老年阻塞性睡眠呼吸暂停患者远期缺血性脑卒中的风险评分模型： 多中心前瞻性队列研究

目的 基于临床资料分析老年阻塞性睡眠呼吸暂停（OSA）患者远期缺血性脑卒中发生的独立危险因素,构建老年OSA患者缺血性脑卒中风险评分模型并进行验证,为相关临床治疗提供参考。方法 采用多中心前瞻性队列设计。2015年1月~2017年10月,多中心连续纳入年龄≥60岁、基线无明显心脑血管病史且无重要临床指标缺失的的首次确诊为OSA的老年患者进行随访,随访结局为缺血性脑卒中的发生情况。收集所有纳入研究对象的基线人口学资料、临床特征、睡眠参数指标、实验室和超声检查结果,以3∶1的比例将其随机分为建模组856例和验证组258例。采用LASSO回归用于变量的降维和筛选,并基于Cox比例风险回归构建老年OSA相关的缺血性脑卒中风险评分预测模型。结果 共入组1141例研究对象,中位随访42（41,54）月内,58例发生缺血性脑卒中,累计发病率为5.08%,其中建模组和验证组缺血性脑卒中的累计发病率分别为5.14%和4.91%（P<0.05）。多变量逐步Cox比例风险回归的变量筛选结果显示,年龄（HR=3.44,95% CI：2.38~7.77）、空腹血糖（FPG）（HR=2.13,95% CI：1.22~3.72）、升主动脉内径（HR=2.60,95% CI：1.04~4.47）、左心房前后径（HR=1.98,95% CI：1.75~2.25）和最低氧饱和度（LSpO2）（HR=1.57,95% CI：1.20~1.93）是缺血性脑卒中发生风险的独立危险因素（P<0.05,P<0.01）;利用ROC曲线分析进行比变量转化,以这5个风险变量的回归系数比取整数构建老年OSA患者远期缺血性脑卒中风险评分模型。Bootstrap 法（自抽样次数=500）前后,建模组队列风险评分模型的ROC曲线下面积（AUC）分别为0.84（95% CI：0.78~0.90）和0.85（95% CI：0.78~0.89）,验证组队列风险评分模型的ROC曲线下面积（AUC）分别为0.83（95% CI：0.73~0.93）和0.82（95% CI：0.72~0.90）,提示模型预测效能较好且稳健性高。以模型最佳临床截点的对应值进行风险分层后的生存分析结果显示,高风险组OSA患者的缺血性脑卒中累积发生率高于低风险组（P=0.021）。结论 该模型有助于在老年人群中识别高风险OSA患者进行早期干预,以降低今后与OSA潜在相关的缺血性脑卒中风险。     

Stroke in patients aged over 75 years: outcome and predictors.

The outcome and predictors of stroke rehabilitation were studied prospectively in 96 patients (mean age 81.3 +/- 5.4 years) admitted to geriatric wards from a well-defined area over one year. Of these, 32 (33%) died (median survival 11 days), 52 (54%) returned home (median hospital stay 69 days) and 12 (13%) required long-term care (median hospital stay 164 days). Deaths and discharges showed a bimodal pattern; nearly 40% of the patients died or were discharged within 2 weeks of admission. Early death correlated with level of consciousness (P = 0.02), neurological deficit (P = 0.01) and prestroke Barthel scores (P = 0.04) on admission. Patients with right- rather than left-sided hemiparesis (P = 0.02), good motor power (P = 0.002) and without sensory deficit/inattention (P = 0.002) were discharged early. Discharge home was adversely affected by poor awareness of deficit (P = 0.02), hemianopia (P = 0.03) and incontinence (P = 0.02) assessed at 2 weeks. Stroke survivors with Barthel score < 6 and Mental Test Score < 4 at 2 weeks after stroke required long-term care.     

