头孢唑肟注射剂治疗下呼吸道和尿路感染单盲、随机对照、多中心临床研究

目的评价抗菌新药头孢唑肟注射剂治疗下呼吸道和尿路感染的疗效和安全性。方法采用前瞻性、单盲、随机对照方法,进行新药头孢唑肟注射剂的多中心临床试验。选择下呼吸道和尿路感染患者,试验组使用头孢唑肟注射剂(重庆西南合成制药股份有限公司研制),对照组使用哈药集团制药总厂生产的头孢唑肟注射剂,剂量均为每次1~2g,每8~12小时静脉滴注1次。疗程7~14d。结果本研究共入选病例255例,最终完成试验者243例,其中试验组122例,对照组121例,两组的有效率分别为95.08%和95.87%。其中肺炎试验组49例,有效率100%;对照组49例,有效率97.96%。慢性支气管炎急性细菌感染试验组14例,对照组12例,有效率均为100%。急性肾盂肾炎试验组40例,有效率97.50%;对照组39例,有效率97.43%。复杂性尿路感染试验组17例,有效率76.47%;对照组18例,有效率83.33%。反复发作性上尿路感染试验组2例,治愈及复发各1例;对照组3例,治愈2例,显效1例。两组疗效差异无统计学意义。本研究病例中,可行微生物评价者共166例,其中试验组81例,对照组85例,共获病原菌82株及86株,经治疗后试验组的细菌清除率...     

比阿培南治疗细菌性肺炎和尿路感染的多中心随机对照临床试验

目的评价比阿培南治疗细菌性肺炎和尿路感染的疗效和安全性。方法本研究为多中心、开放、随机对照试验,细菌性肺炎和尿路感染患者分别按中心分层随机接受比阿培南或美罗培南治疗。结果①比阿培南组和美罗培南组有效率分别为87.0%(107/123)和90.1%(109/121),其中两组细菌性肺炎有效率分别为90.0%(63/70)和91.9%(57/62),尿路感染有效率分别为83.0%(44/53)和88.1%(52/59);②两组细菌清除率分别为96.3%(77/80)和98.8%(79/80),其中肺炎细菌清除率分别为100%(42/42)和100%(39/39),尿路感染细菌清除率分别为92.1%(35/38)和97.6%(40/41);③两组不良反应发生率分别为4.7%(6/129)和3.1%(4/128),药物相关实验室异常发生率分别为17.1%(22/129)和19.5%(25/128),分别有2例(1.6%)和4例(3.1%)因不良反应终止治疗。经统计学分析两组的有效率、细菌清除率和不良反应发生率差异均无统计学意义。结论比阿培南治疗细菌性肺炎和尿路感染疗效确切,患者耐受性良好,其临床和细菌学疗效以及不良反应发生率均与对照药美罗培南相仿。     

Homeopathic care for the prevention of upper respiratory tract infections in children: a pragmatic, randomised, controlled trial comparing individualised homeopathic care and waiting-list controls

OBJECTIVE: To investigate whether individualised treatment by homeopaths is effective in preventing childhood upper respiratory tract infection (URTI). METHODS: Open, pragmatic, randomised parallel-group trial with waiting-list group as control. One hundred and sixty-nine children below the age of 10 years, recruited by post from children previously diagnosed with URTI, were randomly assigned to receive either pragmatic homeopathic care from one of five homeopaths for 12 weeks or to a waiting-list control using self-selected, conventional health care. RESULT: There was a significant difference in median total symptom score in favour of homeopathic care (24 points) compared to the control group (44 points) (p = 0.026). The difference in the median number of days with URTI symptoms was statistically significant with 8 days in the homeopathic group and 13 days in the control group (p = 0.006). There was no statistical difference in the use of conventional medication or care between the two groups. CONCLUSION: In this study, there was a clinically relevant effect of individualised homeopathic care in the prevention of URTI in children.     

