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.
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 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.