60岁以上反流性食管炎临床诊治及内镜分析

目的：探讨60岁以上反流性食管炎的临床诊治及内镜分析。方法：抽取本院2010年8月到2013年8月收治的84例反流性食管炎患者作为研究对象,并将其分为对照组(年龄<60岁)和观察组(年龄≥60岁),每组42例,分析和比较两组的临床特点。结果：从临床症状来看,观察组发生慢性咳嗽、胸痛及支气管炎者居多,反酸、烧心者偏少,与对照组比较有统计学意义( P<0.05);在内镜分级方面,发现观察组B级为12例(28.6％),D级为5例(11.9％),与对照组20例(47.6％)和1例(2.4％)比较,差异均有统计学意义( P<0.05);经治疗8周后,所有患者的病情均得到有效控制。结论：60岁以上反流性食管炎多引发慢性咳嗽、胸痛及支气管炎等一系列临床症状;通过及时的内镜检查和药物治疗,可有效防控反流性食管炎。     

国产盐酸依托必利片Ⅱ期临床研究总结

目的 观察国产依托必利对功能性消化不良的疗效及安全性。方法 进行多中心双盲随机对照研究，共观察功能性消化不良患者238例。随机分为实验组：119例，盐酸依托必利片50mg 1日3次；对照组：119例．多潘立酮10mg 1日3次。疗程均为4周。结果 治疗28d时，依托必利组，上腹疼痛、上腹饱胀、嗳气、旱饱、进食减少、反酸、烧心、恶心、呕吐等症状的总有效率分别为87．5％、81．3％、81．3％、86．4％、86．2％、90．9％、89．6％、91．7％、96．8％。多潘立酮组分别为82．O％、82．9％、79．3％、85．5％、76．0％、84．2％、86．0％、93．3％、86．7％。两组间比较，在上腹疼痛、上腹饱胀、嗳气、烧心及恶心等症状疗效无明显差别。在旱饱、进食减少、反酸及呕吐等症状依托必利优于多潘立酮。两组治疗后均能使胃排空率明显增加，胃半排空时间及口盲时间明显缩短，但两组间比较均无明显差别。结论 依托必利是疗效较好、副作用较小的全胃肠道促动力药。     

Primary prevention with metoprolol in patients with hypertension. Mortality results from the MAPHY study

The present study of primary prevention in white men aged 40 to 64 years attempts to investigate whether a beta-blocker given as initial antihypertensive treatment would lower total mortality to a greater extent than thiazide diuretics. Patients were randomized to metoprolol (n = 1609, 8110 patient-years) or a thiazide diuretic (n = 1625, 8070 patient-years). The median follow-up time was 4.2 years. The mean dose of metoprolol was 174 mg/d, and of thiazide diuretics, 46 mg/d of hydrochlorothiazide or 4.4 mg/d of bendroflumethiazide. Identical control of blood pressure was achieved using a fixed therapeutic schedule. Total mortality was significantly lower for metoprolol than for thiazide diuretics because of fewer deaths from coronary heart disease and stroke. Total mortality was also significantly lower in smokers randomized to metoprolol. The benefit demonstrated in patients treated with metoprolol seems to have important implications for clinical practice.     

7849例老年首诊病人血压测值结果分析

目的 :分析老年首诊病人的血压状况。方法 :我院于 1998年 4月开始 ,在门诊设专室专人为 35岁及以上首诊病人测量血压。 4年中 ,已为 6 0岁及以上老年首诊病人测血压 784 9例 ,通过微机将其资料进行统计分析。按照 1999年中国高血压防治指南进行诊断和分类。结果 :784 9例老年病人中检出高血压 394 6例 (5 0 .2 7% ) ,检出率随年龄增高而增高。 1、 2、3级高血压的检出率分别为 30 .17%、 14 .5 2 %、 5 .88%。单纯收缩期高血压、单纯舒张期高血压、收缩期及舒张期高血压检出率分别为 2 9.4 2 %、 2 .0 3%及 18.83%。单纯收缩期高血压、收缩期及舒张期高血压病人的均脉压分别为 (72 .7± 13.5 )mm Hg、 (6 7.0± 15 .6 ) mm Hg。结论 :老年首诊病人中高血压检出率较高 ;单纯收缩期高血压为老年人主要的高血压类型 ,其次为收缩期及舒张期高血压型 ,其脉压明显增宽 ;医院门诊应重视对老年首诊病人测量血压     

Colonoscopy in patients aged 80 years or older and its contribution to the evaluation of rectal bleeding.

