A multicentre,randomized, controlled trial of oseltamivir in the treatment of influenza in a high-risk Chinese population

ABSTRACT

Objective:?To evaluate the efficacy and safety of oseltamivir treatment in a population at high risk for influenza.

Research design and methods:?This was a randomized, open-label, controlled trial involving Chinese patients with chronic respiratory diseases (chronic bronchitis, obstructive emphysema, bronchial asthma or bronchiectasis) or chronic cardiac disease. Patients showing symptoms of influenza were randomly assigned to receive oral oseltamivir 75?mg twice daily for 5 days (oseltamivir group), or symptomatic treatment (control group) within 48?h after symptom onset.

Main outcome measures:?The main outcome measures were duration and severity of illness in influenza-infected patients. Other outcome measures included incidence of complications, antibiotic use, hospitalization and total medical cost.

Results:?Of the 118 recruited patients, 56 were identified as influenza-infected through laboratory tests (oseltamivir, N = 27; control, N = 29). Relative to symptomatic treatment, oseltamivir significantly reduced the duration of influenza symptoms by 36.8% (?p = 0.0479), and the severity by 43.1% (?p = 0.0002). In addition, oseltamivir significantly reduced the duration of fever by 45.2% (?p = 0.0051), and the time to return to baseline health status by 5 days (?p = 0.0011). The incidence of complications (11% vs. 45%, p = 0.0053) and antibiotic use (37% vs. 69%, p = 0.0167) were also significantly lower in the oseltamivir group compared with the control group. The cost of treating influenza and its complications was comparable between the two groups (?p = 0.2462).

Conclusions:?Oseltamivir is effective and well tolerated in high-risk patients with chronic respiratory or cardiac diseases. It can reduce the duration and severity of influenza symptoms and decrease the incidence of secondary complications and antibiotic use, without increasing the total medical cost.     

A new mesalazine gel enema in the treatment of left-sided ulcerative colitis: a randomized controlled multicentre trial

BACKGROUND: A new mesalazine rectal gel preparation (without propellant gas) has been recently developed to improve topical treatment in distal ulcerative colitis. AIM: To evaluate the efficacy, safety and patient tolerability of mesalazine gel enema compared with mesalazine foam enema in the treatment of patients with acute left-sided ulcerative colitis. METHODS: In a randomized multicentre investigator-blind parallel group trial, 103 patients with mild to moderate left-sided colitis or proctosigmoiditis were randomly allocated to mesalazine 2 g gel enema (n = 50 evaluable patients) and mesalazine 2 g foam enema (n = 53 evaluable patients) for 4 weeks. Clinical symptoms, endoscopic and histological findings were assessed at entry, 2 and 4 weeks. Patients' evaluation of treatment tolerability and acceptability was assessed at 2 and 4 weeks. RESULTS: After 4 weeks of treatment, clinical remission was achieved by 76% of mesalazine gel enema-treated patients and 69% of patients treated with mesalazine foam enema (P = 0.608). Endoscopic remission rates at week 4 were 51 and 52% for the mesalazine gel and foam enemas, respectively (P = 0.925). Histological remission was achieved by 30% of patients in both groups. Patients reported that the new mesalazine gel preparation was significantly better tolerated than the foam enema. Patients in the foam group had significantly more difficulty in retention (25% vs. 6%, P < 0.05), abdominal bloating (50% vs. 26%, P < 0.005) and discomfort during administration (48% vs. 26%, P < 0.05). CONCLUSION: The new mesalazine gel enema is efficacious and significantly better tolerated than the mesalazine foam enema.     

甲磺酸加替沙星氯化钠注射液治疗细菌感染的多中心随机对照临床研究

目的评价新药甲磺酸加替沙星氯化钠注射液治疗常见致病菌引起的呼吸系统、泌尿系统细菌感染性疾病的临床疗效和安全性.方法以盐酸左氧氟沙星注射液为对照药,采用多中心随机盲法阳性对照平行试验设计方法,进行治疗急性细菌性感染疾病安全性和有效性临床研究.结果甲磺酸加替沙星氯化钠注射液组(试验组)治疗呼吸道感染、泌尿系统感染的临床痊愈率和有效率分别为68.97%、91.95%、79.31%和93.10%;细菌阴转率分别为95.65%和83.33%,左氧氟沙星注射液组(对照组)治疗呼吸道感染、泌尿系统感染的临床痊愈率和有效率分别为63.86%、91.57%、86.21%和96.55%;细菌阴转率分别为92.19%和96.15%.试验组与对照组ADR发生率分别为5.51%、6.35%.两组比较差异均无统计学意义.应用甲磺酸加替沙星氯化钠注射液未见严重不良反应.结论新药甲磺酸加替沙星氯化钠注射液治疗临床常见致病菌引起的呼吸系统、泌尿系统感染临床疗效较好而不良反应率较低,与盐酸左氧氟沙星注射液相似,有较高的临床应用价值.     

