Efficacy and Safety of Corneal Transplantation Using Corneas from Foreign Donors versus Domestic Donors: A Prospective, Randomized, Controlled Trial

Purpose. To assess the efficacy and safety of corneal transplantation using corneas from foreign donors.Methods. One hundred and eight patients needing therapeutic penetrating keratoplasty were randomly divided into 2 groups (54 cases/group): foreign group using foreign donor corneas and domestic group using domestic donor corneas. Clinical outcome and incidence of postoperative complications were compared between groups.Results. No significant difference with respect to the therapeutic outcome and postoperative Best Corrected Visual Acuity (BCVA) and neovascularization by final follow-up was observed between the two groups. The graft thickness in the foreign group was statistically higher than the domestic group at 1 month postoperatively, but not at 3, 6, and 12 months postoperatively. Corneal endothelial cell density in the domestic group was statistically higher than in the foreign group at 3, 6, and 12 months postoperatively. Corneal epithelial abnormalities in the foreign group were significantly higher than that in domestic group. The primary graft failure, incidence of graft survival, and postoperative complications such as immunologic rejection, graft infection, and secondary glaucoma were not significantly different between the two groups.Conclusions. Corneal transplantations using foreign donor corneas are as effective and safe as those using domestic donor corneas.

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Colistin versus meropenem in the empirical treatment of ventilator-associated pneumonia (Magic Bullet study): an investigator-driven, open-label, randomized, noninferiority controlled trial

Critical Care ◽

10.1186/s13054-019-2627-y ◽

2019 ◽

Vol 23 (1) ◽

Cited By ~ 10

Author(s):

José M. Cisneros ◽

◽

Clara María Rosso-Fernández ◽

Cristina Roca-Oporto ◽

Gennaro De Pascale ◽

...

Keyword(s):

Controlled Trial ◽

Empirical Treatment ◽

Early Termination ◽

Magic Bullet ◽

Ventilator Associated Pneumonia ◽

Efficacy And Safety ◽

Serious Adverse Events ◽

Carbapenem Resistant ◽

Number Of Patients ◽

Significant Difference

Abstract Background Colistin is recommended in the empirical treatment of ventilator-associated pneumonia (VAP) with a high prevalence of carbapenem-resistant gram-negative bacilli (CR-GNB). However, the efficacy and safety of colistin are not well defined. Methods A multicenter prospective randomized trial conducted in 32 European centers compared the efficacy and safety of colistin (4.5 million unit loading dose followed by a maintenance dose of 3 million units every 8 h) versus meropenem (2 g every 8 h), both in combination with levofloxacin (500 mg every 12 h) for 7–14 days in patients with late VAP. Between May 2012 and October 2015, 232 patients were randomly assigned to the 2 treatment groups. The primary endpoint was mortality at 28 days after randomization in the microbiologically modified intention-to-treat (mMITT) population. Secondary outcomes included clinical and microbiological cure, renal function at the end of the treatment, and serious adverse events. The study was interrupted after the interim analysis due to excessive nephrotoxicity in the colistin group; therefore, the sample size was not achieved. Results A total of 157 (67.7%) patients were included in the mMITT population, 36 of whom (22.9%) had VAP caused by CR-GNB. In the mMITT population, no significant difference in mortality between the colistin group (19/82, 23.2%) and the meropenem group (19/75, 25.3%) was observed, with a risk difference of − 2.16 (− 15.59 to 11.26, p = 0.377); the noninferiority of colistin was not demonstrated due to early termination and limited number of patients infected by carbapenem-resistant pathogens. Colistin plus levofloxacin increased the incidence of renal failure (40/120, 33.3%, versus 21/112, 18.8%; p = 0.012) and renal replacement therapy (11/120, 9.1%, versus 2/112, 1.8%; p = 0.015). Conclusions This study did not demonstrate the noninferiority of colistin compared with meropenem, both combined with levofloxacin, in terms of efficacy in the empirical treatment of late VAP but demonstrated the greater nephrotoxicity of colistin. These findings do not support the empirical use of colistin for the treatment of late VAP due to early termination. Trial registration ClinicalTrials.gov, NCT01292031. Registered 9 February 2011.