Colonoscopies performed in patients aged 80 years or older at the Sheba Medical Center were analysed according to the primary indication for the procedure: 101 colonoscopies were performed because of rectal bleeding of at least 2 months duration, and 335 for all other indications. Carcinoma of the large bowel was found in 29 (28.7%) bleeders, with the rectum being the most frequently involved site (12 patients). Among the non-bleeders, the prevalence of cancer was significantly lower (33 cases, 9.8%; P less than 0.001), and rectal carcinoma was less common (five patients, P = 0.04), but proximal tumours were more frequent. Of patients with cancer who had operations, the majority (72%) had a tumour confined to the bowel wall (Dukes A or B). The rate of adenomas was similar for both groups (34% vs 29%). The non-bleeders complained more frequently of abdominal pain or a change in bowel habits as compared to the bleeders, but both groups had similar rates for anaemia and weight loss. In all, 47% of these octogenarians with cancer, and 26% with adenomas were referred for colonoscopy because of rectal bleeding. This procedure was found to be safe in old age, as we recorded only four (0.9%) non-fatal complications among our series, a similar figure to the overall incidence of complications at our Institute. In conclusion, our data indicate that rectal bleeding in octogenarians warrants a complete colonic investigation, preferably by total colonoscopy.     

Results from a multicentre trial of metoprolol and a study of hypertensive patients with chronic obstructive lung disease.

Ninety-nine patients took part in a multicentre, long-term study of metoprolol in the treatment of hypertension. Significant reductions in blood pressure and heart rate were achieved by the use of metoprolol alone, or in combination with other antihypertensive agents. Side effects were similar to those seen with other beta-adrenergic blocking agents, except that bronchospasm and cold extremities were rarely encountered. Results of monitoring for the abnormal eye symptoms and antinuclear factor titre are discussed. In a second study, 14 hypertensive patients with asthma (11 patients) or history thereof (three patients), received metoprolol for their hypertension. In general, no significant change in forced expiratory volume in one second (FEV1) was found, despite significant reduction in blood pressure and heart rate. The concomitant use of a beta2-agonist is discussed.     

Efficacy of pegylated interferon-alpha-2a plus ribavirin for patients aged at least 60 years with chronic hepatitis C

Background  In China, patients with hepatitis C virus (HCV)-associated liver disease are getting older, and thus the number of deaths due to such disease is increasing. The efficacy of combination therapy with ribavirin and interferon for chronic HCV infection in elderly patients has not been fully clarified. The aim of the present study was to evaluate the efficacy and tolerability of the combination therapy in the elderly patients.

Methods  Sixty-eight chronic hepatitis C patients, who received the combination therapy, were classified into two age groups: elderly group (³60 years, n=25) and non-elderly group (<60 years, n=43). Rapid virological response, complete early virological response, sustained virological response, relapse, non-response rate, and safety were compared between the elderly group and non-elderly group.

Results  Overall sustained virological response was lower in the elderly group than non-elderly group (44% vs. 75%, P=0.012, OR=0.270, and 95% CI 0.095–0.768). Among patients with HCV genotype 1, sustained virological response was lower in the elderly group than non-elderly group (45% vs. 77%, P=0.015, OR=0.247, 95% CI 0.078–0.781). The proportions of dose reduction due to laboratory abnormalities were significantly higher in the elderly group than non-elderly group (60.0% vs. 32.6%, P=0.027). Multiple binary Logistic regression analysis confirmed that patient age was an associated factor for sustained virological response.

