硫普罗宁钠治疗急慢性肝炎的随机、双盲模拟、平行对照的临床研究

目的：评价硫普罗宁钠治疗急慢性肝炎的有效性与安全性。方法：采用随机、双盲模拟、阳性药平行对照试验方法。硫普罗宁钠200 mg静滴Qd,对照组用凯西莱（硫普罗宁）200 mg静滴Qd。疗程均为4周,停药后随访4周。结果：共治疗急性肝炎患者7例,慢性肝炎患者18例。急性肝炎组：试验组与对照组4周末ALT下降率分别为69.14±39.23%及68.23±45.12%,试验组显效率33.33%,总有效率100%,对照组显效率25%,总有效率100%,两组疗效比较无显著性差异（P〉0.05）。慢性肝炎组：试验组与对照组4周末ALT下降率分别为44.34±53.41%及35.01±74.67%,试验组显效率22.22%,总有效率77.78%,对照组显效率11.11%,总有效率66.67%,两组疗效比较无显著性差异（P〉0.05）。急性肝炎组未见不良反应,慢性肝炎组中试验组及对照组不良反应发生率均为5.00%。结论：硫普罗宁钠具有保肝降酶作用,临床上用于治疗急慢性肝炎患者安全有效。     

Feasibility of Ballistic Strength Training in Subacute Stroke: A Randomized,Controlled, Assessor-Blinded Pilot Study

Objective

To establish the feasibility and effectiveness of a 6-week ballistic strength training protocol in people with stroke.

国产来氟米特治疗类风湿关节炎的随机双盲对照试验

目的与进口来氟米特(商品名:爱若华,美国欣凯公司产品)相比较,观察国产来氟米特(leflunomide,LFM)治疗活动期类风湿关节炎(类风关)的疗效和不良反应.方法采用随机、双盲双模拟、阳性药物平行对照研究方法,将56例活动期类风关患者随机分为两组,分别服用受试药和对应模拟片各2片,疗程24周,并比较其疗效.结果与治疗前比较,治疗12周时,除血沉外,两组在各个主要指标方面均较各自治疗前明显改善(P<0.05);治疗24周后,两组在血沉、C-反应蛋白等指标上与治疗前比较,差异无统计学意义,其它各主要指标均较治疗前明显改善(P<0.05).两组间各项主要指标改善值在治疗12周和24周时差异均无统计学意义(P>0.05).按国内综合评价指标分析,治疗12周时,爱若华组改善率为37.0%,国产来氟米特组为64.0%,两组间差异有统计学意义(P<0.05);治疗24周时,爱若华组为81.5%,国产来氟米特组为77.3%,两组在改善率方面的差异无统计学意义(P>0.05).此外,两组不良事件发生率的差异也无统计学意义.结论国产来氟米特与爱若华比较具有相似的疗效和安全性.     

Novel Use of Hydromorphone as a Pretreatment Agent: A Double-blind, Randomized, Controlled Study in Adult Korean Surgical Patients

Background

Hydromorphone is a potent μ-opioid selective agonist that has an onset time within 5 minutes and reaches peak effect between 10 and 20 minutes. However, it may show immediate analgesic effect to rocuronium-induced pain because of its peripheral analgesic property and also may attenuate noxious stimuli from tracheal intubation during induction. The opioid receptors are known to be present in peripheral sensory nerve terminals as well as in the dorsal root ganglion and the central terminal of primary afferent nerves. Therefore, we hypothesized that hydromorphone may be considered a potent pretreatment or adjuvant drug during the induction of anesthesia with its peripherally and centrally mediated analgesia.

Objective

The aim of this study was to compare the effects of pretreatment with hydromorphone in reducing rocuronium-induced withdrawal movements and hemodynamic changes during tracheal intubation with the effects of fentanyl and normal saline.

Methods

In this double-blind, randomized, controlled study, consecutive adult patients aged 20 to 70 years who were scheduled to undergo general anesthesia for elective gastric or colorectal surgery at the Samsung Seoul Hospital (Seoul, Republic of Korea) were randomly assigned to receive 5 mL hydromorphone 0.03 mg/kg or fentanyl 2 μg/kg or normal saline. Thirty seconds after administering the study drug, anesthesia was induced with 2.5% thiopental sodium 5 mg/kg. After loss of consciousness, rocuronium 0.6 mg/kg was injected and immediate withdrawal movements were recorded. Two minutes after rocuronium injection, tracheal intubation was performed and hemodynamic changes were observed.