地红霉素治疗急性细菌性呼吸道感染142例多中心随机对照临床研究

目的评价地红霉素片治疗急性细菌性呼吸道感染的疗效和安全性。方法采用多中心、随机、双盲、双模拟和平行对照临床研究方法，将确诊为急性呼吸道感染的患随机分为2组。试验组口服地红霉素片，500mg每日1次，疗程7d；对照组口服阿奇霉素片，500mg，每日1次，疗程5d。结果地红霉素组69例，有效率为88．4％(61／69)，痊愈率为33．3％(23／69)；阿奇霉素组73例，有效率为86．3％(63／73)，痊愈率为39．7％(29／73)；2组细菌清除率分别为85．1％(40／47)和90．7％(49／54)；不良反应发生率分别为14．5％(10／69)和5．5％(4／73)，以上指标2组之间统计学处理差异无显性。结论地红霉素片可以安全有效地用于治疗急性细菌性呼吸道感染。     

注射用头孢唑肟钠治疗细菌性感染的多中心随机对照临床研究

目的评价国产注射用头孢唑肟钠治疗呼吸系统及泌尿系统细菌性感染的l临床疗效和安全性。方法采用多中心、随机、盲法、平行对照试验设计，选择呼吸系统和泌尿系统细菌性感染患者，试验组（A组）应用国产注射用头孢唑肟钠，对照组（B组）应用进口注射用头孢唑肟钠（商品名益保世灵），用法均为2．0g，静脉滴注，每12小时1次；下呼吸道感染疗程为7～14d，泌尿系统感染为5～14d。结果本研究共入选病例144例，其中下呼吸道感染和泌尿系统感染各72例。A、B两组基本临床特征差异无统计学意义，资料具有可比性。疗效分析显示．A组与B组的痊愈率分别为81．9％和63．9％，总有效率分别为98．6％和98．6％，两组差异无统计学意义（P〉0．05）。A、B两组细菌清除率分别为100％和98．4％（P〉0．05）。本研究两组不良反应发生率均较低（2．8％与2．8％，P〉0．05），未见严重不良反应。结论国产注射用头孢唑肟钠对临床常见致病菌引起的下呼吸道、泌尿系统感染，临床疗效较好而不良反应发生率低，有较高的临床应用价值。     

Effects and cost of glycyrrhizin in the treatment of upper respiratory tract infections in members of the Japanese maritime self-defense force: Preliminary report of a prospective, randomized, double-blind, controlled, parallel-group, alternate-day treatment assignment clinical trial

Background: Upper respiratory tract infections (URTIs) account for at least half of all acute illnesses. Specific antiviral therapy has not been developed against most respiratory viruses thought to cause URTIs. The pharmacologic action of glycyrrhizin has been shown to produce anti-inflammatory activity, modulation of the immune system, inhibition of virus growth, and inactivation of viruses.Objective: The aim of this study was to assess the tolerability, efficacy, and cost of glycyrrhizin in improving the severity and duration of signs and symptoms of URTIs. The primary end point was tolerability, and the secondary and points included improvement in signs and symptoms of URTI and cost.Methods: Members of the Japanese Maritime Self-Defense Force (SDF) treated for URTIs from January 2002 to May 2002 in the SDF Etajima Hospital (Hiroshima, Japan) were eligible for this prospective, randomized, double-blind, controlled, parallel-group, alternate-day treatment assignment study. All patients in this study fulfilled the following enrollment criteria: admitted to the hospital on the first arrival day as an outpatient; fever (body temperature <38.0°C) with signs and symptoms of URTI (headache, sore throat, rhinorrhea, pharyngitis); and had not received antibiotics or oseltamivir phosphate for 4 weeks before the study. Patients who were admitted on an even day received an IV drip infusion of 40 mL of glycyrrhizin (0.2%) and 500 mL of lactated Ringer's solution daily during hospitalization (glycyrrhizin group). Patients who were admitted on an odd day received an IV drip infusion of 500 mL/d of lactated Ringer's solution only (control group). Adverse effects were assessed by the physicians during hospitalization, using patient interview and laboratory analysis.Results: Forty-one consecutive patients entered the study; 15 patients (15 men, 0 women; mean [SD] age, 25.2 [1.5] years) were assigned to the glycyrrhizin group and 269 patients (24 men, 2 women; mean [SD] age, 22.6 [0.9] years) were assigned to the control group. The 2 groups were similar in terms of baseline characteristics. The mean duration of hospitalization was shorter (P = 0.01), the mean maximum body temperature 24 to 48 hours after admission was less (P = 0.05), and the cost of therapy (P = 0.03) was less in the glycyrrhizin group than the control group. No AEs were reported.Conclusions: In this study of hospitalized patients with URTIs, glycyrrhizin therapy was associated with a shorter hospitalization, lower-grade fever, and lower cost of therapy compared with controls, showing that it may be beneficial to patients with URTIs without acute bacterial infections.     

