PURPOSE: We investigated the effectiveness and safety of DA-3030 for prophylatic use in patients receiving chemotherapy for malignant disease. MATERIALS AND METHODS: Seventy cancer patients were randomized to receive chemotherapy alone (36 patients) or with DA-3030 administered (34 patients) after stratified block randomization according to chemotherapeutic regimen. DA-3030 was subcutaneously administered at the dose of 100 pg/m/day for 10 days from 24 hours after the completion of chemotherapy. RESULTS: Of the 70 enrolled patients, 62 patients were evaluable. The neutropenia (absolute neutrophil count [ANC] <1,000/mm) occurred in 9 of 32 (28.1%) of the DA-3030 group and 21 of 30 (90.0%) of the control group, giving relative risk for control group of 0.154 (95% confidence interval [CI], 0.05 to 0.45; p-0.0001). Severe neutropenia (ANC 500/mm') occurred in 4 of 32 (12.5%) of the DA-3030 group and in 20 of 30 (66.7%) of the control group (relative risk for control group of 0.316 [95% CI, 0,18 to 0.55]; p=0.0001). The mean duration of neutropenic period (+/-standard error) was 1.13+/-0.34 days in the DA-3030 group and 6.73+/-0.69 days in the control group respectively, and was significantly shorter in the DA-3030 group (p<0.0001). And, there was higher nadir ANC in the OA-3030 group than that in the control group (p=0.0001); the mean nadir ANC was 2,547+/- 343/mm and 442+/-120/mm, respectively. The DA-3030 group had significantly higher incidence of myalgia in comparison to the control group (43.8% compared with 3.3%; p=0.001). However, it was tolerable and was easily managed by conservative therapy CONCLUSION: The use of DA-3030 was effective in preventing chemotherapy-induced neutropenia.
Drug Therapy* ; Humans ; Incidence ; Myalgia ; Neutropenia* ; Neutrophils ; Random Allocation

BACKGROUND: Corona virus disease 2019 (COVID-19) has spread around the world since its outbreak, and there is no ascertained effective drug up to now. Lianhua Qingwen (LHQW) has been widely used in China and overseas Chinese, which had some advantages in the treatment of COVID-19. OBJECTIVE: To evaluate the efficacy and safety of LHQW for COVID-19 by conducting a systematic review with meta-analysis. METHODS: A comprehensive literature search was conducted in 12 electronic databases from their establishment to October 30, 2021. Note Express 3.2.0 was used for screening of trials, and the data was independently extracted in duplicate by 2 researchers. The risk of bias of randomized controlled trials (RCTs) and retrospective studies were assessed by using the Cochrane collaboration tool and Newcastle Ottawa Scale, respectively, followed by data analysis using RevMan 5.3. The RCTs or retrospective studies to treat COVID-19 using LHQW were included. The intervention measures in the experimental group were LHQW alone or combined with chemical drugs (LCWC), and that in the control group were chemical drugs (CDs). Outcome measures included computed tomography (CT) recovery rate, disappearance rates of primary (fever, cough, fatigue), respiratory, gastrointestinal and other symptoms, exacerbation rate and adverse reaction. Subgroup analysis was conducted according to whether LHQW was combined with CDs and the different treatment methods in the control group. RESULTS: Nine trials with 1,152 participants with COVID-19 were included. The CT recovery rates of LHQW and LCWC were 1.36 and 1.32 times of CDs, respectively (P<0.05). Compared with CDs, LCWC remarkably increased the disappearance rates of fever, cough, fatigue, expectoration, shortness of breath, and muscle soreness (P<0.05). LHQW also obviously decreased the exacerbation rate, which was 0.45 times of CDs alone (P<0.05). There was no obvious difference between LCWC and CDs in adverse reaction (P>0.05). CONCLUSIONS LHQW was more suitable for treating COVID-19 patients with obvious expectoration, shortness of breath and muscle soreness. LHQW had advantages in treating COVID-19 with no obvious exacerbation. (PROSPERO No. CRD42021235937).
COVID-19/drug therapy* ; Cough/drug therapy* ; Drugs, Chinese Herbal/adverse effects* ; Dyspnea/drug therapy* ; Fatigue/drug therapy* ; Humans ; Myalgia/drug therapy*

