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A randomized, controlled, open label non-inferiority trial of intravenous ferric carboxymaltose versus

《医学前沿（英文）》 doi: 10.1007/s11684-023-1001-2

摘要： Iron deficiency (ID) and ID anemia (IDA) pose significant public health concerns in China. Although iron sucrose (IS) treatment is well-established in the country, ferric carboxymaltose (FCM) offers the advantage of higher doses and fewer infusions. This open label, randomized, controlled, non-inferiority trial was conducted at multiple sites in China to compare the outcomes of FCM (maximum of 2 doses, 500 or 1000 mg iron) and IS (up to 11 infusions, 200 mg iron) treatments in subjects with IDA. The primary endpoint was the achievement of hemoglobin (Hb) response (an increase of ≥2 g/dL from baseline) within 8 weeks, whereas secondary endpoints included changes in Hb, transferrin saturation, and serum ferritin levels. Among the 371 randomized subjects, a similar percentage of subjects treated with FCM and IS achieved Hb-response (FCM 99.4%, IS 98.3%), thereby confirming the non-inferiority of FCM compared with IS (difference 1.12 (−2.15, 4.71; 95% confidence interval (CI))). Furthermore, a significantly higher proportion of FCM-treated subjects achieved early Hb-response at Week 2 (FCM 85.2%, IS 73.2%; difference 12.1 (3.31, 20.65; 95% CI)). Additionally, the increase in TSAT and serum ferritin levels from baseline was significantly greater at all time points for FCM-treated subjects. The safety profiles of FCM and IS were comparable, with the exception of transient hypophosphatemia and pyrexia, which are consistent with FCM’s known safety profile. In conclusion, FCM proves to be an efficacious treatment for IDA, providing faster Hb-response and correction of ID with fewer administrations than IS.

关键词： iron deficiency     anemia     intravenous iron     ferric carboxymaltose     iron sucrose     Hb response     early response    

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based on traditional Chinese medicine patterns on patients with pneumoconiosis: a pilot double-blind, randomized, and placebo-controlled study

《医学前沿（英文）》 2022年 第16卷 第5期   页码 736-744 doi: 10.1007/s11684-021-0870-5

摘要： Effective therapy options for pneumoconiosis are lacking. Traditional Chinese medicine (TCM) presents a favorable prospect in the treatment of pneumoconiosis. A pilot study on TCM syndrome differentiation can evaluate the clinical efficacy and safety of TCM and lay a foundation for further clinical research. A double-blind, randomized, and placebo-controlled trial was conducted for 24 weeks, in which 96 patients with pneumoconiosis were randomly divided into the control and treatment groups. Symptomatic treatment was conducted for the two groups. The treatment group was treated with TCM syndrome differentiation, and the control group was treated with placebo. The primary outcomes were the six-minute walking distance (6MWD) and the St. George Respiratory Questionnaire (SGRQ) score. The secondary outcomes were the modified British Medical Research Council Dyspnea Scale (mMRC), Chronic Obstructive Pulmonary Disease Assessment Test (CAT), Hospital Anxiety and Depression Scale (HADS), and pulmonary function. Only 83 patients from the 96 patients with pneumoconiosis finished the study. For the primary outcome, compared with the control groups, the treatment group showed a significantly increased 6MWD (407.90 m vs. 499.51 m; 95% confidence interval (CI) 47.25 to 135.97; P <0.001) and improved SGRQ total score (44.48 vs. 25.67; 95% CI −27.87 to −9.74; P <0.001). The treatment group also significantly improved compared with the control group on mMRC score (1.4 vs. 0.74; 95% CI −1.08 to −0.23; P =0.003), CAT score (18.40 vs. 14.65; 95% CI −7.07 to −0.43; P =0.027), and the total symptom score (7.90 vs. 5.14; 95% CI −4.40 to −1.12; P <0.001). No serious adverse events occurred. This study showed that TCM syndrome differentiation and treatment had a favorable impact on the exercise endurance and quality of life of patients with pneumoconiosis.

