Efficacy and safety of antifibrotic agents in the treatment of CTD-ILD and RA-ILD: A systematic review and meta-analysis.

OBJECTIVE: The clinical spectrum of connective tissue disease-associated interstitial lung disease (CTD-ILD) and rheumatoid arthritis-associated interstitial lung disease (RA-ILD) ranges from asymptomatic findings on radiographic imaging to a rapidly progressive illness leading to respiratory failure and death. The treatment is always challenging due to the paucity of proven effective treatments. Nintedanib and pirfenidone are recently approved antifibrotics in idiopathic pulmonary fibrosis. This study aimed to investigate the efficacy and safety of antifibrotic agents in the treatment of CTD-ILD and RA-ILD. METHODS: Relevant databases were searched for randomized controlled trials that compared pirfenidone or nintedanib with placebo in patients with CTD-ILD and RA-ILD. The primary outcome was the change in forced vital capacity (FVC). The odds ratio or risk ratio with 95% confidence interval (CI) was estimated for categorical data, and the mean difference with 95% CI was estimated for continuous data. The I2 statistic was used to assess heterogeneity, and meta-analysis was performed when possible. RESULTS: Ten studies with a total of 880 participants met the inclusion criteria. Of these, four studies were included in the meta-analysis. According to the pooled result, the annual decline of FVC was significantly decreased in the antifibrotic agent arm compared to that in the placebo arm (MD 70.58 mL/yr, 95% CI 40.55 to 100.61). CONCLUSION: This review suggests a potential benefit and safety of antifibrotic treatment in slowing the decline of FVC in patients with CTD-ILD and RA-ILD. Further large-sample, random-controlled, high-quality trials are needed to provide more evidence in the decision-making regarding the use of antifibrotics in this group of patients. CLINICAL TRIAL REGISTRATION: PROSPERO; No: CRD42022369112; URL: https://www.crd.york.ac.uk/prospero/.

A systematic pharmacology-based in vivo study to reveal the effective mechanism of Yupingfeng in asthma treatment.

BACKGROUND: The clinical effect of Yupingfeng (YPF) has been confirmed in asthma patients, however, it lacks a study to verify its pharmacological mechanism. HYPOTHESIS/PURPOSE: To reveal the molecular basis and potential pharmacological mechanism of YPF in the treatment of asthma. STUDY DESIGN AND METHODS: First, a systems pharmacology-based method integrating pharmacokinetic screening, target prediction, network analyses, GO and KEGG analyses were used for the systematic deciphering of the mechanism of YPF in asthma. Second, differentially expressed genes (DEGs) between asthma patients and healthy controls were identified by GEO2R online tool. Third, based on systems pharmacology and DEGs results, molecular docking was performed utilizing the Discovery Studio 2020 Client version to detect the binding capacity between compounds and targets. Finally, ovalbumin (OVA)-challenged C57BL/6 mice were treated with YPF or its effective compound to assess the predictions. RESULTS: A total of 35 active compounds were filtered out, with 87 potential targets being identified for further analysis after target fishing and matching. Quercetin, kaempferol, and wogonin were identified as the main ingredients in YPF. The signaling pathways of phosphatidylinositol 3-kinase (PI3K)/protein kinase B (AKT), tumor necrosis factor (TNF) and IL-17 were identified as the top signaling pathways in KEGG enrichment analysis. GEO2R tools of NCBI discovered five DEGs that overlapped with the therapeutic targets of YPF. Wogonin was proven to be the top active compound in YPF through the results of molecular docking. In vivo experiments indicated that YPF and wogonin significantly attenuated airway resistance and lung inflammation by decreasing the levels of inflammatory cytokines and key factors in PI3K/AKT, IL-17, and TNF signaling pathways. CONCLUSIONS: YPF and its main active compound wogonin may exert some therapeutic effects on asthma inflammation through multiple molecular targets and signaling pathways including PI3K/AKT, IL-17 and TNF-α.

Recommendations for reporting adverse drug reactions and adverse events of traditional Chinese medicine.