Conclusion  Among patients with HCV genotype 1, the elderly patients had lower sustained virological response than non-elderly patients during pegylated interferon-alpha-2a plus ribavirin combination therapy.

     

75岁及以上高龄结直肠癌患者手术治疗安全性、远期疗效及腹腔镜手术可行性评估

目的 评估≥75岁高龄结直肠癌患者手术安全性、远期疗效及腹腔镜手术的可行性.方法 回顾性分析2007年9月-2010年10月在复旦大学附属华山医院普通外科接受手术治疗的≥60岁的301例结直肠癌患者,分为高龄组(≥75岁,132例)及低龄组(≥60且＜75岁,169例),评估高龄结直肠患者的手术危险因素,高龄患者接受根治手术的风险因素、安全性及远期疗效.回顾性分析2009年1月-2010年10月共27例年龄≥75岁并接受一期腹腔镜下根治性手术的结直肠癌患者(腔镜组)及同期56例年龄≥75岁并接受一期开放根治术的患者(开放组)的临床资料,比较两组近期疗效,探讨腹腔镜手术在高龄结直肠癌患者中的安全性和适用性.结果 高龄组内科合并症发生率为75.8％(100/132),显著高于低龄组的50.9％(86/169,P=0.000).高龄组术后并发症发生率为48.5％(64/132),显著高于低龄组的32.0％(54/169,P=0.004);两组手术相关死亡率分别为2.3％(3/132)、1.8％(3/169),差异无统计学意义;两组术后镇痛要求、术后排气时间、进食半流质时间、保留导尿管时间的差异均无统计学意义(P值均＞0.05),高龄组术后住院时间显著长于低龄组(P＜0.05).患者随访于2011年4月30日完成,平均随访时间为(34.5±0.8)个月,其中213例健在,18例带瘤生存,59例死亡,失访11例.高龄组术后平均生存时间为(32.1±1.0)个月,术后3年总生存率为62.1％,无进展生存率为56.9％.低龄组平均生存时间为(36.6±1.2)个月,术后3年生存率为79.0％,无进展生存率为74.5％.COX多因素回归分析显示,手术根治性及肿瘤分期、分化程度是影响预后的主要因素(P值均＜0.05).结论 在≥75岁高龄结直肠癌患者中,通过进行术前综合病情评估,选择合适的病例进行根治性手术治疗,加强监护,积极治疗合并症,不仅可使患者安全耐受手术,而且可获得满意的远期效果.腹腔镜手术安全可靠,近期疗效满意,应成为治疗高龄结直肠癌患者的首选.     