PURPOSE: We planned to evaluate the toxicity and efficacy of DA-3030 to determine the recommended dose for phase III clinical trial based on the biologically active doses from phase I/II clinical trial. MATERIALS AND METHODS: Open non-randomized phase I/II study was carried out in 64 cancer patients with chemotheray-induced myelosuppression. After 1 cycle of control period (chemotherapy without DA-3030), DA-3030 was started 24 hours after the second cycle of chemotherapy to 4 groups of patients with the doses of 50 microgram/m2/day (step I), 100 microgram/m2/day (step II), 150 microgram/m2/day (step III), 200microgram/m2/day (step IV) by once-a-day subcutaneous administration for 10 days. RESULTS: Of the 64 enrolled patients, 46 patients were evaluable. Tmax reached after 2 hours of injection in step I and 4 hours in step II-IV. Terminal half life was 1.8 hours in step I and 3.2 hours in step II, 3.3 hours in step III, 3.0 hours in step IV. Area under the curve (AUC) and AUMC increased dose dependently from step I through step IV. Total clearance rate decreased in a dose dependent manner but the volume of distribution showed no differences between the steps.The mean nadir count of total WBC and neutrophil increased in all 4 steps of DA-3030 administration. Also the duration of leukopenia, equal to or less than 2,000/uL or neutropenia and the recovery time of WBC or neutrophil from nadir decreased with DA-3030 administration in all 4 steps. But no differece of DA-3030 effect was found among 4 steps. When we compared the clinical efficacy of DA-3030 with total WBC and neutrophil criteria, it was 58.3% and 58.3% in step I, 90.0% and 80.0% in step II, 91.7% and 91.7% in step III, 75.0% and 70.0% in step IV. Although the duration of antibiotics administration showed no difference between control and DA-3030 administration period in step I, it decreased with DA-3030 administration in step II-IV. Infection was found only in step I. Life-threatening side effect was not found in all steps. Only mild myalgia was found without any dose relationship. CONCLUSION: When we considered the efficacy, toxicity and pharmacokinetic parameters, we suggest that 100microgram/m2 is an appropriate dosage for the phase III clinical trial.
Anti-Bacterial Agents ; Drug Therapy* ; Half-Life ; Humans ; Leukopenia ; Myalgia ; Neutropenia* ; Neutrophils

We describe here a case of female patient who presented with mild proximal weakness, myalgia, and markedly elevated CPK, which could be ascribed to paraneoplastic necrotizing myopathy in association with ovarian adenocarcinoma. A histologic examination of the vastus lateralis muscle showed necrosis of muscle fibers without inflammatory cell infiltration. Her neurologic symptoms improved following tumor resection and systemic chemotherapy. Paraneoplastic necrotizing myopathy may be a presenting manifestation of malignancy, and early recognition and prompt treatment are crucial for the clinical improvement.
Adenocarcinoma* ; Drug Therapy ; Female ; Humans ; Muscular Diseases* ; Myalgia ; Necrosis ; Neurologic Manifestations ; Quadriceps Muscle

BACKGROUND: Combination chemotherapy including platinum is based on treatment of advanced non-small cell lung cancer (NSCLC). But combination chemotherapy is not tolerable in elderly patients. Paclitaxel is one of the most active single chemotherapeutic agent in advanced NSCLC. We evaluated the efficacy and safety of single paclitaxel chemotherapy in elderly with advanced NSCLC. METHODS: From September 2002 to May 2004, a total 24 patients aged 70 years and older with advanced NSCLC were enrolled in this study. Treatment was consisted with paclitaxel 135 mg/m2 intravenously for 3hrs on day 1. Chemotherapy repeated every three weeks until disease progression or severe toxicity developed. RESULTS: Of the 24 patents, only 18 patient can be evaluated and 4 partial remission, 11 stable diseases and 3 progressive diseases were observed. Based on an intent-to-treatment analysis, The overall response rate was 17%. The estimated median survival and median time to progression were 44 weeks and 18 weeks, respectively. The major toxicity were grade 3 or 4 neutropenia (6%). Other toxicity were myalgia, neuropathy, nausea and oral mucositis, but all of them were usually mild (grade 1, 2) and recovered spontaneously. There were no treatment- related deaths. CONCLUSIONS: This single low dose paclitaxel chemotherapy is highly tolarable with activity comparable to that of conventional dose regimens especially in elderly advanced non-small cell lung cancer.
Aged* ; Carcinoma, Non-Small-Cell Lung ; Disease Progression ; Drug Therapy ; Drug Therapy, Combination ; Humans ; Myalgia ; Nausea ; Neutropenia ; Paclitaxel* ; Platinum ; Stomatitis

