Objective To assess the effectiveness and safety of Shuangjie Capsule (Piece) in the treatment of acute upper respiratory tract infection. Methods The multiple center, double-blinded, double-dummy and randomized controlled method was adopted to observe 770 patients who were divided into the treatment group A (n=330, treated with Shuangjie Capsule 3 pieces tid), treatment group B (n=330, treated with Shuangjie Piece 3 pieces tid) and the control group (n=110, treated with Chaihuang Piece 3 pieces tid). The therapeutic course for three groups was 5 days. Results Among 770 included patients, 724 and 718 were screened for intention to treat (ITT) and per-protocol population set (PPS) analysis, respectively. For the effectiveness on upper respiratory tract infection, in treatment group A, the markedly effective rate were 83.60% (ITT) and 84.69% (PPS) respectively, and effective rate were 98.39% (ITT) and 99.02% (PPS) respectively; in treatment group B, the markedly effective rate were 83.28% (ITT) and 83.22% (PPS) respectively, and effective rate were 99.04% (ITT) and 99.03% (PPS) respectively; while in the control group the markedly effective rate were 68.62% and 69.30% respectively, and effective rate were 98.04% and 99.01% respectively. The effectiveness of treatment group were significantly better than that of control group (Plt;0.05). For effects on TCM syndrome, in treatment group A, the markedly effective rate were 83.92% (ITT) and 85.02% (PPS), and effective rate were 98.07% (ITT) and 98.70% (PPS); in treatment group B, the markedly effective rate were 83.92% (ITT) and 83.87% (PPS), and effective rate were 99.36% (ITT) and 99.35% (PPS); while in the control group the markedly effective rate were 74.51% (ITT) and 75.24% (PPS), and effective rate was 98.04% (ITT) and 98.02% (PPS). It also showed a statistical significance between treatment and control group (Plt;0.05). ITT and PP analysis have the same results. No major adverse effect was found in the observation.Conclusion Shuangjie Capsule (Piece) shows a definite effect with no obvious toxic-adverse effects.
Objective To evaluate the therapeutic effect, safty and tolerance of Gankeshuangqing Capsule in the treatment of patients suffering from wind-heat syndrome (acute upper respiratory infection or acute bronchitis). Methods The clinical trials were designed multicentered, double blind, double dummy, randomized and parallel positive drug controlled. A total of 289 patients participated in the trials. Those who suffered from acute upper respiratory infection were given throat virus-detection to make a definite diagnosis of the origins of disease. Results Among the 40 patients who were diagnosed with virus infection, 81.82% in Gankeshuangqing group were healed, but only 50.00% in control group, and significant differences were observed between the two groups (Plt;0.05). At the end of the third day of treatment, the rates of cure and excellence in patients suffering from acute upper respiratory infection were 80.00% in Gankeshuangqing group, and 68.57% in control group, and both groups showed good therapeutic effect，but there was no significant difference between the two groups (Pgt;0.05). At the end of the seventh day of treatment, the rates of cure and excellence in patients suffering from acute bronchitis were 82.35% in Gankeshuangqing group, and 63.77% in control group, and both groups showed good therapeutic effect, and there were significant differences between the two groups (Plt;0.05)；only one patient in Gankeshuangqing group had constipation during the treatment, but there was no evidence showing that it is caused by Gankeshuangqing. Conclusion The results show that Gankeshuangqing Capsule has a definite effect on wind-heat syndrome (acute upper respiratory infection or acute bronchitis) with good safety.