中医及中西医结合治疗老年单纯收缩期高血压的多中心随机双盲对照临床试验

背景：单纯收缩期高血压（isolated systolic hypertension,ISH）是老年人的常见病,严重危害老年人的健康。中医及中西医结合治疗模式在改善老年ISH患者生活质量以及保护靶器官等方面具有一定优势,但需要进一步的循证医学研究。目的：观察中医（降压胶囊）及中西医结合（降压胶囊联合尼莫地平）治疗模式对老年ISH患者血压、血管活性物质的影响及其安全性。设计、场所、受试者和干预措施：采用多中心、随机双盲、阳性对照的试验设计。按标准入选中国中医科学院西苑医院、北京延庆县中医院及延庆社区卫生服务中心的老年ISH患者270例,采用随机区组法分为中医组（降压胶囊联合尼莫地平模拟药）、中西医结合组（降压胶囊联合尼莫地平）和西医组（尼莫地平联合降压胶囊模拟药）,每组各90例。疗程为4周。主要结局指标：观察各组治疗后诊室血压和动态血压水平,血管活性物质如内皮素-1（endothelin-1,ET-1）、一氧化氮（nitric oxide,NO）、血栓素B_2（thromboxane B_2,TXB_2）和6-酮-前列腺素1α（6-ketoprostaglandin1α,6-keto-PGF1α）水平的变化,并评价其安全性。结果：治疗结束后,中医组脱落10例（80例完成试验）,中西医结合组脱落14例（76例完成试验）,西医组脱落5例（85例完成试验）。治疗后各组收缩期血压值低于治疗前,差异均有统计学意义（P〈0.05）,中西医结合组收缩期血压明显低于中医组或西医组（P〈0.05）。治疗后各组24 h平均收缩压及昼间平均收缩压明显降低,中西医结合组夜间平均收缩压亦明显降低,与治疗前比较,差异有统计学意义（P〈0.05）;中西医结合组24 h平均收缩压和昼间平均收缩压低于中医组和西医组（P〈0.05）。治疗后各组患者血清NO、血浆6-keto-PGF1α水平均升高,而血浆ET-1和TXB_2水平降低（P〈0.05）,且中西医结合疗法对降低血浆TXB_2含量的作用明显优于中医或西医疗法（P〈0.05）。结论：中医及中西医结合治疗模式应用于老年ISH患者的疗效肯定,安全性高,且中西医结合治疗模式在降压及相关指标改善等方面具有明显协同增效的优势,值得进一步研究。     

1990—2016年不同发展水平国家≥70岁人群疾病负担趋势分析

目的：分析1990—2016年全球不同发展水平国家≥70岁老年人口的疾病负担差异及变化趋势。 方法：采 用全球疾病负担(global burden of disease,GBD)研究中社会人口学指数将全球195个国家分为高、偏高、中等、偏低 和低5个发展水平。利用2016年GBD研究课题组估算数据,评价不同发展水平国家间≥70岁人口在伤残调整寿命年 (disability-adjusted life years,DALY)上的差异及变化趋势,估算DALY排名居前十位的疾病及危险因素造成的健康 损失比重。 结果：1990—2016年间,5类发展水平国家≥70岁人口的标化DALY率总体均呈下降趋势,高、偏高、中 等、偏低和低5类发展水平国家DALY/10万人下降幅度分别为23.9%,21.3%,23.4%,18.8%和16.3%。1990年,低和较 低发展水平国家≥70岁年龄标化DALY率分别为高发展水平国家的1.67倍和1.49倍,2016年分别为1.83倍和1.59倍,差 距扩大。标化DALY率下降主要来自于过早死亡寿命损失年的降低。2016年,低和较低发展水平国家≥70岁人口面临 着传染性疾病和慢性非传染性疾病均高发的疾病模式;环境污染和不良卫生条件相关的危险因素在低和较低发展水 平国家中造成严重的疾病负担。 结论：1990—2016年间,尽管5类发展水平国家的疾病负担均有所下降,但发展水平 较低国家的下降幅度低于发展水平偏高的国家,加剧了高发展水平国家和低发展水平国家之间的老年人健康差距。 国际组织及各国政府应根据当前面临的主要疾病和危险因素采取措施,缩小不同发展水平国家之间老年人的健康 差距。     

高龄髋部骨折围手术期治疗的临床研究

目的 探讨高龄髋部骨折的围手术期治疗特点及减少并发症、降低病残和病死率的治疗方法.方法 回顾性分析116例高龄髋部骨折患者围手术期治疗的临床资料.结果 89例获得1年以上的随访,根据Harris髋关节功能评分标准,优良率为87.6%;术后并发症发生率21.3%.结论 围手术期治疗是手术成功的关键,高龄髋部骨折行手术治疗是安全有效的.     

