As a kind of intervention measures of traditional Chinese medicine, acupuncture-moxibustion is highly adopted on global clinical practice. Even though the global clinical trial registration system was established more than 10 years ago, the proportion of acupuncture-moxibustion clinical trial registration is still very low; and it is very problematic on the methodological quality and report quality in the published acupuncture-moxibustion clinical trials. In order to manage particularly the acupuncture-moxibustion clinical trials, China Academy of Chinese Medical Sciences, collaborated with China Association of Acupuncture and Moxibustion and World Federation of Acupuncture Societies, established the Acupuncture-Moxibustion Clinical Trail Registry (AMCTR). AMCTR is a secondary registry platform affiliated to the Chinese Clinical Trial Registry (ChiCTR) and WHO International Clinical Trials Registry Platform (ICTRP), specifically for the acceptance and management of clinical trials in the field of acupuncture and moxibustion. It is a nonprofit academic organization, located in China Academy of Chinese Medical Sciences.

Objective To systematically review the safety and effectiveness of 6% hydroxyethyl starch (HES) 130/0.4 and crystalloid solution for the patients undergoing elective surgery .Methods We searched the Medline , EMBASE , CENTRAL , CNKI and Wanfang databases for randomized controlled trials involving comparison of the safety and effectiveness of 6% HES 130/0.4 and crystalloid solution for the patients undergoing elective surgery . The major evaluation indexes included intraoperative blood loss , postoperative incidence of dialysis and intraoperative incidence of hypotension . The secondary evaluation indexes included mortality , perioperative incidence of nausea and vomiting , coagulation function , renal function and incidence of adverse events .The two reviewers independently screened ,evaluated and extracted the data .Meta-analysis was performed using the Cochrane Collaboration’s RevMan 5.2 software .Results Ten trials involving 693 patients were included in our meta-analysis .Eight trials were in English and 2 trials were in Chinese .Comparison of the safety and effectiveness of 6% HES 130/0.4 and balanced solution was conducted in 7 trials (498 patients in total) ,and the results showed that 6% HES 130/0.4 reduced the intraoperative incidence of hypotension (OR 0.31 ,95% CI 0.13-0.75 ) and perioperative incidence of nausea and vomiting , (OR 0.08 , 95% CI 0.01 to 0.67 ) in the patients undergoing spinal anesthesia ( P< 0.05 );there was no significant difference in the intraoperative incidence of hypotension ,perioperative incidence of nausea and vomiting ,mortality ,and intraoperative blood loss under general anesthesia or combined spinal-epidural anesthesia between the two solution groups ( P> 0.05 );heterogeneity was found in the urine output under general anesthesia ( P<0.000 01 ,I2 =93% ) .The safety and effectiveness were compared between 6% HES 130/0.4 and normal saline in 3 trials (195 patients in total) and the results showed that there was no significant difference in the intraoperative blood loss ,intraoperative incidence of hypotension ,perioperative incidence of nausea and vomiting ,coagulation function ,renal function ,and incidence of adverse events between the two solution groups ( P> 0.05 ) .Conclusion 6% HES 130/0.4 is safe and effective when applied for the patients undergoing elective surgery .

Objective To assess the diagnostic value of glycosylated hemoglobin A1c (HbA1c) ≥6.5％ for diabetes in Chinese adults with oral glucose tolerance test(OGTT) as the reference standard.Methods Major databases were searched to get all diagnostic tests with HbA1c ≥ 6.5％ for diabetes in Chinese adults.QUADAS items were used to evaluate the quality of the eligible studies.Meta-disc software was used to perform comprehensive quantitative assessment for all included studies and summary ROC (SROC) curve were drawn.Results A total of 11 studies were included.The outcomes of the diagnostic value with HbA1c ≥6.5％ were as the following:pooled sensitivity 0.62 (95％ CI:0.60-0.64),pooled specificity 0.96 (95％ CI:0.95-0.96),diagnostic odds ratio (DOR) 40.25 (95％ CI:20.79-77.95) and AUCSROC 0.7702 (sx =0.0636).Conclusions The diagnostic specificity is pretty high for the diagnostic test with HbA1c ≥6.5％,while sensitivity is low.Combination of HbA1c and glucose tests is needed to reduce the missed diagnosis rate.