Results

A total of 194 patients were enrolled, with 65 in the hydromorphone group, 67 in the fentanyl group, and 62 in the saline group. The overall incidence of withdrawal movements was significantly lower in the hydromorphone group (2 patients; 3.1%) and the fentanyl group (5 patients; 7.5%) (both, P < 0.001) than in the saline group (36 patients; 58.1%). The mean arterial pressure (MAP) and heart rate (HR) after intubation (median [interquartile range]) in the fentanyl group (101.5 [84−115] mm Hg; 93.5 [82−102] beats per minute [bpm]) and the hydromorphone group (93.0 [83−106] mm Hg; 90.0 [86.3−93.6] bpm) were significantly lower than these measures in the saline group (111.5 [105−123] mm Hg; 103.5 [96−113] bpm) (fentanyl group MAP and HR, P < 0.001; hydromorphone group MAP and HR, P < 0.001).

Conclusions

Pretreatment with hydromorphone and fentanyl may have similar effectiveness in reducing withdrawal movements in response to rocuronium injection pain and inducing immediate general anesthesia.     

Effects of Ivermectin in Patients With COVID-19: A Multicenter,Double-blind,Randomized, Controlled Clinical Trial

PurposeGiven the coronavirus disease 2019 (COVID-19) pandemic, there is a global urgency to discover an effective treatment for patients withthis disease. This study aimed to evaluate the effects of the widely used antiparasitic drug ivermectin on outcomes in patients with COVID-19.MethodsIn this randomized, double-blind clinical trial, patients with COVID-19 admitted to 2 referral tertiary hospitals in Mazandaran, Iran, were randomly divided into 2 groups: intervention and control. In addition to standard treatment for COVID-19, the intervention group received a single weight-based dose (0.2 mg/kg) of ivermectin; the control group received the standard of care. Demographic, clinical, laboratory, and imaging data from participants were recorded at baseline. Patients were assessed daily for symptoms and disease progression. The primary clinical outcome measures were the durations of hospital stay, fever, dyspnea, and cough; and overall clinical improvement.FindingsSixty-nine patients were enrolled (mean [SD] ages: ivermectin, 47.63 [22.20] years; control, 45.18 [23.11] years; P = 0.65). Eighteen patients (51.4%) in the ivermectin group and 18 (52.9%) in control group were male (P = 0.90). The mean durations of dyspnea were 2.6 (0.4) days in the ivermectin group and 3.8 (0.4) days in the control group (P = 0.048). Also, persistent cough lasted for 3.1 (0.4) days in the ivermectin group compared to 4.8 (0.4) days in control group (PP = 0.019). The mean durations of hospital stay were 7.1 (0.5) days versus 8.4 (0.6) days in the ivermectin and control groups, respectively (P = 0.016). Also, the frequency of lymphopenia decreased to 14.3% in the ivermectin group and did not change in the control group (P = 0.007).ImplicationsA single dose of ivermectin was well-tolerated in symptomatic patients with COVID-19, and important clinical features of COVID-19 were improved with ivermectin use, including dyspnea, cough, and lymphopenia. Further studies with larger sample sizes, different drug dosages, dosing intervals and durations, especially in different stages of the disease, may be useful in understanding the potential clinical benefits ivermectin. Iranian Registry of Clinical Trials identifier: IRCT20111224008507N3.     

阿立哌唑治疗精神分裂症的随机双盲对照试验

【目的】评价阿立哌唑治疗精神分裂症的疗效及安全性。【方法】收集精神分裂症患者38例,采用随机、双盲、双模拟、利培酮平行对照研究,阿立哌唑组18例与利培酮组20例分别口服阿立哌唑10~30 mg/d与利培酮2~6 mg/d,疗程42 d。【结果】治疗结束时,两组PANSS总分与BPRS总分较治疗前均显著降低(P<0.01);阿立哌唑组与利培酮组PANSS总分减分率分别为(72.3±21.1)%和(66.2±31.4)%,差异无显著性(P>0.05)。临床总有效率:阿立哌唑组88.9%,利培酮组65.0%,差异无显著性(P>0.05)。阿立哌唑常见的不良反应为:失眠、心动过速、口干、肌强直、便秘、震颤,发生率与利培酮相当。【结论】国产阿立哌唑治疗精神分裂症的疗效及不良反应与利培酮相似,是一种安全而有效的抗精神病药。     