PURPOSE: Paclitaxel and cisplatin, active drugs in the treatment of non-small-cell lung cancer (NSCLC), have been found to be synergistic and less myelotoxic in combination when the paclitaxel is given 24 hr prior to the cisplatin. Their antitumor activity and toxicity in patients with advanced NSCLC has been evaluated herein. MATERIALS AND METHODS: Seventy-four chemonaive patients, with advanced NSCLC, were enrolled. Paclitaxel, 175 mg/m2, was administered on day 1, followed 24 hr later by cisplatin, 75 mg/m2, on day 2. RESULTS: The overall response rate, median time to progression and median survival time were 51%, 7.1 months (95% confidence interval (CI), 5.5~8.7 months) and 13.7 months (95% CI, 11.3~16.1 months), respectively. There were significant differences in the overall survival rates in relation to stage and the ECOG performance status(PS). The toxicity was mainly nonhematological. Grade > or =3 neuropathy occurred in 2 (3%) patients, myalgia in 3 (4%), and bone pain in 3 (4%). The hematological toxicity was mild, and no grade 3 or 4 neutropenia was observed. CONCLUSION: The combination of paclitaxel and cisplatin is an effective and tolerable treatment regimen for advanced NSCLC during first line chemotherapy. The main toxicity was nonhematological, such as peripheral neuropathy, myalgia and bone pain, whereas the hematological toxicity itself was mild.
Cisplatin* ; Drug Therapy ; Drug Therapy, Combination* ; Humans ; Lung Neoplasms* ; Lung* ; Myalgia ; Neutropenia ; Paclitaxel* ; Peripheral Nervous System Diseases ; Survival Rate

This study aims to explore the efficacy and safety of Lianhua Qingwen preparations combined with Oseltamivir in the treatment of influenza patients. PubMed, Cochrane Library, EMbase, SinoMed, CNKI, Wanfang, and VIP were searched for the randomized controlled trials(RCTs) involving the comparison between the influenza patients treated with Lianhua Qingwen preparations combined with Oseltamivir and those treated with Oseltamivir alone. Fever clearance time was taken as the primary outcome indicator. Clinical effective rate(markedly effective and effective), time to muscle pain relief, time to sore throat relief, time to cough relief, time to nasal congestion and runny nose relief, time to negative result of viral nucleic acid test, and adverse reactions were taken as the secondary outcome indicators. The data were extracted based on the outcome indicators and then combined. The Cochrane collaboration's tool for assessing risk of bias was used to evaluate the quality of a single RCT, and the grading of recommendations assessment, development and evaluations(GRADE) system to assess the quality of a single outcome indicator. RevMan 5.3 was employed to analyze data and test heterogeneity. Finally, 16 RCTs involving 1 629 patients were included for analysis. The Meta-analysis showed that Lianhua Qingwen preparations combined with Oseltamivir was superior to Oseltamivir alone in the treatment of influenza in terms of clinical effective rate(RR=1.16, 95%CI [1.12, 1.20], P<0.000 01), fever clearance time(SMD=-2.02, 95%CI [-2.62,-1.41], P<0.000 01), time to muscle pain relief(SMD=-2.50, 95%CI [-3.84,-1.16], P=0.000 2), time to sore throat relief(SMD=-1.40, 95%CI [-1.93,-0.85], P<0.000 01), time to cough relief(SMD=-1.81, 95%CI [-2.44,-1.19], P<0.000 01), time to nasal congestion and runny nose(SMD=-2.31, 95%CI [-3.61,-1.01], P=0.000 5), and time to negative result of viral nucleic acid test(SMD=-0.68, 95%CI [-1.19,-0.16], P=0.01). However, due to the low quality of the trials, the above conclusions need to be proved by more high-quality clinical studies. In addition, we still need to attach importance to the adverse reactions of the integrated application of Chinese and western medicines.
Cough/drug therapy* ; Drugs, Chinese Herbal/adverse effects* ; Humans ; Influenza, Human/drug therapy* ; Myalgia/drug therapy* ; Nucleic Acids/therapeutic use* ; Oseltamivir/adverse effects* ; Pharyngitis/drug therapy* ; Rhinorrhea