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Effect of Xiangbin Prescription in Gastrointestinal Function After Gynecological Abdominal Surgery: a Randomized Controlled Trial

10.21203/rs.3.rs-660427/v1 ◽

2021 ◽

Author(s):

Yuyan Wu ◽

Jinxuan Lin ◽

Haiping Zeng ◽

Yi Chen ◽

Zhiqiang Chen ◽

...

Keyword(s):

Postoperative Complications ◽

Abdominal Surgery ◽

Controlled Trial ◽

Controlled Study ◽

Chewing Gum ◽

Control Group ◽

Gastrointestinal Function ◽

Blank Control Group ◽

Randomized Controlled ◽

Significant Difference

Abstract Background: Recovery of gastrointestinal function after gynecological abdominal surgery is a major clinical problem. An effective intervention to promote the rapid recovery of gastrointestinal function postoperatively is lacking. This randomized trial investigated whether Xiangbin prescription (XBP) was feasible in terms of efficacy and safety on gastrointestinal function recovery in patients after gynecological abdominal surgery. Methods: A randomized controlled study was conducted, in which 190 patients with gynecological abdominal surgery who met the inclusion and exclusion criteria were enrolled. They were assigned randomly to XBP group, chewing gum group or blank control group, and respectively received the following treatments: took the XBP twice a day, chewed a piece of gum for about 15 minutes each 4 hours, or received conventional western basic treatment, starting on postoperative day 1 until defecation. Three groups were compared in terms of primary outcomes including the time of the first defecation and the time of the first flatus and secondary outcomes including the level of Ghrelin (GHRL) and the incidence of postoperative complications. Meanwhile, the safety of this trial was evaluated. Results: There was no statistical difference in baseline characteristics among the three groups. For the time of the first flatus, XBP group (22.33 ± 6.68 h) showed less time compared with the chewing gum group (23.06 ± 7.37 h), while it was shorter than that in the blank control group (25.86 ± 7.93 h) with significant difference (P < 0.05). As for the time of the first defecation, XBP group (38.65 ± 12.96 h) showed shorter time significantly compared with both the chewing gum group (47.29 ± 14.50 h) and the blank control group (54.01 ± 20.32 h) (P < 0.05). For the postoperative GHRL levels, XBP group was higher than that in the chewing gum group with no significant difference and had more significant improvement of the GHRL levels at postoperative day 3 compared with the blank control group (P < 0.05). For postoperative complications, XBP group had lower incidence than the other two groups but with no significant difference. For safety evaluations, no serious adverse events occurred in the three groups. Conclusions: XBP could promote the recovery of gastrointestinal function after gynecological abdominal surgery and it is overall safe. Trial registration: This trial was retrospectively registered by Chinese Clinical Trial Registry with the identifier number, ChiCTR1900026327, at September 30, 2019. http://www.chictr.org.cn/.

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Efficacy and Safety of Clearing Heat and Detoxifying Injection in the Treatment of Influenza: A Randomized, Double-Blinded, Placebo-Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2014/151235 ◽

2014 ◽

Vol 2014 ◽

pp. 1-8 ◽

Cited By ~ 4

Author(s):

Yu Liu ◽

Yuhong Huang ◽

Baolin Wei ◽

Xinqiao Liu ◽

Yaqing Zhang ◽

...

Keyword(s):

Severity Score ◽

Influenza A ◽

Controlled Trial ◽

Influenza Virus Infection ◽

Rapid Test ◽

Secondary Outcome ◽

Efficacy And Safety ◽

Clearance Time ◽

Fever Clearance Time ◽

Significant Difference

Objective. To evaluate the efficacy and safety of CHDI in the treatment of influenza infection.Method. A randomized double-blind, double dummy trial was conducted. Influenza patients with a positive influenza A rapid test diagnosis were randomized to receive CHDI or oseltamivir. Primary outcome was assessed by the median fever alleviation time and clearance time, and secondary outcome was total scores of influenza symptoms.Results. One hundred thirty-nine participants were screened and 34 had a RT-PCR laboratory confirmation of influenza virus infection. Fever alleviation time was 2.5 and 5 hours in CHDI and oseltamivir, respectively, and fever clearance time was 32.5 and 49 hours. The HR of fever alleviation and clearance time shows no significant difference between two groups. Total scores of influenza symptoms descended significantly in both groups after treatment and descended more in CHDI than oseltamivir on day 2. Similar to total symptoms severity score, fever severity score descend more significantly in CHDI than oseltamivir on day 2, and there were no differences on other symptoms.Conclusions. CHDI have a similar effect to oseltamivir in reducing the duration of influenza illness. CHDI was well tolerated, with no serious adverse events noted during the study period.

