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.
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.
ObjectiveTo observe the efficacy of intravitreal injection of conbercept (IVC) combined with subthreshold micropulse laser photocoagulation (SMLP) in the treatment of diabetic macular edema (DME). MethodsA randomized controlled trial. From December 2020 to January 2022, 100 patients (100 eyes) with DME diagnosed by examination in Shanxi Aier Eye Hospital were included in the study. The patients were randomly divided into IVC group (50 eyes) and IVC+SMLP group (50 eyes). All the eyes were treated with IVC once a month for 3 times, and the eyes in IVC+SMLP group were treated with SMLP within 2 weeks after IVC. All affected eyes were examined by best corrected visual acuity (BCVA), which was statistically converted to logarithm of the minimum angle of resolution (logMAR) visual acuity. The central macular thickness (CMT) was measured by optical coherence tomography. Before the treatment, the logMAR BCVA of patients in IVC group and IVC+SMLP group were 0.56±0.04 and 0.55±0.03, respectively. The CMT were (437.36±11.35) μm and (434.58±10.88) μm, respectively. There was no significant difference in logMAR BCVA and CMT between the two groups (t= 0.476, 1.027; P＞0.05). The patients were followed up for 12 months after treatment. The times of IVC and the changes of BCVA and CMT were compared between the two groups. Independent sample t-test was used to compare the logMAR BCVA, CMT and times of IVC between groups. ResultsAfter 12 months treatment, the logMAR BCVA of IVC group and IVC+SMLP group were (241.63±29.79) μm and (240.47±30.46) μm, respectively. Compared with those before treatment, 12 months after treatment, the BCVA of the two groups increased significantly (t=7.014, 5.608; P＜0.001), while CMT decreased significantly (t=8.126, 6.013; P＜0.001). There was no significant difference in BCVA and CMT between the two groups (t=0.835, 0.764; P＞0.05). The number of IVC in IVC group and IVC+SMLP group were (8.15±2.04) times and (5.91±1.80) times, respectively, and the difference was statistically significant (t=5.210, P＜0.001). ConclusionsBoth IVC+SMLP and IVC alone can effectively reduce CMT and increase BCVA in patients with DME. Combination therapy can reduce the number of IVC.
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.
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.
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.
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.
截止至2002年6月,有关阑尾炎治疗的临床证据如下:①辅助性抗生素治疗:1项RCT和1项回顾性RCT发现,经阑尾切除术的复杂性和单纯性阑尾炎的成人和儿童,预防性使用抗生素可显著减少伤口感染和腹腔内脓肿.②辅助性抗生素治疗(儿童复杂性阑尾炎):1项系统评价的亚组分析发现,使用抗生素可显著减少伤口感染.③辅助性抗生素治疗(儿童单纯性阑尾炎):1项系统评价的亚组分析发现,使用抗生素不减少伤口感染.1项儿童单纯性阑尾炎的回顾性RCT发现,预防性使用抗生素不能减少伤口感染,但该RCT的样本量太小,不能排除有临床差别.④抗生素治疗和手术:1项成人疑诊阑尾炎的RCT发现,与手术治疗比较,抗生素保守治疗可减少治疗开始后12 h到10 d的疼痛和吗啡的使用.但采取抗生素保守治疗的患者有35%在1年内再次因急性阑尾炎入院,并行阑尾切除术.⑤腹腔镜手术和开腹手术(成人):1项系统评价发现,腹腔镜手术可以减少伤口的感染,减轻手术后第1天的疼痛,减少住院时间以及恢复工作的时间,但增加手术后腹腔内脓肿的发生.⑥腹腔镜手术和开腹手术(儿童):1项系统评价发现,腹腔镜手术可以减少伤口的感染,减少住院时间,但不能减轻手术后第1天的疼痛,不能减少恢复的时间和腹腔内脓肿的发生.⑦开腹手术和不治疗:无RCT证据.⑧开腹阑尾切除术中对残端的内翻处理:1项RCT发现,两次包埋和单纯结扎比较,不能减少伤口的感染、住院时间和腹腔内脓肿的发生.
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.