关键词： pneumoconiosis     randomized controlled trials     traditional Chinese medicine    

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older patients with chronic obstructive pulmonary disease: a subgroup analysis from a four-center, randomized, controlled study

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《医学前沿（英文）》 2014年 第8卷 第3期   页码 368-375 doi: 10.1007/s11684-014-0360-0

摘要：

This study aimed to evaluate the efficacy of comprehensive therapy based on traditional Chinese medicine (TCM) patterns on older patients with chronic obstructive pulmonary disease (COPD) through a four-center, open-label, randomized controlled trial. Patients were divided into the trial group treated using conventional western medicine and Bu-Fei Jian-Pi granules, Bu-Fei Yi-Shen granules, and Yi-Qi Zi-Shen granules based on TCM patterns respectively; and the control group treated using conventional western medicine. A total of 136 patients≥65 years completed the study, with 63 patients comprising the trial group and 73 comprising the control group. After the six-month treatment and the 12-month follow-up period, significant differences were observed between the trial and control groups in the following aspects: frequency of acute exacerbation (P≤0.040), duration of acute exacerbation (P = 0.034), symptoms (P≤0.034), 6-min walking distance (6MWD) (P≤0.039), dyspnea scale (P≤0.036); physical domain (P≤0.019), psychological domain (P≤0.033), social domain (P≤0.020), and environmental domain (P≤0.044) of the WHOQOL-BREF questionnaire; and daily living ability domain (P≤0.007), social activity domain (P≤0.018), depression symptoms domain (P≤0.025), and anxiety symptoms domain (P≤0.037) of the COPD-QOL. No differences were observed between the trial and control groups with regard to FVC, FEV1, and FEV1%.

关键词： chronic obstructive pulmonary disease     older adult     clinical trial     Bu-Fei Jian-Pi granules     Bu-Fei Yi-Shen granules     Yi-Qi Zi-Shen granules    

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Low-carbohydrate diets lead to greater weight loss and better glucose homeostasis than exercise: a randomizedclinical trial

《医学前沿（英文）》 2021年 第15卷 第3期   页码 460-471 doi: 10.1007/s11684-021-0861-6

摘要： Lifestyle interventions, including dietary adjustments and exercise, are important for obesity management. This study enrolled adults with overweight or obesity to explore whether either low-carbohydrate diet (LCD) or exercise is more effective in metabolism improvement. Forty-five eligible subjects were randomly divided into an LCD group (n=22) and an exercise group (EX, n=23). The subjects either adopted LCD (carbohydrate intake<50 g/day) or performed moderate-to-vigorous exercise (≥30 min/day) for 3 weeks. After the interventions, LCD led to a larger weight loss than EX (−3.56±0.37 kg vs. −1.24±0.39 kg, P<0.001), as well as a larger reduction in fat mass (−2.10±0.18 kg vs. −1.25±0.24 kg, P=0.007) and waist circumference (−5.25±0.52 cm vs. −3.45±0.38 cm, P=0.008). Both interventions reduced visceral and subcutaneous fat and improved liver steatosis and insulin resistance. Triglycerides decreased in both two groups, whereas low-density lipoprotein cholesterol increased in the LCD group but decreased in the EX group. Various glycemic parameters, including serum glycated albumin, mean sensor glucose, coefficient of variability (CV), and largest amplitude of glycemic excursions, substantially declined in the LCD group. Only CV slightly decreased after exercise. This pilot study suggested that the effects of LCD and exercise are similar in alleviating liver steatosis and insulin resistance. Compared with exercise, LCD might be more efficient for weight loss and glucose homeostasis in people with obesity.

关键词： low-carbohydrate diet     obesity     nonalcoholic fatty liver disease     continuous glucose monitoring     mean sensor glucose    

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Lingguizhugan Decoction, a Chinese herbal formula, improves insulin resistance in overweight/obese subjects with non-alcoholic fatty liver disease: a translational approach