Inhibitory effects of Cheongsangbangpoong-tang on both inflammatory acne lesion and facial heat in patients with acne vulgaris: A double-blinded randomized controlled trial

ObjectivesTo investigate the inhibitory effects of an herbal formulation of Cheongsangbangpoong-tang (CBT) on inflammatory acne lesions as the control of the ‘Heat’ pattern.DesignA single center study. Randomized, placebo-controlled, parallel group, double-blind trialSettingFifty-six subjects, who had more than 10 acne inflammatory lesions each, were randomly allocated into the CBT or placebo groups and took 5 g CBT extract (CBT group) or 5 g placebo extract (control group), respectively, three times a day for 8 weeks. Pattern identification, change of the inflammatory and non-inflammatory acne lesions, temperature of the facial points, serum cortisol level, serum dehydroepiandrosterone-sulfate level, number rating scale, investigator global assessment (IGA), and severity score on the Korean acne grading system were measured.Main outcome measuremean change of the inflammatory acne lesions.ResultsAfter CBT/placebo administration, the percentage count of inflammatory lesions in subjects was significantly reduced in the CBT group when compared with the control group. The other outcomes showed no significant difference between the two groups. On pattern identification, subjects with the Wind-Heat pattern (風熱型, WHP) and Disharmony of the thoroughfare and conception vessels pattern (衝任不調型, DTCVP) tended show better effect than those with other patterns.ConclusionsCBT is a potential therapeutic agent for the treatment of acne vulgaris, linked to inhibition of inflammatory lesions and facial heat.Trial registrationCRiS (Clinical Research Information Service, Republic of Korea), KCT0001468. Registered 06 May 2015.     

头孢克洛和阿莫西林-克拉维酸治疗小儿急性细菌性下呼吸道感染的随机对照研究

目的 对比研究头孢克洛混悬剂和阿莫西林-克拉维酸（4：1）干糖浆治疗小儿急性细菌性下呼吸道感染的疗效及安全性。方法采用前瞻性、随机平行对照、单盲（研究者设盲）、多中心的研究方法，于2001年9月至2002年9月间将确诊急性细菌性下呼吸道感染患儿220例，随机分入口服头孢克洛混悬剂组110例和口服阿莫西林-克拉维酸（4：1）干糖浆组110例，疗程10d。观察临床疗效、细菌清除率和不良反应等。结果220例患儿，其中急性支气管炎135例（头孢克洛组65例，阿莫西林-克拉维酸组70例），急性肺炎85例（头孢克洛组45例，阿莫西林-克拉维酸组40例），两组均有良好治疗反应，各临床征象明显改善，头孢克洛组总有效率85．5％（95％CI78．9％～92．0％），阿莫西林-克拉维酸组82、7％（95％CI75．7％～89．8％），两组比较P=0．580。细菌总阳性率55．9％，前3位细菌为流感嗜血杆菌、肺炎链球菌和卡他莫拉菌，治疗后细菌清除率头孢克洛组70．7％，阿莫西林-克拉维酸组70．8％，Fisher精确检验P=1．000。服药顺应性头孢克洛组95．0％，阿莫西林-克拉维酸组90．8％，不良反应有恶心、呕吐（两组分别为1．8％，2．7％），腹痛（2．7％，3．6％），腹泻（6．4％，9．1％），组间差异均无显著性（P〉0．05）。结论头孢克洛混悬剂和阿莫西林-克拉维酸干糖浆治疗小儿急性细菌性下呼吸道感染依然有效和安全。     

