[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.

[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.

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.

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.

[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.

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.

[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.

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.

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.

[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 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.

[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.

[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.

Effects of Astragalus membranaceus in promoting T-helper cell type 1 polarization and interferon-gamma production by up-regulating T-bet expression in patients with asthma.

OBJECTIVE: To explore the effect of Astragalus membranaceus (AM) on T-helper cell type 1 (Thl) specific transcription factor T-box expressed in T cells (T-bet) expression and Thl/Th2 equilibrium. METHODS: The levels of T-bet mRNA in peripheral blood mononuclear cells (PBMCs) from 15 patients with asthma and 15 healthy subjects were determined by reverse transcription-polymerase chain reaction (RT-PCR). PBMCs in asthma patients were incubated with AM and then the concentration of interferon gamma (IFN-gamma) and interleukin-4 (IL-4) in the supernate before and after AM intervention were determined by ELISA. The numbers of CD4 + CCR3 + and CD4 + CCR5 + cells were counted by flow cytometry. RESULTS: The expression of T-bet mRNA and the level of IFN-gamma were lower, but level of serum IL-4 was higher in asthma patients when compared with those in healthy subjects respectively. After AM (60 microg/ml) intervention, the former two parameters raised and showed a positive correlation between them, while the level of IL-4 was decreased. The mean percentage of CD4 + CCR3 + cells in asthma patients was significantly higher but that of CD4 + CCR5 + cells was lower when compared with those in healthy subjects respectively. After AM intervention, the abnormal change in the two indexes was improved to certain extent, showing a reversing status of Th2 polarization. CONCLUSION: AM could increase the expression of T-bet mRNA and Thl cytokines such as IFN-Y, and might reverse the Th2 predominant status in asthma patients.

[Problems and strategies in clinical trials of traditional Chinese medicine].

To explore the problems and the strategies in clinical trials of traditional Chinese medicine (TCM), including the method and concealment of randomizing, equipoise of baseline, blindness and outcome measures, adverse reaction observation, statistical method and publication bias. The consolidated standard of reporting trials (CONSORT) is recommended to be applied in order to improve the quality of design and report of randomized controlled trials (RCTs) of TCM, and in case of human is taken as the subject of trial, according to the fundamental ethical principle, the clinical trial design should be censored by institutional review board (IRB), and the informed consent should be signed to protect the rights and interests of the trial participator.

[Effect of dexamethasone on expression of fractalkine in lipopolysaccharide-induced acute lung injury].

OBJECTIVE: To investigate the effect of dexamethasone on the expression of fractalkine (FKN) in lipopolysaccharide (LPS)-induced acute lung injury (ALI). METHODS: The rat model of ALI was established by injection of LPS at the dose of 4 mg/kg. 42 Wistar rats were randomly divided into the normal group (n=6), LPS group (n=18), and dexamethasone (DEX) group (n = 18), and then the rats in both LPS and DEX groups were divided into three subgroups (1 h, 2 h and 4 h after injection of LPS), respectively. The pathological condition and the wet/dry ratio (W/D) of the lung were observed, and serum TNF-alpha level, and FKN mRNA of the lung were detected with ELISA and RT-PCR. RESULTS: The W/D, serum TNF-alpha level, and FKN mRNA of the lung were significantly increased in LPS group, compared with those in normal group (all P < 0.05), but the W/D, serum TNF-alpha level, and FKN mRNA of the lung in the DEX group were much more decreased than those in the LPS group (all P < 0.05). In addition, the expression of FKN mRNA in the lung tissue positively correlated with the concentration of TNF-alpha (r = 0.674, P <0.05). CONCLUSION: The findings suggested that pre-treatment with dexamethasone could inhibit the TNF-alpha level and prevent the increase of the expression of FKN mRNA, which may be one of the mechanisms by which DEX serves as a protection against LPS-induced lung injury.

Relationship between bone mineral density and syndrome types described in traditional chinese medicine in chronic obstructive pulmonary disease: a preliminary clinical observation.

Osteoporosis is a common finding following chronic obstructive pulmonary disease (COPD), but there are few reports on the relationship between bone mineral density (BMD) and the syndrome types described in traditional Chinese medicine (TCM) in patients with COPD. A cross-sectional medical survey was used in this study. Twenty-six male patients with COPD and 26 age-matched male healthy subjects were recruited. The symptom questionnaire survey of TCM was implemented, and thereafter the COPD patients were divided into two subgroups: type of deficiency of the lung and spleen (TDLS) and type of deficiency of the lung, spleen and kidney (TDLSK). BMD of lumbar spine (L2-4), non-dominant femoral neck (Neck), Ward's triangle (Ward's), and great trochanter (Troch) were measured by dual-energy x-ray absorptiometry. In addition, the other bone turnover markers were also examined. The results showed that BMD was much more decreased in TDLSK than that in TDLS patients (p < 0.05), and BMD in the patients of the TDLS subgroup without symptoms of kidney-vacuity has showed the decreased trend from healthy subjects to TDLS patients. Furthermore, there was a higher incidence of osteoporosis in patients with TDLSK compared with that in TDLS (p < 0.05, OR > 2.0). Therefore, the data suggest that: (1) BMD might be a marker more sensitive than the symptom for the diagnosis of kidney-vacuity in COPD patients; (2) the deficiency of kidney would be the key factor of bone mineral loss; and (3) that invigorating the kidney should be performed in the phase of TDLS in COPD patients in advance.