喹硫平治疗精神分裂症的随机、平行对照和多中心临床研究

目的 :评价喹硫平治疗精神分裂症的疗效及安全性。方法 :精神分裂症病人 12 5例 ,其中喹硫平组 6 5例 ,给喹硫平 30 0～ 6 0 0mg·d- 1治疗 ;利培酮组 6 0例 ,给利培酮 3～ 6mg·d- 1治疗。观察时间6wk。疗效评定用PANSS ,BPRS ,CGI。安全性评价用TESS等。结果 :经 6wk治疗后 ,喹硫平组总有效率为 80 % ,利培酮组为 88% ,2组相比P >0 .0 5;喹硫平组血清催乳素浓度为 399IU±s 4 50IU ,利培酮组为 1351IU± 76 3IU ,P <0 .0 1。喹硫平组不良反应有失眠 (9% )、ECG轻度异常 (8% )、兴奋或激越 (8% )等。喹硫平组静坐不能的发生率 (0 )显著低于利培酮组 (10 % )。结论 :喹硫平治疗精神分裂症疗效与利培酮相当 ,但对血清催乳素的影响小 ,锥体外系症状少     

甲磺酸加替沙星片治疗急性细菌感染性疾病的多中心随机对照临床研究

目的　评价新药甲磺酸加替沙星片治疗常见致病菌引起的呼吸系统、泌尿系统细菌感染性疾病的临床疗效和安全性。方法　以盐酸左氧氟沙星片为对照药 ,采用多中心随机盲法阳性对照平行试验设计方法 ,进行甲磺酸加替沙星片治疗急性细菌性感染疾病安全性和有效性临床研究。结果　试验组甲磺酸加替沙星氯化钠片治疗呼吸道感染、泌尿系统感染的临床痊愈率和有效率分别为 74 .73%和 96 .70 %、90 .91%和10 0 % ;细菌阴转率分别为 97.92 %和 97.96 %。对照组左氧氟沙星片治疗上述感染的临床痊愈率和有效率依次分别为 80 .2 2 %和 97.80 %、86 .6 7%和 96 .6 7% ;细菌阴转率分别为 98.6 1%和 96 .15 %。试验组与对照组不良反应发生率分别为 6 .87%和 6 .0 6 %。两组比较差异无统计学意义。应用甲磺酸加替沙星片未见严重不良反应发生。结论　新药甲磺酸加替沙星片治疗临床常见致病菌引起的呼吸系统、泌尿系统感染临床疗效较好而不良反应发生率较低 ,与盐酸左氧氟沙星片相似     

糖降肾康颗粒治疗糖尿病肾病随机双盲安慰剂对照多中心临床试验

目的评价糖降肾康颗粒治疗糖尿病肾病(DN)的临床疗效与安全性。方法采用随机、双盲、双模拟、安慰剂平行对照、多中心临床试验设计。低剂量组:糖降肾康颗粒1袋+糖降肾康颗粒模拟剂1袋,3次·d~(-1),口服。高剂量组:糖降肾康颗粒2袋,2次·d,模拟剂2袋,1次·d~(-1),口服。安慰剂组:模拟剂,2袋,3次·d~(-1),口服。8 wk为一个疗程。所有受试者在试验期间糖尿病基础治疗不变。观察临床疗效,治疗前、治疗4 wk和8 wk末检查尿微量白蛋白排泄率(UAER)、24 h尿蛋白定量和空腹血糖。结果共纳入194例Ⅲ或Ⅳ期DN患者,剔除8例,脱落2例,184例按方案完成试验。高剂量组临床控制率为47%,低剂量组为42%,安慰剂组为18%,高、低剂量组疗效优于安慰剂组(P<0.01),而高、低剂量组间无显著差异(P>0.05)。治疗后,高、低剂量组和安慰剂组UAER分别为(83±157)、(212±612)和(298±783)μg·min~(-1),24 h尿蛋白定量分别为(477±427)、(675±856)和(812±1318)mg,高、低剂量组均低于安慰剂组(P<0.01)。试验过程中未出现严重不良反应。结论糖降肾康颗粒治疗DN具有良好的疗效,且安全性良好。     