Clearly report adverse effect or adverse event occurred in the clinical practice is very important for understanding the potential risk of using a drug for treatment of diseases, and with other advantages. This document aims to help healthcare providers to organize, report, and publish information on ADR/AE occurrences and to identify the nature of the ADR/AE in TCM and integrative medicine practice. This document provides recommendations on constructing a title, basic factors of writing an abstract and the text of ADR/AE reporting. In each part, there are some samples could be references for the development of a report and ADR/AE. We welcome any comments for improving this recommendation.

Adverse drug reactions linked to Ciwujia injection: a systematic review of 521 cases.

OBJECTIVE: To analyze adverse drug reactions (ADRs) associated with Ciwujia injection and possible contributing factors. METHODS: We searched all clinical studies and ADR reports of Ciwujia injection from the China National Knowledge Infrastructure (CNKI) database. Relevant information such as disease treated; menstruum and compatibility of the Ciwujia injection; age, gender, and allergic history of ADR cases; and the types, occurrence time and severity of the ADRs were collected and analyzed. RESULTS: In the 800 clinical studies of Ciwujia injection's efficacy and safety, 97 (12.1%) reported 285 ADR cases. There were 144 ADR reports for the drug describing a total of 236 ADR cases. Most of the ADR reports described cases of anaphylactic shock, while the most common ADR reported in clinical studies was local pain; 27.7% of ADR cases were I to II class in all 521 cases, and four anaphylactic shock cases died. CONCLUSION: The relevant information of ADRs for Ciwujia injection was insufficiently reported in included studies. The ADR type distribution between clinical studies and ADR reports was inconsistency. Most of the reported ADRs were mild, and were treated successfully by slowing down the drip velocity or by withdrawing the drug and treating the symptoms. As Ciwujia injection was one of the highest numbers of ADR reports of traditional Chinese medicine injections, high quality ADR monitoring, standardized ADR reporting, and timely analysis risk factors of ADRs are extremely urgent.

Avoiding adverse drug reactions to Chinese medicine injections.

A total of 109 varieties of Chinese medicine injections (CMI) have been approved by the State Food and Drug Administration of China, all of which have the potential to induce adverse drug reactions (ADRs). Major ADRs include systemic anaphylaxis, anaphylactic shock, acute intravascular hemolysis, hepatorenal damage, skin lesion, cardiac damage, respiratory system injury, and gastrointestinal disorders. Contributing factors of ADRs include healthcare workers' inadequate attention to ADRs of CMI, complex ingredients, allergic uncertainties, and inappropriate drug use in children and the aged. To decrease ADRs resulting from CMI, it is essential to improve the selection of drug indications, delivery of proper dosage regimens, compliance with drug instructions, and selection of solvents for the drugs.

Adverse events to Houttuynia injection: A systematic review.

OBJECTIVE: To systematically assess the main clinical features of Houttuynia injection-associated adverse drug reactions (ADRs), as described in published reports, and to contribute to the post-marketing re-evaluation and clinical practices of Houttuynia injection. METHOD: We searched the electronic databases- PubMed, EMBASE, the Chinese National Knowledge Infrastructure (CNKI), the Chinese Science and Technology Journal Full-text Database (VIP) and the Chinese Biomedical Disc (CBMdisc), for articles published through June 2010. We then extracted and analyzed the data. RESULTS: A total of 645 articles were included, with a total of 1232 ADR cases reported. Respiratory diseases accounted for 52.44% of all cases of Houttuynia injection ADRs, followed by reproductive system diseases (4.30%) and urinary system diseases (3.73%). Multiple systems or organs were involved in the ADRs, the top five were: respiratory system (37.42%), skin (34.66%), digestive system (25.49%), circulatory system (25.41%), and nervous system (23.96%). Serious systemic adverse reactions accounted for 22.56% of total ADRs. Of the reported 1,232 ADR cases, 286 ADR cases reported previous allergies in detail; allergy to penicillin accounted for 15.03% of the total cases with the allergic history, followed by unknown drugs (8.05%), and sulfonamides (3.15%). Among the ADR cases, Houttuynia injection was commonly used together with cephalosporins, penicillins, and macrolides. Macrolides combined with Houttuynia injection showed higher ADR risk than Houttuynia injection used alone (RR = 8.80, 95% CI 6.12 to 12.65, P < 0.0001). The ADR risk for intravenous injection of Houttuynia injection was higher than that of intramuscular injection (OR = 6.86, 95% CI 1.88 to 56.95, P= 0.0016). We used the WHO ADR Classification Criteria to divide the ADR cases into four grades. There were 22.56%, 36.28%, 16.48%, and 24.68% cases of Grade I, II, III, and IV, respectively. Anaphylactic shock accounted for 58.99% of the most serious ADRs (Grade I). All cases of death were caused by allergic shock, except one, who died of multiple organ failure caused by anaphylactic purpura. The fastest-onset three ADR cases occurred in one minute after injection. CONCLUSION: The respiratory system was the most common system treated in Houttuynia injection ADR cases. It was also the most common site of ADR symptoms. The ADRs of Houttuynia injection were serious. The precautions should be taken to prevent the anaphylactic shock. Intravenous injection and the combination with with cephalosporins, penicillins, and macrolides increased the ADR risk of Houttuynia injection.