Effect of Extracorporeal Shock Wave Therapy on Muscle Mass and Function in Patients Undergoing Maintenance Hemodialysis: A Randomized Controlled Pilot Study

Patients undergoing maintenance hemodialysis (MHD) are susceptible to muscle wasting and decreased muscle function, resulting in shorter survival time. This study was aimed at evaluating the effect of radial extracorporeal shock wave therapy (rESWT) on muscle mass and function in patients on MHD. This single blind controlled study was conducted on patients on MHD from September 2018 to December 2019. Eighteen patients were enrolled in the rESWT and control groups. rESWT was performed once a week for 12 wk in both quadriceps femoris muscles of the ESWT group. Finally, 15 patients were assessed for body composition, handgrip strength, physical performance and blood chemistry before rESWT, after rESWT and at a 12-wk follow-up. Leg lean mass and appendicular skeletal muscle mass index increased significantly in the ESWT group compared with the control group (p = 0.001 and p = 0.017). The timed up-and-go test and sit-to-stand tests revealed greater significant improvement in the ESWT group (p = 0.023 and p = 0.046). This study is the first to report that rESWT can improve muscle mass and function in MHD patients. A subsequent study will be conducted to validate the clinical effects of rESWT in a larger sample of patients undergoing MHD.     

Pilot Study of Low-dose Naltrexone for the Treatment of Chronic Pain Due to Arthritis: A Randomized,Double-blind,Placebo-controlled,Crossover Clinical Trial

PurposeLow-dose naltrexone (LDN) is commonly used to control pain and other symptoms, especially in patients with autoimmune diseases, but with limited evidence. This study tests the efficacy of LDN in reducing chronic pain in patients with osteoarthritis (OA) and inflammatory arthritis (IA), where existing approaches often fail to adequately control pain.MethodsIn this randomized, double-blind, placebo-controlled, crossover clinical trial, each patient received 4.5 mg LDN for 8 weeks and placebo for 8 weeks. Outcome measures were patient reported, using validated questionnaires. The primary outcome was differences in pain interference during the LDN and placebo periods, using the Brief Pain Inventory (scale, 0–70). Secondary outcomes included changes in mean pain severity, fatigue, depression, and multiple domains of health-related quality of life. The painDETECT questionnaire classified pain as nociceptive, neuropathic, or mixed. Data were analyzed using mixed-effects models.FindingsSeventeen patients with OA and 6 with IA completed the pilot study. Most patients described their pain as nociceptive (n = 9) or mixed (n = 8) rather than neuropathic (n = 3). There was no difference in change in pain interference after treatment with LDN (mean [SD], −23 [19.4]) versus placebo (mean [SD], −22 [19.2]; P = 0.90). No significant differences were seen in pain severity, fatigue, depression, or health-related quality of life.ImplicationsIn this small pilot study, findings do not support LDN being efficacious in reducing nociceptive pain due to arthritis. Too few patients were enrolled to rule out modest benefit or to assess inflammatory or neuropathic pain. ClinicalTrials.gov identifier: NCT03008590.     

Peripartum Management of Gestational Diabetes Using a Digital Health Care Service: A Pilot,Randomized Controlled Study

PurposeThe prevalence of gestational diabetes mellitus (GDM) is increasing, and multifaceted interventions are effective in the management of GDM. This study aimed to develop and evaluate a model for the management of GDM with the use of mobile health care.MethodsThis was a prospective, randomized controlled pilot study. A total of 21 patients who were diagnosed with GDM during 24–28 weeks of gestation were randomly divided into a conventional management (CM) group (n = 10) and a mobile management (MM) group (n = 11). The CM group received conventional GDM management and could freely use the mobile health care application. The MM group received mobile health care services, including tailored mobile coaching. After delivery, obstetric outcomes were collected, and 75-g oral glucose tolerance test was performed at 5–12 weeks postpartum.FindingsBaseline characteristics, including glycosylated hemoglobin (HbA_1c), were not significantly different between the 2 groups. No statistically significant differences were found in rates between the 2 groups for (1) neonate large for gestational age and (2) cesarean section at the time of delivery. No significant difference was found in HbA_1c between the 2 groups after delivery. However, postpartum homeostatic model assessment insulin resistance, body mass index, weight, and percentage of body fat were significantly lower in the MM group.ImplicationsThe MM group had no significant difference in glycemic index compared with the CM group. However, the MM group had effective weight control and improved insulin resistance after delivery. This study indicated that mobile health care services could be an efficient GDM management tool. ClinicalTrials.gov identifier: NCT03838380.     