《医学前沿（英文）》 2022年 第16卷 第5期   页码 745-759 doi: 10.1007/s11684-021-0880-3

摘要： Lingguizhugan Decoction (LGZG) has been investigated in basic studies, with satisfactory effects on insulin resistance in non-alcoholic fatty liver disease (NAFLD). This translational approach aimed to explore the effect and underlying mechanism of LGZG in clinical setting. A randomized, double-blinded, placebo-controlled trial was performed. A total of 243 eligible participants with NAFLD were equally allocated to receive LGZG (two groups: standard dose and low dose) or placebo for 12 weeks on the basis of lifestyle modifications. The primary efficacy variable was homeostasis model assessment of insulin resistance (HOMA-IR). Analyses were performed in two populations in accordance with body mass index (BMI; overweight/obese, BMI ≥ 24 kg/m2; lean, BMI < 24 kg/m 2). For overweight/obese participants, low-dose LGZG significantly decreased their HOMA-IR level compared with placebo (−0.19 (1.47) versus 0.08 (1.99),P = 0.038). For lean subjects, neither dose of LGZG showed a superior effect compared with placebo. Methylated DNA immunoprecipitation sequencing and real-time qPCR found that the DNA N6-methyladenine modification levels of protein phosphatase 1 regulatory subunit 3A (PPP1R3A) and autophagy related 3 (ATG3) significantly increased after LGZG intervention in overweight/obese population. Low-dose LGZG effectively improved insulin resistance in overweight/obese subjects with NAFLD. The underlying mechanism may be related to the regulation of DNA N6-methyladenine modification of PPP1R3A and ATG3. Lean subjects may not be a targeted population for LGZG.

关键词： insulin resistance     non-alcoholic fatty liver disease     Chinese herbal medicine     randomized controlled trial     DNA N6-methyladenine modification    

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Efficacy and safety of benralizumab in patients with eosinophilic asthma: a meta-analysis of randomizedplacebo-controlled trials

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《医学前沿（英文）》 2018年 第12卷 第3期   页码 340-349 doi: 10.1007/s11684-017-0565-0

摘要：

Benralizumab is a monoclonal antibody that targets interleukin-5 receptor α to deplete blood eosinophils and improve the clinical outcomes of allergic asthma. We conducted a meta-analysis to evaluate the safety and efficacy of different doses of benralizumab in patients with eosinophilic asthma. All randomized controlled trials involving benralizumab treatment for patients with eosinophilic asthma, which were searched in PubMed, Embase, and the Cochrane Library published until January 2017, as well as the rate of asthmatic exacerbation, pulmonary functionality, asthma control, quality of life scores, and adverse events were included. Randomized-effect models were used in the meta-analysis to calculate the pooled mean difference, relative risks, and 95% confidence intervals. Five studies involving 1951 patients were identified. Compared with the placebo, benralizumab treatment demonstrated significant improvements in the forced expiratory volume in 1?s (FEV1), Asthma Quality of Life Questionnaire scores, decreased asthmatic exacerbation and Asthma Control Questionnaire-6 (ACQ-6) scores. Benralizumab treatment was also not associated with increased adverse events. These findings indicated that benralizumab can be safely used to improve FEV1, enhance patient symptom control and quality of life, and reduce the risk of exacerbations and ACQ-6 scores in patients with eosinophilic asthma. Furthermore, our meta-analysis showed that benralizumab with 30 mg (every eight weeks) dosage can improve the health-related quality of life and appear to be more effective than 30 mg (every four weeks) dosage. Overall, data indicated that the optimal dosing regimen for benralizumab was possibly 30 mg (every eight weeks).

关键词： benralizumab     anti-interleukin-5     monoclonal antibody     eosinophilic asthma     meta-analysis    

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versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial

《医学前沿（英文）》 2023年 第17卷 第1期   页码 93-104 doi: 10.1007/s11684-021-0892-z

摘要： We conducted a prospective study to assess the non-inferiority of adjuvant chemotherapy alone versus adjuvant concurrent chemoradiotherapy (CCRT) as an alternative strategy for patients with early-stage (FIGO 2009 stage IB–IIA) cervical cancer having risk factors after surgery. The condition was assessed in terms of prognosis, adverse effects, and quality of life. This randomized trial involved nine centers across China. Eligible patients were randomized to receive adjuvant chemotherapy or CCRT after surgery. The primary end-point was progression-free survival (PFS). From December 2012 to December 2014, 337 patients were subjected to randomization. Final analysis included 329 patients, including 165 in the adjuvant chemotherapy group and 164 in the adjuvant CCRT group. The median follow-up was 72.1 months. The three-year PFS rates were both 91.9%, and the five-year OS was 90.6% versus 90.0% in adjuvant chemotherapy and CCRT groups, respectively. No significant differences were observed in the PFS or OS between groups. The adjusted HR for PFS was 0.854 (95% confidence interval 0.415–1.757; P = 0.667) favoring adjuvant chemotherapy, excluding the predefined non-inferiority boundary of 1.9. The chemotherapy group showed a tendency toward good quality of life. In comparison with post-operative adjuvant CCRT, adjuvant chemotherapy treatment showed non-inferior efficacy in patients with early-stage cervical cancer having pathological risk factors. Adjuvant chemotherapy alone is a favorable alternative post-operative treatment.