The STandards for Reporting Interventions in Clinical Trials Of Moxibustion (STRICTOM), in the form of a checklist and descriptions of checklist items, were designed to improve reporting of moxibustion trials, and thereby facilitating their interpretation and replication. The STRICTOM checklist included 7 items and 16 sub-items. These set out reporting guidelines for the moxibustion rationale, details of moxibustion, treatment regimen, other components of treatment, treatment provider background, control and comparator interventions, and precaution measures. In addition, there were descriptions of each item and examples of good reporting. It is intended that the STRICTOM can be used in conjunction with the main CONSORT Statement, extensions for nonpharmacologic treatment and pragmatic trials, and thereby raise the quality of reporting of clinical trials of moxibustion. Further comments will be solicited from the experts of the CONSORT Group, the STRICTA Group, acupuncture and moxibustion societies, and clinical trial authors for optimizing the STRICTOM.

Chaihu Injection (CI), which is widely used in treatment of febrile diseases, is an aqueous solution of Chaihu (Radix Bupleuri Chinensis) or Nanchaihu (Radix Bupleuri Scorzonerifolii) prepared by steam distillation.

Objective To investigate the long-term outcome and prognostic factors of patients with nasopharyngeal carcinoma treated with intensity-modulated radiation therapy (IMRT). Methods From February 2001 to December 2006, 419 patients with nasopharyngeal carcinoma in Cancer Center of Sun yatsen University received IMRT. The number of patients with stage Ⅰ,Ⅱ,Ⅲ and Ⅳ disease was 28, 113, 202 and 76, respectively. In all, 182 and 237 patients received radiotherapy alone and chemoradiotherapy. The prescription doses were as follows:66-70 Gy/25 -30 f to GTV_(nx), 60 -64 Gy/25 -30 f to GTV_(nd), 55 -62 Gy/25 -30 f to CTV_1, and 42 -54 Gy/25 -30 f to CTV_2. Results The median follow-up time was 49 months (6 -94 months). The number of patients with follow-up of 1-, 3-, and 5-year were 419,360 and 166, respectively. Twenty-one, 13 and 57 patients had local recurrence, regional recurrence and distant metastasis, respectively. The 5-year local control (LC) rate, regional control (RC) rate and free from distant metastasis survival rate was 92.7%, 95.8% and 85.5%, respectively. The 5-year disease-free survival (DFS) and disease-specific survival (DSS) was 76. 3% and 84.4%, respectively. In univariate analysis, T stage, primary tumor volume, N stage and volume of cervical nodes before treatment were significant predictors of DFS and DSS, favoring the patients with early T stage (84. 1% vs. 67.6% ,Χ~2 = 12. 16, P = 0. 000 : 92. 1% vs. 75. 1% ,Χ~2 = 14. 86 . P = 0. 000) , primary tumor volume less than 20 cm~3 (89. 1% vs. 62. 9% ,Χ~2 =14. 13,P=0.000;96.2% vs. 72. 1% ,Χ~2 =38. 76,P=0.000), early N stage (81.1% vs. 64. 5%, Χ~2 = 15.49, P = 0. 000; 87. 8% vs. 76. 1%, Χ~2 = 10. 89, P = 0. 001) and volume of cervical nodes less than 5 cm~3 (83. 3% vs. 68. 8%, Χ~2 = 14. 13, P = 0. 000 ; 90. 0% vs. 78. 1%, Χ~2 = 10. 71 ,P =0. 001). Multivariate analysis showed that primary tumor volume (Χ~2 = 26. 81, P = 0. 000 and Χ~2 = 28. 47, P = 0. 000) and N stage (Χ~2 = 4. 92, P = 0. 026 and Χ~2 = 9.50, P = 0. 002) were independent predictive factors for both DFS and DSS. No grade 4 acute and late toxicities were observed. In 243 patients with follow-up time more than 3 years, only 2. 8% suffered from grade 3 late toxicifies. Conclusions IMRT with or without chemotherapy can improve the long-term survival of patients with nasopharyngeal carcinoma, especially in LC and RC. Distant metastasis becomes the main treatment failure. Primary tumor volume and N stage are significant prognostic factors. Acute and late toxicities are acceptable.

Objective To evaluate the effect of intensity-modulated radiation therapy(IMRT) on parotid function in nasopharyngeal carcinoma(NPC). Methods Eighty-three NPC patients received prima-ry IMRT between 2001 and 2003. Xerostomia before radiotherapy, at the end of radiotherapy, at 6-month, 1-,2-,3-,4- and 5-year after radiotherapy were investigated, respectively. The relation between xerostomia and parotid dose distribution was analyzed. Results Of all the patients,4,31,31 and 17 had stage Ⅰ,Ⅱ,Ⅲ and ⅣA disease, respectively. Sixteen patients received chemo-radiotherapy. The median followed-up time was 65 months. The 5-year local control and regional control rate were 96% and 95% ,respectively. The 5-year overall survival rate was 80%. The mild xerostomia rate at the seven time points was 42%, 51%, 71%, 77%, 58%, 38% and 26%. The corresponding moderate xerostomia rate was 52%, 53%, 21%,8%, 3%, 2% and 2%, respectively. No serious xerostomia was observed. The mean dose of the bilateral parotid glands was 34.34 Gy. Xerostomia at 6-month after radiotherapy was positively correlated with the mean dose of the parotid glands, and D50 was the independent factor in predicting the xerostomia. Parotid function was well protected when the mean dose and D50 were no more than 33 Gy and 29 Gy,respectively. Conclusions IMRT can improve the local-regional control of NPC and protect the parotid glands from radiation-induced in-jury.