激励式护理干预促进自然分娩的随机对照研究

目的 探讨建立一种以激励为核心的心理护理干预方法，促进自然分娩，降低剖宫产率。方法 将200例产妇随机分为激励组和对照组。每组各100例，采用焦虑自评量表（SAS）、抑郁自评量表（SDS）进行心理测评，在此基础上有针对性地在激励组开展激励式护理干预：以分娩时间限定的激励式心理护理、助产士担任的导乐全程陪产．心理暗示假慰，辅以拉马策（Lamaze）呼吸法；对照组按常规产科护理进行。结果 激励组的产程时间、剖宫产率、新生儿窒息率均低于对照组（P〈0．05）.结论 激励式护理干预能有效的缩短产程．降低刮宫产率，减少新生儿窒息的发生，促进自然分娩，提升了产科护理质量。     

Efficacy and Safety of the Remimazolam-Alfentanil Combination for Sedation During Gastroscopy: A Randomized,Double-blind,Single-center Controlled Trial

PurposePropofol infusion is a popular single drug of choice for sedation in the gastrointestinal endoscopy suite. Drug combinations are more beneficial than single-drug regimens in gastroscopy sedation. However, the cardiopulmonary complications of propofol sedation raise concern. Remimazolam is a novel, ultra-short-acting benzodiazepine sedative, and alfentanil is a weak opioid. During endoscopic procedures, remimazolam is an effective and safe sedative procedure. No synergistic effect has been reported when remimazolam was combined with alfentanil in gastroscopy sedation. Here, we evaluated the effective dose, sedative efficacy, and safety of the remimazolam-alfentanil combination in gastroscopy sedation and compared the results with those of the propofol-alfentanil combination.MethodsThis study was conducted in two parts. In Part 1, Dixon's up-and-down method (sequential distribution) was adopted for determining the 95% effective dose (ED95) (95% CI) and 95% CI of remimazolam combined with 5 µg/kg alfentanil. In Part 2, after obtaining the predictive remimazolam ED95, 161 patients were randomized into the remimazolam group (remimazolam-alfentanil) and the propofol group (propofol-alfentanil). The effectiveness of the drug combinations was measured according to successful sedation parameters. Changes in vital signs and the appearance of adverse events were used to assess the safety of drug combinations. Evaluation of patient and physician satisfaction was included as quality indicators of treatment.ResultsBaseline demographic and clinical characteristics were comparable between the 2 parts of the study. The ED95 of remimazolam in inhibiting a positive response to gastroscopy placement into the pharyngeal cavity was 0.33 mg/kg (95% CI, 0.289 to 1.023). The procedure success rate was 97.53% in the remimazolam group and 97.50% in the propofol group. The difference in the success rate of the procedure between the remimazolam and propofol groups was 0.03% (95% CI, –2.5 to 2.4). However, the incidence of injection pain, hypotension, respiratory depression, and dizziness was lower in the remimazolam group compared with the propofol group (P < 0.05). Furthermore, patients from the propofol group were more likely to be drowsy, and their work efficiency was reduced the day after leaving the hospital, whereas patients in the remimazolam group were less affected (P < 0.05).ImplicationsThe ED95 of remimazolam was 0.33 mg/kg when it was combined with alfentanil (5 µg/kg) for gastroscopy sedation. The sedation strategy of remimazolam-alfentanil has noninferior efficacy, fewer adverse effects, and a better postoperative recovery process than propofol-alfentanil for patients undergoing gastroscopy. Chinese Clinical Trials Registry identifier: ChiCTR2100051565.     

