scholarly journals Clinical efficacy of a combination of propofol and etomidate in pediatric anesthesia, and its effect on vital indices in patients

2021 ◽  
Vol 20 (9) ◽  
pp. 1975-1981
Author(s):  
Li Li ◽  
Yangzi Ding ◽  
Junli Yao ◽  
Qiongge Sun ◽  
Fengchao Zhang
Keyword(s):  
Clinical Efficacy ◽  
Induction Time ◽  
Adverse Reactions ◽  
Pediatric Anesthesia ◽  
Clinical Effectiveness ◽  
Anesthesia Induction ◽  
Anesthetic Effect ◽  
Group A ◽  
Medical University

Purpose: To study the clinical effectiveness of a combination of propofol and etomidate as pediatricanesthesia, and its influence on some vital factors in the patients.Methods: A total of 104 children who underwent appendectomy, hepatobiliary surgery and excision ofbone tumor in Xuzhou Children's Hospital, Xuzhou Medical University, Xuzhou, China from June 2018 to June 2020, were selected for this retrospective study. The patients were divided into groups A, B and C. In group A, 40 patients received the combination of propofol and etomidate, 32 patients received propofol only, while group C comprised 32 patients who received etomidate only. Vital indices such asanesthesia induction time, wake-up time after surgery, anesthetic effect, and adverse reactions were determined.Results: In group A, the mean arterial pressure (MAP) and heart rate (HR) were improved; anesthesia induction time and wake-up time after surgery were shorter, and anesthetic effect was more obvious in children with grades I and II. However, there was no grade III anesthetic effect, although there was a lower incidence of adverse reactions in this group.Conclusion: The use of a combination of propofol and etomidate results in higher clinical efficacy of pediatric anesthesia than either propofol or etomidate alone. Furthermore, the combination produces better quality of vital indices in the patients

Observation of clinical efficacy and survival of lung cancer patients with UMIPIC combined with low-dose chemotherapy.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21605-e21605
Author(s):  
Jianbin Feng ◽  
Peng Jing ◽  
Feng Gao ◽  
Jian Liu ◽  
Wei Han ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Survival Time ◽  
Clinical Efficacy ◽  
Adverse Reactions ◽  
Low Dose ◽  
Survival Rates ◽  
Lung Cancer Patients ◽  
Group A ◽  
Group B ◽  
Low Dose Chemotherapy

e21605 Background: To observe the clinical efficacy and survival of UMIPIC combined with low-dose chemotherapy in patients with lung cancer. Methods: 840 patients with lung cancer underwent UMIPIC treatment from January 2011 to December 2015 were selected as the study subjects, 341 cases combined with low-dose chemotherapy in group A and 499 cases not combined with chemotherapy in group B. All patients were diagnosed with lung cancer and signed a consent form for treatment. The patients were treated according to the UMIPIC treatment guidelines. This study was mainly to observe the adverse reactions, clinical efficacy, survival time and survival rate of lung cancer patients after receiving UMIPIC combined with or without low dose chemotherapy. Results: The common adverse reactions in group A were fever 38.12%, followed by pain 9.38%, hemoglobin 7.94%, white blood cells 5.01%, nausea 2.35%, liver function damage 1.19%, vomiting 1.17%, and kidney function damage 0.30%; Common adverse reactions in group B were fever 38.68%, followed by pain 13.23%, hemoglobin reduction 12.87%, white blood cell reduction 5.29%, nausea 2.00%, vomiting 2.00%, liver function damage 1.92%. The hemoglobin reduction in group A was significantly lower than that in group B (P < 0.05), and there was no difference in the other adverse reactions (P > 0.05). Clinical efficacy of the two groups revealed that the benefit rate of group A was 95.45% higher than that of group B 93.47% (P > 0.05). After follow-up, it was found that the average survival time and median survival time of patients in group A were 20.744 and 13.270 months, respectively, which were significantly higher than those of group B at 19.514 and 10.070 months (P < 0.05). The survival rates of the two groups of patients, The 1-year, 2-year, and 5-year survival rates of group A patients are 52.48%, 23.60%, and 16.95%, and the 1-year, 2-year, and 5-year survival rates of group B patients are 42.96% and 17.07 % And 10.26%, the one-year survival rate of group A was significantly higher than that of group B (P < 0.05). Conclusions: UMIPIC combined with low-dose chemotherapy has a good clinical effect in treating lung cancer without increasing the incidence of adverse reactions, and a significant effect on extending survival time and improving survival rate of lung cancer patients.