关键词： chemotherapy     cervical cancer     lymph node metastasis     concurrent chemoradiotherapy     quality of life    

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Non-closure of the peritoneum and subcutaneous tissue at radical hysterectomy: A randomized controlledtrial

Zhou-Fang XIONG MD, Wei-Hong DONG MD, Ze-Hua WANG MD,

《医学前沿（英文）》 2010年 第4卷 第1期   页码 112-116 doi: 10.1007/s11684-010-0016-7

摘要： We conducted a trial to assess the influence of closure or nonclosure of the peritoneum and subcutaneous tissue on the clinical outcomes of cervical cancer patients who underwent radical hysterectomy with lower abdominal cross incision. This randomized controlled trial was performed on 158 cervical cancer patients in our hospital between January 2002 and June 2004. Eighty-two patients were allocated to the “closure” group and 76 patients to the “nonclosure” group. Results showed that non-closure of the peritoneum and subcutaneous tissue could shorten operation time and febrile duration, reduce antibiotics requirement, increase the volume of drainage and decrease the incidence of liquefaction of subcutaneous fat (<0.05). There was no difference in blood loss, postoperative complications, bowel function restoration and post-operative stay between the two groups (>0.05). Our study revealed that closure of the peritoneum and subcutaneous tissue provides no immediate postoperative benefits while unnecessarily lengthening surgical time and anesthesia exposure. The practice of closure of the peritoneum and subcutaneous tissue at radical hysterectomy should be questioned.

关键词： cervical cancer     radical surgery     peritoneum     subcutaneous tissue    

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versus multi-course methotrexate for low-risk gestational trophoblastic neoplasia: a multi-centric randomizedclinical trial

《医学前沿（英文）》 2022年 第16卷 第2期   页码 276-284 doi: 10.1007/s11684-021-0855-4

摘要： We aimed to evaluate the effectiveness and safety of single-course initial regimens in patients with low-risk gestational trophoblastic neoplasia (GTN). In this trial (NCT01823315), 276 patients were analyzed. Patients were allocated to three initiated regimens: single-course methotrexate (MTX), single-course MTX+ dactinomycin (ACTD), and multi-course MTX (control arm). The primary endpoint was the complete remission (CR) rate by initial drug(s). The primary CR rate was 64.4% with multi-course MTX in the control arm. For the single-course MTX arm, the CR rate was 35.8% by one course; it increased to 59.3% after subsequent multi-course MTX, with non-inferiority to the control (difference –5.1%, 95% confidence interval (CI) –19.4% to 9.2%, P=0.014). After further treatment with multi-course ACTD, the CR rate (93.3%) was similar to that of the control (95.2%, P=0.577). For the single-course MTX+ACTD arm, the CR rate was 46.7% by one course, which increased to 89.1% after subsequent multi-course, with non-inferiority (difference 24.7%, 95% CI 12.8%–36.6%, P<0.001) to the control. It was similar to the CR rate by MTX and further ACTD in the control arm (89.1% vs. 95.2%, P=0.135). Four patients experienced recurrence, with no death, during the 2-year follow-up. We demonstrated that chemotherapy initiation with single-course MTX may be an alternative regimen for patients with low-risk GTN.

关键词： gestational trophoblastic neoplasia (GTN)     methotrexate (MTX)     dactinomycin (ACTD)    

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Effects of exercise therapy on bone mineral density in early postmenopausal women: a controlled trial

Shilin DENG MD ,

《医学前沿（英文）》 2009年 第3卷 第3期   页码 323-329 doi: 10.1007/s11684-009-0061-2

摘要： The purpose of this article is to determine the effect of a well-designed combined aerobic, resistance, and extension exercise program on bone mineral density (BMD) in postmenopausal women. The population comprised 45 postmenopausal women, who exercised over 12months (exercise group), and 36 women who served as a non-training control group. BMD of the hip, and lumbar spine was measured at the baseline and 12th month. Repeated measurement analysis of variance and nonparametric test were utilized to compare differences between the exercise group and controls. Thirty-six out of 45 persons in the exercise group and 36 controls completed the study. Average compliance was 82.2% for the whole exercise group at the 12th month. All the subjects had decreased BMD, but the rate of bone loss was lower in the exercise group than in the control group at the L4 and hip. Although the exercise program in this study may probably reduce the rate of bone loss in weight-bearing skeletal sites, we do not suggest the exercise by itself be viewed as prevention or treatment for osteoporosis. Further, the exact dose-response relationship of exercise and bone mass in early postmenopause is not clear.