A randomized, controlled study of Kan Jang versus amantadine in the treatment of influenza in Volgograd

Two randomized, parallel-group clinical studies with a verum and a control group were performed to investigate the effect of a standardized extract (SHA-10) of Andrographis panaiculata (N.) fixed combination Kan Jang in the treatment of diagnosed influenza viral infection. The pilot study was performed on 540 patients with 71 Kan Jang-treated patients with the second phase conducted enrolling 66 patients. The differences in the duration of sick leave and frequency of post-influenza complications indicate that the Kan Jang phytopreparation not only contributes to quicker recovery, but also reduces the risk of post-influenza complications. Kan Jang was well tolerated by patients.     

复方芩兰口服液联合奥司他韦治疗流行性感冒的多中心随机双盲双模拟对照研究

目的 分析复方芩兰口服液联合奥司他韦治疗流行性感冒的多中心随机双盲双模拟对照研究。方法 采用多中心随机、双盲、双模拟对照研究,纳入3个医院门诊或住院部在2021年4月—2023年5月收治的240例流行性感冒患儿,按区组随机化方法并根据1∶1∶1比例原则将所有患者分为3组,即对照1组、对照2组、治疗组,每组各80例。对照1组用温开水冲服磷酸奥司他韦颗粒体,体质量≤15 kg,30 mg/次;体质量16～23 kg,45 mg/次;体质量24～40 kg,60 mg/次;体质量>40 kg,75 mg/次;2次/d;同时服用复方芩兰口服液安慰剂,用法用量同对照2组。对照2组口服复方芩兰口服液,患儿≤1岁,2.5 mL/次;1岁<患儿≤3岁,5 mL/次;3岁<患儿≤7岁,5～10 mL/次;患儿>7岁,10～20 mL/次;3次/d;同时服用磷酸奥司他韦颗粒安慰剂,其用法用量同对照1组。治疗组口服复方芩兰口服液和磷酸奥司他韦颗粒,用法用量与对照1组、2组相同。3组连续治疗1周。观察3组的临床疗效、症状缓解时间。比较3组治疗前后中医症候评分、炎症因子、免疫球蛋白、免疫...     

文拉法辛缓释剂治疗抑郁症的双盲、随机、平行对照、多中心临床研究

目的 :比较文拉法辛缓释剂与氟西汀治疗抑郁症的疗效及安全性。方法 :文拉法辛缓释剂组(文拉法辛组 ) 6 4例 ,年龄为 4 1a±s 13a ,氟西汀组6 3例 ,年龄为 4 2a± 12a。按双盲双模拟法文拉法辛组用量 75m·d- 1,qd或氟西汀组用量 2 0mg·d- 1,qd。共 6wk。疗效评定采用HAMD ,HAMA及CGI。安全性评价应用TESS、实验室检查及体检。结果 :经过 6wk治疗 ,文拉法辛组痊愈率 6 9% ,有效率为 83%。氟西汀组的痊愈率 5 9% ,有效率为 71% ,P >0 .0 5。另外 ,文拉法辛组的抗抑郁作用起效较快 ,对伴随的焦虑症状也有较好疗效。文拉法辛组不良反应轻 ,安全性好 ;常见不良反应有 :恶心、呕吐、口干及出汗等。结论 :文拉法辛缓释剂是一种安全而有效的抗抑郁药 ,病人对药物的耐受性及依从性好     

进口阿莫西林-舒巴坦治疗社区获得性肺炎的多中心随机对照研究

目的 评价进口阿莫西林-舒巴坦(特福猛)治疗轻、中度社区获得性肺炎(CAP)的有效性和安全性.方法 采用随机多中心研究设计.受试组接受特福猛治疗,轻度患者剂量为1.5 g/12 h;中度患者剂量为3.0 g/12 h;对照组接受注射用头孢呋辛钠(西力欣)治疗,轻度患者剂量为1.5 g/12 h;中度患者剂量为1.5g/8 h.各组均为静脉滴注,疗程7～14 d.结果 共327例患者入选,可进行疗效分析的病例共316例.受试组痊愈率和有效率分别为32.9%和88.2%,相应的对照组分别为33.5%和89.0%,两组相比差异无统计学意义(P>0.05).受试组和对照组细菌清除率分别为85.2%和85.5%,两组相比差异无统计学意义(P>0.05).两组药物相关不良反应发生率分别为6.06%和4.93%,组间差异无统计学意义(P>0.05).结论 进口阿莫西林-舒巴坦对轻、中度CAP临床疗效较好,使用安全,有较高的临床应用价值.     