纤支镜吸痰联合振动排痰治疗老年吸入性肺炎60例对比研究

目的:评价纤支镜吸痰联合振动排痰治疗老年吸入性肺炎患者的有效性和安全性。方法:将60例老年吸入性肺炎患者随机分为治疗组30例和对照组30例。两组均给予抗感染、祛痰、雾化吸入及对症治疗。治疗组在上述治疗基础上给予纤支镜吸痰联合振动排痰治疗。观察两组治疗前后患者临床疗效、呼吸频率、体温、白细胞计数变化。结果:纤支镜吸痰联合振动排痰治疗老年吸入性肺炎患者有效率96.7%,对照组有效率66.7%,差异有统计学意义(P<0.05)。结论:纤支镜吸痰联合振动排痰治疗老年吸入性肺炎疗效明显,值得临床上推广应用。     

Antihypertensive efficacy of metoprolol XL/Low dose chlorthalidone (6.25 mg) combination: a randomized,comparative study in Indian patients with mild-to-moderate essential hypertension

Objective

High blood pressure is one of the most important risk factors, directly responsible for increasing the cardiovascular morbidity and mortality. The primary objective was to evaluate the efficacy of metoprolol XL/chlorthalidone against metoprolol XL/hydrochlorothiazide with respect to mean fall in systolic and diastolic blood pressure. The secondary objective was to compare the response rates and to evaluate the tolerability of study medications in patients with mild-tomoderate essential hypertension.

Methods

Total 130 eligible patients (65: metoprolol XL 25 mg/chlorthalidone 6.25 mg; 65: metoprolol XL 25 mg/HCTZ 12.5 mg) were enrolled in this randomized, comparative, multicentric, 12-weeks study. Sixty-two patients from each group completed the study. After 4-weeks of treatment, non-responders from chlorthalidone 6.25 mg combination group were shifted to metoprolol XL 50 mg/chlorthalidone 12.5 mg and non-responders from HCTZ 12.5 mg combination group were escalated to metoprolol XL 50 mg/HCTZ 12.5 mg.

Results

The study treatment groups were comparable with respect to demography and baseline disease characteristics. Both the starting therapies were comparable with respect to mean fall in SBP (p = 0.788) and DBP (p = 0.939), and response rates (p = 1.0) after 4-weeks of therapy. Also both the step-up therapies showed similar mean fall in SBP (p = 0.277) and DBP (p = 0.507) at the end of 12-weeks. However, significantly more number of patients from chlorthalidone 12.5 mg/metoprolol XL 50 mg group responded to therapy as compared to that from HCTZ 12.5 mg/metoprolol XL 50 mg group (p = 0.045). All the reported adverse events were of mild-to-moderate intensity. There were no clinically significant trends in electrolytes (Na⁺, K⁺, Cl^-)and fasting blood sugar, evident across the treatment groups.

Conclusion

Chlorthalidone in combination with metoprolol XL is as effective and well tolerated as widely used combination of metoprolol XL/HCTZ, thus providing an alternative therapeutic option.     

60岁以上瓣膜病患者的瓣膜置换术65例临床分析

目的 总结60岁以上瓣膜病患者的手术治疗经验及死亡原因.方法 回顾性分析2003年1月至2008年12月60岁以上65例瓣膜病患者的临床资料.男32例,女33例,年龄60～78 (63.1±4.1)岁.均在全麻体外循环下行瓣膜置换术,停跳手术19例,不停跳手术46例.其中MVR 29例,AVR 18例,DVR 18例,同期TVP 23例,左房血栓清除8例,共置入瓣膜83枚,机械瓣50枚,生物瓣33 枚,转机时间51～305(105.2±48.7)min,阻断24～160(72.3±29.6)min,住院时间7～109(33.5±17.7)d.结果 术中死亡2例,术后住院期间死亡5例,早期死亡率10.77%.放弃治疗6例(未随访),术后并发症13例,呼吸功能不全5例,切口愈合不良3例,肺部感染2例,胸腔积液2例,精神症状1例.随访6 ～77 个月,随访50例,院外死亡3例.结论 选择恰当手术时机,充分术前准备,改善心功能,术中谨慎操作,良好心肌保护,术后加强监护,对60岁以上瓣膜病患者行瓣膜置换术是安全可行的.     