关键词： early postmenopausal women     bone mineral density     exercise     effects    

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Effects of Shuanghuanglian oral liquids on patients with COVID-19: a randomized, open-label, parallel-controlled, multicenter clinical trial

Li Ni, Zheng Wen, Xiaowen Hu, Wei Tang, Haisheng Wang, Ling Zhou, Lujin Wu, Hong Wang, Chang Xu, Xizhen Xu, Zhichao Xiao, Zongzhe Li, Chenze Li, Yujian Liu, Jialin Duan, Chen Chen, Dan Li, Runhua Zhang, Jinliang Li, Yongxiang Yi, Wei Huang, Yanyan Chen, Jianping Zhao, Jianping Zuo, Jianping Weng, Hualiang Jiang, Dao Wen Wang

《医学前沿（英文）》 2021年 第15卷 第5期   页码 704-717 doi: 10.1007/s11684-021-0853-6

摘要： We conducted a randomized, open-label, parallel-controlled, multicenter trial on the use of Shuanghuanglian (SHL), a traditional Chinese patent medicine, in treating cases of COVID-19. A total of 176 patients received SHL by three doses (56 in low dose, 61 in middle dose, and 59 in high dose) in addition to standard care. The control group was composed of 59 patients who received standard therapy alone. Treatment with SHL was not associated with a difference from standard care in the time to disease recovery. Patients with 14-day SHL treatment had significantly higher rate in negative conversion of SARS-CoV-2 in nucleic acid swab tests than the patients from the control group (93.4% vs. 73.9%, =0.006). Analysis of chest computed tomography images showed that treatment with high-dose SHL significantly promoted absorption of inflammatory focus of pneumonia, which was evaluated by density reduction of inflammatory focus from baseline, at day 7 (mean difference (95% CI), −46.39 (−86.83 to −5.94) HU; =0.025) and day 14 (mean difference (95% CI), −74.21 (−133.35 to −15.08) HU; =0.014). No serious adverse events occurred in the SHL groups. This study illustrated that SHL in combination with standard care was safe and partially effective for the treatment of COVID-19.

关键词： COVID-19     SARS-CoV-2     Shuanghuanglian oral liquid     clinical trial    

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植物乳杆菌CCFM8610缓解肠易激综合征并改善肠道菌群失调——一项随机、双盲、安慰剂对照的先导性临床试验 Article

刘洋, 郁辛杰, 于雷雷, 田丰伟, 赵建新, 张灏, 钱龙, 王群, 薛正青, 翟齐啸, 陈卫

《工程（英文）》 2021年 第7卷 第3期   页码 376-385 doi: 10.1016/j.eng.2020.06.026

摘要：

腹泻型肠易激综合征（irritable bowel syndrome with diarrhea, IBS-D）是一种伴有腹泻等复杂临床症状的慢性肠功能障碍，对患者的日常生活和精神状态具有极大影响。一些研究报道称，摄入益生菌可显著缓解多种肠道疾病。本研究的目的是探究一株具有多种保健作用的益生植物乳杆菌（Lactobacillus plantarum）CCFM8610对IBS-D的缓解作用。这项研究是一项为期12周的随机、双盲、安慰剂对照的先导性临床试验。75名患者被随机分配接受安慰剂、低聚糖或植物乳杆菌CCFM8610 [每天1 × 1010 CFU（菌落形成单位）]，进行为期两周的观察、8周的干预及两周的后续随访。采用IBS症状严重程度量表（IBS-SSS）及IBS生活质量量表（IBS-QOL）评定患者的临床症状和生活质量。在干预期结束时，测定肠道菌群组成和多样性的变化。结果表明，口服植物乳杆菌CCFM8610显著降低了IBS-SSS和IBS-QOL评分，减轻了IBS-D症状的严重程度，恢复了肠道菌群的多样性，降低了与腹胀相关的甲烷短杆菌属（Methanobrevibacter）的相对丰度，增加了厌氧棒状菌属（Anaerostipes）、双歧杆菌属（Bifidobacterium）、丁酸弧菌属（Butyricimonas）及臭杆菌属（Odoribacter）等丁酸生产种属的相对丰度。这些结果表明，摄入植物乳杆菌CCFM8610可以显著缓解IBS-D患者的临床症状及肠道菌群失调。植物乳杆菌CCFM8610对IBS-D的缓解作用可能与肠道中丁酸生产种属的相对丰度上升有关。

