deteriorated and died. Results Among the 84 patients,49 patients received thrombolysis and sequential anticoagulation therapy( thrombolysis group) , 35 patients received anticoagulation therapy alone( anticoagulation group) . As compared with the anticoagulation group, the thrombolysis group had higher effective rate( defined as patients who were cured, markedly improved or improved, 81. 6% versus 54. 3%, P = 0. 007) , lower critical event occurrence ( defined as clinical condition deteriorated or died, 2. 0% versus 14. 3% , P = 0. 032) . There was no significant difference in bleeding rates between the two groups ( thrombolysis group 20. 4% versus anticoagulation group 14. 3% , P gt; 0. 05) . No major bleeding or intracranial hemorrhage occurred in any of the patients. Conclusions Thrombolysis therapy may be more effective than anticoagulation therapy alone in patients with acute sub-massive pulmonary thromboembolism, and thus warrants further prospective randomized control study in large population.
至2002年2月,有关晚期卵巢癌的手术治疗效果和细胞毒性化疗效果的临床证据如下:⑴在改进生活质量方面的任何治疗效果的证据都不充分. ⑵晚期卵巢癌的手术治疗: ①先行手术加化疗与单用化疗相比较:缺乏相关RCT. ②先行手术与不手术比较:缺乏相关RCT. ③在初次手术加化疗后一定间隔期的缩瘤术:1个RCT发现,初次手术加化疗后一定间隔期的缩瘤术提高总的存活年限为3.5年;另1个RCT则认为该方法对存活率没有显著性作用,但可能系检验效能不够而没有发现潜在的临床重要作用. ④常规二次手术:2个RCT认为,在晚期卵巢癌初次手术后常规进行二探手术的存活率并不优于术后只进行化疗的对照组. ⑶晚期卵巢癌的细胞毒性药物化疗: ①铂剂+紫杉醇方案:1篇系统评价和另1个RCT认为,晚期卵巢癌初次手术后,以铂剂+紫杉醇为基础的化疗能延长存活时间和总存活率. ②含铂剂的化疗方案:1篇系统评价发现,铂剂加入任何不含铂剂的方案都能显著提高存活率,尤其是铂剂加入联合治疗方案. ③卡铂+紫杉醇与卡铂+多烯紫杉醇比较:未找到比较这两种方案疗效的高质量RCT. ④含铂剂的联合方案与不含铂剂的联合方案比较:7个RCT比较了这两种方案;大多数RCT发现含铂剂的方案能改善结局,其益处和危害依赖于具体方案;没有研究显示铂剂能显著减少存活时间和总存活率. ⑤联用铂剂与单用铂剂比较:1篇系统评价和另3个RCT认为没有证据表明,延长存活时间和总存活率上,联用铂剂优于单用铂剂. ⑥紫杉醇+顺铂与紫杉醇+卡铂比较:1个RCT表明在延长存活时间和总存活率上两者无显著性差异,虽然不足以排除临床上的重要作用.
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.
(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 explore the effectiveness, safety and applicability of focused ultrasound (FU) in rural patients with cervicitis-related diseases. Methods Patients with cervicitis-related diseases (n=8 352) from 80 township health centers of 9 counties in Chongqing were enrolled in this multicenter clinical study, and they were treated with CZF Model of FU for one time and then were visited in the following 3 months. According to the category 4 scoring method and the curative index, the effectiveness, safety and applicability in 7027 cases (1 156 mild cases, 5 312 moderate cases, 559 severe cases) with complete records were analyzed. The influencing factors were also analyzed with logistic regression analysis. Results A total of 6 413 cases (91.26%) were treated within 5 minutes. After 3-month follow-up, the total effective rate was 99.59%, and 5 012 cases (71.32%) were cured. Just little or medium amount of vaginal bleeding occurred in 656 cases (9.34%) after treatment, while only 12 cases (0.17%) had bleeding in the similar amount tomenstruation, which were relieved by hemostasis and anti-inflammatory treatment. Conclusion As a promising new therapy, focused ultrasound therapy for treating cervicitis-related diseases is safe and effective, with little postoperative bleeding and short-term of vaginal effusion, so it is suitable to be popularized in rural areas.
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.