The safety of withholding hydrocortisone during preoperative periods in pituitary adenomas patients with an intact HPA axis: A meta-analysis of randomized controlled trials.

OBJECTIVES: For patients with pituitary adenomas with an intact hypothalamus-pituitary-adrenal axis before surgery, whether routine steroid therapy is needed is still controversial. We conducted a meta-analysis to assess the safety of withholding hydrocortisone compared with hydrocortisone in pituitary adenoma patients during preoperative periods. MATERIAL AND METHODS: We searched PubMed, Embase, Web of Science, and Cochrane Library databases up to November 2022 using inclusion and exclusion criteria. We employed either a fixed-effect or random-effect model for the analysis and assessed heterogeneity using the I2 statistic. RESULTS: Three studies involving 512 patients out of 400 studies were conducted. The pooled data revealed a higher incidence of postoperative transient diabetes insipidus in the no-hydrocortisone group than in the hydrocortisone group (RR, 1.88; 95% CI, 1.13 to 3.12; p = 0.02). The cortisol level in the no-hydrocortisone group was lower than in the hydrocortisone group after tumor removal (mean difference, -36.82; 95% CI, -44.27 to -29.38; p < 0.00001) but higher on the second day after surgery (mean difference, 4.04; 95% CI, 2.38 to 5.71; p < 0.00001). No significant differences were observed in early adrenal insufficiency (RR, 1.04; 95% CI, 0.37 to 2.96; p = 0.93), adrenal insufficiency in the third month after surgery (RR, 1.56; 95% CI, 0.70 to 3.48; p = 0.28), cortisol level on the first day after surgery (mean difference, 0.24; 95% CI, -11.25 to 11.73; p = 0.97), postoperative permanent diabetes insipidus (RR, 1.61; 95% CI, 0.43 to 6.07; p = 0.48), postoperative delayed hyponatremia (RR, 1.06; 95% CI, 0.41 to 2.74; p = 0.91), or postoperative blood glucose level (mean difference, -0.41; 95% CI, -1.19 to 0.37; p = 0.31) between the no-hydrocortisone and hydrocortisone groups. CONCLUSION: Withholding preoperative steroid therapy is safe for pituitary adenomas patients with an intact hypothalamus-pituitary-adrenal axis.

Efficacy of integrated Traditional Chinese Medicine and anti-retroviral therapy on immunological nonresponse in patients with human immunodeficiency virus/acquired immunodeficiency syndrome: a Meta-analysis of randomized controlled trial.

OBJECTIVE: To explore the efficacy of integrating Traditional Chinese Medicine (TCM) and anti-retroviral therapy (ART), a customized combination of different classes of medications which was also called cock-tail treatment, on the immunological nonresponse (INR) in people living with human immunodeficiency virus (HIV) (PLWH). METHODS: Relevant literature in databases such as China National Knowledge Infrastructure Database (CNKI), Wanfang Digital Journal, Chinese Medical Journal Database (CMJD), Chinese Biomedical Literature Database (CBM), PubMed, Cochrane, and Embase was reviewed by two independent investigators. Data were extracted from the studies according to the eligible criteria and analyzed using Review Manager 5.3. RESULTS: Nine randomized controlled trials (RCTs) with 1078 patients were analyzed. Our analyses showed that CD4 T cell counts in the treatment group improved compared with that in the control group [mean difference (MD) = 13.51, 95% confidence interval (CI): 7.42-19.60, P < 0.0001]. There was no significant difference between the treated and control groups after 3 months (MD = 25.31, 95% CI: ?2.78 to 53.41, P = 0.08). However, after 6 and 12 months, the response of the treatment group was superior to the control group (MD = 27.45, 95% CI: 7.09-47.81, P = 0.008 and MD = 27.34, 95% CI: 6.31-48.37, P = 0.01, respectively). The clinical efficacy of the treatment group was also higher than that of the control group (RR = 1.75, 95% CI: 1.16-2.65, P = 0.007). However, CD45RO and CD45RA T cell counts did not differ significantly between the two groups (MD = 12.37, 95% CI: ?6.71 to 31.45, P = 0.20 and MD = 5.67, 95% CI: ?3.00 to14.35, P = 0.20, respectively). CONCLUSION: The combined treatment strategy of integrated TCM and Western Medicine promotes long-term reconstitution of the immune system and thus, is beneficial and has potential use for improving INR in PLWH. However, large-scale RCTs are required to provide evidence for optimal intervention strategies.

Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study.

BACKGROUND: Colorectal cancer (CRC) is the second most common cause of cancer-related deaths and has the third highest incidence in the world. Almost half of the patients with CRC have metastases at the time of diagnosis. However, the treatment for patients with metastatic CRC that progresses after approved conventional chemotherapy is still controversial. Chinese medicine (CM) has unique characteristics and advantages in treating metastatic CRC. OBJECTIVE: To assess the effectiveness and safety of CM in patients with metastatic CRC after failure of conventional chemotherapy. METHODS: The study is a multicenter prospective cohort study. A total of 384 patients with documented metastatic CRC after failure of conventional chemotherapy will be included from 9 hospitals among Beijing, Shanghai, Nanjing, and Guizhou, and assigned to three groups according to paitents' wishes: (1) integrated Chinese and Western medicine (ICM) group receiving CM herbal treatment combined with Western medicine (WM) anti-tumor therapy, (2) Chinese medicine (CM) group receiving only CM herbal treatment, and (3) WM group receiving only WM anti-tumor therapy. The primary endpoint is the overall survival (OS). Secondary endpoints include the progression free survival (PFS), quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaire, tumor control, and CM symptom score. DISCUSSION: This prospective study will assess the effectiveness and safety of CM in treating metastatic CRC after conventional chemotherapy failure. Patients in the ICM group will be compared with those in the WM group and CM group. If certified to be effective, national provision of CM treatment in metastatic CRC will probably be advised. (Registration No. NCT02923622 on ClinicalTrials.gov).

An 84-month observational study of the changes in CD4 T-lymphocyte cell count of 110 HIV/AIDS patients treated with traditional Chinese medicine.

This study aimed to evaluate the therapeutic effect of traditional Chinese medicine (TCM) by observing the changes in CD4 T-lymphocyte cell count of 110 cases with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) treated continuously with TCM for 84 months. Information of 110 HIV/AIDS patients from 19 provinces and cities treated with TCM from 2004 to 2013 was collected. Changes in the indexes of CD4 counts ( ≤ 200, 201-350, 351-500 and > 500 cells/mm(3)) at five time points (0, 12, 36, 60 and 84 months) and different treatments [TCM and TCM plus antiretroviral therapy (ART)] were compared. Repeated measures test indicated no interaction between group and time (P > 0.05). Degrees of increasing and decreasing CD4 count of the two groups at four different frames were statistically significant compared with the baseline. The CD4 count between the two groups was not statistically significant. For CD4 count of ≤ 200 cells/mm(3), the mean CD4 count changes were 21 and 28 cells/mm(3) per year for the TCM group and TCM plus ART group, respectively. For CD4 count of 201-350 cells/mm(3), the mean CD4 count changes were 6 and 25 cells/mm(3) per year for the TCM group and TCM plus ART group, respectively. For CD4 count of 351-500 cells/mm(3), the mean CD4 count changes were -13 and -7 cells/mm(3) per year for the TCM group and TCM plus ART group, respectively. For CD4 count of > 500 cells/mm(3), the mean CD4 count changes were -34 and -17 cells/mm(3) per year for the TCM group and TCM plus ART group, respectively. Long-term use of TCM could maintain or slow the pace of declining CD4 counts in patients with HIV/AIDS, and may achieve lasting effectiveness.

[Study on the four-year retention rate and influencing factors for 2,353 AIDS patients by Chinese medicine].

