Mohanty Bijaya, Sunder Ashok, Satyanarayan Bhagyalakshmi, Kumar Manish, Shukla Rajiv, Ahmed Asif
Department of Medicine, Tata Main Hospital, Jamshedpur, Jharkhand, India.
Department of Anaesthesia, Tata Main Hospital, Jamshedpur, Jharkhand, India.
J Family Med Prim Care. 2021 Nov;10(11):4236-4241. doi: 10.4103/jfmpc.jfmpc_578_21. Epub 2021 Nov 29.
After the first case of Covid-19 was identified in Wuhan City, China, the numbers increased rapidly all over the world putting a huge burden on the entire healthcare system. Managing these cases posed a great challenge to the treating clinicians in the absence of targeted therapy. At this juncture, few modalities got approved as EUA (Emergency use under authorization) drugs namely Remdesivir, Convalescent Plasma (CP), and Tocilizumab (TCZ) to treat this deadly disease.
To analyze the success rates of EUA therapies for Covid-19 pneumonia in our hospital.
This was a prospective observational study conducted from April 2020 to October 2020 in the department of Medicine at Tata Main Hospital, Jamshedpur, Jharkhand. All adults with moderate to severe Covid-19 as per the WHO criteria were enrolled in the study with their informed consent. Patients with estimated glomerular filtration rate <30 mL/min, deranged liver function tests, electrocardiographic abnormalities, and deranged hematological parameters were excluded from the study. Thorough clinical evaluation was done in all cases. Routine investigations together with CRP, LDH, serum Ferritin, D Dimer and IL6, Chest X-Ray, and HRCT thorax were done in all cases. ECG was done in all cases and 2D-ECHO in selected ones. Depending on their clinical and radiological criteria, patients were treated with various modalities approved under EUA with close monitoring of clinical, biochemical, and radiological parameters. Presenting symptoms, clinical findings, co-morbidities, laboratory parameters, and radiological assessment were analyzed, and statistical analysis was done. The survival rate and in-hospital mortality was analyzed.
We had a total of 448 patients who were included in our study, out of which 326 were males and 122 were females with a male to female ratio of 2.7:1. Their age varied between 16 and 91 years with an average age of 51.4 years with a standard deviation (SD) of +/- 6.4 years. About 255 patients (57%) received only Remdesivir (176 males, 79 females), 139 (105 males, 35 females) patients (31%) received Remdesivir along with two units of CP, and 38 (32 males, 6 females) patients received a combination of Remdesivir, CP, and TCZ. All patients in our study tolerated the drugs well. About 5% of cases who received CP had minor transfusion reactions. One patient had TRALI and three patients had TACO, which was managed aggressively. Asymptomatic transaminitis was seen in 36% patients. The survival rate in patients treated with Remdesivir was 78%, those with Remdesivir and CP was 44%, and those with all three was 13%. The mean length of stay was 14.23 days with a SD of 9.06 days in patients treated with TCZ in comparison to other two modalities, which was 13.88 days with a standard variation of +/- 8.71 days in Remdesivir and 13.88 days with a SD of 8.73 days in patients treated with CP that was stastically significant.
Though the success rate of various drugs under EUA varies in different studies from all over the world, the data to support their use are encouraging. We also observed satisfying results in our study specially with the use of Remdesivir. Therefore, EUA agents should be used early to fight against COVID-19 along with the other measures as per the protocol laid by ICMR and MoHFW.
在中国武汉市发现首例新冠病毒病病例后,全球病例数迅速增加,给整个医疗系统带来了巨大负担。在缺乏针对性治疗方法的情况下,管理这些病例给治疗临床医生带来了巨大挑战。在这个关头,少数几种药物被批准作为紧急使用授权(EUA)药物,即瑞德西韦、康复期血浆(CP)和托珠单抗(TCZ)来治疗这种致命疾病。
分析我院EUA疗法治疗新冠病毒病肺炎的成功率。
这是一项前瞻性观察性研究,于2020年4月至2020年10月在恰尔肯德邦贾姆谢德布尔的塔塔主医院内科进行。所有符合世界卫生组织标准的中重度新冠病毒病成年患者在获得知情同意后纳入研究。估计肾小球滤过率<30 mL/分钟、肝功能检查异常、心电图异常和血液学参数异常患者被排除在研究之外。对所有病例进行了全面的临床评估。所有病例均进行了常规检查以及CRP、LDH、血清铁蛋白、D-二聚体和IL-6检测、胸部X线检查和胸部HRCT检查。所有病例均进行了心电图检查,部分病例进行了二维超声心动图检查。根据患者的临床和影像学标准,采用EUA批准的各种治疗方法对患者进行治疗,并密切监测临床、生化和影像学参数。分析患者的症状表现、临床发现、合并症、实验室参数和影像学评估,并进行统计分析。分析生存率和住院死亡率。
我们的研究共纳入448例患者,其中男性326例,女性122例,男女比例为2.7:1。他们的年龄在16至91岁之间,平均年龄为51.4岁,标准差(SD)为±6.4岁。约255例患者(57%)仅接受瑞德西韦治疗(男性176例,女性79例),139例患者(31%)(男性105例,女性35例)接受瑞德西韦联合两单位CP治疗,38例患者(男性32例,女性6例)接受瑞德西韦、CP和TCZ联合治疗。我们研究中的所有患者对药物耐受性良好。接受CP治疗的患者中约5%出现轻微输血反应。1例患者发生输血相关急性肺损伤(TRALI),3例患者发生输血相关循环超负荷(TACO),均进行了积极处理。36%的患者出现无症状转氨酶升高。接受瑞德西韦治疗的患者生存率为78%,接受瑞德西韦和CP治疗的患者生存率为44%,接受三种药物联合治疗的患者生存率为13%。与其他两种治疗方法相比,接受TCZ治疗的患者平均住院时间为14.23天,标准差为9.06天,接受瑞德西韦治疗的患者平均住院时间为13.88天,标准差为±8.71天,接受CP治疗的患者平均住院时间为13.88天,标准差为8.73天,差异具有统计学意义。
尽管世界各地不同研究中EUA批准的各种药物的成功率各不相同,但支持其使用的数据令人鼓舞。我们在研究中也观察到了令人满意的结果,特别是使用瑞德西韦。因此,应按照印度医学研究理事会(ICMR)和印度卫生与家庭福利部(MoHFW)制定的方案,尽早使用EUA药物并结合其他措施来对抗新冠病毒病。