Objective To evaluate the clinical effect and safety of Gankeshuangqing capsule in the treatment of acute upper respiratory infection (AURI).Methods A total of 144 patients with wind-heat syndrome (acute upper respiratory infection) were recruited and randomized into the Gankeshuangqing group (administered with Gankeshuangqing capsule and symptomatic treatment for 3 days) and the ribavirin group (administered with ribavirin tablets and symptomatic treatment for 3 days). And the severity scores of pathogenetic conditions, efficacy rates and adverse drug reaction were estimated at the end of the experiment. Results A total of 144 patients (72 in the Gankeshuangqing group, 72 in the ribavirin group) were enrolled in this trial, of whom 9 were dropped out (3 from the Gankeshuangqing group, 6 from the ribavirin group) and 11 were excluded (4 from the Gankeshuangqing group, 7 from the ribavirin group). A significant difference was observed in the rates of cure and excellence: 85.51% (59/69) for the Gankeshuangqing group, and 66.67% (44/66) for the ribavirin group, respectively (Plt;0.05) (FAS data set). A significant difference was observed in the rates of cure in fervescence, pharyngodynia and pars nasalis catarrhus symptome: 70.00%, 78.26%, 56.90% in the Gankeshuangqing group, and 40.38%, 51.52%, 36.21% in the ribavirin group, respectively (Plt;0.05) (FAS data set). There was no significant difference in the rates of cure in tussis between the two groups: 32.08% for the Gankeshuangqing group, and 34.00% for the ribavirin group, respectively (Pgt;0.05) (FAS data set). There were 2 adverse drug reactions observed in the ribavirin group, whose white blood cell count was decreased, but in the Gankeshuangqing group, no adverse drug reaction was found. Conclusion The results indicate that Gankeshuangqing Capsule shows a definite effect on wind-heat syndrome (acute upper respiratory infection) with good safety.
The clinical practice guideline on traditional Chinese medicine alone or combined with antibiotics for patients with acute upper respiratory infection in children was issued by China Association of Chinese Medicine in June 2017. Base on the evidence, consensus and experience, five manage groups, steering committee, consensus expert group, systematic review group, drafting group and secretary group, have promoted the project. The main work process refers to up-to-date clinical practice guideline definitions of institute of medicine and quick recommendations guide of guidelines international network and WHO. In order to provide readers with a better understanding of the guideline, the drafting process of guideline principle, main work process, and basis policy were described in detail in this paper. The guidelines’ scientific characteristics, accuracy and practicability were better exhibited in attempt to enhance its promotion and application.
Objective To evaluate and select essential medicine for children with fever and adult gastrointestinal flu caused by common cold using evidence-based approaches based on the burden of disease for township health centers located in eastern, central and western regions of China. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) 12 guidelines were included, 11 of which were evidence-based or based on expert consensus. We offered a recommendation for medicines used in the treatment including analgesics and antipyretics, decongestants, antihistamines, cough-relieving drug, phlegm-removing drug and drug for gastrointestinal symptoms. (2) A result of four RCTs (very low quality) indicated that in the treatment of children with cold, ibuprofen suspension had an antipyretic effect similar to paracetamol solution (for oral use) with a pooled result of 6-hour efficiency in relieving fever (RR 1.48, 95%CI 0.66 to 3.30, P=0.34). The major adverse effects of ibuprofen suspension included gastrointestinal reaction and profuse sweats (RR=1.23, 95%CI 0.72 to 2.11, P=0.45). With good applicability, ibuprofen suspension (for oral use with no need to be supervised) cost 1.93 yuan daily. (3) A result of three RCTs (low quality) indicated that after given for 30 minutes and one hour, paracetamol solution (suppository) was fairly superior to ibuprofen suspension in lowering the high temperature caused by fever (given for 30 min: MD= –0.16°C, 95%CI –0.21 to –0.11, Plt;0.01; given for one hour: MD= –0.19°C, 95%CI –0.28 to 0.10, Plt;0.01). As to adverse reaction, paracetamol solution (suppository) mainly included anal irritation, skin rashes and profuse sweats, which had a comparative result of incidence with ibuprofen suspension (RR=1.84, 95%CI 0.62 to 5.44, P=0.27). For children with fever, paracetamol solution (suppository) cost 0.90 yuan daily. With good applicability, paracetamol solution (suppository) was administered via the anus. Conclusion (1) We offer a b recommendation for ibuprofen suspension (2 g/100 mL) or acetaminophen (0.1 g/suppository) as symptomatic treatment used in children with fever, pain and discomfort caused by common cold, and for Huo Xiang Zheng Qi Jiao Nang (0.3 g/ capsule) used in adults with gastrointestinal flu. We also offer a weak recommendation for acetylcysteine (injection, 300 mg/mL, 10 mL/ampoule) used in patients with paracetamol poisoning. (2) In order to produce high-quality local evidence, we proposed that large-scale, well-designed, high-quality clinical and pharmacoeconomic studies on ibuprofen suspension and acetaminophen suppository in the treatment of children with fever, pain and discomfort caused by common cold should be further carried out. Besides, we proposed that large-scale, well-designed, high-quality clinical and pharmacoeconomic studies on Chinese patent drugs of Huo Xiang Zheng Qi used in chidren and Huo Xiang Zheng Qi Jiao Nang used in adults should further carried out. Moreover, we suggest that epidemiological investigation as well as clinical and pharmacoeconomic studies of acetylcysteine injection for paracetamol poisoning should be carried out and the instructions of acetylcysteine injection should be added in the guidelines of essential medicine in China. Finally, further studies on evidence of oxymetazoline, dextromethorphan and other Chinese patent drugs with the effect of relieving cough and treating cold should be carried out.