OBJECTIVE: To analyze the retention rate and its influencing factors of HIV/AIDS patients by Chinese medicine (CM) maintenance treatment in the first 5 provinces in China. METHODS: Kaplan-Meier method was used to analyze the retention rate of treatment in patients. Cox hazard regression model was used to assess factors that might influence the treatment time of Chinese medication. RESULTS: Totally 2,353 patients took part in this four-year study. Of them, 1,156 (49. 1%) were male, 2,344 (99. 6%) were Han nationality, 2,260 (96%) were married, 2,219 (94.3%) had junior middle-schooling or below, the average age was 41.52 +/- 8.98 years, 1,758 (74.7%) received paid blood donation, 478 (20.3%) received blood transfusion, 737 (31.3%) were absent of symptoms, 963 (40.9%) received combined treatment of CM and Western medicine. The median time within the four years was 44.84 months. The average retention rate for 1, 2, 3, 4 years of CM treatment were 86.6%, 78.4%, 72.2%, 65.6%, respectively. The results of Cox model indicated that the drop-out risk could be reduced in combined treatment of CM and Western medicine patients (HR=0. 805, P<0.01) and AIDS patients (HR=0. 769, P<0.01). The drop-out risk could be increased by the infection route of paid blood donation (HR =1. 373, P<0.01). CONCLUSIONS: The four-year retention rate of the 2 353 patients by CM treatment in the first 5 provinces in China was 65. 6%. Route of infection, whether or not in combination of Western medicine, and staging showed influence on CM maintenance treatment time.

[Study of Tripterygium hypoglaucum Hutch and Celastrus orbiculatus thunb by FTIR spectrum].

The FTIR spectra of Tripterygium hypoglaucum Hutch (THH) and Celastrus orbiculatus Thunb were studied. The result shows that the two herbs have different ratio of main substance calcium oxalate and dulcitol, so their absorption frequency and form are different as well. In addition, there is an obvious difference between Celastrus orbiculatus stem and root, and both the peak forms of calcium oxalate and dulcitol in the FTIR spectra of roots are sharper and stronger than those of stems. Therefore FTIR can be a fast and reliable method to identify THH and Celastrus orbiculatus.

Cohort study on the effect of a combined treatment of traditional Chinese medicine and Western medicine on the relapse and metastasis of 222 patients with stage II and III colorectal cancer after radical operation.

OBJECTIVE: To evaluate the effectiveness of a comprehensive therapy of traditional Chinese medicine (TCM) in reducing the relapse and metastasis of stage II and III colorectal cancer based on conventional Western medicine (WM) therapy. METHODS: Two hundred and twenty-two patients in total, diagnosed as stage II and III colorectal cancer from February 2000 to March 2006, were recruited from Xiyuan Hospital, China Academy of Chinese Medical Sciences and the General Hospital of Beijing Military Area. They were followed-up once every 3-6 months. Twenty cases dropped out from the cohort. The remaining 202 patients were all treated with routine WM treatment [including R0 radical operation, or chemotherapy or/and radiotherapy according to national comprehensive cancer network (NCCN) clinical guidelines]. These patients were assigned to two groups based on whether or not they were additionally treated with TCM comprehensive therapy (orally administered with a decoction according to syndrome differentiation, combined with a traditional patent drug over one year). Ninety-eight patients from Xiyuan Hospital were treated with WM and TCM (combined group), and 104 patients from the General Hospital of Beijing Military Area were treated with WM alone (WM group). The demographic data at baseline were comparable, including the operation times, age, sex, TNM staging, and pathological types. The patients were followed-up for one to five years. Up to now, there are 98, 98, 77, 64, and 47 patients with 1, 2, 3, 4, and 5 years of follow-up in the combined group, respectively; and 104, 104, 97, 81, and 55 patients in the WM group, respectively. The results of the 5-year follow-up of all the patients will be available in 2011. RESULTS: The relapse/metastasis rate of 1-, 2-, 3-, 4-, and 5-year were 0 (0/98), 2.04% (2/98), 11.69% (9/77), 14.06% (9/64), and 21.28% (10/47) in the combined group, and were 4.80%(5/104), 16.35% (17/104), 21.65% (21/97), 25.93% (21/81), and 38.18%(21/55) in the WM group, respectively. A significant difference was found in the second year between the two groups (chi (2)=12.117, P=0.000). Median relapse/metastasis time was 26.5 months in the combined group and 16.0 months in the WM group. CONCLUSION: The combined therapy of TCM and WM may have great clinical value and a potential for decreasing the relapse or metastasis rate in stage II and III colorectal cancer after conventional WM therapy.