左氧氟沙星与头孢曲松联合阿奇霉素治疗社区获得性下呼吸道感染的对照研究

目的比较左氧氟沙星注射液与头孢曲松注射液＋口服阿奇霉素在治疗社区获得性下呼吸道感染中的疗效和安全性。方法采用随机、开放、对照研究，共入选88例患者，其中试验组43例，接受左氧氟沙星治疗，500mg每日1次静脉滴注；对照组45例，接受头孢曲松＋阿奇霉素治疗，头孢曲松2g每日1次静脉滴注，阿奇霉素口服，每日0．25g（首次0．5g）。治疗7～10d后评价临床和细菌学疗效。结果左氧氟沙星组的总有效率为86．0%，头孢曲松＋口服阿奇霉素组为84．4％；试验组细菌清除率为93．3％，对照组为92．9％，差异均无显著性（P〉0．05）。两组患者中发现非典型病原体感染共12例，其中5例为肺炎支原体，4例为肺炎衣原体，3例为嗜肺军团菌。所有12例非典型病原体感染患者均痊愈。患者对左氧氟沙星和头孢曲松＋口服阿奇霉素均有良好的耐受性。结论左氧氟沙星和头孢曲松＋口服阿奇霉素都可以作为治疗社区获得性下呼吸道感染的有效、安全的药物。     

Andrographis paniculata in the symptomatic treatment of uncomplicated upper respiratory tract infection: systematic review of randomized controlled trials

OBJECTIVE: To assess the efficacy of Andrographis paniculata in the symptomatic treatment of uncomplicated upper respiratory tract infection. METHODS: Systematic review of the literature and meta-analysis of randomized controlled trials. Mean difference in the reduction in symptom severity scores between treatment and control groups was calculated to obtain an overall estimate of effect. RESULTS: Four studies met our inclusion criteria and were reviewed. A total of 433 patients reported in three trials were included in the statistical analysis. Andrographis paniculata fixed combination with Acanthopanax senticosus was more effective than placebo. The mean difference was 2.13 points (95% CI 1.00-3.26 points, P=0.0002) on the symptom severity score. The difference in effects between A. paniculata and placebo was 10.85 points (95% CI 10.36-11.34 points, P<0.0001) in favour of A. paniculata. CONCLUSION: Current evidence suggests that A. paniculata extract alone or in combination with A. senticosus extract may be more effective than placebo and may be an appropriate alternative treatment of uncomplicated acute upper respiratory tract infection.     

司帕沙星注射液与氧氟沙星注射液治疗急性呼吸道感染的随机对照试验

目的评价司帕沙星注射液治疗急性中、重度呼吸道感染的有效性与安全性.方法采用多中心随机对照试验.试验药司帕沙星每次200mg,静脉滴注,每日一次;对照药氧氟沙星每次200mg,静脉滴注,每日二次,疗程均为7-14天.试验组和对照组各30例.结果两组的治愈率分别为33.33%与26.67%,有效率分别是80.00%与76.67%.细菌清除率分别是89.66%与89.29%.药物不良反应发生率分别是13.33%与16.67%.本组病例未见光敏反应.以上结果经统计学处理差异均无统计学意义(P＞0.05).结论司帕沙星注射液是治疗急性呼吸道感染的一种有效药物.     

