Objective To assess the quality of the published randomized controlled trials published in Journal of Beijing University of Traditional Chinese Medicine (JBUTCM), Acta Universitatis Traditionis Medicalis Sinensis Pharmacologiaeque Shanghai (AUTMSPS), Journal of Guangdong University of Traditional Chinese Medicine (JGUTCM), and Journal of Chengdu University of Traditional Chinese Medicine (JCUTCM) from 2000 to 2005. Method Guided by the Cochrane Center hand-searching guidelines, we searched 24 volumes (111 issues) of the four journals. The data were extracted according to the principles of clinical epidemiology and consolidated standards of reporting trials (CONSORT), as well as an evaluation scale for randomized controlled trials (RCTs). The data were managed by descriptive analysis and uniformity test. Results There were 365 RCTs. The diagnostic criteria were reported in 297 trials (81.37%). The inclusion and exclusion criteria were reported in 143 trials (39.18%) and 132 trials (36.16%), perspectively, None mentioned the estimation of sample size. The randomization and allocation concealment were reported in 70 trials (19.18%) and 9 trials, perspectively. The baseline data were described in 292 trials (80.00%). Blinding was mentioned in 35 trials (9.59%).Withdrawal occurred in 20 trials (5.48%). Informed consent was acquired in 2 trials. Adverse drug reactions were described in 97 trails (26.58%). Conclusion There are deficiencies in the reporting of these RCTs, Most of the trials do not describe the randomization, only a few trials use the allocation concealment and blinded method, no description of comparability of baseline data, most of the trials do not report the inclusion and exclusion criteria, and none estimate the sample size. These problems indicate that it is necessary to improve the quality of clinical research in Chinese medicine and pharmacology.
目的:观察活血化瘀法治疗重症急性胰腺炎并发胰腺假性囊肿的临床效果。方法:对并发假性囊肿的重症急性胰腺炎(severe acute pancreatitis,SAP)患者采用活血化瘀为主,内服中药以桃红四物汤加减,六合丹外敷腹部或胁肋部,丹参注射液静脉滴注。结果:105例并发假性囊肿的SAP患者中14例因感染发生脓肿而手术,12例因假性囊肿压迫胃肠导致不全性肠梗阻而进行择期囊肿内引流术,79例经活血化瘀治疗后好转。结论：大多数SAP并发胰腺假性囊肿可以通过活血化瘀法得到控制,并发感染或者肠梗阻者仍需要积极手术治疗。
ObjectiveTo summarize and analyze the etiologies of recurrent acute pancreatitis (RAP) and then conclude the prevention and treatment strategies.MethodSearching relevant literatures of PubMed, CNKI, Wanfang data and other databases in recent years, the etiologies of RAP were analysed and reviewed, then the prevention and treatment strategies were developed.ResultsThe causes of RAP included abnormal function and structure of biliopancreatic duct, metabolic factors, bad living habits, genetic factors and so on. Then based on etiologies of RAP, prevention and treatment strategies of it were summarized.ConclusionsWith the developments of related researches and clinical diagnosis and treatment technologies, the etiologies of RAP are gradually revealed. It is of great significance to clarify the etiologies of RAP and make prevention and treatment strategies for reducing the recurrence of acute pancreatitis.
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 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.