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Design and implementation of botulinum toxin on cricopharyngeal dysfunction guided by a combination of catheter balloon, ultrasound, and electromyography (BECURE) in patients with stroke: study protocol for a randomized, double-blinded, placebo-controlled trial

Trials ◽

10.1186/s13063-021-05195-8 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Mengshu Xie ◽

Zulin Dou ◽

Guifang Wan ◽

Peishan Zeng ◽

Hongmei Wen

Keyword(s):

Clinical Trial ◽

Botulinum Toxin ◽

Controlled Trial ◽

Second Phase ◽

Residual Pressure ◽

Efficacy And Safety ◽

Cricopharyngeal Muscle ◽

Significant Difference ◽

Cricopharyngeal Dysfunction ◽

Double Blinded

Abstract Background Cricopharyngeal dysfunction (CPD) occurs in various neurological disorders, especially stroke. The treatment approaches of CPD include swallowing training, cricopharyngeal dilation, botulinum toxin (BTX) injection, and cricopharyngeal myotomy. BTX injection into the cricopharyngeal muscle is effective and safe for some patients with dysphagia, with a success rate between 43 and 100% (mean = 76%). However, well-designed randomized controlled clinical trials are needed to verify its efficacy and safety for the treatment of CPD. The objective of this study is to explore the efficacy and safety of BTX for neurogenic cricopharyngeal achalasia, when administering an injection into the cricopharyngeal muscle guided by a novel precise positioning method, that combines ultrasound, catheter balloon, and electromyography (BECURE). Methods BECURE is a single-center randomized, placebo controlled, double-blinded, superiority clinical trial. To detect a significant difference between the 2 groups, a sample size of 44 patients is estimated. The intervention is BTX versus placebo, with 1:1 randomization. The randomization sequence from 1 to 44 was generated using the Statistical Package for Social Sciences. The study is divided into two phases. In the first phase, patients will be injected with BTX or the placebo. In the second phase, patients who received a placebo injection and those who did not respond to the first BTX injection will receive an injection of BTX. The primary outcome is the score of the Functional Oral Intake Scale (FOIS). The secondary outcomes are as follows: upper esophageal sphincter (UES) residual pressure, UES resting pressure, duration of UES relaxation, velopharyngeal and laryngopharyngeal peak pressure, UES opening, pharyngeal construction ratio, residue of bolus in the epiglottis valley or piriform sinus, and penetration and aspiration. Discussion Dysphagia is a common complication of stroke. There is lack of high-quality evidence for the efficacy of BTX in treating neurogenic CPD. This study will clarify whether BTX injection into the cricopharyngeal muscle can be effective and safe for patients with stroke and CPD. Trial registration Chinese Clinical Trial Register (ChiCTR1900025562). Registered on September 1, 2019.

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Comparison between bovine carotid artery graft and polytetrafluoroethylene graft for haemodialysis vascular access: A systematic review and meta-analysis

The Journal of Vascular Access ◽

10.1177/1129729820926088 ◽

2020 ◽

pp. 112972982092608

Author(s):

Ioannis D Kostakis ◽

Ioannis Loukopoulos

Keyword(s):