Effect of Perineural Dextrose Injection on Ulnar Neuropathy at the Elbow: A Randomized,Controlled, Double-Blind Study

ObjectiveTo compare perineural dextrose injection efficacy in the treatment of ulnar neuropathy at the elbow with a control group.DesignProspective double-blind randomized control study.SettingTraining and research hospital.ParticipantsThe study was completed with 40 patients with ulnar neuropathy at the elbow.InterventionNormal saline (0.9% sodium chloride) was injected in patients in the control group (n=20; mean age=38.1±10.7 years; median duration of symptoms=4.5 months), and 5% dextrose was injected in patients in the dextrose group (n=20; mean age=43.6±13.5 years; median duration of symptoms=5 months), perineurally under ultrasound guidance twice at 2-week intervals. Ultrasound-guided perineural injection of 1 cc each was administered into the ulnar nerve, 2 cm and 4 cm distal to the medial epicondyle, at the level of the medial epicondyle, and 2 cm and 4 cm proximal to the medial epicondyle. The amount of total fluid injected was 5 cc.Main Outcome Measure(s)At baseline and weeks 2, 4, and 12, the patients were evaluated with the Visual Analog Scale for pain and the Disabilities of the Arm Shoulder and Hand questionnaire for disability. Electrophysiological evaluation was performed with ulnar nerve conduction studies, and the ulnar nerve cross-sectional area was measured on ultrasonography.ResultsThe improvements in pain, disability, ulnar motor nerve velocity, and ulnar nerve cross-sectional area in the dextrose group were superior to those in the control group, especially at weeks 4 and 12 (P<.001, using independent samples t tests).ConclusionPerineural 5% dextrose may be an effective alternative therapy for those with ulnar neuropathy at the elbow for up to the 12th week.     

Efficacy and Safety of a Traditional Herbal Medicine, Hochu-ekki-to in the Long-term Management of Kikyo (Delicate Constitution) Patients with Atopic Dermatitis: A 6-month, Multicenter, Double-blind, Randomized, Placebo-controlled Study

Hochu-ekki-to is a traditional herbal (Kampo) medicine that has been shown to be effective for patients with Kikyo (delicate, easily fatigable, or hypersensitive) constitution. Previous case reports have suggested that this herbal drug was effective for a certain subgroup of patients with atopic dermatitis (AD). We aimed to evaluate the efficacy and safety of Hochu-ekki-to in the long-term management of Kikyo patients with AD. In this multicenter, double blind, randomized, placebo-controlled study, 91 Kikyo patients with AD were enrolled. Kikyo condition was evaluated by a questionnaire scoring system. All patients continued their ordinary treatments (topical steroids, topical tacrolimus, emollients or oral antihistamines) before and after their protocol entry. Hochu-ekki-to or placebo was orally administered twice daily for 24 weeks. The skin severity scores, total equivalent amount (TEA) of topical agents used for AD treatment, prominent efficacy (cases with skin severity score = 0 at the end of the study) rate and aggravated rate (more than 50% increase of TEA of topical agents from the beginning of the study) were monitored and evaluated. Seventy-seven out of 91 enrolled patients completed the 24-week treatment course (Hochu-ekki-to: n = 37, placebo: n = 40). The TEA of topical agents (steroids and/or tacrolimus) was significantly (P < 0.05) lower in the Hochu-ekki-to group than in the placebo group, although the overall skin severity scores were not statistically different. The prominent efficacy rate was 19% (7 of 37) in the Hochu-ekki-to group and 5% (2 of 40) in the placebo group (P = 0.06). The aggravated rate was significantly (P < 0.05) lower in the Hochu-ekki-to group (3%; 1 of 37) than in the placebo group (18%; 7 of 39). Only mild adverse events such as nausea and diarrhea were noted in both groups without statistical difference. This placebo-controlled study demonstrates that Hochu-ekki-to is a useful adjunct to conventional treatments for AD patients with Kikyo constitution. Use of Hochu-ekki-to significantly reduces the dose of topical steroids and/or tacrolimus used for AD treatment without aggravating AD.     

Comparison of Oxycodone and Hydrocodone for the Treatment of Acute Pain Associated with Fractures: A Double-blind, Randomized, Controlled Trial