[Randomized controlled trial on haiguiyuyang capsule in the treatment of duodenal ulcer].

OBJECTIVE: To assess the efficacy and safety of haiguiyuyang capsule in the treatment of duodenal ulcer (also diagnosed as weiwan pain and hanrecuoza syndrome according to the theory of TCM). METHODS: This is a multi-center clinical trial cooperatively conducted from May 2003 to March 2004 in accordance to the principle of informed consent, to the criteria for subject inclusion, exclusion, discontinuation, and to the relevant guidelines for evaluating the therapeutic effects of new TCM drugs. The design of double-blind, double-dummy and randomized controlled trial was adopted. 438 patients were randomized to the Test group (n = 330, treated with haiguiyuyang capsule) and to the Control group (n = 108, treated with ranitidine). The therapeutic course for both groups was 6 weeks. RESULTS: Regarding the efficacy in treating duodenal ulcer, in the Test group, the Marked Efficacy Rate was 66.37% and the Total Efficacy Rate was 82.13%; in the Control group, the Marked Efficacy Rate was 68.61% and the Total Efficacy Rate was 93.34%; there was no significant difference between the two groups (P>0.05). Regarding the efficacy in treating the syndrome diagnosed by TCM, in the Test group, the Marked Efficacy Rate was 70.31% and the Total Efficacy Rate was 93.34%; in the control group, the rates were 71.29% and 91.66% respectively; there was no significant difference between the two groups (P>0.05). Besides, regarding the abatement of distention and fullness of stomach after treatment, the haiguiyuyang capsule was better than ranitidine (P<0.05). No adverse side-effect was observed. CONCLUSION: The efficacy of haiguiyuyang capsule in treating duodenal ulcer is similar to that of ranitidine. No obvious adverse effect of it was observed in this trial.

[Clinical observation on effect of kesuning granule in treating acute onset of chronic bronchitis].

OBJECTIVE: To prove the effect of Kesuning Granule (KSNG) in treating chronic bronchitis in exacerbation (Phlegm-Heat syndrome) and objectively evaluate its safety. METHODS: The double-blinded, double-dummy and randomized controlled method was adopted to observe 120 patients, who were divided into the treated group (n = 60, treated with KSNG 8 g, three times a day) and the control group (n = 60, treated with Jinbei Tankeqing Granule (JBTKQ) 7 g, three times a day). The therapeutic course for both groups was 6 days. RESULTS: In the treated group, the markedly effective rate was 58.33% and effective rate was 93.33%, while in the control group, they were 51.67% and 91.67% respectively, no significant difference was found between the two groups. For therapeutic effects on TCM syndromes, the markedly effective rate and effective rate in the treated group was 68.33% and 93.33% respectively and in the control group, 66.67% and 90.00% respectively, also showed insignificant difference. The effect initiative time was earlier in the treated group than that in the control group significantly (P < 0.05). No adverse effect was found in the observation. CONCLUSION: KSNG shows a definite clinical effect with no obvious toxic-adverse effects.

[Study on correlation between bone mineral density and syndrome type of TCM in patients with chronic obstructive pulmonary disease].

OBJECTIVE: To explore the correlation between bone mineral density and Syndrome type of TCM in patients with chronic obstructive pulmonary disease (COPD) for providing the base of clinical integrative traditional Chinese and western medical therapy for the disease through the Syndrome typing and determination of changes in bone metabolism and bone density. METHODS: Bone mineral density (BMD) of lumbar vertebrae 2-4, femoral neck, Ward's triangle and trochanter in 27 COPD male patients, 25 male control subjects and 25 healthy persons were determined using dual energy X-ray absorptiometry, patient's Syndrome type, their blood levels of total protein, albumin, alkaline phosphatase, bone glaprotein, hydroxyproline, calcium, phosphate, urine levels of calcium/creatine and phosphorous/creatine as well as arterial blood gas were also determined. RESULTS: The BMD in COPD patients accompanied with respiratory failure or with course > 10 years was higher than that in COPD patients without respiratory failure or with course < or = 10 years, BMD in COPD patients of Fei-Pi-Shen type was lower than that in those of Fei-Pi, but the urine hydroxyprdine in the former was higher than that in the latter (all P < 0.05). CONCLUSION: (1) COPD is a risk factor for osteoporosis; (2) Shen Deficiency is the key and nucleus of secondary osteoporosis to COPD; (3) It is inferred that early regulation of Shen may be facilitated to prevent osteoporosis in COPD patients.