Systematic Review ◽

Carotid Artery ◽

Vascular Access ◽

Controlled Trial ◽

Meta Analysis ◽

Graft Infection ◽

Mean Difference ◽

Cochrane Central Register ◽

Pseudoaneurysm Formation ◽

Significant Difference

Background: There is a renewed interest in using bovine carotid artery grafts for haemodialysis vascular access after recent advances in conduit manufacturing and endovascular management of access-related complications. Our aim was to summarize the results of the recent studies comparing bovine carotid artery grafts with polytetrafluoroethylene grafts as vascular access for haemodialysis. Methods: A systematic review was conducted for original articles comparing bovine carotid artery with polytetrafluoroethylene grafts for haemodialysis vascular access published between January 2000 and December 2019 searching the databases of Medline, Scopus, Google Scholar, ClinicalTrials.gov and the Cochrane Central Register of Controlled Trials. Results: Four studies were included (one prospective randomized controlled trial and three retrospective studies) with 676 patients in total (bovine carotid artery: 395, polytetrafluoroethylene: 281). There was lower graft infection rate per patient-year in bovine carotid artery grafts (mean difference: −0.03, p < 0.0001). Bovine carotid artery grafts required fewer interventions per patient-year to maintain or restore patency (mean difference: −0.81, p = 0.002). No significant difference was detected regarding pseudoaneurysm formation (p = 0.24), steal syndrome (p = 0.11) or patency rates (primary: 1 year: p = 0.15, 2 years: p = 0.69; primary assisted: 1 year: p = 0.18, 2 years: p = 0.54; secondary: 1 year: p = 0.22, 2 years: p = 0.17). Conclusion: Bovine carotid artery and polytetrafluoroethylene grafts have similar short-term and long-term outcomes, with a possible advantage of bovine carotid artery grafts concerning graft infections and number of required interventions. Thus, bovine carotid artery grafts can be a useful alternative modality for haemodialysis vascular access.

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Apatinib Mesylate in the treatment of advanced progressed lung adenocarcinoma patients with EGFR-TKI resistance —A Multicenter Randomized Trial

Scientific Reports ◽

10.1038/s41598-019-50350-6 ◽

2019 ◽

Vol 9 (1) ◽

Author(s):

Ping Fang ◽

Liqin Zhang ◽

Xianru Zhang ◽

Jiawen Yu ◽

Jun Sun ◽

...

Keyword(s):

Lung Adenocarcinoma ◽

Kinase Inhibitors ◽

Controlled Trial ◽

Objective Response ◽

Control Group ◽

Efficacy And Safety ◽

Double Blind ◽

Significant Difference ◽

Tki Resistance ◽

Egfr Tki

Abstract Few pieces of evidence have been published on the use of Apatinib Mesylate (AM) against EGFR-TKI resistance in lung adenocarcinoma (LA) patients. Here, we investigate the clinical efficacy and safety of AM in the treatment of advanced progressed epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) resistant LA patients. We conducted a double-blind, randomized controlled trial in 68 patients admitted to 18 hospitals of Anhui province in China. The efficacy and safety of AM treatment were evaluated in terms of progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR), as well as related adverse events (AE). A literature knowledge database analysis and a pathway model reconstruction were performed to decipher the relevant mechanism may be involved. Our results showed that, compared to the control group, AM presented improved efficacy in PFS (P = 0.033), ORR (P < 0.001), and DCR (P < 0.001). No significant difference was observed between case and control group in terms of AE, and no drug-related death occurred. Pathway analysis supports that Apatinib can be repurposed for the treatment of LA. Our results suggested that AM could be a potential option for advanced progressed LA patients to combat EGFR-TKI resistance.

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Comparing a biosimilar follitropin alfa (Cinnal-f®) with Gonal-f® in women undergoing ovarian stimulation: An RCT

International Journal of Reproductive BioMedicine ◽

10.18502/ijrm.v19i11.9917 ◽

2021 ◽

Author(s):

Batool Hossein Rashidi ◽

Khashayar Sayyari ◽

Ramin Heshmat ◽

Saeid Amanpour ◽

Ensieh Shahrokh Tehraninejad ◽

...