The clinical effect of Chitosan nanoparticles against Helicobacter pylori

2020 ◽  
Vol 10 (7) ◽  
pp. 1116-1121
Author(s):  
Jing Wang ◽  
Xinhong Wang ◽  
Min Li ◽  
Suxiang Fan
Keyword(s):  
Triple Therapy ◽  
Clinical Efficacy ◽  
Adverse Reactions ◽  
Chitosan Nanoparticles ◽  
High Dose ◽  
Significant Difference ◽  
Oral Liquid ◽  
Group A ◽  
The Difference ◽  
Group B

The objective of this study was to observe the clinical effect of Chitosan nanoparticles therapy on Helicobacter pylori (HP) infection. Three treatment groups (A, B, and control group C) were randomly assigned with 60 cases of HP each, making 180 cases. Group C received standard triple therapy (omeprazole + amoxicillin + clarithromycin), group A got a routine dose of Chitosan nanoparticles plus triple therapy, and group B got a high dose of Chitosan nanoparticles plus triple therapy. The course of treatment in each group was 7 days. The eradication rate, clinical efficacy and adverse reactions were observed. Up to 172 patients finished the experiment, with 59 patients in Group A, 57 in Group B and 56 in Group C. In a total analysis set (FAS), the eradication rates of HP in Group A, Group B and Group C were 80.00%, 80.70%, and 71.67%, respectively. There was no significant difference between the two groups (P > 0.05). In accordance with the PPS, the HP eradication rates of group A, B, and C were 81.36%, 80.70% and 76.79%, respectively, and there was no significant difference between the two groups (P > 0.05). The clinical efficacy of group A, B, and C were 91.67%, 91.23%, and 70.00%, respectively. The differences among the three groups were statistically significant (P < 0.05). In accordance with the PPS, the clinical efficacy of group A, B and C was 93.22%, 91.23%, and 75.00%, respectively. With a P-value of less than 0.05, the results indicated that the difference between the two groups was statistically significant. There were 21 adverse reactions in the experiment, including 3 in group A, 6 in group B, and 12 in group C. The difference was statistically significant (P < 0.05) between group A and B compared with group C, the difference was statistically significant (P < 0.05); the difference between group A and group B was statistically significant (P < 0.05). In conclusion the therapeutic effect of Chitosan nanoparticles and oral liquid, combined with triple therapy on HP infection is satisfactory, with less adverse reactions are. However, the findings suggest that it is not desirable to use a high dose Chitosan nanoparticles and oral liquid.

scholarly journals Clinical Observation of Dexmedetomidine Combined with the Mixture of Propofol and Etomidate on Painless Gastroscopy in Children

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Liao Sha ◽  
Zhifang Wu ◽  
Xianhui Zhang ◽  
Lishuai Wei
Keyword(s):  
Adverse Reactions ◽  
Pediatric Patients ◽  
Clinical Observation ◽  
Body Movement ◽  
The Body ◽  
Anesthetic Effect ◽  
Group A ◽  
Group B