[Systematic review on the application and adverse reactions of shengmai injection].

OBJECTIVE: To investigate the clinical application and adverse reactions of shengmai injection and their related factors. METHODS: China National Knowledge Infrastructure (CNKI) database was searched with the key word of "Shengmai Injection" from January 1983 to March 2009 to collect the literature regarding clinical study on shengmai injection, and the dose, indication, medicating path and method, solvent of the drug used, as well as the duration of treatment course and adverse reaction occurred were analysed. RESULTS: Finally, 647 documents involving 28,305 patients were included. Adverse reactions occurred in 215 patients, including anaphylactic response (anaphylactic shock, systemic anaphylaxis and skin rash) in 56 patients, and the adverse reactions on various systems, organs and tissues in 159 patients among whom there were a case of acute severe liver damage and a case of heart damage with severe sinus arrest. All patients were improved after treatment with no report of dead case. CONCLUSION: Shengmai injection has been widely applied in clinical practice since it came into the market in 1983, and its chief adverse reaction is the anaphylactic reaction. Excepting the relation with individual constitution, the occurrence of the adverse reaction is also related to its improper clinical application, such as incorrect combination with other drugs, over-high dosage used and age factor, etc. The prevention, monitoring and in time treatment of the adverse reactions and standardized rational medication of the drug should be stressed in the application of Shengmai Injection by clinical physicians.

[Andrographolide drop-pill in treatment of acute upper respiratory tract infection with external wind-heat syndrome: a multicenter and randomized controlled trial].

OBJECTIVE: To evaluate the safety and efficacy of andrographolide drop-pill in treatment of acute upper respiratory tract infection with external wind-heat syndrome. METHODS: A multicenter, randomized controlled trial was conducted. In phase I, 202 patients with acute upper respiratory tract infection were randomly divided into two groups: trial group (n=101) and control group (n=101). In phase II, 276 patients with acute upper respiratory tract infection were randomly divided into two groups: trial group (n=138) and control group (n=138). The patients in the trial group received andrographolide drop-pill, at a dose of 1.5 g, three times a day; the patients in the control group received andrographolide tablet, at a dose of 1.5 g, three times a day. The therapeutic courses in both groups were 3 days. Clinical symptoms, physical signs, adverse effects, blood, urine and stool tests, hepatorenal function and electrocardiogram were examined before and after the treatment. RESULTS: After treatment in the phase I, the cure rates in the trial group and the control group were 44.55%, 42.57% (full analysis set, FAS) and 45.00%, 43.00% (per protocol set, PPS), and the total obvious rates were 94.06%, 94.06% (FAS) and 95.00%, 95.00% (PPS), respectively. There were no significant differences between the two groups (P>0.05). In the phase II, the cure rates in the trial group and the control group were 39.13%, 33.82% (FAS) and 38.69%, 33.58% (PPS), and the total obvious rates were 96.38%, 96.32% (FAS) and 96.36%, 96.27% (PPS), respectively. There were no significant differences between the two groups (P>0.05) too. No adverse effects were found in the trial. CONCLUSION: Andrographolide drop-pill is effective and safe in the treatment of acute upper respiratory tract infection with external wind-heat syndrome.

Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials.

