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OBJECTIVE: To systematically review the effectiveness and safety of Pingxiao capsule adjuvant chemotherapy in the treatment of breast cancer. METHODS: A total of 8 databases including the Cochrane Library, PubMed, EMBASE, Engineering Index, Chinese Biomedical Literature Database, Wanfang database, China National Knowledge Infrastructure Database, and China Science and Technology Journal Database were searched for the Randomized Controlled Trials (RCTs) of Pingxiao capsule combined with chemotherapy in the treatment of breast cancer published before June 2022. Two researchers independently screened the literature, extracted data, and evaluated the risk of bias. R language was used for estimating risks of bias of included studies, data analysis, and plotting. RESULTS: A total of 15 RCTs involving 1272 patients were included in this study. Meta-analysis results indicated that compared with chemotherapy alone, Pingxiao capsule combined with chemotherapy could significantly improve breast cancer patients' objective response rate of breast cancer patients [rate ratio () = 1.35, 95% confidence interval () (1.12, 1.63), = 0.0017], the disease control rate [=1.16, 95% (1.08, 1.25), < 0.0001], the quality of life [ =1.42, 95% (1.16, 1.74), = 0.007], and the level of the immune cells [CD3+: standardized mean difference () =1.42, 95% (0.76, 2.09), < 0.001; CD4+: =1.18, 95% (0.70, 1.66), < 0.001]. In addition, Pingxiao capsule combined with chemotherapy can also significantly reduce CD8+ level ( < 0.0001) and reduce the symptoms of decreased white blood cell count [ = 0.62, 95% (0.39, 0.85), < 0.0001], and the occurrence of adverse reactions such as gastrointestinal adverse reactions and limb pain ( < 0.05). CONCLUSIONS: Pingxiao capsule can significantly improve the efficacy of chemotherapy, the quality of life and immune function of patients, and reduce the clinical side effects caused by chemotherapy. However, high-quality randomized clinical trials with large samples are required for further verification of these results.
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Neoplasias da Mama , Humanos , Feminino , Terapia Combinada , Neoplasias da Mama/tratamento farmacológico , China , Bases de Dados FactuaisRESUMO
ObjectiveTo evaluate the clinical safety of Naoxintong （NXT） capsules after marketing， find out the potential risk factors of the drug as soon as possible， and reveal the incidence， nature， and clinical manifestations of the adverse events （ADE） and adverse reactions （ADR） of NXT capsules， so as to provide a basis for safe use of the drug in clinical practice. MethodA prospective， large-sample， multi-center observational cohort study was conducted to monitor all the 7 345 inpatients and outpatients orally taking NXT in 14 hospitals in China from January to December in 2018， with at least one follow-up. The demographic characteristics， disease type， NXT medication， ADR occurrence， characteristics， and prognosis of the patients were collected. SPSS 23.0 was used for single-factor and multivariate logistic regression to predict the influencing factors of ADR. ResultThe male and female patients accounted for similar proportions. There were 5 081 patients （79.40%） aged ≥60 years and 3 153 patients （49.27%） with body mass index （BMI） exceeding the normal standard. There were 344 （5.38%） patients with a history of allergy to medicines and food， 9 （0.14%） patients with a family history of allergy， and 52 （0.81%） patients with a history of allergic diseases. The ADRs associated with NXT occurred in 22 patients， with the incidence of 0.34%. The clinical manifestations of ADR appeared in 31 cases， involving 10 organs/systems， of which gastrointestinal system damage was the most common （17， 54.84%）. All ADRs were mild or moderate. Most ADRs （19， 86.36%） occurred within 4 weeks after administration. The patients with alleviated NXT-associated ADRs accounted for 81.82%. No indicators related to significant increases in ADR risks were found. ConclusionNXT is well tolerated in the general population. The hospital centralized monitoring for the clinical safety of oral Chinese patent drugs based on HIS data and Web tracking and follow-up system is an essential means for the post-market research on the safety of drugs.
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OBJECTIVE：To provide reference for r ational use of TCM decoction piece. METHODS ：Electronic questionnaire survey was conducted on the use （dose，ingredient number ）of TCM decoction piece prescriptions in 12 TCM hospitals from 10 provinces（regions，cities）. Through the hospital information system ，416 100 outpatient prescriptions of TCM decoction piece were collected from the First Affiliated Hospital of Henan University of TCM （our hospital ）during May 2016 to Apr. 2019，and were analyzed in terms of prescription dose ，the number of ingredients and use of TCM decoction pieces. At the same time ，the use of TCM decoction piece prescription were analyzed in different departments ，and the clinical application status of TCM decoction pieces prescription were investigated and relevant suggestions were put forward. RESULTS ：The average dose of TCM decoction piece prescriptions in 12 hospitals were 129.60-245.00 g，and the average number of ingredients were 11.90-18.25；the average dose of TCM decoction piece prescriptions in pediatric department was lower than other departments. The average dose of TCM decoction piece prescriptions in our hospital was 242.21 g；55.75％ of the prescription dose were distributed in 201-300 g，and 15.22％ were over 300 g. The average number of ingredients in prescriptions was about 15，and the prescriptions with 11-20 ingredients accounted for 87.75％，those with more than 20 ingredients accounted for 6.64％. Top 20 TCM decoction pieces in TCM prescriptions of our hospital had different degrees of overdose. Three decoction pieces with the highest frequency of overdose were Radix Curcumae processed by vinegar （85.51％），Atractylodes macrocephala stir-fried with bran （82.10％）and A. macrocephala（79.13％）. The number of TCM decoction piece prescriptions in internal medicine department accounted for 40.84％ in our hospital ；there were a lot of TCM prescriptions with dose exceeding 300 g（11.98％ and 18.69％）and the number of ingredients exceeding 18（14.60％ and 9.53％）in internal medicine department and surgery department. The proportion of pediatric TCM decoction piece prescriptions with more than 18 ingredients accounted for 24.09％. CONCLUSIONS ：The overall dosage of TCM decoction piece prescriptions is relatively high ，the number of ingredients is too much ，and the overdose of single-flavored TCM decoction piece is common. Internal medicine department and surgery department should focus on controlling the number of and the dosage of single-flavored decoction pieces of TCM prescriptions to standardize the prescribed dosage. Gynecology department needs to focus on controlling the dosage of single-flavored TCM pieces and pediatrics department should pay special attention to the use of prescription ingredients ，so as to ensure a more scientific and reasonable standard for the clinical application of TCM decoction piece.
