scholarly journals Efficacy of integrating short-course chemotherapy with Chinese herbs to treat multi-drug resistant pulmonary tuberculosis in China: a study protocol

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Shun-Xian Zhang ◽  
Lei Qiu ◽  
Cui Li ◽  
Wei Zhou ◽  
Li-Ming Tian ◽  
...  

Abstract Background Tuberculosis (TB) caused Mycobacterium tuberculosis (M.tb) is one of infectious disease that lead a large number of morbidity and mortality all over the world. Although no reliable evidence has been found, it is considered that combining chemotherapeutic drugs with Chinese herbs can significantly improves the cure rate and the clinical therapeutic effect. Methods Multi-drug resistant pulmonary tuberculosis (MDR-PTB, n = 258) patients with Qi-yin deficiency syndrome will be randomly assigned into a treatment group (n = 172) or control/placebo group (n = 86). The treatment group will receive the chemotherapeutic drugs combined with Chinese herbs granules (1 + 3 granules), while the control group will receive the chemotherapeutic drugs combined with Chinese herbs placebo (1 + 3 placebo granules). In addition, MDR-PTB (n = 312) patients with Yin deficiency lung heat syndrome will be randomly assigned to a treatment (n = 208) or control/placebo (n = 104) group. The treatment group will receive the chemotherapeutic regimen combined with Chinese herbs granules (2 + 4 granules), while the control group will receive the chemotherapeutic drugs and Chinese herbs placebo (2 + 4 placebo granules). The primary outcome is cure rate, the secondary outcomes included time to sputum culture conversion, lesion absorption rate and cavity closure rate. BACTEC™ MGIT™ automated mycobacterial detection system will be used to evaluate the M.tb infection and drug resistance. Chi-square test and Cox regression will be conducted with SAS 9.4 Statistical software to analyze the data. Discussion The treatment cycle for MDR-PTB using standardized modern medicine could cause lengthy substantial side effects. Chinese herbs have been used for many years to treat MDR-PTB, but are without high-quality evidence. Hence, it is unknown whether Chinese herbs enhances the clinical therapeutic effect of synthetic drugs for treating MDR-PTB. Therefore, this study will be conducted to evaluate the clinical therapeutic effect of combining Chinese herbs and chemotherapeutic drugs to treat MDR-PTB cases. It will assist in screening new therapeutic drugs and establishing treatment plan that aims to improve the clinical therapeutic effect for MDR-PTB patients. Trial registration This trial was registered at ClinicalTrials.gov (ChiCTR1900027720) on 24 November 2019 (prospective registered). Graphical Abstract

2021 ◽  
Vol 20 (9) ◽  
pp. 1991-1997
Author(s):  
Xiaomei Ma ◽  
Dehui Yang ◽  
Weichun Shen ◽  
Wei Liang ◽  
Qian Lin

Purpose: To determine the therapeutic effect of Xuezhitong capsule in patients with microvascular angina (MVA), and its impact on vascular endothelial function.Methods: In total, 172 MVA patients treated in Beijing City Fengtai District Nanyuan Hospital from September 2017 to September 2019 were selected and randomized into control group which received conventional treatment, and treatment group which received Xuezhitong capsules plus. There were 86 patients in each group. Therapeutic effect, levels of inflammatory factors, i.e., high-sensitivity C- reactive protein (hs-CRP), interleukin-(IL-6), tumor necrosis factor-α (TNF-α), and vascular endothelial factors such as nitric oxide (NO), thromboxane B2 (TXB2) and endothelin (ET), were determined.Results: Markedly higher total treatment effectiveness was observed in the treatment group than in the control group (89.53 % vs. 72.94 %; p < 0.05). In both groups, treatment reduced the levels of hs-CRP, IL-6, TNF-α, TXB2 and ET, but elevated NO, with better results for treatment group than the control group (p < 0.05). Better optimizations of total cholesterol (TC), triglycerides (TGs), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein (HDL) were observed in the treatment group, relative to the control group (p < 0.05). Patients in the treatment group experienced fewer (8.14%) adverse reactions than those in control group (21.18 %, p < 0.05).Conclusion: Xuezhitong capsule, when combined with conventional treatment, exerts high therapeutic effectiveness and safety in MVA patients by inhibiting inflammatory reactions, optimizing endothelialfunction, reducing blood lipid levels, and decreasing the incidence of cardiovascular adverse events. Thus, the combination therapy is a potentially superior therapeutic strategy to the conventional approach for the management of MVA patients.