Although all Chinese materia medica (CMM) come from nature, CMM interventions have both therapeutic effects and adverse effects (AEs). Normally, AEs in randomized controlled trial (RCT) with traditional Chinese medicine (TCM) could be divided into five types as follows: 1) AEs under proper TCM principles and guidelines, such as the toxicity (acute and chronic) and allergy; 2) AEs due to improper usage without following TCM principles, involving without following the TCM therapeutic principles, over-dosage, improper processing and preparation methods, improper formula strategy, etc; 3) AEs due to contamination in CMM, such as heavy metal and pesticides contaminations in Chinese herbal medicine interventions, and intentional or unintentional contamination with drug(s); 4) AEs due to replacement of CMMs; 5) AEs due to drug-herb interaction. AEs of TCM should be treated properly. Overestimation or underestimation about AEs of TCM intervention will bring a wrong message to patients and health care providers. In order to give readers a more comprehensive understanding about the safety issue of study intervention, Consolidated Standards of Reporting Trials (CONSORT) for TCM should involve the background information on side effects of each CMM constituents and/or the study intervention, specific outcome assessment on AEs, the details of reported AEs and the interpretation of the AEs occurrence in a structural RCT report.

Precise reporting of traditional Chinese medicine interventions in randomized controlled trials.

Traditional Chinese medicine (TCM) intervention should be concisely and precisely reported in randomized controlled trials (RCTs). Based on State Food and Drug Administration's categories, we recommend reporting the interventions as follows: (1) Single Chinese herbal medicine-based/formula-based/extraction-based intervention includes 1) Name, dosage format and registration; 2) The composition and quality of intervention; 3) Pharmaceutical processing and quality control; 4) Stability of final product and quality control; 5) Function and safety description; 6) Dosage and treatment course; 7) Control group. (2) Active compound-based TCM drug intervention includes 1) Name of active compound(s); 2) Original source of active compound(s); 3) The brief process obtaining active compound(s); 4) Percentage of active compound(s) in final product; 5) Added materials and its quality and quantity control. Besides, the detailed information of intervention can be published as an online supplement in web site.

Appropriately selecting and concisely reporting the outcome measures of randomized controlled trials of traditional Chinese medicine.

Evaluating outcome is the primary means by which different medical modalities can be compared with regard to effectiveness. In traditional Chinese medicine (TCM), this focus has prompted practitioners to search for outcome measures that can objectively verify the effectiveness of TCM interventions, especially in the context of randomized controlled trials (RCTs). Commonly used indexes for outcome assessment in RCTs of TCM can be categorized into two types: TCM-specific outcomes such as tongue and pulse characteristics, and Western medicine (WM)-specific outcomes such as blood test and X-ray examination results. Some studies include both types of indicators. During the trial design, it is necessary to consider the rationales of selecting outcome assessments, the purpose and study approach, balance between objective and subjective indexes, standardization of outcome assessment, and standardized outcome indexes. We recommend to report the outcome assessment in RCTs of TCM in the following format: 1) identifying the primary and secondary outcomes based on the purpose and hypothesis of the trial; 2) defining the primary and secondary outcomes clearly; 3) presenting the rationale of selection; 4) presenting the method with aims to standardize the assessment process; 5) presenting the method to improve the reliability of assessment; and 6) stating the termination criteria in the trial.

[Mahuang Zhisou Capsule in treatment of acute upper respiratory tract infection of external wind-cold syndrome: a multi-center, randomized controlled, and double-blind trial].

OBJECTIVE: To evaluate the efficacy and safety of Mahuang Zhisou Capsule (MHZSC), a compound traditional Chinese herbal medicine, in treatment of acute upper respiratory tract infection of wind-cold syndrome. METHODS: A multi-center, double-blind, double dummy, randomized controlled trial was conducted. A total of 240 patients were randomized into treatment group (120 cases, treated with MHZSC) and control group (120 cases, treated with Mahuang Zhisou Pill). The therapeutic course was 3 days. RESULTS: Seven cases were excluded and three cases lost to follow-up. Two hundred and thirty-three cases entered intention-to-treat (ITT) analysis and 230 cases fitted in per-protocol population set (PPS) analysis. After treatment, the therapeutic effect of upper respiratory tract infection was calculated by ITT and PPS analysis respectively. The significant response rate and total response rate in the treatment group were 78.07% and 98.25% (ITT and PPS), while the significant response rates in the control group were 70.59% (ITT) and 70.69%(PPS), and the total response rates were 95.80% (ITT) and 95.69% (PPS) respectively. There were no significant differences in clinical efficacy between the two groups (P>0.05). CONCLUSION: MHZSC is effective and safe in treatment of acute upper respiratory tract infection of external wind-cold syndrome.