关键词： 植物乳杆菌     肠易激综合征     肠道菌群     丁酸     临床试验    

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长双歧杆菌CCFM1077通过调节肠道微生物组成和粪便代谢物来减轻高脂血症——一项随机、双盲、安慰剂对照的临床试验 Article

储传奇, 姜金池, 于雷雷, 李易文, 张松礼, 周巍, 王群, 赵建新, 翟齐啸, 田丰伟, 陈卫

《工程（英文）》 2023年 第28卷 第9期   页码 193-205 doi: 10.1016/j.eng.2023.04.010

摘要：

越来越多的研究表明肠道菌群及其代谢物在高脂血症的发展中至关重要。长双歧杆菌（Bifidobacterium longum, B. longum）CCFM1077已在动物中显示出降脂作用。本研究旨在评估B. longum CCFM1077在降低高脂血症患者血脂水平方面的潜力，并调查该菌对患者的血清脂质异常、肠道菌群和粪便代谢物的影响。本研究是一个为期六周的随机、双盲、安慰剂对照的试验。高脂血症患者（N = 62）被随机分配接受安慰剂（N = 31）或B. longum CCFM1077 [每日1.0×1010个菌落形成单位（CFU）；N = 31]。在基线和干预终点检查了包括总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）、总甘油三酯（TG）和高密度脂蛋白胆固醇（HDL-C）在内的血清脂质水平。肠道菌群组成和多样性的变化是基于16S核糖体RNA（rRNA）V3~V4区域的测序在干预期结束时进行。利用超高效液相色谱（UPLC）-Q-Exactive Orbitrap/质谱仪进行了粪便的非靶向代谢组学分析。口服B. longum CCFM1077六周显著降低了高脂血症患者的血清TC（p < 0.01）和LDL-C（p < 0.01）水平。B. longum CCFM1077的治疗显著增加了肠道菌群的多样性和抗肥胖相关属的相对丰度，包括Lactobacillus、Butyricicoccus、Bifidobacterium和Blautia，而减少了与肥胖相关属的相对丰度，包括Alistipes、Megamonas和Catenibacterium。此外，一些关键代谢产物[胆汁酸（BA）、生物素和咖啡因]及其相应的代谢途径（主要胆汁酸生物合成，牛磺酸和次牛磺酸代谢，生物素代谢，嘌呤代谢和咖啡因代谢）被B. longum CCFM1077富集，因此可能降低血脂水平。B. longum CCFM1077是一种具有降低高脂血症患者血清TC和LDL-C水平潜力的益生菌菌株。其潜在机制可能与抗肥胖相关属和粪便代谢物的增加有关。这些发现为将来在管理高脂血症患者中应用益生菌奠定了基础。

关键词： 益生菌     长双歧杆菌     高脂血症     肠道菌群     粪便代谢物     胆汁酸    

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Tocilizumab in patients with moderate or severe COVID-19: a randomized, controlled, open-label, multicentertrial

Dongsheng Wang, Binqing Fu, Zhen Peng, Dongliang Yang, Mingfeng Han, Min Li, Yun Yang, Tianjun Yang, Liangye Sun, Wei Li, Wei Shi, Xin Yao, Yan Ma, Fei Xu, Xiaojing Wang, Jun Chen, Daqing Xia, Yubei Sun, Lin Dong, Jumei Wang, Xiaoyu Zhu, Min Zhang, Yonggang Zhou, Aijun Pan, Xiaowen Hu, Xiaodong Mei, Haiming Wei, Xiaoling Xu