美金刚治疗阿尔茨海默病的随机双盲对照试验

目的评估盐酸美金刚治疗阿尔茨海默病(AD)的疗效与安全性。方法采用随机、双盲双模拟、阳性药对照、剂量可调整的研究方法,58例AD患者随机分为2组,试验组予盐酸美金刚5~20 mg,po,qd,对照组予盐酸多奈哌齐片5~10 mg,po,qd,共16 wk。采用简易智能状态检查量表(MMSE)、日常生活能力量表(ADL)、临床疗效总评量表(CGI)总体疗效指标评估临床疗效,以不良反应量表(TESS)评估不良反应情况,每4 wk随访一次。结果2组MMSE总评分均有一定程度提高,在12、16 wk后与基线相比差异均有高度统计学意义(P<0.01),2组MMSE加分比较,差异无统计学意义(P>0.05)。2组CGI总体疗效差异无统计学意义(P>0.05)。2组ADL总评分治疗前后自身比较,差异无统计学意义(P>0.05)。试验组1例(3.4%)出现头晕,对照组6例(20.7%)出现不良反应,主要表现是胃肠道反应与兴奋。试验组的不良反应发生率低于对照组(P<0.05)。结论美金刚能一定程度改善或稳定AD患者的认知功能,疗效与多奈哌齐相当,不良反应发生率低,安全性较好。     

阿立哌唑治疗精神分裂症的多中心随机双盲对照试验

目的:评价阿立哌唑治疗精神分裂症的疗效及安全性。方法:采用多中心随机双盲双模拟、阳性药平行对照的方法。以利司哌酮(昔名利培酮)为对照,受试者分别口服阿立哌唑10~30 mg.d-1与利司哌酮2~6 mg.d-1,疗程42 d。结果:共收集精神分裂症病人222例,其中阿立哌唑组111例与利司哌酮组111例。治疗结束时,2组PANSS总分与BPRS总分较治疗前均显著降低(P<0.01);PANSS总分减分率阿立哌唑组(65±s28)%,利司哌酮组为(67±26)%,差异无显著意义(P>0.05)。临床总有效率:阿立哌唑组为77.0%,利司哌酮组为79.2%,2组比较差异无显著意义(P>0.05)。阿立哌唑组常见的不良反应为:静坐不能、震颤、失眠、心动过速,不良反应较利司哌酮组少。结论:阿立哌唑治疗精神分裂症的疗效与利司哌酮相似,不良反应较利司哌酮为少,是一种安全而有效的抗精神病药。     

乙氧苯柳胺软膏治疗慢性湿疹的随机对照临床试验

目的：研究乙氧苯柳胺软膏治疗慢性湿疹的疗效和安全性。方法：６０ 例慢性湿疹病人,３０ 例（ 男性２３ 例,女性７ 例;年龄５０ ａ ±ｓ １５ ａ） 用乙氧苯柳胺软膏均匀涂布患处,ｔｉｄ , ４ ｗｋ 为一个疗程;另３０例（ 男性２４ 例,女性６ 例,年龄４４ ａ ±１４ ａ） 采用乙氧苯柳胺软膏基质（ 基质） 均匀涂敷患处,ｔｉｄ ,４ ｗｋ 为一个疗程。结果：乙氧苯柳胺胺膏２ ｗ ｋ 和４ ｗｋ 时的总有效率分别为２０ ％ 和６３ ％ ,基质的总有效率分别为１０ ％ 和１４ ％ 。乙氧苯柳胺软膏的不良反应发生率为７ ％ ,基质为３ ％ 。结论：乙氧苯柳胺软膏治疗慢性湿疹有效,不良反应发生率与基质无明显差异。     

Pilot randomized, controlled trial of pramipexole to augment antipsychotic treatment

The preferential dopamine D(3)-agonist pramipexole (4.25±0.38 mg/day) or placebo were added for up to 12 weeks to ongoing antipsychotic treatment for 24 adult patients with DSM-IV schizophrenia or schizoaffective disorder. Pramipexole was generally well-tolerated (82% trial-completion), and yielded greater decreases in PANSS-total scores (drug/placebo=2.1; p=0.04), with similar decreases in PANSS positive and negative scores and 6.7-fold greater reduction of serum prolactin concentrations compared to placebo. There were no differences in ratings of mood, cognition or extrapyramidal symptoms, all of which were low at intake.     