[A multiple center, randomized, controlled, double-blinded and double-dummy trial of Yiqing Shuangjie Capsule and Tablet in treating acute upper respiratory tract infection with the syndrome of heat attacking the lung and Weifen].

OBJECTIVE: To evaluate the efficacy and safety of Yiqing Shuangjie Capsule and Tablet in treating acute upper respiratory tract infection with wind-warm syndrome. METHODS: The multiple center, double-blinded, double-dummy and randomized controlled method was conducted. Three hundred and sixty patients were randomly divided into the treatment group A (n=120, treated with Yiqing Shuangjie Capsule and Chaihuang analogues), treatment group B (n=120, treated with Yiqing Shuangjie Tablet and Chaihuang analogues) and the control group (n=120, treated with Chaihuang Tablet and Yiqing Shuangjie Capsule analogues). Every drug was administered 3 pills each time. Patients in the three groups were all treated for 5 days and three times daily. The accumulated scores of syndrome, clinical symptoms, adverse effect and body temperature were recorded before and after the treatment. The safety indexes, such as routine tests of blood, urine and stool, hepatic and renal function tests and electrocardiogram (ECG) were taken before and after the treatment. RESULTS: Three cases were excluded and eighteen cases lost to follow-up. There were 343 patients who entered to the intention-to-treat (ITT) analysis and 339 patients fitted in the per-protocol population set (PPS) analysis. After treatment, the therapeutic effects of respiratory tract infection were calculated by ITT and PPS analysis respectively. The rates of total obvious effect were 84.96% and 87.27% respectively in the treatment group A, and the total response rates were 96.46% and 97.27% respectively. The rates of total obvious effect were 85.47% and 86.20% respectively in the treatment group B, and the total response rates were 97.45% and 97.41% respectively. In the control group, the rates of total obvious effect both were 72.57%, and the total response rates both were 99.12%. There was significant difference among the three groups (P<0.05). The effects of traditional Chinese medicine syndrome were also detected by ITT and PPS analysis respectively. In the treatment group A, the total obvious effect rates were 84.07% and 85.46% respectively, and the total response rates were 96.46% and 97.27% respectively. In the treatment group B, the rates of total obvious effect were 88.89% and 89.65% respectively, and the total response rates were 97.44% and 97.41% respectively. In the control group, the rates of total obvious effect both were 72.57%, and total response rates both were 99.12%. There was also statistical significant difference among the three groups (P<0.05). ITT and PPS analysis had the same results. No adverse effect was found in the trial. CONCLUSION: Yiqing Shuangjie Capsule and Tablet are effective and safe in treating acute upper respiratory tract infection of wind heat syndrome without obvious adverse effect.

The quality of reporting of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China.

BACKGROUND: The number of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) is increasing. However, there have been few systematic assessments of the quality of reporting of these trials. OBJECTIVE: This study was undertaken to evaluate the quality of reporting of RCTs in TCM journals published in mainland China from 1999 to 2004. METHODS: Thirteen TCM journals were randomly selected by stratified sampling of the approximately 100 TCM journals published in mainland China. All issues of the selected journals published from 1999 to 2004 were hand-searched according to guidelines from the Cochrane Centre. All reviewers underwent training in the evaluation of RCTs at the Chinese Centre of Evidence-based Medicine. A comprehensive quality assessment of each RCT was completed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist (total of 30 items) and the Jadad scale. Disagreements were resolved by consensus. RESULTS: Seven thousand four hundred twenty-two RCTs were identified. The proportion of published RCTs relative to all types of published clinical trials increased significantly over the period studied, from 18.6% in 1999 to 35.9% in 2004 (P < 0.001). The mean (SD) Jadad score was 1.03 (0.61) overall. One RCT had a Jadad score of 5 points; 14 had a score of 4 points; and 102 had a score of 3 points. The mean (SD) Jadad score was 0.85 (0.53) in 1999 (746 RCTs) and 1.20 (0.62) in 2004 (1634 RCTs). Across all trials, 39.4% of the items on the modified CONSORT checklist were reported, which was equivalent to 11.82 (5.78) of the 30 items. Some important methodologic components of RCTs were incompletely reported, such as sample-size calculation (reported in 1.1% of RCTs), randomization sequence (7.9%), allocation concealment (0.3 %), implementation of the random-allocation sequence (0%), and analysis of intention to treat (0%). CONCLUSION: The findings of this study indicate that the quality of reporting of RCTs of TCM has improved, but remains poor.