2017 ◽  
Vol 4 (1) ◽  
pp. 51
Author(s):  
Fara Disa Durry ◽  
Bambang Wirjatmadi

The epidemiology of Tuberculosis (TB) showed that TB is a disease which is associated with malnutrition. Malnutrition and lacking of certain essential nutrients required by immune system might cause immune function deficiency resulting higher susceptibility to bacterial and viral infections. There is positive correlation between immune system and high nutrient contents, such as Vitamin C, zinc, and antioxidants that brings good effect on infections, including Tuberculosis. One of the efforts conducted to help promoting improving albumin level on pulmonary tuberculosis patients is through zinc and sulphate provision followed by Omega-3 supplementation. This study was conducted in 2015 aimed to analyze the role of Zinc Sulphate Omega-3 provision in improving albumin level on pulmonary tuberculosis patients in Paru Hospital, Surabaya.This study applied randomized study design using Pre-test and Post-test Control group design on patients suffering pulmonary tuberculosis. This study was conducted by administering Zinc Sulphate and Omega-3 on treatment group and placebo on the control group. The samples of this study consisted of 20 pulmonary tuberculosis patients divided into two groups: treatment group and control group. Each group consisted of 10 patients. Statistical analysis was conducted using paired T-test and independent t-test. The results is There were significant differences in albumin level (p = 0.001) in the treatment group before and after supplementation Zinc Sulphate And Omega 3. While in the control group between before and after supplementation Zinc Sulphate And Omega 3 showed no significant differences in body weight (p = 0.224). The conclusions is Zinc Sulphate and Omega 3 plays a role in increasing albumin level respondents. There are significant differences on albumin level before and after supplementation Zinc Sulphate And Omega 3.


1970 ◽  
Vol 116 (533) ◽  
pp. 443-445 ◽  
Author(s):  
R. Denson ◽  
D. Sydiaha

Favourable results have been reported from the use of lysergide in a wide variety of psychiatric conditions, but controlled studies (2, 3, 4) have not confirmed the existence of a therapeutic effect. In this experiment, alcoholics and neurotics who had been referred by Saskatoon psychiatrists for LSD treatment were allocated at random to Treatment and Control groups after undergoing a series of psychological tests. The members of the Treatment group were offered up to five LSD experiences at intervals of two weeks, whereas those in the Control group were informed that this type of therapy would be made available to them after a twelve-month waiting period. Accounts of the LSD experiences were sent to the referring psychiatrists, who were expected to continue to provide standard treatment to the members of both groups.


2007 ◽  
Vol 35 (06) ◽  
pp. 929-936 ◽  
Author(s):  
Xue-Ling Fang ◽  
Qiang Fang ◽  
Jian-Jun Luo ◽  
Xia Zheng