Objective: To observe the anesthetic effect of dexmedetomidine combined with the mixture of propofol and etomidate on painless gastroscopy in children. Methods: A total of 80 pediatric patients who underwent painless gastroscopy in the Guangxi Minzu Hospital from January 2019 to September 2020 were randomly divided into two groups, A and B, with 40 patients in each group. Group A was given A mixture of etomidate 20 mg and propofol 0.2g, Dexmedetomidine was pumped into group B 10min before surgery, 0.4 g/kg. HR, SBP, DBP, SpO2 and BIS were continuously monitored after entering the room. The doses of propofol and etomidate were recorded, as well as the time of waking and leaving the hospital. Adverse reactions such as hypotension, hypoxemia, nausea, vomiting and dizziness were recorded too. Results: Compared with group A, the dosage of propofol and etomidate in group B was significantly reduced (P < 0.001), the time of waking and out of the chamber were significantly shortened (P < 0.001), the body movement in the incidence of intraoperative was significantly reduced (P < 0.001), and the nausea, vomiting and dizziness in the incidence of postoperative were significantly reduced (P < 0.05). Conclusion: Dexmedetomidine combined with propofol and etomidate mixture can be safely used in painless gastroscopy in children, which can significantly reduce the dosage of propofol and etomidate, reduce the occurrence of adverse reactions, and shorten the time of resuscitation and discharge.

scholarly journals Meta-Analysis of Clinical Efficacy and Safety of Tripterygium wilfordii Polyglycosides Tablets in the Treatment of Chronic Kidney Disease

2021 ◽  
Vol 2021 ◽  
pp. 1-27
Author(s):  
Yan-Li Guo ◽  
Feng Gao ◽  
Tai-Wei Dong ◽  
Yang Bai ◽  
Qiao Liu ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Nephrotic Syndrome ◽  
Kidney Disease ◽  
Clinical Efficacy ◽  
Adverse Reactions ◽  
Meta Analysis ◽  
Computer Search ◽  
Efficacy And Safety ◽  
Tripterygium Wilfordii

Objective. Tripterygium wilfordii polyglycosides tablet (TGt) is an oral preparation extracted from plant Tripterygium wilfordii. It has the effects of anti-inflammation and inhibition of cellular and humoral immunity. However, many reports of adverse reactions caused by TGt have limited its application. In this paper, the clinical efficacy and safety of TGt in the treatment of chronic kidney disease (CKD) were verified by data mining and analysis, so as to provide theoretical data support for the application and development of TGt. Methods. A computer search of the following databases was conducted: PubMed, Web of Science, CBM, VIP, Wanfang Data, and CNKI. The search time limit is from the establishment of the database to September 2020. We searched for clinical randomized controlled trials of TGt in the treatment of CKD. The main types of CKD involved are nephrotic syndrome (NS), primary nephrotic syndrome (PNS), refractory nephrotic syndrome (RNS), and IgA nephropathy (IgAN). RevMan 5.2 and Stata 12.0 software were used to evaluate the literature quality and analyze the data. Finally, GRADEpro software was used to evaluate the quality of evidence. Results. According to the inclusion and exclusion criteria, 75 articles with a total of 6418 subjects were included. The results of the meta-analysis showed that TGt could reduce 24-hour urinary protein, increase serum albumin, improve clinical efficacy, and reduce disease recurrence rate in patients ( P < 0.05 ) with CKD compared with adrenocortical hormones or immunosuppressants. TGt could significantly reduce the level of serum creatinine (Scr) in patients with CKD ( P < 0.05 ), but it was not significant in reducing the level of blood urea nitrogen ( P > 0.05 ). In terms of safety evaluation, in patients with CKD, it could significantly reduce the incidence of gastrointestinal adverse reactions and neurogenic dizziness and headache ( P < 0.05 ). However, in terms of adverse reactions such as liver injury, respiratory infection, and leukopenia, TGt was as harmful as corticosteroids or immunosuppressants ( P < 0.05 ). The quality of the evidence was evaluated with GRADEpro software, and the results showed that TGt was strongly recommended for the treatment of CKD. Conclusion. TGt has certain efficacy in the treatment of CKD and has fewer side effects in certain types of diseases. The effect of TGt combined with other drugs is better than that of single use. This paper also has some limitations. Due to the limited number of the included studies, with all being from China, there may be methodological differences. Therefore, more high-quality literature data from different countries are needed.

scholarly journals Application of Different Doses of Dexmedetomidine Combined with General Anesthesia in Anesthesia of Patients with Traumatic Tibiofibular Fractures and Its Effect on the Incidence of Adverse Reactions

