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.
临床证据检索和评价截止至2002年3月.结果: ⑴硬化性苔癣: ①口服视黄醛(阿维A): 1个小样本RCT经过20～22周随访发现,阿维A与安慰剂相比,能显著减轻瘙痒和减小病变程度,但与严重的脱皮、脱发有关.②外科手术:我们未找到手术治疗妇女硬化性苔癣疗效的充足证据.③局部用0.05%丙酸氯倍他索(又名氯氟美松):1个小样本RCT经过3个月的治疗发现,局部用丙酸氯倍他索比局部用丙酸睾丸酮或矿物油软膏能更有效地控制症状.高质量的前瞻性观察性研究发现,丙酸氯倍他索用于维持治疗时副作用轻微.④局部用睾丸酮:2个小样本RCT认为,不管是用于12个月的初始治疗,还是在用了丙酸氯倍他索16周后的继续治疗,都没有证据证明丙酸睾丸酮比矿物油软膏更能缓解症状.丙酸睾丸酮与男性化有关.⑵外阴上皮内瘤样病变:我们发现,外阴上皮内瘤样病变的外科手术治疗效果和局部应用α-干扰素治疗效果,目前临床证据不足.
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 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.
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.
(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.