Objectives Re-evaluation the clinical evidence of. anti-virus medicines for virosis communicable respiratory disease on the effectiveness, safety and health economy. Methods To search CL (2003 Issue 1), Medline (1966-2003.5), CCOHTA, SBU, NICE and NCCHTA and collect all CSRs and HTA with computer . The quality of evaluation partly based on QUOROM will be done before results analysed. If heterogeneity does not exist in CSRs and HTA, a Meta-analysis will be re-conducted. Results 4 CSRs (38 RC, n=22 835) and 5 HTA (28 RCT, n=139 281) were included. Due to the significant heterogeneity between these studies, further Meta-analysis could not be conducted, and descri ptive conclusions were conducted only. Conclusions Neuraminidase inhibitors (zanamivir and oseltamivir) are more effective than placebo in reducing the duration of symptoms of patients with basic disease, and have limited effectiveness in health adults. But, both are well tolerated and reduce the rate of contracting influenza in all individuals. For prevention, neuraminidase inhibitors cost more and are not suitable as first-line drug. 2. Diamantane is more effective than placebo in reducing the duration of having fever, and effectively prevents the influenza A. Amantadine and rimantadine have comparable effectiveness in the prevention, although rimantadine induces fewer adverse effects than amantadine. 3. The number of the childrenpatients of upper respiratory tract infection prevented and treated by ribavirin is too small to draw any conculsion now.
Objective To evaluate the safety and efficacy of Jinlianqingre capsule in treatment of acute upper respiratory tract infection （external wind-heat syndrome）. Methods A multi center, double-blind, double dummy, randomized controlled trial was conducted. A total of 226 patients with acute upper respiratory tract infection were randomized into two groups：the trial group （116 patients）received Jinlianqingre capsule and the control group （110 patients） received Jinlianqingre granule. The therapeutic courses of both groups were 3 days. Results The total significant effective rates and the total effective rates of acute upper respiratory tract infection were 66.38 % and 95.69% in the trial group respectively, and 60.91% and 95.45% in the control group respectively. There were no statistical differences between the two groups （P 〉0.05）. The total significant effective rates and the total effective rates of Chinese medicine symptoms were 70.69% and 97.41% in the trial group respectively, and 69.09% and 93.64% in the control group respectively. There were no statistical differences between the two groups （P 〉0.05）. Besides, the efficacy of Jinlianqingre capsule was better than that of Jinlianqingre granule with respect to fever duration after treatment; there were statistical differences between the two groups （P〈0. 05 ）. No adverse effects were found in the trial group. Conclusions Jinlianqingre capsule is effective and safe in treatment of acute upper respiratory tract infection （external wind-heat syndrome）.
Objective To compare the costs of Danmu extract syrup and Xiaoer Chiqiao Qingre granules for the treatment of acute upper respiratory tract infection (AURI) in children. Methods We conducted this prospective cohort study from July 2018 to June 2020. Children with AURI in the pediatric outpatient department and emergency department of West China Second Hospital were enrolled, and were divided into two groups: Danmu extract syrup group (Danmu group) and Xiaoer Chiqiao Qingre granule group (Chiqiao group) according to the treatment. The pharmacoeconomic evaluation took the medical and health system as the research perspective and considered direct medical costs, including registration fees, drug fees, inspection fees, testing fees, and treatment fees. A cost-effectiveness analysis or a cost minimization analysis was adopted according to the results of efficacy between the two groups. Results We enrolled 1 036 children with AURI. After propensity score matching, 252 in the Danmu group and 253 in the Chiqiao group were included. There was no statistically significant difference in the symptom recovery time between the two groups. The cost minimization analysis showed that the total costs (median difference ?21.55) and drug costs (median difference ?7.24) of the Danmu group were significantly lower than those of the Chiqiao group (P<0.001). The results of the subgroup and sensitivity analyses were consistent with the primary analysis. Conclusion Danmu extract syrup is a cost-saving alternative compared with Chiqiao granules for AURI in children.