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Jizheng Zhang ◽  
Xiaohua Sun ◽  
Wenjie Cheng ◽  
Wanlu Ren
Keyword(s):  
General Anesthesia ◽  
Adverse Reactions ◽  
Anesthesia Induction ◽  
Intraoperative Hypotension ◽  
Extubation Time ◽  
Group A ◽  
T1 And T2 ◽  
Group B ◽  
Group D ◽  
Different Doses

Objective. To explore the application of different doses of dexmedetomidine combined with general anesthesia in patients with traumatic tibiofibular fractures. Methods. A total of 120 patients with traumatic tibiofibular fractures treated in our hospital (January 2018–January 2021) were selected as the research subjects and equally grouped into group A, group B, group C, and group D according to the dosage of dexmedetomidine. Group B, group C, and group D were pumped with 0.3 μg/kg, 0.5 μg/kg, and 0.8 μg/kg load doses of dexmedetomidine before anesthesia induction, with the same doses for maintenance during surgery. Group A was intravenously pumped with the same amount of normal saline and received tracheal intubation after anesthesia induction, with propofol and remifentanil to maintain general anesthesia during surgery. Results. No notable differences in general data were observed among the groups ( P  > 0.05). Ramsay sedation scores of all groups showed a downward trend after drug withdrawal. At 10 min, 30 min, and 60 min, the scores of groups C and D were markedly higher than those of groups A and B ( P  < 0.05), and the scores were higher in group D than those in group C ( P  < 0.05). The HR changes at each period were close between groups A and B ( P  > 0.05). The HRs at T1 and T2 in group C were slightly lower than those in group D ( P  > 0.05), and the HRs at T1 in groups A and B were remarkably higher than those in groups C and D, and were higher than those at T0 and T2 ( P  < 0.05). The SBP levels of all groups began to rise at T0, peaked at T1, and decreased to a lower level at T2 than that at T0. Moreover, the SBP levels of groups C and D at T1 and T2 were notably lower compared with groups A and B ( P  < 0.05). With a lower DBP level in group C than the other three groups at T1, the DBP levels were notably lower in groups C and D than those in groups A and B at T2 ( P  < 0.05). With no statistical difference in the MAP levels at T0 among the four groups ( P  > 0.05), the MAP levels in group A at T1 and T2 were obviously higher compared with groups C and D ( P  < 0.05). The extubation time in group A was notably longer than that that in groups B, C, and D ( P  < 0.05), with longer extubation time in group B than that in groups C and D ( P  < 0.05). The orientation recovery time in group D was markedly shorter than that in groups A, B, and C ( P  < 0.05). The incidence of cognitive dysfunction, chills, and restlessness in groups C and D was notably lower compared with groups A and B ( P  < 0.05), with a higher incidence of chills, intraoperative hypotension, and delayed awakening in group D than in group C ( P  < 0.05). Conclusion. Dexmedetomidine at doses of 0.5 μg/kg and 0.8 μg/kg has a better effect in the maintenance of general anesthesia for patients with traumatic tibiofibular fractures, with faster orientation recovery, better recovery of postoperative cognitive function, and a lower incidence of adverse reactions. Dexmedetomidine at 0.5 μg/kg is recommended in view of the increased risk of excessive sedation, chills, restlessness, and intraoperative hypotension in patients at 0.8 μg/kg.

scholarly journals The Clinical Efficacy of Phytochemical Medicines Containing Tanshinol and Ligustrazine in the Treatment of Stable Angina: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Li Gao ◽  
Tong Wu ◽  
Juan Wang ◽  
Zhuoran Xiao ◽  
Chunhua Jia ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Efficacy ◽  
Stable Angina ◽  
Meta Analysis ◽  
Clinical Effectiveness ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Better Than