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OBJECTIVE： To investigate the historical evolution and clinical application of “eighteen incompatible medicaments” and “nineteen medicaments of mutual restraint” of TCM， and to provide reference for enriching the contents of rational use of TCM. METHODS： Through the methods of literature mining， using “eighteen incompatible medicaments” “nineteen medicaments of mutual restraint” “incompatible medicaments” “clinical use” “ADR” “ADE” as keywords， retrieved from CNKI， Wanfang， VIP database （from the date of database establishment to August 2018） and library of Henan University of TCM， related literatures about “eighteen incompatible medicaments” and “nineteen medicaments of mutual restraint” were extracted and combed， and the history and clinical application of them were summarized and analyzed. RESULTS & CONCLUSIONS： “Eighteen incompatible medicaments” is one of the main contents of TCM basic theory. The word is first published in Shubencao， which is the concrete embodiment of the “opposite” in the “seven compatibility regularities” of TCM， and the number of “eighteen incompatible medicaments” of TCM recorded in the medical books of TCM is different from each other in the past dynasties. “Nineteen medicaments of mutual restraint” is one of the taboos of TCM compatibility， which is first found in Shennong’s Herbal. There are mixed use of “mutual inhibition” “incompatible” and “mutual restraint” in all dynasties， and there is still controversy about the attribution of “seven compatibility regularities” of “nineteen medicaments of mutual restraint” among physicians. Regardless of ancient medical books， modern medical books， various editions of Chinese Pharmacopeia， literature reports and clinical applications， there are compatibility usage of drug pairs of “eighteen incompatible medicaments” and “nineteen medicaments of mutual restraint”. Among them， 8 kinds of set prescription preparations containing drug pair of “eighteen incompatible medicaments” were involved in 2015 edition of Chinese Pharmacopoeia （part Ⅰ）， most of which were Aconitum carmichaelii/Aconitum kusnezoffii-Bletilla striata/Ampelopsis japonica； 9 kinds of set prescription preparations containing drug pair of “nineteen medicaments of mutual restraint” were also involved， most of which were Syringa oblate-Curcuma rcenyujin， Cinnamomum cassia-Halloysitum rubrum. Although there are medical records or literature pointing out that it can be used to treat critical and difficult diseases， and some studies have preliminarily confirmed the compatibility rationality of individual incompatibility medicaments/medicaments of mutual restraint， the conclusions of relevant studies are not entirely consistent， and the intensity of research evidence is not high， and the research evidence is insufficient. Basic researches should be strengthened and large-scle， multiple-center and high-quality clinical studies are needed to confirm this conclusion so as to guaratetee the rationality and safety of drug use in clinic.
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Objective: To detect the vascular paths in the lateral wall of maxillary sinus using cone beam computer tomography (CBCT), and to retrospect the surgical managements of avoiding bleeding complication during the lateral approach maxillary sinus elevation.Methods: The documents of 71 consecutive patients with 81 sides maxillary sinus elevation surgery were collected.The vascular paths in the lateral wall of maxillary sinus were detected by the preoperative CBCT, and the messages about the vascular in surgical records were analyzed.Results: The paths of the vascular could be detected in 77 (95.1%) sides maxillary sinus in the reconstruction panoramic images of CBCT.At the position of the first molar, the paths of the vascular of the lateral maxillary sinus walls could be detected in 54 sides (66.7%) in the reconstruction coronal images of CBCT, and the other 27 sides (33.3%) could not be detected.Two approximately parallel paths of the vascular were found in 3 sides (3.7%) of the lateral maxillary sinus walls.The different diagnoses occurred in 6 sinuses between two observers.The kappa of diagnostic consistency of the two observers was 0.842 (P<0.001).The mean distance between the lower border of the vascular path to the plane of the alveolar crest of 54 sides maxillary sinuses was about (13.0±4.7) mm.The mean distance between lower border of vascular path to the plane of the floor of the sinus was (9.3±4.8) mm.The vascular path was located in the floor wall in 1 sinus.During the lateral approach maxillary sinus elevation operation, intraosseous vessels were dissected in 4 sides sinus lateral wall, the vascular path was avoided consciously in 3 sides, and the sinus elevation surgery had to be given up in 1 side for the vessel was torn and bleeding.There were no vascular related messages in 73 sides of the lateral approach maxillary sinus elevation operation records.Conclusion: The vascular paths of maxillary sinus wall could be detected by CBCT in most cases.Preoperative CBCT examination was proved to be reliable.The vascular paths of maxillary sinus wall should be examined carefully.It was helpful to make the surgical design perfectible and reduce the risk of tearing the vessel in operation.