As salvage therapy for recurrent ovarian cancer, Taxol has been tried alone or combined with cisplatin, or carboplatin. Paclitaxel (Taxol) is an antineoplastic agent; isoloated from the back of the western yew which acts as an antimicrotubule agent. In our study, 28 patients were eligible and assessable, Taxol was administered at a dose of 175 mg/m2, infused over 3hr every 21 days. A total of 161 courses of Taxol were infused, and the median treatmemt cycle was 6.25 cycles (1 to 16 cycles). The overall response rate was 21.4%, but we found higher response rate in sensitive group to platinum combined therapy than resistant. The median survival duration was 10.2 months and the median duration of follow up was 25.0 months. The worst severe toxicity was grade 4 leukopenia and expirement with sepsis. 39% of patients experienced myalgia and 25% experienced nausea, vomiting and diarrhea. Other adverse effects were not important or considerable. Taxol has been shown to be the most useful agent in patients with advanced ovarian cancer who had shown sensitivity with platinum previously, and Taxol has yielded low response rate in platinum-resistant patients. Further more study is repuired about Taxol itself, its optimal dose, combinding use with other antitumor agent, and as first line therapy in the treatment of advanced ovarian carcinoma.
Carboplatin ; Cisplatin ; Diarrhea ; Drug Therapy* ; Follow-Up Studies ; Humans ; Leukopenia ; Myalgia ; Nausea ; Ovarian Neoplasms ; Paclitaxel* ; Platinum ; Salvage Therapy* ; Sepsis ; Vomiting

As salvage therapy for recurrent ovarian cancer, Taxol has been tried alone or combined with cisplatin, or carboplatin. Paclitaxel (Taxol) is an antineoplastic agent; isoloated from the back of the western yew which acts as an antimicrotubule agent. In our study, 28 patients were eligible and assessable, Taxol was administered at a dose of 175 mg/m2, infused over 3hr every 21 days. A total of 161 courses of Taxol were infused, and the median treatmemt cycle was 6.25 cycles (1 to 16 cycles). The overall response rate was 21.4%, but we found higher response rate in sensitive group to platinum combined therapy than resistant. The median survival duration was 10.2 months and the median duration of follow up was 25.0 months. The worst severe toxicity was grade 4 leukopenia and expirement with sepsis. 39% of patients experienced myalgia and 25% experienced nausea, vomiting and diarrhea. Other adverse effects were not important or considerable. Taxol has been shown to be the most useful agent in patients with advanced ovarian cancer who had shown sensitivity with platinum previously, and Taxol has yielded low response rate in platinum-resistant patients. Further more study is repuired about Taxol itself, its optimal dose, combinding use with other antitumor agent, and as first line therapy in the treatment of advanced ovarian carcinoma.
Carboplatin ; Cisplatin ; Diarrhea ; Drug Therapy* ; Follow-Up Studies ; Humans ; Leukopenia ; Myalgia ; Nausea ; Ovarian Neoplasms ; Paclitaxel* ; Platinum ; Salvage Therapy* ; Sepsis ; Vomiting

Dermatomyositis is an idiopathic inflammatory myopathy characterized by progressive symmetric proximal muscle weakness and typical cutaneous lesions. Recently the association of adult dermatomyositis and malignancy has generated much attention. A 56-year-old male presented with skin eruptions, proximal muscle weakness, and a neck mass on the right side. Diagnosis of dermatomyositis was established by clinical investigation, muscle enzyme study, electromyogram, and histological findings of the skin and muscle. A computerized tomography scan and histologic finding of right neck mass showed nasopharyngeal carcinoma. The patient was treated with chemotherapy and radiotherapy, and showed partial remission of nasopharyngeal carcinoma, with some improvement of the skin eruptions. But muscle weakness and myalgia were aggravated. He was then treated with systemic steroids (prednisolone) and azathioprine.
Adult ; Azathioprine ; Dermatomyositis* ; Diagnosis ; Drug Therapy ; Humans ; Male ; Middle Aged ; Muscle Weakness ; Myalgia ; Myositis ; Neck ; Radiotherapy ; Skin ; Steroids