口服加替沙星与左氧氟沙星治疗下呼吸道和尿路感染的前瞻性多中心随机对照研究

目的：评价加替沙星片治疗下呼吸道感染及尿路感染的疗效与安全性。方法：以左氧氟沙星片为对照药，在248例下呼吸道和尿路感染中进行疗效和安全性的多中心随机对照观察。加替沙星组125例，其中下呼吸道感染50例，尿路感染75例；左氧氟沙星组123例，其中下呼吸道感染54例，尿路感染69例。给药方案分别为治疗下呼吸道感染加替沙星片400mg1次／d口服，左氧氟沙星片200mg2次／d口服，疗程均为7—14d；肾盂肾炎、复杂性尿路感染及反复发作性尿路感染加替沙星片400mg1次／d口服，左氧氟沙星200mg2次／d口服，疗程均为7—14dl急性单纯性下尿路感染加替沙星片200mg1次／d口服，左氧氟沙星片100mg2次／d口服，疗程均为5d。结果：加替沙星组125例和左氧氟沙星组123例的临床有效率分别为95．2％(119／125)和91．9％(113／123)，临床痊愈率分别为68．8％(86／125)和63．4％(78／123)；细菌清除率分别为89．3％(100／112)和89．5％(94／105)；不良反应发生率分别为25．3％(40／158)和18．6％(30／161)，实验室检查异常发生率为14．7％(22／150)和15．8％(24／152)。上述结果经统计学处理，差异均无显性。结论：本研究结果显示加替沙星片治疗下呼吸道及尿路感染的疗效和安全性与左氧氟沙星片相仿。     

Effectiveness and safety of electrical moxibustion for knee osteoarthritis: A multicenter,randomized, assessor-blinded,parallel-group clinical trial

BackgroundThe prevalence of knee osteoarthritis (KOA) is increasing, and it has emerged as a major health issue. Studies have been reported that moxibustion is effective for treating KOA, but conventional moxibustion is difficult to control the intensity of stimulation and causes smoke, harmful gases, or odors. An electrical moxibustion (EM) device was developed to solve these problems, so we conducted this study to evaluate the effectiveness and safety of EM as a treatment for KOA.MethodsThis is a multicenter, randomized, assessor-blinded, parallel-group clinical trial. Participants with KOA were randomly allocated into EM, traditional indirect moxibustion (TIM), or usual care groups. The moxibustion groups were received 12 sessions of moxibustion treatment at six acupuncture points (ST36, ST35, ST34, SP9, EX-LE4, SP10) over a period of 6 weeks. The usual care group was received usual treatment and self-care. The primary outcome was the degree of pain measured by numerical rating scale (NRS). The second outcomes were measured using visual analog scale, Korean version of the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life five dimension five level scale, and warm sense threshold and heat pain threshold. For safety assessment, laboratory test and adverse events (AEs) were recorded.ResultsA total of 138 participants were assigned. While there was no significant NRS change in the usual care, EM and TIM showed significant decrease after treatment. Compared to the usual care, the mean change of NRS in the EM and TIM was significantly different, but there was no significance between two groups. Regarding secondary outcomes, EM and TIM also showed significant difference compared to the usual care, but there was no significance between two groups. Regarding safety assessment, while usual care showed significant safety among three groups, EM showed seven treatment-related AEs by four participants compared TIM’s 10 events by 10 participants. In addition, there was no blister caused by burns in the EM, which occurred four cases in the TIM.ConclusionThis study shows that EM is effective to improve the pain and function by KOA with a certain level of safety.     

Flavonoid-containing supplements for preventing acute respiratory tract infections: A systematic review and meta-analysis of 20 randomized controlled trials