Background: Previous studies have demonstrated the efficacy of oxycodone and hydrocodone for the treatment of acute pain. However, to the best of the authors' knowledge, no previous reports have compared the efficacies of these commonly prescribed agents. Objectives: To compare the efficacies of oxycodone and hydrocodone for the treatment of acute pain associated with fractures in emergency department (ED) patients. Methods: This prospective, double‐blind, randomized, controlled trial was conducted at an urban trauma center with an annual census of 65,000. Eligible participants included ED patients over the age of 12 years with fractures who consented to participate. Subjects were randomized to receive either oxycodone (5 mg orally [po]) with acetaminophen, or hydrocodone (5 mg po) with acetaminophen. Measurements included demographic information; pain scores on a verbal numeric rating scale at baseline and at 30 and 60 minutes; vital signs at baseline and at 30 and 60 minutes; and adverse effects. Ninety‐five‐percent confidence intervals (95% CIs) constructed about means and proportions were used to assess differences between the oxycodone and hydrocodone groups in analgesic efficacy and side effects. Results: Seventy‐three subjects were randomized to receive oxycodone or hydrocodone. Sixty‐seven subjects completed the ED study period (n= 35, oxycodone; n= 32, hydrocodone). There was no difference between the two groups in age, weight, gender, ethnicity, diagnoses, baseline pain scores, or vital signs. Patients in both groups had pain relief from baseline to 30 minutes (oxycodone mean change 3.7, 95% CI = 2.9 to 4.6; hydrocodone mean change 2.5, 95% CI = 1.7 to 3.3), and from baseline to 60 minutes (oxycodone mean change 4.4, 95% CI = 3.2 to 5.6; hydrocodone mean change 3.0, 95% CI = 2.1 to 3.9). There was no difference in pain between the patients treated with oxycodone and hydrocodone at 30 minutes (mean difference between groups ?0.6, 95% CI =?1.8 to 0.5) or at 60 minutes (mean difference ?0.5, 95% CI =?2.0 to 1.0). There was no difference between the groups in nausea, vomiting, itching, or drowsiness; however, the hydrocodone patients had a higher incidence of constipation (oxycodone 0%, hydrocodone 21%, difference in proportions 21%, 95% CI = 3% to 39% more with hydrocodone). Conclusions: Treatment with acetaminophen and either oxycodone, 5 mg po, or hydrocodone, 5 mg po, resulted in pain relief among ED patients with acute fractures, and there was no difference between the two agents at 30 and 60 minutes. Adverse effect profiles were similar, with the exception of a higher incidence of subsequent constipation with the use of hydrocodone. These results suggest that oxycodone and hydrocodone have similarly potent analgesic effects in the first hour of treatment for ED patients with acute fractures.     

Locomotion Improvement Using a Hybrid Assistive Limb in Recovery Phase Stroke Patients: A Randomized Controlled Pilot Study

Objective

To compare the efficacy of gait training using a single-leg version of the Hybrid Assistive Limb (HAL) on the paretic side with conventional gait training in individuals with subacute stroke.

Design

Randomized open controlled pilot trial.

Setting

Hospitalized care.

Participants

Convenience sample of 44 patients who met the criteria; 12 patients refused. After randomization (N=32), 10 patients withdrew and a total of 22 poststroke participants (HAL group: n=11; conventional group: n=11) completed the randomized controlled trial.

Interventions

All participants received twelve 20-minute sessions in 4 weeks of either HAL (wearing the single-leg version of the HAL on their paretic side) or conventional (performed by skilled and experienced physical therapists) gait training.

Main Outcome Measures

Outcome measures were evaluated prior to training and after 12 sessions. Functional Ambulation Category (FAC) was the primary outcome measure, whereas secondary outcome measures included maximum walking speed, timed Up and Go test, 6-minute walk distance, Short Physical Performance Battery, Fugl-Meyer Assessment of Lower Extremity, and isometric muscle strength (hip flexion and extension, knee flexion and extension).

Results

No participants withdrew because of adverse effects. Participants who received gait training with the HAL showed significantly more improvement in the FAC than those who received conventional gait training (95% confidence interval, .02–.88; P=.04). Secondary measures did not differ between the 2 groups.

Conclusions

The results obtained in this randomized controlled trial suggest that a gait training program with the HAL could improve independent walking more efficiently than conventional gait training.     