Background. Phytochemical medicines containing tanshinol and ligustrazine are commonly used in the treatment of stable angina in China, but their clinical effectiveness and risk have not been adequately assessed. In this paper, we conducted a systematic review and meta-analysis to evaluate the clinical efficacy. Methods. Relevant randomized controlled trials (RCTs) of phytochemical medicines containing tanshinol and ligustrazine in the treatment of stable angina were searched in electronic databases. The search date was up to March 31, 2020, and the languages of the RCTs were limited to English and Chinese. Results. A total of 28 studies, including 2518 patients, were included in the meta-analysis. It was shown that the adjunctive therapy of phytochemical medicines containing tanshinol and ligustrazine was better than the conventional therapies in the improvement of stable angina according to the clinical efficacy in symptoms (n = 2518, RR = 1.24, 95% CI: 1.20 to 1.29, P < 0.01 ) and clinical efficacy in electrocardiography (n = 1766, RR = 1.29, 95% CI: 1.19 to 1.40, P < 0.01 ). Conclusion. The meta-analysis supported the use of phytochemical medicines containing tanshinol and ligustrazine in the treatment of stable angina. However, quality of the evidence for this finding was low due to a high risk of bias in the included studies. Therefore, well-designed RCTs are still needed to further evaluate the efficacy.

scholarly journals Effects of Arteriovenous Thrombolysis Combined with Mechanical Thrombectomy on Efficacy and Neurological Function of Acute Cerebral Infarct Patients

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Tao Ding ◽  
Liwen Tang ◽  
Bohong Hu ◽  
Junxin Yuan ◽  
Xiangdong Li ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Clinical Efficacy ◽  
Adverse Reactions ◽  
Mechanical Thrombectomy ◽  
Length Of Hospital Stay ◽  
Neurological Function ◽  
Nihss Score ◽  
Group A ◽  
Group B ◽  
Acute Cerebral Infarct

Objective. To investigate the effects of arteriovenous thrombolysis combined with mechanical thrombectomy on clinical efficacy, neurological function, and the changes of nerve injury markers of acute cerebral infarct (ACI) patients. Methods. A total of 143 cases with ACI admitted to our hospital from June 2017 to June 2019 were elected as research subjects. Among them, 69 cases of patients who received treatment of arteriovenous thrombolysis were considered as group A, and 74 cases of patients who received treatment of arteriovenous thrombolysis combined with mechanical thrombectomy were considered as group B. NIHSS score, clinical efficacy, vascular recanalization, adverse reactions, hemodynamics, neurological injury indexes, duration of coma, length of hospital stay, and prognosis of patients in the two groups were compared. Results. After treatment, the NIHSS score of group A was higher than that of group B (P<0.05), the clinical efficacy of group B was better than that of group A, and the incidence of adverse reactions was lower than that of group A (P<0.05). There was no difference in vascular recanalization rate, duration of coma, and prognosis between the two groups (P>0.05). Length of hospital stay, maximum peak velocity after treatment (Vs), and mean flow rate (Vm) of group A were lower than those of group B, while vascular resistance index (RI), pulsatility index (PI), serum glutamic acid (Glu), neuron-specific enolase (NES), and S100β protein detected by enzyme-linked immunosorbent assay (ELISA) of group A were higher than those of group B (P<0.05). Conclusion. Arteriovenous thrombolysis combined with mechanical thrombectomy has a significant effect on ACI, with high safety and quick effect. In addition, it has a stronger effect on improving and protecting the neurological function of patients, which is worth promoting in clinical practice.

scholarly journals Effect Observation on Modified Zishen Tongguan Decoction Combined with Acupuncture in Treatment of Urinary Retention after Cervical Cancer Surgery and Its Influence on the Incidence of Adverse Reactions

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Shujuan Wang ◽  
Min Wang ◽  
Hongbin Zhang
Keyword(s):  
Cervical Cancer ◽  
Urinary Retention ◽  
Clinical Efficacy ◽  
Flow Rate ◽  
Adverse Reactions ◽  
Cancer Surgery ◽  
Urinary Flow ◽  
Days Of Therapy ◽  
Group A ◽  
Group B