BackgroundThis systematic review and meta-analysis was conducted to investigate the efficacy and safety of flavonoid-containing supplements in preventing acute respiratory tract infection (ARTI).MethodsRandomized controlled trials (RCTs) investigating the effects of flavonoid-containing supplements on ARTI prevention in the aspects of ARTI incidence, mean ARTI sick days, symptoms, bio-immune markers, and adverse effects were searched in 5 databases. Data were searched from inception to November 26, 2021. Stata 16.0 was used to perform the meta-analysis.ResultsTwenty RCTs (n = 4521) were included in this systematic review and meta-analysis. Pooled results showed that in the flavonoid-containing supplement group, the ARTI incidence and mean ARTI sick days were significantly decreased compared to those in the control group (RR = 0.81, 95% CI: 0.74–0.89, p < 0.001; WMD = −0.56, 95% CI: −1.04 to −0.08, p = 0.021; respectively). In 8 RCTs, flavonoids were singly used for interventions, ARTI incidence in the experimental group significantly decreased compared to that in the control group (RR = 0.85, 95% CI: 0.72–1.00, p = 0.047). In ten RCTs, flavonoid-containing mixtures were applied for interventions, and ARTI incidence in the experimental group significantly decreased compared to that in the control group (RR = 0.79, 95% CI: 0.71–0.89, p < 0.001). Furthermore, the ARTI incidence and mean ARTI sick days were significantly decreased in the experimental group compared to those in the control group in the flavan-3-ols subgroup (RR = 0.79, 95% CI: 0.67–0.92, p = 0.002; WMD = −2.75, 95% CI: −4.30 to −1.21, p < 0.001; respectively) and the multiple subclasses subgroup (RR = 0.75, 95% CI: 0.63–0.88, p = 0.001; WMD = −0.56, 95% CI: −1.11 to −0.01, p = 0.046; respectively). However, the bio-immune markers including interleukin-6, hypersensitive-c-reactive-protein, tumor necrosis factor-α, and interferon-γ did not differ between the flavonoid group and the control group. Moreover, in the flavonoid-containing supplement group, the incidence of adverse reactions did not increase compared to that in the control group (RR = 1.16, 95% CI: 0.78–1.73, p = 0.469).ConclusionsThis systematic review and meta-analysis showed that flavonoid-containing supplements were efficacious and safe in preventing ARTIs. The most important limitations result from the small number of trials, poor quality of some included RCTs, differences in the composition and types of interventions, principal subclasses of flavonoids, methods of administration, and methodology. Moreover, only a few RCTs conducted independent verification of the flavonoid supplements used in the trial in terms of purity and potency, which may lead to a potential source of bias. Thus, larger and better-designed studies are needed to further verify this conclusion.     

双解胶囊(片剂)治疗急性上呼吸道感染(风温病热在肺卫证)的多中心双盲双模拟随机对照临床试验

目的观察双解胶囊(片剂)治疗急性上呼吸道感染(风温病热在肺卫证) 的疗效．并对其安全性作出评价。方法采用多中心随机双盲双模拟阳性药物平行对照临床试验方法,对急性上呼吸道感染(风温病热在肺卫证)患者770例,按3:3:1比例随机分为双解胶囊组(胶囊组)330例,双解片剂组(片剂组)330例,及柴黄片组(对照组)110例。胶囊组给予双解胶囊,片剂组给予双解片,对照组给予柴黄片,均每次3粒(片),每日3次。疗程均为5天。结果纳入患者770例,随机化763例,剔除28例,脱落17例,最终进入意向治疗(ITT)分析724例,符合方案集分析(PPS)718例。其中上呼吸道感染疗效:ITT分析显示胶囊组愈显率83．60％,总有效率98．39％;片剂组分别为 83．28％,99．04％;对照组分别为68．62％,98．04％。PPS分析显示胶囊组愈显率84．69％,总有效率99．02％;片剂组分别为83．22％,99．03％;对照组分别为 69．30％,99．01％。试验组(胶囊、片剂)疾病疗效优于对照组(P<0．05), ITT分析与PPS分析结果一致。中医证候疗效:ITT分析显示胶囊组愈显率 83．92％,总有效率98．07％;片剂组分别为83．92％,99．36％;对照组分别为 74．51％,98．04％。PPS分析显示胶囊组愈显率85．02％,总有效率98．70％;片剂组分别为83．87％,99．35％;对照组分别为75．24％,98．02％。试验组(胶囊、片剂)中医证候疗效优于对照组(P<0．05),ITT分析与PPS分析结果一致。观察中未发现明显不良反应。结论双解胶囊(片剂)治疗急性上呼吸道感染(风温病热在肺卫证)的疗效确切,未发现明显毒副作用。     

A randomized controlled feasibility trial comparing safety and effectiveness of prehospital pacing versus conventional treatment: 'PrePACE'