Keyword(s):

Intracytoplasmic Sperm Injection ◽

Ovarian Stimulation ◽

Recombinant Dna ◽

Controlled Trial ◽

Follicle Stimulating Hormone ◽

Efficacy And Safety ◽

Follitropin Alfa ◽

Significant Difference ◽

Secondary Outcomes ◽

Stimulating Hormone

Background: Advances in recombinant DNA technology led to the development of recombinant follitropin alfa. Recombinant human follicle-stimulating hormone products are used to stimulate follicular maturation. Objective: To compare the efficacy and safety of a biosimilar-candidate recombinant human follicle-stimulating hormone (Cinnal-f® ; CinnaGen, Iran) with the reference product (Gonal-f® ; Merck Serono, Germany) in women undergoing ovarian stimulation for intracytoplasmic sperm injection (ICSI). Materials and Methods: In this randomized controlled trial, a total sample size of 200 women (age < 35 yr, candidate for ICSI) was calculated. Participants began a pituitary downregulation protocol with buserelin. They received 150 IU daily of either Cinnal-f® or Gonal-f® from the second day of their cycle. The primary outcome of the study was the percentage of metaphase II (MII) oocytes. The secondary outcomes included the number and quality of oocytes retrieved, duration of stimulation, fertilization rate, embryo quality, the number of clinical and ongoing pregnancies, and the incidence of ovarian hyperstimulation syndrome (as an important safety marker). Results: A total of 208 women were enrolled, of whom, 200 completed the study period. Ovarian stimulation with Cinnal-f® resulted in a comparable percentage of MII oocytes as with Gonal-f® (78.64% vs 80.02%, respectively; p = 0.81). No statistically significant difference was seen in the secondary outcomes between the groups. Conclusion: Cinnal-f® proved non-inferior to Gonal-f® , based on the percentage of MII oocytes in women aged < 35 yr undergoing ICSI. Our findings confirm that the efficacy and safety profiles of Cinnal-f® and Gonal-f® are similar. Key words: Follitropin alfa, Biosimilar, Efficacy, Safety, Intracytoplasmic sperm injection.

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Efficacy and Safety of Sahastara Remedy Extract Capsule in Primary Knee Osteoarthritis: A Randomized Double-Blinded Active-Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/6635148 ◽

2021 ◽

Vol 2021 ◽

pp. 1-10

Author(s):

Narin Kakatum ◽

Piya Pinsornsak ◽

Puritat Kanokkangsadal ◽

Buncha Ooraikul ◽

Arunporn Itharat

Keyword(s):

Blood Pressure ◽

Knee Osteoarthritis ◽

Controlled Trial ◽

Essential Medicine ◽

Ethanolic Extract ◽

Blood Chemistry ◽

Osteoarthritis Of The Knee ◽

Efficacy And Safety ◽

Double Blind ◽

Significant Difference

Sahastara (SHT) remedy is a Thai traditional medicine described in the Thai National List of Essential Medicine (NLEM) for the relief of muscle pain. The purpose of this study was to investigate the efficacy and safety of SHT remedy extract capsule for treating primary OA. A phase 2, double-blind, randomized, and controlled trial study was used to determine the clinical efficacy and safety of SHT in comparison with diclofenac for the treatment of knee OA. The outcome of reduce pain was measured from VAS, 100 meter time walk, and the WOMAC score of day 14 and day 28 which should reduce significantly when compared with day 0 and should be equal with or better than diclofenac. Blood pressure and blood chemistry values at day 14 and day 28 did not change when compared with day 0. The results found that SHT remedy ethanolic extract capsule can reduce all OA knee scores at day 14 and day 28 significantly when compared with day 0 and also no significant difference with diclofenac ( P > 0.05 ). The SHT also showed safety values on blood pressure and blood chemistry. The SHT was observed that it had no serious side effect. The results of this study are the first report of using the SHT ethanolic extract capsule in the treatment of primary osteoarthritis of the knee. It can be recommended as an anti-inflammatory herbal drug for reducing pain in knee osteoarthritis patients.

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First-In-Asian Double-Blind Randomized Trial To Assess The Efficacy And Safety Of Insulin Sensitizer In Nonalcoholic Steatohepatitis Patients

10.21203/rs.3.rs-596467/v1 ◽

2021 ◽

Author(s):

Jee-Fu Huang ◽

Chia-Yen Dai ◽

Chung-Feng Huang ◽

Pei-Chien Tsai ◽

Ming-Lun Yeh ◽

...

