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1.
Article in Chinese | WPRIM | ID: wpr-906431

ABSTRACT

Objective:To observe the effect of modified Bazhentang on the nutritional status and immune function of patients with Qi and blood deficiency syndrome in neoadjuvant chemotherapy (NAC) for gastric cancer. Method:One hundred and ten patients were randomly divided into observation group and control group with 55 cases each. Both groups accepted FOLFOX6 protocol. Patients in control group took Jianpi Shengxue tablets orally, 3 tablets/time, 3 times/day. Patients in observation group received modified Bazhentang, 1 dose/day. The course of treatment was six weeks in both groups. Before and after treatment, scores were graded according to patient generated-subjective global assessment (PG-SGA), Qi and blood deficiency syndrome, and the Revised Piper Fatigue Scale (PFS-R). Levels of serum total protein (TB), albumin (ALB), prealbumin (PAB), CD4<sup>+</sup>, CD8<sup>+</sup>, helper T lymphocyte 17 (Th17), regulatory T cell (Treg), immunoglobulin G (IgG), IgM, and IgA were detected before and after therapy. Body mass index (BMI) and fat free mass index (FFMI) were measured before and after treatment. Weight loss was recorded, and the acute or subacute toxicity of anticancer drugs was evaluated. Result:The degree of malnutrition in the observation group was lower than that in the control group (<italic>Z</italic>=2.401,<italic>P</italic><0.01). The levels of TB, ALB and PAB in the observation group were higher than those in the control group (<italic>P</italic><0.01). The CD4<sup>+</sup>, Treg and CD4<sup>+</sup>/CD8<sup>+</sup> levels in the observation group were higher than those in the control group (<italic>P</italic><0.01). The CD8<sup>+</sup>, Th17 and Th17/Treg levels were lower than those in the control group (<italic>P</italic><0.01). Besides, the levels of IgM and IgA in the observation group were higher than those in the control group (<italic>P</italic><0.01). The PG-SGA score and weight loss in the observation group were lower than those in the control group (<italic>P</italic><0.01). The BMI and FFMI data of the observation group were higher than those of the control group (<italic>P</italic><0.05). The scores of PFS-R and Qi-blood deficiency syndrome were lower than those of the control group (<italic>P</italic><0.01). The incidence of nausea and vomiting in the observation group was 45.45% (25/55), lower than 65.45% (36/55) in the control group (<italic>χ</italic><sup>2</sup>=4.452,<italic>P</italic><0.05). Conclusion:Modified Bazhentang can be used to assist gastric cancer patients with NAC, which can improve nutritional status and immune function, promote immune balance, reduce clinical symptoms and fatigue, and reduce chemotherapy toxicity and side effects, so it is worthy of clinical use.

2.
Article in Chinese | WPRIM | ID: wpr-258411

ABSTRACT

To evaluate the efficacy and safety of Choudongning (CDN)capsule in children with Tourette's syndrome of spleen deficiency and phlegm accumulation through a randomized double-blind three-arm controlled phase Ⅲ study in 588 patients from 8 hospitals. The included patients were randomly divided into test group, positive control group and placebo group at the ratio of 3∶1∶1. Patients in the test group orally took CDN capsules and simulated Tiapridal tablets; the patients in positive control group took Tiapridal tablets and simulated CDN capsules; whereas the patients in placebo group orally took the simulated agents of the above two drugs. The treatment course was 6 weeks for three groups. The global grading rates, YGTSS scores and its factor scores, the degree of social function damage, as well as traditional Chinese medicine syndrome efficacy were evaluated as the outcome measures on efficacy. The AEs/ADRs, vital signs and laboratory testing were observed as outcome measures on safety. The total effective rate of YGTSS was 75.92% in the test group, 72.65% in the positive control group, and 37.29% in the placebo group. Non inferiority test stands between the test group and the positive control group, and they were superior to placebo group in efficacy with statistical difference. Significant difference had also been found among the 3 groups in YGTSS tics score, motor tics score, vocal tics, degree of social function damage and traditional Chinese medicine syndrome efficacy. During the study, there were 5 (1.42%)ADRs in the test group, 10 (8.55%)in the positive control group and 3 (2.54%)in the placebo group. The incidence of ADRs in the test group was lower than that in the positive control group, with statistical difference. It is clear to say that CDN capsule can effectively treat the Tourette's syndrome of spleen deficiency and phlegm accumulation. Its efficacy is not inferior to the commonly used Tiapridal tablets, with even less adverse reactions, so it has clinical application value.

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