OBJECTIVE: To evaluate the feasibility of a prehospital randomized controlled trial comparing transcutaneous pacing (TCP) with dopamine for unstable bradycardia. METHODS: Unstable bradycardic patients who failed to respond to a fluid bolus and up to 3mg atropine were enrolled. The intervention was dopamine or TCP with crossover to dopamine if TCP failed. The primary outcome was survival to discharge or 30 days. Randomization compliance, safety, follow-up rates, primary outcome, and sample size requirements were assessed. RESULTS: Of 383 patients with unstable bradycardia, 151 (39%) failed to respond to atropine or fluid and were eligible for enrollment and 82 (55%) were correctly enrolled. Fifty-five (36%) of eligible patients could not be enrolled for practical reasons; 3 had advance directives, 32 met inclusion criteria on arrival at hospital and in 20 cases, paramedics chose not to enroll based on the circumstances of the case. The remaining 13 were missed cases; 8 were missing randomization envelopes and in 5, the paramedic forgot. Randomization compliance was 95% (78/82). Forty-two (51%) patients were randomized to TCP and seven of these crossed over to dopamine. Two cases were randomized but did not receive the intervention; either due to lack of time or loss of IV access. Three adverse events occurred in each group. Survival to discharge or 30 days in hospital was 70% (28/40) and 69% (29/42) in the dopamine and TCP groups, respectively with 100% follow up. To detect a 10% relative difference in 30 days survival between treatment arms, a sample size of 690 per group would be required. CONCLUSIONS: It is feasible to conduct a prehospital randomized controlled trial of TCP for unstable bradycardia and a definitive trial would require a multi-centre study.     

帕珠沙星治疗急性泌尿系统感染的多中心随机对照临床研究

目的评价国产帕珠沙星注射液治疗急性泌尿系统感染的疗效和安全性。方法采用多中心、单盲、区组随机、平行对照试验设计，以左氧氟沙星注射液为对照药，帕珠沙星每次静滴300mg，左氧氟沙星每次静滴200mg，两药均每日用药2次，疗程7～10d。结果本研究共纳入117例，帕珠沙星组和左氧氟沙星组分别为58例和59例，其中帕珠沙星组1例因细菌培养为耐药大肠埃希菌生长而剔除，故两组进行全分析集（FAS）和符合方案分析集（PPS）分析的病例数均分别为57例和59例。疗程结束时帕珠沙星组与左氧氟沙星组的痊愈率和有效率分别为71．9％与67．8％和93．0％与83．1％，细菌清除率和阴转率均分别为97．6％与93．8％，两组比较差异无显著性。帕珠沙星组和左氧氟沙星组的不良反应发生率分别为12．1％和15．3％，差异无显著性，均主要表现为恶心、腹泻、局部刺激及血清转氨酶增高等。两组均未见严重不良事件发生。结论国产帕珠沙星注射液与左氧氟沙星注射液治疗泌尿系统中、重度急性细菌性感染均疗效确切，安全性较好。     

Effects of motion style acupuncture treatment in acute low back pain patients with severe disability: A multicenter,randomized, controlled,comparative effectiveness trial

Reviews of the efficacy of acupuncture as a treatment for acute low back pain (aLBP) have shown that there is insufficient evidence for its effect and that more research is needed. Motion style acupuncture treatment (MSAT) is novel in that it requires a part of the patient’s body to move passively or actively while acupuncture needles are retained. A multicenter, randomized, comparative effectiveness trial was conducted to evaluate the effects of MSAT in aLBP with severe disability. A total of 58 aLBP patients with severe functional disability (defined per Oswestry Disability Index [ODI] ?60%) were recruited and assigned randomly to receive 1 session of either conventional diclofenac injection (n = 29) or MSAT (n = 29). The primary outcome measured improvement in LBP using the 10-point numerical rating scale of LBP, and the secondary outcome assessed disability using the Oswestry Disability Index at 30 minutes and at 2, 4, and 24 weeks after treatment. Analyses were by intention to treat. The numerical rating scale of the MSAT group decreased 3.12 (95% confidence interval = 2.26, 3.98; P < .0001) more than that of the injection group and the Oswestry Disability Index of the MSAT group decreased 32.95% (95% confidence interval = 26.88, 39.03; P < .0001) more than that of the injection group, respectively. The difference between the 2 groups maintained statistical significance at 2 and 4 weeks after treatment. These results suggest that MSAT has positive effects on immediate pain relief and the functional recovery of aLBP patients with severe disability.