[Dinggui Oil Capsule in treating irritable bowel syndrome with stagnation of qi and cold: a prospective, multi-center, randomized, placebo-controlled, double-blind trial].

OBJECTIVE: To evaluate the efficacy and safety of Dinggui Oil Capsule in treating irritable bowel syndrome (IBS) with stagnation of qi and cold. METHODS: A prospective, randomized, placebo-controlled, double-blind clinical study was undertaken. One hundred and ninety-eight patients with IBS and syndrome of stagnation of qi and cold were randomly divided into high-dose Dinggui Oil group (DGO-H, 1.2 g, 3 times daily; n=66), low-dose Dinggui Oil group (DGO-L, 0.8 g, 3 times daily, n=66), and placebo group (placebo, 5.0 g, 3 times daily, n=66). Patients in the three groups were all treated for 2 weeks. RESULTS: The total significant effective rates for IBS were 54.1%, 28.8% and 21.9% in the DGO-H, DGO-L, and placebo groups, and the total effective rates for the syndrome of stagnation of qi and cold were 54.1%, 25.8% and 23.4% in the three groups, respectively. Dinggui Oil Capsule showed a higher efficacy than the placebo in relieving the abdominal pain (P<0.01). No adverse effects were found in this trial. CONCLUSION: Dinggui Oil Capsule is effective and safe in relieving abdominal pain due to IBS with stagnation of qi and cold.

Randomized controlled trial on treatment of bronchial asthma of qi-deficiency cold syndrome type by pingchuan yiqi granule.

OBJECTIVE: To evaluate the effect and safety of Pingchuan Yiqi Granule in treating bronchial asthma of qi-deficiency cold syndrome type (BS-QDC). METHODS: With the randomized, positive agent parallel controlled design adopted, the 80 subjects enrolled were assigned in the ratio of 3:1 to two groups, the 60 patients in the trial group were treated with PYG and the 20 in the control group treated with Ruyi Dingchuan Pill (RDP), with the therapeutic course consisting of 7 days for both groups. The clinical effects, effects on TCM syndrome and the changes of lung function after treatment were observed. RESULTS: The effect of the treatment on asthma in the trial group: clinically controlled rate was 6.67%, markedly effective rate 51.67%, improved rate 33.33% and ineffective rate 8.33%; and the corresponding rates in the control group were 5.00%, 50.00%, 30.00%, and 15.00% respectively. Comparison between the two groups showed insignificant difference (P>0.05). The effect on TCM syndrome in the treated group: clinically controlled rate was 11.67%, markedly effective rate 58.33%, effective rate 21.67% and ineffective rate 8.33%; and those in the control group were 10.00%, 50.00%, 30.00% and 10.00% respectively, also showing insignificant difference between the two groups (P>0.05). Lung function test showed that the change on forced expiratory volume in 1 second (FEV1) after treatment in the trial group was of statistical significance (P<0.05), but no significant difference was shown in the change of peak expiratory flow (PEF, P>0.05); while the changes in the control group were just the opposite, showing insignificance in FEV1 (P>0.05) but significance in PEF (P<0.05). Comparison of the therapeutic effect on lung function between the two groups showed no significant difference (P>0.05). No adverse reaction was found in either group in the course of treatment. CONCLUSION: PYG used to treat BS-QDC is effective and safe, it's effect is similar to that of RDP.

[A double-blind, randomized controlled trial of Chaige Qingre Granule in treating acute upper respiratory tract infection of wind heat syndrome].