The therapeutic effect of crude rhubarb on intestinal permeability was investigated in septic patients. Forty septic patients were enrolled in this study and randomly divided into two groups: the crude rhubarb treatment group ( n = 18) and the control group ( n = 22). The same treatments were given to both groups except that the crude rhubarb treatment group was administrated with crude rhubarb powders (3 g, tid, p.o). The levels of procalcitonin, D-lactate in plasma and lactulose/mannitol (L/M) ratio in the urine were determined on the first day and the sixth day after treatment with or without crude rhubarb. There were no significant differences in procalcitonin, L/M ratio and D-lactate on the first day between the crude rhubarb treatment group and the control group ( p > 0.05). However, the ratio of L/M on the sixth day for the control group was 0.167 ± 0.036, while that of the crude rhubarb treatment group was 0.062 ± 0.013 ( p < 0.05). Moreover, the levels of procalcitonin and D-lactate in the crude rhubarb treatment group were obviously lower than those in the control group on the sixth day (procalcitonin: 4.11 ± 1.40 μg/L vs. 2.21 ± 0.61 μg/L ; D-lactate: 0.24 ± 0.06 ng/L vs. 0.09 ± 0.03 ng/L , p < 0.05, both). These data confirmed that crude rhubarb's effects on septic patients of ameliorating intestinal permeability.


2008 ◽  
Vol 9 (5) ◽  
pp. 502-510 ◽  
Author(s):  
Tetsuya Abe ◽  
Masataka Sakane ◽  
Toshiyuki Ikoma ◽  
Mihoko Kobayashi ◽  
Satoshi Nakamura ◽  
...  

Object Bone is frequently the first site and the only site of breast cancer at recurrence. Local control is important especially for metastatic spine cancer, because epidural spinal cord compression is significantly associated with the quality of life and survival of these patients. The authors have developed a local delivery system of paclitaxel in the form of hydroxyapatite-alginate composite beads. This study was conducted to clarify the therapeutic effect in a rat model of metastatic spine cancer. Methods Twenty-one rats with metastatic spine cancer were divided into 3 groups: a local treatment group (6 rats), a systemic treatment group (9 rats), and a control group (6 rats). The hind-limb motor function of the animals was monitored daily by using the Basso-Beattie-Bresnahan scale. The authors monitored the disease-free time and survival times. The log-rank test was used to define statistically significant differences between the 3 groups. Results The animals in the control group developed hind-limb paralysis at a mean of 10.8 days and died at a mean of 16.0 days. The animals treated with 2.4 wt% of paclitaxel-loaded hydroxyapatite-alginate composite beads (the local treatment group) showed a 140–150% increase in the disease-free time and survival time compared with that of the control group. Although an ~ 30-fold higher dosage of paclitaxel was administered, the therapeutic effect was not evident in the systemic treatment group. Conclusions Intraosseous delivery of paclitaxel-loaded hydroxyapatite-alginate composite beads delayed paralysis caused by metastatic spine cancer in rats. The results indicate that intraosseous chemotherapy may provide an effective local treatment of metastatic spine cancer.


2004 ◽  
Vol 24 (5) ◽  
pp. 440-446 ◽  
Author(s):  
Chi-Bon Leung ◽  
Cheuk-Chun Szeto ◽  
Kai-Ming Chow ◽  
Bonnie Ching-Ha Kwan ◽  
Angela Yee-Moon Wang ◽  
...  

Background Peritonitis is a serious complication of peritoneal dialysis (PD). We studied the efficacy of imipenem / cilastatin monotherapy in the treatment of PD-related peritonitis. Methods We performed an open-label, randomized control study comparing imipenem / cilastatin monotherapy (treatment group) versus cefazolin plus ceftazidime (control group) in the treatment of PD peritonitis. The result was further compared to a historic group treated with cefazolin plus netilmycin. Outcome measures were primary response rate at day 10 and complete cure rate. Results We enrolled 51 patients in the treatment group, 51 in the control group, and identified 96 in the historic group. The primary response rate to the assigned antibiotics was 49.0%, 51.0%, and 49.0% for the treatment, control, and historic groups, respectively ( p = 0.97). The primary response rate allowing for change in antibiotic was 82.4%, 90.2%, and 82.3%, respectively, for the three groups ( p = 0.41). The complete cure rate was 72.5%, 80.4%, and 82.3%, respectively ( p = 0.60). Tenckhoff catheter removal was needed in 6 cases in the treatment group, 6 cases in the control group, and 13 cases in the historic group ( p = 0.90). Conclusions We concluded that monotherapy of imipenem / cilastatin has similar efficacy compared to the two standard regimens of cefazolin plus ceftazidime or netilmycin in the treatment of PD peritonitis.