Loxapine versus perphenazine in psychotic patients. A double-blind,randomized, multicentre trial

Summary

A double-blind, randomized, multicentre trial was carried out in 47 psychotic patients to evaluate the efficacy of oral treatment with loxapine compared with perphenazine. In total, 22 patients were included in diagnostic Group I (cases of acute schizophrenia and psychogenic (reactive) psychoses). The average maximum daily dose was 60.0?mg in the loxapine group and 36.8?mg in the perphenazine group. After 3-weeks' treatment, no significant differences were found between the two treatment groups according to the Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression (CGI) Scale or side-effect records. Twenty-five patients were included in diagnostic Group II (cases of chronic schizophrenia). The average daily dosage was 81.1?mg in the loxapine group and 90.1?mg in the perphenazine group. After 10 to 12-weeks' treatment, no significant differences between the two treatment groups could be found according to BPRS, CGI scale, Nurses' Observation Scale for In-patient Evaluation (NOSIE) or side-effect records. The diastolic blood pressure (lying and standing) tended to increase slightly in both treatment groups. In conclusion, it was found that loxapine and perphenazine seemed to be equally effective and, based on experience with parenteral loxapine treatment, it is suggested that further investigation of oral loxapine should be carried out in psychotic patients in whom agitation is a feature.     

头孢美唑钠注射剂治疗呼吸系统感染的随机、双盲、多中心临床试验

目的 评价国产注射用头孢美唑钠治疗中、重度呼吸系统细菌性感染的临床疗效和安全性。方法采用双盲、随机对照、多中心试验设计，以进121头孢美唑钠为对照药物。两组均为每次静脉滴注给药2．0g，q12h。疗程均为5～12d。结果 本次试验共入选病例144例，两组各为72例。可纳入临床疗效ITT分析和PP分析的病例数，试验组分别为70例和66例；对照组分别为67例和65例。治疗结束时试验组和对照组总的临床有效率分别为78．79％和81.54％，两组细菌清除率分别为91．67％和85．71％，不良反应发生率分别为5．56％和8．33％。以上结果经统计学处理均无显著性差异。结论 国产头孢美唑钠注射剂治疗敏感细菌引起的中、重度呼吸道感染的临床疗效确切，安全性好。     

Paroxetine treatment of pathological gambling: a multi-centre randomized controlled trial

Previous studies have suggested the efficacy of serotonergic agents in the treatment of pathological gambling. The aim of the present study was to determine whether treatment with paroxetine in a large sample of subjects with pathological gambling would effectively diminish the severity of gambling symptoms. A 16-week, double-blind, placebo-controlled trial was conducted at five outpatient academic research centres in two countries (USA and Spain). Seventy-six outpatients (mean age 45.4+/-10.6 years; 30 women, 46 men) with pathological gambling were randomized to acute treatment with paroxetine in flexible daily dosages of 10-60 mg/day (n=36) or placebo (n=40). The primary outcome measure was the Clinical Global Impressions scale. Both the paroxetine- and the placebo-treated groups demonstrated comparable improvement at 16 weeks (59% response rate in the paroxetine group, 49% rate in the placebo group; chi squared=0.737; d.f.=1; P=0.390). Paroxetine consistently resulted in a greater percentage of responders at each study visit compared to placebo but failed to demonstrate statistical superiority to placebo on scores on the Clinical Global Impressions scale, the Yale-Brown Obsessive-Compulsive Scale Modified for Pathological Gambling, or the Gambling Symptom Assessment Scale. High rates of symptom improvement were observed in pathological gamblers receiving either paroxetine or placebo after 16 weeks. Paroxetine consistently demonstrated an advantage over placebo on the Clinical Global Impressions scale; however, a larger sample size may have registered significant differences.