Objective To evaluate the effectivity and safety of dual antiplatelet therapy with clopidogrel and aspirin in patients with ST-segment elevation acute yocardial infarction(AMI).Methods We searched for randomized controlled trials(RCTs)and quasi-RCTs in the following electronic databases:PubMed,EMBASE,The Cochrane Library(Issue 3,2007),CBM,CNKI,VIP and Wanfang.Quality assessment and data extraction were conducted by two reviewers independently.Disagreement were resolved through discussion.All data were analyzed by using Review Manager 4.2. Results Ten studies involving a total of 52 433 participants met the inclusion criteria.Metaanalysis results showed that:(1)Compared with aspirin alone,the incidence rates of death caused by any reason(RR=0.91,95% CI:0.85～0.97),recurrent myocardial infarction(RR=0.80,95% CI:0.72～0.89),stroke(RR=0.81,95% CI:0.68～0.96),post-infarction angina(RR=0.35,95% CI:0.19～0.66),incoronary thrombus(RR=0.73,95% CI:0.64～0.83)and the combined endpoint events of death,reinfarction or stroke(RR=0.89,95% CI:0.84～0.95)could be reduced by clopidogrel and aspirin.(2)There were no significant differences in ameliorating the cardiac function and increasing TIMI blood flow of infarct-related artery between the two groups RR=0.97,95% CI:0.92～1.03;RR=1.14,95% CI:1.00～1.30;both P＞0.05.(3)There was no significant difference in bleeding between the tWO groups(RR=1.11,95% CI:0.92～1.34). Conclusions Compared with aspirin alone,clopidogrel plus aspirin has good effects on reducing the incidence rates of death caused by any reason,recurrent myocardial infarction,stroke,post-infarction angina,incoronary thrombus and the combined endpoint events of death,reinfarction or stroke in patients with ST-segment elevation AMI,and it has the same efficacy in ameliorating the cardiac function,increasing TIMI blood flow of infarct-related artery and bleeding.

Objective To evaluate the long-term efficaey of radiotherapy (RT) alone for nasopharyngnal eareinoma(NPC). Methods 934 NPC patients initially treated by conventional RT alone in 1999 were reviewed retrespeetively, including 676 males and 258 females. According to 92' Fuzhou staging system,there were 35 stage Ⅰ,215 stage Ⅱ ,488 stage Ⅲ and 196 stage Ⅳ diseases. All patients were treated by conventional RT alone with two opposing parallel faeio-eervical fields. The total dose delivered to the nasopharynx was 66-88 Gy. The dose to the cervical lymph nodes was 60-70 Gy, while the prophylactic dose to the neck was 50-56 Gy. Results The median follow-up was 67.1 months. The 5- and 8-year overall survival(OS), disease-free sutural, relapse-free survival and metastasis-free survival rates were 68.30%, 67.3% ,64.4% ,72.4% ,and 48.0% ,66.6% ,50.8% ,68.0% (χ2=49.74, P=0.000), respectively. For stage N1patients,the 5-and 8-year overall survival(OS) ,disease-free survival ,relapse-free survival and metastasis-free survival rates were significantly lower than those of stage NO patients [66.0% : 77.4% and 50.3%:59.8%(χ2=33.34,P=0.000);66.8%:76.1% and 66.1%:76.1%(χ2=29.08,P=0.000); 63.4%:72.9% and 48.9% : 58.7% (χ227.65,P=0.000);71.0%:80.8% and 63.4%:68.0%(χ2=26.13,P=0.000)]. And the corresponding rates of stage N<1-2>were significantly higher than stage N3,while no statistical difference was observed between stage N1 and N2. Multivariate analysis showed that sex, age, pathology,T stage and N stage were independent prognisitie factors for OS. Conclusions Radical RT alone could obtain good long-term results in early stage NPC. Tlowever,OS for local-regionally advanced stage NPC was still unsatisfactory because of the high relapse and metastatic rate. Clinical stage and N stage were valuable prognostic factors.

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.