2020 ◽  
Author(s):  
Kin Ho Chan ◽  
Jessica YL Ching ◽  
Kam Leung Chan ◽  
Hoi Yi Lau ◽  
Ka Man Chu ◽  
...  

Abstract BackgroundKnee osteoarthritis (KOA) is a common degenerative joint condition that causes disability and pain amongst the elderly. The prevalence of KOA among persons aged 63 or above is approximately 30%. It is estimated that around 10% of the Hong Kong residents will have KOA by the year 2036. Previous studies have reported the positive effect of Tui-na treatment and Chinese herbal formula Du-Huo-Ji-Sheng Decoction (DHJSD) for KOA treatment. However, the therapeutic effect of the combination of both methods is unknown. The current study aims to evaluate the therapeutic effect of the combined therapy of Tui-na and oral administration of DHJSD on KOA using a randomized controlled design.MethodsThis study protocol describes a prospective, randomized wait-list controlled trial which will be conducted in the Yan Oi Tong Chinese Medicine Clinic cum Training and Research Centres (in Tuen Mun and Islands Districts). The eligible subjects will be randomly assigned to the treatment group and wait-list control group in a 1:1 ratio. Both the treatment and wait-list control groups will receive 8 sessions of Tui-na manipulation. DHJSD will be given to the subjects in the treatment group but not the wait-list group. The primary outcome will be assessed using the WOMAC score at 4 weeks after randomization. The secondary outcomes include the WOMAC scores at 2 weeks and 8 weeks after randomization and the health-related quality of life, the 5-level EQ-5D version (EQ-5D-5L), which will be conducted at 2 and 4 weeks after randomization and at follow-up (8 weeks after randomization).ParticipantsSeventy subjects aged 50 years or above, who meet the criteria of KOA according to the American College of Rheumatology, with Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score ≥ 39 will be recruited.DiscussionThe study will provide clinical evidence for the effectiveness of the combined Tui-na and oral administration of DHJSD for the treatment of subjects with KOA. The study will also provide information for large-scale randomized placebo-controlled trial in the future.Trial registrationClinicalTrials.gov, ID: NCT04492670. Registered on 28 July 2020.


2018 ◽  
Vol 7 (1) ◽  
pp. 62
Author(s):  
Fara Disa Durry ◽  
Bambang Wirjatmadi ◽  
Merryana Adriani

Background: Tuberculosis (TB) is an infectious disease caused by Mycobacterium tuberculosis, can affect almost all organs of the body with the most locations in the lungs. Immunity and high nutrients such as vitamin C, zinc and other antioxidants have shown good effects for infections, including tuberculosis. One effort to help accelerate sputum conversion of people with pulmonary tuberculosis is by supplementation of Zinc Sulphate and Omega 3.Objective: Analyze the role of Zinc Sulphate and Omega 3 on sputum conversion acceleration in patients with pulmonary tuberculosis at Surabaya Paru Hospital 2015.Method: This research use Randomized Pre Post Test Post Control Group Design design. In patients with pulmonary tuberculosis with Zinc Sulphate and Omega 3 in the treatment and placebo group in the control group. A sample of 20 patients consisting of 10 treatment patients and 10 control patients. Statistical test using paired T-Test, Friedman test and Mann whitney.Results: Friedman test showed that in the treatment group showed significant difference in the number of BTA between before and after supplementation (p=0,001), while in the control group significance of 0.141. Mann-Whitney test  showed no significant difference in the amount of reduction of BTA between the treatment group and the control group (p = 0.080). This means that statistically does not show any significant difference.Conclusions: Zinc Sulphate and Omega 3 play a role in accelerating sputum smear conversion of respondents. The results of smear test in pulmonary TB patients with Zinc Sulphate and Omega 3 supplementation showed positive results


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