Keyword(s):

Controlled Trial ◽

Liver Steatosis ◽

Liver Fat ◽

Efficacy And Safety ◽

Double Blind ◽

Insulin Sensitizer ◽

Intention To Treat ◽

End Of Treatment ◽

Significant Difference ◽

Treat Analysis

Abstract Background: The efficacy and safety of insulin sensitizer in Asians with non-alcoholic steatohepatitis (NASH) remain elusive. Aims: The double-blind, randomized, placebo-controlled trial was conducted aiming to investigate the efficacy and safety of pioglitazone in NASH patients. Methods: A total of 90 NASH patients (66 males, age= 44.1 ± 12.7 years) were prospectively randomized into oral pioglitazone 30 mg/day (Arm A) or placebo (Arm B) for 24 weeks. The primary endpoint was the efficacy of pioglitazone in reducing inflammation and liver fat at end-of-treatment (EOT). NASH resolution/improvement without fibrosis worsening were also evaluated.Results: At EOT, there was a significantly decline of alanine aminotransferase (86.9 ± 34.3 to 45.7 ± 35.8 IU/L, P=0.003) level in Arm A patients. In intention-to-treat analysis among 66 patients who completed paired biopsies, The NAFLD activity score (NAS) of 30 Arm A patients significantly decreased from 4.27 ± 1.14 at baseline to 2.53 ± 1.63 at EOT (P< 0.0001), whereas there was no significant change in patients of Arm B (3.94 ± 1.41 vs 3.94 ± 1.51, P= 1.0). NASH improvement without worsening of fibrosis was achieved in 46.7% (14/30) patients in Arm A, compared to 11.1% (4/36) patients in Arm B (P= 0.002). Liver fat content reduced (20.2 ± 9.0 to 14.3 ± 6.9%, P<0.0001) on MRI-PDFF in Arm A compared to their counterparts. No significant difference of adverse events occurred between groups. Conclusions: A 24-weeks pioglitazone treatment was well-tolerated and effective in improving liver histology and reducing liver steatosis in Asian NASH patients. (ClinicalTrials.gov number: NCT01068444)

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Randomized, double-blind, three-arm, parallel-group study to compare the efficacy and safety of a single dose of 100 and 200 mg of mifepristone for cervical ripening in term pregnancies

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20210288 ◽

2021 ◽

Vol 10 (2) ◽

pp. 428

Author(s):

Leonardo J. Orozco ◽

Silvia Guerrero ◽

Mixel J. Rosales ◽

Jose S. Ramos

Keyword(s):

Controlled Trial ◽

Uterine Fibroids ◽

Cervical Length ◽

Mean Value ◽

Cervical Ripening ◽

Efficacy And Safety ◽

Chi Square ◽

Double Blind ◽

Significant Difference ◽

Chi Square Test

Background: Mifepristone is an antiprogestin developed to antagonize the action of progesterone by inhibiting its receptors. It has had a recognized role in the medical termination of early pregnancy, reduction in the volume of uterine fibroids and endometriosis symptoms. A new indication for labor induction and cervical ripening in has been proposed. The objective was to compare the efficacy and safety of mifepristone 100 and 200 mg with placebo for cervical ripening in term pregnancies.Methods: Double-blind, placebo-controlled trial of 90 term pregnancy women randomly assigned to receive orally tablet of 100 mg and 200 mg mifepristone or placebo. Efficacy was assessed by measuring changes in cervical ripening according to Bishop 72 hours after treatment. Statistical analysis was using the t-student test and the chi-square test. The relative risk (RR) was determined with a 95% confidence interval.Results: The bishop score and the number of contractions at 48 hours in the group of 200mg of mifepristone presented a significantly higher mean value in relation to the placebo (p=0.04). At 72 hours, cervical length showed a significant difference (p<0.01) in both mifepristone groups compared to the placebo group. Also, at 72 hours a significant increase in the mean duration of contractions was demonstrated in the 100 mg mifepristone group.Conclusions: There was a significant increase in Bishop's score for the 200 mg mifepristone group probably due to a significant increase in contractions at 24 hours. No differences were observed between groups in adverse events.

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