《医学前沿（英文）》 2021年 第15卷 第3期   页码 486-494 doi: 10.1007/s11684-020-0824-3

摘要： Tocilizumab has been reported to attenuate the “cytokine storm” in COVID-19 patients. We attempted to verify the effectiveness and safety of tocilizumab therapy in COVID-19 and identify patients most likely to benefit from this treatment. We conducted a randomized, controlled, open-label multicenter trial among COVID-19 patients. The patients were randomly assigned in a 1:1 ratio to receive either tocilizumab in addition to standard care or standard care alone. The cure rate, changes of oxygen saturation and interference, and inflammation biomarkers were observed. Thirty-three patients were randomized to the tocilizumab group, and 32 patients to the control group. The cure rate in the tocilizumab group was higher than that in the control group, but the difference was not statistically significant (94.12% vs. 87.10%, rate difference 95% CI −7.19%–21.23%, = 0.4133). The improvement in hypoxia for the tocilizumab group was higher from day 4 onward and statistically significant from day 12 ( = 0.0359). In moderate disease patients with bilateral pulmonary lesions, the hypoxia ameliorated earlier after tocilizumab treatment, and less patients (1/12, 8.33%) needed an increase of inhaled oxygen concentration compared with the controls (4/6, 66.67%; rate difference 95% CI −99.17% to −17.50%, = 0.0217). No severe adverse events occurred. More mild temporary adverse events were recorded in tocilizumab recipients (20/34, 58.82%) than the controls (4/31, 12.90%). Tocilizumab can improve hypoxia without unacceptable side effect profile and significant influences on the time virus load becomes negative. For patients with bilateral pulmonary lesions and elevated IL-6 levels, tocilizumab could be recommended to improve outcome.

关键词： tocilizumab     coronavirus disease 2019 (COVID-19)     cytokine storm    

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特力阿扎维林治疗新冠病毒肺炎的疗效和安全性——一项随机对照试验 Article

吴效科, 于凯江, 王永晨, 徐万海, 马红丽, 侯艳, 李悦, 蔡本志, 朱丽影, 张敏, 胡晓丽, 高敬书, 王宇, 秦慧超, 王文杰, 赵鸣雁, 吴霞, 张勇, 李璐, 李康, 杜智敏, Ben Willem J. Mol, 杨宝峰

《工程（英文）》 2020年 第6卷 第10期   页码 1185-1191 doi: 10.1016/j.eng.2020.08.011

摘要：

目前，尚无有效疗法可治愈由新型冠状病毒（severe acute respiratory syndrome coronavirus 2, SARS-CoV-2）引起的新型冠状病毒肺炎（coronavirus disease 2019, COVID-19）。为了评估抗病毒药物特力阿扎维林治疗COVID-19的有效性和安全性，本研究针对感染COVID-19的成年住院患者开展了一项随机双盲对照试验。本研究从10个分中心招募COVID-19患者，并将患者按1:1的比例随机分为两组。试验组的患者每天服用250 mg的特力阿扎维林药物3~4次，对照组患者则服用安慰剂，为期共7 d。主要结局指标为临床改善时间，临床改善时间的定义为随机分组28 d内患者的体温、呼吸频率、血氧饱和度、咳嗽频率和肺CT（计算机断层扫描，computed tomography）所显示的肺部感染吸收情况全部恢复正常的时间。次要结局指标包括主要结局指标的各个组成成分，如肺部感染吸收的平均时间和吸收比例，以及用咽拭子采样法连续2次SARS-CoV-2核酸检测阴性的转阴率。与此同时，记录合并的治疗药物、不良事件和严重不良事件。由于需要进行住院治疗的新增感染病例的减少，本研究在招募52名患者后便停止招募。将52名患者随机分为服用特力阿扎维林药物的试验组（n = 26）和服用安慰剂的对照组（n = 26）。结果显示，两组临床改善时间并无明显差异[中位数，7 d vs. 12 d；风险比（RR）为2.0；95％置信区间（CI）为0.7~5.6；p = 0.2]。服用特力阿扎维林的试验组中有10例患者发生临床改善，服用安慰剂的对照组中有6例患者出现临床改善（38.5％ vs. 23.1％，RR为2.1；95％CI为0.6~7.0；p = 0.2）。除了肺部感染的吸收情况外（试验组50.0％，对照组26.1％），其余主要结局指标的所有指标均在28 d内恢复正常。此外，试验组的患者对呼吸系统、心脏、肾、肝或凝血功能等方面的的合并治疗较对照组少。尽管特力阿扎维林药物对COVID-19患者的疗效尚未达到统计学上的显著性水平，但本研究结果表明，由于特力阿扎维林药物具有抗病毒作用，将其用于COVID-19的治疗也可能具有一定的疗效。对此，需要进一步的研究来予以证明和确认。

关键词： 新型冠状病毒肺炎     特力阿扎维林     有效性     安全性    

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