OBJECTIVE: To evaluate the safety and efficacy of Chaige Qingre Granule, a traditional Chinese compound herbal medicine, in treating acute upper respiratory tract infection of wind heat syndrome. METHODS: A multi-center, double-blinded, randomized controlled trial was conducted. In the phase II, 60 patients with acute upper respiratory tract infection were randomly divided into the trial group (n=30) and the control group (n=30). In the phase III, 112 patients were randomly divided into the trial group (n=84) and the control group (n=28). The trial group received 6 g Chaige Qingre Granule, and the control group received 6 g Fufang Shuanghua Granule (another traditional Chinese compound herbal medicine). The two groups were all treated for 3 days and four times daily. Clinical symptoms, syndromes, adverse effect, blood, urine and stool test, hepatorenal function and electrocardiogram were examined before and after the treatment. RESULTS: After treatment, the overall obvious response rates of the trial group and the control group were 78.57%, 82.14% (by per-protocol analysis) and 75.86%, 79.31% (by intention-to-treat analysis) respectively, and the overall response rates of the two groups were 96.43%, 100% (by per-protocol analysis) and 93.10%, 96.55% (by intention-to-treat analysis) respectively in phase II. There were no significant differences between the two groups (P>0.05). In the phase III, the overall obvious response rates of the trial group and the control group were 90.54%, 73.08% (by per-protocol analysis) and 88.16%, 70.37% (by intention-to-treat analysis) respectively, and the overall response rates of the two groups were 94.59%, 96.15% (by per-protocol analysis) and 92.11%, 92.59% (by intention-to-treat analysis) respectively. There were no statistical differences between the two groups (P>0.05) too. No adverse effects were found in the trial. CONCLUSION: Chaige Qingre Granule is effective and safe in treating acute upper respiratory tract infection of wind heat syndrome.

[Effect of Shenqi Fuzheng injection on fractalkine expression in lung tissue of rats with lipopolysaccharide-induced acute lung injury].

OBJECTIVE: To observe dynamically the Fractalkine (FKN) expression in lung tissue of rats with lipopolysaccharide (LPS)-induced acute lung injury (ALI) and the effect of Shenqi Fuzheng Injection (SFI) on it. METHODS: Rat model of ALI was established by intravenous injection of 4 mg/kg of LPS. Forty-two Wistar rats were randomly divided into 7 groups, the normal group, the model group and the SFI group, the latter two were separated respectively into three time phases (the 1 h, 2 h and 4 h after modeling ) groups, 6 rats in each group. Pathological changes and wet/dry weight ratio (W/D) of lung were observed, serum TNF-alpha and FKN mRNA expression in the lung tissue were examined by ELISA and RT-PCR respectively. RESULTS: Severe pathological changes of lung presented in the model groups of all three time phases with a higher W/D ratio, as well as increased serum TNF-alpha level and FKN mRNA expression in lung tissue. The peak of abnormality of serum TNF-alpha level and FKN mRNA expression was shown in the 2 h time phase group. All the above-mentioned abnormal changes were alleviated after treatment in the SFI group (P<0.05). In addition, the level of FKN mRNA expression was found to be positively correlated to the serum TNF-alpha concentration. CONCLUSION: SFI treatment in early stage could relieve the pathological changes and edema in lung tissue, decrease serum TNF-alpha and down-regulate FKN mRNA expression, playing a protective role in LPS-induced ALI rats.

[A randomized controlled trial of Yiqi Pingchuan Granule in treating acute attack of bronchial spasm due to asthma of qi deficiency and cold syndrome].

OBJECTIVE: To evaluate the safety and efficacy of Yiqi Pingchuan Granule in treating acute attack of asthma due to qi deficiency and cold syndrome. METHODS: A randomized controlled trial was conducted. A total of 80 patients with an acute attack of asthma were included. They were allocated into two groups randomly in a ratio of three to one. Sixty patients in the treatment group received Yiqi Pingchuan Granule and 20 patients in the control group received Ruyi Dingchuan Pill. Patients in both groups were treated for 7 days. RESULTS: There were no significant differences in traditional Chinese medicine syndrome, clinical symptoms and lung function between the two groups (P>0.05). After treatment, the forced expiratory volume in 1 second was increased in the treatment group (P<0.05), and the peak expiratory flow was accelerated in the control group (P<0.05). No significant side effects were noted in both groups. CONCLUSION: Yiqi Pingchuan Granule is safe and effective in treating acute attack of asthma due to qi deficiency and cold syndrome.