Objective. To explore the effect observation on modified Zishen Tongguan decoction combined with acupuncture in the treatment of urinary retention after cervical cancer surgery and its influence on the incidence of adverse reactions. Methods. The clinical data of 84 patients suffered from urinary retention after radical resection of cervical cancer (December 2018–December 2019) in the oncology department of Jinan Municipal Hospital of Traditional Chinese Medicine were selected for retrospective analysis. According to the order of admission, they were divided into group A (n = 42), treated with conventional therapy, modified Zishen Tongguan decoction, and acupuncture, and group B (n = 42), treated with conventional therapy. The clinical efficacy of the two groups was observed, the urination function indexes after therapy were recorded, and the clinical efficacy and incidence of adverse reactions were analyzed. Results. After therapy, compared with group B, the average urinary flow rate, maximum urinary flow rate, bladder compliance (BC) level value, and the number of patients with good recovery of bladder function of group A were obviously higher P < 0.05 , and the urination time and detrusor pressure were obviously lower P < 0.001 . There was no significant difference in the average scoring of overactive bladder syndrome score (OABSS) between the two groups at 7 days of therapy p > 0.05 . The average OABSS of group A at 14 days of therapy was obviously lower than that of group B P < 0.001 . Compared with group B, the total clinical effective rate of group A was obviously higher P < 0.05 , while the total incidence of adverse reactions was obviously lower P < 0.05 . Conclusion. Modified Zishen Tongguan decoction combined with acupuncture is a reliable method to treat urinary retention after cervical cancer surgery, which greatly improves the urination function of patients, as well as the clinical efficacy. Further research will help create a better solution for patients with urinary retention after cervical cancer surgery.

scholarly journals Effect of capecitabine combined with irinotecan on the safety of colon cancer treatment, patients’ adverse reactions and quality of life

2021 ◽  
Vol 20 (11) ◽  
pp. 2413-2418
Author(s):  
Ingjuan Fan ◽  
Qing Li ◽  
Weijie Zhong ◽  
Shuang He ◽  
Kangbao Li
Keyword(s):  
Quality Of Life ◽  
Colon Cancer ◽  
Cancer Treatment ◽  
Cancer Patients ◽  
Adverse Reactions ◽  
Clinical Prognosis ◽  
Group A ◽  
Group B ◽  
The Impact

Purpose: To study the impact of the combination of capecitabine and irinotecan on the safety of colon cancer treatment, adverse reactions and wellbeing of patients.Methods: Colon cancer subjects (n =120) admitted to Guangzhou First People’s Hospital, Guangzhou, China were assigned equally to two groups (A and B) according to their order of admission, and they received intravenous infusion of irinotecan. In addition, group A patients were administered capecitabine, but those in B group were given tegafur, gimeracil and oteracil porassium. The patients in groups A and B were compared with respect to the incidence of unwanted effects, quality of life (QoL), and overall clinical efficacy of the treatments.Results: Cases of nausea and vomiting, delayed diarrhea and sensory neuropathy of the patients were significantly reduced in group A, relative to group B. Moreover, QoL score after treatment was markedly higher in group A than in group B, while the objective response rate (ORR) of colon cancer patients in group A was also significantly higher than that in group B (p < 0.05). However, no obvious difference in disease control rate (DCR) was observed between groups A and B (p > 0.05).Conclusion: Combined capecitabine and irinotecan therapy effectively improves clinical prognosis, reduces the incidence of adverse reactions, and is safe in colon cancer patients. Therefore, the combined treatment may be beneficial in the management of colon cancer.

scholarly journals Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: pragmatic randomised Trial and economic evaluation (CONSTRUCT)

2016 ◽  
Vol 20 (44) ◽  
pp. 1-320 ◽  
Author(s):  
John G Williams ◽  
M Fasihul Alam ◽  
Laith Alrubaiy ◽  
Clare Clement ◽  
David Cohen ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Reactions ◽  
Randomised Trial ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Mean Difference ◽  
Serious Adverse Events ◽  
Steroid Resistant ◽  
Significant Difference