Ditiocarb sodium (diethyldithiocarbamate) therapy in patients with symptomatic HIV infection and AIDS. A randomized, double-blind, placebo-controlled, multicenter study.

We randomized 389 symptomatic patients with human immunodeficiency virus (HIV) infection to ditiocarb sodium (400 mg/m2 orally for 24 weeks) or a placebo. Patients were well balanced according to Centers for Disease Control (CDC) group, CD4+ cell number, and duration of disease prior to entry. Ten new acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections occurred in the treated patients and 21 in the controls. Reduction of new opportunistic infections in the ditiocarb group was significant in all patients (relative risk [RR], 0.44) and in patients with AIDS (CDC groups IV-C1 and IV-D) (RR, 0.12). The size of the effect of ditiocarb was maintained when data were reanalyzed after exclusion of a patient who progressed to Pneumocystis carinii pneumonia who was not strictly CDC-defined (RR, 0.46), or when considering as new opportunistic infections three events, which were clinically active at entry, but for which the definitive diagnosis was made during study (RR, 0.49). The administration of ditiocarb did not induce any major adverse clinical or biological reactions. We conclude that, in this study, ditiocarb was safe and reduced the incidence of opportunistic infections in patients with symptomatic HIV infection.     

吡柔比星为主的联合化疗方案治疗老年非霍奇金淋巴瘤临床研究

目的：观察吡柔比星为主的联合化疗方案（CTOP方案）治疗老年非霍奇金淋巴瘤（NHL）的临床疗效。方法：将我院2008年2月～2009年4月收治的61例老年NHL患者随机分为观察组（31例）和对照组（30例）,分别采用CTOP方案和CHOP方案治疗。结果：观察组的完全缓解率高于对照组,两组差异有统计学意义（P〈0．05）;观察组的不良反应发生率低于对照组,两组差异有统计学意义（P〈0．05）。结论：CTOP方案治疗老年NHL疗效满意,且不良反应少,是目前治疗老年NHL的理想方法之一。     

Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: a randomized, double-blind, placebo-controlled multicenter trial

Background  Tumor necrosis factor-α is a key mediator in the pathogenesis of psoriasis. Infliximab is a monoclonal antibody that specifically binds to tumor necrosis factor-α. The purpose of this study was to validate the efficacy and safety of 5 mg/kg infliximab therapy in Chinese patients with moderate to severe plaque psoriasis.

Methods  In this multicenter, double-blind, placebo-controlled trial, 129 patients with moderate-to-severe psoriasis were randomized to the induction therapy (weeks 0, 2 and 6) with infliximab 5 mg/kg (n=84) or placebo (n=45), followed with infliximab 5 mg/kg scheduled at week 14 and week 22 in the infliximab group, and infliximab 5 mg/kg scheduled at weeks 10, 12 and 16 in the placebo group. The primary end point was the proportion of patients who achieved at least 75% improvement in Psoriasis Area and Severity Index (PASI 75 response rate) from baseline at week 10.

Results  At week 10, 81.0% of patients treated with infliximab (5 mg/kg) achieved a 75% or greater improvement compared with 2.2% of patients treated with placebo (P <0.001). A significant improvement in PASI, Physician’s Global Assessment (PGA) and Dermatology Life Quality Index (DLQI), was seen from week 6 through week 14 in the infliximab group compared with the placebo group. Through week 22, PASI, PGA, DLQI were well maintained. The incidence of adverse events for the infliximab treatment group was slightly higher in comparison to the placebo treatment group during the first 10 weeks without statistical significance. However, there were 3 cases of tuberculosis that developed during the 26 weeks treatment with infliximal.

Conclusions  Infliximab treatment was effective as induction and maintenance treatments for Chinese patients with moderate to severe plaque psoriasis. Most drug-induced adverse events were mild to moderate, and well tolerated. Screening for tuberculosis is essential and prophylactic treatment should be given if necessary.