艾司西酞普兰治疗抑郁症有效性和安全性的随机双盲阳性药物对照试验

目的评价艾司西酞普兰治疗抑郁症的有效性和安全性。方法选择符合CCMD-3诊断标准的内源性抑郁症患者56例,随机分配到艾司西酞普兰试验组和西酞普兰阳性药物对照组,每组各28例,进行双盲、为时6周的观察评估。利用汉密尔顿抑郁量表(HAMD)、临床总体印象(CGI)和汉密尔顿焦虑量表(HAMA)进行疗效评定,并根据症状、体征、实验室和心电图检查结果评价药物安全性。结果全分析集结果显示,治疗结束时试验组HAMD的减分为15.1±7.8,对照组HAMD的减分为12.1±7.7,两者差异无统计学意义(t=1.42,P=0.1613);基于HAMD减分率的显效率,试验组为78.6%,对照组为67.9%,两组差异无统计学意义(χ2=0.8195,P=0.3653)。治疗结束时试验组HAMA评分从治疗前的15.1±3.7降至3.3±4.5,对照组从治疗前的14.0±4.1降至5.0±3.7,两组差异无统计学意义(t=1.5756,P=0.1223)。CGI评分结果表明,在观察的各个时点两者的评分结果差异均无统计学意义。治疗结束时试验组显著进步以上的患者占90.0%,对照组为87.8%,两组差异无统计学意义(CMH检验值为1.5013,P=0.2205)。综合整个试验过程的安全性数据集的分析结果显示,试验组不良反应发生率为32.5%,对照组为30.8%,两者差异无统计学意义(χ2=0.0770,P=0.7814)。试验组中常见不良反应有恶心(11.7%)、口干(9.2%)、头晕(5.8%)、失眠(3.3%)、乏力(2.5%)、转氨酶升高(1.7%)、心悸(1.7%)、便秘(1.7%)等。结论与广泛使用的西酞普兰一样,艾司西酞普兰治疗内源性抑郁症有效、安全。     

Efficacy and Tolerability of Cyproheptadine in Poor Appetite: A Multicenter,Randomized, Double-blind,Placebo-controlled Study

PurposeCyproheptadine, an antihistamine and antiserotonergic agent, is an appetite stimulant that is efficacious in promoting weight gain in children and adults with poor appetite. Despite numerous studies showing that cyproheptadine achieved positive outcomes, studies documenting its effectiveness on appetite are limited. This study evaluated the efficacy and tolerability of cyproheptadine in adults with poor appetite in South Korea.MethodsPatients aged 19 to 64 years with poor appetite were randomly assigned to receive either cyproheptadine or placebo for 8 weeks. The primary end point was the difference between the groups in change in appetite, as measured by the Korean version of the Edmonton Symptom Assessment System from the beginning to the end of the study period. The secondary end points included effects on weight, anthropometrics, body composition, Simplified Nutritional Appetite Questionnaire–measured appetite, and toxicities. A total of 375 patients were randomly assigned to the two groups (189 cyproheptadine, 186 placebo).FindingsThe cyproheptadine group experienced a mean (SD) change in appetite score of –2.42 (0.12) compared with –2.03 (0.13) in the placebo arm, representing a statistically significant appetite gain in the cyproheptadine group (difference, +0.38 [0.18]; 95% CI, –0.73 to –0.04; P = 0.0307). Patients in the cyproheptadine group experienced significant increases in weight and body mass index. The most common adverse event was somnolence, as predicted. Cyproheptadine was well tolerated, with one serious adverse event (colitis) which was classified as a moderate adverse effect unlikely to be related to the study drug.ImplicationsWe present the largest randomized, double-blind, placebo-controlled clinical trial of cyproheptadine versus placebo in healthy adults with poor appetite using the lowest effective dosage of cyproheptadine. Cyproheptadine is a safe treatment option in patients with poor appetite. Our findings provide important information for the use of cyproheptadine to ameliorate poor appetite in adults. Further randomized studies focused on the effect of cyproheptadine in older populations are needed.     

罗哌卡因与利多卡因联合用于膝关节镜术后镇痛的随机双盲安慰剂对照试验

目的研究膝关节腔内联合应用罗哌卡因与利多卡因的镇痛效果。方法采用随机双盲安慰剂对照的试验方法,将90例膝关节镜手术患者分为3组,每组分别在术毕膝关节腔内注入0.9%生理盐水(NS组)和罗哌卡因(R组)、罗哌卡因 利多卡因(R L组),并进行镇痛评估,记录术后补救性镇痛药总用量。结果R组术后2h休息时、术后1~8h运动时的视觉模拟评分(VAS评分)明显低于NS组(P<0.05)。RL组术后0.5～2h休息时及术后清醒至术后24h运动时的VAS评分明显低于NS组(P<0.05)。结论膝关节腔内注射罗哌卡因能明显减轻患者术后疼痛程度。罗哌卡因 利多卡因关节腔内注射能减轻患者术后清醒即刻的疼痛程度,达到术后早期镇痛的目的。