BackgroundThe efficacy of infliximab and ciclosporin in treating severe ulcerative colitis (UC) is proven, but there has been no comparative evaluation of effectiveness.ObjectiveTo compare the clinical effectiveness and cost-effectiveness of infliximab and ciclosporin in treating steroid-resistant acute severe UC.MethodBetween May 2010 and February 2013 we recruited 270 participants from 52 hospitals in England, Scotland and Wales to an open-label parallel-group, pragmatic randomised trial. Consented patients admitted with severe colitis completed baseline quality-of-life questionnaires before receiving intravenous hydrocortisone. If they failed to respond within about 5 days, and met other inclusion criteria, we invited them to participate and used a web-based adaptive randomisation algorithm to allocate them in equal proportions between 5 mg/kg of intravenous infliximab at 0, 2 and 6 weeks or 2 mg/kg/day of intravenous ciclosporin for 7 days followed by 5.5 mg/kg/day of oral ciclosporin until 12 weeks from randomisation. Further treatment was at the discretion of physicians responsible for clinical management. The primary outcome was quality-adjusted survival (QAS): the area under the curve (AUC) of scores derived from Crohn’s and Ulcerative Colitis Questionnaires completed by participants at 3 and 6 months, and then 6-monthly over 1–3 years, more frequently after surgery. Secondary outcomes collected simultaneously included European Quality of Life-5 Dimensions (EQ-5D) scores and NHS resource use to estimate cost-effectiveness. Blinding was possible only for data analysts. We interviewed 20 trial participants and 23 participating professionals. Funded data collection finished in March 2014. Most participants consented to complete annual questionnaires and for us to analyse their routinely collected health data over 10 years.ResultsThe 135 participants in each group were well matched at baseline. In 121 participants analysed in each group, we found no significant difference between infliximab and ciclosporin in QAS [mean difference in AUC/day 0.0297 favouring ciclosporin, 95% confidence interval (CI) –0.0088 to 0.0682;p = 0.129]; EQ-5D scores (quality-adjusted life-year mean difference 0.021 favouring ciclosporin, 95% CI –0.032 to 0.096;p = 0.350); Short Form questionnaire-6 Dimensions scores (mean difference 0.0051 favouring ciclosporin, 95% CI –0.0250 to 0.0353;p = 0.737). There was no statistically significant difference in colectomy rates [odds ratio (OR) 1.350 favouring infliximab, 95% CI 0.832 to 2.188;p = 0.223]; numbers of serious adverse reactions (event ratio = 0.938 favouring ciclosporin, 95% CI 0.590 to 1.493;p = 0.788); participants with serious adverse reactions (OR 0.660 favouring ciclosporin, 95% CI 0.282 to 1.546;p = 0.338); numbers of serious adverse events (event ratio 1.075 favouring infliximab, 95% CI 0.603 to 1.917;p = 0.807); participants with serious adverse events (OR 0.999 favouring infliximab, 95% CI 0.473 to 2.114;p = 0.998); deaths (all three who died received infliximab;p = 0.247) or concomitant use of immunosuppressants. The lower cost of ciclosporin led to lower total NHS costs (mean difference –£5632, 95% CI –£8305 to –£2773;p < 0.001). Interviews highlighted the debilitating effect of UC; participants were more positive about infliximab than ciclosporin. Professionals reported advantages and disadvantages with both drugs, but nurses disliked the intravenous ciclosporin.ConclusionsTotal cost to the NHS was considerably higher for infliximab than ciclosporin. Nevertheless, there was no significant difference between the two drugs in clinical effectiveness, colectomy rates, incidence of SAEs or reactions, or mortality, when measured 1–3 years post treatment. To assess long-term outcome participants will be followed up for 10 years post randomisation, using questionnaires and routinely collected data. Further studies will be needed to evaluate the efficacy and effectiveness of new anti-tumour necrosis factor drugs and formulations of ciclosporin.Trial registrationCurrent Controlled Trials ISRCTN22663589.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 44. See the NIHR Journals Library website for further project information.

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